Isis Pharmaceuticals, Inc. (ISIS)

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ISIS Pharmaceuticals, Inc. (ISIS)

Q2 2011 Earnings Call

August 4, 2011 4:30 PM ET


Stanley Crooke – Chairman and CEO

Kristina Lemonidis – Director, Corporate Communications

Lynne Parshall – CFO and COO


Laura Ekas – Collins Stewart

Shiv Kapoor – Morgan Joseph

Carol Werther – Summer Street

Lucy Lu – Citigroup



Welcome to Isis Pharmaceuticals’ Second Quarter Financial Results Conference Call. Leading the call today from Isis is Dr. Stan Crooke, Isis Chairman and CEO. Dr. Crooke, please begin.

Stanley Crooke

Good afternoon, and thank you for joining us on today’s conference call to discuss our second quarter financial results. Lynne will discuss our financials, and after that I’ll give a brief update on some of our recent activities.

Joining us on the call today are Lynne Parshall, COO and CFO; Beth Hougen, Vice President of Finance; and Kristina Lemonidis, Director of Corporate Communications. Kris, will you read our forward-looking language statement please?

Kristina Lemonidis

I will. Good afternoon. A reminder to everyone that this webcast includes forward-looking statements regarding Isis’ financial position and outlook, Isis business, the planned commercialization of mipomersen and the therapeutic and commercial potential of Isis technologies and products in development including the business of Regulus, Isis’ jointly owned subsidiary. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.

Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.

Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31st, 2010 and its most recently quarterly report on Form 10-Q , which is on file with the SEC. Copies of this and other documents are available from the company.

And with that, I’ll turn the call over to Lynne.

Lynne Parshall

Thanks, Kris. We continue to make progress in the first half of 2011 highlighted by our announcement last week that Genzyme successfully submitted the mipomersen marketing application to the EMA and remains on track to submit our NDA later this year. The mipomersen European regulatory submission has a significant achievement and brings mipomersen closer to patient with severe risk of dying from cardiovascular disease.

We hope mipomersen will be the therapeutic alternative that will help them lead longer healthier lives. Also last week the registered trade name for mipomersen was unveiled. So now we’ll get used to using the trade name Kynamro. As usual the purpose of the call today is to report our financial performance for the second quarter of 2011. I’m assuming you’ve read the details of the financial results in our press release, so I’ll just cover the highlights. As always I’ll be happy to take questions at the end of the call.

We remain on track to meet our guidance for 2011. We ended the first half of the year with nearly $400 million in cash, and a pro forma net operating loss of approximately $24 million. Already this year we’ve recognized a significant amount of revenue from our GSK collaboration including a $5 million milestone payment we received with the initiation of the Phase I study of ISIS-CRPRx the first drug to enter development under our alliance.

We also began amortizing the $3 million upfront fee we received from GSK for the expansion of our collaboration. This has been very successful collaboration and we look forward to selecting the next drug candidates to move into our pipeline. Our revenue in the first half of 2011 was lower compared to the first half of 2010 principally due to the timing of milestones and other payments.

We anticipated this flow of revenue and it was offset by new revenue we received from GSK this year. The big milestone we plan to earn this year is the $25 million that we will earn when the FDA accepts the NDA filing for marketing approval for Kynamro. We’ve factored this milestone into our 2011 financial guidance.

Already this year we’ve made significant progress in many areas of our pipeline. Just this quarter we initiated Phase I studies for PTP1B and TTR drugs or that begin dosing in the Phase 2 program for our CFT drug and of course we continue to make progress in all of our other ongoing studies many of which will be completed later this year or early next year.

This progress translates into higher cost for these program offset by lower cost associated with the completion of the mipomersen Phase 3 program that supports our initial regulatory filings. As a result, our expenses for the first half of 2011 are essentially flat compared to the first half of 2010. Although we expect our expenses to increase modestly in the second half of the year, we remain on track to meet our guidance of an NOL in the low $40 million range.

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