Protalix BioTherapeutics, Inc. (NYSE:PLX) Q3 2020 Results Conference Call October 29, 2020 8:30 AM ET Company Participants Chuck Padala - LifeSci Advisors, Investor Relations Dror Bashan - President & Chief Executive Officer Eyal Rubin - Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright Operator Greetings and welcome to the Protalix Biopharmaceuticals Third Quarter 2020 Financial Results and Business Update. At this time all participants are in a listen-only mode. ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q2 2020 Results Earnings Conference Call August 10, 2020 8:30 AM ET Â Company Participants Chuck Padala - LifeSci Advisors, Investor Relations Dror Bashan - President and CEO Eyal Rubin - Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright Operator Good morning, ladies and gentlemen. And welcome to the Protalix BioTherapeutics Second Quarter 2020 Earnings Call. As a reminder, this conference is being recorded. I would now lik ...

Protalix Bio Therapeutics (NYSE:PLX) Q1 2020 Earnings Conference Call June 1, 2020 8:30 AM ET Company Participants Dror Bashan - President, Chief Executive Officer Eyal Rubin - Senior Vice President, Chief Financial Officer Chuck Padala - Investor Relations Conference Call Participants Boobalan Pachaiyappan - HC Wainwright Philippa Gardner - Jefferies Walter Goering - private investor Operator Greetings and welcome to the Protalix Bio Therapeutics first quarter 2020 earnings conference call. At this time, a ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q4 2019 Earnings Conference Call March 12, 2020 8:30 AM ET Company Participants Monique Kosse - IR, LifeSci Advisors Dror Bashan - President & CEO Eyal Rubin - CFO Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright Peter Welford - Jefferies Operator Greetings and welcome to the Protalix Biopharmaceuticals reports Fourth Quarter and Full-Year 2019 Financial and Business Results Conference Call. At this time, all participants are in a listen-only mod ...

Protalix BioTherapeutics, Inc. CORPORATE UPDATE | FEBRUARY 2020 Note Regarding Forward-Looking Statements This presentation (the "Presentation") contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements, including, among others, statements regarding expectations as to regulatory approvals, market opportunity for, and potential sales of, the Company's product and product candid ...

Investment Highlights - Protalix has a revenue-generating marketed drug for Gaucher disease[4] - The company's pipeline includes products in active clinical phase development, such as pegunigalsidase alfa (PRX-102) for Fabry disease, tulinercept for Inflammatory Bowel Disease, and alidornase alfa (PRX-110) for multiple indications[4] - A BLA submission for Fabry disease is anticipated by Q2 2020[4] - Protalix utilizes an advantageous proprietary ProCellEx® platform for recombinant protein expression and cGMP manufacturing, successfully inspected and audited by multiple regulatory agencies, including the US FDA and EU EMA[4] Commercial Performance & Partnerships - Sales in Brazil provide a consistent revenue stream for 5+ years, validating the company's ability to bring a treatment from concept to market and support long-term production[11] - In 2019, sales to the Brazilian Ministry of Health amounted to approximately $91 million[11] - Approximately 20% of Gaucher patients in Brazil are treated with alfataliglicerase (Elelyso®)[11] - Protalix has a global partnership with Chiesi Farmaceutici S·p·A, including a $50 million upfront payment and potential milestone payments of over $1 billion, plus tiered royalties of 15-35% (ex-US) and 15-40% (US)[22] Product Pipeline & Milestones - The Fabry disease market is estimated to be over $14 billion and growing at a CAGR of approximately 10%[15] - Final results from the BRIDGE trial are expected in Q2 2020, and final results from the BRIGHT trial are expected in Q4 2020[34] - Protalix anticipates FDA approval of pegunigalsidase alfa in Q4 2020 and a launch in Q1 2021[34]

Financial Data and Key Metrics Changes - Protalix recorded revenues from selling goods of $12.1 million during the nine-month period ended September 30, 2019, an increase of $4.9 million, or 67%, compared to the revenues of $7.2 million for the same period of 2018, primarily due to higher sales of Elelyso in Brazil [16] - Research and development expenses, net, were $35 million for the nine months ended September 30, 2019, an increase of $11.3 million, or 47%, compared to $23.8 million for the same period of 2018, mainly due to increased clinical trial costs [17] - Selling, general and administrative expenses for the nine months ended September 30, 2019, were $6.9 million, a decrease of $1.9 million, or 21%, compared to $8.7 million for the same period in 2018 [18] - Net loss for the nine months ended September 30, 2019, was $18.6 million, or $0.13 per share, compared to a net loss of $21 million, or $0.14 per share, for the same period in 2018 [19] - As of September 30, 2019, the company had $21.4 million in cash and cash equivalents [20] Business Line Data and Key Metrics Changes - The ongoing clinical studies for PRX-102 continue to show outstanding data, with the BALANCE Phase III study designed to evaluate the safety and efficacy of PRX-102 on renal function in Fabry patients [7][8] - Interim results from the BRIDGE study indicate a mean improvement in kidney function for patients switched from Replagal to PRX-102, with the switch being well tolerated [12] Market Data and Key Metrics Changes - In Brazil, Protalix has achieved approximately 23% market share for taliglucerase, with an average growth of about 15% year-over-year expected in the next few years [52] Company Strategy and Development Direction - The company plans to submit a Biologics License Application (BLA) for PRX-102 by April 2020 under an accelerated approval pathway, based on data from completed and ongoing clinical studies [10] - A reverse stock split is proposed to regain compliance with the NYSE American, which is seen as essential for attracting institutional investors [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the outcome of ongoing studies and the potential of PRX-102 to address unmet medical needs in Fabry patients [10][11] - The company is making significant progress and is committed to its goals, thanking patients, investigators, and shareholders for their support [22] Other Important Information - The company has convened a special meeting with stockholders to approve amendments to its certificate of incorporation, including a reverse stock split and a reduction in the total number of authorized shares [14] Q&A Session Summary Question: Has the pre-BLA meeting with the FDA taken place? - Yes, the pre-BLA meeting with the FDA took place in October, and the company will share the minutes publicly once received [28] Question: What are the usage patterns and government ordering in Brazil for taliglucerase? - The company sees alignment between orders and production, achieving around 23% market share and expecting steady growth [52] Question: What are the gating items remaining for the completion of the FDA submission for PRX-102? - Protalix and Chiesi are working closely together on the submission, with responsibilities shared between both companies [56] Question: What feedback has Chiesi provided regarding its commercial preparations for the potential future US launch of PRX-102? - While specific details were not disclosed, preparations have started, and the company is pleased with Chiesi's progress [58]

Protalix Biotherapeutics, Inc. (NYSE:PLX) Q2 2019 Earnings Conference Call August 8, 2019 8:30 AM ET Company Participants Dror Bashan - President & CEO Conference Call Participants Edward Marks - H.C. Wainwright & Co. Peter Welford - Jefferies Operator Good morning ladies and gentlemen and welcome to the Protalix Second Quarter 2019 Financial Results and Corporate Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions wi ...

Protalix Biotherapeutics, Inc. (NYSE:PLX) Q1 2019 Earnings Conference Call May 6, 2019 8:30 AM ET Company Participants Yossi Maimon - CFO, VP, Treasurer & Secretary Moshe Manor - CEO, President & Director Conference Call Participants Edward Marks - H.C. Wainwright & Co. Peter Welford - Jefferies Operator Good day, ladies and gentlemen, and welcome to the Protalix First Quarter 2019 Financial Results and Corporate Conference Call. [Operator Instructions]. As a reminder, this call will be recorded. I would no ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q4 2018 Earnings Conference Call March 18, 2019 8:30 AM ET Company Participants Yossi Maimon - CFO Moshe Manor - CEO Conference Call Participants Ram Selvaraju - H.C. Wainwright Operator Good day, ladies and gentlemen, and welcome to the Protalix Full Year 2018 Financial Results and Corporate Update. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for todayÂ's conference, Yossi Maimon, Chief Fina ...