Earnings Labs

Ionis Pharmaceuticals, Inc. (IONS)

Q4 2007 Earnings Call· Thu, Mar 13, 2008

$74.19

+3.36%

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Transcript

Operator

Operator

Welcome to ISIS Pharmaceuticals fourth quarter financial results conference call. Today's call is being recorded. Leading the call today from ISIS is Dr. Stan Crooke, ISIS Chairman and CEO. Dr. Crooke, please begin.

Stan Crooke

Chairman

Good morning and thanks everyone for joining us on today's conference call to discuss the financials for the fourth quarter and the full year of 2007. Joining me today on the call are Lynne Parshall, COO and CFO; Jeff Jonas, Executive Vice President; Beth Hougen, Vice President of Finance and Kristina Lemonidis, Associate Director of Investor Relations. The financials that we will discuss today demonstrate that 2007 was a transformational year for the company, and that the momentum established in 2007 continues strong in 2008. We have led the way to a new drug discovery platform. We are the leaders of antisense technology and we have successfully executed the unique business strategy it's built on, the efficiency and productivity of antisense. As a result of all of these successes we can confidently state that for the foreseeable future we will not need to return to Wall Street to raise additional cash. At Isis we have pioneered the creation of RNA-based drug discovery and Ibis based infectious organism identification technology. Antisense technology changes drug discovery and drug development. Similarly Ibis technology changes the identification of infectious organisms. Using antisense technology we can rapidly evaluate all potential targets to support a data-driven decision about which targets are likely to be the best for drug discovery. Antisense's best based drug discovery and early development of processes are more rapid, less expensive, and more likely to succeed than with other technologies. And our drugs are more specific, more effective, better tolerated and more predictable than other drugs. So when partners engage in partnership with Isis they certainly are focused on the opportunities presented by our drugs, but more than that they are accessing our technology with the goal of enhancing the productivity of their R&D programs. Similarly when Abbott entered into a strategic relationship…

Kristina Lemonidis

Management

Thanks, Stan, good morning everybody. A reminder to everyone, this webcast includes forward-looking statements regarding our business, the financial outlook for Isis as well as its Ibis Biosciences subsidiary and its Regulus joint venture, 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 is forward-looking statement and should be considered an at-risk statement, including those statements that are described as Isis' goals. 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 in human therapeutics and in the endeavor of building a business around such products. 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' 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, 2006, and its quarterly report on Form 10-Q for the quarter ending September 30th, 2007, which are on file with the SEC. Copies of these and other documents are available from the company. And now I would like to turn it over to Lynne.

Lynne Parshall

COO

Thanks Kristina. As usual I am assuming that you have all had an opportunity to read the press release we issued this morning. So I am not planning to reiterate what is detailed in the press release. But I will be happy to answer questions at the end. As Stan said, 2007 was a transformational year for Isis. We reduced our net operating loss from our projected high $60 million loss to a loss of $29 million and we dramatically strengthened our balance sheet and we are predicting another 50% reduction in our NOL in 2008 over 2007. We have already added approximately $270 million in new cash and we are making great progress towards finalizing our Genzyme contract, so we will add an additional $175 million shortly, bringing the total cash from our partnerships to nearly $450 million. Based on our existing cash and committed cash including the $175 million Mipomersen licensing fee due from Genzyme, but not including the up to $210 million we could receive from Abbott. We expect that our 2008 yearend cash balance will be greater than $450 million and will last for at least five years. Additionally, we are very encouraged about the Abbott-Isis relationship, and are optimistic that Abbott will exercise its option to acquire Ibis. That would give us the opportunity to receive up to an additional $210 million. Furthermore, we expect our net operating loss excluding non-cash compensation to be less than $15 million in 2008, so all the positive financial momentum of 2007 will continue into 2008. Mipomersen continued to perform very well and its performance is representative of the performance that all our drugs are capable of delivering. It shows very strong activity, tolerability and consistent predictable performance from patient to patient, across patient population and in the presence…

Stan Crooke

Chairman

Thanks Lynne. 2007 was a great year and we have an equally aggressively and exciting agenda for 2008. Let me begin with Mipomersen. We're initiating other components of our Phase 3 program including studies in patients with heterozygous headaches. We also plan to report important new safety data that we hope will support our belief that Mipomersen is well tolerated by the liver. These data will include an update on the experience we're gaining in our open label extension study. In this study, we are acquiring important data in patients treated with Mipomersen for actually quite for long times now. Further, we plan to report data from our MRI study, designed to evaluate the effects of Mipomersen on fat levels in the lever. While these are safety data, they are key data because they address the sole remaining question about Mipomersen and that is, is it going to be tolerated with long-term treatment. We look forward to presenting those data from both of our studies this year. We also expect to have progressive report with the rest of the cardiovascular pipeline. Our CRP inhibitor ISIS 353512 should enter clinical trails in the middle of the year and we expect to select a development candidate for PCSK9 with our partner BMS. I believe we have the most exciting pipeline in metabolic disease of any company large or small. This is comprised of a novel insulin sensitizer, a dual acting glucagon receptor integrator that increases GLP-1 and preserves the pancreas function, a liver selected with corticoid receptor inhibitor and an SGL2T inhibitor that increases glucose excretion in the urine. Four drugs each unique and each complimentary in terms of mechanism to the other. We expect to report results from an important Phase 2 study in which our PTP-1b inhibitor and insulin sensitizer…

Operator

Operator

(Operator Instructions) Our first question will come from Salveen Kochnover from Jefferies Salveen Kochnover - Jefferies & Co.: Hi, thank you for taking my questions. Stan, it looks like you initiated more than one Phase III heterozygous FH trial of Mipomersen. Could you describe the design of these trials as well as provide time lines for the Phase III Mipomersen data releases this year? Thanks.

Stan Crooke

Chairman

We are initiating the entire Phase III program. And that does include trials in heterozygous FH and the trials are focused on patients with heterozygous FH who have coronary artery disease…. [call ends abruptly]