Q1 2026 Protalix BioTherapeutics Inc Earnings Call
Operator 3: Good morning, ladies and gentlemen, welcome to the Protalix BioTherapeutics Q1 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 Protalix. Thank you. Please go ahead.
Operator: Good morning, ladies and gentlemen, welcome to the Protalix BioTherapeutics Q1 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 Protalix. Thank you. Please go ahead.
Speaker #3: I will now turn the conference over to our host, Mr. Mike Moyer, of Leisi Advisors Investor Relations for Protalix. Thank you. Please go ahead.
Speaker #2: Thank you, operator, and welcome to the Protalix BioTherapeutics Q1 2026 financial results and business update conference call. With me today are Dror Bashan, president and CEO of Protalix, and Gilad Mamlok, senior vice president and chief financial officer.
Mike Moyer: Thank you, operator. Welcome to the Protalix BioTherapeutics Q1 2026 financial results and business update conference call. With me today are Dror Bashan, President and CEO of Protalix, and Gilad Mamlok, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates were issued this morning and are 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. Welcome to the Protalix BioTherapeutics Q1 2026 financial results and business update conference call. With me today are Dror Bashan, President and CEO of Protalix, and Gilad Mamlok, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates were issued this morning and are 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.
Speaker #2: 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.
Speaker #2: The earnings release and this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties. They may cause actual results to differ materially from the statements made.
Speaker #2: 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.
Speaker #2: Dror?
Speaker #3: Thank you, Mike. And thank you, everyone, for joining our Q1 2026 financial results and business update call. I want to begin by highlighting two points that underscore the strength of our business today.
Dror Bashan: Thank you, Mike, and thank you everyone for joining our Q1 2026 financial results and business update call. I want to begin by highlighting two points that underscore the strengths of our business today. First, during the quarter, we received the $25 million milestone from Chiesi following the European Commission approval of Elfabrio's every four weeks dosing regimen. As a result, we ended the first quarter of this year with $51 million in cash, providing us with a strong balance sheet and substantial financial flexibility and sufficient funds to support our ongoing operations as well as our phase II RELEASE study with PRX-115. Second, we are reaffirming our 2026 guidance. We continue to expect total revenue for the year to range from approximately $78 to 83 million, inclusive of the $25 million milestones received from Chiesi.
Dror Bashan: Thank you, Mike, and thank you everyone for joining our Q1 2026 financial results and business update call. I want to begin by highlighting two points that underscore the strengths of our business today. First, during the quarter, we received the $25 million milestone from Chiesi following the European Commission approval of Elfabrio's every four weeks dosing regimen. As a result, we ended the first quarter of this year with $51 million in cash, providing us with a strong balance sheet and substantial financial flexibility and sufficient funds to support our ongoing operations as well as our phase II RELEASE study with PRX-115. Second, we are reaffirming our 2026 guidance. We continue to expect total revenue for the year to range from approximately $78 to 83 million, inclusive of the $25 million milestones received from Chiesi.
Speaker #3: First, during the quarter, we received a $25 million milestone from KSE, following the European Commission approval of a fabulous every four weeks dosing regimen.
Speaker #3: As a result, we ended the first quarter of this year with $51 million in cash, providing us with a strong balance sheet and substantial financial flexibility.
Speaker #3: And sufficient funds to support our ongoing operations, as well as our phase two release study with PRX 115. Second, we are reaffirming our 2026 guide 2026 guidance.
Speaker #3: We continue to expect total revenue for the year to range from approximately $78 million to $83 million, inclusive of the $25 million milestones received from KSE.
Speaker #3: Within that outlook, we anticipate a fabulous revenue excluding milestones of approximately $33 to $35 million and LLI revenues of approximately $20 to $23 million.
Dror Bashan: Within that outlook, we anticipate Elfabrio revenues excluding milestones of approximately USD 33 to 35 million and Elelyso revenues of approximately USD 20 to 23 million. Taken together, this guidance reflects the strengths of our commercial partnerships and our confidence in execution across our business for the year ahead. We entered 2026 with good momentum with the regulatory progress for Elfabrio in Europe, which triggered the $25 million milestone payment, the continued enrollment of our PRX-115 phase II RELEASE study, and a growing focus on our rare renal disease preclinical pipeline. We remain confident in our strategy for the years ahead. Our partner, Chiesi, continues to execute it well with Elfabrio across approved markets. Following the European Commission recent approval of every 4 weeks regimen, we believe Elfabrio is well-positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy.
Dror Bashan: Within that outlook, we anticipate Elfabrio revenues excluding milestones of approximately USD 33 to 35 million and Elelyso revenues of approximately USD 20 to 23 million. Taken together, this guidance reflects the strengths of our commercial partnerships and our confidence in execution across our business for the year ahead. We entered 2026 with good momentum with the regulatory progress for Elfabrio in Europe, which triggered the $25 million milestone payment, the continued enrollment of our PRX-115 phase II RELEASE study, and a growing focus on our rare renal disease preclinical pipeline. We remain confident in our strategy for the years ahead. Our partner, Chiesi, continues to execute it well with Elfabrio across approved markets. Following the European Commission recent approval of every 4 weeks regimen, we believe Elfabrio is well-positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy.
Speaker #3: Taken together, this guidance reflects the strength of our commercial partnerships and our confidence in execution across our business for the year ahead. We entered 2026 with a good momentum, with a regulatory progress for a fabulous in Europe, which triggered the $25 million milestone payment, the continued enrollment of our PRX 115 phase two release study, and a growing focus in our on our rare renal disease preclinical pipeline.
Speaker #3: We remain confident in our strategy for the years ahead. Our partner KSE continues to execute it well with a fabulous across-approved markets. Following the European Commission recent approval of every four weeks regimen, we believe a fabulous is well positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy.
Speaker #3: This added dosing flexibility strengthens the fabulous competitive position and supports broader adoption over time. In the United States, the FDA approved dosing regimen remains unchanged.
Dror Bashan: This added dosing flexibility strengthens Elfabrio's competitive position and supports broader adoption over time. In the United States, the FDA-approved dosing regimen remains unchanged. Looking longer term, with the global Fabry market projected to approach approximately $3.2 billion by 2031, we believe Elfabrio has the potential to achieve a meaningful 15% to 20% market share globally, supported by its differentiated profile. We believe our revenue mix, particularly the continuing expansion of Elfabrio, positions us well for substantial long-term value creation. On our clinical side, PRX-115 continues to move forward as planned. The phase II RELEASE study is actively enrolling, and we remain encouraged by the program profile based on the phase I data. We believe it has the potential to improve outcomes for patients with uncontrolled gout. We continue to expect top-line results in the H2 2027.
Dror Bashan: This added dosing flexibility strengthens Elfabrio's competitive position and supports broader adoption over time. In the United States, the FDA-approved dosing regimen remains unchanged. Looking longer term, with the global Fabry market projected to approach approximately $3.2 billion by 2031, we believe Elfabrio has the potential to achieve a meaningful 15% to 20% market share globally, supported by its differentiated profile. We believe our revenue mix, particularly the continuing expansion of Elfabrio, positions us well for substantial long-term value creation. On our clinical side, PRX-115 continues to move forward as planned. The phase II RELEASE study is actively enrolling, and we remain encouraged by the program profile based on the phase I data. We believe it has the potential to improve outcomes for patients with uncontrolled gout. We continue to expect top-line results in the H2 2027.
Speaker #3: Looking longer term, with the global fabulous market projected to approach approximately $3.2 billion by 2031, we believe a fabulous has the potential to achieve a meaningful 15 to 20 percent market share globally, supported by its differentiated profile.
Speaker #3: We believe our revenue mix, particularly the continued expansion of a fabulous positions us well for substantial long-term value creation. On our clinical side, PRX 115 continues to move forward as planned.
Speaker #3: The phase two release study is actively enrolling, and we remain encouraged by the program profile based on the phase one data. We believe it has the potential to improve outcomes for patients with uncontrolled gout.
Speaker #3: We continue to expect top-line results in the second half of 2027. Beyond 115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage.
Dror Bashan: Beyond 115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage. In our view, our business model limits downside risk while preserving meaningful upside as we advance our clinical programs and continue our commercial partnership. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook.
Dror Bashan: Beyond 115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage. In our view, our business model limits downside risk while preserving meaningful upside as we advance our clinical programs and continue our commercial partnership. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook.
Speaker #3: In our view, our business model limits downside risk while preserving meaningful upside as we advance our clinical programs and continue our commercial partnership. With that, I will turn the call over to Gilad for a detailed review of our financial results and
Speaker #2: Thank you, Dror. For the first quarter of 2026, total revenue was $33.8 million, driven mainly by the $25 million milestone payment received from KSE following approval of the every four weeks dosing regimen for a fabulous in Europe.
Gilad Mamlok: Thank you, Dror. For Q1 2026, total revenue was $33.8 million, driven mainly by the $25 million milestone payment received from Chiesi following approval of the every 4 weeks dosing regimen for Elfabrio in Europe. This milestone underscores the value embedded in our commercial partnerships. Revenues from selling goods were $7.4 million, compared to $10 million in Q1 2025. This change reflects lower Elelyso purchases by Pfizer and Fiocruz, mainly due to timing and inventory dynamics, and was partially offset by sales to Chiesi. As we have noted previously, quarterly product revenues can fluctuate based on partner purchasing patterns, and we encourage investors to focus on full year performance rather than quarter-to-quarter viability. Cost of revenues was $4.1 million, compared to $8.2 million for the same period in 2025.
Gilad Mamlok: Thank you, Dror. For Q1 2026, total revenue was $33.8 million, driven mainly by the $25 million milestone payment received from Chiesi following approval of the every 4 weeks dosing regimen for Elfabrio in Europe. This milestone underscores the value embedded in our commercial partnerships. Revenues from selling goods were $7.4 million, compared to $10 million in Q1 2025. This change reflects lower Elelyso purchases by Pfizer and Fiocruz, mainly due to timing and inventory dynamics, and was partially offset by sales to Chiesi. As we have noted previously, quarterly product revenues can fluctuate based on partner purchasing patterns, and we encourage investors to focus on full year performance rather than quarter-to-quarter viability. Cost of revenues was $4.1 million, compared to $8.2 million for the same period in 2025.
Speaker #2: This milestone underscores the value embedded in our commercial partnerships. Revenues from selling goods were $7.4 million, compared to $10 million in the first quarter of 2025.
Speaker #2: This change reflects lower LLI purchases by Pfizer and Fiocus, mainly due to timing and inventory dynamics, and was partially offset by sales to KSE.
Speaker #2: As you have noted previously, quarterly product revenues can fluctuate based on partner purchasing patterns and we encourage investors to focus on full-year performance rather than quarter to quarter viability.
Speaker #2: Cost of revenues was $4.1 million, compared to $8.2 million for the same period in 2025. The decrease was mainly attributable to lower sales volumes to Pfizer and Fiocus, partially offset by increased sales to KSE.
Gilad Mamlok: The decrease was mainly attributable to lower sales volumes to Pfizer and Fiocruz, partially offset by increased sales to Chiesi. R&D expenses increased to $5.4 million, up from $2.5 million in the prior year period, driven mainly by preparations for an initiation of the PRX-115 phase II RELEASE study. This increase reflects a deliberate allocation of capital towards advancing PRX-115, which remains our top clinical priority. SG&A expenses were $3.1 million, up $0.5 million, reflecting modest growth year over year, largely attributable to personnel-related costs.
Gilad Mamlok: The decrease was mainly attributable to lower sales volumes to Pfizer and Fiocruz, partially offset by increased sales to Chiesi. R&D expenses increased to $5.4 million, up from $2.5 million in the prior year period, driven mainly by preparations for an initiation of the PRX-115 phase II RELEASE study. This increase reflects a deliberate allocation of capital towards advancing PRX-115, which remains our top clinical priority. SG&A expenses were $3.1 million, up $0.5 million, reflecting modest growth year over year, largely attributable to personnel-related costs.
Speaker #2: R&D expenses increased to $5.4 million, up from $3.45 million in the prior year period. Driven mainly by preparations for and initiation of the PRX 115 phase two release study.
Speaker #2: This increase reflects a deliberate allocation of capital toward advancing PRX 115, which remains our top clinical priority. FG&A expenses were $3.1 million, up 0.5 million reflecting modest growth year over year, largely attributable to personnel-related costs.
Speaker #2: As a result of the milestone revenues and ongoing cost discipline, net income for the quarter was $18.3 million, or $23 cents per share, and $22 cents on a fully diluted basis.
Gilad Mamlok: As a result of the milestone revenues and ongoing cost discipline, net income for the quarter was $18.3 million, or $0.23 per share, and $0.02 on a fully diluted basis, compared to a net loss of $3.6 million or $0.05 per share in the prior year period. Importantly, the company continues to operate a profitable commercial business and milestones provide additional upside without changing our underlying expense base. Turning to the balance sheet, cash equivalents, and short-term bank deposits totaled $51 million as of 31 March 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement. In summary, we remain in a strong financial position and well-capitalized to advance our key programs to the next set of clinical and commercial milestones.
Gilad Mamlok: As a result of the milestone revenues and ongoing cost discipline, net income for the quarter was $18.3 million, or $0.23 per share, and $0.02 on a fully diluted basis, compared to a net loss of $3.6 million or $0.05 per share in the prior year period. Importantly, the company continues to operate a profitable commercial business and milestones provide additional upside without changing our underlying expense base. Turning to the balance sheet, cash equivalents, and short-term bank deposits totaled $51 million as of 31 March 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement. In summary, we remain in a strong financial position and well-capitalized to advance our key programs to the next set of clinical and commercial milestones.
Speaker #2: Compared to a net loss of $3.6 million or $0.05 per share in the prior year period. Importantly, the company continues to operate a profitable commercial business and milestones provide additional upside without changing our underlying expense base.
Speaker #2: Turning to the balance sheet, cash, cash equivalents, and short-term bank deposits total $51 million as of March 31, 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement.
Speaker #2: In summary, we remain in a strong financial position and well capitalized to advance our key programs to the next set of clinical and commercial milestones.
Speaker #2: With that, I will turn the call back over to Dror. Dror, thank you. Gilad, to conclude, as we look ahead, we do so from a position of strength.
Gilad Mamlok: With that, I will turn the call back over to Dror. Dror?
Gilad Mamlok: With that, I will turn the call back over to Dror. Dror?
Dror Bashan: Thank you, Gilad. To conclude, as we look ahead, we do so from a position of strength. With a $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as of 31 March of this year, giving us the financial flexibility to continue investing in the programs and partnerships that will drive our next stage of growth. We are reaffirming our 2026 guidance and our expectation that Elfabrio can achieve 15% to 20% market share of the Fabry market by 2031. This reflects our confidence in the product, our partnership with Chiesi, and the continued expansion of Elfabrio global. Now I would like to ask the operator to open the call for questions.
Dror Bashan: Thank you, Gilad. To conclude, as we look ahead, we do so from a position of strength. With a $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as of 31 March of this year, giving us the financial flexibility to continue investing in the programs and partnerships that will drive our next stage of growth. We are reaffirming our 2026 guidance and our expectation that Elfabrio can achieve 15% to 20% market share of the Fabry market by 2031. This reflects our confidence in the product, our partnership with Chiesi, and the continued expansion of Elfabrio global. Now I would like to ask the operator to open the call for questions.
Speaker #2: With the $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as of March of 31st of this year.
Speaker #2: Given that the financial flexibility to continue investing in programs and partnerships that will drive our next stage of growth. We are reaffirming our 2026 guidance and our expectation that a fabulous can achieve 15 to 20 percent market share of the fabulous market by 2031.
Speaker #2: This reflects our confidence in the product, our partnership with KSE, and the continued expansion of a fabulous globally. Now, I will turn I would like to ask the operator to open the call for questions.
Speaker #3: Thank you. 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.
Operator 3: Thank you. 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 is from Ram Selvaraju with H.C. Wainwright. Please proceed.
Operator: Thank you. 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 is from Ram Selvaraju with H.C. Wainwright. Please proceed.
Speaker #3: You may press star two if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker #3: Our first question is from Ram Sarvaju with HC Wainwright. Please proceed.
Speaker #4: Thank you so much for taking our questions and congratulations on a good quarter. I wanted to ask if you could comment on the core determinants of the cadence with which you expect to receive revenue from KSE regarding a fabulous sales.
Ram Selvaraju: Thank you so much for taking our questions, and congratulations on a good quarter. I wanted to ask if you could comment on the core determinants of the cadence with which you expect to receive revenue from Chiesi regarding Elfabrio sales. What you think the likelihood is, if any, of increases to the full year 2026 guidance for Elfabrio related royalty-based revenue. Thank you.
Ram Selvaraju: Thank you so much for taking our questions, and congratulations on a good quarter. I wanted to ask if you could comment on the core determinants of the cadence with which you expect to receive revenue from Chiesi regarding Elfabrio sales. What you think the likelihood is, if any, of increases to the full year 2026 guidance for Elfabrio related royalty-based revenue. Thank you.
Speaker #4: And if what you think the likelihood is, if any, of increases to the full year 2026 guidance for a fabulous-related royalty-based revenue. Thank you.
Speaker #5: So hey, Raman, thank you. So I think as we mentioned last time, we just KSE, we received the approval for one in four weeks on 5th of March.
Dror Bashan: Hey, Ram Selvaraju. Thank you. I think as we mentioned last time, Chiesi, we received the approval for 1 in 4 weeks on 5 March. Chiesi is now in a process of going country by country and getting the local reimbursement approval. I think we are going to see the effect mostly in H2, and we expect H2 to be much stronger with regards to Chiesi sales. At that point of time, we still stick to the same guidelines we provided.
Dror Bashan: Hey, Ram Selvaraju. Thank you. I think as we mentioned last time, Chiesi, we received the approval for 1 in 4 weeks on 5 March. Chiesi is now in a process of going country by country and getting the local reimbursement approval. I think we are going to see the effect mostly in H2, and we expect H2 to be much stronger with regards to Chiesi sales. At that point of time, we still stick to the same guidelines we provided.
Speaker #5: And KSE is now in a process of going country by country and getting the local reimbursement approval. So I think we are going to see the effect mostly in the second half of the year and we expect the second half of the year to be much stronger with regards to KSE sales.
Speaker #5: At that point of time, we still stick to the same guidance we provided.
Speaker #4: And secondly, can you provide any commentary on how enrollment is going in the release trial and if you can potentially provide us with timing for completion of enrollment?
Ram Selvaraju: Secondly, can you provide any commentary on how enrollment is going in the RELEASE trial? If you can potentially provide us with timing for completion of enrollment.
Ram Selvaraju: Secondly, can you provide any commentary on how enrollment is going in the RELEASE trial? If you can potentially provide us with timing for completion of enrollment.
Speaker #5: We, as we said before, we are not updating regarding the continuing progress of the enrollment. It does progress, as we mentioned. We have many sites open.
Dror Bashan: As we said before, we are not updating regarding the continuing progress of the enrollment. It does progress, as we mentioned. We have many sites open. Our target is to finish enrollment by the end of 2026 and have the top line results in H2 2027.
Dror Bashan: As we said before, we are not updating regarding the continuing progress of the enrollment. It does progress, as we mentioned. We have many sites open. Our target is to finish enrollment by the end of 2026 and have the top line results in H2 2027.
Speaker #5: Our target is to finish enrollment by the end of 2026 and have the top end results in the second half of 2027.
Speaker #4: And then lastly, with respect to the positioning of 115 in the overall gout market, do you expect this to change meaningfully with the advent of next-generation URAP1 inhibitors or do you anticipate that the treatment refractory gout the refractory gout market segment is more or less likely to remain the same?
Ram Selvaraju: Lastly, with respect to the positioning of 115 in the overall gout market, do you expect this to change meaningfully with the advent of next generation URAT1 inhibitors? Or do you anticipate that the refractory gout market segment is more or less likely to remain the same?
Ram Selvaraju: Lastly, with respect to the positioning of 115 in the overall gout market, do you expect this to change meaningfully with the advent of next generation URAT1 inhibitors? Or do you anticipate that the refractory gout market segment is more or less likely to remain the same?
Speaker #5: So Ram, this is Dror. Thank you. We believe that the I would say this segment of uncontrolled gout patients will stay and there will be I would say enough room and growing even for patients qualified for Uricuts.
Dror Bashan: Ram, this is Dror. Thank you. We believe that this segment of uncontrolled gout patients will stay and there will be enough room and growing even for patients qualified for uricase.
Dror Bashan: Ram, this is Dror. Thank you. We believe that this segment of uncontrolled gout patients will stay and there will be enough room and growing even for patients qualified for uricase.
Speaker #4: Thank you.
Ram Selvaraju: Thank you.
Ram Selvaraju: Thank you.
Speaker #5: You're welcome.
Dror Bashan: You're welcome.
Dror Bashan: You're welcome.
Speaker #2: Thank you.
John Vandermosten: Thank you.
Dror Bashan: Thank you.
Speaker #3: Our next question is from John Zandermeisten with Sachs. Please proceed.
Operator 3: Our next question is from John Vandermosten with Sachs. Please proceed.
Operator: Our next question is from John Vandermosten with Sachs. Please proceed.
Speaker #4: Good morning, Dror Galan or good afternoon. I know you mentioned that it's only the very first initial stages of the launch of Alphabrio for every four weeks.
John Vandermosten: Good morning, Dror, Gilad, or good afternoon. I know you mentioned that it's only the very first initial stages of the launch of Elfabrio for every 4 weeks. Do you have any initial data or initial insight into the, you know, the uptake in the market on that, on that approach?
John Vandermosten: Good morning, Dror, Gilad, or good afternoon. I know you mentioned that it's only the very first initial stages of the launch of Elfabrio for every 4 weeks. Do you have any initial data or initial insight into the, you know, the uptake in the market on that, on that approach?
Speaker #4: But do you have any initial data or initial insight into the uptake in the market on that approach?
Speaker #5: It's too early for that, John. Good morning and thank you. But we do see I mean, when we talk with KSE, I mean, they're optimistic about the progress and they expect to see the progress.
Dror Bashan: It's too early for that, John. Good morning, and thank you. We do see I mean, when we talk with Chiesi, I mean, they are optimistic about the progress and they expect to see the progress. Again, in terms of seeing the actual results, I don't think we're going to see them before the H2 of the year.
Dror Bashan: It's too early for that, John. Good morning, and thank you. We do see I mean, when we talk with Chiesi, I mean, they are optimistic about the progress and they expect to see the progress. Again, in terms of seeing the actual results, I don't think we're going to see them before the H2 of the year.
Speaker #5: But again, in terms of think we're going to see them before the second half of the year.
Speaker #4: Understood. And there was a mention in the press release about KSE continuing launches and regulatory efforts. Around the globe, and can you give us an update on how things are going on that respect?
John Vandermosten: Understood. There was a mention in the press release about Chiesi continuing launches and regulatory efforts around the globe. Can you give us an update on, you know, how things are going in that respect, any new geographies, and any geographies that we should expect in the next few months or next quarters, in terms of expanding exposure of patients to Elfabrio?
John Vandermosten: Understood. There was a mention in the press release about Chiesi continuing launches and regulatory efforts around the globe. Can you give us an update on, you know, how things are going in that respect, any new geographies, and any geographies that we should expect in the next few months or next quarters, in terms of expanding exposure of patients to Elfabrio?
Speaker #4: Any new geographies, and any geographies that we should expect in the next few months or next quarters in terms of expanding exposure of patients to Alphabrio?
Speaker #5: So the few targets from KSE in the next 12 months, I would say some are more significant, some are less, but we are going to report them immediately once there's approval.
Dror Bashan: There are a few targets from Chiesi in the next 12 months, I would say. Some are more significant, some are less, but we are going to report them immediately once there's approval. It's a continuous route of getting more approvals, and we see what they have in the pipelines, and then we will update as soon as they receive the approval.
Dror Bashan: There are a few targets from Chiesi in the next 12 months, I would say. Some are more significant, some are less, but we are going to report them immediately once there's approval. It's a continuous route of getting more approvals, and we see what they have in the pipelines, and then we will update as soon as they receive the approval.
Speaker #5: But it's a continuous route of getting more approvals, and we see what they have in the pipeline, and we will update as soon as they receive the approval.
Speaker #4: And then there's also a mention of Purex 119, and I was wondering what's the next milestone for Purex 119? And I'm thinking also in terms of getting into the clinic or I&D submission or something like that.
John Vandermosten: There's also mention of PRX-119, and I was wondering what's the next milestone for PRX-119? I'm thinking also, you know, in terms of like getting into the clinic or IND submission or something like that. How does that look, that program?
John Vandermosten: There's also mention of PRX-119, and I was wondering what's the next milestone for PRX-119? I'm thinking also, you know, in terms of like getting into the clinic or IND submission or something like that. How does that look, that program?
Speaker #4: How does that look, that program?
Speaker #5: Well, we are developing and putting together different activities, if I may say, to make sure that we have we are on the right path, if I may say.
Dror Bashan: We, you know, we are developing and, you know, putting together different activities, if I may say, to make sure that we have a, you know, we are on the right path, if I may say. We will update soon, I believe, I hope, by the end of this quarter, whether I mean, to which specific indication this mechanism of action works and then we will, of course, detail when we expect to start phase I.
Dror Bashan: We, you know, we are developing and, you know, putting together different activities, if I may say, to make sure that we have a, you know, we are on the right path, if I may say. We will update soon, I believe, I hope, by the end of this quarter, whether I mean, to which specific indication this mechanism of action works and then we will, of course, detail when we expect to start phase I.
Speaker #5: We will update soon, I believe. I hope by the end of this quarter or I mean, to which specific indication this mechanism of action works and then we will, of course, detail when we expect to start phase one.
Speaker #4: Okay. All right. Thank you for taking my questions.
John Vandermosten: Okay. All right. Thank you for taking my questions.
John Vandermosten: Okay. All right. Thank you for taking my questions.
Speaker #5: Thank you.
Dror Bashan: Thank you.
Dror Bashan: Thank you.
Speaker #3: There are no further questions at this time. I would like to turn the floor back over to Dror Bashan for closing remarks.
Operator 3: There are no further questions at this time. I would like to turn the floor back over to Dror Bashan for closing remarks.
Operator: There are no further questions at this time. I would like to turn the floor back over to Dror Bashan for closing remarks.
Speaker #5: So, thank you, everybody, for joining us today. We are looking forward to talking to you next quarter. Thank you.
Dror Bashan: Thank you everybody for joining us today, and we are looking forward to talk to you next quarter. Thank you.
Dror Bashan: Thank you everybody for joining us today, and we are looking forward to talk to you next quarter. Thank you.
Operator 3: Thank you. This will conclude today's conference. You may disconnect at this time and thank you for your participation.
Operator: Thank you. This will conclude today's conference. You may disconnect at this time and thank you for your participation.
