輝瑞 (PFE) 2008 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Icagen's first quarter conference call.

My name is Jen, and I will be your coordinator for today.

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

We will be facilitating a question-and-answer session toward the end of today's conference.

(OPERATOR INSTRUCTIONS).

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

I will now turn the presentation over to Dr.

Richard Katz, Chief Financial Officer.

Please proceed, sir.

Thank you.

Good morning, everyone, and thanks for joining us today to discuss Icagen's corporate research and clinical progress, as well as our financial results for the first quarter of 2008.

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 today with a company overview, and an update on our research and clinical programs.

I will review our financial results, and following that, all of us will be available to take your questions.

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

Our 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 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 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.

So with that, let me now turn the call over to Kay.

Thanks, Rich.

Good morning, and thank you for joining us on the phone or via the Webcast.

Icagen is making great progress based on the pipeline accomplishments which we had in 2007.

Whether we are talking about our clinical programs or our research programs, we are making substantial progress.

As you will remember, we're focused on epilepsy, inflammation and pain.

All of those disease areas are ones that -- in which there is significant need and market potential.

I will first update you on the 665 program, then our progress with the senicapoc, and then finally, we will focus in the new leads and advances in our pain program.

As a reminder, ICA-665 is a selective opener of subtypes of KCNQ potassium channels which have been validated by both genetic and physiological evidence as targets for new treatments for patients with neuroexcitability disorders such as epilepsy.

By selectively opening these channels, these agonists like 665 should be useful for disorders characterized by excessive neuroexcitability -- epilepsy, neuropathic pain, and others.

Today, we have announced the successful completion of our single ascending dose study of 665 conducted in healthy volunteers.

During this initial phase I study, the drug candidate was well-tolerated, with no serious adverse events.

We also announced today that we have initiated a second phase I study of 665, the multiple ascending dose study, to continue to assess the safety, tolerability and pharmacokinetics or PK of this novel compound.

Now, prior to beginning the ascending doses in this multidose second study, we will explore the PK of our new tablet formulation, which replaces the powder formulation which we utilized in the first study.

Analysis of the PK of the new tablet will be followed by enrolling sequential cohorts of healthy subjects who will receive ICA-665 twice each day.

We're currently considering various trial designs for our phase II trial for 665.

In broad outline, though, we expect that this will be a placebo-controlled parallel group study of a range of doses of 665 in patients with treatment resistant epilepsy.

Once we complete the protocol, I will be in a better position to provide an update on the initiation timeline and to estimate the timing for the topline data.

Let me step back a moment, though, and explain why we are excited about the substantial potential for 665.

Over 2.5 million people in the U.S.

have a neuroexcitability disorder called epilepsy.

Approximately 30% of these individuals continue to have seizures, despite treatment with available drugs.

Additionally, current therapies may lead to troubling side effects.

Besides epilepsy, there are other neuroexcitability disorders, such as serious and chronic pain conditions, in which new approaches are really needed.

As a very selective KCNQ agonist, ICA-665 represents a new approach for patients who either are resistant to or experience acceptable side effects with currently available drugs.

In our nonclinical study, 665 has demonstrated efficacy in models of a wide range of epilepsy syndromes, including a study which we had conducted at the NIH that indicates the potential for efficacy in patients who suffer from treatment-resistant seizures.

In addition to this, our internal nonclinical studies, and those conducted at independent laboratories, show that 665 also has potential in the treatment of certain pain disorders.

We are therefore very enthusiastic about the potential for this compound, as we are for the potential for senicapoc in asthma.

Let me turn now to talk about our asthma program.

Senicapoc, or 17043, is our novel oral small molecule which has shown anti-inflammatory activity in nonclinical studies, and which is being pursued in asthma.

Earlier this year, as we reported, the FDA accepted our IND submission for senicapoc in asthma and we initiated a multiple ascending dose study in healthy volunteers to assess the safety, tolerability and PK of senicapoc at higher doses than those that we had previously tested.

As an update, dosing for this study has recently been completed.

Now we are undergoing the final follow-up in the data collection and analyses for that study.

And we will use these data from that final PK study to select the doses for subsequent clinical evaluations of senicapoc in asthma patients.

We continued to work with our thought leaders to finalize our phase II study, which we have planned for asthma -- in asthma in the second half of 2008.

As currently conceived, the study will be a randomized, placebo-controlled parallel group study with approximately 15 patients per arm.

Each patient will receive a once-a-day oral dose of senicapoc or placebo.

This study will measure lung function using the clinically relevant endpoint, FEV1, or forced expiratory volume in the first second, as a measure of resistance in the airways to the flow of air.

FEV1 response to a challenge will be compared before and after treatment with either senicapoc or placebo.

So when the phase II design and the protocol are completed, I will be able to provide a better update on the timing of initiation of the dosing and the estimated time to topline data for that study.

I think it is clear that there is a need for a novel orally active potentially disease modifying therapy for asthma.

There are approximately 24 million adults and 10 million children in the United States who have been diagnosed with asthma, with expectations for growth in these numbers as we face things like environmental pollution and airborne allergens.

Most of the treatments that are available today for asthma are administered via inhalation, and many are directed primarily as symptomatic relief, and are often used on a rescue basis.

Therefore, there remains a need for oral medications that exert longer duration control over the underlying to the pathophysiology of asthma, thereby reducing the frequency of asthma attacks and the need for the use of rescue therapies and steroids.

Our nonclinical data supports the potential anti-inflammatory effects of senicapoc, specifically to reduce antigen-induced increases in airway resistance and airway hyperreactivity.

These positive nonclinical data combined with previously recorded phase I clinical safety with senicapoc as human subjects demonstrate the potential for this compound to be an important novel once-a-day oral therapy for the treatment of asthma.

Now, lastly, our progress in our pain program.

In our multitarget sodium channel and calcium channel pain programs, we have identified leads and advanced leads targeting a variety of ion channels in the pain pathway.

And we demonstrated convincing animal efficacy with many of our compounds.

This work has resulted in a broad portfolio of issued and pending patents and patent applications.

We are especially pleased with the progress of our ongoing research and development collaboration with Pfizer on three sodium channel targets for the treatment of pain.

In March, as we have announced, this collaboration was broadened to include an alliance with Birkbeck College, University of London to further our knowledge of the structural biology of sodium channels.

We expect that through the combined efforts of the Pfizer and Icagen teams, we have excellent opportunity to identify a series of drug candidates targeting the sodium channels.

Currently, we are studying a group of our compounds in nonclinical toxicity studies.

As these studies are completed later this year, we will update you on our progress and plans towards selecting clinical candidates.

So in summary, we had a strong start to 2008, and with our solid cash balance, we are well positioned to continue this positive movement through the balance the year.

We're looking forward to important achievements in our clinical programs as we move closer and closer to phase II studies in epilepsy and asthma, and in our research programs as we work toward identification of clinical candidates.

Let me now turn the call over back over to Rich to review our first quarter financial results.

Thanks, Kay.

Revenues for the first quarter of 2008 totaled $3.0 million.

This compared to $2.0 million during the comparable period in '07, representing an increase of 49%.

This increase was due primarily to our collaboration with Pfizer, and it was formed during the third quarter of '07, partially offset by a decrease in revenue due to the termination of our collaboration with McNeil.

Operating expenses for the first quarter of '08 were $7.0 million.

This compared to $8.9 million from the comparable period of 2007, representing a decrease of 21%.

The decrease in operating expenses was primarily due to decreased R&D expense related to the development of senicapoc, which was partially offset by increased R&D expenses related to the development of 665.

Net loss for the first quarter of '08 was $3.6 million.

This compared to $6.5 million during the same period in 2007, representing a decrease of 44%.

And this decrease was again primarily related to the increase in revenues, as well as a decrease in operating expenses that were noted.

To conclude my remarks, I would like to note our significant cash balance, which was approximately $46 million as of the end of the first quarter.

Based upon this cash balance, coupled with the ongoing R&D funding from Pfizer and our continued focus on tightly managing our burn rate, we remain confident that we have sufficient capital to continue to drive the progress of our clinical programs through 2009.

That will conclude the financial update.

And we will now be pleased to take your questions.

(OPERATOR INSTRUCTIONS).

Christopher James, Rodman & Renshaw.

Congratulations on the progress made during the quarter.

I just have a few questions with these programs.

Starting with 665, when would we expect to see some data from the phase I single ascending dose and the multiple ascending dose studies?

This is Seth Hetherington, Chris.

We will probably position the first phase I study for presentation at a scientific meeting yet to be determined, but likely toward the latter part of this year.

And we have not had any internal discussions about any other way of articulating that data at an earlier time such as a press release.

So I think it would -- the best thing to say it would probably be presented at a scientific meeting later this year.

And let me just add, Chris, it is a pretty vanilla study.

As you know, the phase I study, as you increase the doses and if we had reported the studies really went well and it was well-tolerated and there were no serious adverse events.

So it is not one of those earth shattering completions that herald a lot of inattention.

Sure, sure.

And moving on to senicapoc, given the wealth of data that you have collected so far, what opportunities do you envision to advance this a little bit faster just given the safety data that you have collected?

Well, this is a new IND from the prior indication for which it was under investigation.

And I think our overall general timeline that we have articulated before are pretty reasonable, and about as fast as one would expect.

In fact, they are really geared toward an expectation that if things go well, which they have so far, in that we have not had any hiccups in the development process.

So again, later half of this year, we are looking toward initiating the phase II program for senicapoc for asthma.

And how high did you do in the dose for sickle cell?

And how high do expect to go in asthma?

Sickle cell disease dose was following a loading dose, and maintenance of 10 milligrams per day for adults.

We have extended that up to 40 milligrams per day as a maintenance dose in adults.

And that is a study in healthy volunteers.

That has gone well.

That last cohort is still in the process of being followed.

But we have that dynamic range now -- fourfold above where we were in sickle cell disease to work with.

And which doses we actually take forward to study still is under discussion.

Thanks.

With respect to the Pfizer collaboration, any additional color you give on when you expect to find a clinical candidate?

Well, as I said today, we're doing some early stage toxicity studies with a number of our compounds, and that would help us firm of our decisions about what to take forward, and when.

But until we get a little further along in those studies as well as other studies that we have ongoing, I cannot give a better estimate of the timing of those events.

It is going well, and as I have mentioned a number of times before, it is a very large program of -- we have added resources to it.

On both sides we are very excited about it, and the progress is substantial.

But there is a lot of work to do.

I will give you better color on that as we move through these studies and others that we have ongoing.

Thanks.

And I guess finally for Richard, can you give us an idea of what the R&D budget will look like relative to -- in the second half, relative to that of the first half?

Yes, Chris.

There will be some step up, of course, because we are going to be initiating two phase II studies.

So we had guided toward a total cash burn of approximately 20 to 24 over the course of the year.

And you will see a little bit more of that on the back half than you did in the first half.

(OPERATOR INSTRUCTIONS) Chris Richard, Merlin Nexus.

Thanks for taking my call.

I wanted to know what the DLT was in the phase I single ascending dose study.

It had no dose limiting toxicity -- let me back up.

Is this for 665 or senicapoc?

Oh, 665 -- I'm sorry.

Right, we had no dose limiting toxicity in any patient.

And why did you stop dosing then?

We felt we were at levels pharmacokinetically that far exceeded what we needed for efficacy.

That is based on the animal studies that we had done previously.

You will remember that 665 worked across a broad range of animal models that represented different types of epilepsy and were used -- are used standardly in the preclinical evaluation of any epileptic drugs.

So we had not seen any dose limiting toxicity.

We didn't see any reason to continue going up.

And we felt it was really time to move on to a multidose study.

So all of those considerations really led to the decision to just stop the single-dose study and move on.

(OPERATOR INSTRUCTIONS).

As there are no further questions in queue, I will turn the call back to management for closing remarks.

Sure.

Well, thank you all for joining us.

We appreciate your time today, certainly, and we look forward to providing you another update in our second quarterly call.

Thank you.

Ladies and gentlemen, we thank you for your participation in today's conference.

This concludes the presentation, and you may now disconnect.

Have a good day.