Isis Pharma's Q1 Loss Widens

Isis Pharmaceuticals, Inc. (ISIS) reported first quarter 2014 loss of 27 cents per share, wider than the year-ago loss of 3 cents per share and the Zacks Consensus Estimate of a loss of 23 cents per share.

First quarter revenues decreased 35.1% from the year-ago quarter to $28.2 million, missing the Zacks Consensus Estimate of $33 million.

Lower revenues and higher costs led to the wider loss.

The Quarter in Detail

In the reported quarter, Isis’ revenues decreased due to the nature and timing of license fees, milestone-related payments and other payments from its partners.

R&D expenses increased 39.5% year over year to $53.4 million. SG&A expenses increased 27.9% year over year to $4.4 million.

Isis announced positive phase II data on ISIS-APOCIIIRx, as a single agent as well as in combination with fibrates, in patients with high to extremely high triglyceride levels. The company intends to initiate a phase III study on ISIS-APOCIIIRx in patients suffering from familial chylomicronemia syndrome (FCS) in mid-2014 and a second phase III study later this year in patients with triglycerides higher than 880 milligrams per deciliter. Isis Pharma will file for the marketing approval of ISIS-APOCIIIRx in 2016. ISIS-APOCIIIRx received orphan drug status in the EU for the treatment of FCS.

Meanwhile, Isis Pharma completed a phase II study on ISIS-GCGRRx for type II diabetes. Results should be out shortly. Results from another phase II study on diabetes candidate ISIS-PTP1BRx should be out in late 2014 or early 2015. The company intends to initiate a phase II study on ISIS-GCGRRx for Cushing's syndrome.

Isis Pharma has partnered programs with Biogen Idec Inc. (BIIB) and Roche (RHHBY), among others. In collaboration with Biogen, Isis intends to initiate a phase III study on ISIS-SMNRx for the treatment of spinal muscular atrophy (SMA) in infants (mid-14) and children (second half of 2014).

Isis is developing ISIS-HTTRx for the treatment of Huntington’s disease in collaboration with Roche.

The company expects to end 2014 with three drugs in phase III development and nine in phase II development.

In 2014, Isis Pharma continues to expect net operating loss in the low $50 million range and a cash balance of more than $575 million. The company continues to expect revenues of more than $160 million in 2014 including amortization of upfront fees (more than $45 million) and milestone payments (more than $110 million).

Isis Pharma currently carries a Zacks Rank #4 (Sell).A better-ranked stock in the biotech sector is Alexion Pharmaceuticals, Inc. (ALXN) carrying a Zacks Rank #1 (Strong Buy).

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