輝瑞 (PFE) 2008 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Second Quarter 2008 Icagen Earnings Conference Call.

My name is Marusha and I'll be your coordinator for today.

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

We will be facilitating a question and answer section towards the end of this conference.

(OPERATOR INSTRUCTIONS)

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

I would now like to turn this presentation over to your host for today's call, Mr.

Richard Katz, Chief Financial Officer.

You may proceed, sir.

Thank you, operator.

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 second 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 our 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, 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.

This quarter has been marked by a successful progression of all of our programs in both research and clinical development.

Our employees, and our board, and our management team remain focused on executing our strategic plan to discover and develop novel ion channel compounds for patients in need and in markets where there are substantial opportunities.

I'll first update you on the Senicapoc program for asthma, then the progress that we've made in ICA-665 for epilepsy, and finally, briefly review the progress in our research programs.

You will remember that Senicapoc or ICA-043 is our selective novel small molecule blocker of the potassium ion channel KCa3.1.

We recently reported the successful completion of our phase I multiple ascending dose clinical trial of Senicapoc in healthy volunteers.

This study was designed to assess the safety, tolerability, and pharmacokinetics, or PK of Senicapoc at doses higher than those tested in previous clinical studies of this compound, in order to allow sufficient dose flexibility in future asthma studies.

As in all our previous non-clinical and healthy volunteer clinical studies, Senicapoc was well tolerated at all doses tested, which included once a day doses from 15 milligrams to 40 milligrams.

Top line analyses in the data provide a consistent pattern of dose proportional PK consistent with once daily dosing.

There were no serious adverse events, no dose limiting toxicities, and no drop outs from the study.

With these data and the positive data from our non-clinical asthma study in hand, and after discussions with leaders in the field, we submitted to the UK regulatory authorities our plans to initiate a proof of concept trial for Senicapoc in patients with allergen induced asthma.

Now, these are patients in whom an asthmatic response occurs when they are exposed to an allergens.

These exposures or challenges and their effects on these patients can be measured in a well controlled clinical setting, as we find in certain UK sites.

This proof of concept study will be a randomized, placebo controlled, parallel group trial in patients having mild intermittent asthma.

30 patients will be divided equally between a treatment and a placebo arm, giving us 90% power.

First, each patient's baseline lung function and response to an inhaled allergen will be measured and then each patient will be randomly assigned to either receive placebo or Senicapoc, and they will receive doses of these once a day for two weeks.

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

The primary endpoint will be a decrease in FEV1 or forced expiratory volume in the first second, which we will measure 4 to 10 hours after the allergen challenge.

This response is called the LAR or Late Asthmatic, or Late Airway Response.

This will provide an assessment in the change in resistance in the airways to the flow of air when the patient is exposed to an allergen to which he responds.

We will compare this decrease in FEV1 between patients receiving placebo and those receiving Senicapoc, of course adjusting for baseline responses.

Moreover, a number of other preliminary function and safety parameters will be assessed during the study.

Finally, after the two week treatment, patients will enter an eight week follow up period to assess safety and further PK.

The study should be completed by the middle of next year, so top line data from this first asthma study is targeted at this time for the third quarter of 2009.

In addition to this first proof of concept allergen challenges study, in collaboration with leading asthma experts we are planning one other phase II trial for Senicapoc to explore other types of asthma patients, such as those having chronic or poorly controlled asthma, and to explore a wider dose range in preparation for a subsequent phase III program.

This second phase II study would likely begin in early 2009.

One of the reasons we are excited about Senicapoc's potential in asthma is that if it works, it will represent a new oral therapy with an innovative, mechanistic approach, thus combining both convenience and delivery, and therapeutic benefit for patients not currently well controlled on their medications, or just not happy with their current treatment regimen.

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

This is especially the case, we believe, for this compound, Senicapoc, which could be taken orally once a day to reduce the frequency and severity of asthma attacks.

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

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

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

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

During the second quarter, we initiated a multiple ascending dose phase I clinical trial to further asses the safety, tolerability, and PK of 665.

This ongoing study follows a successful completion of a single ascending dose trial in 54 healthy volunteers.

We demonstrated that the compound was well tolerated with no serious adverse events, no dose limiting side effects, and demonstrated PK consistent with twice a day dosing.

We recently expanded the ongoing, multi-dose trial to include a group of patients with epilepsy in order to gain insight into 665's safety and PK in patients currently well controlled on other anticonvulsant medications.

Following the successful completion of this ongoing phase I trial, we plan to initiate one or more phase II clinical trials of 665 in patients with treatment resistant epilepsy.

Although the protocol is still under discussion, we anticipate that the overall design of our phase II protocol will be a double blind, placebo controlled, parallel group study.

It would evaluate the effectiveness of 665 in reducing seizure frequency in patients with treatment resistant simple or complex partial seizures.

The doses for this phase II study will be determined once we complete our phase I studies.

In this type of phase II study, there is typically an 8-week baseline phase to determine the number of seizures experienced by patients on their current treatment regimen.

At the end of this period, patients meeting a set of criteria would be randomized to receive placebo or 665 for 12 weeks while they continue to take one or two other anticonvulsant medications.

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

Once we've completed the final protocol for this phase II study and have addressed any issues, if there are any, with the regulatory authorities, we will be able to better provide information on the final design, the study start date, and to estimate the duration from the first patient in to top line results.

In general though, including enrollment time and date of follow up for these types of studies, it will take approximately 18 to 24 months to complete these studies, certainly depending on the total number of patients enrolled, and the number and location of study sites.

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

As a very selective KTNQ agonist, ICA-665 may represent a better alternative for patients who continue to have seizures despite their current medications.

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

Additionally, as we have reported, in non-clinical studies in doses that were effective in models of epilepsy, ICA-665 appeared to have a better side effect profile than many currently available drugs have in the same in vivo models.

Besides epilepsy, there are other neuroexcitability disorders such as serious chronic pain, for which new approaches are needed as well.

ICA-665 has just demonstrated efficacy in non-clinical models of pain, providing evidence of the general applicability of this KTNQ agonist to these other disorders.

We are currently evaluating our options for future clinical trials of 665 in various pain disorders.

Let me now turn to our preclinical and research efforts.

Our ongoing discovery research programs are focused on novel approaches to inflammation and to CNS disorders, primarily in the pain area.

These programs are in various stages of development from identifying new chemotypes to the selection of optimized compounds.

Over the next 1 to 2 years these efforts are targeted to grow the Icagen pipeline and to allow for strategic partnerships, which could provide near and long-term revenue to the company.

As you may remember, in 2007 one of these discovery research programs led to a multiyear collaboration with Pfizer on three sodium channel targets for pain.

In this collaboration, the joint Icagen Advisor Team has made substantial progress.

We have selected a series of leading compounds for additional preclinical testing for the first of these three targets.

For each of the other two targets, we are optimizing leads from our initial series and choosing new series or chemotypes for future compound selection.

We have targeted the selection of clinical candidate compounds over the next 6 to 12 months.

Clinical candidate compounds will be advanced as rapidly as possible and to proof of concept clinical trials, and each will be subject to staged milestone payments to Icagen.

In all cases of Icagen's discover research efforts, our programs have yielded patents and patent applications covering composition of matter, uses of the compound, and in some cases even patents on the targets.

For example, in the second quarter alone we added three new US filing and received two new US issued patents.

So in summary of our progress, we believe that we are building value to shareholders in both our clinical and preclinical programs We're looking forward to completing the preparation for and the initiation of our phase II studies in asthma and epilepsy.

We also look forward to completion of the identification of backup compounds for our clinical compounds and to identify new compounds to add to our pipeline.

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

Thank you, Kay.

I'll be focusing my comments today on the results for the most recent quarter, but I'll be happy to address any issues regarding the year to date 6-month results in our Q&A discussion.

Revenues for the second quarter of 2008 totaled $3.2 million.

This compared to $3.4 million during the comparable period in 2007, representing a slight decrease of about 6%.

This decrease was due to the termination of the company's collaboration with McNeil during the third quarter of '07, but was largely offset by revenue generated by the formation of our collaboration with Pfizer, also during the third quarter of '07.

Operating expenses for the second quarter of '08 were $7.1 million and this compared to $10.3 million for the same period in 2007, representing a decrease of approximately 30%.

This decrease in the operating expenses was primarily due to decreased research and development expense related to the development of Senicapoc due to the termination of our phase III trial for sickle cell disease, as well as the termination of our collaboration with McNeil.

As a reminder, as a result of the termination of the McNeil collaboration, during the second quarter of '07 the company incurred a non-cash expense of approximately $1.6 million that was associated with the write-down of any capitalized license payment that had previously been made to Children's Medical Center Corporation in connection with that collaboration.

Net loss for the second quarter of '08 was $3.7 million and this compared to $6.5 million during the same period in 2007, representing a decrease of 42%.

And this decrease in the net loss, again, was due to the lower R&D expenses for the period, partially offset by a small decrease in revenues.

To conclude my remarks, I would just like to note our significant cash balance which was approximately $43 million as of the end of the 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 in the clinical programs and the research programs through 2009.

So that will conclude our prepared remarks and we'll now be pleased to you're your questions.

Operator, are there any questions?

(OPERATOR INSTRUCTIONS) You have no questions at this time.

Well, we would like to thank everyone for joining us on the call today and certainly we look forward to continuing to keep you update, and we appreciate your attendance and interest in Icagen.

Thank you.

Thank you for your participation for this conference.

This concludes the presentation.

You may now disconnect.

Good day.