Chelsea Therapeutics International Ltd. (
Q2 2011 Earnings Call
July 26, 2011 4:30 PM ET
Kate McNeil - IR
Dr. Simon Pedder - President and CEO
Nick Riehle - CFO
Dr. Art Hewitt - CSO
Dr. Bill Schwieterman - CMO
Keith Schmidt - VP of Marketing and Sales
Alan Carr - Needham & Company
Jonathan Eckard - Leerink Swann
David Moskowitz - Roth Capital
Liana Moussatos - Wedbush Securities
Juan Sanchez - Ladenburg, Thalmann & Co.
Previous Statements by CHTP
» Chelsea Therapeutics International CEO Discusses Q1 2011 Results - Earnings Call Transcript
» Chelsea Therapeutics CEO Discusses Q4 2010 Results - Earnings Call Transcript
» Chelsea Therapeutics International, Ltd. Q2 2010 Earnings Call Transcript
Good day, ladies and gentlemen, and welcome to the Chelsea Therapeutics International, Second Quarter Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Kate McNeil. You may begin.
Thank you. Good afternoon, and welcome to Chelsea Therapeutics’ second quarter 2011 conference call. We announced our second quarter results this afternoon just after the close of the U.S. financial markets, and our press release can be found on our website at www.chelseatherapeutics.com.
Joining me from Chelsea is Dr. Simon Pedder, our President and Chief Executive Officer; Mr. Nick Riehle, our Chief Financial Officer; Dr. Art Hewitt, our Chief Scientific Officer; and of course, Dr. Bill Schwieterman, our Chief Medical Officer and Mr. 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 that you will 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 the Securities Exchange Act of 1934 as amended, copies of which are available on our website or may be requested directly from the company.
That said, I’ll now turn the call over to Dr. Pedder. Simon, go ahead.
Dr. Simon Pedder
Thanks Kate. And good afternoon everyone. We appreciate you joining today’s discussion. In the light of the number truly significant events had lie ahead of us in the coming weeks and months, we are particularly pleased to have this opportunity to touch base with you and bring you all this feed in our recent achievements and ongoing progress.
The last quarter and particularly the last several weeks have been a very busy time to everybody at Chelsea. In addition to the continued efforts from our clinical team, we’ve already begun to benefit from contributions made by our newly established medical affairs and sales and marketing teams. Collectively the entire team here has dedicated a considerable time and energy towards the planned registration and commercialization of Northera.
And I can honestly say the result of these efforts have been remarkable. During the past quarter, evidence of these efforts are clear in the early completion of our dedicated Northera QTc Study, the progress made in our Phase II Trial of CH-4051in Rheumatoid Arthritis, the success of our participation in the Annual Movement Disorder Society meeting, as well as the progress made in our new drug application or NDA for Northera.
Of course we are not the only one excited by the potential of our pipe line, as I am sure you saw this morning, we reported the results of our first investigative sponsored Phase II trial of Droxidopa that provided a solid clear indication of the breath of potential future indications for Droxidopa.
However, before we get into the details surrounding these efforts and achievements, I will have Nick get us started by providing a review of our first quarter financial results, then I will ask Art to provide you with the more detail update covering the status of our ongoing clinical programs and this morning’s study results followed by an update from Bill and Keith on our regulatory progress and the commercial plans for Northera and finally we will open up the call for Q &A. Nick..
Thanks Simon. Adjusted reported net loss for the quarter end June 30 was 13.3 million or $0.21 per share versus a net loss of $9.9 million or $0.25 per share for the same period of 2010.
For the first six months of the year we reported a net loss of $27.1 million or $0.46 per share compared to a net loss of $16.2 or $0.43 per share for the first half of 2010.
Research and development expenses for the second quarter were $10.7 million, which reflects an increase from $8.4 million for the second quarter 2010. This increase in R&D expense reflects cost associated with the planned commercialization of Northera and includes approximately $1.6 million related to the manufacturing process and process validation of commercial drug product. $1.3 million related to the completion of dedicated QTc study to support our application for approval of Northera in the US. Approximately point $0.9 million related to the preparation of the Northera NDA and approximately $29 million for the initiation of medical affairs activities.
Offsetting these increases was an overall decrease of approximately $2 million year-over-year and aggregate Northera NOH clinical trial expenses. For the six month ended June 30th R&D expenses came in $22.1 million versus $13.3 million for the first half of 2010. Similar to results for the quarter R&D expenses for the first six month of 2011 were primarily driven by increased cost associated with a planned registration and anticipated launch of Northera.