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Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP)

Completion of EoR Meeting with FDA for Northera Capsules NDA

May 23, 2012 8:30 AM ET

Executives

Kathryn McNeil – Head-Investor & Media Relations

Simon Pedder – President & CEO

Nick Riehle – VP-Administration and CFO

Bill Schwieterman – Chief Medical Officer

Art Hewitt – Chief Scientific Officer

Analysts

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Alan Carr – Needham & Company

Liana Moussatos – Wedbush Securities, Inc.

Juan Sanchez – Ladenburg Thalmann Securities.

Steven Salamon – ROSALIND Advisors

Operator

Good day ladies and gentlemen, and welcome to the Chelsea Therapeutics May 22 Conference Call. At this time, all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions)

As a reminder this conference is being recorded.

I would now like to turn the call over to your host, Kathryn McNeil. Please go ahead.

Kathryn McNeil

Thank you operator. Good morning everyone and thank you for joining us for our call this morning. A press release related to today’s call can be found on our website, www.chelseatherapeutics.com.

Joining me from Chelsea this morning is Simon Pedder, our President, Chief Executive Officer, Mr. Nick Riehle, our Chief Financial Officer, Dr. Bill Schwieterman, Chief Medical Officer and Dr. Art Hewitt, Chief Scientific Officer.

Following formal remarks by Dr. Pedder, the conference call will open for questions. However, before I turn the call over to Dr. Pedder to get us going, let me note that some of the remarks you’ll hear today contain forward-looking statements regarding future events including our intention to modify the primary endpoint for Study 306B, submit additional data to the FDA, resubmit the NDA for the treatment of Neurogenic OH, anticipated expenses for 2012, cash levels and liquidity to fund the company’s operating plans and the company’s anticipated performance.

Actual events might differ materially from those projected in this forward-looking statement. Additional information concerning factors that could cause actual results to materially differ from those in this forward-looking statement contained in our press release issued today, our most recent 10-Q and 10-K filed with the SEC, which are available on the SEC and other public websites including our own or they can be requested directly from the company.

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

Simon Pedder

Thanks Kate and good morning everyone. I’d like to thank you for joining us on our call this morning and also thank you for your patients as we held our hosting our call this quarter until we had completed our meeting with the FDA, and received official meeting minutes from the agency.

The primary purpose of this call is to provide you with an update of our interactions with the FDA subsequent to the receipt of the Complete Response Letter for our Northera New Drug Application in March.

However, as we did not host a conference call in conjunction with the release of our first quarter operating results and because our clinical and regulatory strategy for Northera impact or forecast. I will also ask Nick to provide you with a brief review of our financials and share with you some update guidance prior to opening the call for your questions.

Before we get into a detailed discussion, I would like to point out that quite a lot of transpired since we received the Complete Response Letter from the agency including written and verbal communications prior to our meeting, the meeting itself and of course receipt of official FDA minutes from the meeting. It is important to note that we have not completed our discussions with the FDA or reached a final agreement with them regarding plans to provide additional clinical efficacy data for our Northera NDA.

Collectively however, the interactions we have had to date with the FDA have been productivity and meaningfully informed our thinking and our strategy to moving forward with our NDA. In this regard, some of our discussion today will not only involve information and feedback contained in our written communication with the agency, but also some speculation and conclusions drawn from on interaction to date as well.

As we detailed in our last call and today’s press release, the Complete Response whether we received in March included the request that we submit data from an additional positive study to support the efficacy demonstrated in Study 301 and the recommendation that such a study be designed to demonstrate durability of affect over two to three months period.

As we reported to you at the time the Complete Response Letter from the agency, noted several concerns related to the impact of our highest enrolling clinical site on the overall study results. The FDA noticed that these results had a disproportionate positive effects on the outcome of the trough and that if you exclude these patients from the study analysis, while still positive the results will less decisive.

Because of this consent, the FDA could not accept Study 301 alone as sufficient efficacy as – as a significant evidence of efficacy for approval. Since the FDA has never previously raised any questions or concerns about this particular center and because there had been two independent site visits as well as the successful FDA audit of this site during the NDA review. We initially interpreted that concerns related to the site in the context of our seeking approval based on the outcome of the single pivotal study and the associated FDA guidance for a single study approval outlined in the Complete Response Letter specifically that said no single site should provide an unusually large fraction of the patients and no single investigator or site should be disproportionately responsible for the favorable affect seen.

The CR letter went on to indicate that if the analysis shows that a single site is largely responsible for the effect. The credibility of a multi-centered study is diminished. We interpret this to mean that the agency was less comfortable relying on the highly statistical significance outcome of Study 301 and therefore would prefer to see a second confirmatory study to demonstrate efficacy.

Whether we have come to realize in our subsequent communication and discussion with the FDA is that their concerns about the results reported from this site were most significant than the Complete Response Letter indicated.

During our meeting with the FDA, they indicated that the near end of the review cycle and after the advisory committee meeting, the division focused on the fact that the result of this site appeared almost too good to be true. Beyond the robustness of the effect demonstrated by the patients at this site, the FDA had questions regarding the number and the rate which this site had been able to enroll patients with some of the less commentation subgroups included in our target population.

During the meeting, we were able to provide an initial response to these concerns and provided what we felt with meaning contacts to these issues. Since we were well aware that this site had contributed the most patients to Study 301, we were proactive in initiating multiple sites that is before this trial even ended including two independent site visits following the conclusion of the study.

The FDA also audited this site during the course of our NDA review and at no point that any of these visits find any significant errors in the conduct of the trial or any reason to doubt the veracity of the data.

We were also able to provide the division with some additional background information on this site alerting into the fact that this was a major referral center with a large in catchment area such as they would have a relatively large number of patients with our anemic failure from which to readily draw from making rapid enrollment of these patients feasible.

Regardless, we take the integrity of our study conduct in data very seriously and are more than happy to drive the division not only with the source documentation and site visit information, but also take a closer look at the site and do anything in our power to laying (inaudible) concerns related to the data from this center.

Purely based on the number of patient enrollment by this site, an analysis of 301 excluding this data does not result in a statistically significant outcome for the trial. As such, we have provided the agency with various sensitivity analyses of the efficacy data for Study 301 including the favorable trend for efficacy at U.S. centers, of course, anything is actually found that ultimately called data from the site into question, the agency might not bring Study 301 positive despite the positive efficacy trend seen that there is analysis excluding the data from this center.

It is noteworthy that the division was clear both during the meeting as well as the meeting minutes that with the exception of the site in question. The review team takes no issues with the results to Study 301, the favorable efficacy data for all U.S. sites, favorable data for the secondary endpoints in Study 302 and positive blood pressure data in Study 305.

Furthermore, the agency confirmed that there are no additional items other than what was outlined in the Complete Response Letter that are required for approval. Given the scope and the significance of the issues raised by the division and its briefing documents and discussed during the FDA Advisory Committee in February, we view this as a significant achievement and are pleased with the prior safety consent appeared and adequately addressed.

Gaining this understanding about Study 301 also shifted our understanding of the FDA recommendations regarding an additional positive study. While the FDA noted in the Complete Response Letter, their recommendation that the additional study be two to three months in duration. It now appears as though, the specific duration of the support of data is to some extent secondary to confirming efficacy with another positive study.

Our initial proposal based on interpretation of the Complete Response Letter called for a submission of data from Study 306B at the one-week post-titration visit. With longer term data to be decided on a post-approval basis to allow us to significantly increase enrollment to power for significance at eight weeks without delaying approval of the full-time it would take to enroll and complete a substantially larger study.

Ultimately, we felt this would confirm the efficacy of Study 301 through one week and characterize the drugs chronics effect over time.

The agency was initially reluctant to accept this proposal, so adding up concerns related to the unblended interim analysis of Study 306A. During the meeting, we clarified the patients currently enrolled in 306B would not unblended or included in our original 306A interim. This opened up the meeting for discussion and comment on how we might use data from 306B to satisfy the agencies interest and additional support of efficacy data.

In the course of our discussions of 306B, we had discussions regarding both potential endpoints and appropriate time points for assessing efficacy. As anticipated, it peers as though, OHSA item #1 which specifically access dizziness and lightheadedness would be a suitable measure of symptomatic improvement.

When it comes to the time point for assessing dizziness, the guidance from the division was less definitive in nature. While they were clearly noting they would like to see data beyond the one-week post-titration time point, there is lots of discussion of the options but not consensus among FDA attendees at the meeting as to what would be deem acceptable.

And while it’s asserted full approval could be based on robust study results for the acute symptomatic indication. If any consensus was reached, it was up the more general longer is better for (ph). Interestingly, this is fairly aligned with the comments and the conclusions of the FDA Advisory Committee meeting in which panelist express interests in longer term data that ultimately concluded that the potential treatment benefit coupled with a significant unmet medical need wanted approval of Northera and outweigh the need for additional study confirming durability prior to approval, ultimately leading to recommendations of approval of our NDA.

Based on discussions with the FDA, we have decided to submit a modified plan inclusive of a protocols announced and the appropriate blinding documentation. That proposes a change in the primary endpoint of Study 306B to OHSA item #1 or dizziness at visits five, which is two weeks post-titration. Those of you are familiar with the design of 306B will recall that since patients first time they go a blinded titration that can be up to two weeks in duration, by visit by some patients will be in the drug for a total of one month.

In conjunction with changing the endpoint of Study 306B to OHSA item #1, we plan to increase enrollment to 200 patients in order to be adequately power to demonstrate a 1.2 unit improvement relative to placebo with a standard deviation of 3. As we indicated in this morning’s press release, we already have 161 patients enrolled in Study 306B and anticipate we can reach a target enrollment of 200 patients early in the fourth quarter.

To achieve this goal, we plan to add approximately 15 new sites and now arcade additional internal staffing resources towards patient recruitment initiatives. Although we don’t yet FDA approval no our proposal, our hope is that by not only continuing enrollment into 306B, but also ramping up recruitment efforts that we can minimize the time required for resubmission of our NDA.

Assuming the FDA agrees with our modified proposal, we anticipate that the data from 306B would be available for submission to the agency in the first quarter of 2013. The FDA has indicated this would be likely to be considered a class 2 resubmission with a 6-month action date put in potential approval in the third quarter 2013.

Now, before we open up the call for questions, I will ask Nick to briefly review our current financials and provide some update guidance for the remainder of the year. Nick?

Nick Riehle

Thanks Simon. Regarding the first quarter results, Chelsea reported a net loss for the quarter ended March 31 of $15.6 million or $0.23 per share versus a net loss of $13.9 million or $0.25 per share for the same period in 2011. Research and development expenses for the first quarter were $8.7 million, which was down from $11.5 million in the first quarter of 2011. This reflects a significant decrease in clinical and related drug development costs with Northera registration programs winding down but was offset by higher cost really through advisory committee meeting and medical science liaison activities.

Selling, general and administrative expenses were $6.9 million for the three months ended March 31 reflecting an increase from the $2.4 million recorded for the same period in 2011. The increase was primarily related to Northera launch preparations undertaking as we approach the FDA goal data for our NDA.

Chelsea ended the first quarter 2012 with $51.7 million in cash and cash equivalents. Based on our current assumptions regarding the clinical and regulatory pathway for Northera, Chelsea anticipates full-year 2012 operating expenses to be in the $44 million to $48 million with full-year R&D of $27 million to $29 million and full-year SG&A in the range of $17 million to $19 million.

Chelsea expects to end the year with approximately $17 million to $20 million and cash and cash equivalents from existing reserves which can be expected to provided sufficient liquidity to fund the company’s operations into the second quarter of 2013.

This concludes coverage for an expanded 306B program and reflects rapid contractions during the current quarter for sales and marketing activity. Simon?

Simon Pedder

Thanks, Nick. Just add to Nick’s comments, though the biggest changes to our forecast tend from adjustments to our Northera program and our plan to resubmission of our NDA, is important to note that our anticipated R&D expense also include expenses related to our Phase 2 trial of CH 4051 in rheumatoid arthritis.

Although that study has recently concluded and we expect to have top line results in a week or so, there are expenses that carry forward as we officially close out the study and complete final study reports.

With that said, I recognize that we have presented with you a great deal of information. So now I’d like to open up the call for questions. Operator?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Our first question comes from Robyn Karnauskas from Deutsche Bank. Your line is open.

Robyn Karnauskas – Deutsche Bank

Hi guys, thanks for taking my question. I guess I was wondering, could you remind us again of 306A and the dizziness endpoint over thrive and specific significant of that endpoint over time? And the second question is, when will you get confirmation do you think from the FDA regarding the trial designed and if the FDA doesn’t agree, how do you go forward in future?

Simon Pedder

Thanks. Well, and I’ll start-off. I mean we reported the results of 306A at Movement Disorder Meeting in Toronto and what we showed in that was that the one week post-titration period, there was 1.5 delta difference in favor of the drug, 1.3 at two weeks post-approval, I’m sorry two weeks post-titration at week four, it was 1.1 delta and at the end of the study of week eight, eight weeks past titration, it was 0.9.

There wasn’t statistical significance because of the low numbers. Obviously if we had a much larger study, we would have reached statistical significance but that was only 51 patients. And I…

Robyn Karnauskas – Deutsche Bank

I guess as a follow-up to that…

Simon Pedder

…the clinical trial must be correct. Sorry Rob what was second part.

Robyn Karnauskas – Deutsche Bank

I want to follow-up to that but, yeah, the follow-up to that question. First of all, so, it seems like your discussions with the FDA that you’re still debating as and I’m just curious where, like how are you confident that if you proceed with this endpoint that they’ll accept it and seems like there’re still lot of debate and after going to the panel, it seems like the FDA was just not – we’re very confused as to what they really should approve this type of drug on, what endpoints. And how do you really get comfortable that the FDA will accept this endpoint?

Simon Pedder

I think we’re relatively comfortable because of the nature of discussion that we had at the agency. So I’ll ask Bill to add.

Bill Schwieterman

Well Robyn, I don’t think they were confused. You have to remember this was an end of phase, excuse me, end of review meeting and they were providing general guidance to us in the absence really of us committing a formal pulse to them. So the discussion was wide ranging and really sort of on broad themes about what they want to do and that was reflected in the press release as well.

It was clear that they would look very carefully at shorter term endpoints in Study 306B and we’re considering a range of different options, but much of that would depend upon the specifics of that also that we put forward as well as the supporting documentation. For example, in the blinding document, we came away feeling that we had reached a pretty good apparent consensus that endpoint short of the eight week, endpoint would be acceptable but of course until we actually get the proposal into them that the supporting blinding documents into them and get there a whole buy in as in any situation to get. These just are never starting about exactly what they’ll accept or not.

Simon Pedder

Yeah. What was clear in the discussion that we had with the agency and now is clear from discussion that was had at the advisory committee is that we’re believing, we’re all on agreement about the importance of dizziness, the item #1 and that’s clear and the only question that’s left is that, when we had discussion with the agency, we certainly didn’t think that we need to show it out to week eight. In discussion we had in the meeting minutes, they say that they’d be willing to say something shorter than that and so that’s the only thing that needs to be finalized.

Robyn Karnauskas – Deutsche Bank

Okay, thank you.

Operator

Our next question comes from Alan Carr from Needham & Company. Your line is open.

Alan Carr – Needham & Company

Hi, thanks for taking my questions. Any changes in, I guess, is on the other side of the table in terms of personnel, has that been – is that being consistent?

Simon Pedder

No, the important people, Dr. Stockbridge and Dr. Unger were in the meeting with us.

Alan Carr – Needham & Company

And, Robyn asked this, but I’m not sure if you answered. But – the timeline to clarifying this protocol with the FDA, what are your thoughts on that and then you have to submit this proposal but do you have a sense of when that might be wrapped up in terms of getting a response from them about other two weeks is okay?

Simon Pedder

Yeah, I mean, Alan, we’re rapidly working on this. We’ve been obviously hitting the ground running after the Complete Response Letter. So we’ve been working as clinical team now, actually for quite sometime on various proposals and with our statisticians and I’ll let Art coming on this as well but it’s not like we haven’t been thinking of options and we actually run to the FDA even in the short time period after the Complete Response Letter with a full briefing document and a draft proposal.

So we’ve been working on it. We have our statisticians working on it. The meeting was actually very good and providing guidance and I anticipate actually in a relatively near future, we’re going to be able to submit something to them and get some feedback short. With that I’ll let Art also comment on this.

Art Hewitt

I’d only add that, I mean 306 provides just with a wealth of data over a fairly significant period of time and that there are multiple ways in which we can potentially use this data to satisfy the concerns of the FDA. So it’s not a simple process that just come up with one way to satisfy all those concerns, but we do believe 306 allows us those opportunities.

Alan Carr – Needham & Company

Are you going to have an SPA for this?

Simon Pedder

We’re not anticipating one, Alan. We certainly want to get the definitive meeting when it’s back from them, but unless there is a request from the agency, we’re not going to actually do that since we think we have fairly clear guidance on what we need to do.

Art Hewitt

Yeah.

Simon Pedder

Alan, just although we’ve got no set deadline for the FDA response for the proposal, just in our request to have the meeting with the FDA was a Complete Response Letter. They responded very quickly. They worked with us to get a meeting. They allowed us enough time to prepare the briefing documents that quickly after didn’t meet without sense. So we like, we expect that they’ll have the same type of interest in meeting with us because this is something, which we think is beneficial to both parties.

Alan Carr – Needham & Company

And Bill last thing, if you could clarify this for me. The 306A patients, are they going to be included or excluded in this contemplated new 306B?

Bill Schwieterman

They will be most evidently excluded from the primary analysis of 306B. However, clearly this is still an important dataset in and out itself so it’ll be included into the revised NDA submission.

Alan Carr – Needham & Company

All right. Thanks very much.

Simon Pedder

Yeah, just to be clear, the 161 that we recruited in 306B do not contain patients, the 51 patients that were in 306A.

Alan Carr – Needham & Company

Thanks.

Operator

Our next question comes from Liana Moussatos from Wedbush Securities. Your line is open.

Liana Moussatos – Wedbush Securities

Hi, with site, the large site that’s under reviewed, does that impact your enrollment of 306B. What percent of patients that have been enrolled the 161 patients came from that site? And are you still only enrolling Parkinson’s?

Simon Pedder

We do not have that site involved. That was a non-U.S. center all of 306A and all of 306B is just U.S. and all of it’s just Parkinson’s Liana.

Liana Moussatos – Wedbush Securities

Thank you.

Operator

Our next question comes from Juan Sanchez from Ladenburg. Your line is open.

Juan Sanchez – Ladenburg Thalmann Securities

Hi, guys. When do you think we are going to know whether or not if Study 301 has seen a positive by the FDA? You think – is that before in process or we are going to know after you file the NDA or when do you – can we give me some clarity on that?

Simon Pedder

Well we’re obviously continuing to look at that center. We still believe that’s a good center and then the emphasis is obviously to find something wrong with this center. We did – we had two independent audits that were performed that showed nothing, indicated nothing wrong. The FDA did an audit of that center after the NDA and did not find in any areas of concern.

So our viewpoint moving forward is going to be that that’s a good center until we learn anything differently. But so far, the only thing that occurred that’s identified that center is relatively robust data came from that center. It’s – we think it’s a very good center and then the placebo patients got worse and the patients who got droxidopa got a lot better and that’s the outstanding issue with the center.

Juan Sanchez – Ladenburg Thalmann Securities

And how many patients are we talking about in this site?

Simon Pedder

18.

Juan Sanchez – Ladenburg Thalmann Securities

They were, for the most part, Parkinson’s or…

Simon Pedder

Yeah, half Parkinson’s half PAF roughly a couple of end-to-ends to non-diabetic polyneuropathies.

Juan Sanchez – Ladenburg Thalmann Securities

Got it. Okay, thank you.

Simon Pedder

Those patients were also very young compared to the overall population. So the incidence of the younger patients and the incidents of PAF actually ties into the rest of the results that we found from that study.

Juan Sanchez – Ladenburg Thalmann Securities

Okay. Thank you.

Operator

(Operator Instructions). Our next question comes from Steven Salamon from ROSALIND Advisors. Your line is open.

Steven Salamon – ROSALIND Advisors

Yeah, sorry to keep little more focus on this one site. Was there a specific statistical analysis that was done that suggests that the data was too good to be true as you stated? And again, just to clarify, so this is a non-U.S. site and it’s not included in Study 306?

Simon Pedder

Correct. We haven’t performed any specific statistics on the center. I think what’s important is that, when we look at what the point differential when it comes to the telpher (ph) of the study, if we remove that site. If we just look at U.S. centers, they’re still a very meaningful clinical benefit. When you remove 18 patients from 160, you obviously lose a lot of power and that’s the problem. If we powered back up, we could have statistical significance. When we look at the U.S. patients, we have – what we see is a robust and clinically relevant.

And I think the FDA identified that as well. It’s just clear that this one center that recruited a lot of patients had a robust effect and they pointed out that they’ve been surprised by that and we said, we were not surprised by that. That’s why we did two audits and we reminded them that they had also audited the center and no relevant findings were found.

Steven Salamon – ROSALIND Advisors

And you’re going to do a further enquiry. Is there any – do you have any sense as to when this issue might be put to bed and how you will sort of disclose around that?

Simon Pedder

Well, we don’t know what the timelines of the – with the agency would be. We’re obviously continuing to tell the agency. We’re continuing to look at the data from that center and if we have anything else significance, we’ll obviously report it.

Steven Salamon – ROSALIND Advisors

Okay. Thank you, Simon.

Simon Pedder

Thank you.

Operator

We have a follow-up question or comment from Liana Moussatos from Wedbush Securities. Your line is open.

Liana Moussatos – Wedbush Securities

Thank you. So our fall is now a secondary point?

Simon Pedder

Yes. I mean this is the one thing that has changed and this changes from obviously the feedback that the agency gave at the advisory committee and obviously the feedback that the agency gave us at our most recent meeting. I mean from our viewpoint, if we look at Parkinson disease patients when it comes to dizziness, it’s our most robust outcome. It was the most robust outcome in Study 301. It was the most robust outcome in Study 306. So if they are going to move away from fall to another outcome, we’re obviously delighted that will move into vision us.

Liana Moussatos – Wedbush Securities

Okay. And if you say everything is positive, we have to do another trial which falls to get it on a label or well this be enough for a label?

Simon Pedder

Obviously that’s data dependent. That being said, we’re not looking at this going to be a study that’s going to lead a false indication. It’s now a study with dizziness as to the primary endpoint to lead to the approval for NOH.

Liana Moussatos – Wedbush Securities

Okay. And the modified plan you brought up that you were proposing. What was the power level for 1.2 units?

Simon Pedder

That’s 1.2 at 200 patients has a power of 80% with a standard deviation of 3.

Liana Moussatos – Wedbush Securities

Okay. And then my last question is, you mentioned the RA, the Phase 2 RA trial maybe we get results in a week or so. Is that positive, what are you going to do with that going forward? Does your runway include taking that forward or are you thinking about partnering or what’s the thought there?

Simon Pedder

We’ve always been pretty open that we would partner that rheumatoid arthritis is a huge indication, but it’s large clinical needed to be done global clinical trials needed to be done. So clearly that’s something that we’ve always been upfront that we partner for Phase 3.

Liana Moussatos – Wedbush Securities

Great, thank you very much.

Simon Pedder

Thank you Liana.

Operator

You have another follow-up question or comment from Juan Sanchez from Ladenburg. Your line is open.

Juan Sanchez – Ladenburg Thalmann Securities

Yeah, one last question. Do you know the results from the 18 patients (inaudible) versus placebo on, no, no, wrong question. I apologize. I was mixing something else there. Bye-bye.

Simon Pedder

Okay. No problem.

Juan Sanchez – Ladenburg Thalmann Securities

Yeah.

Operator

I’m showing no further questions at this time. I will now turn the call back over to Simon Pedder for closing remarks.

Simon Pedder

I just like to thank you all for participating. Obviously we look forward to updating you accordingly as we gain more information and wish you a great day. Take care everybody.

Operator

Ladies and gentlemen that does conclude today’s conference. You may all disconnect and have a wonderful day.

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