plxProtalix BioTherapeutics Inc. (NYSEMKT:PLX) reported financial results for the quarter ended March 31, 2015.

“We continue to execute on our strategy for accelerated growth, which centers on developing products with clinically superior profiles and clear competitive advantages,” said Moshe Manor, Protalix’s President and Chief Executive Officer. “We have a number of key milestones anticipated to occur over the next few quarters that have the potential to create significant shareholder value. We plan to announce interim and full results from our phase I/II clinical trial of PRX-102 for the treatment of Fabry disease during the second half of 2015. Around year-end, we anticipate holding an end of Phase II meeting with the U.S. Food and Drug Administration for PRX-102, and initiating proof of concept clinical trials in patients for both oral antiTNF and AIR DNase. In the first half of 2016, we expect to launch a pivotal head-to-head phase III clinical trial of PRX-102 for the treatment of Fabry disease, and report results from our oral antiTNF and AIR DNase trials.”

Financial Results for the Quarter Ended March 31, 2015

  • Net loss narrowed to $6.0 million, or $0.06 per share, for the first quarter of 2015 down $1.3 million or 19% from $7.3 million, or $0.08 per share, for the same period in 2014.
  • Total revenues for the first quarter of 2015 were $4.4 million compared to$6.7 million for the first quarter of 2014. The decrease resulted primarily from a decrease of$1.8 million of products sold inBrazil and a decrease of$597,000 of products we delivered at cost toPfizer Inc. under our license agreement.
    • During April 2015, we delivered an additional $1.3 million of products to Brazil.
  • Revenue from our share of net income from the collaboration under the Pfizer agreement increased 3% to $705,000 for the first quarter 2015 compared to $687,000 for the first quarter of 2014. The increase resulted primarily from the $5.4 million in revenues generated by Pfizer, mainly in the United States, during the three months ended March 31, 2015 compared to $4.0 for the three months ended March 31, 2014.
  • Cost of revenues was $2.4 million for the first quarter of 2015, a decrease of $1.7 million or 41%, compared to $4.1 million for the same period in 2014.
  • Selling, general and administrative expenses decreased 48% to $1.9 million for the first quarter of 2015 compared to $3.7 million for first quarter of 2014. The decrease resulted primarily from a decrease of $1.0 million in salaries expenses, mainly due to bonuses that were paid during the first quarter of 2014, and the devaluation of the New Israeli Shekel against the U.S. dollar during the period.
  • Cash and cash equivalents as of March 31, 2015 were $48.0 million representing cash consumption for the quarter of approximately $6.8 million.

First Quarter and Recent Operational and Clinical Highlights

  • In January 2015, we announced a new strategy for accelerated growth focused on developing products with potentially clinically superior profiles that offer a clear competitive advantage over other products.
  • For PRX-102, we announced completion of enrollment in our Fabry disease trial on February 2, 2015. We expect to release interim data from the 1mg/kg dose cohort of the trial during the third quarter of 2015, with final results to be released by year-end. We anticipate holding an end of Phase II meeting with the U.S. Food and Drug Administration around year-end and intend to launch a phase III head-to-head pivotal trial comparing PRX-102 to a commercially available enzyme replacement therapy for the treatment of Fabry disease in early 2016.
  • For PRX-106, our oral antiTNF product candidate, a phase I trial is currently on-going. We expect to select an indication for the product candidate and to initiate a proof of concept efficacy study around year-end with results expected in the first half of 2016.
  • We are also currently evaluating clinical sites for our planned AIR DNase clinical trial, which is expected to first enroll healthy volunteers and then cystic fibrosis patients. The trial is being designed to run as a head-to-head study comparing AIR DNase to Pulmozyme. We expect that this trial will be launched around year-end with results to be released in the first half of 2016. (Original Source)

Shares of Protalix Biotherapeutics closed today at $2.11, down $0.03 or 1.4%. PLX has a 1-year high of $4.20 and a 1-year low of $1.53. The stock’s 50-day moving average is $1.97 and its 200-day moving average is $2.03.

On the ratings front, Jefferies analyst Eun Yang upgraded PLX to Buy rating, with a price target of $2.60, in a report issued April 23. The current price target implies an upside of 23.2% from current levels.

According to TipRanks.com, Yang has a total average return of 2.8%, a 61.2% success rate, and is ranked #1262 out of 3594 analysts.

Protalix BioTherapeutics Inc is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on itsproprietary ProCellEx protein expression system, or ProCellEx.