Protalix BioTherapeutics(PLX) - 2020 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the year ended December 31, 2020, the company recorded revenues from selling goods of $16.2 million, compared to $15.8 million for the same period in 2019, indicating a slight increase [26] - Revenues from license and R&D services for the year ended December 31, 2020 were $46.7 million, up from $38.8 million in 2019, primarily due to revenue recognized from updated cost estimations of completed Phase III clinical trials of PRX-102 [26] - Research and development expenses net for 2020 were $38.2 million, down from $44.6 million in 2019, attributed to the completion of two Phase III clinical trials and reduced costs related to the BALANCE study [27] - Selling, general and administrative expenses increased to $11.1 million in 2020 from $9.9 million in 2019, mainly due to higher share-based compensation costs [28] - Cash, cash equivalents, and short-term bank deposits were approximately $38.5 million at the end of 2020, compared to approximately $18 million at the end of 2019 [29] Business Line Data and Key Metrics Changes - The lead pipeline candidate, PRX-102, is aimed at treating Fabry disease, with the therapeutic market forecasted to be around $1.9 billion in 2021, growing at a CAGR of approximately 9.5% [10] - The company has submitted a BLA for PRX-102 to the U.S. FDA, with a priority review status and an adjusted PDUFA date of April 27, 2021 [11] Market Data and Key Metrics Changes - The company anticipates that the market opportunity for moderate to severe pulmonary sarcoidosis could be significant, potentially reaching hundreds of millions of dollars, although it is difficult to estimate if it will exceed $1 billion in the coming years [39] Company Strategy and Development Direction - The company aims to advance its clinical programs and has a roadmap for upcoming strategic milestones, including the potential commercial launch of PRX-102 later in 2021 [6][8] - The company is also developing additional candidates such as PRX-110 for respiratory diseases and PRX-115 for refractory gout, with plans to commence Phase 1 clinical trials in 2022 [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and operational readiness despite challenges posed by the global pandemic, looking forward to an exciting year ahead [23][32] - The company is prepared for the commercial launch of PRX-102, with all necessary preparations in place, including marketing and sales teams [38] Other Important Information - The company raised approximately $40 million in gross proceeds through a public equity offering in early 2021 and an additional $8.8 million through its ATM program [30] - The company has $58 million of convertible notes on its balance sheet that could potentially be redeemed in December 2021 [30] Q&A Session Summary Question: What are your thoughts on Elelyso sales performance in 2020, and what are your expectations for 2021? - Management indicated that Elelyso sales were approximately $16 million in 2020, with expectations for 2021 to remain similar, potentially slightly better, but impacted by the pandemic in Brazil [34] Question: What are your expectations regarding the PDUFA date for PRX-102? - Management confirmed the PDUFA date is April 27, 2021, and they are prepared for a launch shortly after approval [35] Question: Can you comment on the launch preparation activities for PRX-102 and pricing information? - Management stated that preparations are complete and will discuss pricing post-approval [37] Question: What is the market opportunity for moderate to severe pulmonary sarcoidosis? - Management noted that there is a significant unmet need in this area, estimating a market potential of hundreds of millions of dollars [39] Question: What are the implications of the BRIGHT study for modifying the label for PRX-102? - Management indicated that the BRIGHT study outcomes are not part of the submitted BLA, but they plan to submit a clinical supplement post-approval [43] Question: How are FDA inspections going? - Management did not provide specific insights but assured that updates will be shared once available [49]