Chelsea Therapeutics CEO Discusses Q3 2010 Results – Earnings Call Transcript

Chelsea Therapeutics CEO Discusses Q3 2010 Results â¿¿ Earnings Call Transcript
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Chelsea Therapeutics International Ltd. (

CHTP

)

Q3 2010 Earnings Call Transcript

November 1, 2010 4:30 pm ET

Executives

Kathryn McNeil – IR

Simon Pedder – President & CEO

Nick Riehle – VP, Administration & CFO

Bill Schwieterman – VP and Chief Medical Officer

Keith Schmidt – VP, Sales and Marketing

Art Hewitt – VP, Drug Development and Chief Scientific Officer

Analysts

Andrew Vaino – Roth Capital

Liana Moussatos – Wedbush Securities

John Sullivan – Leerink Swann

Presentation

Operator

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Good day, ladies and gentlemen, and welcome to the Chelsea Therapeutics third quarter 2010 earnings conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instruction will follow at that time. (Operator instructions) As a reminder this conference call is being recorded.

I would now like to introduce your host for today’s conference, Ms. Kathryn McNeil. Ma’am, you may begin.

Kathryn McNeil

Thank you and welcome to Chelsea Therapeutics third quarter 2010 conference call. We announced our third quarter results this afternoon just after the close of the U.S. financial markets and our press release can be found on our Web site at www.chelseatherapeutics.com.

Joining me from Chelsea is Dr. Simon Pedder, President and Chief Executive Officer; Nick Riehle, Chief Financial Officer; Dr. Art Hewitt, Chief Scientific Officer; Dr. Bill Schwieterman, our Chief Medical Officer and Keith Schmidt, our VP of Marketing and Sales.

Before I turn the call over to Dr. Pedder, let me note that some of the remarks you might hear today may contain forward-looking statements about the company’s performance. Actual future results might differ materially from those projected in these forward-looking statements.

Additional information concerning factors that could cause actual results to materially differ from those in these forward-looking statements is contained in our SEC filings and periodic reports under Securities Exchange Act of 1934 as amended; copies of which are available on our Web site or maybe requested from the company directly.

With that said, I’ll now turn the call over to Dr. Pedder. Go ahead, Simon.

Simon Pedder

Thanks, Keith and good afternoon, everyone. We know this is a busy time and we appreciate you taking the time to join us for our third quarter call this afternoon. Having recently hosted a call to discuss our Phase III results and having subsequently had a chance to meet with many of you in person, we will try to keep this call brief and to get as many questions as you may have.

That said, this has been truly a remarkable quarter for Chelsea and I’m delighted to have this opportunity not only to recap some of our achievements but also to take some time to highlight the impact of these developments going forward and our plans and expectations for the coming quarters.

I know everyone shared in the recent excitement surrounding the positive outcome of Study 301 in September. I still haven’t tired of sharing the data with folks and have had the opportunity to speak to a lot of them in the last couple of weeks and I’m very much looking forward to the presentation of our 301 findings later this week at the Annual American Autonomic Society meeting here in Florida.

While the positive data from Study 301 reflects a successful conclusion of that study, these results jumpstart the beginning of a very busy period in the broader NOH program as we begin our preparations for filing in earnest work to complete our remaining NOH studies and begin to lay the foundation for executing our commercial strategy for Northera here in the U.S.

Of course the completion of Study 301 was not only our commercial success in the quarter. We also got some preliminary validation in our fibromyalgia study and initiated our Phase II trial of CH-4051 in rheumatoid arthritis. As many of you will recall, Chelsea was founded around this portfolio of metabolically inert antifolate and we have always deeply believed in the promise for these compounds.

As treatment protocols in rheumatoid arthritis increasingly shift towards earlier intervention with these modifying therapies, we believe that the opportunities for a highly potent well tolerated oral treatment will continue to grow substantially.

So, we are really excited to see this program ramp up and as we begin to approach data for CH-4051 in RA next year, I am looking forward to having more opportunity to discuss this program with you in greater detail.

To begin our review of the quarter, I will have Nick provide you a brief summary of our financial results and then I will turn the call over to Bill, Keith and Art each of whom will provide some additional color in each of our programs and finally I’ll have the operator open up the call for questions.

Nick Riehle

Thanks, Simon. Good afternoon everyone. For our third quarter, we had a net loss of $8.8 million or $0.22 per share versus a net loss of $7.1 million or $0.22 per share for the comparable period in 2009. For the nine months ended September 30, we had a loss of $24.9 million or $0.65 per share compared to a net loss of $19.8 million or $0.64 per share for the prior year period.

Note however, that during the first nine months of 2009 we recognized the one-time gains related to the recovery of previously reported impairments associated with our holding some auction rate securities. Excluding these gains, our net loss for the first nine months of 2009 on a non-GAAP basis was $24.2 million or $0.78 per share.

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