Sequenom, Inc. (SQNM)

Lazard Capital Markets 8th Annual Healthcare Conference Call

November 15, 2011 8:30 a.m. ET


Paul Maier - Chief Financial Officer

Ronald Lindsay - Director and EVP of Research and Development

Harry Hixson - Chairman and Chief Executive Officer


Sean Lavin - Lazard Capital Markets


Sean Lavin

- Lazard Capital Markets

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I think we will go ahead and get started. I am Sean Lavin, medical technology analyst here at Lazard Capital Markets. Today we have the full Sequenom team. Harry Hixson, CEO, is going to start off. We will also hear from Paul Maier, CFO, and Ron Lindsay, Executive Vice President of Research and Development. Thank you.

Harry Hixson

Thank you, Sean, and thanks to Lazard Capital for inviting us and thank you for coming to our presentation today. This is our forward-looking statements slide and safe-harbor and I think you should familiarize yourself with that. Sequenom, as a company, we operate in two segments. We have a genetic analysis business which is the early part of our business. More recently we have moved over into molecular diagnostics.

The core business that we have right now, most of our revenue comes from the genetic analysis business and the instrument sales, and the consumables. This business is transitioning from academic research work that started originally into the translational applications and clinical diagnostics. From our genetic analyst business we are seeing most of our new and interesting opportunities for molecular diagnostics. So the genetic analysis business and the molecular diagnostics business so we think are synergistic.

Revenue in 2010 was $47.5 million, through the first three quarters of this year, $40.4 million. We have almost a million shares outstanding. We have locations in the -- main locations in San Diego. And we have two CLIA labs. We have a wholly owned subsidiary called Sequenom Center for Molecular Medicine. It’s a wholly owned CLIA, Clinical Laboratory Improvement Act Laboratory. And we have locations in Grand Rapids, Michigan, and we have one also in San Diego.

Our current LDTs, which are cystic fibrosis carrier screen, fetal RHD and age related macular degeneration test. Those are all tested on our MassARRAY platform. Those tests are performed and services in Grand Rapids. We recently introduced the trisomy 21 detection LDT, MaterniT21, and that test is done in CLIA laboratory facility in our San Diego operation.

I wanted to review with you our goals from 2011. We presented these at a healthcare conference in January 2011, and I just wanted to -- we have been keeping you posted on how we have been doing throughout the year but at least this is for Sequenom Corporation. And we have met all of those goals. Actually we met them all by the end of October in ten months. We had a set of goals also -- some that were much more critical while the company was progressing, that related to Sequenom Center for Molecular Medicine, the LDT, CLIA laboratory.

These were -- we put these up in January, and you can see we had a pretty aggressive timetable. We met all of those. We did the same thing in 2010, and we showed our progress throughout the year, and we will do the same thing again in January 2012 for 2012 and we will keep you posted as we achieve them. We had a very good year, at least through the end of October. Since we met all of our goals and we are still pushing ahead pretty hard for the reminder of the year.

Our genetic analysis business has been very good for us. And basically good penetration of our target markets focusing now primarily on translational and basic research. Although we have a good business in pharma -- agriculture genomics, in pharmaceutical and biotech. In 2010, we had a 19% growth in revenue, year-to-year. The first nine months of the year were up 8% over last year. So this is basically driven by our new MassARRAY system, which is faster, better and much less expensive to manufacture for us.

Lots of publications. Over 250 in 2010 using this platform. We continue to develop research use only panels for the research community. This also is a key for our future molecular diagnostics as well. This is our current product profile. You can see we have Cystic Fibrosis Carrier Screening, Rhesus D genotyping. We have just introduced our trisomy 21 LDT. We also have our age related macular degeneration test which we introduced in the late spring. We are continuing to work towards filing a pre-market approval application for our trisomy 21 test.

We have been in discussion with the FDA about how to design these protocols and what other things would be required. We met with the FDA the last day of January. We have been in continuous discussions by telephone and email since then. We are working at the details of what will be required for us to file a complete PMA. The one things that’s very clear is that the -- there would be additional studies required beyond what we have already accomplished in the women’s and infant study, the study published in Genetics and Medicine. So, we have not quite reached closer with the FDA. Although I think we are getting quite close.

We think there is an advantage in having approved trisomy 21 test with the FDA. We can promote broadly based on the approved indications in the package insert. And we think that it sets up a higher barrier for competitors as well. Our current plan is we think we will file this pre-market approval application in 2013. Obviously, we will have to reach agreement with the FDA, and then we have to have the timely execution of the clinical trials and pre-clinical studies to support the filing.

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