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Targacept, Inc. (NASDAQ:TRGT)

Q3 2009 Earnings Call Transcript

November 5, 2009 5:00 pm ET

Executives

Alan Musso – VP, CFO and Treasurer

Don deBethizy – President and CEO

Analysts

Terence Flynn – Lazard Capital Markets

Juan Sanchez – Ladenburg

Alan Carr – Needham & Company

Bret Holley – Oppenheimer and Company

Kim Lee – Wedbush Securities

Operator

Good afternoon, and welcome to the Targacept's third quarter 2009 financial results conference call. I will now turn the call over to Targacept management.

Alan Musso

Thank you, Ken. I am Alan Musso, Targacept's Chief Financial Officer. Before we get started today, I would like to remind you that some statements made, or responses given during this conference call constitute forward-looking statements, made under the provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements include statements other than statements of historical facts regarding without limitations the progress, scope or duration of the development of TC-5214, AZD3480, AZD1446 or TC-5619, or any of our other product candidates, its size, design, conduct or objective of any clinical trial, the timing for initiation or completion of or availability of results from any clinical trial or the indications for which such product candidate may be developed.

The benefits that may be derived from any Targacept product candidate; a strategic alliance, collaboration, licensing or other arrangement with respect to TC-5214; any payments with AstraZeneca or GlaxoSmithKline may make to us; or our plans, expectations or future operations, financial position, revenues, costs or expenses.

Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including, without limitation, those described under the heading Forward-Looking Statements in the press release that we issued earlier today or under the heading, Risk Factors in our most recent Annual Report on Form 10-K and in our subsequently filed quarterly reports on Form 10-Q and other filings that we make with the Securities and Exchange Commission.

Such forward-looking statements speak only as of today and should not be relied upon as representing our views as of any date after today. We disclaim any obligation to update any forward-looking statement, except as required by applicable law.

I will now turn the call over to our President and Chief Executive Officer, Don deBethizy.

Don deBethizy

Thank you, Alan. Good afternoon and thank you for joining us. On today’s call I will discuss recent portfolio and corporate developments, and Alan will review our financial results for the third quarter ended September 30, 2009 which we have just released. And then we will open up the call for your questions.

The last few months have been a very exciting period for Targacept. We presented the results from our highly successful clinical study of TC-5214 as an augmentation treatment for major depressive disorder or MDD. We received the $10 million milestone payment from AstraZeneca associated with our ADHD product candidate AZD3480. And we further strengthened our financial position with a common stock financing in October that secured net proceeds of $44.4 million.

Let me now review the programs in a little more detail. Let me begin with TC-5214, a nicotinic receptor channel blocker that represents a promising new mechanism for the treatment of depression and for which we have retained commercial rights. Last month, at a satellite meeting of the 39th Annual Meeting of the Society for Neuroscience, we presented data from our Phase IIb MDD trial of TC-5214. The trial was a two phase study conducted at 20 sites in India and three sites in the United States.

In the first phase, 579 subjects with MDD received first line treatment with Citalopram Hydrobromide for eight weeks, 20 milligrams daily for the first four weeks and 40 milligrams daily for the next four weeks. Citalopram marketed in the US as Celexa is a commonly prescribed antidepressant from the drug class known as a selective serotonin re-uptake inhibitor or SSRI.

At the end of the eight week long first phase, subjects who score on the Montgomery-Asberg Depression Rating Scale, or MADRS had improved less than 50% and was no lower than 17 and whose clinical global impression severity of illness score was no lower than 4 were considered partial or non-responders and randomized into the double-blind second phase of the trial.

In the double-blind second phase, subjects continued their Citalopram treatment and also received either add-on TC-5214 or add-on placebo for an additional eight weeks. The daily dosage of 5214 was initially 2 milligrams and could be increased at the discretion of the investigator to 4 milligrams and to 8 milligrams based on tolerability and therapeutic response. The primary outcome measure for the trial was mean change between add-on 5214 and add-on placebo from double-blind baseline as measured by AMD at week 16. The intent to treat dataset included 265 subjects in the second phase.

Now let me summarize for you the clinical trial results which were consistent across all outcome measures. On the trial’s primary endpoint AMD, there was a 13.75 point improvement which was 6.0 points greater for the add-on TC-5214 arm than the 7.75 point improvement seen in the add-on placebo arm. This result was highly statistically significant on an intent to treatment basis by a P value of less than 0.001.

Highly statistically significant results were also achieved on all of the trial secondary outcome measures, including MADRS, the Quick Inventory of Depressive Symptomatology – Self Reporting scale known as QIDS and the assessments of irritability, disability, cognition, severity of illness and global improvement.

In the study, the positive effects of TC-5214 were evident after only two weeks and grew steadily over the trial’s duration, culminating in remission for twice as many subjects in the TC-5214 group. Importantly 5214 exhibit a favorable tolerability profile in the trial with the most frequent adverse events being headache, constipation and dizziness.

We continue to be active in discussions with multiple pharmaceutical company with the goal of identifying a strategic partner to assist in the global development and plan commercialization of TC-5214. In addition, we are focused on executing the necessary activity to facilitate the initiation of Phase III development in the second quarter of 2010, following a planned end of Phase II meeting with FDA which we expect will occur in early 2010.

Augmentation or add-on therapy represents a compelling therapeutic approach to help millions of patients with depression for which currently available options are inadequate. In a landmark five-year study conducted by the National Institute of Mental Health known as Sequenced Treatment Alternatives to Relieve Depression or STAR*D approximately 63% of participating MDD patients did not achieve remission following initial treatment with Citalopram alone.

It was about two-thirds of an estimated 14.8 million American patients that still suffer with depressive systems despite treatment. The unmet medical need is clear and the commercial opportunity significant. We believe that our clinical results such as clear benefits for TC-5214 relative to existing treatment option and with favorable outcomes in Phase III development that 5214 could become the augmentation treatment of choice in depression.

While TC-5214 has understandably received a tremendous amount of attention, we have multiple first-in-class product candidates in our portfolio, all representing areas of profound unmet needs and for which there is increasing scientific support for the promise of NNR therapeutics. The unique breadth of potential therapeutic applications for the NNR mechanism is certainly evident in our three clinical stage product candidate in development for cognitive disorders.

I would like to start off first with a description of our progress on TC-5619. There are scientific evidence to support the role of the alpha7 NNR in cognition. Our product candidate TC-5619 is highly selective for the alpha7 NNR. We expect shortly to initiate a Phase II clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia which I will refer to as CDS.

The planned trial is designed to enroll approximately 200 subjects who are currently taking a medication from the drug class known as atypical antipsychotics to be randomly assigned to one of three dose groups 5619 or to placebo and dosed over a 12-week period. We will be conducting the study in both smokers and non-smokers. The primary efficacy outcome measure of the trial is change from baseline on the Groton Maze Learning item of the CogState Schizophrenia Test Battery on each of three measurement dates as compared to placebo.

Cognitive dysfunction in schizophrenia is recognized as a large unmet medical need. Approximately 7.9 million people in the world, seven major pharmaceutical markets suffer from schizophrenia. And it is estimated that approximately 75% of people with schizophrenia are cognitively impaired.

There is currently no drug approved in the United States or Europe specifically for CDS and 5619 was generally well tolerated at doses up to 600 milligrams in Phase I clinical trials and 5619 has shown promising activity in preclinical testing in models of cognition and schizophrenia.

If 5619 achieves proof of concept in the planned Phase II trial, AstraZeneca would have the right to license TC-5619 on the terms of our collaboration agreement which provide for us to receive a $40 million fee from AstraZeneca and be eligible for a substantial successful based milestones and escalating double-digit royalty.

Let’s move to our second cognition compound AZD3480. We previously announced positive top line results from the Phase II trial of AZD3480 in adults with Attention Deficit/Hyperactivity Disorder or ADHD that we conducted with AstraZeneca. AZD3480 which modulates the activity of the alpha4beta2 NNR was well tolerated in the trial with stimulate like effect seen at the 50-milligram dose group and a placebo-like side effect profile.

Based on the achievement of the objectives of the Phase II trial, AstraZeneca made a $10 million milestone payment to us in July. AstraZeneca plans to conduct further development of AZD3480 for ADHD including clinical studies to include both younger subjects and adults.

Now our third compounded development for cognition is AZD1446. 1446 is a product candidate for Alzheimer's disease that is selective for the alpha4beta2 NNR subtype and which we discovered is part of our preclinical research collaboration with AstraZeneca. AstraZeneca has completed the initial Phase I single and multiple raising dose clinical trials of AZD 1446 and it’s now progressed 1446 into a Phase I safety and tolerability study in healthy elderly volunteers.

Now let’s move on to some of our preclinical work. In addition to our clinical stage assets, we also continue to work on multiple preclinical programs including those that are part of our alliance with GlaxoSmithKline and remains very active in publishing new developments in the NNR field and collaborating with many notable researchers who share our enthusiasm for applying the potential of NNR therapeutics to build health and restore independence for millions of patients who are afflicted with CNS diseases and disorders.

A particular note is a recent publication in the journal Medical Hypotheses authored by Targacept scientist Doctors Bencherif and Lippiello that discuss how many of the mechanisms propose to underlie Alzheimer's disease may have a common link to the alpha7 NNR dysfunction.

And now let me turn the call over to Alan Musso, our Chief Financial Officer.

Alan Musso

Thank you, Don. Let me now review with you our financial results for the third quarter of 2009. We ended the third quarter of 2009 with $75.3 million in cash, cash equivalents and short-term investments. In October 2009 after the end of the third quarter we completed a public offering of 2.2 million shares of common stock at a price of the public of $21 per share which generated net proceeds to Targacept of $44.5 million.

Following completion of the offering, we now expect that our current cash free sources will be sufficient to meet our operating requirements at least through the first half of 2012 and that we will have at least 105 million in cash, cash equivalents and short-term investments at December 31st, 2009. This cash runway guidance assumes the funds required for Phase III clinical development and TC-5214 will be secured through a potential future strategic alliance, collaboration, licensing or other arrangement.

Turning to our operating results, we had net income of $1.3 million for the third quarter of 2009 compared to a net loss of $7.6 million for the third quarter of 2008. This change for the 2009 period was primarily attributable to a $10 million milestone payment received from AstraZeneca based on the achievement of the objective in the completed Phase II trial of AZD3480 in adults of ADHD.

Our net operating revenues totaled $12.7 million for the third quarter of 2009 compared to $4.1 million for the third quarter of 2008. The higher net operating revenues for the 2009 period were primarily attributable to an increase of $9.8 million in milestone and license fees from collaborations revenue, partially offset by a decrease of $1.3 million in collaboration, research and development revenue. The increased in milestone and license fees from collaboration revenue is a result of the $10 million milestone payment we received from AstraZeneca.

Our research and development expenses totaled $9.6 million for the third quarter of 2009, compared to $10.7 million for the third quarter of 2008. The lower research and development expenses for the 2009 period were principally attributable to a decrease of $2 million in costs incurred for third-party research and development services in connection with our clinical-stage product candidates, with substantially all of these costs incurred for TC-5214 and TC-5619, partially offset by an increase of $641,000 in costs incurred for third-party research and development services in connection with our preclinical programs and an accrued expense of $350,000 under our agreements with the University of Kentucky Research Foundation.

Our general and administrative expenses were $1.6 million for the third quarter of 2009, compared to $1.4 million for the third quarter of 2008. The higher general and administrative expenses for the 2009 period were principally attributable to professional and consulting fees related to business development activities.

Our net interest income was a $120,000 for the third quarter of 2009, compared to $514,000 for the third quarter of 2008. This decrease was attributable to lower short-term interest rates and a lower average cash and investment balance.

Now, let me turn the call back over to Don.

Don deBethizy

Thanks, Alan. We are obviously enthusiastic about the recent clinical successes of our Phase II trials of TC-5214 for major depressive disorder and AZD3480 for ADHD.

With our pipeline breadth, alliances with AstraZeneca and GSK and a cash position over $105 million, we are well positioned to drive forward our business towards achieving our mission of providing superior treatment options for complex diseases and improve patient lives by developing innovative new drugs that exploit the unique role of NNRs.

And now, I would like to open the call for questions. Operator?

Question-and-Answer Session

Operator

(Operator instructions) Our first question comes from the line of Terence Flynn with Lazard Capital Markets. Please proceed.

Terence Flynn – Lazard Capital Markets

Hi, thanks for taking the questions and congrats on all the progress. I joined the call a little late, so I was just wondering you might have touched on this already, but if you could possibly give us an update on ongoing partnership discussions for 5214 and how those are going?

Don deBethizy

Thanks, Terrence. As I indicated on the – in the call, we are actively involved in that, we are continuing to speak to multiple partners, and we are on track for our goal of having a partner in place before we start Phase III in the second quarter of 2010.

Terence Flynn – Lazard Capital Markets

Okay. And I guess have you given any guidance on terms of what a Phase III trial might cost in the event that you don’t want your partner decide that the terms aren’t as favorable?

Don deBethizy

No. We haven’t given any guidance around that, because we want to – we don’t want to talk about Phase III design and cost until we have had the end of Phase II meeting which we just reported today would be in early 2010.

Terence Flynn – Lazard Capital Markets

Okay, great. And then just one last question on 5619, can you provide us with how you are thinking about that CDS trial given what you’ve learnt with your past experience with 3480 and that setting and anything you might have learned that you are incorporating into this new Phase II?

Don deBethizy

Sure. The 3480 of course is an alpha4beta2 focused targeted compound. And we did the HALO trial with AstraZeneca in a 100% in smokers, so nicotine which has a preference for alpha4beta2 was on board in those patients.

In this trial, we are doing – it’s an alpha7 compound 5619, so we are targeting a different subtype. That subtype has been associated with familial schizophrenia. There has been some progress made by other alpha7 compounds in the clinic. So we feel like that this receptor mechanism should have better activity.

And then by looking at both smokers and non-smokers, we have the opportunity to differentiate whether nicotine being onboard has an effect. I might add that nicotine’s inherent activity at alpha7 is somewhat less than its activity at alpha4beta2. So, it will be interesting to see how 5619 performs in smokers as well as non-smokers.

Terence Flynn – Lazard Capital Markets

Great. Thanks a lot.

Don deBethizy

Thanks, Terrence.

Operator

Our next question comes from the line of Juan Sanchez with Ladenburg. Please proceed.

Juan Sanchez – Ladenburg

Hi, guys.

Don deBethizy

Hi, Juan.

Juan Sanchez – Ladenburg

Just only one question about the ADHD program with AstraZeneca. I mean historically how much of a risk are we taking by moving from a short duration trial into a longer duration trial. Have you seen historically several drugs failing because of the sure positive outcomes with few weeks of outcomes and then the drug didn’t work just because the duration of trial was long for the drug?

Don deBethizy

Well, I think in this case, we are very fortunate with AZD3480 it’s now been studied in over a 1000 subjects and patients. We have seen a consistent signal on attention in almost every trial we’ve run. Just to remind everybody, we hit all three primary endpoints in age associated memory impairment trial, Phase IIb trial with a 193 elderly 50 to 80 years of age. And the first primary endpoint was attention. And we also saw an improvement in the subject global improvement scale which included attention memory and speed of thinking.

So with that backdrop around 3480, we have a lot of confidence in the results that we saw in the smaller Phase II that we completed in adults with ADHD. And then some collaborating support for that comes from the studies done by Abbott with ABT089, those were significant Phase II trials where they saw an effect. ABT089 is an alpha4beta2 targeted compound.

It has different pharmacology at alpha4beta2 than 3480 and which could limit its utility going forward, but 3480 has the kind of receptor functional activity that we think will be ideal for attention in ADHD. So we are quite optimistic that our Phase II results will translate into a good efficacy signal in the Phase IIb that AstraZeneca will be running.

Juan Sanchez – Ladenburg

Thank you. And my final question is in the recent due diligence on the depression market, how do you think (inaudible) Wellbutrin are being used these days?

Don deBethizy

Could you say the last? I missed the last part of that.

Juan Sanchez – Ladenburg

(inaudible) recently about the depression market, how do you think Wellbutrin and gooseberry are being used today?

Don deBethizy

That’s a good question. We recognized that – we have learned in the interacting with various people around this area that Wellbutrin is often used second line when – or third line when physicians are concerned about the side effect profile of an SSRI or an SNRI.

We also know from the STAR*D work that Wellbutrin or bupropion can be used as augmentation and that is used as – even though there are not controlled studies out there around and no labeling around Wellbutrin there is a parent off label used as an augmentation on top of SSRIs and SNRI.

I don’t know the extent of that and we don’t have good clarity around that, but I do believe that some of the worldwide sales that are seen with Wellbutrin are used both as a monotherapy and as an alternative to current therapy, label therapies as well as an augmentation.

Juan Sanchez – Ladenburg

Thank you.

Don deBethizy

You’re welcome.

Operator

(Operator instructions) Our next question comes from the line of Alan Carr with Needham & Company. Please proceed.

Alan Carr – Needham & Company

Hi, good afternoon.

Don deBethizy

Hi, Alan.

Alan Carr – Needham & Company

I missed a little bit of the call, but I wanted to ask you a bit about the cash position and your partnering discussions around the depression drug. How much – get a sense of how much leverage you have in these discussions, and how far into Phase III you all feel like you could go with your current resources?

Don deBethizy

I will let Alan answer that.

Alan Musso

Yes, we clearly feel that we have the availability to get Phase III underway. At the same time, we also feel very confident of the progress that we are making in our partnering discussions. As I mentioned, the guidance that we gave suggest that we have got a cash runway to the middle of 2012 that has the assumption that a partner is in place to fund Phase III.

As we mentioned a little bit earlier, we haven’t given specific information around the cost of Phase III and we are going to reserve that information until we have the end of Phase II meeting with FDA which is likely to occur at the beginning of 2010.

Alan Carr – Needham & Company

Okay. And then a second question, AstraZeneca presented a little bit of extra information or data from your 3480 trial in ADHD. They got lost a bit in all the excitement around the 5214 data. Could you highlight some of that and review the implications of that data and how this might shape its position commercially in ADHD.

Don deBethizy

Sure. I think you are right. I think people have been really focused on the 5214 in our depression results. And 3480 has made tremendous progress even though we – people got focused on the inconclusive Alzheimer’s results from a year ago and then the negative HALO results.

But we – I think we’ve all looked and lots of thought leaders had an opportunity to look at those data and there are – there is evidence when you go back and look at from a post-hoc analysis if the Alzheimer’s results that it appears that if we had run that trial longer than 12 weeks and had used somewhat less well Alzheimer’s patients we had newly diagnosed Alzheimer’s patients with very high MMC scores.

So we – when we take the most well patients out of that dataset, we find that 3480 did separate from placebo. So there is good evidence that 3480 is active. It’s – as I already mentioned on the call onto a question around age associated memory impairment, we had activity there, we have activity in ADHD. It’s been in well over a 1000 subjects and patients. It’s always consistently shown activity that I am optimist about the development of 3480. I might also add that 1446 is the first compound to come out of our research collaboration and moved through the clinic and it moved – it just sailed through Phase I showing very good safety and tolerability.

And from a preclinical standpoint, it has excellent cognitive enhancing properties. So we are optimistic about 1446 as well. And then we now have the opportunity with 5619 to be testing the hypothesis around the alpha7 target on cognition in schizophrenia. And I am quite excited about that compound because it – that compound is the most selective alpha7 compound developed to date. It has a very wide therapeutic index and I believe could attack this serious unmet need in schizophrenics.

Alan Carr – Needham & Company

Okay, great. Thanks very much.

Operator

Our next question comes from the line of Bret Holley with Oppenheimer and Company. Please proceed.

Bret Holley – Oppenheimer and Company

Hi, thanks for taking the question. I am wondering about 5214 and the onset of effect. It looks like the onset of effect is fairly comparable for the atypicals and your highlight has been particularly important attribute. And I am just wondering if you could give me a little bit more information on how you view this is the comparable profile of the drugs? Obviously I don’t think they are exclusive of each other, but I am just wondering about that particular aspect of the data.

Don deBethizy

Well one of the things in the context of second line therapy which we believe 5214 should be able to be used, we are looking at the environment of SSRIs and SNRIs really. Those compounds have a much longer onset of efficacy taking weeks usually. And if the first line therapy as we have indicated two-thirds of people don’t respond to the first line therapy.

So now, if you were to switch to a second line SSRI or SNRI, you are talking months before you are able to get efficacy. So I think that’s why we are excited is it’s unlikely that atypical antipsychotics are going to be used in second line therapy. And so the fact that they have rapid onset within two weeks isn’t applicable in first or second line therapy because you have a side effect profile that includes metabolic disorder and potential movement disorders that are irreversible.

So our sense is that when we talk about being excited about rapid onset, our first time point was two weeks, it could be quicker than that, we are not sure. But we do have a separation of two weeks which was our first measurement. And in the context of first and second line therapy where you have weeks to onset that’s why we are excited.

Bret Holley – Oppenheimer and Company

And I know you had a fairly linear drop on AMD over the weeks in the trial and that you have tossed around it, you’ve potentially of a longer duration than Phase III testing. I guess the question I have is where do you stop? I mean where do you think you get to the point of diminishing returns based on benefit?

Don deBethizy

That’s a good question, Brett. And we have been having a number of discussions around that as we prepare for our end of Phase II meeting about whether we should extend the treatment period and there is some support for that internally. So we are sorting through that.

It wouldn’t be a very long extension, because you probably do get some diminishing returns, but we are looking at that. And the final protocols have been decided upon, and of course we will have to wait for end of Phase II feedback from the FDA. So we will keep you posted on that.

Bret Holley – Oppenheimer and Company

Okay. Very well. Thanks.

Don deBethizy

Thanks Brett.

Operator

Our final question comes from the line of Kim Lee - Wedbush Securities. Please proceed.

Kim Lee – Wedbush Securities

Good afternoon. Congrats on a good quarter.

Don deBethizy

Thanks, Kim.

Kim Lee – Wedbush Securities

Great. I have a couple of questions for you, but the first is on the AZD1446 program, when do you foresee initiating a Phase II study?

Don deBethizy

AZ has not given us guidance yet and we haven’t – we really haven’t discussed what we are going to publicly disclose around that. I do know that that compound has finished Phase I. They are in the midst of doing their – they have initiated this Phase I in healthy elderly. And so I would hope that we are looking at sometime in 2010. And we will get better clarity about that as they proceed with and complete the Phase I in the elderly.

Kim Lee – Wedbush Securities

Okay. So, would you say that AZ is driving most of the development of this product or is it a 50-50 decision making?

Don deBethizy

No, they are driving the development of the licensed compounds 3480 and 1446. We are driving the development of 5619 because it’s in the option mechanism. We still participate with them.

We have – as you can imagine over the four years of the collaboration, we have developed an excellent working relationship with them. So we are actively involved in advising them around the science and clinical development, but they are driving timelines and final decision on both of those programs.

Kim Lee – Wedbush Securities

Okay, great. Thanks for the clarity. And a final question for Alan, can you possibly breakdown the total revenues as far as how much were from inversing sales versus collaboration research and grants versus milestones and licensing fees?

Alan Musso

Yes, sure. In the quarter, our collaboration research and development was a $1.059 million. The milestone and license fees was $11.405 million. The inversing sales were $189,000 and then grant revenue in the quarter was $81,000.

Kim Lee – Wedbush Securities

Grants $81,000. Great, thanks so much.

Don deBethizy

Thanks, Kim.

Alan Musso

(inaudible).

Operator

This concludes our question-and-answer session. Dr. DeBethizy, back to you for closing comments.

Don deBethizy

Thanks, Ken. Well, I wanted to thank everyone for joining us this afternoon. And we look forward to speaking with you again soon. It’s been an exciting quarter and we are looking forward to the last quarter of the year and moving into 2010. Thanks a lot.

Operator

This concludes our presentation today. Thank you. And you may please now disconnect. Have a good day.

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