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Ionis Incurs Wider-than-Expected Loss in Q1, Stock Down

Ionis Pharmaceuticals, Inc. IONS reported a loss of 52 cents per share in the first quarter of 2016, wider than the year-ago loss of 14 cents and the Zacks Consensus Estimate of a loss of 50 cents. The company’s shares plunged 7.8% following the release of first-quarter results.

Total revenues in the quarter plunged 41.1% year over year to $36.9 million. Revenues also missed the Zacks Consensus Estimate of $39.9 million.

The Quarter in Detail

Research, development & patent expenses increased 25.6% year over year to almost $81 million. General & administrative expenses also increased 41.5% year over year to $10.6 million.

Ionis has made significant progress with its pipeline. While enrollment in a phase III study on volanesorsen in patients with familial chylomicronemia syndrome is complete with data anticipated in the first half of 2017, another phase III study in patients with familial partial lipodystrophy is well underway.

We note that Ionis has partnership programs with companies like Biogen Inc. BIIB and GlaxoSmithKline plc GSK among others. Under its collaboration with Biogen, enrollment in a phase III study (CHERISH) on nusinersen for the treatment of spinal muscular atrophy (SMA) in children is complete and enrollment in another phase III study (ENDEAR) in infants with SMA is expected to complete within the coming months. Data from both these studies are expected in the first half of 2017.

In addition to these phase III studies, nusinersen is being evaluated in several phase II studies for the same indication.

On the other hand, IONIS-TTRRx is being developed in collaboration with Glaxo for all forms of transthyretin (TTR) amyloidosis. Data from a phase III study (NEURO-TTR) on IONIS-TTRRx in patients with familial amyloid polyneuropathy (FAP) is also expected in the first half of 2017.

Glaxo also plans to initiate a phase III study (CARDIO-TTR) on IONIS-TTRRx in patients with the cardiomyopathy form of TTR amyloidosis. The company is working closely with the FDA to get the study started. Additionally, Glaxo is planning to evaluate IONIS- TTRRx in an orphan study in patients with the familial form of TTR amyloidosis as well as the wild type form.

Positive data from studies on volanesorsen, nusinersen and IONIS-TTRRx would allow the company to file for approval thereafter.

In a separate press release, Ionis announced that Kastle Therapeutics has acquired global rights to develop and commercialize Kynamro (mipomersen sodium). In the U.S., Kynamro is approved for the treatment of patients with homozygous familial hypercholesterolemia to reduce low density lipoprotein-cholesterol, apolipoprotein B, total cholesterol and non-high density lipoprotein-cholesterol as an adjunct to lipid lowering medications and diet.

The deal with Kastle will see Ionis receiving up to $95 million, which includes an upfront payment of $15 million, a $10 million payment on the third anniversary of the deal and up to $70 million in sales milestones. Beginning 2017, Ionis will earn royalties on global sales of Kynamro in the mid-to-low teens. Additionally, Ionis will receive a 10% equity stake in Kastle's parent company.  Meanwhile, Sanofi Genzyme, the specialty care global business unit of Sanofi SNY, will be eligible to receive a 3% royalty on sales of Kynamro and 3% of the cash payments Ionis receives from Kastle.

2016 Guidance Intact

For 2016, Ionis continues to expect net operating loss in the low $60 million range and a cash balance of more than $600 million.

Our Take

Ionis’ first-quarter results were disappointing with the company reporting a wider-than-expected loss and revenues missing expectations. Nevertheless, Ionis’ agreements with leading health care companies continue to validate its antisense technology and provide the company with funds in the form of upfront, milestone and other payments. We are also positive on the Kastle deal for Kynamro.

The company expects several milestone payments for the rest of the year along with pipeline updates. We expect investor focus to remain on pipeline updates from the company.

Ionis is a Zacks Rank #2 (Buy) stock. Sanofi is another favorably ranked stock in the health care sector carrying the same Zacks Rank as Ionis.

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