Ariad Pharmaceuticals, Inc. (ARIA - Analyst Report) reported first quarter loss of 36 cents per share, wider than the year-ago loss of 25 cents per share but narrower than the Zacks Consensus Estimate of a loss of 37 cents per share.
First quarter revenues were $6.5 million, compared with $0.08 million in the year-ago quarter. Revenues surpassed the Zacks Consensus Estimate of $4 million.
Research and development expenses increased 43.4% year over year to $41.3 million. The increase was attributable to the company’s efforts to develop and manufacture Iclusig and AP26113. Selling, general and administrative expenses increased 161.2% year over year to $29.5 million. The massive increase was primarily attributable to the expenses incurred by the company in preparation of the launch of Iclusig.
By the end of the reported quarter, more than 325 patients in the US were given Iclusig. We note that in Dec 2012, the US Food and Drug Administration (FDA) granted accelerated approval to Iclusig for use in heavily pretreated patients, suffering from resistant and refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig generated $6.4 million of US net sales in the quarter. Around 300 unique physician prescribers for Iclusig and above 250 unique accounts using Iclusig were noted at the end of Apr 2013.
In Mar 2013, Ariad received a positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) for Iclusig for the treatment of CML and Ph+ALL. Ariad expects to gain approval by Jun 2013. Ariad has filed a Marketing Authorization Application (MAA) for Iclusig in Switzerland and expects to file for approval in Canada and Australia in the third quarter of the year.
Iclusig is in the phase III EPIC study, in which it is being compared to imatinib in patients with newly diagnosed CML. Ariad is presently enrolling patients for the study with interim data likely to come out in the third quarter of 2014. Iclusig is in another phase III study, SPIRIT 3, for which enrollment will start in the third quarter of 2013.
Meanwhile, the phase I part of the phase I/II study on AP26113 is about to complete. Ariad expects to begin phase II expansion cohorts by June. Simultaneously, Ariad also plans to start a pivotal study of AP26113 in ALK-positive non-small-cell lung carcinoma (NSCLC) patients who are resistant to crizotinib in the third quarter of the year.
Ariad currently carries a Zacks Rank #3 (Hold). Currently, companies like Lannett Company, Inc. (LCI - Snapshot Report) , Santarus, Inc. and Catalyst Pharmaceutical Partners Inc. (CPRX - Analyst Report) look more attractive with a Zacks Rank #1 (Strong Buy).