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Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)

Q3 2009 Earnings Call Transcript

November 2, 2009 4:30 pm ET

Executives

Kathryn McNeil – Director, IR

Dr. Simon Pedder – President and CEO

Nick Riehle – VP, Administration and CFO

Analysts

Anupam [ph] – Oppenheimer

Liana Moussatos – Wedbush

Juan Sanchez – Ladenburg Thalmann & Co.

Andrew Vaino – Roth Capital Partners

Operator

Good day and welcome to the Chelsea Therapeutics International third quarter earnings call. Today’s call is being recorded. At this time, I would like to turn the conference over to Director of Investor Relations, Kathryn McNeil. Please go ahead, ma’am.

Kathryn McNeil

Thank you. Good after, and welcome to our call. We announced our third quarter 2009 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 Therapeutics today is Dr. Simon Pedder, President and Chief Executive Officer; Nick Riehle, our Chief Financial Officer; and Dr. Art Hewitt, Vice President of Drug Development.

Before I turn the call over to Dr. Pedder, let me note that some of the remarks you might hear today might 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 and risks factors that could cause actual results to materially differ from those in these forward-looking statements is contained in our SEC filings and periodical reports under the Securities Exchange Act of 1934 as amended, copies of which are also available on our website or maybe (inaudible) directly from the Company.

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

Dr. Simon Pedder

Thanks, Kate, and good afternoon everyone. It’s been an eventful few months at Chelsea, and I’d like to thank each of you for participating in today’s call to review these recent developments and discuss our expectations for the coming months. Before we can get into our financial results for the quarter, I want to quickly provide you with an update on the status of each of our development programs, and to review the third quarter which included a couple of significant announcements related to our Phase III Droxidopa program in neurogenic orthostatic hypotension or NOH.

While our NOH program was our primary operational focus in the third quarter, and continues to be our most closely watched program, it remains substantial developmental activities across the remainder of our pipeline. So I would like to start there before getting into more detailed discussions of our Phase III program in NOH.

As you know, we are also developing Droxidopa for several indications beyond neurogenic orthostatic hypotension. And earlier this year we initiated a Phase II trial evaluating Droxidopa for the treated of fibromyalgia. This trial being led by Dr. Ernest Troy of Kings College in London is actively enrolled in patients at multiple centers in United Kingdom. As you will recall, this is a rather complex trial that consists of 12 arms to evaluate and compare multiple dosages of Droxidopa, both alone and in combination with multiple dosages of carbidopa versus placebo. We are currently planning to conduct an interim analysis after approximately of 50% of the patient’s have been enrolled.

This analysis is primary being done to determine if each of the twelve arms of the study, merit continued evaluation, or if any of the arms can be collapsed and the scope of the study narrowed. Based on current enrolment, we would expect this analysis to be conducted mid year, next year depending how many arms of the study are continued, full data from this trial could come in late 2010. However, if there is apparent empathy in a significant number of studies, the trial may continue into early 2011.

As we have previously discussed, the unique design of this trial should allow us not only to explore the role and potential therapeutic application of norepinephrine in fibromyalgia, but by pairing Droxidopa with carbidopa to limit peripheral metabolism of Droxidopa the trial should also allow us to closely examine the central effect of norepinephrine and its indication.

In addition to potentially treating fibromyalgia, there has been significant interest in better understanding the potential benefit of Droxidopa for the treatment of adult attention deficit hyperactivity disorder or ADHD. As ADHD is characterized as disorder of decreased norepinephrine activity in the free frontal cortex, there is a fascinating theoretical premise for examining the efficacy of Droxidopa in combination with carbidopa in ADHD, and we have been working closely with the investigator for this study, Dr. Adler [ph] in New York to facilitate an exploratory Phase II trial.

This will be a single-center, 12-week study conducted under physician sponsored I&D, and is intended to evaluate 20 adult ADHD patients. While this is being a physician run study and we have a limited control over its timing, we have been working closely with Dr. Adler in the final preparations over the last several months, and believe the study is expected to be under way in the next few weeks, and should likely yield data in the second quarter of 2010.

We are very pleased to be working with Dr. Adler on this study.

Next, I would like to give you a brief update on our antifolate program, as both CH-1504 and CH-4051 ensure their good bit of much deserved visibility and attention at this year's ACR conference in Philadelphia a few weeks ago. We look forward to second half to have Dr. Ed Keystone from the University of Toronto to give a platform presentation on the findings from updates to Proof of Concept trial in CH-1504, which demonstrated the non-metabolized, methotrexate are not required for efficacy and that a once daily metabolically inert antifolate could achieve comparable ACR responses to standard weekly dose just with methotrexate in the treatment of rheumatoid arthritis.

As have been the case for most of the year, it was CH-4051 that continues to generate the greatest buzz amongst physicians and potential partners at the conference. We believe the CH-4051 has tremendous promise as a treatment for rheumatoid arthritis supported by a robust body of pre-clinical data suggesting proven inhibition of the enzyme dihydroorotate reductase, and Phase I data demonstrating its impressive safety and tolerability at levels believed to exceed likely therapeutic dosages. We are all excited to see what was CH-4051 can do in the Phase II trail.

As we’ve discussed on our last call, we are eager to keep this development program on, track and during the third quarter began the manufacturing of drug substance that will enable a timely transition into a Phase II program, either on our own or in collaboration with the partner.

Based on the feedback from our advisory board, as well as input from potential partners with whom we have been in contact, we have made substantial progress in defining the next steps for CH-4051 and expect to have made our final decisions regarding the phase II trial designs at the end of the year.

At this juncture, we are leading towards leveraging our existing body of toxicology work to conduct a three months Phase II trial in rheumatoid arthritis that could be initiated by mid-year 2010. And we look forward to updating you if things progress.

We are still weighing the pros and cons of conducting the study in methotrexate naive patients versus methotrexate partial responders. But, as I have said, we expect to make a final determination by year-end and look forward to updating you on our final protocol decisions providing more detailed guidance from the timing of such a study and moving ahead with CH-4051.

Now, turning to our Droxidopa Phase III program in NOH. In the late September, we reported top line results from the Study 302, the first of our two studies to be completed from our Phase III program.

Both of our Phase III studies in NOH are designed to demonstrate the benefit of Droxidopa in treating the symptoms of NOH. As no other compound has successfully demonstrated symptomatic benefit to the FDA satisfaction, there were some inherent challenges in selecting an end point to meet this objective.

Unlike more common indications such as rheumatoid arthritis, let’s say, there is not a single widely accepted scale used to measure symptomatic benefit in NOH.

In consultation with the key opinion leaders and the FDA, we opted to utilize both the relatively new orthostatic hypotension questionnaire or OHQ as well as the more broadly used validated clinical global impressions scales as end points to assess the ability of Droxidopa to effective symptoms of NOH and provide a clinically meaningful improvement in a patients quality of life.

The OHQ as a comprehensive questionnaire that consists two components, part one, the Orthostatic Hypotension Symptom Assessment or OHSA, which assesses the frequency and the intensity of NOH symptoms; and part two, the orthostatic hypotension daily activities scale or OHDAS which assesses the burden of NOH symptoms on daily activities.

We use item one on the OHSA, which measures dizziness as the primary outcome measure, and compared to mean change in OHSA item 1 scores 14 days following randomization to continued therapy with Droxidopa or withdrawn to placebo. Each remaining individual questions on both square scales as well as accomplishes score for each were included at secondary outcome measures along with the both physician and patient assess CGI ratings of diseased severity and improvement.

Out of the total of 182 titrated, a total of $101 NOH patients were deemed [ph] symptomatic responders and had a clinical blood pressure improvement during the open label dose titration phase. And we’re ultimately randomized to continue drug therapy or be withdrawn to a placebo in the two week double-blind Phase III study.

Patients withdrawn to placebo reported a 1.9 unit increase for worsening of symptoms in the OHSA item one compared to a 1.3 unit increase reported by patients treated with Droxidopa, resulting in a difference of 0.6 units between arms. For those of study, they also meet its primary objective and show us just meaningful difference between Droxidopa and placebo on the primary end point. 16 out of the 17 totally predefined endpoints evaluating symptomatic and functional benefit showed positive trends favoring Droxidopa, five of which demonstrated statistically significant improvement with Droxidopa treatment.

Further, the incidence of falls reported in this study strongly supports the clinical benefit of Droxidopa. They’re not included as an endpoint, falls will capture as an adverse event in the incident of patients reported falls clearly demonstrates a marked difference in between groups with 12% of six patients in the placebo group reporting a fall compared to 2% or one patient in the Droxidopa group. Highly consistent with the existing body of clinical work Droxidopa was safe and well tolerated at all dosages with comparables or few adverse events or serve adverse events reported for Droxidopa patients than placebo.

However, I would like to point out that a recent review with a full data set in preparation for FDA meeting revealed an error in the initial lines of these things which, initially showed the only patient who experienced supine hypotension which was defined as greater than 200 millimeters of mercury was in the placebo round.

This patient was, in fact, in the Droxidopa arm reflecting a 2% incidence of supine hypotension at this level; still modest compared to the 13.4% of mylagen patients reporting supine hypotension in excess of 200 millimeters of mercury. Overall, the collective data represents a compelling risk to benefit profile and we remain confident in Droxidpoda’s therapeutic benefit.

Through our continued analysis of available data, we have identified several key observations, that appear likely to have an impact in the outcome of Study 302, including a high rate of response in placebo round of the trial evidenced by the fact that nearly half of the placebo patients reported no change and no level of dizziness between randomization and the end of study despite having being withdrawn from drug treatment.

This may, in part, result from patients in the placebo on modifying their behavior to avoid or limit activity that would cause a recurrence of the symptoms, while patients on Droxidopa may have increased activity resulting in great orthostatic challenge and the likelihood of triggering symptoms of orthostatic hypotension.

There also appears to be greater-than-anticipated carryover effect following the week of sustained drug treatment prior to randomization withdrawn. This was seen not only with the OHSA Item 1 score, but also in the remaining secondary symptom assessment parameters as well.

Significantly, you will also see this affecting the objective measure of standing blood pressure, which continued to demonstrate and increase over baseline values recorded at the beginning of the study.

As previously reported, we have requested a meeting with the FDA to review the findings from Study 302, and discuss the potential implications for Study 301, and our registration program in this indication. In preparation for this meeting, we have engaged independent consultants and statisticians to conduct a sensitivity analysis of each of the end points used in Study 302.

Preliminary indications from this ongoing analysis which we plan to share in detail with the FDA, suggest that Item 1 of the OHSA scale may not be even most reliable or sensitive to measure of treatment effecting its diverse patient population.

Rather the, OHDAS [ph] which asks the patients about their NOH symptoms, which effected daily life appears to be more uniformly capturing the treatment benefits and correlates to both decision and patient assessed CGI insulin’s [ph] and its various scores.

Based on these findings, we believe there are multiple alternative endpoints either that could be taken singularly or as a composite that are both clinically meaningful and more sensitive to treatment affects, and would therefore be better in measuring treatment outcome. As such, we have requested the FDA to consider a change in our primary endpoint for Study 301.

As previously reported, we reached our number one at the 118 patients in the Study 301 in early September. And in keeping with the titration and randomization schedule for Study 301, we had our last patient’s, last visit for this trail occur a couple of weeks ago. However, we have opted [ph] to hold off an unblinding or conducting any data analysis of our Study 301, until we have met with the FDA later this month.

Following feedback from the agency as to their prepared outcome measures and recommendations for filing, we will amend our statistical analysis plan as needed and report our findings accordingly. We originally anticipating reporting top [ph] from study 301 in December, but having decided to wait for until after our FDA meeting to move forward on this. It is likely that these results will not be available until January 2010 at the earliest.

In conjunction with our correct for change in the primary end point, we have requested feedback from the agency regarding the size and the powering of study 301.

We also requested feedback concerning the suitability of filing an NDA based on a strong outcome and Study 301, supported findings from Study 302 and a robust data package from the Japanese registration program or what if any, additional studies maybe required.

We hesitate to predict the final outcome of our discussions with the agency. However, we believe the often designation and fast track status already awarded to Droxidopa reflects the agency’s appreciation for both the unmet medical needs is in this indication an inherent difficulty of working with a limited patient population.

Accordingly, we anticipate there are upcoming meeting will be collaborative and highly productive. We look forward to sharing with you the outcome of this meeting, reporting the detail of if any changes to Study 301 and updating you on the anticipated timing of Study 301 results and future NDA filings in NOH.

Before opening up the call for questions I will ask our Chief Financial Officer, Nick Riehle to wrap up our prepared remarks with a review of the quarterly financial highlights. Nick?

Nick Riehle

Thanks, Simon. For the third quarter of 2009, Chelsea's net loss was $7.1 million or $0.22 per share, versus a net loss of $10.1 million or $0.34 per share for the same period in 2008. Our year-to-date net loss of $20 million or $0.64 per share is down from our net loss for the first nine months of 2008, up $26 million or $0.87 per share.

However, excluding the 2008 ARS impairment charges and the 2009 recapture those charges, the current year loss of $24 million would reflect a slight increase from $22 million in 2008.

Research and development expenses for the third quarter of 2009 were $5.4 million compared to $7 million for the same period in 2008. This decrease in R&D expenses for the quarter primarily reflects our Phase III program in neurogenic orthostatic hypotension as it is approached its intended conclusion and the completion of our Phase II trial of CH-1504 in RA and our Phase II trial Droxidopa in the intradialytic hypotension earlier this year both of which were active during the comparable period at last year.

Year-to-date, R&D expenses have remained flat year-over-year at approximately $20 million. Selling, general and administrative expenses of $1.7 million for the quarter were up versus $1.2 million for the same period 2008, primarily as a result of having initiated market research and commercialization activity for Droxidopa.

Similarly, selling, general and administrative expenses for the nine months ended September 30th 2009 were $4.4 million compared to $4 million for the first nine months of 2008.

Chelsea ended the quarter with $30 million in cash and cash equivalent, after using $22.6 million to fund operations to the first nine months of the year. This reflects a net increase of $8.5 million from December 31st 2008 with the addition of liquidity obtained to the favorable settlements of our auction rate holdings, and the proceeds from our registered direct offering in July which after deducting related expenses resulted in net proceeds to the company of $12.4 million.

In keeping with prior guidance, we expect to end the year with approximately $20 million in cash and cash equivalents and intend to remain highly judicious in our user fronts aiming to contain costs while we continue to move our various development programs forward.

Accordingly, we anticipate that our current resources can fund our ongoing activities into the third quarter of 2010. This projection include the initiation of both CH-4051 Phase II study and the investigated was ADHD study, as well as the continuation of our Fibromyalgia program and any of several likely scenarios for NOH that could result from our upcoming meetings with the FDA. Simon?

Dr. Simon Pedder

Thanks, Nick. Finally, before I open the call for questions, I’d like to take a moment to welcome a new addition to the Chelsea management team. As we announced this morning, Bill Schwieterman has agreed to come on Board as Chelsea's Chief Medical Officer.

Though we've been fortunate enough to benefit from Bill’s extra ordinary depth with knowledge and expertise go through his involvement in our rheumatology Advisory Board, and more recently as the member of our Board of Directors. We are thrilled that he has accepted our offer to join the team full time and assume the responsibility for medical and regulatory affairs at Chelsea.

Having formally served as the Chief of the Medicine Branch and Chief of the Immunology and Infectious Disease Branch in the Division of Clinical Trials at the FDA. We expect Bill’s unique perspectives and expertise over 10 year at the FDA will be a tremendous asset to us both in the near-term and as we work with the FDA on defining our NDA filing requirements. But also in the long run as we continue to advance additional Droxidopa indications along with our antifolate portfolio which Bill has a card-carrying [ph] rheumatologist has a great deal of interest.

With that said and at this point, I’ll turn the call over to operator for Q&A.

Question-and-Answer Session

Operator

(Operator instructions) And our first question will come from Brian Abrahams with Oppenheimer.

Anupam – Oppenheimer

Hi, guys. This is Anupam [ph] in for Brian. Quick question, is there anything specific we should be looking for from Dr. Kaufmann's presentation at AF [ph] in a couple of weeks?

Dr. Simon Pedder

We have given the kind of 10,000 fee [ph] of the data. I think that Dr. Kaufmann who gave a little bit more detail but I don’t think there is any surprises – we’ve talked in pretty much detail about the primary and secondaries and I think Dr. Kaufmann's presentation is going to basically give a little bit more flavor on that, but I wouldn't expect, the story doesn’t change, still the same ending.

Anupam – Oppenheimer

Okay. We’ve heard a lot about your plan for – with the FDA, do you had any discussions with the EMEA regarding the passport for Droxidopa?

Dr. Simon Pedder

We have not had any discussions with the EMEA since the 302 results, no.

Anupam – Oppenheimer

Okay. I guess, those are all my questions so far.

Dr. Simon Pedder

Well, thanks a lot.

Anupam – Oppenheimer

Jump back in the queue.

Operator

We’ll move on Liana Moussatos with Wedbush

Liana Moussatos – Wedbush

Thank you. In this, are you planning to announce the results of the FDA meeting in December or we – and so you announced the top line data from 301 trial in January?

Dr. Simon Pedder

We will probably get back to on the outcome of the FDA meeting in early December.

Liana Moussatos – Wedbush

Okay. And what’s the status, how will you characterize the status of the antifolate partnership? You mentioned the CH-4051 Phase 2 design, you announced that by year end, any kind of indication about a partnership?

Dr. Simon Pedder

Well, we had the benefit of meeting with lots of people at the ACR meeting in Philadelphia just a couple of weeks ago. That was a great for us not just having a chance to talk to partners, but also talk to a number of key opinion leaders in the field. And I think that’s what the large (inaudible) is finalizing, getting closing to finalizing what we’re going to do in our Phase 2. But we’ve always said we appreciate the fact that 4051 has just completed Phase 1, but we’ve always said that we look for Phase 2 type deal. And, if that means taking the drug ahead ourselves and doing the study the people to want to see them, we'll go ahead and do it.

Liana Moussatos – Wedbush

Okay. And what was the stock-based compensation expense in Q3?

Dr. Simon Pedder

I think you’ve shocked our CFO by actually asking him a question. Well done.

Nick Riehle

Yes, let me get back to you. Just off the top of my head, (inaudible). We’ll get the number and say at the end of the call, Liana.

Liana Moussatos – Wedbush

Okay. And when will the 10-Q come out?

Nick Riehle

It should be out just about – at around the time the call the started.

Liana Moussatos – Wedbush

Okay, thank you.

Dr. Simon Pedder

Thank you, Liana.

Operator

And Juan Sanchez from Ladenburg Thalmann has our next question.

Juan Sanchez – Ladenburg Thalmann & Co.

Good afternoon, guys.

Dr. Simon Pedder

Hey, Juan.

Juan Sanchez – Ladenburg Thalmann & Co.

The FDA, do you expect single meeting to solve all the issues or there is a situation where we could have several meetings?

Dr. Simon Pedder

Well I obviously would not like to predict the outcome of that meeting, but certainly in the previous experience we’ve had in talking to the FDA, I could state that our – we’ve gotten the desired outcome that we wanted. And that doesn’t mean that it is going to be a favorable outcome to this meeting, but certainly the FDA has answered the questions that we’ve put in forward, and we’ve obviously put forward the questions we want answers. So I will expect that we would come out knowing what we need to know.

Juan Sanchez – Ladenburg Thalmann & Co.

Are you going to tell in Item 1 is not your favor [ph] primary end point? Are you going to propose one end point as an alterative or several end points on the final outcome will come out of the discussion?

Dr. Simon Pedder

Well, we are giving our sensitivity analysis. Clearly we think more different outcomes are more reliable than others. And we’ve provided in our briefing document that information. And we certainly believe that, information showed very clearly that Item 1 is not as sensitive as a number of the other outcome parameters, which we would be delighted in moving to before our primary analysis in 301.

Juan Sanchez – Ladenburg Thalmann & Co.

Yes, but which one of the others –because there are several potential endpoints?

Dr. Simon Pedder

I think that we would look at any of the OHDAS [ph] scores especially looking at the composite score which obviously indicates the benefit of the drug on the activities of daily living. We would also look for either the globals or in fact the OHQ composite score, which is the total of the entire score very much like the unified Parkinson's disease rating scale has a total number. These are all outcome scales that we think are sensitive. They’d also show very clearly the benefit of Droxidopa and the symptomatology or the functional aspects of the disease.

Juan Sanchez – Ladenburg Thalmann & Co.

And I would like to (inaudible) for end use when you say the pros and cons of Phase II program in metro naïve versus metro failures. What are the pros and cons of each of these two mergers?

Dr. Simon Pedder

Well, I will make a couple of comments, and I will pass to Art Hewitt to make some additional ones. With a naive population you’ve got a population that traditionally shows an ACR response to somewhere about ACR 20 somewhere in the 50%. And so improve on that you probably got to get ATR 20s in the 70s. So maybe a little bit more of a hurdle, but they are also patients who are not a re-factorial [ph] patient population whereby with the methotrexate partial responders, you know that they haven’t responded fully to methotrexate.

So, in a controlled trial with methotrexate is controlled. It probably going to get very low ACR 20s, maybe into the 20%, and that's it easier to get a bandage from an efficacy view point. And I would add when it comes to partial responder, one of the comments would be why does these patients not respond to methotrexate. Some of these patients may have – make these fast metabolizers off methotrexate with some. It’s well very known that methotrexate has a very wide bioavailability range.

We have very good bioavailability with 4051, and because like all our drugs we don’t have to undergo any metabolism, we think likelihood of showing a positive benefit in that population is pretty good.

Juan Sanchez – Ladenburg Thalmann & Co.

Okay. Thank you, guys.

Dr. Simon Pedder

Thank you, Juan.

Operator

(Operator instructions) We'll go now to Andrew Vaino with Roth Capital Partners.

Andrew Vaino – Roth Capital Partners

Just two quick questions. You mentioned that you’re going to moved NDA by the end of November to give us certificate [ph]?

Dr. Simon Pedder

We’ve just given a general guideline that it's going to be in second half of the month. We have not – given date for FDA meetings but we have been pretty good about giving timelines and as we mentioned because we'll have finalizing meeting and it’s all that, we'll give an update probably in early December.

Andrew Vaino – Roth Capital Partners

Okay. Second, in terms of the – you just discussed the methotrexate naive versus experience patients. How big an issue is DHFR over expression in methotrexate resistant?

Dr. Simon Pedder

Well, that’s a good question. I don’t think that methotrexate resistant is a single factor responsible for methotrexate. I think that may be in a certain population, some patients who have poor absorption of methotrexate, Dr. (inaudible) always said that he can get anybody to response methotrexate as long as he can get them of enough to populous patients can tolerate high dosages of it. And of course, the fact that some patients may not respond because they quick Metabolite is into 7-hydroxy and so that’s probably multi-facet but I think it would be very interesting. I don’t know if anybody is actually looked specifically what the breakdown is across groups.

Andrew Vaino – Roth Capital Partners

Great. Thank you.

Dr. Simon Pedder

Thank you, Andy.

Operator

And that concludes, the time we have questions. At this point, I’d like to turn the conference back to Dr. Pedder for closing remarks.

Dr. Simon Pedder

Before I finally finish this up, I just want to get back with Liana that we did have $424,000 in the quarter for stock-based compensation expenses and was $2 million for the year-to-date.

Okay. So with that, I’d like to thank you all for participating on today’s call. I hope you found it informative and that has given you some insight that we’re approaching in the next few months.

We know there be many questions that remain and we look forward to providing a further update on the status of plan following on meeting with the FDA. Have a great evening everybody.

Operator

Again, that concludes our conference. We do thank you for joining us.

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Source: Chelsea Therapeutics International Ltd. Q3 2009 Earnings Call Transcript
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