[Executive Summary](index=1&type=section&id=Executive%20Summary) [Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) Protalix BioTherapeutics reported Q2 2025 financial results, with first-half revenues from product sales increasing 50% year-over-year, driven by Elfabrio® sales to Chiesi, anticipating quarterly fluctuations in global orders but strong long-term growth - Revenues from product sales increased by **50% year-over-year** in the first half of 2025, primarily driven by Elfabrio® sales to Chiesi[2](index=2&type=chunk) - Elfabrio®, for Fabry disease treatment, has a current global market size of approximately **$2.3 billion**, projected to grow to **$3.2 billion by 2030**[2](index=2&type=chunk) - The company anticipates quarterly fluctuations in Elfabrio®'s global order patterns during its early launch phase but remains confident in its long-term growth potential[2](index=2&type=chunk) [Strategic Business and Clinical Updates](index=1&type=section&id=Strategic%20Business%20and%20Clinical%20Updates) The company is advancing PRX-115 development, with a randomized Phase II trial expected to commence in H2 2025 and the first patient enrolled in Q4 2025 - Development of PRX-115, a recombinant PEGylated uricase product candidate for uncontrolled gout, continues to advance[2](index=2&type=chunk) - A randomized Phase II trial for PRX-115 is expected to be initiated in **H2 2025**, with the first patient enrolled in **Q4 2025**[2](index=2&type=chunk) [Corporate and Management Changes](index=1&type=section&id=Corporate%20and%20Management%20Changes) The company announced Eyal Rubin's departure as CFO, with Gilad Mamlok appointed as his successor, effective August 24, 2025, to ensure a smooth transition - Eyal Rubin will step down as Chief Financial Officer, with Gilad Mamlok appointed as the new Senior Vice President and CFO, effective **August 24, 2025**[3](index=3&type=chunk)[4](index=4&type=chunk) [Business and Financial Highlights](index=1&type=section&id=Business%20and%20Financial%20Highlights) [Corporate Developments](index=1&type=section&id=Corporate%20Developments) The company was included in the Russell 3000® and Russell 2000® Indexes and completed a smooth CFO transition, with Gilad Mamlok succeeding Eyal Rubin - The company was included in the Russell 3000® and Russell 2000® Indexes at market close on **June 27, 2025**[7](index=7&type=chunk) - Gilad Mamlok has joined the company and is collaborating with outgoing CFO Eyal Rubin to ensure a smooth transition, with Eyal Rubin providing support until **October 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) [Clinical and Regulatory Progress](index=3&type=section&id=Clinical%20and%20Regulatory%20Progress) The European Medicines Agency (EMA) is evaluating Chiesi's Elfabrio® label change application to include a 2 mg/kg dose every four weeks for adult Fabry disease patients - The European Medicines Agency (EMA) is evaluating Chiesi's application for an Elfabrio® label change to include a **2 mg/kg dose every four weeks** for adult Fabry disease patients[7](index=7&type=chunk) - This label change application was accepted for review in **December 2024**[7](index=7&type=chunk) [Financial Performance Analysis](index=3&type=section&id=Financial%20Performance%20Analysis) In Q2 2025, the company's revenues from product sales grew 16% year-over-year, R&D expenses surged 100% due to PRX-115 trial preparations, and net income turned profitable [Revenue Breakdown](index=3&type=section&id=Revenue%20Breakdown) Company Q2 revenues from product sales increased 16% year-over-year, primarily driven by higher sales to Chiesi, while license and R&D services revenue remained stable | Revenue Type | Q2 2025 (million USD) | Q2 2024 (million USD) | Y-o-Y Change (%) | | :------------------------- | :-------------------- | :-------------------- | :--------------- | | Revenues from Product Sales | 15.4 | 13.3 | 16% | | License and R&D Services Revenue | 0.2 | 0.2 | 0% | - The increase in revenues from product sales was primarily due to an **$8.0 million increase** in sales to Chiesi, partially offset by a **$4.7 million decrease** in sales to Fiocruz (Brazil) and a **$1.2 million decrease** in sales to Pfizer[7](index=7&type=chunk) - License and R&D services revenue is expected to remain minimal, excluding potential regulatory milestone payments[7](index=7&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Q2 cost of goods sold decreased by 38%, R&D expenses surged 100% due to PRX-115 clinical trial preparations, and SG&A expenses declined by 26% | Expense Type | Q2 2025 (million USD) | Q2 2024 (million USD) | Y-o-Y Change (%) | | :--------------------------------- | :-------------------- | :-------------------- | :--------------- | | Cost of Goods Sold | 5.9 | 9.5 | -38% | | Research and Development Expenses | 6.0 | 3.0 | 100% | | Selling, General and Administrative Expenses | 2.6 | 3.5 | -26% | - The decrease in cost of goods sold was primarily due to reduced sales to Pfizer and Fiocruz (Brazil), partially offset by increased sales to Chiesi[7](index=7&type=chunk) - The increase in R&D expenses primarily stemmed from preparations for the planned Phase II clinical trial for PRX-115, with R&D expenses expected to continue to increase significantly as product candidates advance into later-stage clinical trials[7](index=7&type=chunk)[8](index=8&type=chunk) - The decrease in selling, general and administrative expenses was mainly due to a **$0.6 million reduction** in salaries and related expenses and a **$0.3 million decrease** in selling expenses[9](index=9&type=chunk) [Net Income, EPS, and Cash Position](index=4&type=section&id=Net%20Income,%20EPS,%20and%20Cash%20Position) The company achieved net income of $0.164 million and $0.00 EPS in Q2 2025, holding $33.4 million in cash and cash equivalents and short-term bank deposits | Metric | Q2 2025 | Q2 2024 | | :------------------------------- | :------------- | :------------- | | Net Income (Loss) | $0.164 million | ($2.20 million) | | Earnings Per Share (Basic and Diluted) | $0.00 | ($0.03) | - As of **June 30, 2025**, the company held **$33.4 million** in cash and cash equivalents and short-term bank deposits[9](index=9&type=chunk) [Tax Implications](index=4&type=section&id=Tax%20Implications) Q2 tax expenses were $0.5 million, primarily due to GILTI income and TCJA Section 174, with the company evaluating the impact of the H.R.1 bill | Metric | Q2 2025 | Q2 2024 | | :------------------ | :------------- | :------------- | | Tax Expenses (Benefit) | $0.5 million | ($0.1 million) | - Tax expenses primarily resulted from GILTI income and the impact of Section 174 of the U.S. Tax Cuts and Jobs Act (TCJA), which requires capitalization and amortization of R&D expenses[9](index=9&type=chunk) - The H.R.1 bill, passed on **July 4, 2025**, reinstated current deductions for domestic R&D expenditures, and the company is evaluating the new legislation's impact on its consolidated financial statements[9](index=9&type=chunk) [Company Profile and Outlook](index=5&type=section&id=Company%20Profile%20and%20Outlook) [About Protalix BioTherapeutics](index=5&type=section&id=About%20Protalix%20BioTherapeutics) Protalix is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell expression system, with FDA approval, partnerships with Pfizer and Chiesi, and a pipeline including PRX-115 and PRX-119 - Protalix is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins through its proprietary ProCellEx® plant cell expression system[12](index=12&type=chunk) - The company is the **first to receive U.S. FDA approval** for a protein produced through a plant cell suspension expression system[12](index=12&type=chunk) - Protalix licensed global development and commercialization rights for taliglucerase alfa, for Gaucher disease, to Pfizer, retaining full rights in Brazil; its second product, Elfabrio®, received **FDA and EMA approval in May 2023**, and is partnered with Chiesi Farmaceutici S.p.A. for global development and commercialization[12](index=12&type=chunk)[13](index=13&type=chunk) - The company's development pipeline includes product candidates such as PRX-115 for uncontrolled gout and PRX-119 for NETs-related diseases[13](index=13&type=chunk) [Forward-Looking Statements and Risks](index=6&type=section&id=Forward-Looking%20Statements%20and%20Risks) This press release contains forward-looking statements subject to known and unknown risks and uncertainties that could cause actual results to differ materially from expectations, including commercialization risks for Elfabrio®, market acceptance, competition, regulatory actions, impact of the Israeli regional conflict on operations, clinical trial failures or delays, and global economic conditions - Non-historical statements in this press release are forward-looking statements, subject to known and unknown risks and uncertainties that could cause future actual experiences and results to differ materially from those expressed[14](index=14&type=chunk) - Key risks include those related to Elfabrio® commercialization (market acceptance, competition, reimbursement, and regulatory actions, including a black box warning in FDA approval), potential disruptions to company operations from the Israeli regional conflict, regulatory approval and commercial success risks for other products and candidates, clinical trial failures or delays, and global economic conditions and supply chain challenges[14](index=14&type=chunk) - The company undertakes no obligation to update this information unless required by law[15](index=15&type=chunk) [Financial Statements](index=9&type=section&id=Financial%20Statements) [Consolidated Balance Sheets](index=9&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were $78.486 million, an increase from December 31, 2024, primarily due to higher trade receivables, with total liabilities slightly decreasing and shareholders' equity increasing Summary of Consolidated Balance Sheets (in thousand USD) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------- | :------------ | :---------------- | | **Assets:** | | | | Cash and Cash Equivalents | 17,895 | 19,760 | | Short-term Bank Deposits | 15,503 | 15,070 | | Trade Receivables | 9,443 | 2,909 | | Inventories | 21,131 | 21,243 | | Total Current Assets | 65,485 | 60,078 | | Total Assets | 78,486 | 73,417 | | **Liabilities and Shareholders' Equity:** | | | | Total Current Liabilities | 24,091 | 25,621 | | Total Liabilities | 28,583 | 30,206 | | Shareholders' Equity | 49,903 | 43,211 | [Condensed Consolidated Statements of Operations](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2025, total revenue was $15.658 million, with net income of $0.164 million and $0.00 EPS, a significant improvement from the prior year's net loss of $2.203 million and $0.03 loss per share Summary of Condensed Consolidated Statements of Operations (in thousand USD, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :------------------------------- | :------ | :------ | :------ | :------ | | Revenues from Product Sales | 15,440 | 13,304 | 25,435 | 16,981 | | License and R&D Services Revenue | 218 | 170 | 336 | 241 | | **Total Revenues** | **15,658** | **13,474** | **25,771** | **17,222** | | Cost of Goods Sold | (5,870) | (9,456) | (14,050) | (12,058) | | Research and Development Expenses | (5,992) | (2,961) | (9,467) | (5,848) | | Selling, General and Administrative Expenses | (2,624) | (3,484) | (5,227) | (6,599) | | Operating Income (Loss) | 1,172 | (2,427) | (2,973) | (7,283) | | Financial Expenses (Income), Net | (511) | 155 | (98) | 278 | | Tax Expenses (Benefit) | 497 | (69) | 384 | (207) | | **Net Income (Loss)** | **164** | **(2,203)** | **(3,455)** | **(6,798)** | | Earnings (Loss) Per Share - Basic | 0.00 | (0.03) | (0.04) | (0.09) | | Earnings (Loss) Per Share - Diluted | 0.00 | (0.03) | (0.04) | (0.09) | [Additional Information](index=4&type=section&id=Additional%20Information) [Conference Call and Webcast Details](index=4&type=section&id=Conference%20Call%20and%20Webcast%20Details) Protalix BioTherapeutics hosted a conference call and webcast on August 14, 2025, to discuss financial results and provide business updates, with detailed participation and replay information provided Conference Call Details | Date: | August 14, 2025, Thursday | | :------------ | :------------------------ | | Time: | 8:30 AM ET | | Toll-Free: | 1-877-423-9813 | | International: | 1-201-689-8573 | | Conference ID: | 13755073 | Webcast Details | Company Link: | https://ir.protalix.com/news-events/events | | :-------------- | :--------------------------------------- | | Webcast Link: | https://tinyurl.com/yc272tbr | | Conference ID: | 13755073 | - A replay of the conference call will be available for two weeks in the investor section's events calendar on the company's website[11](index=11&type=chunk) [Investor Contact](index=8&type=section&id=Investor%20Contact) Investor relations contact information is provided for inquiries - Investor Contact: Mike Moyer, Managing Director, LifeSci Advisors[16](index=16&type=chunk) - Contact Phone: **+1-617-308-4306**, Email: **mmoyer@lifesciadvisors.com**[16](index=16&type=chunk)

Core Viewpoint - Protalix BioTherapeutics reported a significant increase in revenues driven by the sales of Elfabrio® and provided updates on its product pipeline and management changes [2][4][6]. Financial Highlights - Revenues from selling goods for Q2 2025 were $15.4 million, a 16% increase from $13.3 million in Q2 2024, primarily due to an $8.0 million increase in sales to Chiesi [6][7]. - Cost of goods sold decreased by 38% to $5.9 million in Q2 2025 from $9.5 million in Q2 2024 [7]. - Research and development expenses doubled to approximately $6.0 million in Q2 2025 from $3.0 million in Q2 2024, mainly due to preparations for the Phase 2 trial of PRX-115 [7][17]. - Selling, general, and administrative expenses decreased by 26% to $2.6 million in Q2 2025 from $3.5 million in Q2 2024 [7]. - The net income for Q2 2025 was approximately $164,000, compared to a net loss of $2.2 million in Q2 2024 [7][17]. Business Updates - Protalix is advancing the development of PRX-115, with a Phase 2 trial expected to start in the second half of 2025 [2][4]. - The company appointed Gilad Mamlok as the new Chief Financial Officer, succeeding Eyal Rubin, who will assist during the transition until October 2025 [3][6]. - Protalix has been added to the Russell 3000® and Russell 2000® Indexes as of June 27, 2025 [6]. Product Pipeline - Elfabrio® is positioned for growth in the Fabry disease market, which is currently valued at approximately $2.3 billion and is expected to grow to $3.2 billion by 2030 [2][12]. - The European Medicines Agency is reviewing a submission for a new dosing regimen for Elfabrio® [6].

Core Viewpoint - Protalix BioTherapeutics, Inc. will release its financial results for the quarter ended June 30, 2025, and provide a business and clinical update on August 14, 2025 [1] Group 1: Financial Results and Conference Call - The management will host a conference call to discuss the financial results and provide updates on recent corporate and regulatory developments [2] - The conference call is scheduled for August 14, 2025, at 8:30 a.m. EDT [3] Group 2: Webcast and Participation Details - The conference will be webcast live from the Protalix website, and participants are encouraged to access the call at least 15 minutes early [4] - A replay of the call will be available for two weeks on the Events Calendar of the Company's website [4] Group 3: Company Overview - Protalix is focused on the development and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system [5] - The company has FDA approval for its first product, taliglucerase alfa, for the treatment of Gaucher disease, and its second product, Elfabrio®, was approved in May 2023 [5][6] - Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio [6]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the company includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain best practices in content production and search engine optimization [5]

Company Overview - Pluxee N.V. is a global player in Employee benefits and Engagement, operating in 29 countries [1] - The company offers a broad range of solutions across Meal & Food, Wellbeing, Lifestyle, Reward & Recognition, and Public Benefits [1] - Pluxee has over 5,000 engaged team members and serves more than 500,000 clients, 37 million consumers, and 1.7 million merchants [1] Financial Transactions - As of June 30, 2025, the liquidity account held 198,165 ordinary shares valued at €6,347,475 [3] - During the first half of 2025, Pluxee purchased 718,910 ordinary shares for €14,773,178 across 4,467 transactions [3] - The company disposed of 719,962 ordinary shares for €15,127,389 across 4,431 transactions during the same period [3] Previous Period Comparison - In the previous half-yearly report as of December 31, 2024, the liquidity account had 200,439 ordinary shares valued at €5,878,911 [3] - From July 1, 2024, to December 31, 2024, Pluxee purchased 972,323 ordinary shares for €19,626,472 across 6,377 transactions [3] - The company disposed of 848,300 ordinary shares for €17,195,841 across 5,661 transactions during that period [3] Initial Contract Assets - At the start of the liquidity contract on January 31, 2024, the liquidity account had assets amounting to €10,000,000 [3]

Core Insights - Pluxee demonstrated solid organic growth performance in Q3 Fiscal 2025, achieving total revenues of 310 million euros, which represents an 11.1% organic growth year-on-year [2][6][9] - The company confirmed its full-year financial objectives, reflecting strong execution and performance over the first nine months of the fiscal year [5][24] Financial Performance - Total revenues for Q3 Fiscal 2025 reached 310 million euros, up from 297 million euros in Q3 Fiscal 2024, marking an 11.1% organic growth and a 4.3% reported growth [2][9] - Operating revenue was 270 million euros, reflecting an 11.1% organic growth and a 5.4% reported growth [10][12] - Float revenue amounted to 39 million euros, growing 10.8% organically but declining 2.2% in reported terms [11][12] Regional Performance - Continental Europe generated 134 million euros in revenues, up 6.5% organically, while Latin America saw revenues of 121 million euros, growing 13.8% organically [2][15] - The Rest of the World reported revenues of 55 million euros, with a 15.2% organic growth despite a decline in reported terms [2][18] Business Segments - Employee Benefits segment generated 270 million euros in operating revenue, up 12.3% organically, driven by strong client acquisition and improved retention rates [7][12] - Other Products & Services reported 40 million euros in operating revenue, showing a modest 0.5% organic growth [14][36] M&A Activity - The company signed the acquisition of MyBenefits in Romania, which is expected to enhance technological capabilities and generate sustainable growth synergies [20][21][22] - Integration efforts for Cobee in Spain and Benefício Fácil in Brazil are ongoing, alongside a fully operational partnership with Santander [23][24] Outlook - Pluxee maintains its financial objectives for Fiscal 2025, expecting low double-digit organic growth in total revenues and float revenue [24][27] - The company anticipates a recurring EBITDA margin expansion of +150 basis points at Fiscal 2024 constant rates for Fiscal 2025 [27]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Financial Data and Key Metrics Changes - The company reported revenues of $53 million for the fiscal year 2024, indicating a strong cash-generating position for a biotech firm [6][29] - Cash at the end of the last quarter was $34.7 million, with projections to approach cash flow positive by the end of 2024 [29][30] Business Line Data and Key Metrics Changes - The first product, El Eliza, has generated approximately $12 million in Brazil, while global sales through Pfizer are only $50 million out of a $1 billion market, indicating commercialization challenges [9][34] - The second product, El Fabrio, is expected to capture 15% to 20% of a $3.1 billion market, potentially generating $130 million to $150 million in sales for Protalix [13][19] Market Data and Key Metrics Changes - The Fabry market was valued at $2.2 billion last year, with expectations for growth to $3.1 billion by 2030 [12][13] - The gout treatment market is projected to be $5.6 billion with a 6.4% CAGR, highlighting significant potential for the PRX-115 product [25] Company Strategy and Development Direction - The company aims to enhance its platform and explore rare renal diseases, while also focusing on the development of PRX-115 for gout treatment [28][30] - A strategic partnership with Chiesi is crucial, with a tiered royalty agreement that could yield significant revenue based on sales performance [14][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in commercialization for El Eliza but remains optimistic about future partnerships to improve market penetration [10][34] - The company believes that by 2030, total sales could reach between $120 million to $230 million, contingent on successful product launches and market acceptance [35] Other Important Information - The company has no debt and has cleaned its balance sheet, positioning itself for a fresh start [30] - Management noted that the share price drop following the first quarter results was disproportionate and attributed it to market reactions rather than operational failures [31][34] Q&A Session Summary Question: Is it reasonable to liken the competitive advantage of PRX-115 to that of El Fabrio? - Management believes PRX-115 could represent an even stronger competitive advantage due to its potential dosing regimen, which could significantly reduce treatment frequency compared to existing therapies [37] Question: What are the implications of sales fluctuations? - Sales are highly dependent on shipment logistics, and even minor delays can impact revenue recognition, but the company remains optimistic about profitability [38] Question: What are the expected costs for the upcoming trials? - The projected costs for the trials are manageable, estimated at around $24 million over two and a half years, which is significantly lower than previous trials [39]

Financial Data and Key Metrics Changes - The company recorded revenues from selling goods of $10 million for Q1 2025, an increase of $6.3 million or 170% compared to $3.7 million for Q1 2024, primarily due to increased sales to Pfizer and Fearcruz in Brazil [11][12] - Cost of goods sold was $8.2 million for Q1 2025, an increase of $5.6 million or 215% from $2.6 million for Q1 2024 [12] - Net loss for Q1 2025 was approximately $3.6 million or $0.05 per share, compared to a net loss of $4.6 million or $0.06 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenues from license and R&D services were $100,000 for both Q1 2025 and Q1 2024, with expectations for minimal future revenues from this line [11][12] - Total research and development expenses were approximately $3.5 million for Q1 2025, an increase of $600,000 or 21% compared to $2.9 million for Q1 2024, driven by advancements in the clinical pipeline [12][13] - Selling, general, and administrative expenses decreased to $2.6 million for Q1 2025, a decrease of $500,000 or 16% compared to $3.1 million for Q1 2024 [13] Market Data and Key Metrics Changes - The company is focused on the clinical development of PRX-115, with plans to initiate a Phase II study in patients with gout later this year [4][7] - The European Medicines Agency (EMA) has validated a submission to reduce the dosing frequency for PEGUNIGARCID, which is expected to be reviewed in Q4 2025 [8] Company Strategy and Development Direction - The company aims to build on the momentum from its first-in-human study of PRX-115 and is evaluating additional pipeline candidates for further development [4][9] - The focus remains on early-stage development assets and leveraging the Procedex platform to enhance the product development pipeline [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and balance sheet, indicating that the three streams of revenue will support the next phase of pipeline development [17] - The company anticipates a promising year ahead, with ongoing efforts to drive innovation and create long-term value for patients and shareholders [17] Other Important Information - Cash, cash equivalents, and short-term bank deposits were approximately $34.7 million as of March 31, 2025 [15] - The company expects minimal revenues from R&D services going forward, primarily from potential regulatory milestone payments [12][51] Q&A Session Summary Question: Visibility on El Fabrio milestone - Management noted that Kiese's sales efforts are strong, with recruitment of commercial patients exceeding expectations, but specific numbers cannot be disclosed due to confidentiality [20][21][22] Question: Dosing frequency changes in the US - Management confirmed that an application has been submitted to Kiese, and updates will be provided as they become available [23][24] Question: Comparison with other gout medications - Management indicated that more information will be available after the Phase II trial, which is designed to have high statistical power [25][26][27] Question: Options close to expiration - The majority of warrants from the 2020 PIPE transaction expired, with a minimal amount exercised [30][31] Question: U.S. patients in Phase II trial - The majority of patients will be enrolled in the U.S., with hopes for a good safety and immunogenicity profile [36][37] Question: Effects of U.S. pharmaceutical tariffs - Management clarified that the relationship with Kiese is not expected to be impacted by the tariffs, as sales are made to Kiese, not directly to the U.S. market [42][44][45] Question: Remaining value of the contract with Kiese - Management explained that future revenues from Kiese will primarily consist of regulatory milestones, with potential milestones estimated up to $75 million, depending on sales performance [49][51][53]

Financial Data and Key Metrics Changes - The company recorded revenues from selling goods of $10 million for the three months ended March 31, 2025, an increase of $6.3 million or 170% compared to $3.7 million for the same period in 2024 [10] - The cost of goods sold was $8.2 million for the three months ended March 31, 2025, an increase of $5.6 million or 215% from $2.6 million for the same period in 2024 [11] - The net loss for the quarter ended March 31, 2025, was approximately $3.6 million or $0.05 per share, compared to a net loss of $4.6 million or $0.06 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenues from license and R&D services were $100,000 for the three months ended March 31, 2025, consistent with the same period in 2024 [10] - Total research and development expenses were approximately $3.5 million for the three months ended March 31, 2025, an increase of $600,000 or 21% compared to $2.9 million for the same period in 2024 [12] Market Data and Key Metrics Changes - The company noted an increase in sales to Pfizer by $5.9 million and an increase of $400,000 in sales to Fearcruz in Brazil, contributing to the overall revenue growth [10] Company Strategy and Development Direction - The company is focused on initiating a Phase II clinical trial for its gut product candidate PRX-115 later this year, building on the momentum from promising Phase I results [4][6] - The company continues to evaluate additional pipeline candidates, including PRX-119 and other early-stage clinical assets, to strengthen its product development pipeline [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and balance sheet, indicating that the three streams of revenue will support the next phase of pipeline development [17] - The management highlighted strong sales efforts and recruitment of commercial patients, which are exceeding expectations [21][56] Other Important Information - Cash, cash equivalents, and short-term bank deposits were approximately $34.7 million as of March 31, 2025 [15] - The company expects minimal revenues from license and R&D services going forward, primarily from potential regulatory milestone payments [11][51] Q&A Session Summary Question: Any visibility on an El Fabrio milestone? - Management indicated that Kiese's sales efforts are strong, and the pace of recruitment of commercial patients is above expectations, but specific numbers cannot be disclosed due to confidentiality [20][22] Question: Is there any effort for a similar dosing frequency approach in the U.S.? - Management stated that the application with Kiese is ongoing, and updates will be provided as they become available [23][24] Question: Will U.S. patients be enrolled in the Phase II trial for gout? - Management confirmed that the majority of patients will be enrolled in the U.S. [36] Question: Any increase in the list price of El Fabrio in response to U.S. tariffs? - Management stated that there are no current plans for a price increase, but this could change depending on future tariff impacts [45] Question: What is the approximate value of the contract left to be paid out by Kiese? - Management explained that future revenues from Kiese will primarily consist of regulatory milestones, with potential milestones estimated up to $75 million, but this is minimal at this point [51][52]