Nanosphere, Inc. (NSPH)
Q2 2010 Earnings Call
August 05, 2010 5:00 p.m. ET
William P. Moffitt III - Chief Executive Officer
J. Roger Moody Jr. – Chief Financial Officer
Michael K. McGarrity - Chief Marketing Officer
Good day ladies and gentlemen and welcome to the Second Quarter 2010 Nanosphere Incorporated Earnings Conference Call. My name is Kaleen and I’ll be your coordinator for today. At this time all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today’s conference. (Operator Instructions).
As a reminder this conference is being recorded for replay purposes. Before this call begins, Nanosphere would like to state that certain statements made during this conference call which are not based on historical fact may be deemed to constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 because these forward-looking statements involve known and unknown risks and uncertainties, there are important factors that could cause actual results, events or developments to differ materially from those expressed or implied from these forward-looking statements.
Such factors include those described from time to time in Nanosphere's filings with the United States Securities and Exchange Commission. Please note that Nanosphere undertakes no duty to update this information.
I would now like turn the presentation over to your host for today’s conference to Mr. Bill Moffitt, CEO. Please proceed.
Thank you, Kaleen. Good afternoon everyone and thanks for joining us for Nanosphere’s Investor conference call covering the second quarter of 2010. In a few moments I’ll turn the call over to Roger Moody, Chief Financial Officer and Mike McGarrity, Chief Marketing Officer. But first let me give you my perspective on our progress towards near term milestones which will drive growth over the next several quarters.
We continue to make good progress with all programs that will provide the foundation for our goal of building a global molecular diagnostics company. With a primary focus on creating customer and shareholder value through menu expansion and greater functionality and applicability of our Verigene System.
As I review the progress we've made there are three key points about our business that I want to make sure I deliver. First, we're making progress against our milestones for expanding the test menu for the Verigene System in the areas of infectious disease, human genetics, pharmacogenetics and protein assays. These tests will increase the applicability of the Verigene System and will generate increased utilization resulting in greater disposable cartridge volume.
Second, the tests that we have in development address critical market needs ranging from faster, more accurate infectious disease assays to pharmacogenetic assays where testing is a point of care that enables timely and accurate therapy is becoming increasingly important.
And third, as we expand our test menu the Verigene SP with its simplicity and sample to resolve operation will become even more applicable. This should fuel greater market penetration and increased utilization.
Now let me spend a few minutes providing an update on some key product development programs. In the pharmacogenetic market segment we are about to file a PMA with the FDA for our 2C19A assay used to guide anti-platelet therapy using copiligril more commonly known by the brand name PLAVIX. In our pre-IDE discussions with the FDA we learned that if we want approval for an intended use statement that links the assay to dosing of copiligril the submission must be a PMA as the assay falls into the class III category.
Essentially acknowledging the increased risk of using ENV diagnostic assay to specifically guide drug selection and dosing. You'll recall at the FDA re-label copiligril with the black box warning specifically calling out genetic mutations that affect an individual's ability to metabolize the drug to its active form. Approximately over 50% of the population depending upon ethic background has one or more mutations that lead to inadequate metabolism of the drug thereby significantly reducing the effectiveness of the drug. This reduced effectiveness of copiligril leads to a higher incidence of adverse events following both acute coronary syndrome and percutaneous coronary intervention such as standing.
These complications include death from cardiovascular causes, bio-cardio inflection stroke as well as strength thrombosis. There is a significant market interest in this assay as Mike McGarrity will review with you in a few moments. We expect to submit the PMA application to the FDA within this month.
In infectious diseases we have commenced our FDA 5-10-K clinical trials for an expanded respiratory viral panel. Once cleared this new respiratory panel will be the most comprehensive rapid panel on the market. The panel will contain Influenza A, Influenza
Be, RSV A and B and sub typing for seasonal H1, seasonal H3 and 2009 noble H1N1or swine flew as it has become known.
This panel has also designed to include detection of viral mutations leading to oseltamivir resistance or commonly known by the brand name Tamiflu. We are working with FDA to determine guidance for submission of this resistance marker. So we will proceed with cynical trials and submissions of the panel with holding that marker until we have further clarifications on its inclusion.
Once cleared this assay will offer costumers the ability to run a comprehensive flu assay including sub-typing in one test that will run on the easy to use sample to result Verigene SP system. We expect to file our 510(k) for this assay in the fourth quarter and we will be prepared to launch ahead of the flu season.