Isis CEO Discusses Q3 2010 Results - Earnings Call Transcript
Isis Pharmaceuticals, Inc (
)
Q3 2010 Earnings Call
November 04, 2010 04:30 p.m. ET
Executives
Stan Crooke - CEO
Kristina Lemonidis - Director, IR
Lynne Parshall - CFO & COO
Analysts
Laura Ekas - Collins Stewart
Ted Tenthoff - Piper Jaffray
Mark Monane - Needham
Shiv Kapoor - Morgan Joseph
Charles Polsky - William Harris Investors
Presentation
Operator
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Isis Pharmaceuticals Inc. Q2 2009 Earnings Call Transcript
Welcome to Isis Pharmaceuticals Third Quarter Financial Results Conference Call. Leading the call today from Isis is Dr. Stan Crooke, Isis Chairman and CEO. Dr. Crooke, please begin.
Stan Crooke
Good afternoon and thanks everyone for joining us on today's call to discuss our third quarter financial results. Joining me on the call today are Lynne Parshall, COO and CFO; Beth Hougen, Vice President of Finance; and Kristina Lemonidis, Director of Corporate Communication. Kris, will you please read our forward-looking statements.
Kristina Lemonidis
I sure will. Good morning, everyone. A reminder to everyone that this webcast includes forward-looking statements regarding Isis's business; the financial outlook for Isis as well as Regulus, its jointly-owned subsidiary; and the therapeutic and commercial potential of Isis technologies and products and development. 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 never materialized or proved correct could cause its results to differ materially from those expressed or implied by such forward-looking statements.
Although Isis's forward-looking statements reflects 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 31, 2009 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the company.
And with that, I'll turn the call over to Lynne to review our financial results.
Lynne Parshall
Thanks, Kris. As usual I'll assume that you've read the details of the third quarter financial results in our press release. And I'll of course be happy to take questions at the end of today's call. We've continued to make excellent progress this year. We have now completed four positive Phase 3 studies of mipomersen. And we're on track to file for marketing approval in the first half of the year, to bring mipomersen to our initial patient population. These are patients at severe risk for cardiovascular events, and we hope mipomersen will be the therapeutic alternative that will help them lead longer healthier lives.
This year we also established an exciting new alliance with GSK that we believe will be extremely productive for both companies. Our existing partnerships also continue to be successful and advancing antisense drugs discovered by us. Already this year, we've received more than $65 million from our partners, in up front and milestone payments, including $40 million we've received from GSK. We've finished the third quarter with pro-forma net operating loss of $23.1 million for the first nine months this 2010 and we ended the quarter with nearly $500 million in cash.
Now I would like to take a few moments to compare our 2010 revenue to 2009. As you probably heard me say, our revenue consists of several different components including amortization of upfront fees we received from our partners. Our NDA revenue to support our collaborations, milestone payments, sub license fees, plus revenue we earn from other miscellaneous transactions. Already this year, we've had new revenue from almost all of these sources. Recognizing revenue from the amortization of the $35 million upfront payment we received from our new alliance with GSK.
We received sub licensing revenue from Regulus new alliance with Sanofi-Aventis. And we've received $13 million in milestone payments, the most recent of which was $5 million from GSK for identifying a development candidate. We keep most of these milestones in the middle of the year. Although in the first quarter -- fourth quarter of this year, we expect to achieve additional milestones. Most of these milestones will not result in significant new revenue.
This means that our fourth quarter revenue will be lower than previous quarters this year. We are in a position of financial strength and we're now able invest more of our internal resources to enhance the value of our drugs and bring new drugs into our pipeline. You've seen the effects of our implementation of this drug, which we reflected in our expenses this year.
In addition, we and Genzyme completed mipomersen's Phase 3 program to support our first filings for marketing approval and the expenses from this program are also reflected in our increased expenses this year compared to last.
As we look to the fourth quarter, we have a number of internal programs that are advancing. We will begin Phase 2 programs for our CRP and eIF-4E, which once completed should provide us with clinical proof of concept. We will begin clinical development of our Factor 11and APOCIII program which we moved into our pipeline late last year. And finally we'll be adding to our pipeline. All of these activities will continue to increase the value of our maturing pipeline and increase our expenses in the fourth quarter of this year.
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