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Executives

Fran Barsky - Director, Investor Relations

John Plachetka - Chairman, President and CEO

Marshall Reese - EVP, Product Development

Bill Hodges - SVP, Finance & Administration and CFO

Analysts

Michael Tong - Wachovia Securities

Ian Sanderson - Cowen

Ken Trbovich - RBC Capital Markets

Lucy Lu - Citi

Michael Higgins - Rodman & Renshaw

POZEN, Inc. (POZN) Q2 2008 Earnings Call Transcript July 29, 2008 10:00 AM ET

Operator

Good morning. My name is Heather and I will be your conference operator today. At this time, I would like to welcome everyone to POZEN's second quarter 2008 earnings conference call. All lines have been placed in a listen-only mode and the floor will be open for questions following the presentation. (Operator Instructions) As a reminder, today's conference call will be recorded. I would now like to introduce your host for today's conference, Ms. Fran Barsky, Director of Investor Relations. Ms. Barsky, you may begin.

Fran Barsky

Thank you, Heather, and good morning. On behalf of POZEN, I would like to welcome everyone to today's second quarter conference call. By now, you should have already received a copy of the Company's press release. However, if you do not have it, you can access one on the home page of our website at www.pozen.com. You can also access a replay of this conference call on the home page of our website.

Before we begin, I need to remind you that various remarks that we may make about future expectations, plans and prospects for the Company constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

In particular, any observations that we may make about the expected timing and amounts of royalty payments from GlaxoSmithKline and other revenue expected from our collaboration partners, the prospects for approval of any of our drug candidates or the way in which the FDA may consider our new drug applications or any particular trial results, future trial plans and the likelihood of results of any future trials, the adequacy of financial resources to accomplish our goals or future revenues are based on our current expectations and are subject to a number of risks and uncertainties.

Including our inability to know with certainty what standards the FDA will use to evaluate drug candidates and how that may change or evolve over time, how the FDA evaluates data, what the results of future trials may be, whether those trials will cost much more than we have estimated that they will cost or than they have historically cost, how the FDA weighs risks of drugs, including risks of drugs that have been in use for many years, the decisions of our collaboration partners, our dependence on our collaboration partners for the sales and marketing of our products once approved, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet and whether our resources will be depleted by events other than clinical trials and efforts to obtain regulatory approvals such as the lawsuit that has been filed against POZEN and certain individuals.

Additional factors that affect our forward-looking statements are discussed in our most recent quarterly report on Form 10-Q, which is on file with the SEC. In addition, these forward-looking statements represent only the Company's expectations as of today. While the Company may elect to update these forward-looking statements, it specifically disclaims any obligation to do so. Any forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to today.

With us today from management, we have Dr. John Plachetka, Chairman, President and Chief Executive Officer of POZEN, Dr. Marshall Reese, Executive Vice President, Product Development and Bill Hodges, Chief Financial Officer, Senior Vice President of Finance and Administration. At this point, I would like to turn the call over to Dr. Plachetka. John?

John Plachetka

Thanks, Fran. As everybody knows, GSK has launched the new migraine product, Treximet, and it is now available at pharmacies and we and the development team here at GlaxoSmithKline and POZEN, the joint team, are extremely proud of bringing that new medicine to patients. The feedback we have had from individual patients has been outstanding and we are very proud of being able to bring a medicine to the marketplace that helps patients in their daily lives.

As all of you have been, we have been following weekly IMS numbers and we can report that the overall scripts continue to increase on a weekly basis and while GSK is making steady progress, they are still waiting for their DDMAC approval from the FDA on their advertising materials, including their DTC. So GSK management is very committed to the product. They have demonstrated exceptional sales ability in the migraine space. They have got a great team in place and above all, they are really committed to the needs of the migraine patient.

We have noticed recently they have continued to submit abstracts on Treximet to scientific conferences. Recently, five abstracts were presented at the American Headache Society meeting, which was held at the end of June. So while we are pleased with the progress GSK's sales force has made so far, we look forward to them continuing in this effort and actually doing an excellent job as they bring it to a wider audience.

Now, moving on to our PN400 program, we are on schedule with our pivotal trials and we look forward to finishing them by the end of the year and we anticipate having top-line results early next year and we will work with AstraZeneca on the best way to disseminate that information.

On the PA program, Dr. Reese will provide you with the specifics relating to the proof-of-concept studies we have been conducting on this program, but I am happy to report that we have demonstrated that PA32540 is bioequivalent to 325 milligrams of enteric coated aspirin, which was a key feature of this development program.

Because this product has worldwide potential, we are also planning to meet with key regulatory agencies in the EU during the third quarter, mostly to confirm that the current trials in the U.S. will also qualify as pivotal trials for the new drug applications outside the U.S. So let me turn the call over to Dr. Reese who will give you more information about these programs.

Marshall Reese

Thanks, John. As you mentioned, since we view the PA program as a global opportunity, we submitted briefing documents and now have confirmed meeting dates agreed with several European regulatory authorities. We will be meeting with the U.K., Germany, Sweden and the Netherlands in August and September to review the PA program and to gain feedback on the acceptability of the U.S. program endpoint for the European submission.

We did the same thing with our PN program about two years ago and it was found to be acceptable by those same European authorities. But we will not know how they view the PA program until we meet with each of them.

With respect to our PN 400 program, all studies remain on schedule to allow an NDA submission during the first half of next year. As we stated at the last earnings call, the pivotal efficacy trials are fully enrolled and the subjects are progressing through the six months of therapy. As you will undoubtedly recall, these studies compare PN 400, which is 20 milligrams of immediate release esomeprazole plus 500 milligrams of delayed release naproxen administered twice a day to 500 milligrams of enteric coated naproxen also administered twice a day.

In addition to these pivotal studies, there is a 12 month open label safety study, which was also fully enrolled earlier this year and is on schedule as well.

Certain additional studies requested by our partner, AstraZeneca, are also ongoing and we believe they will be completed in time to include them in the NDA next year. Information on these studies can be found on the clinicaltrials.gov website. They are designed to compare the efficacy of PN 400 with Celebrex.

The PN 200 study results were presented at a platform presentation this past May at the Digestive Disease Week or DDW. The results were well received and showed a clinically significant benefit of PN 200 versus enteric coated naproxen through the six month period. This product used immediate release omeprazole plus delayed release naproxen and the design is very similar to our pivotal PN 400 studies.

These results showed a cumulative incidence of gastric ulcers, which was the primary endpoint, of 8.3% for PN 200 versus 29.4% for 500 milligrams of enteric coated naproxen, which was clinically significant and also highly statistically significant with a p-value less than 0.001. In addition, about 25% of the subjects in the study were also taking low-dose aspirin. The PN 200 study had significantly fewer observed gastric ulcers than those on naproxen plus aspirin.

One unexpected positive finding was that there were significantly fewer subjects in the PN 200 group who developed a duodenal ulcer than in the naproxen group. The incidence of duodenal ulcers is a secondary endpoint in our pivotal PN 400 studies as well.

Next, I would like to review the PA program. As John mentioned, we have demonstrated bioequivalence between our PA32540 product and 325 milligrams of enteric coated aspirin. Based on our understanding with the FDA, this would allow us to claim all of the cardiovascular secondary prevention claims as stated in the aspirin package insert.

We also submitted a Phase III protocol to the FDA for a special protocol assessment or an SPA last month. The FDA is still reviewing our protocol and we expect them to provide comments later this summer. After we hear from our European regulatory agencies and finalize our SPA, we can decide when and how to kick off our Phase III PA32540 program. However, it is likely that we may kick off the long-term, 12 months, long-term safety study that often controls the timing of an NDA submission.

Now we have also initiated two Phase I studies with two different formulations of our PA product. One study is with the primary formulation, PA32540, and the second study is with the new formulation, PA08140. Now this product contains 81 milligrams of delayed release aspirin and 40 milligrams of immediate release omeprazole. In both of these studies, subjects were dosed once a day for two weeks. Each study had three arms -- the PA alone versus PA plus Celebrex versus aspirin plus Celebrex. The Celebrex dose was 200 milligrams a day in both arms and in both studies. The aspirin dose was kept constant in each study and was either 81 milligrams or 325 milligrams. The primary endpoint was a Lanza grade 3 or 4 upper GI damage as has been the case in all of our previous Phase I studies with PA.

The PA08140 study has been recently completed and the top-line results demonstrate that no grade 3, 4 damage was observed with either the PA8140 arm alone or when PA8140 was combined with Celebrex. However, both treatment groups were significantly different from the 81 milligram aspirin plus Celebrex group, which had a 26.7% grade 3, 4 Lanza damage. And as you might imagine, that was highly significant.

Additionally, there were two gastric ulcers in the aspirin plus Celebrex arm, but no ulcers in either of the PA arms. Now this study demonstrates that aspirin, even at low doses, even at doses as low as 81 milligrams in conjunction with other NSAIDs, including the COX-2s, can cause significant gastric damage. The PA32540 study is nearing completion and we will discuss those results when they are available.

Now one of the things you will be hearing more about in the future is some new exploratory programs. For instance, we are looking at different strengths of our PA product to determine how they protect against ulcers at high doses of aspirin. As ulcerogenic as 325 milligrams of aspirin can be based on the literature, studies show that higher doses of aspirin cause even greater GI toxicities. However, higher doses of aspirin may be useful for the treatment of pain such as those associated with chronic illnesses such as arthritis.

And as you have heard John speak about before, higher doses of aspirin have been shown to reduce the risk of developing several types of cancer, including colon cancer. These higher doses seem to be associated with a high enough risk of gastrointestinal toxicity that precludes its routine use in many patients who could derive benefit. So we are currently planning to explore whether we can deliver these higher doses of aspirin with a much lower risk of gastric ulceration much like our PN program. We are also planning to determine the effectiveness and safety of higher doses of aspirin in patients with chronic pain conditions using our PA formulation technology.

That is just some of the exploratory areas we are thinking about and thanks to the continuing creativity of our scientists, we may be able to advance at least one more program into a proof-of-concept study within the next, say, four to eight months. So while we have plenty to do with our current Phase III PN 400 program and our planning for the PA32540 Phase III program, we continue to add new ideas that we can slot in behind these to keep our new product flow coming on a consistent basis. Now let me turn the call back over to John.

John Plachetka

Thanks, Marty. Let me ask Bill Hodges to review our financial results.

Bill Hodges

Thank you, John. Looking at our financial statements for the second quarter of 2008, revenue totaled $33.1 million as compared to $11.9 million for the same period in 2007. The second quarter revenue includes $20 million in milestone payments from GSK, $3.7 million of amortization of upfront payments received under the AstraZeneca agreement; revenue of $8.6 million for development work performed under the agreement and accrued Treximet royalties of approximately $824,000. We estimate that approximately 125,000 packages of Treximet were sold by GSK in quarter two and this obviously includes the pipeline fill.

Total operating expenses were $20.3 million as compared to $16.5 million for the same period in 2007. The increase in operating expenses over the second quarter of 2007 resulted primarily from a $3 million increase in the development costs for the PN 400 program. We are still on target to complete the pivotal study this year and plan the PN 400 NDA in the first half of 2009.

Non-cash stock option-based compensation expenses were $1.7 million in the second quarter of 2008 as compared to $1.1 million in the second quarter of 2007.

Net income for the second quarter of 2008 was $13.3 million, or $0.43 per share on a diluted basis compared to a net loss of $3.8 million or a $0.13 loss per share on a diluted basis in the second quarter of 2007. For the six months ended June 30, 2008, revenue totaled $41 million as compared to $19.6 million in 2007. The increase in revenue is primarily due to the receipt of the $20 million in milestone payments from GSK.

Total operating expenses were $36.2 million as compared to $27.1 million for the same period in 2007. The increase in operating expenses was primarily due to an increase in costs associated with the PN program. Non-cash stock option-based compensation expenses were $2.7 million in the first six months of 2008 compared to $2.5 million in the first six months of 2007.

Net income for the six months ended June 30, 2008 was $6 million or $0.19 per share on a diluted basis compared to a net income or a net loss, I am sorry, of $5.9 million or a $0.20 per share loss on a diluted basis for the same period in 2007.

At June 30, 2008, cash, cash equivalents and short-term investments totaled $72.2 million compared to $73.9 million at December 31, 2007. We have a $9.4 million receivable balance due from AstraZeneca and GSK at the end of the quarter.

We are reconfirming our guidance from our first quarter conference call in that we expect revenue to be in the range of $62 million to $68 million, which includes the $20 million in milestone payments already received from GSK for the 2008 year.

Revenue for development work performed under the AZ agreement is expected to be in the $22 million to $24 million range and we continue to monitor Treximet prescriptions and expect to refine our estimate of expected royalties on our third quarter call. It is still too early to determine the actual sales trends and therefore would have [found] our previous estimate. We believe the key sales driver is when GSK gets FDA approval for its advertising and promotional materials, particularly the direct-to-consumer advertising.

Total operating expenses for the 2008 year are expected to be in the range of $67 million to $71 million. Non-cash stock-based compensation expense of $5 million to $6 million is included in our operating expense estimate. As Marty mentioned, we are currently evaluating the timing of starting Phase III for our PA32540 product and possibly advancing our exploratory development pipeline and may decide to accelerate some studies into quarter four of this year.

If we accelerate certain exploratory development studies and start the PA32540 Phase III studies, we would likely need to slightly increase our operating expense guidance for the year. Therefore, we will update you on any revisions to operating expenses in our third-quarter earnings call. Those are our financial results and outlook. Let me now turn to the call back over to Dr. Plachetka. John?

John Plachetka

Thanks, Bill and let's open it up for questions, operator. Go ahead.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from the line of Michael Tong with Wachovia Securities.

Michael Tong - Wachovia Securities

Hi, good morning. Bill, I just want to make sure I heard you correctly. Given your current revenue guidance and the breakout that you provided in your commentary, you are still looking at $5 million to $9 million in Treximet royalties at this point, which you may or may not adjust on your third quarter conference call?

Bill Hodges

Correct. We think it is too early to know what the exact sales trend is, so we think that -- we are confirming our guidance that we gave at the end of the first quarter, reconfirming.

Michael Tong - Wachovia Securities

And then just on the PA program, what factors, other than the feedback from the FDA regarding your SPA protocol, would determine whether you accelerate or start the Phase III before the end of the year or not?

John Plachetka

Michael, I am not going to answer that question, but just say general business factors.

Michael Tong - Wachovia Securities

General business? Maybe a little bit more insight on that?

John Plachetka

Well, it is more of a strategic decision and it involves other sorts of implications rather than just can we do the studies.

Michael Tong - Wachovia Securities

Okay. Thanks.

Operator

Our next question comes from the line of Ian Sanderson with Cowen.

Ian Sanderson - Cowen

Great. Thanks for taking the question. Just a quick question for Bill on the P&L. In what revenue line are the Treximet royalty revenues included? And secondly, on the AstraZeneca, the R&D revenues from AstraZeneca, should we assume that that tapers towards the end of the year as you near completion of the Phase III trials there?

Bill Hodges

Well, the first question, the Treximet royalties are in the licensing revenue line.

Ian Sanderson - Cowen

Okay.

Bill Hodges

With regard to the AstraZeneca development revenue, we are getting paid to run the PN 400 Celebrex studies. So as those studies wind down, you would expect to see that number wind down. It is towards the end of the year, but I don't know that the fourth quarter is going to be significantly less.

John Plachetka

But there is actually a lag in when we get charged for things. How studies run is -- you get a lot of charges as you go through the study, but there is oftentimes almost a 60-day lag on what is really a billable event.

Ian Sanderson - Cowen

Okay. And if I could follow-up on Treximet, just to clarify, do you know the extent of GSK's sampling program on Treximet and what portion of that 125,000 boxes, if any, includes sampling? And secondly, do you, just to clarify, do you get paid on the sample program in any way?

John Plachetka

We get a royalty on net sales. Relative to sampling, you will have to talk to GSK and see if they will break that number out for you.

Ian Sanderson - Cowen

Okay, thank you.

Bill Hodges

But within the sales, there is zero samples. The samples would be outside of the sales number.

Ian Sanderson - Cowen

Right. Okay, thanks.

Operator

Our next question comes from the line of Ken Trbovich with RBC Capital Markets.

Ken Trbovich - RBC Capital Markets

Thanks for taking the questions. Just really quickly, I guess, John, on the PN program, I know you had mentioned some of these exploratory trials that are going on for PA, but are there any plans from the standpoint of AstraZeneca or yourselves to look at pharmacoeconomic benefits? I mean obviously there is all the literature around patient's failure to take coadministration and physician failure to prescribe. Have there been any efforts to look at the pharmacoeconomic benefits of the combination?

John Plachetka

For PN?

Ken Trbovich - RBC Capital Markets

For PN, yes.

John Plachetka

Yes, I think there is going to be a substantial body of evidence that is already available. This is going back some years to when the COX-2s were first introduced. It was very clear then that the morbidity associated with ulcerations secondary to regular NSAID was in fact having a tremendous drag on the healthcare costs of these patients. So that data has been well-published.

The established linkage between cost savings and preventing ulcers and preventing bleeding complications is irrefutable. You can look through any of the literature from either rofecoxib or [celocoxib]. By providing the same benefit in terms of reducing ulceration with PN, we believe that this is an intuitive finding that people are going to have very little difficulty absorbing.

Now whether or not we do specific work with the PN program is a second issue. AstraZeneca has a very detailed program for promoting this product, but I don't think that they have talked about it publicly. So I think we will not be able to make any comments in that regard.

Ken Trbovich - RBC Capital Markets

Okay, and then just with regard to the DDMAC review of the Treximet materials, are there any voluntary or sort of self-imposed restrictions on DTC marketing that would also apply to GSK either because of pharma guidelines or stated policy?

John Plachetka

Well, so far as I understand it, we voluntarily -- or GSK voluntarily submits all the information ahead of time. This is not a restriction. There is no regulation that says that you can't launch at risk, but once you voluntarily submit the materials, you basically have to wait until they comment on it. I believe that is correct, isn't it, Marty?

Marshall Reese

Yes, I believe that is correct.

John Plachetka

So God bless them at the agency. They have 500 open positions. They have moved people from one division to another. It is a tough time, they are trying to put out fires everyplace. They're under a tremendous amount of scrutiny and they are doing the best that they can possibly do. I think we will get a very reasonable turnaround time from them given the circumstances. I would look for GSK to have all their tools in place during this quarter and be able to go forward with that.

And that is going to be a major inflection point. I mean they basically have achieved a very nice start to the launch of Treximet with a package insert detail and one reprint. So they have done an outstanding job given what they have been able to use and I look for a major upturn in marketshare and penetration once they have all their tools available to them.

Ken Trbovich - RBC Capital Markets

Okay, and then just one final question. The comments around the sort of formulation side for alternative work on PA, sounded like you were looking at obviously higher doses of aspirin and potential therapeutic uses for that. Are there any things on the table from a formulation or development side outside of the PA and PN programs that we know of today that you folks sort of see on the horizon for future development efforts longer term?

John Plachetka

Well, we believe that the PA franchise is in fact a franchise. It is multiple strengths and multiple combinations. We have given some information about an 81 milligram form of PA. That is regarded as a completely safe dose. Two-thirds of people in the United States take the 81 milligram dose. On the other hand, it is not completely safe. If you have risk factors such as concomitant NSAID use, you are going to develop an ulcer with this. Now we did a study with celocoxib, which is regarded as a very safe agent, but it is very commonly administered today because of its cardiovascular risk profile with low-dose aspirin.

The data that Marty talked about demonstrated without question that you change the profile of celocoxib and you make it look like an NSAID. So therein lies another opportunity for a different form of aspirin. Our 325 is in fact the dose we believe to be the optimal dose from both an efficacy and a safety standpoint in the marketplace, but I am not sure the marketplace is right there with us yet. But I think that they will go there. Right now, about a third of the people in the United States take 325 milligrams of aspirin.

When you talk to prescribers as we have done in our market research, the prescribing physicians will tell you that they give 325 and 81 milligrams to patients, but they choose the higher dose for people who have greater risk. So even though the literature does not clearly support a dose response, physicans' behavior indicates that they believe there is a dose response. And that is one of the reasons that we are developing the 325.

And in addition to that, the aspirin resistance is much lower for the 325. Now as you look across the array of things that aspirin does, the ability to prevent colon cancer occurs at a minimum dose of 325, but it appears to rise, almost in a linear fashion, up to 1200 milligrams a day. So a separate dosage form that would be either a once or twice a day dosage form that would allow physicians to take advantage of that would be in order.

As would a dosage form that would allow physicians to use aspirin as it was originally intended to be used as a pain reliever. But if we can reduce the ulcerogenic properties, we hope that we can essentially redefine the risk benefit profile of aspirin across a wide array of doses and this, we view each as a separate commercial opportunity. That is a long-winded answer, but every program with each strength could be viewed separately because they are all separate indications.

Ken Trbovich - RBC Capital Markets

Sure and so you see the PA program as having multiple opportunities. I guess part of my question was focused on whether there is anything there in the works outside of PA and PN that we haven't necessarily heard of previously.

John Plachetka

Well, we actually are looking at some other programs. We continue to explore ways to improve things for migraine care. We obviously are getting a lot of experience with proton pump inhibitors in the immediate release form and so we continue to look at ways to develop products for unmet medical needs. As most everybody knows, the proton pump inhibitors are slow in onset. We are obviously concerned about trying to improve proton pump inhibitors, which would essentially say make them more effective and make them work much more quickly than the slower onset delayed release product.

So maybe there is a way to change the product profiles that are out there today and we are taking a look at those things. So reflux, ulcer healing, those are the sorts of indications that some of our exploratory programs are aimed at. But we will have more to say about that later on as we go forward. Probably before the end of the year, you will hear more about these programs.

Ken Trbovich - RBC Capital Markets

Okay, thank you.

John Plachetka

Yes.

Operator

(Operator Instructions) Our next question comes from the line of Lucy Lu with Citi.

Lucy Lu - Citi

Good morning.

John Plachetka

Hi, Lucy.

Lucy Lu - Citi

Hi, I was just wondering if the study of PN 400 in high-risk patients is still ongoing because on the clinicaltrials.gov site it says the study has been terminated.

John Plachetka

Yes, it has. Marty will fill you in on what happened there.

Marshall Reese

Yes, we terminated that with agreement from the FDA. It was just very, very difficult to enroll and the FDA agreed with us.

Lucy Lu - Citi

Okay. And it is not going to impact your regulatory process?

Marshall Reese

No, this was a pilot study if you recall, not a pivotal study. And we will address it in the labeling.

Lucy Lu - Citi

Okay. And then can you please provide some more details on studies that compare PN to Celebrex? What is the primary endpoint and what is the treatment duration?

John Plachetka

Well, you can go to clinicaltrials.gov and look at all that information. I think it is all spelled out in fair detail.

Marshall Reese

They are standard OA studies.

Lucy Lu - Citi

Okay, thanks.

Operator

Our next question is a follow-up question from the line of Michael Tong with Wachovia Securities.

Michael Tong - Wachovia Securities

My question has been answered. Thanks.

Operator

Our next question comes from the line of Michael Higgins.

Michael Higgins - Rodman & Renshaw

Good morning. Thanks for taking my question. The question relates to PA and the cost and the timing to get that to an NDA submission. Could you benchmark that as it compares to the PN 400 program minus the omeprazole costs?

John Plachetka

Well, the benchmark timeline would be about the same, could be a little bit less. Relative cost, probably about the same also. It is not likely that we will have any major program like the Celebrex comparator trial, which is actually quite costly in there because aspirin is by itself approved for cardiovascular. There is no other product with this broad an indication, so PA would in fact be the second entry versus regular aspirin. And so we would have substantial clinical and we believe economic, as well as therapeutic advantages over plain or enteric coated aspirin for cardiovascular protection.

Michael Higgins - Rodman & Renshaw

And is the plan to look for a partner after the Phase II and when might that Phase II be completed? What is your best guess at this point?

John Plachetka

Yes, I mean we generally don't comment on the plan for partnering. It is obviously a strategic decision.

Michael Higgins - Rodman & Renshaw

Okay, thank you.

Operator

(Operator Instructions) If there are no further questions, we will turn the call back over to Dr. Plachetka for any closing comments.

John Plachetka

Okay, thanks very much. We appreciate everybody's questions this morning and thanks for participating. We are going to be attending a couple of conferences in sunny and cool New York in August. We will be at the Bank of Montreal conference and also Goldman Sachs is having a small-cap healthcare one-on-one day in New York and if you need any additional information, you can call Fran and she will give you the times and places on those. But after the last quarter and profitability for this quarter and a good quarter, we feel good about where we are. We thank everybody for coming. Those of you who are going on vacation, enjoy August and we will talk to you in the fall.

Operator

Thank you for participating in today's POZEN second quarter 2008 earnings conference. You may not disconnect.

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