Q2 2024 Protalix BioTherapeutics Inc Earnings Call

Raghuram Selvaraju: Raghuram Selvaraju, Good morning, ladies and gentlemen, and welcome to the Protalix biotherapeutics second quarter 2024 financial results and business results conference call. As a reminder, this conference call is being held I will now turn the conference over to our, Mr. Mike Moyer of Lifestyle Advising, you may begin your call. Thank you, operator, and welcome to the Protalix Biotherapeutics second quarter 2024 financial results and With me today are Dror Bashan, President and CEO of Protalix, and Eyal Rubin, Senior Vice President and Chief Financial Officer.

Good morning, ladies and gentlemen, and welcome to the boot Alex Biotherapeutics second quarter 2024.

The business results conference call.

Operator: As a reminder, this conference call is being recorded.

As a reminder, this conference call is being recorded.

Mike Moyer: I will now turn the conference over to our host, Mr. Mike Moyer of Life Side of Life. You may begin your conference.

Now I'll turn the conference over to our host Mr. Mike Weiner.

Speaker Change: You may begin your conference.

Dror Bashan: Thank you, operator, and welcome to the Italics by the Therapeutics second quarter, 2024 financial results and business update conference call.

Raghuram Selvaraju: 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 released in this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and Protalix filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan, Dror. Thank you, Mike.

Speaker Change: Thank you operator, and welcome to the Calix Biotherapeutics second quarter 2024 financial results and business update conference call with me today are Michel <unk>, President and CEO for Calix, titled Rubin, Senior Vice President and Chief Financial Officer.

Dror Bashan: With you today are Dror Bashan, president and CEO of Protalix, and Eyal Rubin, 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 and the press release. The earnings release and this teleconference includes forward-looking statements. These forward looking statements are subject to known and unknown risks and uncertainties that may cause actual results different. Material statements made factors that could cause actual results to differ are described in the disclaimer and the Protalix filing with the U.S.

Speaker Change: Press release announcing the financial results and corporate update was issued this morning and is available now on for Calix website. Please take a moment to read the disclaimer about forward looking statements in the press release.

Speaker Change: The earnings release and this teleconference includes 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 statements made.

Speaker Change: Factors that could cause actual results to differ are described in the disclaimer for calix filings with the U S Securities and Exchange Commission I will now turn the call over to Mr. Sean George.

Unknown Executive: Securities and Exchange Commission.

Dror Bashan: I will now turn the call over to Mr. Bashan, Dror. Thank you, Mike, and thank you everyone for joining our second quarter 2024 financial results and business update call. I will begin by reviewing our recent accomplishments before handing the call to Eyal. We will provide a review of our financial results. We will then, of course, open the line for questions.

Dror Bashan: And thank you, everyone, for joining us for our second quarter 2024 financial results and business update. I will begin by reviewing our recent accomplishments before handing the call to Eyal, who will provide a review of our financial results. We will then, of course, open the line for questions.

Thank you Mike and thank you everyone for joining our second quarter of 'twenty 'twenty four financial results and business update call I will begin by reviewing our recent accomplishments before ending the call its way up.

Speaker Change: We'll provide a review of our financial results. We would that we would then of course open the line for questions I will turn first.

Dror Bashan: I will turn first to PRX-115, which is our Reconvenant Pagulated Eureka's candidate produced for Protalix platform in development for the treatment of uncontrolled goat. We recently announced encouraging results, initial top-line results from the first seven cohorts of the first-in-human phase one clinical study of PRX-115. As a reminder, this study is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the results. We will provide safety, tolerability, pharmacokinetics, and pharmacodynamics following a single dose of PRX-115 in subjects with elevated euric acid levels. The preliminary results from the first seven cohorts demonstrated that PRX-115 exposure increased in those dependent manner and PRX-115 rapidly reduced plasma euric acid concentrations to below the guideline level of 6 milligram per debted it.

Dror Bashan: I will turn first to PRX115, which is our recombinant-pegylated uric acid candidate produced through our Protalix platform in development for the treatment of uncontrolled gout. We recently announced encouraging results, initial top-line results, from the first seven cohorts of the first in-human Phase I clinical study of PRX115. As a reminder, this study is a double-blind, placebo-controlled, single-ascending dose study designed to evaluate safety, tolerability, Pharmacokinetics, and Pharmacodynamics following a single dose of PRX-115 in subjects with elevated euric acid levels.

Speaker Change: Rigs 115, which is a recombinant pegylated uricase candidate produced well for Salix platform in development for the treatment for uncontrolled gout.

Dror Bashan: The preliminary results from the first seven cohorts demonstrated that PRX-115 exposure increased in a dose-dependent manner, and PRX-115 rapidly reduced plasma euric acid concentrations to below the guideline level of 6-mg per density. PRX-115 was also generally well-tolerated.

Speaker Change: We recently announced encouraging results when you see our top line results from the first seven cohorts of the first in human Phase one clinical study of <unk>. One one choice as a reminder, these studies are double blind placebo controlled single ascending dose study designed to evaluate safety tolerability.

Dror Bashan: Based on the initial top-line results of these initial seven cohorts and the review and acceptance of the safety data by the Safety Monitoring Committee for those escalating, we expanded the Phase I study by adding an eighth cohort so we could analyze a higher dose of PRX115 and its potential to result in an increased exposure time. Dosing in these eight cohorts is now complete, and the 85-day follow-up period is in progress. We expect them.

Dror Bashan: Top-line results from the full study will be available in the fourth quarter of this year. In addition to the expansion of the Phase 1 study, we have already initiated preparations for a Phase 2 trial of PRX115 in patients with uncontrolled gout. We plan to meet and communicate with the regulatory authorities in the U.S., Europe, and elsewhere to discuss our Phase 2 plans and the overall clinical program with the goal of initiating the Phase 2 study in the mid of next year.

Speaker Change: So home cooking ethics, and pharmacodynamics following a single dose of BRL 115 in subjects with elevated uric acid lasers.

Speaker Change: The preliminary results from the seven from the first seven cohorts demonstrated the PRA 115 exposure increase in dose dependent manner in Pra's 115 rapidly rapidly reduce plasma concentrations to below the guided level of six milligrams per deciliter.

Dror Bashan: PRX-115 was also generally well tolerated based on the initial top-line results of these initially seven cohorts. The review and acceptance of the safety data by the safety monitoring committee for those escalating. We expanded the phase one study by adding an 8 cohorts so we can analyze a higher dose of PRX-115 and its potential to result in an increased exposure time. Those in this 8 cohorts is now complete, and the 85 days follow-up period is in progress.

Speaker Change: Parex 115.

Speaker Change: It was also generally well tolerated based on the initial top line results.

Speaker Change: D C. Initially cyclical votes, and the review and acceptance of the safety data safety monitoring committee full dose escalating we expect we extended the phase one study.

Speaker Change: By adding an H score. So we can analyze how youll goes off Gary It's 115 and its potential to result in increased and increased exposure time.

Speaker Change: Dosing in this age cohort is now complete.

Speaker Change: And the 85 day four days follow up period is in progress.

Dror Bashan: We expect top-line results from the full study to be available in the fourth quarter of this year. In addition to the expense of the phase one study, we have also initiated already appropriations for phase two trial of PRX-115 in patients with uncontrolled doubt. We plan to meet and communicate with irregular authorities in the US, Europe, and Europe to discuss our phase two plans and our overall clinical programs with the goal of initiating the phase two study in the mid of next year.

Speaker Change: We expect to.

Speaker Change: Top line results from the full study to be available in the fourth quarter of this year.

Speaker Change: In addition to the expansion of the phase one.

Speaker Change: D wave also initiates already of preparations for it.

Speaker Change: Phase II tried with Parex 115 in patients with uncontrolled gout, we plan to meet and communicate with their regulatory authorities in the U S. Europe.

Speaker Change: In Europe to discuss all phase two planes in the overall clinical program with a goal of initiating the phase two study in the middle of next year.

Dror Bashan: Our commercial partner, Kiesi Global Road Disease, remains committed to a successful commercialization of El Fabrio and has a worth of experience on their team. Kiesi has invested heavily in the road disease space, and we are confident that they will continue to penetrate the market and build the fabric franchise for the longer term.

Dror Bashan: Our commercial partner, Chiesi Global Rare Disease, remains committed to a successful commercialization of Alfabrio and has a wealth of experience on their team. Chiesi has invested heavily in the rare disease space, and we are confident that they will continue to penetrate the market and build a strong franchise for the longer term. Our next pipeline candidate also expressed hope for SEDEX is PRX119. PRX119 is a pegylated recombinant human DNase candidate in development for the potential treatment of diseases associated with neutrophil extracellular traps, or NETs. Excessive formation or accumulation of NETs can result in different pathological effects, which have been observed in various autoimmune, inflammatory, and fibrotic conditions.

Speaker Change: Oh commercial partner he is a global rare disease remains committed to a successful commercialization of in February and has a wealth of experience when they're on their team shares. He has invested heavily in the rare disease space.

Speaker Change: And we are confident that they will continue to penetrate the market and be the fabry franchise for the longer term.

Dror Bashan: Our next pipeline candidate also expressed full post-selects is PRX-119. PRX-119 is a pagulated, recombinant eureka's UND&R's candidate in development for the potential treatment of diseases associated with nutrofuel extracellular traps or nets. Accessive formation or accumulation of nets can result in different pathological effects, which have been observed in various autoimmune, inflammatory, and therapeutic conditions.

Speaker Change: Our next pipeline candidate also.

Speaker Change: Express Salix these peer rates one one night.

Speaker Change: Yeah. It makes 119 is a pegylated recombinant jewelry cause human DNS candidate in development for the potential treatment of diseases associated with neutral food extracellular trips well Nate.

Speaker Change: Especially formation or accumulation of snips can result in different pathology can fix which have been observed info right oh to immune inflammatory and fibrotic conditions.

Dror Bashan: Beyond PRX-115 and PRX-119, we are focusing our R&D efforts on early-stage developments, assets to build our product development pipeline. We have fined, you know, pathway going forward to focus on leveraging our prosthetics platform and prioritizing renal rare disease indications. With regard to the therapeutic areas, our strategy moving forward is to prioritize renal rare disease and the core of portalic development pipeline. This is a logical focus for our company given our existing experience and the network and resources we build through the diligent and dedicated efforts throughout the February development program. For example, PRX-119 is being evaluated for nets related renal autoimmune-associated diseases.

Dror Bashan: Beyond PRAS-115 and PRAS-119, we are focusing our R&D efforts on early stage developments, assets to build our product development type. We have fine-tuned our pathway going forward to focus on leveraging our Protelix platform and prioritizing renal rare disease indications. With regard to therapeutic areas, our strategy moving forward is to prioritize renal disease as the core of the Protalix development pipeline. This is a logical focus for our company given our existing experience and the network and resources we have built through the diligent and dedicated efforts undertaken throughout the Fabry development program. For example, PRX119 is being evaluated for NET-related renal autoimmune diseases.

Speaker Change: Beyond Pier rigs 115 in Pra's 119, we are focusing our R&D efforts on early stage development assets.

It's to be the product development pipeline.

We have fine tuned our press way going forward to focus on leveraging golf, we're sitting sportswomen prioritizing renal rare disease indications.

Speaker Change: If we go to the therapeutic areas I always thought that you can win moving forward is to prioritize renal rare diseases is the cool orthotic development pipeline. This is a logical focus for our company given our existing experience.

Speaker Change: And the niche walk and resources, we've been through the diligent and dedicated therefore.

Speaker Change: Throughout the property development program for example, pier rigs one one is being evaluated for <unk> related renal autoimmune associated diseases.

Dror Bashan: In addition, we have identified potential key high-and-met-need indication in which, on which we plan to focus our initial efforts, such as ADP-KD, Alport syndrome, FSGS, and others. Work is currently ongoing to identify assets for these and other indications.

Dror Bashan: In addition, we have identified potential key high unmet need indications on which we plan to focus our initial effort, such as ADPKD, Alport syndrome, FSGS, and others. Work is currently ongoing to identify assets for these and other indications. In order to expand our platform, we are evaluating novel plant-based drug delivery systems that may allow protective delivery of different modalities into specific tissues.

Speaker Change: In addition, we have identified as potential key high unmet need indications in which on which we plan to focus our initial vehicles that.

Speaker Change: As a D. P. P D alcohol syndrome. If it's G is an arduous work is currently ongoing to identify assets for these and other indications.

Dror Bashan: In order to expand our platform, we are evaluating novel plant-based drug delivery systems that may allow protective delivery of different modalities into specific tissues. These exploratory studies are ongoing, and we look forward to updating you on the progress of these efforts as they progress. In addition to our prosthetics platform, we intend to explore other modalities such as small molecules and oligonucleotides to take advantage of highly innovative opportunities.

Speaker Change: In order to expand our platform well.

Speaker Change: Evaluating novel plant based drug delivery system that may allow protective delivery of different modalities into specific tissues.

Speaker Change: These.

Dror Bashan: Exploratory studies are ongoing, and we look forward to updating you on the progress of these efforts as they progress. In addition to our Protalix platform, we intend to explore other modalities such as small molecules and oligonucleotides to take advantage of highly innovative opportunities. Before turning the call to Eyal, I want to note that our strong cash position will enable the repayment of our convertible note. Due next month in September, actually September 1st, and to maintain our ongoing operation, including the phase two study in Gout.

Speaker Change: Laboratory studies ongoing and we look forward to updating you on the progress of these efforts as they progress.

Speaker Change: In addition to our prosthetics platform, we intend to do.

No other modalities, such as small molecules oligonucleotide to take advantage of highly innovative opportunities.

Dror Bashan: Before turning the call to AR, I want to note that our strong cash position will enable the repayment of our convertible notes due next month in September, actually in September 1st, and to maintain our ongoing operation, including the phase 2 study in GALT. In addition, we expect phase 2 key as it to gradually continue as key as it anticipates future approvals and lunches in additional markets.

Speaker Change: Before turning the call Toyota.

Speaker Change: I want to note that our strong cash position will enable the repayment of our convertible notes.

Do you mix in next month in September actually in September 1st and to maintain our ongoing operation, including the phase two study in golf.

Dror Bashan: In addition, we expect phase two PSD to gradually continue as PSD anticipates future approvals and launches in additional months. With that, it is now my pleasure to turn the call over to Eyal for a review of our financials. Eyal, please.

Speaker Change: In addition, we expect sales to peers.

Speaker Change: Gradually continue is QC anticipates future approvals and launches in additional markets.

Eyal Rubin: With that, it is now my pleasure to tell the call over to Ayala for review of our financials. Ayala, please. Thank you, Drawer.

Speaker Change: With that it is now my pleasure to turn the call over to Yaniv for review of our Plano jumps.

Speaker Change: Please.

Eyal Rubin: Thank you, Dror, and thank you everyone for joining today's call. I'm going to review your second quarter, 2024 Finanches. We recorded revenues from selling goods of $13.3 million during the three months ended June 30, 2024, a decrease of $1.8 million, or 12%. Convert the revenue of those 15.1 million for the three months ended June 30, 2020. The decrease is altered primarily from a decrease of 10 million in sales to Chiesa, partially offset by an increase of 4.7 million in sales to Brazil and an increase of 3.5 million in sales to Pfizer.

Yaniv: Thank you Dror and thank you everyone for joining today's call and we review our second quarter 2020 for financials.

Eyal Rubin: And thank you, everyone, for joining today's call. And we review our second quarter of 2024 financials. We recorded revenues from selling goods of 13.3 million during the three months and the June 30 of 2024. The decrease of 1.8 million or 12 percent compared to revenues of 15.1 million for the three months and the June 30 of 2020. 33. The decrease is altered primarily from a decrease of 10 million in sales to key, as a partially offset by an increase of 4.7 million in sales to Brazil and an increase of 3.5 million in sales to Pfizer.

Yaniv: We recorded revenues from selling goods $13 3 million during the three months ended June 30th 'twenty 'twenty, four a decrease of $1 8 million or 12% comp.

Yaniv: Compared to revenues of $15 1 million for the three months ended June 30th 2023.

Yaniv: This resulted primarily from a decrease of 10 million cells can be partially offset by an increase of four.

Yaniv: $4 7 million themselves to Brazil, and an increase of three point finally in sales to Pfizer.

Eyal Rubin: Sales to key as in three months ended June 30, 2023, where in connection with a commercial launch and inventory buildup of El Fabrio after its approval for marketing in the United States and the European Union. The increases in sales to Brazil and Pfizer during 3 months ended June 30, 2024, resulted primarily from the timing of delivery. The recorded revenues from the license and R&D services of 0.2 million for the 3 months ended June 30, 2024, a decrease of 19.8 million or 99% compared to revenues of 20 million for the 3 months ended June 30, 2023.

Eyal Rubin: Set up to KSV in the three months ended June 30, 2023, acquisition in connection with a commercial launch and inventory buildup of El Fabrio after its approval for marketing in the United States and the European Union. The increases in sales to Brazilian Pfizer during the three-month end of June 30, 2024 resulted primarily from the timing of delivery. We recorded revenues from licensed and R&D services of 0.2 million for the three-month end of June 30, 2024, a decrease of $19.8 million or 99% compared to revenues of $20 million for the three-month end of June 30, 2023. License revenues from MRD services are comprised primarily of revenues the company recognizes in connection with the Chiesi agreement.

Yaniv: So forgive me and three months ended June 32023 were in connection with the commercial launch and inventory buildup over fab real I'll say.

Speaker Change: So promo for marketing in the United States and in your opinion.

Creases in themselves and Brazilian Pfizer during three months ended June 32024 resulted primarily from the timing of delivery.

Speaker Change: We recorded revenues from license and R&D services all points 2 million for three months ended June 30th 'twenty 'twenty four a decrease of $19 8 million or 99% compared to revenues of $20 million for the three months ended June 32023.

Eyal Rubin: Revenue from license and R&D services are comprised primarily of revenue that the company recognized in connection with the KSA Agreement. The revenues from license and R&D services for the 3 months ended June 30, 2023, were the result of the 20 million regulatory milestone payments from KSA in connection with the FDA approval of El Fabrio granted during that period. Cost of goods sold was 9.5 million for the 3 months ended June 30, 2024, an increase of 3.4 million or 56% from cost of goods sold of 6.1 million for the 3 months ended June 30, 2023. The increasing cost of goods sold was primarily the result of an increase in sales to Pfizer and to Brazil.

Speaker Change: Revenues from license. The R&D services are comprised primarily of revenues the company recognized in connection with the kidney agreement.

Eyal Rubin: The revenues from licensed R&D services for the three months ended June 30, 2023 were the result of the $20 million regulatory milestone payment from Chiesi in connection with the FDA approval of El Fabrio granted during that period. Cost of goods sold was $9.5 million for the three months ended June 30, 2024, an increase of $3.4 million or 56% from costs of goods sold of $6.1 million for the three months ended June 30, 2022.

The revenues from license R&D services for the three months ended June 32023 were the result of the 20 million regulatory milestone payments from <unk> in connection with the FDA approval.

Speaker Change: Fabio granted during that period.

Speaker Change: Cost of goods sold was $9 5 million for three months ended June 32024, an increase of $3 4 million or 56% from cost of goods sold of $6 1 million for the three months ended June 30th 2023, namely.

Eyal Rubin: The increase in cost of goods sold was primarily the result of an increase in sales to Pfizer and, For the three months ended June 30, 2024, the company said research and development expenses were approximately $3 million, comprised of approximately half a million subcontractor related expenses, approximately $1.6 million of salary related expenses, approximately 0.2 million of material related expenses, and approximately 0.7 million of other expenses.

Speaker Change: The increase in cost of goods sold was primarily the result of an increase in sell through Pfizer and to Grill steaks.

Eyal Rubin: For the 3 months ended June 30, 2024, the company told research and development expenses where approximately 3 million comprise of approximately half a million subcontractor related expenses, approximately 1.6 million of salary and related expenses, approximately 0.2 million of material related expenses, and approximately 0.7 million of other expenses. For the 3 months ended June 30, 2023, the company told research and development expenses were approximately 4.5 million, comprise of approximately 1.7 million of subcontractor related expenses, approximately 2 million of salary and related expenses, approximately 0.1 million of material related expenses, and approximately 0.7 million of other expenses.

Speaker Change: For the three months ended June 32020 for the company total research and development expenses were approximately $3 million comprised of approximately half a million subcontractor related expenses approximately $1.6 million of salary and related expenses, approximately <unk> 2 million of materials labor and expenses and approximately <unk> 7 million.

Speaker Change: Other expenses for the three months ended June 30th 2023, the company's total research and development expenses were approximately $4 5 million comprised of approximately one 7 million of subcontractor related expenses, approximately $2 million of salary and related expenses of approximately $1 million of material related expenses and <unk>.

Eyal Rubin: For the three months ended June 30, 2023, the company's total research and development expenses were approximately $4.5 million, comprised of approximately $1.7 million of subcontractor-related expenses, approximately $2 million of salary-related expenses, approximately $0.1 million of material-related expenses, and approximately $0.7 million of other expenses. The total decrease in research and development expenses for the three months ended June 30, 2024 was $1.5 million, or 33% compared to the three months ended June 30, 2020.

Speaker Change: <unk> 7 million of other expenses.

Eyal Rubin: Total decrease in research and development expenses for 3 months ended June 30, 2024, was 1.5 million or 33% compared to 3 months ended June 30, 2023. The decrease in research and development expenses resulted primarily from the completion of the company's for preclinical program and the regulatory process related to the review of a Fabrio BLA in the U.S. and the MAA in the European Union by the applicable regulatory agencies. Selling general administrative expenses were 3.5 million for the 3 months ended June 30, 2024, a decrease of 0.5 million or 13% compared to 4 million for 3 months ended June 30, 2023.

Speaker Change: Total decrease in research and development expenses for the three months ended June 30 of 2024 was $1 5 million or 33% compared to the three months ended June 32023.

Eyal Rubin: The decrease in research and development expenses resulted primarily from the completion of the company's Fabry Clinical Program and the regulatory process related to the review of Alfabrio BLA in the U.S. and the MAA in the European Union by the applicable regulatory agency. Selling General Administrative Expenses were $3.5 million for the three months ended June 30, 2024, a decrease of $0.5 million, or 13%, compared to $4 million for the three months ended June 30, 2023. The decrease resulted primarily from a decrease of $0.5 million in salary and related expenses.

Speaker Change: The decrease in research and development expenses resulted primarily from the completion of the company's for preclinical program and they were a little starting process related to the review of our Fabio BLA in the U S and the MAA in the European Union and by the applicable regulatory agencies.

Speaker Change: Selling general and administrative expenses were $3 5 million for the three months ended June 30th 'twenty 'twenty four a decrease of <unk> 5 million or 13% compared to 4 million for the three months ended June 30th 2023. The decrease resulted primarily from a decrease of $45 million in salary and related expenses.

Eyal Rubin: The decrease resulted primarily from a decrease of 0.5 million in salary and related expenses. Transial income nets were 0.2 million for 3 months ended June 30, 2024. Difference is older primarily from a higher interest income and bank deposits and lower notes interest expenses due to the notes conversion executed in 2023. In the three months and the June 30, 2024, recorded the tax benefits of approximately 0.1 million compared to income taxes of 0.3 million for three months and the June 30, 2023. Income taxes recorded are primarily the result of the provision for current taxes in respect of Section 174 of the US Tax Cuts and Jobs Act, which was enacted in December 2017.

Eyal Rubin: Financial income net was 0.2 million for three months ended June 30, 2024 compared to financial expenses net of 0.8 million for three months ended June 30, 2022. The difference resulted primarily from higher interest income on bank deposits and lower notes interest expenses due to the notes conversion executed in 2020. In the three months ended June 30, 2024, it recorded a tax benefit of approximately 0.1 million compared to income taxes of 0.3 million for the three months ended June 30, 2024. The income taxes recorded are primarily the result of the provision for current taxes in respect of Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017.

Financial income net or <unk> 2 million for three months ended June 30th 'twenty 'twenty four.

Speaker Change: The financial expenses net of $8 million for three months ended June 32023.

Speaker Change: Different resulted primarily from a higher interest income on bank deposits and lower notes interest expenses due to the notes converted and executed in 2023.

Speaker Change: In the three months ended June 32024 recorded a tax benefit of approximately $1 billion compared to income taxes of <unk> 3 million for three months ended June 32023.

Speaker Change: Taxes recorded are primarily the result.

Speaker Change: The provision for current taxes irrespective of section 174 of the U S tax cuts and jobs Act, which was enacted in December 2017.

Eyal Rubin: Cash, Cash Approval, and short-term bank deposits were approximately 45 million at June 30, 2020. As Dror mentioned, we believe our cash position is sufficient to enable the repayment of our considerable notes due September 1, 2024 and for our ongoing operation. The net loss for the 3 months ended June 30, 2024 was approximately $2.2 million or $0.03 per share basic and diluted compared to a net income of $19.3 million or $0.29 per share basic and $0.21 per share diluted for the same period in 2022.

Eyal Rubin: Cash prevalence in short and bank deposits were approximately 45 million at June 30, 2024. As Dror mentioned, we believe our cash position is sufficient to enable the repayment of our considerable notes due September 1, 2024, and for our ongoing operations.

Speaker Change: Cash cash equivalents and short term bank deposits were approximately 45 million at June 30 of 2024 as Dror mentioned, we believe our cash position is sufficient to enable the repayment of our convertible notes due September 1st 2024 and for our ongoing operations.

Eyal Rubin: Net loss for the three months and the June 30, 2024, was approximately 2.2 million, or three cents per share basic and diluted, compared to a net income of 19.3 million, or 29 cents per share basic and 21 cents per share diluted, for the same period in 2023. Since the end of the quarter and the June 30, 2024, the company collected approximately 4.6 million in the aggregate from sale to Pfizer and approximately 2.3 million from the sales to Brazil.

Speaker Change: Net loss for the three months ended June 32024 was approximately $2 2 million or three cents per share basic and diluted compared to net income of $19 3 million or 29 cents per share basic and <unk> 21 per share diluted for the same period in 2023.

Dror Bashan: Since the end of the quarter, the end of June 30, 2024, the company collected approximately $4.6 million in the aggregate from sales to Pfizer and approximately $2.3 million from sales to Brazil. I will now turn the call back. Thanks, Eyal. To conclude, I would like to express my confidence in Protalix and our enhanced strategy to enable the next phase of pipeline development. We have three streams of revenues, sales in Brazil to Pfizer and to Piazzi, and we expect our revenues to continue and grow.

Speaker Change: At the end of the quarter ended June 30th 2024, the company collected approximately $4 6 million in the aggregate from sales to Pfizer and approximately $2 3 million from the sales to Brazil.

Dror Bashan: I will now turn the call back to you, Dror. Thanks, Ayal.

Speaker Change: I will now turn the call back to you Dror.

Dror: Thanks to.

Dror Bashan: To conclude, I would like to express my confidence in ProTalics and our enhanced strategy to enable the next phase of pipeline development. We have three streams of revenues: sales in Brazil, to Pfizer, and to Piazzi, and we expect our revenues to continue and grow. We are pleased with the interim results from our PRX-115 clinical study, and we are eager to report the top-line results soon.

Dror: To conclude I would like to express my confidence in Photonics and I went ahead strategy.

Speaker Change: To enable the next phase of pipeline development, we have three streams of revenues sales in Brazil to Pfizer into Kersey and we expect total revenues to continue and grow we are pleased with the interim results from opioids 115 clinical study and we are eager to report the top line results soon.

Dror Bashan: We are pleased with the interim results from our PRX 115 clinical study, and we are eager to report the top-line results soon. We are also continuing to leverage our platform and expertise to develop a pipeline of early-stage assays with the potential to address rare renal diseases.

Dror Bashan: We are also continuing to leverage our platform and expertise to develop a pipeline of early-stage assets with the potential to address rare diseases, and we look forward to updating our progress as we continue to drive innovation and create long-term value.

Speaker Change: We also we are continuing to leverage our platform and expertise to develop a pipeline of early stage assets with the potential to address rare renal diseases and we look forward to updating you on our progress as we continue to drive innovation and create long term value.

Dror Bashan: For both patients and stakeholders, thank you very much, and I will return now to the operator to open the call for questions. Thank you.

Speaker Change: For both patients and stockholders. Thank.

Operator: And we look forward to updating you on our progress as we continue to drive innovation and create long-term value for both patients and stakeholders. Thank you very much, and I will return now to the operator to open the call 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 one on your telephone key. A confirmation tone will indicate that the line is in question. You may press star two if you would like to remove your question. For participants using sneaker equipment, it may be necessary to pick up your handset before pressing star two.

Speaker Change: Thank you very much and that wouldn't return now to the operator to open the call for questions.

Speaker Change: Thank you we will now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad a.

Operator: We will now be conducting a question and answer session. If you would like to ask the question, please press star 1 on your telephone keypad. A confirmation tone will indicate the line is in the question key. You may press star 2 if you necessary to pick up your answer before pressing star keys.

Speaker Change: A confirmation tone will indicate your 19th and the question and keep.

Speaker Change: You May press Star two if you will that you would do.

Speaker Change: Thank you.

Speaker Change: All participants using speaker equipment, it may be necessary to pick up in your hands at what point do you start.

Operator: One more, please allow me to pull four questions.

Operator: One moment, please, while we go to questions. Our first question comes from the line of John Vandermosten with VAG. Please proceed with your questions. Great. Thank you. And hello, Dror and Eyal.

Speaker Change: One moment please.

Speaker Change: Four questions.

John Vandermosten: Our first question comes from the line of John, Andrew. We'll see with that.

Speaker Change: Our first question comes from the line of Jon Vander in Washington.

John Vandermosten: Please receive your question. Great. Thank you, Ann.

Speaker Change: Please proceed with your question.

Jon Vander: Great. Thank you and Hello door anyhow.

John Vandermosten: Hello, Dora, and El. How was the uptake bin for El Fabrio by payers? Can you give us a sense of how negotiations have been going there? To get it to make it available and to get it on formularies. Can you give us a sense of that?

John Vandermosten: How has uptake been for El Fabrio by payers? Can you give us a sense of how negotiations have been going there to get it to make it available and to get it on formularies? Can you give us a sense of that? And have you been able to, or has the CAZ been able to sign any of the big payers to get it and make it available?

Jon Vander: How is the uptake been for all Fabry, Oh by by payers and can you give us a sense of how negotiates the negotiations have been going there to get it do to make it available and end to getting on formularies can you give us a sense of that and have you been able to or has a case he'd been able to sign any.

Dror Bashan: Have you been able to or has KAZ been able to sign any of the big payers to get it and make it so, John, I think we have discussed in the past, you know, Kiezi is a private company so all I can say from what we know is that they are doing well and they are, I don't know pair by pair but as far as we see the numbers of what we know, they do well and they plan to penetrate in a more significant way going forward of course, both in the US and also in other markets in Europe and outside of Europe.

Jon Vander: The big the big payers to get it and make it available.

Dror Bashan: So, John, I think we have discussed it in the past, you know, Kiezi is a private company, so all I can say from what we know is that they are doing well, and they are, I don't know, payer by payer, but as far as we see the numbers we know, they are doing well, and they plan to penetrate in a more significant way going forward, of course, both in the US and also in other markets in Europe. And outside of Europe, so actually, we are very, we are very pleased with the fact that we are now about a year, give or take from their launch in the US and about.

Jon Vander: So.

Jon Vander: John I think we are discussing departure little kids he's he's a private company. So all I can say from what we know is.

Speaker Change: They're all doing great and there are I.

Speaker Change: I don't know payer by payer, but it's probably as we see the numbers on what we know they do win.

Speaker Change: And they claim to.

Speaker Change: [noise] penetrate in a more significant way going forward of course.

Speaker Change: Both in the U S and also in other markets in Europe and outside of Europe. So actually we're very we are very pleased from the we all know about the year.

Dror Bashan: So, actually, we are very pleased from the; we are now about a year, give or take, from their launch in the US and about seven months, I believe, since the drug is available in Germany, for example, which is one of the biggest markets outside the US. The outcomes are good, and they do very well, and we expect them to expect them. We, what we expect from what we understand, is that this will continue to be so.

Speaker Change: We'll take from their launch in the U S and about.

Dror Bashan: 7 months I believe since the drug is available in Germany, for example, which is... One of the biggest markets outside the US, and the outcomes are good and they do very well, and we expect the little [inaudible] Spectrum, what we expect from what we understand is that this will continue to be so. Okay, and another thing I'm hoping you can help us with is to estimate. Unknown Attendee, Dror Bashan, Eyal Rubin, Charles Padala, Mike Moyer, Ale Linhart, Not at the moment. You know, it depends on shipment.

Speaker Change: They've been month I believe since the drug has already been in Germany for example, which is.

Speaker Change: One of the biggest market outside the U S.

Speaker Change: And the outcomes are good and they do everywhere and we expect them to.

Speaker Change: Expect them, we what we expect from what we understand is that this will continue to be so.

John Vandermosten: Okay, and another thing I'm hoping you can help us with is to estimate, you know, the sales, the sales numbers. I know that it's pretty lumpy still; we're probably still kind of inventory building and getting a sense of what, you know, the sales would need to be. But do you have an idea when you can provide some guidance in terms of what the sales to KAC might be? Not at the moment; you know, it depends on shipments. So, right now what we do, as you rightly said, we, they order a batches of the drug product to their stock.

Speaker Change: Okay and.

Speaker Change: The thing I'm, hoping you can help us with our is is to estimate.

Speaker Change: You know the sales the sales numbers I know that it's pretty lumpy still where you know, we're probably still kind of inventory building and getting a sense of what the sales would need to be but do you do you have an idea of when you can provide some guidance in terms of what are the sales to key Asian he might be.

Dror Bashan: So right now, what we do, as you rightly said, they order batches of the drug product into their stock. This is also the agreement. Since we are now in the first year, and I assume in the next 12 months, it's more or less the same because they're also penetrating Europe, and they had stopped before.

Speaker Change: Hmm.

Speaker Change: I'm not at the moment, you'll know it depends on shipment. So right now what we do is as you rightly said we are they order.

Speaker Change: Because of the drug product to those stops. This is also the agreement since we are now in the first year and I assume in the next 12 months, it's more or less the same because we're also penetrating to Europe and they had started before so it's.

Dror Bashan: This is also the agreement. Since we are now in the first year, and I assume in the next 12 months, it's more or less the same because they're also penetrating to Europe and the headstock before. So, it's, it would take a while until we'll have, I would say, ongoing basis forecast. Right now we are; we try just to be cautious. It's not that we try to hide something good for bid. It is just that, you know, it could be that one batch is not stamped on the 25th of November or 25th of end of a quarter, and it sleeps to the next quarter because of some, I don't know, QA concern or only God knows what.

Dror Bashan: So it's, it would take a while until we have, I would say, an ongoing basis for her. Right now, we are, we try just to be cautious. It's not that we try to hide something, God forbid.

Speaker Change: It would take a while until we would have I would say ongoing basis forecast.

Speaker Change: No. We all we try just to be cautious he thought that we try to hide something God forbid. It would suggest that you know it could be that one bad she's not stamped on the 25th November 'twenty for yourself and of our quarterly.

Dror Bashan: It is just that, you know, it could be that one batch is not stamped on the 25th of November or the 25th of the end of the quarter, and it slips to the next quarter because of some, I don't know, QA concern or only God knows what. So we don't want to say we will hit X millions of dollars; then it will be minus five or minus seven million because of, you know, a batch to Brazil, a batch to Chile, only God knows what. So we think we need a bit more time. But again, I want to emphasize, we are pleased with what Chiesi is doing. And I'm not saying this in order to make a V in the checkbox.

Speaker Change: Flips to the next quarter because of some I don't know few a concern the only God knows what so we don't want to say, we will eat X millions of dollars than it would be minus five and minus seven medium because you know a bitch to Brazil, but who cares you only god knows what.

John Vandermosten: So, we don't want to say we will hit X millions of dollars; then it would be minus 5 or minus 7 million because, you know, a batch to Brazil, a batch to QA is the only God knows what. So, we think we need a bit more time, but again, I want to emphasize we are pleased with what QA is doing, and I'm not saying in order to make a view on the checkbox. Well, very much pleased. They are focused; they put a lot of effort, and we see good results. And the anticipation that this will continue and or gradually continue going forward the next years ahead of us.

So we think we need to beat them, all time, but again I want to emphasize.

Speaker Change: We are pleased with what he is doing.

Speaker Change: And look I'm, not saying in order to make a V on the checkbooks well very much. Please.

Dror Bashan: We are very much pleased. They are focused, they put a lot of effort in, and we see good results. And the anticipation that this will continue and will gradually continue going forward the next years ahead of us. Do they provide, do you have ongoing meetings with the team where they update you kind of on how it's going, or is it a little bit more arm's length? No, no, not only myself, but they also sit with our team on multiple disciplines, you know, medical operations, etc., and also update the management and board of Protalix, in another relationship. Just to make it clear, the relationship is very good, and whenever we ask, we don't do it every other week, of course, but when we ever ask for an update or discussion with our board or management, So Chiesi and Giacomo Yeah, that you guys had that, that Kayla event last year, which was pretty helpful.

Speaker Change: They'll focus they put a lot of effort and we see good results and the anticipation that this will continue and it will gradually continue going forward. The next years ahead of us.

John Vandermosten: Did they provide, do you have ongoing meetings with the team to where they update you kind of on how it's going, or is it a little bit more? Yes. Okay. No, no, no, no, no, no, not only myself, but they also sit with our team on multiple disciplines, you know, medical operations, et cetera, and also update management and both of Portalis. Okay. So, the relationship, just to make it clear, the relationship is very good, and whenever we ask, we don't do it every other week, of course, but whenever we ask for an update or discussion with our board or management. So Kiezi and Djokomo Kiezi, you know, they have been, they have been to do so.

Speaker Change: Do they provide do you have ongoing meetings with with the team to where they update you kind of on how its going or is it a little bit more.

Speaker Change: Okay.

Speaker Change: They they're not only myself, but they also see it with our team on multiple disciplines, you know medical operations et cetera, and also updates management and board of.

Speaker Change: Alex.

Speaker Change: Okay, and that's the relationship just to make it clear the relationship all very good and whenever we ask we don't do it every other week of course, but when we ever we asked for an update or discuss with our board of management.

Speaker Change: So.

Speaker Change: Yes, Ian Juggled Nokia's. He you know they are happy to happy to do so.

Unknown Executive: Right.

Speaker Change: Right, Yeah that that you guys had that that that cable event last year, which was pretty helpful. When they presented so maybe we can do that again.

John Vandermosten: Yeah, that, that, you guys had that, that KLO event last year, which was pretty helpful in, in, in the presented. So maybe we can do that again.

Unknown Executive: Are there any, are there any milestones that you might expect from in the next year, related to sales? I don't think you've disclosed kind of the details on that. But I mean, is there, is there might there be one the next 12 months or so? Or is it further out than that based on your kind of view at this point? You know, it depends on, of course, on the pace of the sales. Difficult for me to tell you today, even. And we do a, that's what technical difficulties we do seem sent. We have. Oh, it cut out.

John Vandermosten: So maybe we can do that again. Are there any milestones that you might expect from the next year related to sales? And I don't think you've disclosed kind of the details on that. But I mean, might there be one in the next 12 months or so? Or is it, or is it further out than that?

Speaker Change: Are there any are there any milestones that you might expect from in the next year are related to sales and no I don't think you've disclosed kind of the details on that but I mean is that is this is it might there be one in the next 12 months or so or is or is it further out than that based on your kind of view at this point you know it depends on of course on the peso.

Operator: at that point. You know, it depends, of course, on the pace of the sales. Difficult for me to tell you today, even though And we do apologize for the technical difficulties. It seems that we have, Oh, it cut out. I'm back. Dror, are you still there?

Speaker Change: Hussein.

Difficult for me to tell you today even.

Speaker Change: Okay.

Operator: As a reminder, this conference call is being recorded.

Mike Moyer: I will now turn the conference over to our host, Mr. Mike Moyer of Life Side of life. You may begin your conference. Thank you operator and welcome to the italics by the therapeutics second quarter, 2024 financial results and business update conference call.

Speaker Change: And we do apologize for technical difficulty, we do seems that Ed.

Unknown Executive: With you today are Dror Bashan president and CEO of Protalix and Eyal Rubin 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 and the press release. The earnings release and this teleconference includes forward looking statements. These forward looking statements are subject to known and unknown risks and uncertainties that may cause actual results different material statements made factors that could cause actual results to differ are described in the disclaimer and the Protalix filing with the U.S. Securities and Exchange Commission.

Speaker Change:

Dror Bashan: I'm back. Is, uh, drawer, are you still there? He's dying back; he's dying back again. Okay.

Speaker Change: Oh, it cut out I'm back.

Speaker Change: Yeah.

It's dror are you still there.

Operator: He's dialing back, and Murthy Singh Radio, Tower Station Main Studio, Derby Radio, and Gangannai Radio have called, but the line had lost the operator CTN, but there was no caller today on the station line, sir, and we will try to get a new line sometime soon. Great. Well, I can ask another one why he's doing that, Eyal, for you.

Speaker Change: It seems as if the law.

Speaker Change: He's dialing back.

Speaker Change: He's dialing back again.

Speaker Change: Okay.

Unknown Executive: Great.

Eyal Rubin: Well, I can ask another one why he's doing that. Y'all for, um, for you is, um, are there any conferences that you're targeting for PRX 115? Uh, to report the phase one data coming up this fall, I think you said that it will be ready soon. And I was wondering if there's like a certain conference that you're targeting. No, we just partitioned one and, uh, I was there early June, and the, uh, the full set of data from the eighth quarter, it's from all eight courts. Actually, you're going to be released, uh, sometimes around early November.

Speaker Change: Great well I I can ask another one why he's doing that at all for for you is.

Eyal Rubin: Are there any conferences that you're targeting for PRX 115? to report the phase one data coming up this fall? I think you said that it would be ready soon, and I was running if he was like a s**t. Now we just participated in one, it was early June, and the full set of data from all eight cohorts is actually going to be released sometime around early November. So I guess that until then, obviously, we're going to work behind the scenes to get everything done, meet with the agencies, as Dror mentioned, getting prepared for phase two By the way, we do plan to attend the ACR meeting. OK. All right. Thank you. Thanks, John. Thank you. We do have Dror back.

Speaker Change: Are there any conferences that you're targeting for P. Rx 115 to report the phase one data coming up this fall I think you said that it'll be ready soon.

Speaker Change: And I was wondering if there's like a certain.

Speaker Change: Conference that you're targeting.

Speaker Change: No we just purchased one.

Dror Bashan: I will now turn the call over to Mr. Bashan, Dror. Thank you, Mike and thank you everyone for joining our second quarter 2024 financial results and business update call. I will begin by reviewing our recent accomplishments before handing the call to Eyal. We will provide a review of our financial results. We will then of course open the line for questions.

Speaker Change: June and the full set of data from the Ace cohorts for all eight cohorts actually youre going to be released.

Speaker Change: Sometimes around early November sorry, Yes, then until then they honestly we're going to work then seems to get everything done immediately.

Eyal Rubin: So I guess then, until then, uh, obviously we're going to work there and since to get everything done, meet with the agencies. As raw men should getting prepared for the phase two. And I get that the next fall is going to probably be the next conference that they, uh, we will be, uh, joining. Okay. By the way, we do plan to, uh, uh, attend the ACR. Okay. Thank you, well. Thanks, Sean. Thank you. We do have your back as well.

Speaker Change: As Joel mentioned getting to prepare for the phase two and I guess that the next hole is going to probably be the next conference that day, we will be a a joining.

Dror Bashan: I will turn first to PRX-115 which is our Reconvenant Pagulated Eureka's candidate produced for Protalix platform in development for the treatment of uncontrolled goat. We recently announced encouraging results, initial top-line results from the first seven cohorts of the first in human phase one clinical study of PRX-115. As a reminder, this study is a double blind placebo controlled single ascending those study designed to evaluate the results. We will provide safety, tolerability, pharmacokinetics and pharmacodynamics following a single dose of PRX-115 in subjects with elevated euric acid levels.

Speaker Change: Okay.

Speaker Change: The way, we do plan to attend.

Speaker Change: Attending ACR.

Speaker Change: Okay.

Dror Bashan: The preliminary results from the first seven cohorts demonstrated that PRX-115 exposure increased in those dependent manner and PRX-115 rapidly reduced plasma euric acid concentrations to below the guideline level of 6 milligram per debted it. PRX-115 was also generally well tolerated based on the initial top-line results of these initially seven cohorts. The review and acceptance of the safety data by the safety monitoring committee for those escalating. We expanded the phase one study by adding an 8 cohorts so we can analyze a higher dose of PRX-115 and its potential to result in an increased exposure time. Those in this 8 cohorts is now complete and the 85 days follow-up period is in progress. We expect top-line results from the full study to be available in the fourth quarter of this year.

Speaker Change: Alright, Thank you will.

Speaker Change: Okay.

Sean George: Thanks, Sean.

Speaker Change: We do have joined back as well.

Dror Bashan: Yes, I apologize for being cut off. Thank you.

Speaker Change: Yes, I apologize for being cutoff.

Speaker Change: Right.

Operator: Yes, I apologize for being cut. Thank you. Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Good morning, this is Dan Onferon.

Speaker Change: Thank you. Our next question comes from the line of Matthew Ram Southern garages at H C. Wainwright. Please proceed with your question.

Dan: Our next question comes from the line of, uh, Radio Ram, uh, Self-Roger with H.C. Wait, please proceed with your question. Good morning. This is Dan on for on. Thanks for taking our question. Uh, where does Prodelix envision positioning PRX 115 with respect to Kersteksev? Uh, how does Prodelix see PRX 115 stacking up against, uh, at the L212 from so the, um, we'd like to ask and follow up if we could. So, you know, we are now, as we mentioned, we are finalizing the phase one. Uh, the phase two will be with multiple doses; hopefully, if phase two will mimic what we saw, what we see in the phase one, I think we have a very interesting alternative to both ends.

Dror Bashan: Thanks for taking our questions. Where does Protalix envision positioning PRX 115 with respect to CRISPEXA? And how does it see PRX 115 stacking up against SEL212 from SOBI?

Speaker Change: Good morning. This is Dan on for Ron Thanks for taking our question.

Matthew Ram: Where does proteolix envision positioning P. Rx $1 15 with respect to KRYSTEXXA.

Speaker Change: How does prototypes C. P. R X 115 stacking up against at the L 212 from Sobey, we'd like to ask some follow ups if we could.

Matthew Ram: Yes.

Dror Bashan: And we'd like to have some follow-ups if we can. So, you know, we are now, as we mentioned, finalizing phase one. The phase two will be with the multiple dose. Hopefully, phase two will mimic what we see in phase one.

Speaker Change: So you know we all know as we mentioned, we all find that I think the phase one.

Speaker Change: The phase two will be the multiple dose ultra leaf phase two will mimic what we saw what we see in the phase one and I think we have a very interesting alternative to both enzymes.

Dror Bashan: I think we have a very interesting alternative on both ends. We hope this will fly. This is the intent. This is the aim and the goal. I would say again, and I said, I think I said it also at the investment event, if we would have seen outcomes that are, let's say, good or fit only once in two weeks, infusion, as Chris Texer does today, we probably wouldn't continue the program. This is not the intent.

Dror Bashan: Times, but you know, we hope this will fly. This is the intent, this is the aim and the goal. I would say again, and I think I said it also, the investment event. If we would have seen outcomes which are, let's say, good or fit only once in two weeks infusion as Chris Texas does today, we probably wouldn't continue in the program; this is not the intent.

Speaker Change: But you know.

Dean Tinsley: We hope this will feel like this is dean Tinsley.

Dean Tinsley: This is the aim and the goal I would tell you again and I said I think I said the bulk or the.

Dean Tinsley: Investment.

Dean Tinsley: If we would have seen.

Speaker Change: Outcomes, which are let's say Google feet only once in two weeks.

Speaker Change: The infusion as KRYSTEXXA does today, we would probably wouldn't continue into the program. This is not the intent.

Dror Bashan: In addition to the expense of the phase one study, we have also initiated already appropriations for phase two trial of PRX-115 in patients with uncontrolled doubt.

Dan: Awesome, that makes sense.

Dror Bashan: Awesome. That makes sense. Um, could you elucidate on some of your early stage R&D efforts and which programs you find promising? Do you expect to monetize or partner with an oral anti-TNF candidate or has that program been suspended? This program has been off. We are evaluating, I would say, more than half a dozen. Programs.

Awesome that makes sense could you elucidate on some of your early stage R&D efforts and which programs you find promising do you expect to monetize our partner the oral anti TNF candidate or has that program been suspended.

Dror Bashan: Could you elucidate on some of your early stage R&D efforts in which programs you find promising? And do you expect to monetize a part of the oral anti-TNF candidate, or has that program been suspended? Well, this program has been off. We are evaluating I would say more than half a dozen programs are very early stage right now. Once we sign or bring them in with validated, I would say, for clinical data, we will share, of course. You know, until then, we don't want to be seen, you know, dreaming or something like this. So we operate; we are looking, I would say, very diligently in any opportunity.

Dror Bashan: We plan to meet and communicate with irregular authorities in the US, Europe, and Europe to discuss our phase two plans and our overall clinical programs with the goal of initiating the phase two study in the mid of next year. Our commercial partner, Kiesi Global Road Disease, remains committed to a successful commercialization of El Fabrio and has a worth of experience on their team. Kiesi has invested heavily in the road disease space and we are confident that they will continue to penetrate the market and build the fabric franchise for the longer term.

Speaker Change: This program has been off.

Speaker Change: We are evaluating I would say.

Speaker Change: More than half a dozen.

Dror Bashan: They're very early stage right now, but once we sign or bring them in with validated, I would say, Proclinical data, we will share, of course, you know, I think then we don't want to be seen, you know, dreaming or something like this. So we operate. We are looking, I would say, very diligently at any opportunity.

Speaker Change: Program, though very early stage right now.

Speaker Change: Once we sign or bring them in.

We validated the I would say.

Speaker Change: Okay.

Speaker Change: Preclinical data, we will learn we will share of course, you know what it is then we don't want to be seen you know dreaming or something like this so we operate.

Dror Bashan: Our next pipeline candidate also expressed full post-selects is PRX-119. PRX-119 is a pagulated, recombinant eureka's UND&R's candidate in development for the potential treatment of diseases associated with nutrofuel extracellular traps or nets. Accessive formation or accumulation of nets can result in different pathological effects which have been observed in various autoimmune inflammatory and therapeutic conditions.

Dror Bashan: We believe we have the right resources to do so. And we hope to be able to update you on the first or two firsts, maybe even two programs that will get into the pipe. Thanks. That's really exciting. We look forward to hearing about it. Assuming full repayment of the convertible notes due next month, does the company plan to repay these or replace the notes with new notes with a different maturity date?

Speaker Change: We are looking at I would say very diligently and any opportunity. We believe we have the right.

Dan: We believe we have the right resources to do so. And we hope to be able to update in the next, I don't know, quote or two on the first or two firsts, maybe even two programs that will get into the pipe. Thanks, that's really exciting. We look forward to hearing about it.

Speaker Change: Sources to do so and we hope to.

Be able to update in the next I don't know quarter or two.

Speaker Change: On the first two proposals may be even two programs that would get into the pipe.

Speaker Change: Thanks.

Speaker Change: Exciting we look forward to hearing about yes.

Dror Bashan: Yes, assuming full repayment of the convertible notes due next month, does the company plan to repay these or replace the notes with new notes with a different maturity day? And what position do you guys have related to debt or future cap structure? So currently, and we plan, I mean, currently and not because I try to be cautious. We plan to pay the notes by September 1st. We do not intend to refinance or take a new debt, if I may say. As both of us mentioned, I believe both the other may self, we have sufficient resources to maintain our ongoing operations, inclusive of the phase two of the gout.

Dror Bashan: Beyond PRX-115 and PRX-119, we are focusing our R&D efforts on early-stage developments, assets to build our product development pipeline. We have fined, you know, pathway going forward to focus on leveraging our prosthetics platform and prioritizing renal rare disease indications. With regard to the therapeutic areas, our strategy moving forward is to prioritize renal rare disease and the core of portalic development pipeline. This is a logical focus for our company given our existing experience and the network and resources we build through the diligent and dedicated efforts throughout the February development program.

Dror Bashan: And what position do you guys have related to debt or future cap structure? So currently, and we plan, I mean, currently, and not because I try to be cautious, we plan to pay the notes by September 1st. We do not intend to refinance or take a new depth, if I may say so.

Speaker Change: I mean currently nothing because I tried to be cautious we plan to.

Speaker Change: The pay their notes by September 1st.

Dror Bashan: As both of us mentioned, I believe both the other myself. We have sufficient resources to maintain our ongoing operations inclusive of phase two of the gout. As we mentioned, we have three streams of news, which we expect to grow in the future. You know, so this is the situation.

Speaker Change: We do not intend to refinance all take a new depth, if I may say.

Speaker Change: As both of US mentioned I believe both the other myself, we have sufficient resources to maintain our ongoing operations inclusive of the phase two of the of the gout.

Dror Bashan: For example, PRX-119 is being evaluated for nets related renal autoimmune associated diseases. In addition, we have identified potential key high-and-met-need indication in which, on which we plan to focus our initial efforts, such as ADP-KD, Alport syndrome, FSGS, and others. Work is currently ongoing to identify assets for these and other indications.

Dror Bashan: As we mentioned, we have three screens of range of the news, which we expect them to grow in the future. You know, so this is the situation right now.

Speaker Change: As we mentioned we have three streams of range with news, which we expect them to grow in the future.

Speaker Change: And you know so this is the situation right now.

Dror Bashan: Awesome. Certainly, I would summarize that. I would add that certainly, ProTelix moved from, I would say, from a financial point of view, kind of a dangerous zone to a much more stabilized financial position. It's always good to have more money, but you know, we didn't raise even one dime in the last, I believe, five or six quarters, so we would do it cautiously. Thank you so much for answering my questions. Thank you.

Dror Bashan: Right. [inaudible] Certainly, I would add that, from a financial point of view, Protalix moved from, I would say, kind of a danger zone to a much more stable financial position. It's always good to have more money, but you know... We didn't raise even one dime in the last, I believe.

Speaker Change: Awesome and they certainly someone I would summarize that I would add that certainly protonix moved from I would say from a financial point of view, we're going to kind of a danger zone to a much more stabilized.

Dror Bashan: In order to expand our platform, we are evaluating novel plant-based drug delivery systems that may allow protective delivery of different modalities into specific tissues. These exploratory studies are ongoing and we look forward to updating you on the progress of these efforts as they progress. In addition to our prosthetics platform, we intend to explore other modalities such as small molecules and oligonucleotides to take advantage of highly innovative opportunities.

Speaker Change: <unk> financial position.

Speaker Change: Always good to have more money, but you know.

Speaker Change: We didnt raise even one time in the last I believe five.

Dror Bashan: Evo Six Quarters. So we will do it cautiously. Thank you so much for answering my questions. Thank you. Thank you. And there are no further questions at this time. I would like to turn the floor back to Dror for closing.

Speaker Change: Five or six quarters.

Speaker Change: So we would do it cautiously.

Speaker Change: Thank you so much for answering my questions.

Speaker Change: Thank you.

Speaker Change: Thank you.

Unknown Executive: And there are no further questions at this time.

Speaker Change: And there are no further questions at this time I would like to turn the floor back to George for closing remarks.

Dror Bashan: I would like to turn the floor back to the door for closing. So, thanks everybody again. Thank you for the time and the patience. We look forward to meeting with you on our next water, and hopefully we'll have good news to report. Thank you very much. Thank you.

Dror Bashan: Before turning the call to AR, I want to note that our strong cash position will enable the repayment of our convertible notes due next month in September actually in September 1st and to maintain our ongoing operation, including the phase 2 study in GALT.

Dror Bashan: So thank you everybody again. Thank you for the time and the patience. We look forward to meeting with you in our next quarter, and hopefully, we'll have good news to report.

George: So thanks, everybody again, and thank you for the time and the patience.

George: We look forward to meeting with you in our next quarter and.

George: Hopefully we'll have good news to report.

Dror Bashan: In addition, we expect phase 2 key as it to gradually continue as key as it anticipates future approvals and lunches in additional markets.

Operator: Thank you very much. Thank you. And this does conclude today's teleconference. We thank you for your participation. You may disconnect your line at this time.

Speaker Change: Thank you very much.

Operator: Thank you. Nibiru Production, John Vandermosten, Unknown Executive, Unknown Attendee, Boobalan Pachaiyappan Raghuram Selvaraju, Dror Bashan, Beèze neighborhoods have been the center of interest in Sub-Saharan Africa. They have often depicted their women in large layers of silk and evaporated them in the severe winters of her first year before she returned to Pakistan in June 1988. The initiative was shown by Oam, a superbist, in the 1960s whose work was breaking more records than any man can imagine. A few millions of biologies could also be exported bonairally from Samoa during the 1990s.

Speaker Change: Thank you.

Operator: And this concludes the teleconference. Thank you for your participation. You may disconnect your line at this point.

Speaker Change: And this does conclude today's teleconference. We thank you for your participation you may disconnect your lines.

Eyal Rubin: With that, it is now my pleasure to tell the call over to Ayala for review of our financials. Ayala, please. Thank you, Drawer. And thank you everyone for joining today's call. And we review our second quarter of 2024 financials. We recorded revenues from selling goods of 13.3 million during the three months and the June 30 of 2024. The decrease of 1.8 million or 12 percent compared to revenues of 15.1 million for the three months and the June 30 of 2020.

Speaker Change: [noise].

Eyal Rubin: 33. The decrease is altered primarily from a decrease of 10 million in sales to key as a partially offset by an increase of 4.7 million in sales to Brazil and an increase of 3.5 million in sales to Pfizer. Sales to key as in three months ended June 30, 2023, where in connection with a commercial launch and inventory buildup of El Fabrio after its approval for marketing in the United States and the European Union.

Eyal Rubin: The increases in sales to Brazil and Pfizer during 3 months ended June 30, 2024 resulted primarily from the timing of delivery. The recorded revenues from the license and R&D services of 0.2 million for the 3 months ended June 30, 2024, a decrease of 19.8 million or 99% compared to revenues of 20 million for the 3 months ended June 30, 2023. Revenue from license and R&D services are comprised primarily of revenue that the company recognized in connection with the KSA agreement.

Eyal Rubin: The revenues from license and R&D services for the 3 months ended June 30, 2023, where the result of the 20 million regulatory milestone payments from KSA in connection with the FDA approval of El Fabrio granted during that period. Cost of goods sold was 9.5 million for the 3 months ended June 30, 2024, an increase of 3.4 million or 56% from cost of goods sold of 6.1 million for the 3 months ended June 30, 2023.

Eyal Rubin: The increasing cost of goods sold was primarily the result of an increase in sales to Pfizer and to Brazil. For the 3 months ended June 30, 2024, the company told research and development expenses where approximately 3 million comprise of approximately half a million subcontractor related expenses, approximately 1.6 million of salary and related expenses, approximately 0.2 million of material related expenses, and approximately 0.7 million of other expenses. For the 3 months ended June 30, 2023, the company told research and development expenses were approximately 4.5 million comprise of approximately 1.7 million of subcontractor related expenses, approximately 2 million of salary and related expenses, approximately 0.1 million of material related expenses, and approximately 0.7 million of other expenses.

Eyal Rubin: Total decrease in research and development expenses for 3 months ended June 30, 2024 was 1.5 million or 33% compared to 3 months ended June 30, 2023. The decrease in research and development expenses resulted primarily from the completion of the company's for preclinical program and the regulatory process related to the review of a Fabrio BLA in the U.S, and the MAA in the European Union by the applicable regulatory agencies. Selling general administrative expenses were 3.5 million for the 3 months ended June 30, 2024, a decrease of 0.5 million or 13% compared to 4 million for 3 months ended June 30, 2023.

Eyal Rubin: The decrease resulted primarily from a decrease of 0.5 million in salary and related expenses. Transial income nets were 0.2 million for 3 months ended June 30, 2024, 23. Difference is older primarily from a higher interest income and bank deposits and lower notes interest expenses due to the notes conversion executed in 2023. In the three months and the June 30, 2024 recorded the tax benefits of approximately 0.1 million compared to income taxes of 0.3 million for three months and the June 30, 2023.

Eyal Rubin: Income taxes recorded are primarily the result of the provision for current taxes in respect of section 174 of the US Tax Cuts and Jobs Act, which was enacted in December 2017. Cash prevalence in short and bank deposits were approximately 45 million at June 30, 2024. As Dror mentioned, we believe our cash position is sufficient to enable the repayment of our considerable notes due September 1, 2024 and for our ongoing operations. Net loss for the three months and the June 30, 2024 was approximately 2.2 million or three cents per share basic and diluted compared to a net income of 19.3 million or 29 cents per share basic and 21 cents per share diluted for the same period in 2023. Since the end of the quarter and the June 30, 2024, the company collected approximately 4.6 million in the aggregate from sale to Pfizer and approximately 2.3 million from the sales to Brazil.

Dror Bashan: I will now turn the call back to you, Dror. Thanks, Ayal.

Dror Bashan: To conclude, I would like to express my confidence in ProTalics and our enhanced strategy to enable the next phase of pipeline development. We have three streams of revenues, sales in Brazil, to Pfizer and to Piazzi, and we expect our revenues to continue and grow. We are pleased with the interim results from our PRX-115 clinical study and we are eager to report the top-line results soon.

Dror Bashan: We are also continuing to leverage our platform and expertise to develop a pipeline of early-stage assets with the potential to address rare diseases and we look forward to updating our progress as we continue to drive innovation and create long-term value.

Dror Bashan: For both patients and stakeholders, thank you very much, and I will return now to the operator to open the call for questions. Thank you.

Operator: We will now be conducting a question and answer session.

Operator: If you would like to ask the question, please press star 1 on your telephone keypad. A confirmation tone will indicate the line is in the question key. You may press star 2 if you necessary to pick up your answer before pressing star keys.

Operator: One more, please allow me to pull four questions.

John: Our first question comes from the line of John, Andrew, we'll see with that. Please receive your question. Great. Thank you, Ann.

Dror Bashan: Hello, Dora and El. How was the uptake bin for El Fabrio by Payers? Can you give us a sense of how negotiations have been going there? To get it to make it available and to get it on formularies. Can you give us a sense of that? Have you been able to or has KAZ been able to sign any of the big payers to get it and make it So, John, I think we have discussed in the past, you know, Kiezi is a private company, so all I can say from what we know, that they are doing well and they are, I don't know, payer by payer, but as far as we see the numbers of what we know, they do well, and they plan to penetrate in a more significant way going forward, of course, both in the US, and also in other markets in Europe, and outside of Europe, so actually we are very pleased from the, we are now about a year give or take from their launch in the US, and about seven months I believe since the drug is available in Germany, for example, which is one of the biggest markets outside the US, and the outcomes are good and they do very well, and we expect them to expect them, we, what we expect from what we understand is that this will continue, we need to be so.

Dror Bashan: Okay, and another thing I'm hoping you can help us with is to estimate, you know, the sales, the sales numbers, I know that it's pretty lumpy still, but you know, we're probably still kind of inventory building and getting a sense of what, you know, the sales would need to be, but do you, do you have an idea when you can provide some guidance in terms of what the sales to Kiezi might be? [inaudible] So Kiezi and Djokomo Kiezi, you know, they have been, they have been to do so. Right. Yeah, that, that, you guys had that, that, that KLO event last year, which was pretty helpful in, in, in the presented. So maybe we can do that again.

Dror Bashan: Are there any, are there any milestones that you might expect from in the next year, related to sales? I don't think you've disclosed kind of the details on that. But I mean, is there, is there might there be one the next 12 months or so? Or is it further out than that based on your kind of view at this point? You know, it depends on, of course, on the pace of the sales.

Dror Bashan: Difficult for me to tell you today, even. And we do a, that's what technical difficulties we do seem sent. We have. Oh, it cut out. I'm back. Is, uh, drawer, are you still there? He's dying back, he's dying back again. Okay. Great.

Eyal Rubin: Well, I can ask another one why he's doing that. Y'all for, um, for you is, um, are there any conferences that you're targeting for PRX 115? Uh, to, to report the, the phase one data coming up this fall, I think you said that it will be ready soon. And I was wondering if there's like a certain conference that you're targeting. No, we just partitioned one and, uh, I was there early June and the, uh, the full set of data from the eighth quarter, it's from all eight courts.

Eyal Rubin: Actually, you're going to be released, uh, sometimes around early November. So I guess then until then, uh, obviously we're going to work there and since to get everything done, meet with the agencies. As raw men should getting prepared for the phase two. And I get that the next fall is going to probably be the next conference that they, uh, we will be, uh, joining. Okay.

Unknown Executive: By the way, we do plan to, uh, uh, attend the ACR. Okay. Thank you, well. Thanks, Sean. Thank you.

Dror Bashan: We do have your back as well.

Dror Bashan: Yes, I apologize for being cut off. Thank you.

Dan: Our next question comes from the line of, uh, Radio Ram, uh, Self-Roger with H.C. Wait, please proceed with your question.

Dror Bashan: Good morning. This is Dan on for on. Thanks for taking our question. Uh, where does Prodelix envision positioning PRX 115 with respect to Kersteksev? Uh, how does Prodelix see PRX 115 stacking up against, uh, at the L212 from so the, um, we'd like to ask and follow up if we could. So, you know, we are now as we mentioned, we are finalizing the phase one. Uh, the phase two will be with multiple dose, hopefully if phase two will mimic what we saw, what we see in the phase one, I think we have a very interesting alternative to both ends.

Dror Bashan: Times, but you know, we hope this will fly, this is the intent, this is the aim and the goal. I would say again, and I think I said it also, the investment event. If we would have seen outcomes which are, let's say, good or fit only once in two weeks infusion as Chris Texas does today, we probably wouldn't continue in the program, this is not the intent.

Dror Bashan: Awesome, that makes sense. Could you elucidate on some of your early stage R&D efforts in which programs you find promising? And do you expect to monetize a part of the oral anti-TNF candidate or has that program been suspended? Well, this program has been off. We are evaluating I would say more than half a dozen programs are very early stage right now. Once we sign or bring them in with validated, I would say, for clinical data, we will share of course.

Dror Bashan: You know, until then, we don't want to be seen, you know, dreaming or something like this. So we operate, we are looking, I would say, very diligently in any opportunity. We believe we have the right resources to do so. And we hope to be able to update in the next, I don't know, quote or two on the first or two firsts, maybe even two programs that will get into the pipe.

Eyal Rubin: Thanks, that's really exciting. We look forward to hearing about it. Yes, assuming full repayment of the convertible notes due next month, does the company plan to repay these or replace the notes with new notes with a different maturity day? And what position do you guys have related to debt or future cap structure? So currently and we plan, I mean, currently and not because I try to be cautious. We plan to pay the notes by September 1st.

Eyal Rubin: We do not intend to refinance or take a new debt if I may say. As both of us mentioned, I believe both the other may self, we have sufficient resources to maintain our ongoing operations, inclusive of the phase two of the of the gout. As we mentioned, we have three screens of range of the news, which we expect them to grow in the future. You know, so this is the situation right now.

Dror Bashan: Awesome. Certainly, I would summarize that, I would add that certainly, ProTelix moved from, I would say, from a financial point of view, kind of a dangerous zone to a much more stabilized financial position. It's always good to have more money, but you know, we didn't raise even one dime in the last, I believe, five or six quarters, so we would do it cautiously. Thank you so much for answering my questions. Thank you.

Operator: And there are no further questions that this time.

Dror Bashan: I would like to turn the floor back to the door for closing. So, thanks everybody again. Thank you for the time and the patience. We look forward to meeting with you on our next water and hopefully we'll have good news to report. Thank you very much. Thank you.

Operator: And this concludes the teleconference. Thank you for your participation. You may disconnect your line at this point.