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Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA)

Q4 2008 Earnings Call Transcript

March 10, 2009, 2009 4:30 pm ET

Executives

August Moretti – SVP and CFO

Tom King – President and CEO

Analysts

Ted Tenthoff – Piper Jaffray

Jason Kantor – RBC Capital Markets

Charles Duncan – JMP Securities

Joe Carroll – IMS Health

Operator

Good afternoon, everyone, and welcome to the Alexza Pharmaceuticals 2008 year-end financial results conference call. At this time, all participants are in listen-only mode for the conference. (Operator instructions) Today’s conference is also being recorded and if you have any objections, you may disconnect at this time.

I would now like to turn this afternoon’s conference over to August J. Moretti, Senior Vice President and Chief Financial Officer for Alexza.

August Moretti

Thank you, operator. Good afternoon and welcome to the 2008 year end financial results conference call. Before we get started, I would like to remind you that the matters discussed on the call contain forward-looking statements that involve risks and uncertainties, including those relating to the potential results of future clinical development, Alexza’s ability to commercialize products, the timing of the commercialization of such products, and our projected revenue and expenses. Actual results may differ materially from the results predicted, and recorded results should not be considered an indication of future performance.

These and other risk factors are more fully discussed in our Annual Report on Form 10-K, including under the caption Risk Factors that we filed with the SEC earlier today. Alexza disclaims any obligation to update or revise any forward-looking statement made on this call as a result of new information or future developments. As a reminder, Alexza’s policy is to only provide guidance on product candidates and corporate goals for the future one to two fiscal quarters and to provide update or reconfirm its guidance only by issuing a press release or filing updated guidance with the SEC in a publicly accessible document. Clinical guidance is as of today March 10, and financial guidance relating to the company’s current cash, cash equivalents, and investments is as of December 31, 2008.

I’ll now turn the call over to Tom King, President and CEO of Alexza.

Tom King

Thank you, Augi. Good afternoon and thank you for joining us. I would like to thank all of you and all of our stockholders for the ongoing support and confidence you have shown in Alexza. We look forward to these conference calls when we can update you on our progress and our results.

Notwithstanding these incredible challenges of our current financial markets, Alexza has made great progress with our lead program in 2008, significantly ahead of original expectations for its clinical development and regulatory timelines. I am going to start with a brief description of our operational goals for 2009 and then provide a brief summary of the current status of our product candidate development programs. I will then pass the call back to Augi Moretti to review the fourth quarter and 2008 year end financials. After that we will open up the conference call for questions and answers.

As we have previously disclosed, our efforts in 2009 are going to be primarily focused on the clinical, non-clinical, regulatory, manufacturing and quality systems work necessary to move AZ-004, our lead product candidate to an NDA filing, which we are projecting for early Q1 2010. As a reminder, Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder.

In September 2008 and December 2008, the company announced positive results from its two phase III clinical trials of AZ-004. The trials enrolled 344 acutely agitated patients with schizophrenia and 314 acutely agitated patients with bipolar disorder respectively. Both trials were designed as in clinic, multi center, randomized, double blind and placebo controlled studies. Both trials tested AZ-004 at two dose levels, the 5 milligram and the 10 milligram. Patients are eligible to receive up to three doses of study drug in the 24-hour study period, depending upon their clinical status.

Patients eligible for the study included those who were admitted through an emergency department and those who were already in patients in a hospital setting as long as they had acute agitation at the time of the patient randomization. The primary endpoint for these studies were the commonly used measure of the reduction of agitation, defined as a change in baseline in the PANSS scale, or positive and negative symptoms scale, the excited component, sub component of that score, commonly called the PEC score, measured at two hours after the first dose.

The key secondary end point of both studies was the clinical global impression of improvement commonly called the CGII score also measured at two hours after the first dose. It is important to note that both the five milligram and 10 milligram doses of AZ-004 met both these primary and secondary end points in both trials, with highly statistical significant findings. All results were considered statistically significant at the T is less than 0.05 level as compared to placebo and all statistical analysis were made on an intent to treat basis.

Also in both patients populations, the 10 milligram dose of AZ-004 exhibited a very rapid onset of effect, the statistically significant reductions in agitation at 10 minutes post does, which was the first time point measured in the study. This reduction of agitation was generally sustained throughout the entire 24-hour study period. Side-effects were recorded for each patient throughout the clinical trial period and in both studies, the administration of AZ-004 was generally safe and well tolerated in these patients populations.

In total, Alexza has completed five clinical trials of AZ-004, enrolling more than 800 patients and subjects to date and have announced positive results from all of these studies. In addition to the two phase III studies I just reviewed, we have completed a 50 subject phase I study in healthy volunteers, 129 phase II studies in acutely agitated schizophrenia patients, and a 32 patient dose tolerability and pharmacokinetic study in non-agitated schizophrenic patients. The company completed our end of phase II meeting with the FDA for AZ-004 in September 2007, and we believe we have a clear understanding of the development requirements for filing and NDA for AZ-004.

Moving forward into 2009, we have four NDA support studies to complete, which we discussed with the FDA at our end of phase II meeting of November 2007. These include a single day pulmonary function safety study, a through QT study, a smoker versus non-smoker pharmacokinetic study, and a safety study evaluating subjects with healthy lungs versus those with asthma or COPD. We expect to complete these studies by the end of the third quarter of this year 2009.

At the very same time, we are continuing to a accelerate our commercial manufacturing activities broadly defined as including manufacturing scale up, stability batch manufacture, extended quality systems in our global supply chain for the key components of our Staccato device. Our operational goal is to be ready for an FDA pre-approval inspection at the time of our AZ-004 NDA submission.

Lastly, we continue to have very productive partnering discussions in both the United States and outside the United States for what we feel is an exciting new anti agitation product that is in late stage development with very strong phase III data. AZ-004 has been licensed to Symphony Allegro, Inc or Symphony Allegro, and the company has the right to repurchase all rights to the product candidate.

Alexza is also developing AZ-104 to treat patients suffering from acute migraine headaches. AZ-104 is a lower dose versions of AZ-004. In March 2008, the company announced positive initial results from an in clinic, multi center, randomized, double-blind single administration and placebo-controlled phase IIa proof of concept trial in 168 migraine patients with and without aura. In January 2009, we initiated enrollment of our phase IIb take home study with AZ-104. The AZ-104 phase IIb clinical trial is an outpatient, multi center, randomized double-blind single dose and placebo controlled study in approximately 360 patients with migraines, again with or without aura.

Three doses will be evaluated in the clinical trial, a placebo dose and two doses of AZ-104, the 1.25 milligram and the 2.5 milligram. The primary efficacy endpoint for this trial is headache pain relief at two hours post the dose using the standard four point rating scale from the International Headache Society. Secondary efficacy end points for the trial include pain relief and other symptom assessments at various times points. Safety evaluations will also be made throughout the clinical trial period. We expect data from this outpatient clinical trial to be able to be released in the third quarter of 2009. AZ-104 has been licensed to Symphony Allegro and the company has the rights to repurchase all rights to this product candidate.

As we had previously announced, we have placed the balance of our product pipeline on hold, making the determination to focus only on product candidates that currently have development funding resulting from partnerships. We continue to work diligently in pursuing and developing new partnerships for all of our product candidates, and we have ongoing discussions with regard to many of them.

Now I'm going to turn the call back over to Augi for a review of the financials for 2008.

August Moretti

Thank you, Tom.

Good afternoon, everyone. I would like to summarize the financial information for the quarter and the year ended December 31, 2008 that is included in the form 10 K which was filed today with the SEC. Alexza reported a net loss of 15 million for the quarter ended December 31, 2008 and a net loss of 58.5 million for the full year as compared to a net loss of 13.2 million and 45.1 million for the comparable periods in 2007. Our consolidated results of operations include the operations of Symphony Allegro, loss attributed to controlling interest in Symphony Allegro, reduced net loss for the fourth quarter of 2008 by 2.9 million and reduced net loss for the full year by 18.6 million as compared to 3 .1 million and 10.8 million in the comparable periods in 2007.

We recognized $417,000 of revenue in Q4 2008 and 486,000 of revenue for the year as a result of the amortization of the upfront payment that we received from Endo Pharmaceuticals in January 2008 pursuant to our development agreement with Endo. We announced in January 2009 the mutual termination of our agreement with Endo and we will recognize the balance of the upfront payment, approximately $9.5 million in Q1 2009.

Our operating expenses increased in 2008 specifically GAAP expense relating to research and development increased in the fourth quarter of 2008 and the full-year to 14.4 million and 61.6 million compared to 13.7 million and 45.6 million in the comparable periods in 2007. The increases in R&D expenses are related to increased spending on clinical development of our lead program AZ-004 as well as AZ-104 and AZ-003 which we were developing in partnership with Endo Pharmaceuticals, increased spending on Staccato device development and manufacturing scale up and increased personnel related costs due to increased staffing to support our clinical research and manufacturing efforts.

GAAP G&A expense increase in the fourth quarter of 2008 and the full-year to 4 million and 17.6 million as compared to 3 .7 million and 14.9 in the comparable periods in 2007. The period to period increases result from the higher share-based compensation expenses in 2008, increased staffing for personnel and executive accounting, business development, IT and HR necessary to support our growth, as well is increases in facilities costs, patent related costs and professional fees for legal and accounting services.

At December 31 2008, cash, cash equivalents and marketable securities totaled 58.9 million. This includes 37.6 million of our cash and 21.3 million held by Symphony Allegro that we consolidated on our balance sheet. In January 2009, we announced a significant consolidation of our operations moving forward with a primary focus on the continued development of a AZ-004 Staccato loxapine. The restructuring included a workforce reduction of 52 employees representing approximately a third of our total workforce.

With the reduction in headcount and focus on the development of AZ-004, the company expects to reduce expenses by approximately 21.5 million net of severance costs for fiscal 2009 compared to fiscal 2008, and another reduction of approximately 11.1 million for fiscal year 2010 compared to fiscal year 2009. We anticipate that with current cash, cash equivalents and marketable securities, along with interest earned, expected payments from Symphony Allegro, the proceeds from option exercises and purchases of common stock pursuant to our employee stock purchase plan, that we will be able to maintain currently planned operations into the second quarter of 2010.

I’ll now turn the call back to Tom for completing the remarks.

Tom King

Thanks, Augi.

We believe our Staccato technology and the product candidates we have under development can fundamentally improve and in some cases change the way that many acute and intermittent conditions are treated. The acute treatment of agitation is an excellent example of this possible change in the medical practice resulting from our Staccato technology and AZ-004. Physicians, nurses and patients, all tell us this fact. And while we are committed to building a portfolio of Staccato-based products that will capitalize on this potential, we're critically aware of this very difficult capital markets and the need to prioritize and focus on what we believe are key near term value drivers for Alexza in 2009 and early 2010.

In practice, this means that over the next 12 months with an NDA in our sights for early 2010, a significant majority of our time and efforts will be on AZ-004, both internally as we push forward with our NDA and commercial manufacturing activities, and externally as we begin the AZ-004 commercialization communication activities and continue our US and ex-US partnering discussions. Many companies aspire to develop drugs that will result in an NDA, yet few get to that coveted goal line. We view ourselves as one of those few and even more exciting it is our first NDA that will be based on a novel proprietary technology of which Alexza was founded.

In addition to our AZ-004 activities, we have initiated recently a phase IIb study with AZ-104, the low dose form of Staccato loxapine for migraine and look to see those data from this 360 patient study in the third quarter of this year. Without partner funding, we are currently planning no work on AZ-001, AZ-002, AZ-003 or 007 during 2009.

The start of 2009 has not been easy for Alexza as we made the very difficult decision to reduce the size of the company and the attending expense of the company to focus primarily on our upcoming NDA submission and related activities, which is on track for the first quarter of 2010. As has been our practice since the company was founded, we set aggressive operating goals for each year, including the goals related to our lead program. All of us at Alexza are working very hard to meet those 2009 operational goals.

We would like to thank you again for your time today and for your ongoing interest and support of Alexza. 2009 will be a very exciting year as we march much forward toward our NDA submission and we look forward to updating you on our progress during the coming months.

I would now like to open the conference call up for questions and answers. Thank you.

Question-and-Answer Session

Operator

Ladies and gentlemen, we are ready to open the lines up for your questions. (Operator instructions) Your first question comes from the line of Ted Tenthoff with Piper Jaffray. Please proceed.

Ted Tenthoff – Piper Jaffray

Great, thank you very much. Just looking at 2009, can you give us a sense of roughly what the burn rate may be and kind of what’s the break down between how much the non-clinical studies will cost in preparation for the NDA filing early next year?

Tom King

Well, I’ll let Augi talk to about the specific burn rate item. I think Ted in general our clinical trials, no matter what trial it is, are about out of pocket may be about $10,000 per patient. It is a good way to think about it even though the ones with normal volunteers are a bit more expensive because of the intensive monitoring either in the QT studies or the pulmonary function studies test. So we have 360 patient study in migraine, we probably have about 250 patients in the support study, so that gives you probably about 7 million-ish to 8 million-ish probably in out-of-pocket expenses specific to those clinical trials.

Ted Tenthoff – Piper Jaffray

That is very helpful.

August Moretti

And Ted, on the cash burn, it has been our practice not to give quarterly or annually burn estimates but to give the cash update which as we indicated in this call, we should end the year with sufficient cash to get into the second quarter of 2010, and again that is starting the year with 59.5 million of cash.

Ted Tenthoff – Piper Jaffray

And Augi I apologize if you mentioned this, but does that include taking anything down from the facility?

August Moretti

It does not. Again when you see the K, the facility is still available to us. It is a $50 million equity line of credit. It does have a threshold price of $5, that is a minimum price of $5 and we have not got back to modify that. So it is available to us but only if our share price appreciates, so that getting into the second quarter of 2010 is premised on only using the cash that is on the balance sheet today.

Ted Tenthoff – Piper Jaffray

Okay, great. That’s really helpful. Thanks.

August Moretti

You are welcome.

Operator

Your next question comes from the line of Jason Kantor with RBC Capital Markets. Please proceed

Jason Kantor – RBC Capital Markets

Hi, thanks guys. Could you give us some sense of how the partnering discussions have progressed or changed or how your views of partnering with programs may have changed and when you say you have very productive discussions I mean can you – is something that you would likely have to – is there something that is key or gating in terms of some of these trials that you are running that might be required to get the deal done?

Tom King

Certainly. There is nothing that we have heard from any of our conversations Jason about any of these four studies that are gating during the deal. We view these studies – I mean they are important from a safety perspective in terms of outlining the clinical pharmacology and perhaps the warnings and/or contouring indications to a package insert, but they're not going to affect the safety or the overall efficacy of the product.

So the fact of the clinical trial program actually continuing to be on phase is probably the most important aspect about why some of these discussions have escalated because we are very much on track to the stated goal of having the NDA submission early next year. Notwithstanding the fact that some people view the market opportunity for this product to be smaller than some, the fact that we are marching close to decisions about what the package inserts will say, what the product labeling would say, and more importantly in some cases, what with the pre-commercial communication strategy would be, continue to facilitate our discussions.

So without giving any real specifics, we have multiple discussions with multiple parties with companies that both have a US presence, parties that have only a European presence and then parties that also have a presence on both sides of the Atlantic.

Jason Kantor – RBC Capital Markets

Okay. And then if you could also give us any update to your thinking around the buying back rights from Symphony?

Tom King

Right. We view the buyback of the rights from Symphony as being something that is out there with a – our option expires in December 2010. We view that doing a transaction on AZ-004 as an important component of the potential buyback of those rights, but we also two other products in that basket. So we also have ongoing discussions in the migraine space with AZ-001 which is not a Symphony product and AZ-104, which is a Symphony product, and actually there has been some increased interest in AZ-002, not for panic necessarily, but for some of the other indications where a rapid acting noninvasive benzodiazepine will be of importance. Cluster and refractory-seizures have been an area of interest, the PTSD is an area of interest, pre-operative or pre-procedural sedation is an interest. And so I think all of those have the opportunity to provide inflows of cash that will allow us to approach Symphony with a potential buyback of the Symphony package as we contemplate and complete those transactions.

Jason Kantor – RBC Capital Markets

And do you still think that you need to wait till after an end of phase II meeting for 104 in order to do some kind of migraine partnership?

Tom King

I think we do not. I think having the data from the take home study with loxapine will be an important consideration. The discussions we have had to date in the area of migraine have had interesting views about those two compounds while they both have similar mechanisms in treating migraine headache since they are both dopamine antagonists, they do have different kind of portfolios of effect. We know that AZ-001 appears to be a very potent treator of very severe headaches and it’d probably make sense since it is the leading drug used in the emergency room for that, but we also know that it has a higher incidence of cough in some of the upper airway irritation that we have seen in our phase II studies. Loxapine appears to be a more general drug and side effect profile is not the same as it is with AZ-001 with prochlorperazine. And also at least we have only done one study, but it also appears to be not as potent for treating the most severe headaches. And so some of the parties we talk to, Jason, are interested in making a choice of one versus the other. Now some of the parties that we have an ongoing conversation with actually are looking to position both drugs for different aspects of the migraine market.

Jason Kantor – RBC Capital Markets

Thanks.

Tom King

You are welcome.

Operator

(Operator instructions) Your next question comes from line of Ted Tenthoff with Piper Jaffray. Please proceed.

Ted Tenthoff – Piper Jaffray

Great, thank you. Just a quick follow-up question with respect to the potential for doing platform type deals, in this current environment, is that something where those discussions have really come to stall and most of the focus is really on the products, or just give us an update on kind of what is your thinking on that?

Tom King

Yes, we actually have ongoing discussions at varying degrees of interest I guess and varying degrees of confidentiality with every one of the products that we have in our portfolio. The interesting thing Ted has been with the phase III data with AZ-004 is that there seems to be also a sense of collaboration that the technology can indeed deliver approval pathways for a product. And so if anything has gone the other way where we do have some initial thoughts from outside parties looking at Staccato aerosols as a technology as opposed to a product that we might have chosen. So it is interesting, it is a bit counterintuitive, and I wouldn't necessarily would have thought a year ago, but the advancement of the 004 and FDA interactions we have had with that so we can answer questions on what the FDA views about Staccato aerosols with more precision has open some eyes I think with regard to aerosols produced by the Staccato technology.

Ted Tenthoff – Piper Jaffray

Okay, that is helpful, thanks.

Operator

Your next question comes from the line of Charles Duncan with JMP Securities. Please proceed.

Charles Duncan – JMP Securities

Hi guys. I think most of my questions have been asked and I apologize if this one has as well, but Tom could you give us a little bit more color on the kind of work that you doing to prepare for the filing of the NDA, is there any additional clinical work that needs to be done or is it pretty much (inaudible) type stuff?

Tom King

Right. I think our pre-NDA works falls into three broad categories Charles. We have the four supporting studies that we discussed with the FDA at the end of phase II meeting. Typically, those would have been done under this larger umbrella of the phase III studies, but we find ourselves in a position where the phase II clinical trials went so quickly that these trials now are ones that you have more access to because normally we just would have done that without anybody really knowing about them. We actually have pulled forward all of those studies. In fact the pulmonary function test we had planned to start this year we actually started that late last year. The rest of the studies we had planned to start later this year in the early 2010 with original program and all of them are on slate obviously to get started in the first half of the year and we are looking to see all those trials be finished by the third quarter.

The second piece of the work we're doing is what I’d call the blocking and tackling of things like registration stability lots, walking down the API and the API source, making sure drug metabolism [ph] are in place for all of our global suppliers that they would be ready for pre-approval inspection on the components, those sorts of activities. And the third is being absolutely prepared for a pre-approval inspection by the FDA. So it is our internal goal to have gone through a mock pre-approval inspection internally later this year as we button down all aspects of our quality assurance programs and our quality systems, so that when we hit the send button on the NDA early next year, that we are absolutely ready when the FDA comes in and inspects our manufacturing facility that we are in great shape even ready for that.

So a lot of that is companies traditionally are hanging on for that last phase III study and hoping that the clinical data are good because they have been waiting for a long period of time. We are in I don’t know if it’s an enviable position or not, but our phase IIIs are done, and know unequivocally what the drug does and doesn’t do in those two studies, and now we are working very diligently to complete all of the other aspects of this NDA for AZ-004.

Charles Duncan – JMP Securities

Okay, it’s a good problem to have. One additional follow-up, having you spoken –I am sorry, I am getting on an airplane, and you may have answered this, but have you spoken to the ex-US opportunities and what your strategy is there?

Tom King

Yes. I did mention it a little bit. We have three different groups of potential partners of AZ-004. There is US only based companies, there are companies that are based solely and focused in Europe and then there are companies that have presence on both sides of the Atlantic. On of the items I also wanted to mention that we didn't speak too much about, we’ve actually two abstracts accepted to the APA this year, which is in May in San Francisco. That is also going to be a bit of our coming out party because we also have meetings scheduled with our clinical investigators from domestically we are starting to validate clinical investigators in Europe as we evaluate the regulatory opportunities in Europe, and we also are also starting to work with specific subgroups within the APA, most notably the American Academy of Emergency Psychiatrists, which is a group of physicians that wrote the consensus guidelines on how to treat agitation.

Charles Duncan – JMP Securities

And at that APA meeting, do you expect to have corporate beyond just a regular corporate presence, some sort of an investor meeting?

Tom King

We are not planning investor meetings. The APA is fairly stringent on the types of activities that they allow in or around the meeting, so our meetings are solely focused on clinical key opinion leaders, clinical investigators, and some of the key folks in the area of emergency psychiatry.

Charles Duncan – JMP Securities

And then perhaps finally final question, do you anticipate being able to say maybe by third quarter exactly what you anticipate the regulatory strategy to be in ex-US opportunities?

Tom King

Yes. We actually have been having meetings with various agencies in Europe and of course there are three path ways toward approval in Europe. There is mutual recognition, where you have one country you’ve gained approval and you have that as the rapid tour [ph] for the rest of Europe on a country to country basis. There is the centralized approach and because this is a novel drug and a novel delivery system, we would certainly be available to take that as a path. And there is a third way that has just been introduced within the last several years called de-centralized in which you go and have a country as rapid tour, but you are able to select, so you don't have to go to all 26 countries, if you don’t need to do so. It turns out that loxapine is actually the standard of care in treating acute agitation in France, and there appears to be some high level of interest within the French regulatory authorities of looking at our technology and perhaps being the rapid tour for this product. So there has been a nice interest because of how the drug is used in France as an injection and a very high degree of knowledge about how the drug works and so we actually have had some enthusiastic response from that particular regulatory authority in France.

Charles Duncan – JMP Securities

Do you anticipate any additional clinical work to be able to file in Europe?

Tom King

Our position in the absence of having had those what I would call more effective face-to-face meetings is that we have got an adequate clinical package to go without having to file to gain approval. In Europe you also have a marketing authorization, then you have pricing, and then you also have reimbursement. So our early conversations with potential partners there have indicated that we may want to do some type of health economic studies to facilitate pricing and reimbursement. I think right now the views that our clinical package that we will have in the United States will be adequate to point a clinical package for the registration in Europe.

Charles Duncan – JMP Securities

Okay. Thanks, Tom. Thanks, Augi, for the added color.

Tom King

You are welcome, Charles.

Operator

Your next question comes from the line of Joe Carroll with IMS Health. Please proceed.

Joe Carroll – IMS Health

Hi, Tom. Congratulations. Sounds like everything is going great guns there.

Tom King

Thank you, Joe.

Joe Carroll – IMS Health

I do have a question. This has to do and I got on the call late, but at least for the 004 and 104, their submissions will not go on at the same time, will they?

Tom King

No. That is indeed true. 004 for acute agitation is planned for early 2010. If we had good results with AZ-104 and we are able to secure partnership, we will begin phase III research in migraine in 2010, and those studies are larger. Our end of phase II meeting for prochlorperazine specific to migraine gives us a feel that we are probably talking 1200 to 1500 patients in each of two studies, six months to one year take home study for those trials. So we are talking two to two and a half years worth of clinical trial. So the migraine programs which are basically, the two of them are basically at the same point in time, our products that we get to the marketplace at the soonest until 2013 or 2014.

Joe Carroll – IMS Health

Okay, very good. And I just have one another question, and it has to do, you said the balance of the product portfolio would really be on hold so you can get 004 complete for this year?

Tom King

That’s correct right now. Now that would change in the event that we were to bring on a partnership. So if somebody is – if we are successful in partnering one of those drugs that currently is not moving forward, we would be able to do so very quickly. It would be very easy then move into a phase II series of studies with our sleep drug for example, it would be very easy for us to move into a phase II in clinic study to look at fentanyl for breakthrough pain, but we would only do that development and do those clinical trials with a partner helping us do so.

Joe Carroll – IMS Health

Excellent. Thank you very much. I appreciate your taking the call.

Tom King

Okay. Thank you, Joe.

Operator

With no further questions in the queue, I would like to turn the call back to Mr. Tom King for closing remarks.

Tom King

Great. Thank you, operator. Again, thank you for your time today. It is an incredibly exciting time for us as we move forward toward our first new drug application. I think sometimes we take it for granted because we have had such a good series of accomplishments with AZ-004 over the past couple of years, but we remain highly focused on delivering that new drug application. We believe that that's the business that we are in is delivering new drugs and getting them approved so patients can have them. And we look forward to updating you as we make progress during 2009.

Operator

We thank you for your participation in today's conference. This does conclude your presentation. You may now disconnect and have a great day.

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