Isis Pharmaceuticals, Inc. (ISIS)
Q4 2012 Earnings Call
February 28, 2013 12:00 pm ET
Stanley T. Crooke – Chairman and Chief Executive Officer
D. Wade Walke – Executive Director, Corporate Communications and Investor Relations
B. Lynne Parshall – Director and Chief Operating Officer
Elizabeth L. Hougen - Senior Vice President and Chief Financial Officer
Andrew Goldsmith – Canaccord Genuity
Chad Messer – Needham & Company
Nicholas Bishop – Cowen and Company
Steven Willey – Stifel Nicolaus
Ted Tenthoff – Piper Jaffray
Carol Werther – Summer Street Research
Doug Adams – Tocqueville Asset Management
Previous Statements by ISIS
» Isis Pharmaceuticals' CEO Discusses Update on FDA Approval of KYNAMRO Conference Call (Transcript)
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» ISIS Pharmaceuticals' CEO Presents at Review of CHMP Opinion on KYNAMRO Conference (Transcript)
Stanley T Crooke
Good morning and thanks everyone for joining us on today’s call to discuss our year-end financial results. On the call today, Lynne will review our key 2012 accomplishments; Beth will walk you through our financials and our guidance for 2013. After that, I’ll focus on the busy year we have ahead and our key goals for 2013.
Joining me on today’s call are Lynne Parshall, COO; Beth Hougen, CFO; Wade Walke, Executive Director of Corporate Communications and Investor Relations. Before we begin, I’m pleased to have Beth joining us in our first meeting as CFO to present the financial highlights. Beth was promoted to Chief Financial Officer at the beginning of the year.
As most of you know, Beth has been with us since 2000 and brings significant financial and accounting expertise to her new role at Isis. So congratulations, Beth. And now Wade, will you read our forward-looking language statement, please?
D. Wade Walke
Thanks, Stan. A reminder to everyone that this webcast includes forward-looking statement regarding Isis’ business, the financial outlook for Isis and the therapeutic, and commercial potential of Isis technologies and products, and developments.
Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs including the commercial potential 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 of 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 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.
Now, I’ll turn the call back over to Lynne.
B. Lynne Parshall
Thanks Wade. Good morning, everyone, and thanks for joining us. 2012 was another successful year. Together with Genzyme, we completed the final steps of FDA approval to bring KYNAMRO to the market in the United States for patients with homozygous familial hypercholesterolemia.
We continue to advance our pipeline. We reported positive clinical data from multiple drugs and we initiated numerous clinical studies in a variety of therapeutic settings, which this year will provide us with a steady stream of data.
We added four new partnerships with AstraZeneca and Biogen Idec that will greatly enhance our direct discovery and development efforts in cancer and severe and rare neurological diseases. And we improved our already solid financial positions ending the year with significantly more cash than we started.
In addition, we maintained a relatively flat expense level despite moving many drugs forward in later-stages of clinical development. In short, it was a very busy and successful year. Since we have had a number of conference calls discussed the positive clinical data we’ve reported last year, I’ll just spend a few minutes discussing KYNAMRO in more detail before I turn the call over to Beth to go through our financials.
KYNAMRO has improved in the U.S. for patients with homozygous FH is a landmark event for these very sick patients and for Isis and for Genzyme. KYNAMRO represents an important new therapy for homozygous FH patients who have significant risk of early cardiovascular events and death, despite all currently available therapies.
We’re very enthusiastic about the potential benefit KYNAMRO can bring to these patients. We’re fortunate to have Genzyme, a leader in marketing and selling orphan drugs, commercializing KYNAMRO, Genzyme’s pre-launch efforts have positioned KYNAMRO for a successful launch. Genzyme has begun training and certifying doctors under the REMS program. These doctors are writing prescriptions for their homozygous FH patients, and you will feel confident the reimbursement process.
Genzyme has established a robust program KYNAMRO Cornerstone for patient reimbursement support. This is a no-cost program staffed by dedicated Case Managers that provide disease and product education, nursing and reimbursement support and financial assistance to those who qualify.
Through this program, KYNAMRO patients can get the help they need to easily incorporate KYNAMRO into their lives. We’re pleased with the success so far in the KYNAMRO launch and it’s still very early days. In addition, Genzyme has already explained KYNAMRO in Europe on name patient basements. And of course, the FOCUS FH study is going well. FOCUS FH has been conducted under its file with the FDA and is designed to provide safety and efficacy data to support regulatory filings for severe heterozygous FH patients.