輝瑞 (PFE) 2008 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the third-quarter 2008 Icagen, Incorporated, earnings conference call.

My name is Shamika and I will be your coordinator today.

At this time, all participants are in a 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 presentation over to your host for today's call, Dr.

Richard Katz, Chief Financial Officer.

Please proceed.

Thank you, operator.

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

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

Kay will begin the call today with an update on our clinical and research programs.

I will then review our financial results; and following our prepared remarks, all of us will be available to answer 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 report on Form 10-Q 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.

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.

We are making substantial progress in both our clinical and research programs, and I would like to update you on those now.

First, I will start with the senicapoc program for asthma, and then we will talk about the ICA-665 program for epilepsy.

You will remember that senicapoc, or ICA-043, is our selective, novel, small-molecule blocker of a potassium ion channel called KCa3.1.

We recently initiated a Phase II proof-of-concept clinical trial to evaluate the safety and efficacy of this compound in patients with allergic asthma.

This trial is a double-blind, placebo-controlled, parallel group study that is designed to assess the effect of senicapoc administered once a day for two weeks on the pulmonary function of patients with allergic asthma.

This study will enroll approximately 30 patients randomized in a one-to-one ratio of senicapoc to placebo at two sites in the United Kingdom.

The patients in this study suffer asthmatic responses when they inhale allergens such as dust mites or grass.

Special research sites such as those we have selected in the UK are equipped to conduct clinical trials that measure the effect of drugs like senicapoc on lung responses to allergens.

In this study each patient's baseline lung function in response to an inhaled allergen is measured; and then each patient is randomly assigned to either receive placebo or senicapoc.

After a two-week treatment period, patients will return to the clinic; be challenged once again with the same allergen; and measurements made again of their lung function.

The primary efficacy analysis of this Phase II study is the comparison between the treatment arm of the asthmatic response caused by inhalation of the allergen, measured by FEV1, which is the amount of air that can be forcefully exhaled in 1 second.

Now FEV1, as many of you know, is a standard, commonly-used test to measure lung function.

It is also a part of the endpoints that are measured in clinical trials.

A number of additional pulmonary function and safety parameters will also be assessed during the study.

Finally, after the two-week treatment period, patients will enter a follow-up period to assess the safety and further PK of the drug.

Top-line data from this first asthma study is targeted for the second half of 2009.

This study, this allergic asthma study, is a translational study designed to match our preclinical animal model study in which we measured a decrease in airway resistance and airway hyperreactivity following treatment with senicapoc.

In addition to this first proof-of-concept allergen challenge study, and in preparation for future clinical trials, we are planning an additional Phase II study of the potential benefit of senicapoc in other types of asthma, such as asthma which is exacerbated by exercise.

Exercise is a trigger for bronchoconstriction in the majority of patients having asthma.

Therefore, a positive result in this planned exercise-induced asthma study will broaden the potential market for our drug.

This second Phase II study is targeted to begin in early 2009 with top-line data potentially available near the end of the year.

One of the reasons we are very excited about senicapoc's potential is that it represents an oral once-a-day therapy for asthma working through a novel mechanistic approach.

This combines both convenience and the potential for therapeutic benefit to patients not concurrently controlled well with their own medications.

With millions of patients diagnosed with asthma in the United States and many more worldwide, a successful new drug would find a substantial market.

This is especially the case, we believe, for this compound, which would be taken orally once a day to reduce the frequency and severity of asthma attacks, and which in approximately 200 healthy volunteers has been very well tolerated.

Let me turn to the ICA-665 program, our epilepsy program.

With millions of patients worldwide and approximately 30% that is not well controlled with available drugs, there is a substantial need and market for a drug with a new mechanism of action for patients with epilepsy.

As a reminder, 665 is a selective opener on KCNQ potassium channel subtypes.

These targets have been well validated by both genetic and physiological evidence as new targets for treatments for patients with epilepsy.

By opening selectively these channels, 665 offers a novel mechanism of action that may be a promising approach for the treatment of a variety of CNS neuro-excitability diseases such as epilepsy or neuropathic pain.

In our non-clinical studies, 665 has demonstrated efficacy in a broad range of models of epilepsy syndromes, including studies which were conducted at the NIH as part of its efforts to find new drugs for patients that suffer from treatment-resistant seizures.

Additionally, as we've reported, in nonclinical studies in doses that were effective in models of epilepsy, 665 appears to have an excellent preclinical side effect profile.

Moreover, besides the epilepsy studies, 665 has demonstrated efficacy in a broad spectrum of nonclinical models of pain, providing evidence of the general applicability of this KGNQ agonist to various nervous system disorders.

So let me update you on the current clinical program for this compound, ICA-665.

Following the successful completion of a single ascending-dose trial in 54 healthy volunteers, in which we demonstrated that the compound was well tolerated with no serious adverse events and no dose-limiting side effects, and have PK consistent with twice-a-day dosing, as we had predicted, we initiated a multiple ascending-dose Phase I clinical trial to further assess the safety of this compound.

In this multidose study, which is currently ongoing, we are testing three doses of ICA-665 in three cohorts of healthy volunteers.

These doses are 50, 100, and 200 milligrams bid.

Dosing has recently completed on all three of these cohorts; and to date the drug has been well tolerated.

We've also expanded this ongoing multidose trial to include a group of patients with epilepsy in order to gain insight into 665's safety and PK in patients who are currently well controlled on their anticonvulsive medications.

We anticipate enrolling these epilepsy patients this quarter.

So to ensure a successful launch of our Phase II ICA-665 program, which is targeted to begin in the first half of 2009, we are in the final stages of preparation for this multinational Phase II study with our CRO partner.

If the Phase I data continue to be supportive, and if the initiation of the Phase II follows our current schedule, we expect to have top-line Phase II data in 2010.

The overall design of our Phase II protocol for epilepsy will be a double-blind, placebo-controlled, parallel group study to evaluate the effectiveness of ICA-665 to reduce seizure frequency in patients with treatment-resistant partial seizures.

The study will be powered at 90% with an alpha of 0.05.

Following an eight-week baseline phase to determine the number of seizures experienced by patients on their current drugs, patients meeting a set of criteria will be randomized to receive either placebo or 665; and they will take this drug for 12 weeks while they continue to take their current treatment regimen.

The primary endpoint would be a comparison of seizure frequency between treatment arms, each of which would have approximately 75 patients.

As we complete our epilepsy Phase I program later this year, we look forward to updating you on the safety and tolerability PK of this compound and to providing more details of this planned Phase II program.

So following on the heels of these clinical programs in asthma and epilepsy, our research and preclinical programs are aimed at identifying additional KCNQ compounds that follow on to the 665, as well as compounds to enter preclinical development in our pain and inflammation programs.

And those programs are going quite well.

Over the next one to two years, these efforts in our research and preclinical groups are targeted to produce successes not only in the sodium channel partnership that we have with Pfizer, but also in our internal preclinical pipeline, which produces new opportunities for new clinical programs and new strategic partnerships, which, as you know from our past history, provides revenues to Icagen.

As is our custom, we will provide more details about these research programs as they get closer to the clinic.

So in summary of our progress, we believe that we are building value for our shareholders in both our clinical programs and our preclinical programs.

With the recent initiation of our Phase II program for asthma and the upcoming planned initiation of our Phase II for epilepsy, as well as the leads that we have in our research programs, we can see an increase in news flow for many of these efforts in 2009.

We believe that if we are successful in the execution of these efforts, we can create substantial value from our broad-based ion channel technology platform.

Moreover and importantly, we believe that we can make significant strides in these programs in 2009, while carefully managing our use of cash.

So with that, let me turn the call back over to Rich so that he can update you on our third-quarter financials.

Thank you, Kay.

I will be focusing my comments today on the results for the most recent quarter; but I will be happy to address any questions regarding the year-to-date, nine-month results in our Q&A discussion.

Our revenues for the third quarter of 2008 totaled $3.1 million.

This compared to $12.9 million during the comparable period in 2007, representing a decrease of 76%.

This decrease was due to the termination of the Company's collaboration with McNeil during the third quarter of 2007, partially offset by revenue generated by the formation of our collaboration with Pfizer.

As a reminder, as a result of the termination of the McNeil collaboration during the third quarter of '07, the remaining balance of $10.4 million of deferred revenue associated with that collaboration as of June 30, 2007, was recognized as revenue during the third quarter.

And that is why revenues were so high during the prior quarter.

Operating expenses for the third quarter of '08 were $6.9 million.

This compared to $7.7 million for the same period in 2007, representing a decrease of approximately 11%.

This decrease was primarily due to decreased R&D expense related to the development of senicapoc for sickle cell disease.

That was partially offset by an increase in R&D expenses related to the development of senicapoc for asthma, as well as increased expenses related to the development of 105665 for epilepsy and neuropathic pain.

Net loss for the third quarter of 2008 was $3.6 million as compared to net income of $5.6 million during the same period in '07.

The net loss for the current quarter as compared to the prior comparison quarter in '07 was primarily due to the decrease in revenues as just discussed.

From a balance sheet perspective, I would like to note our significant cash balance, which was approximately $38.7 million as of the end of the quarter.

We certainly remain mindful of the challenging economic conditions and equity market conditions, and continue our close attention to and management of our expenses.

Based upon our current cash balance, the ongoing R&D funding from Pfizer, and our focus on tightly managing our burn rate, we remain confident that we have sufficient capital to continue to drive the progress in both our clinical programs and our research programs through the first quarter of 2010.

We are currently in the process of finalizing our budget for 2009.

As we have done on an annual basis, we will provide financial guidance for 2009 during our next quarterly conference call.

That will conclude our prepared remarks, and we will now be pleased to take your questions.

(Operator Instructions) Chris Richard, Merlin Nexus.

Hello.

Just had a couple of quick questions on -- the first on the senicapoc for exercise-induced asthma.

Could you go a little bit deeper into the -- is it the same sort of endpoint, the same sort of design?

Yes, this is Seth Hetherington, the head of clinical and regulatory.

Exercise as a trigger is very common among patients who have asthma.

Consequently, using this as a trigger is a convenient way of assessing response to a therapeutic agent.

There is a separate indication and regulatory pathway for an approval for exercise-induced asthma.

But that is not necessarily what we are going after.

We would not restrict our development process toward that indication by itself.

However, the ability to use exercise as a trigger, just like the allergy challenge model, is a very convenient way to test in a controlled environment the efficacy of a new compound.

It's complementary to the allergen challenge study in that it shows, through a different mechanism, that you have an effect.

The two of the studies together provide really very firm evidence that would lead you to go on to additional studies.

Okay.

Then Kay mentioned that the KCNQ opener Phase Ib study is accruing now, patients with epilepsy.

Can you -- how many patients have been accrued, and anything new to add to that?

The only thing I can say is that we plan to enroll that group in this quarter.

We plan on six patients with epilepsy being enrolled, primarily to look at safety and pharmacokinetics, and to be able to compare those results to those in healthy volunteers that have come before.

Okay, great.

Thank you and congratulation on the progress.

Thank you.

(Operator Instructions) There are no further questions in the queue.

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

Please proceed.

Sure.

Operator, why don't we wait another 30 seconds or so?

Sometimes people think of something.

Give them a little more time and then if there's no further questions, we will conclude.

(Operator Instructions)

Okay, we will finish up there.

We thank everyone for participating today, and we will look forward to keeping you updated on a regular basis.

Thank you.

Thank you for your participation in today's conference.

This concludes the presentation.

You may now disconnect.

Good day.