Although fourth quarter earnings season is coming to a close, a few companies are yet to report their results. Late last week, Raptor Pharmaceutical Corp. (RPTP) reported its fourth quarter results.
The company posted a loss of 22 cents per share in the fourth quarter of 2013, wider than the Zacks Consensus Estimate of a loss of 17 cents per share. Loss per share in the four month transitional period (on Dec 4, 2012, the company had changed the fiscal year end from Aug 31 to Dec 31) ended Dec 31, 2012 was 35 cents.
In 2013, loss per share was $1.02 narrower than the Zacks Consensus Estimate of a loss of $1.18 per share. For the year ended Aug 31, 2012 loss per share was 75 cents.
In the reported quarter, net product sales were $10.2 million, surpassing the Zacks Consensus Estimate of $9 million. In the four month transitional period ended Dec 31, 2012, Raptor Pharma did not generate any revenues.
In 2013, net product sales were $16.9 million, surpassing the Zacks Consensus Estimate of $16 million. For the year ended Aug 31, 2012, Raptor Pharma did not earn any revenues.
In the reported quarter, Procysbi generated sales of $10.2 million.
By the end of 2013, Procysbi (launched in Jun 2013) generated 236 new prescriptions. Including new and resale prescriptions, the company reported 533 shipments of Procysbi till the end of 2013.
Meanwhile, Raptor Pharma intends to launch the drug in the EU, where it gained approval in Sep 2013, in the first half of 2014. Procysbi has orphan drug designation in both the U.S. and the E.U. for nephropathic cystinosis.
In the reported quarter, R&D expenses were $7.8 million, as against $8.9 million in the four month transitional period ended Dec 31, 2012.
SG&A expenses were $12.4 million, as against $8.9 million in the four month transitional period ended Dec 31, 2012.
Raptor Pharma is working on strengthening its pipeline. In Jan 2014, the company completed enrolling patients for its phase IIb pediatric study on RP103. This study is evaluating the safety and efficacy of RP103 for the treatment of non-alcoholic fatty liver disease (:NAFLD) and non-alcoholic steatohepatitis (NASH) in children. The company expects to complete the study in early 2015. Results should be out in the first half of 2015.
Additionally, top-line results from an 18 month analysis of a phase II/III study on RP103 for Huntington's disease showed a positive trend towards slower disease progression in patients treated with RP103 compared to placebo. Raptor Pharma will also start enrolling patients for a study on RP103, as a treatment for Leigh syndrome, early in the second quarter of 2014.
Raptor Pharma expects net product sales from Procysbi in the range of $55 million−$65 million. Operating expenses are expected in the range of $80 million−$90 million in 2014.
We expect investor focus to remain on the commercialization of Procysbi.
Raptor Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Alexion Pharmaceuticals, Inc. (ALXN), Alkermes plc (ALKS) and Gilead Sciences Inc. (GILD). All these stocks carry a Zacks Rank #1 (Strong Buy).