輝瑞 (PFE) 2009 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome everyone to the First Quarter 2009 Icagen, Incorporated, Earnings Conference Call.

(Operator Instructions) Thank you.

It is now my pleasure to turn the floor over to your host, Dr.

Richard Katz, Executive Vice President and Chief Financial Officer.

Please proceed, sir.

Thank you, operator.

Good morning, everyone, and thank you for joining us today to discuss our corporate research and clinical progress, as well as our financial results for the first quarter of '09.

With me here today is Kay Wagoner, our CEO, as well as Seth Hetherington, our SVP of Clinical and Regulatory Affairs.

Kay will begin the call with a general overview and Seth will then provide an update on the clinical programs and I'll briefly review our financial results for the quarter.

Following our prepared remarks, we will be available to answer any questions that you may have.

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

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 most recent filings 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 to 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.

Let me now turn the call over to Kay.

Thanks, Rich.

My remarks will be brief to allow time for Seth to provide more details on our clinical programs.

The first program that I'd like to talk about is our asset program.

The compound is called Senicapoc.

It's the first KCa 3.1 inhibitor to enter clinical development for asthma and therefore it represents a new approach to this indication.

It has several potential advantages that we believe are significant, including it has preclinical antiinflammatory effects and thus will proposed for chronic use to reduce airway inflammation in asthma, thus, hopefully, preventing or reducing the severity of asthma attacks.

Secondly, it's well tolerated at all the doses we tested, with no dose-limiting toxicity and finally and importantly, it should be easy to use since it can be given orally once per day.

That third point is particularly important that, aside from leukotrienes and leukotriene inhibitors and the corticosteroids, both of which have some limitations, there are very few other asthma therapies that are taken by mouth.

Oral dosing has several significant advantages over inhalation, including, obviously, easy to use and also potentially more effective delivery to the active site because some individuals, particularly children, have challenges using inhalers.

We recently completed enrollment in our first proof-of-concept study in patients with allergic asthma and we are close to two-thirds enrolled in our second proof-of-concept study in patients with exercise-induced asthma.

Both of these studies are quite cost-effective ways in which we can generate proof-of-concept data regarding the use of Senicapoc in asthma.

We would expect to report first-line data from both of these studies later this year and in a moment, Seth will describe our asthma studies in more detail.

The second clinical program is for epilepsy and pain.

We believe we are studying the most selective KCNQ opener in clinical development, a compound called ICA-105665.

We recently reported the successful completion of our Phase I program for this compound and the drug was well tolerated at all dose levels.

There were no serious adverse events, no dose-limiting toxicity, and no apparent need for dose titration.

The pharmacokinetics were linear, dose proportional, and consistent with twice daily dosing.

So, if these findings are sustained in future trials, we could have a significant competitive advantage over other currently available drugs, some of which either have dose-limiting side effects, need to be given say three times a day, or need to be titrated over an extended period of time before achieving a steady dose level.

In this 105665 program, we are completing our plans for a translational pain study, which we hope to initiate by mid-year and Seth will describe that study briefly in a few minutes.

We recently reported that, based on high dose animal studies that we completed in 2008, the FDA placed ICA-105665 on partial hold for epilepsy only.

We've made substantial progress over the last few weeks in preparing a response to the FDA, which we believe will achieve our goal of having the partial clinical hold for epilepsy lifted.

We expect to submit a package of information along with our plans for our proof-of-concept study as soon as feasible.

We are confident that the issues that were raised by FDA are manageable and are not dissimilar to issues raised in other development programs for marketed anti-epileptic drugs and Seth will provide more details on our Phase I and our future plans for this compound in a few minutes.

Just a final few words on our corporate and business development activities.

Clearly we recognize the importance of executing strategic transactions during these unusual economic times and are working in an extremely focused manner to identify the best opportunity for Icagen.

We are actively engaged in dialog with a sizable number of companies and are open to a variety of deal structures.

Our goal is to complete a deal as soon as we identify the best opportunity for the Company and its shareholders.

So let me turn the call over now to Seth to provide an update on our clinical programs and then later to Rich to summarize our financial results.

Thanks very much, Kay.

I'm going to provide you with an update to the clinical programs and I'm very pleased to talk to you today about those programs in asthma, epilepsy, and pain.

First, starting with the asthma program, this is continuing to proceed very nicely and we're on target to complete two proof-of-concept protocols this year.

Each study assesses the asthmatic response to a measured stimulus and the two together will be complimentary in establishing the activity of Senicapoc in this indication.

The allergen study has completed enrollment on schedule.

All patients have finished the treatment phase and have either completed all study procedures or are in the eight-week follow-up stage.

Data should be available in the second half of this year and will include pulmonary function tests, and since we're collecting sputum samples from these patients, we'll also be testing for markers of airway inflammation.

Remember that we believe that Senicapoc will act by decreasing the inflammation, which is, of course, a key component for asthma.

The exercise-induced asthma clinical trial is enrolling at 16 clinical sites, all in the US, and this is our second trial.

It's similar to the allergen challenge study with a goal to show that Senicapoc reduces the asthmatic response to a stimulus, which in this case is exercise.

Approximately 80% of patients with asthma have some degree of bronchospasm in response to exercise.

Patients who are eligible for this study have asthma and a demonstrated reduction in pulmonary function of at least 20% in response to a standard exercise test.

Ultimately, we will enroll 64 patients who will be randomized to either Senicapoc or placebo and treated for four weeks.

Then, at two weeks, and at the end of treatment, the subjects are tested again for their response to exercise.

The goal is to test whether Senicapoc reduces the asthmatic response as measured by pulmonary function testing.

Now let's move on to 665, which our KCNQ channel drug.

We recently presented a summary of our data from the Phase I program at the 10th Antiepileptic Drug Trials Conference in Florida.

Those data showed that the doses we're proposing in future clinical trials, based on preclinical models, should be in the expected therapeutic range.

We also reported that in both volunteers and patients we've not observed dose-limiting toxicity and in side effects we did see were mild, reversible and consistent with those of drugs that act on the central nervous system.

And we've previously discussed with you the partial clinical hold that applies to our epilepsy programs for 665.

We are addressing the requests from the FDA by providing additional data and analyses from preclinical studies and as Kay mentioned, we're confident that our approach will satisfy the FDA and support the continuation of that program.

Assuming that our response successfully leads to the lifting of the partial clinical hold, our next study will be in patients who have photosensitive epilepsy.

This is a special group of patients who have epileptiform brainwave responses to flashes of light that can be detected by an electroencephalogram, or EEG, and that response is called a photosensitive response.

This is a biomarker study, but one that has particular relevance to the treatment of epilepsy and it's a type of study that's been conducted with many of the newer antiepileptic drugs over the past 20 years.

Our objective here is to demonstrate that one or more doses of 665 can reduce the epileptiform brainwave activities in these patients.

If this study is successful, we will be able to correlate dose and blood concentrations of 665 with an impact on the EEG recording.

In this way we establish a dose or doses for further study in other clinical trials.

This is an especially appropriate approach for 665 because, so far, we've not identified a maximum tolerated dose.

The second study to be conducted this year for 665, is a study in pain.

Our current plan is to use models of pain in healthy volunteers to gauge the affect of 665 on reducing the sensation of pain.

This is done by using UV light exposure, e.g., sunburn and capsaicin, which is red pepper, as stimuli.

The details of this program are still in development, but we have engaged experts familiar with this methodology to develop the program.

By the way, this particular study is not subject to our clinical hold, although we will be providing the FDA with the final protocol.

So, in summary, 2009 is shaping up to be a very active year for the clinical programs.

We will have complete data from two studies in asthma and potentially the top-line results from two studies with 665, one in epilepsy and one in pain.

We will have clearer information on the time to data over the next few months as these programs evolve.

And now I'm going to turn this over to Rich to continue on with the conference call.

Thank, Seth.

I'll be very brief on financial highlights for the first quarter.

Revenues were approximately $3.0 million, which was essentially unchanged from '08, and revenues in both periods were from the Pfizer collaboration.

About half of the revenues were from amortization of the initial up-front payment, the other half were from ongoing R&D funding.

Operating expenses during the quarter were $6.0 million, which was down slightly from the $7.0 million of 2008.

That was driven primarily by decreased expenditures in G&A as a result of our cost cutting efforts.

Our net loss was $3.6 million and this compared favorably to the $4.0 million loss in the same period in 2008.

We ended the quarter with approximately $29 million of cash and cash equivalents and thus far are consistent with the guidance that we had provided in the last update.

We'll now open the call to questions, operator.

(Operator Instructions)

Operator, if there are no questions, then we can certainly conclude.

Pardon the interruption.

You do have a question on the line from [Peter Margay] of Griffin Securities.

Please proceed.

Good morning, Kay and Richard, a pleasure to hear your voices again.

Just wondering if you could give us a little bit of additional information regarding the clinical holds.

You alluded to an issue that's not uncommon epilepsy drugs and I just wondered if you could give us a better sense as to what that was.

Sure.

This is Seth Hetherington and I can fill you in a little bit.

Understand that when you conduct preclinical studies the purpose is to assess the risks for potential side effects in people who will participate in future clinical trials.

Now, these preclinical studies are not always predictive of what may happen, but they are used to estimate risk and therefore have to be sufficient in the eyes of the regulatory authorities, such as the FDA, to support further clinical trials.

And some of our early preclinical trials where we used very high doses in rats, there were abnormal movements from the animals that the FDA wanted some more definition on, so they have asked us the characterize these a little bit better.

What they're looking for is a measure of something called "the margin of safety" and there are guidelines in the FDA publications as to how you'd calculate that and what the standards have to be.

We're very convinced and confident that, at the end of the day, by providing them additional analyses on these data and conducting some other data will show that the margin of safety for the planned doses in people really exceeds the requirements by the agency.

We have conducted two studies so far in rats and we have another one that's pending and once we have the results of those studies then we'll be in a better position to gauge what our timeline is on submission to the agencies.

But I think we're on the right track.

Again, other companies have approached this same issue with abnormal movements in animals and that includes many of the more recently approved antiepileptic drugs.

Thank you, Seth.

I appreciate that.

So it sounds like you're going to be able to go back to the FDA with some real data in hand by, what, mid-summer?

Well that might be a reasonable estimate.

Again, we won't have any greater clarity until we actually get all the studies in and have had a chance to look at that and see if we believe there's any additional detail or follow-up that we need to do.

If things go well, I think your estimate is very accurate.

Okay and I assume that the data must be looking pretty good at this point?

We're very confident in what we're seeing, particularly when you put it in the background, again, of what the FDA guidance is on how to analyze the data and if you look at the history of other antiepileptic drugs and the issues that they've addressed as well.

And is the difference between the pain clinical trial and the epilepsy trial related perhaps, in terms of clinical holds, related perhaps to differences in the level of dosing required?

No.

It's not related to level of dosing.

It has to do with the patient population.

The FDA is concerned that the epilepsy patient is a particularly susceptible individual to adverse events and they just want us to get some better detail to them before they're willing to do that.

Studies in healthy volunteers, they feel, are more controlled.

They are not an at-risk population.

They're basically healthy, so they feel that the risks to those subjects are lower than those two patients.

Great.

Well, it sounds very good.

Thank you very much.

All right, thank you.

Thanks for your question, Peter.

(Operator Instructions) And there are no further questions at this time.

I'd like to turn the call back to Dr.

Richard Katz.

Please proceed.

Okay.

Well, just would like to thank everyone for joining us today and we'll look forward to keeping you informed.

Certainly, if you have any follow-up questions, feel free to give me a call.

Thank you for attending today's conference.

This concludes your presentation.

You may now disconnect.

Good day.

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