輝瑞 (PFE) 2009 Q3 法說會逐字稿

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

My name is Louisa and I'll 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 this conference.

(Operator Instructions).

I would now like to turn the call over to Mr.

Richard Katz, Executive VP, Chief Financial Officer, please proceed sir.

Thank you, operator.

Good morning, everyone.

Thanks for joining us today to discuss our corporate R&D and clinical progress as well as our financial results for the quarter.

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

Kay will start with an overview.

I'll then give a financial update and then we will all 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.

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 quarterly reports 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 turn the call over to Kay.

Thanks, Rich.

Let me comment first briefly on the Senicapoc program for asthma.

Early in the quarter, we reported favorable results in our allergen challenge study in patients with allergic asthma.

More recently, we reported that a set of second proof-of-concept study in exercise-induced asthma was not positive.

While we would have preferred a different outcome, it is worth bearing in mind that these were small cost effective proof-of-concept studies to test a very strong hypothesis.

We are continuing to evaluate the results of both studies along with our investigators and our clinical advisors and I'd like to make it clear that while we do not plan to fund additional clinical studies of senicapoc for asthma, we have continued interest from investigators and clinical advisors and pharmaceutical companies who are interested in senicapoc.

So when we complete the final analyses and summarize all our findings, we'll be in a better position to determine next steps, but clearly we will not fund additional studies for senicapoc.

We will move our funding towards our Lead program, which is our KCNQ program, which I'll update you on now.

That program is, as you remember, to identify agonists of the KCNQ potassium channel, the compound that is in clinical trials is ICA-105665.

It's a novel KCNQ agonist and it's in proof-of-concept studies for epilepsy and pain currently.

The first of those studies is in patients with photosensitive epilepsy.

This is a condition in which patients demonstrate seizure like activity on their EEGs or electroencephalogram in response to flashes of light.

We can put these patients in a carefully controlled environment and the study is great because it allows us to directly correlate the drug levels in the blood and correlate those with the suppression of the seizure like EEG responses.

This study therefore provides an excellent means to define the appropriate dose range of ICA-105665 for all of the subsequent trials that we will do, for this compound in epilepsy.

We began this study during the third quarter and expect to have top line data during the first half of 2010.

This is a well-recognized clinical study paradigm.

It's been used to test many known antiepileptic drugs, all of which of course work in the clinic and in the market today.

And those compounds work well in patients who have photosensitive epilepsy.

It's a trial that's supported by experts in the field, such as those clinicians that work with the epilepsy consortium, many of them helped us in the design of the study.

The second trial is a pain study, it's being conducted in healthy volunteers.

This trial is an interesting design, it's a crossover design and will look at the effects of 105665 and compare those to placebo, and see if the compound can decrease the sensation of pain that is induced by two different stimuli.

First, we will inject a small amount of capsaicin intradermally and second, we will simulate a sunburn by exposing a small area of skin to UV light.

So we'll see if the compound reduces the sensation of pain in those two settings.

This study is almost completely enrolled and we expect to have top line data during the first half of 2010.

Just as a remainder, we had a very nice Phase I program for this compound single-dose, multi-dose.

In the multi-dose study, we tested the compound both in volunteers as well as patients, and it was well tolerated on all the doses that we tested.

There were no serious or adverse events and no dose limiting toxicities.

And importantly, no need to dose titrate.

So since the PK is linear, the doses are proportional and we have nice BID dosing, these sorts of characteristics, if they are sustained in future trials really nicely position us with a significant competitive advantage over other currently available drugs.

Because many of those have dose limiting side effects or require frequent dosing, more frequent dosing or need to be titrated over an extended period of time.

So we're very excited about this program, it is our lead program, it has been our lead program and it's a program with multiple compounds and therefore multiple chances for success.

In that light, let me tell you that we have identified advance lead compounds from a new chemical series as follow-ons to 105665 and we are excited about those as well as 105665 itself.

And there has been interest expressed from a number of pharmaceutical companies to share that enthusiasm with us.

So we'll see how that turns out in the future, but we're very excited about this program, which is going quite well.

Our Pfizer collaboration is also going well.

You'll remember that we are focused on three sodium channels for the treatment of various types of pain.

We were pleased to announce recently that we renewed our collaboration with Pfizer.

We do believe that Pfizer's decision to continue this research speaks to their firm commitment to this area of research and studying channels, as well as a strong vote of confidence in the strength of the Icagen scientific team.

We have not identified a clinical compound yet, but we've made substantial progress towards that end, and so we look forward to providing you updates as we progress through that program.

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

We are obviously well aware of the need to conserve capital.

And therefore during 2009, we did implement a number of cost reduction measures, which have been extremely helpful in decreasing our burn rate.

I would like to take this opportunity to publicly express to all the Icagen employees, both those who are current and those caught up in our cost reduction measures, my sincere gratitude for your hard work at Icagen and your patience while we work through these tough times.

Going forward, we will continue to explore additional opportunities to conserve capital.

But we will not compromise our commitment and our focus on our programs in epilepsy and pain.

We also recognize the importance of executing strategic transactions in addition to the Pfizer renewal and therefore we continue to work with our advisors to do so including our advisors at JPMorgan.

While the recent asthma program result represents a small setback, we remain confident in the long-term value inherent in our programs and our technology and our intellectual property.

So with that let me turn it back over to Rich to summarize our financial results.

Okay.

Thank you, Kay.

I am going to focus my remarks on the third quarter results and then during the Q&A, I would be happy to address questions related to the year-to-date results.

So the revenues for the third quarter of 2009 totaled $2.2 million, this compared to $3.1 million during the same period in 2008, representing a decrease of a little less than $1 million.

And this decrease was simply due to the fact that the Pfizer upfront payment became fully amortized during the third quarter and the R&D funding was essentially flat.

Turning to operating expenses, for the third quarter of '09, they were $5.7 million.

This compared to $6.9 million during the same period in '08, so a decrease of approximately $1.2 million.

The decrease was due to three primary factors.

The first and most important, as Kay mentioned, was the implementation of a variety of cost control measures that were implemented during the third quarter.

These included reductions in our expenditures related to a patent prosecution, the salary and benefits expense.

So, we did have a modest work force reduction.

Expenses were related to pre-clinical research and general corporate expenses.

We continued to fund the clinical programs fully.

There was a decrease in expenses related to the development of 665 for epilepsy and pain.

But this was simply due to the timing of the conduct of the studies in this program.

And then third, there was a decrease in the equity compensation expense for the quarter.

Those decreases were partially offset by increases in two areas, one was the clinical program for senicapoc, which was recently concluded.

So we won't have that ongoing expense and then secondly there was a restructuring charge that was incurred as a result of the work force reduction during the quarter.

Putting it together, the net loss for 2009 was $3.5 million, which was roughly flat with the net loss for 2008.

In terms of our cash position, at the end of the third quarter, we had $21.1 million of cash.

As Kay noted, we do now have the benefit of the renewal of the Pfizer collaboration, which will generate approximately $5 million.

Over the one-year period we received about $1.2 million of that $5 million to-date.

Based upon our current projections, we do believe that this is sufficient capital to fund the Company's operations, again for at least the next 12 months.

That will conclude the financial update, and we'll be happy to take your questions.

(Operator Instructions) And at this time we have no questions in the queue.

Okay.

Operator, why don't we just wait another few -- maybe another 10, 15 seconds, sometimes people struggle with the buttons, so we will make sure that there are none.

Sure.

(Operator Instructions)

Okay.

Well, operator, thank you very much.

Participants in the call we appreciate your listening in and we'll look forward to keeping you updated on the next quarterly call.

Thank you.

Thank you for your participation in today's conference.

This concludes the presentation.

You may now disconnect and have a great day.