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Ionis Pharmaceuticals, Inc. (IONS)

Q3 2012 Earnings Call· Tue, Nov 6, 2012

$71.53

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Transcript

Operator

Operator

Welcome to the Isis Pharmaceuticals' Third Quarter Financial Results Conference Call. Leading the call today from Isis is Dr. Stanley Crook, Isis’ Chairman and CEO. Dr. Crook, please begin.

Stanley T Crooke

Management

Good morning and thank you for joining us on today's conference call to discuss our third quarter financial results. Lynne will discuss our financial results and after that, I’ll give you a brief update on pipeline progress and planned activities for the rest of the year. Joining me on today's call are Lynne Parshall, COO and CFO, Beth Hougen, Vice President of Finance, Richard Geary, Senior Vice President of Development, and Wade Walke, Executive Director of Corporate Communications and Investor Relations. Wade, will you please read the forward-looking language statement?

D. Wade Walke

Management

Yes thanks Stan. Good morning everyone. A reminder to everyone this webcast includes forward-looking statements regarding Isis’ business, the financial outlook for Isis and the therapeutic and commercial potential of Isis’ technology and products in development. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs including the plan commercialization on KYNAMRO 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 31, 2011 and its most recently quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company. Now, I’ll turn the call over to Lynne.

B Lynne Parshall

Management

Thanks Wade. Good morning everyone and thank you for joining us. 2012 has been a very successful year so far leading our achievement is of course KYNAMRO. We’re pleased with the FDA Advisory Committee voted in favor of approving KYNAMRO in the U.S. for patients with severe forms of FH. These are patients who had extreme risk of a fatal cardiovascular event despite all the medicine has to offer today. We believe that KYNAMRO can make sound difference for these patients. To that end, we’re working with Genzyme on the next steps for KYNAMRO approval for homozygous FH in the U.S. Genzyme continues to make progress with the European regulatory agency as well, although the process has taken a bit longer than anticipated. The teams continue to ensure that all of the Agency’s questions are answered thoroughly. Although no final decision has been made by the EU regulators, we currently believe that the label for KYNAMRO in Europe maybe somewhat narrower than what we originally proposed and maybe more inline with what we expect to receive in the U.S. We remain on track to hear back from the European Agency by the end of this year. The ongoing focus of FH study, which is under an SPA with FDA, is designed for broadening the KYNAMRO indication. This study is an important element to support for long-term growth potential with KYNAMRO in the patient populations beyond homozygous FH. Genzyme we believe the initial commercial market for KYNAMRO in homozygous FH will be significant and expansion into the severe heterozygous FH population has the added potential to make KYNAMRO, a very significant commercial success. Beyond KYNAMRO, we have an exciting and robust line up of noble first-in-class drugs and over the next three months we expect to report clinical data on a…

Stanley T. Crooke

Management

Thanks Lynne. So in 2012 we’ve had a number of successful, KYNAMRO our flagship drug is (inaudible). We think the positive panel vote and the progress made to bring KYNAMRO to the market or report sense for patients who are in desperate need for KYNAMRO, and for our technology. These patients need to be treated very early in life, and continue on treatment for their entire life. So despite the fact that these patients have the severe disease, it’s essential that the drug used for treatment is that this disease be safe enough to be used throughout their life. then we expect to achieve approval for these patients’ concerns that our technology produces medicines with safety profiles that are more than adequate for the indications we’re pursuing. And I’ve got particular importance for the technology is that we conducted a focused clinical trial on KYNAMRO that evaluating all the markets of systemic information that we can assay. With very careful time courses around each dose of KYNAMRO, we found that KYNAMRO caused no systemic information in human beings. This is not only great news for KYNAMRO, but of course, it’s also great news for the technology. We’re also very pleased with the results from the questions of these studies, the conclusions of the independent lipidologists and the independent CRO will conduct at the trials where the studies were clean. Meaning that there were only incidental observations being not related to KYNAMRO, we and Genzyme agree with those conclusions. Again, this is great news for KYNAMRO and great news for the technology. So 2012 has been a fine year for us on several fronts. We will end the year with a strong cash position, a pipeline promising new medicines and a technology that’s creating novel first-in-class therapies. With the business novel…

Operator

Operator

Thank you. (Operating Instructions) Please stand by for your first question. Your first question comes from the line of Salveen Richter, Canaccord. Your line is open, please go ahead. Salveen K. Richter – Canaccord Genuity, Inc.: Sure, thanks for taking my questions. Just wondering with the amendment of your, Glaxo partnership relating to TTR, were all of the increased milestones related to accelerated development, or did Glaxo gain additional rates to the drug. And then just also wondering the $2.5 million and $7.5 million milestones that you are supposed to get by the end of quarter, should we expect that to be amortized and over whatever period?

B Lynne Parshall

Management

So GSK did not get any additional rates to any additional programs. They enhanced the economics…

Stanley T Crooke

Management

(Inaudible)

B Lynne Parshall

Management

Or any additional rates to this program. The enhanced economics reflects the fact that we are accelerating the development of the program. We hope to be able to put the drug on the market faster with a more efficient and effective development plan. In other words, taking the very positive Phase I results that we have are going directly into our Phase III study, instead of going Phase I, Phase II, Phase III, which would have been more expensive and importantly taken a lot long longer to complete. And so we’re awarded for that increased efficiency, both in terms of additional pre-commercialization milestone, additional milestones while the Phase III trial is ongoing and additional post-commercialization sales milestones. You will remember that we had $10 million milestone under the original agreement that we would get at the beginning of the next study. That $10 million, $2.5 million of it’s being accelerated and we earned that when we signed the amendment. The other $7.5 million will get when the study starts. And those two payments, the $2.5 million and the $7.5 million that we plan to get this year will be amortized over the two and a half year period of the performance for the work under the amendment. Salveen K. Richter – Canaccord Genuity, Inc.: Okay. And then just a follow up question, regarding KYNAMRO, in the FDA documents, there was a comment about how that you could look at efficacy and determine a threshold LDL reduction over a certain time period, and we didn't see that reduction potentially discontinuing the drug. Do you think that’s going to actually play out in the label?

Stanley T Crooke

Management

No. I think just to practice medicine. The facts are, what we saw was, I think actually very reasonable variability in the homozygous FH trial certainly no greater variability than we’re seeing with other drugs in this patient population. And you’ll remember that we showed that the vast majority of the sort of small responders were more of late responders, they occur, we saw them begin to respond a little later than some other patients. So what we believe is that the label where reasons we’d expected and physicians will treat their patients, and monitor the performance of the drug, now if they don't see good performance by 6 to 12 weeks. And they will make changes to the drug and we expect good performance in the vast majority of patients. Salveen K. Richter – Canaccord Genuity, Inc.: Okay. thanks, Stan.

Stanley T Crooke

Management

You bet.

Operator

Operator

Thank you. You have no questions at this time. (Operator Instructions)

Stanley T Crooke

Management

As there are no further questions, I want to thank everyone for their participation. We do have a very full agenda for the end of the year, we will keep you posted on the progress that we make, and then and they get sets up for an exciting year for the pipeline and the technology in KYNAMRO, in 2013. Thanks so much.

Operator

Operator

Thank you for your participation in today's conference, this concludes the presentation. You may now disconnect. Have a good day.