Protalix BioTherapeutics(PLX) - 2019 Q3 - Earnings Call Transcript

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]