Protalix BioTherapeutics Inc. ($PLX), a biopharmaceutical company, is focused on the development of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system. The company recently announced Phase II Clinical Trial Results for alidornase alfa in Cystic Fibrosis (CF). The new clinical data pertaining to ppFEV1 measurement taken after washout of alidornase alfa demonstrates meaningful decrease in efficacy parameters once treatment with alidornase alfa stopped further supporting alidornase alfa clinical efficacy, with over 70% reduction in the presence of pseudomonas, a leading cause of infections and cause of morbidity in CF patients.
The company received another positive news as it received the FDA nod for operating its current manufacturing facility in Carmiel, Israel as a multi-product facility. Protalix BioTherapeutics believes that the conversion will help the company in meeting the increased production needs of taliglucerase alfa, which has seen surge in its demand in Brazil. The approval will also be helpful to ensure the smooth manufacturing process in the event of commercialization of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. Protalix BioTherapeutics further elaborated that the conversion will not require substantial additional capital expenditure.
Protalix BioTherapeutics showed the robustness of its growth in its Q1 numbers. The company reported its total revenue at $2.9 million, up from $679,000 it had generated during the same period of 2016. It also showed marginal reduction in its net losses from $8.6 million to $8.3 million. Its Research and development expenses declined from $6 million to $4.6 million. The Israel based company has also shown substantial increase in its activities in Brazil, increasing its international reach.
The company stock has mimicked the strong operating performance of the company as it skyrocketed 101 percent this year so far. However, it has also seen some pullback, bringing it nearly 40 percent lower than its 52 weeks high of $1.51. The dip provides an interesting entry point as the aforementioned recent developments are expected to provide further positive fillip to the stock price.
The firm currently has three products in the pipeline at varying stages, which require the company to maintain strong liquidity position. The company closed its first quarter with $48 million in cash and cash equivalents. The funds are expected to sustain operations into 2019. However, any debacle in the development process may leave the company starving for funds, potentially hitting its survival prospects. However, Protalix BioTherapeutics has been seeing increase in its revenues, especially in the foreign markets, which may boost its cash chest.
Main upcoming catalyst relates to the shipment of alfataliglicerase as part of a $24.3 million deal. The shipments are expected to occur in June, September and December.
Chief Executive Officer, President, Director
Moshe Manor has served as the company’s President and Chief Executive Officer and as a director of our company since November 2014. Prior to joining Protalix, Mr. Manor served in a number of senior executive positions at Teva Pharmaceutical Industries Ltd. from 1984 through 2012.
Yossi Maimon, CPA
Chief Financial Officer
Yossi Maimon, CPA, joined Protalix Ltd. in 2006 as its Chief Financial Officer and became our Vice President and Chief Financial Officer in 2006. Prior to joining Protalix, from 2002 to 2006, he served as the Chief Financial Officer of Colbar LifeScience Ltd.
Investment strategy - (by Dr KK De)
Entry - Current price point
Profit Point – at the time of launch of Loyon Lotion
Hold duration – Medium Term
Price Target (consensus) - $3.40
Exit - $1.85
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