輝瑞 (PFE) 2010 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the first quarter 2010 Icagen Inc.

Earnings Conference Call.

My name is Shamika and I will be your operator for today.

At this time, all participants are in listen-only mode.

We will conduct a question-and-answer session towards the end of today's conference.

(Operator Instructions).

As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the call over to your host for today's call, Dr.

Kay Wagoner, President and Chief Executive Officer.

Please proceed.

Thank you.

It's great to have you join our call today.

Our remarks will be very brief given our recent earnings call during the first quarter.

We were very pleased to recently report positive results in our Phase IIa study in patients with photosensitive epilepsy and to have those results presented at the Eilat Conference on new antiepileptic drugs in Israel.

Based upon the efficacy demonstrated in that study and the safety and the lack of a maximal tolerated dose in all of our clinical studies to date, the FDA supports our plan to study higher doses, which will place us in a strong position to select the best dosage for subsequent clinical trials.

Seth will review that recent information in a few minutes and give you more details of our upcoming plans.

But first, Rich will give you a financial update.

We will of course be available for questions and answers after those brief updates.

Before we begin, I'd just like to read the following regarding any forward-looking statements that we may make.

Various remarks that we may make about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from these forward-looking statements as a result of various important factors, including those discussed in our less recent Annual Report on Form 10-K as filed with the SEC.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation do so even if our estimates change.

And therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

Financially, the first quarter was very straightforward.

I'll just briefly summarize.

Revenues for the first quarter were $1.5 million.

This is compared to $3 million during the same period in '09.

Revenues were entirely comprised of R&D funding that we received from Pfizer.

The upfront payment from Pfizer that we'd initially received of $12 million on signing the collaboration agreement, that became fully amortized during the third quarter of 2009 and therefore is not reflected, and that accounts for the decrease.

Operating expenses for the first quarter 2010 were $4.7 million.

This is compared to $6.6 million during the same period in '09.

The substantial decrease was due to two primary factors; one, as you are aware, we have a variety of ongoing cost reduction efforts in place, and that was certainly important.

Additionally, we no longer have development expenses associated with Senicapoc for asthma.

And those two factors combined resulted in almost $2 million decrease in operating expenses.

Net loss for the first quarter of 2010 was $3.2 million.

This is compared to $3.6 million during the same period in '09.

And the decrease--the improvement in the net loss for the year was a result of the decreased operating expenses, partially offset of course by the decrease in revenues.

We ended the first quarter with approximately $14.3 million of cash.

I'll be happy to take any questions related to any of that during the Q&A, but let me now turn the call over to Seth to briefly highlight the clinical summary.

Thanks, Rich.

As Kay mentioned, the results from an important proof-of-mechanism study became available in the first quarter of this year.

In that study, we were able to demonstrate that 665 reduced the epileptiform activity in EEG recordings from patients with photosensitive epilepsy that are elicited by flashes of light.

We found positive responses at doses of 100 milligrams and 400 milligrams of 665 as a single dose.

The importance of the study is that it indicates that these doses of 665 penetrates the brain and gauges the target and produces a reduction in neuroexcitability, which is common underlying action of any anti-epileptic drug irrespective of the mechanism.

This was especially important for 665, because we've not identified a maximum-tolerated dose or dose-limiting toxicity at plasma concentrations that we believe would be effective.

As a result, we put to rest the question as to whether doses up to 400 milligrams for achieving brain concentrations of 665 that would reduce neuroexcitability.

We don't know if doses of 665 above 400 milligrams would lead to greater levels of biologic activity.

Consequently, we've provided the FDA with the data on the photosensitivity study and a risk-benefit analysis for studying doses of 500 milligrams and 600 milligrams in additional patients.

The FDA has agreed with that proposal.

We also proposed to the FDA that to demonstrate safety and tolerability of these higher doses we conduct a multiple-dose study in healthy volunteers with daily doses of 500 milligrams and 600 milligrams for seven days.

They agreed to this in principle and requested that we submit a protocol for their review.

The full protocol and minor modifications to the photosensitivity study, as they requested, have been submitted back to the FDA.

And once we receive final comments from them, we will initiate both studies as soon as possible.

We believe that the combination of the extended photosensitivity study and the multiple ascending dose study will give us an exceptional range of doses for taking a significant step forward in the clinical development of 665.

In other words, we believe we will be in a position to conduct a Phase IIb study in the target population of patients with incompletely-controlled partial onset seizures.

That should bring you up to date on where we stand on our clinical goals and our clinical trials.

And I'll turn this back to Kay.

We would be happy to take your questions at this time and provide answers as we go along.

Thank you.

(Operator Instructions).

Your first question comes from the line of Chris James of MLV.

Please proceed.

Hi, good morning, and thanks for taking my questions.

And congrats on your success, specifically with the FDA.

I guess my first question is relating to 665.

What's your best estimate of timing for the start of the Phase II study and when do you think we could potentially see some data there?

And if positive, how do you think it will affect your talks with potential partners or acquirers of Icagen?

Well, I'll take -- this is Seth.

Chris, I'll take the first two parts of that question and leave the last one to Kay or Rich.

We've obviously just sent in the revised protocols to the FDA.

They will give us a response in some timeframe, which is anybody's guess, but relatively soon.

The two trials together will take about three to six months to conduct.

So maybe sometime around the turn of the year, we would expect to be in a position to start the Phase IIb study.

That trial, we are modeling it statistically for a couple of different designs.

The endpoints are going to be the ones that are pretty typical for this kind of trial.

And based on similar types of trials that have been done at this stage in development of other AEDs, a reasonable estimate for the overall time to completion would be 12 to 18 months.

Obviously, it's going to vary depending upon final number of patients, where we conduct it, what statistical model we use, et cetera.

But that's all in the process to become clear by the time we finish up with the next couple of studies.

And, Chris, I think that we do certainly have interest in this program from a number of companies.

I think that further data will only go to increase that interest.

But I wouldn't rule out the possibility that we could do something on the strategic front before that data becomes available.

Great, thank you.

One more for Seth and then -- actually maybe two more for Seth.

How broadly applicable is the photosensitivity model?

For example, does this have efficacy in other forms of epilepsy like mesial temporal epilepsy?

You know, the track record for the photosensitive epilepsy study is pretty good.

Probably a dozen anti-epileptic drugs that are currently marketed have been through this study and show efficacy at the same doses and ranges that are used clinically.

There are a couple of examples where it's been negative and subsequent clinical trials turned out to be negative as well.

So the overall sense among the experts in the field is that this is a pretty good proof-of-mechanism study, and it just happened to fit perfectly our situation because of the characteristics of 665 related to its tolerability, which is clearly excellent.

Whether it predicts specific syndromes, you know, it's a little bit harder to say.

What we're demonstrating is that we're getting to the target.

We're affecting neuroexcitability.

And what we know from preclinical studies is that it affects neuroexcitability across a broad range of models, akin to what you would see with a broadly applicable anti-epileptic drug.

So that's about as far as one could take it until you actually run the clinical trials in any given type of epilepsy.

Great, that's helpful.

And then my final question; in January, your partner, Pfizer, seemed highly enthusiastic about the NaV1.7 program.

Specifically, they mentioned that it's capable of launching a major program, did come up with highly potent and selective candidates and they're able to quickly progress it into the clinic.

How are you progressing with selecting a candidate?

And remind us of the milestones you expect to achieve there?

The progress is very good, and I hope to be able to relate some more specific information about the progress shortly.

We do have some really good lead compounds.

We're doing a variety of studies on those compounds.

And so I think that the enthusiasm of Pfizer in January at the JPMorgan Conference is well placed, and we share that enthusiasm.

And I would like to give you some more specific information, and hopefully I will be able to do that shortly as we hit various milestones in the collaboration.

Great.

Thanks, Kay.

I appreciate the color, and congrats again.

Thanks very much, Chris.

Thanks, Chris.

(Operator Instructions).

There are no questions in the queue.

I would like to turn the call back over to Dr.

Kay Wagoner.

Please proceed.

Thank you, operator, and thanks to everyone for participating today.

And we are happy with the progresses we've made this quarter, and we're really looking for to an exciting second quarter.

Thanks again.

Thank you for your participation in today's conference.

This concludes the presentation.

You may now disconnect.

Good day.