Chelsea Therapeutics International's CEO Discusses Q4 2011 Results - Earnings Call Transcript

Chelsea Therapeutics International, Ltd. ( CHTP)

Q4 2011 Earnings Call

March 6, 2012 4:30 pm ET


Kate McNeil - Director, IR

Simon Pedder - President and CEO

Nick Riehle - CFO

Art Hewitt - CSO

Bill Schwieterman - CMO

Keith Schmidt - VP, Marketing and Sales


Robyn Karnauskas - Deutsche Bank

Liana Moussatos - Wedbush Securities

Alan Carr - Needham & Company

Jonathan Eckard - Leerink Swann

Juan Sanchez - Ladenburg



Good day, and welcome to the Chelsea Therapeutics International fourth quarter conference call. (Operator Instructions) I would now like to introduce the host for today's conference, Ms. Kate McNeil, Director of Investor Relations.

Kate McNeil

Good afternoon and welcome to Chelsea Therapeutics fourth quarter and full year 2011 conference call. We announced our fourth quarter full year 2011 results this afternoon after the close of the U.S. financial markets and our press release can be found on our website at

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

Before I turn the meeting over to Dr. Pedder, let me note that some of the remarks you'll 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 are contained in our SEC filings and periodic reports under Securities and Exchange Act of 1934 as amended, copies of which are available on our website or may be requested from the company directly.

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

Simon Pedder

Good afternoon, everyone. Thank you for taking the time to join us for our call this afternoon. We have clearly had an eventful start 2012 and with that we have had the opportunity to update you already on many of the recent developments. And certainly have had prior occasion to speak to each of significant developments of 2011.

Therefore, it is our intention to keep our prepared remarks for this call relatively brief and highlight for you our current expectations, not only for the next few months, which I know most of you already keenly attuned to, but also for the remainder of the year, as we look forward to several significant milestones throughout the course of 2012.

It is easy to get caught up and focused on the events related to our recent advisory committee meeting and anticipated PDUFA date later this month. However, in looking back in 2011, we see substantial achievements that extend well beyond the completion of our NORTHERA registration program and filing of our NDA for symptomatic neurogenic orthostatic hypotension, also known as Neurogenic OH or NOH.

Over the course of the past year, we unblinded data from our interim analysis of our NORTHERA 306, in which we saw a rather large reduction of falls among patients with symptomatic Neurogenic OH, associated with Parkinson's Disease that were treated with NORTHERA.

This led to some significant changes in the study, ultimately accumulating and restructuring of the trial with an eye towards using this data to potentially submit a supplemental NDA, seeking to expand the NORTHERA label to include the reduction of falls in patients with symptomatic Neurogenic OH associated with Parkinson Disease.

Shortly after our interim analysis of 306, this data was accepted as late-breaking presentation at the 15th Movement Disorder Society, International Congress in Toronto. This is really the preeminent event in the movement disorder world. And we were tremendously pleased by the excitement generated not only by our 306 data, but also with separate presentation of data specifically analyzed in the safety and efficacy of NORTHERA in patients with multiple systems atrophy.

During the course of the past year, we also had the opportunity to report data from two studies of droxidopa unrelated to Neurogenic OH. First, we were pleased to report some very promising data from Dr. Adler's investigator initiated study of droxidopa in adult attention deficit hyperactivity disorder or ADHD.

Though small, this exploratory study showed that droxidopa dramatically improved patients' mean score on the adult ADHD investigator symptom rating scale, the magnitude of the clinical effect and the rapid response to treatment, coupled with the safety tolerability of droxidopa observed in the study, established a compelling proof-of-concept that we believe wants additional study.

This data was filed late in year by topline results from our Phase II trial of droxidopa in patients with fibromyalgia. Fibromyalgia, as most of you are aware, is a complex disorder, characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms.

Data from our study indicated a therapeutic benefit associated with droxidopa as measured by the Short Form McGill Pain Questionnaire, Visual Analog Scale and the Fibromyalgia Index Questionnaire. In considering the outcomes of both of these studies as well as our prior successful Phase II study in intradialytic hypotension, it is clear that there exist several meaningful therapeutic areas to explore with droxidopa.

We also continue to work with investigators on additional exploratory Phase II trials and look forward to identifying the next step for the development of droxidopa after an approval for the treatment of symptomatic Neurogenic OH. Exploring these options is now more compelling opportunity, given the expansion of our intellectual property portfolio for droxidopa in 2011.

Read the rest of this transcript for free on

If you liked this article you might like

Lundbeck to Buy Chelsea Therapeutics for $658M

Lundbeck to Buy Chelsea Therapeutics for $658M

Why Chelsea Therapeutics (CHTP) Stock Is Soaring Today

Why Chelsea Therapeutics (CHTP) Stock Is Soaring Today

Chelsea Exits in Victory With Lundbeck Takeout

Chelsea Exits in Victory With Lundbeck Takeout

Chelsea Therapeutics International Ltd. (CHTP) Shares Soar 14%

Chelsea Therapeutics International Ltd. (CHTP) Shares Soar 14%

'Mad Money' Lightning Round: Zynga Can Go Higher

'Mad Money' Lightning Round: Zynga Can Go Higher