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Dynavax Technologies Corporation (NASDAQ:DVAX)

Q4 2007 Earnings Call

February 19, 2008, 4:15 pm ET

Executives

Shari Annes - Investor Relations Consultant

Dino Dina - President and Chief Executive Officer

Deborah Smeltzer - Vice President, Operations and Chief Financial Officer

Analysts

Bret Holley - Oppenheimer & Company

Katherine Xu - Credit Suisse

Alan Leong - Biotech Stock Research

Brian McCarthy - Merriman Curhan & Ford

Operator

Good day and welcome to the Dynavax Fourth Quarter 2007 Financial Results Conference Call. Today's conference is being recorded. At this time, for opening remarks and introductions, I would like to turn the conference over to Ms. Shari Annes, Investor Relations Consultant. Please go ahead Ma'am.

Shari Annes – Investor Relations Consultant

Thank you. Good afternoon and thank you for joining this call. As you know, the subject of the call is Dynavax's fourth quarter and year-end 2007 financial results and guidance for 2008. Participating in today's call are Dino Dina, President and Chief Executive Officer and Deborah Smeltzer, Vice President, Operations and Chief Financial Officer.

Following my introduction, Dino will provide a summary of the year's achievements. Deborah will review financial results for the quarter and the full year, and after opening the call for your questions, Dino will provide a closing statement.

Please be advised that this conference call will include forward-looking statements that are subject to a number of risks and uncertainties, including statements about our projected cash position and operating results. Actual results may differ materially from those set forth in this call due to the risks and uncertainties inherent in our business, including: achievement of our Merck agreement collaboration objectives and milestones and regulatory approvals under our third party funding arrangements. Continuation of our third party collaboration and funding arrangements; difficulties or delays in research and development; initiation and completion of clinical trials; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

In addition, with respect to the statements by Deborah Smeltzer regarding the financial outlook, I further remind you that they are forward-looking and are based on current expectations. Actual results may differ materially. These statements do not include the potential impact of any equity offerings, new business collaborations, or other transactions that may be closed or entered into after today. And now I'll turn the call over to Dino Dina.

Dino Dina - President and Chief Executive Officer

Thank you. 2007 was a year of significant achievements for Dynavax. Highlighting the year was of course the cooperation we announced with Merck to conceive development and commercialize HELPISAV or enhance two-dose hepatitis B vaccine. This agreement commonly set the commercialization facts for HELPISAV and improved the likelihood of its becoming an important addition to the market for global vaccine.

With an upfront fee of $31.45 million dollars full funding for product development and significant milestones and royalties we gained considerable financial recourses there being leveraged across our other product portfolios. As part of the agreement, we're moving forward to expand our production facility in Düsseldorf to meet the supply requirements of Merck once the product is launched.

Our Phase II study of HELPISAV in Canada in Germany has been completed. As you know, the trail compares the immunogenicity of two-doses of HELPISAV with the immunogenicity for three doses of Anthrax B. With the trail complete, we have stayed on track, which is the next milestone in the HELPISAV program. Importantly in mid 2008 we'll report data from this pivotal Phase III study.

Next I'd like to discuss the landmark, our ragweed allergy immunotherapy. Based on an in-depth and pre-specified analysis of the DARTT trail, we presented an important new set of findings that couldn’t play our meeting last February. We showed that in the Midwest we had successfully recruited individuals with measurable Ragweed Allergy disease and in that geographic area we had shown statistically significant clinical effect for TOLAMBA, much as we had seen in previously successful studies. And of course differently from what the total studies showed.

Later in the year in a presentation made at the College of Allergy Asthma and Immunology, we provided the detailed analysis of the data from the DARTT trail that significantly expanded our understanding of the correlation between skin test parameters and the magnitude of ragweed allergic corneitis symptoms in placebo-treated patients.

Specifically this analysis provided valuable insights that we used to guide the design of future clinical trails. With this extensive understanding of the DARTT trail, we announced in July the $30 million commitment by Deerfield Partners to restart the TOLAMBA development. And the funding was also earmarked to advance our Cat and peanut allergy programs to the clinic. Importantly while Deerfield is providing at risk capital for the TOLAMBA trails we retained all products lines moving forward.

In October, we started environmental exposure chamber study designed to confirm and extend the observations obtained in the DARTT study. We expect that the chamber study data will help us design potential future field studies of TOLAMBA, a study that will increase the likelihood of enrolling patients with measurable disease and therefore, one that will presumably show efficacy. That study would begin in late 2008 or early 2009.

Our plan is to announce results of the chamber study in the first half of this year and more specifically at mid year. With success in the pivotal trail in place, we expect to advance discussions with potential partners for commercialization of this product and the varied specific strategies.

Before turning the discussion to Deborah, I'd like to recap the number of the years that their achievements beyond these two products. In August the NIAID provided us with a follow up grant for our universal flu program. While this grant adds to funding provided by NIH over the past four years, it does not cover all of our research activities. Nevertheless, we believe that we can take this product to the clinic in early '09 and among our top priorities in '08 is finding the supply of conventional vaccine that we will use in our universal flu program.

Also in August we were granted the landmark composition of matter patent covering our proprietary second generation TLR9 agonist. The issuance of this patent provides growth patent coverage for novel and non-obvious molecules that are completely different from our first generation molecules.

Furthermore, we have pending applications in this family that we believe have the potential to expand the scope of our total coverage.

Looking back I think that we have significant advanced our TLR9 platform and Dynavax today is focussed on major product opportunities. Aptly said TOLAMBA and flu and the extension of these products into key franchises.

In two of these key areas we've retained the rights to commercialize our products. Importantly we enter 2008 with bridge of approximately two years of (burn). I will now turn the call over to Deborah to discuss the year's financial results and provide guidance for the year ahead.

Deborah Smeltzer - Vice President, Operations and Chief Financial Officer

Thank you, Dino. First I will review the financial results we reported earlier today for the fourth quarter and year-ended December 31st, 2007. As of December 31st, 2007, Dynavax reported cash, cash equivalent, marketable securities, and investments held by Symphony Dynamo Inc. totaling $88.2 million. This compares to $86.2 million at December 31, 2006.

For the fourth quarter 2007, total revenues were $9.3 million, compared to $2.4 million reported for the fourth quarter in 2006. Total revenues were $14.1 million for the year-ended 31st December 2007 compared to total revenues of $4.8 million reported last year.

The significant increase in revenues for the final quarter and the year reflects Research and Development fundings for the TLR9-based hepatitis B vaccine and asthma program that are provided Dynavax's two collaborative pharma partners, Merck and AstraZaneca respectively. Additionally, revenues include an increase in NIH grant revenue primarily for our universal flu program. The reported revenues do not include the collaboration funding from Symphony Dynamo for our cancer and HCV clinical activities.

On a pro forma basis, including the collaboration funding from Symphony Dynamo, the revenues were $11.4 million for the fourth quarter 2007, compared to $6.9 million for the fourth quarter 2006. For the year-ended December 31, 2007, pro forma revenues were $24.7 million compared to $14.5 million for the same period in 2006.

For the fourth quarter 2007, total operating expenses were $23.3 million compared to $24.4 million for the fourth quarter 2006. For the year ended December 31st, 2007, total operating expenses were $85.2 million compared to $69.8 million for the same period in 2006.

The increase in operating expenses for the year resulted primarily from increased clinical development and licensing activities related to the Company’s product candidate HEPLISAV that was licensed to Merck in the fourth quarter of 2007. Overall organizational growth including the operations of Dynavax Europe and reimbursable expenses related to SDI programs.

The 2007 operating expenses included a one-time $5 million patent license payment for the commercialization of HEPLISAV, and non-cash charges for stock-based compensation and amortization of intangible assets. Excluding one time and non-cash charges, pro forma operating expenses were $22 million for the fourth quarter 2007 compared to $23.3 million for the fourth quarter 2006.

For the year-ended December 31st, 2007, pro forma operating expenses were $75.7 million compared to $61.7 million for the same period in 2006. The net loss of $12.1 million, or $0.30 per share, reported for the fourth quarter 2007 was less than the net loss of $16.5 million or $0.44 per share for the same period in 2006.

Net loss for the year-ended December 31st, 2007 was $60 million or $1.51 per share, compared to a net loss of $52.1 million or $1.61 per share for the same period in 2006.

For the fourth quarter, the improvement in net loss reflected the increase in revenue, in particular revenue associated with the signing of the Merck collaboration. The year's wider net loss was due primarily to increase clinical development expenditures and overall organizational growth offset somewhat by the significant increase in collaboration revenue. The increase in shares used to compute net loss per share resulted from the company's equity financing activities completed in the fourth quarter of 2006.

Now I would like to provide you our financial outlook for 2008. Please note that the following statements are forward looking and are based on current expectations. Actual results may differ materially, except the (results) in 412 these statement do not include the potential impact of any equity offerings, new business collaborations or other transactions that maybe closed or entered into after February 19, 2008.

We begin 2008 with four primary contributions to our Pro forma revenues in total cash. We had two significant collaborations with pharmaceutical companies with Merck for HEPLISAV or enhanced two-dose hepatitis B vaccine in Phase III, and with AstraZeneca for our preclinical asthma program. In addition, Symphony Dynamo contributes to our clinical oncology and preclinical HCV programs, and NIH provides significant grant funding for our preclinical flu program.

We are projecting 2008 Pro forma revenues to be in the range of $42 to $46 million, which is the significant increase compared to 2007. We are projecting 2007 pro-forma operating expenses to be in the range of $80 to $88 million.

We began 2008 with $88 million in total cash, which is defined as cash, cash equivalents and marketable securities including cash held by Symphony Dynamo. We estimate that this provides Dynavax with approximately two years of operating cash.

At the end of 2008, we are projecting total cash to be in the range of 40 to $44 million, without the addition of proceeds from any equity offerings, new business collaborations or other transactions that maybe closed or entered into after today.

Now operator, we would like you to open the call to question-and-answers.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). We will take our first question from Bret Holley with Oppenheimer & Company.

Bret Holley

Yeah, hi. Thanks for taking my questions. I had a question about any additional market research you have done following the Merck deal on the commercial advantages of two-dose HBV vaccine versus three dose vaccine, do you have any additional information of that?

Dino Dina

Well, I think that some of the key aspects of - we will keep looking to, we tried at this stage preliminary that there are some significant upsides to Hepatitis B market that have the potential for expanding that market in a significant way. One that is not immediately obvious, but is built into two dose regimen versus three dose regimen is that by selling two-doses for the price of three and have much better compliance with doses than three, you collect more money per regimen, then you have worked on a three dose administration. And so we expect that to boost revenues from Merck's current market share simply on a profession basis in a measurable way. Beyond that, of course, we expect and I am sure, Merck share being due that the competitive advantage of the vaccine will provide inroads an increased market share compared to today where Glaxo has a significant proportion of those sales.

And then finally, there has been a repeated efforts to bring universal adult immunization to the class as a public health policy which has so far not being brought to provision, as we believe that the recent appearance of data showing that immunity veins in a proportion of the population that was immunized with inferent and is now reaching a goal that this has a good chance of becoming a reality in which case the market would be transformed in a very dramatic way.

Now keep in mind that these are our thoughts and strategies that we are developing and that in particular universal immunization isn't going to be a fact until, it of course and it’s adopted as policy at a government level.

Bret Holley

I guess a followup to that Dino, as you said two for the price of three, does that kind of gives us a general ballpark of where you think pricing factor there?

Dino Dina

I use that as an example, but I believe that that’s probably something that Merck will consider seriously to ensure market penetration. But we don’t have visibility to date to their final pricing strategy.

Bret Holley

Okay. And, then I guess my last question is, is there any possibility given your comment about the veining efficacy vaccine for the FDA is going to be, I guess somewhat more interested in seeing longer term immunization data from your faster -- any of the other policy you have ongoing?

Dino Dina

Well, the (inaudible) of the response is being documented over a reasonable period of time. If you take into account that it's now taking roughly 15 to 20 years to see a veining of immune responses from those original immunizations. It's clearly not in the cards that that's going to be part of the pre-approval package. In fact, we expect that we will follow people to showing hands duration as part of our marketing efforts.

Bret Holley

Okay. Thanks very much.

Operator

We'll take our next question from Katherine Xu with Credit Suisse.

Katherine Xu

Hi! Good afternoon. Just to follow on Bret's question with regards to HEPLISAV what’s primarily Dino about pricing, let's say in young adults and if it's being paid by insurers versus in heart immunized population such as the ESRD patients versus if the policy brings about the universal adult immunization in government setting and government buys it, what the pricing would be?

Dino Dina

I believe that in general prices are pretty uniform across the board in the US, and that the order of magnitude to the $150 to $160 per regimen. There are some discounts that are applied to that, I can't tell you exactly what they are because we don't have that information. And that, typically, there are variations on a country-to-country basis those prices are approximately one-half to two-thirds across European countries. So, I'm not aware today of any differentiated pricing across different categories, what happens in the difficult immunized populations such as ESRD is that as you know there are double-dose regimens that are being used, that bring the total number of immunizations for some of the non-responders up to 16 shots which makes them the cost per individual patient or revenues per individual patients much higher.

Katherine Xu

Alright. Great. I have a number of other questions just to get an update from you, since you're prepared remarks were fairly brief. So the next one is on the TOLAMBA, did you elaborate on the chamber study design dosing and I guess timing is around mid year?

Dino Dina

Yes. So I confirm that. And, the study design is inline with what we've done in this year, it compares united group to placebo group. The immunization regimen and dose are those that were used in the high-dose arm of the DARTT study, which provided an insight that we've used to design the study. So there are no changes there. And the major difference as compared to few studies we've done so far are at two levels. One is that the patients are screened by challenged and they are only patients that meet certain criteria of symptomatology are enrolled into this study that ensures that we have disease. And, then of course the exposure is artificially induced by injecting following to the air in close environment which is a chamber and this is done in a calibrated mode that is fully validated and highly reproducible so that in fact you end up with the study that allows you to look at a typical primary endpoint, which is the adopted endpoint in this study of comparing placebo to treated group after treatment, and that is how the study is going to be evaluated for success, but it also allows you to do non-parametric analysis which are extremely useful including comparing placebo to themselves to get difference on the size of the placebo effect, and then treated group to themselves in terms of how many people improve versus how many did not. And, then those will give us a much better insight into how these studies perform and potentially provide some key suggestion in terms of deciding how big study, and how to enroll the field studies that would follow.

Katherine Xu

So looking around for just only one dosing regimen in this study, just one armor TOLAMBAtm which is a high dose in that?

Dino Dina

Correct.

Katherine Xu

Okay. And you are going; at least the plan is to partner TOLAMBAtm after the chamber study, but before the phase III?

Dino Dina

Well, the timing is a bit tight in that, we anticipate turning the whole thing around in roughly six months. But I didn’t know we had fairly advanced discussions prior to a little stumbling accident at the beginning of '07, and we have continued to cultivate those discussions and maintain contact with various key interested parties. We have also put a lot of thought into how this could be partnered and we’ve discussed essentially three key options. One that would rely on a conventional out licensing deal that’s probably our least favorite one, in that we would like to retain significant market presence for this product if it is successful. The second one that could potentially split the indication along a very clear line, separating the both interventions in highly specialized allergy practices which we could definitely market and sell ourselves versus the pediatric indication that would rely on a much broader penetration of physicians in the field, and therefore would need a much greater sales force, and a typical example of a situation like that along different lines is obvious that Merck with Singular which is promoted by pediatric vaccine sales force. So, I think we have a definite possibility there with a number of companies that have pediatric sales forces and would be interested in this. And so, we will do our best to – and then the final option, I'm sorry, is a classical biotech option. There is a small but emerging and very well defined market for TOLMABA in Europe and we have received some inquiries about the possibility of providing European rights. We haven't been able to really push that much further in that we do need the data to gain additional credibility and our negotiation for that value, but we will certainly move very quickly in all of these directions, when the deal becomes available. And we are not excluding the possibility of using a distribution sales force to help sell the product along with us. We will have to see where we gain most traction. But I wouldn't like to be boxed into a time frame that goes exactly from the minute we get the data, to the minute we start the trial, in that it might take a little bit longer to get the right deal done.

Katherine Xu

But in European the population is a lot smaller though, I mean it…?

Dino Dina

It is smaller, but nevertheless significant in terms of total market value, because it affects the entire Southeast region of France, along the Rhone valley. The entire region of Northern Italy, which is north of Vietnam, the program is specifically all the way from Reno to the ocean, and then the entire – the new border shed, which includes Austria, the Czech Republic, Slovakia, Hungary, and part of the lower Eastern Europe. So in terms of total population is by no means as large as the United States, but it is considerable.

Katherine Xu

Okay, great. If I could move to the universal flu program. Apparently, you need to find a distributor or partner in manufacture of a conventional flu vaccine for you to actually piggyback universal solution too. What kind of partnership do you have in mind right now? What kind of structure can we expect?

Dino Dina

I think that we are looking at two possible outcomes and what would be a straight partnership and there again given the innovation and effort that we put into these program, we would definitely aim as retaining significant market presence in the United States in particular, because flu is really not sold from the conventional sales force, but goes mostly to institutions, government institutions, companies and then to conventional distribution by specialized distributors. So in that context, we believe that we could play a key role both in strategic marketing and selling the vaccines, so that would be our aim.

We are also contemplating - because there is some interest in the field than we are getting some people responses getting into a supply agreement whereby we would purchase vaccine from one of the existing manufacturers and potentially trade again some distributional rights for Europe, if that were necessary and desirable. So we have some flexibility and we are pursuing different avenues and its bit early to say and give you guidance in terms of where we expect to land.

Katherine Xu

Okay. Great, that’s very helpful. And could you provide some update on the hepatitis B and colon cancer studies, those are in Phase I?

Dino Dina

Yes. We are continuing the development of our cancer indication. I think that we haven't reported data on the Phase I study in CRC, but we will probably do so at some not too distant point in the future. I think that the data were sufficiently interesting to encourage us to move forward and we are continuing in colorectal cancer and we are reviewing the possibility right now of continuing either with (inaudible) or a second generation only goal that has enhanced properties, and we haven't reached the kind of decision on that yet. And we are also continuing and starting to put together and follow up to the Phase 1 study that is completed in Hep B therapy which would now move into from uninfected healthy individuals into infected individuals and we anticipate having that study underway probably starting before the end of the year.

Katherine Xu

You haven't presented the healthy volunteer data yet right?

Dino Dina

No, we haven't.

Katherine Xu

Right. Well that's very helpful. Thank you for taking so many of questions.

Operator

Let’s go to Brian McCarthy with Merriman Curhan & Ford.

Brian McCarthy

Hi. Thank you. Actually my question at this point have been answered. Thank you.

Dino Dina

Thank you, Katherine.

Operator

(Operator instruction). Let’s move to (Derek Jones) at (Inaudible).

Unidentified Analyst

Yeah, thanks. I think I do have some questions, so may be Dino, if you can review for us where you currently are in HEPLISAV, what kind of studies are ongoing and planned, I know there is immunogenicity study and safety study, when will those be reporting out and wasn't a big upside for that program in high-risk patients, the ESRD. When is that trial of Phase II going to come in?

Dino Dina

As I mentioned in my brief update, we have completed the Phase III study in Canada and Europe and we will be reporting data from that study later on. We have also completed our Phase II study in Canada and it’s not in the follow up period. We will also report the data roughly in the same timeframe complete by mid year, and then we are still reviewing and in the final stages of configuring the immunogenicity consistent at all study in the US along with our collaborators at Merck and we will need to review that with FDA, and that so, that seem to works and we will be starting hopefully in the very near future.

Unidentified Analyst

Like these are all stage where we come up in currently middle '08, you said then?

Dino Dina

Yeah.

Unidentified Analyst

Right. On TOLAMBO, have you guys learnt anymore on the geographical areas, how important they are for vaccine exposure?

Dino Dina

Nothing more then what we have reported at a collage, I would refer you back to what we have said there, which is that the midwest has simply provided the cleanest change from baseline and appearance of ragweed allergy symptoms in the appropriate season as compared to the south where we do not see the clean change from baseline and the eastern seaboard where we do see a very clean change from baseline but levels of pollen and influence of disease are much lower.

Unidentified Analyst

Then maybe you can incorporate that into your phase III design and I know, Dino, you said you don't want to get boxed into actually telling a timeframe.

Dino Dina

We have been very explicit about the effect of geographical configurations and selections would be critical to reflect over the next I think so. I'm allowing myself to be boxed into that right.

Unidentified Analyst

No I was actually going to go on to say not be boxed in on a deal, now learning what you know from the previous studies would you commence the Phase III without a partner?

Dino Dina

Well let me redo it, judgment on that conductive would depend on a number of circumstances but in principal our company commitment is to do so. I also mean, of course that we can afford to and if the data emerging from the current study would be convincing enough to make us decide to take that risk.

Unidentified Analyst

Okay, maybe one more question on non-Hodgkin's lymphoma. I know you had an ongoing Phase II, any time when that’s you are going to report or currently planned studies on that indication?

Dino Dina

The data have been fully recalled so I don't have anything to add to that. As you recall we indicated that from the responder analysis basis which I would invite you to take for the (great assault) of course, we have a very dramatic extension of the time to progression which more than doubled in that population. So the data intriguing in one of the key difficulties that we have encountered in continuing in that vain is that with the adoption of long-term reduction therapy and maintenance therapy in the US. We have shifted the time to progression from the 9 months that we saw in that original study to multiple years and therefore that study would not be doable in the context of our current symphony arrangement.

Unidentified Analyst

Like I said plans if you would to take that forward?

Dino Dina

Right now, we don't have any plans to take that forward but we will be still looking at the potential for doing additional studies but those would have to be outside of the US.

Unidentified Analyst

Okay understandable. Maybe I have one for Deborah as well. Q4 your collaborative revenue wise, how much actually came in from AstraZeneca?

Deborah Smeltzer

We don't report by partners specifically but it was the minor component of that. The bulk of the revenue is going to come from the Merck collaboration findings.

Unidentified Analyst

So was that, I have amortization over five years, obviously it was shorter timeframe than that. What exactly was it?

Deborah Smeltzer

The early reports in our 10-K when it filed the revenue recognition rules that we will use for the Merck collaboration will go over the full life of the partnership which includes the manufacturing period. So in total we are anticipating that will be roughly 14 years. We will recognize the revenue for the partnership.

Unidentified Analyst

14 years, okay great. Thank you so much.

Deborah Smeltzer

Welcome.

Operator

We'll take our final question from Alan Leong with Biotech Stock Research.

Alan Leong

Hi Dino.

Dino Dina

Hi.

Alan Leong

I noticed, you had little discussed about the new drug, I guess it was SD-101 entering the clinic in phase I. Can you provide a little color about what it is for audience and maybe even the type of indications for which you might aim it at if it is successful in phase I?

Dino Dina

We haven't commented on that study. I will just say that, so that I can try to answer at least a piece of your question that we would bring healthy volunteers and that the main aim is to clear the way both for cancer and hep C.

Alan Leong

Okay, is the new drug covered under the composition of matter patent that you have mentioned?

Dino Dina

I believe that the composition of matter patent that I mentioned in the text was actually one covered in our chimeric molecules. But we do have applications that will cover the class C type of molecules when they issue. But since they haven't issued yet, we don't know what the ultimate scope of those is going to be.

Alan Leong

I appreciate it also that Deborah – and to show you hope to see well, I have some opportune time in near future.

Dino Dina

Thank you.

Deborah Smeltzer

Thank you.

Operator

Mr. Dino there appears to be no further questions at this time. I will turn the conference back over to you for any additional or closing remarks.

Dino Dina

Thank you. So, in `07 I think that there have been significant change in the culture of the company and a better definition of its business strategy driven to a large extent, but as a completion of the Merck deal which reminds you -- provide very significant sort of cash both short term, mid term and long-term. As a result of that we can now look forward to look at the development of some of our key programs in a product focused away and move forward on that business track, create an operating company. And only half incentive so far that the partner that you showed through the discussion, that number of opportunities, and actually very interesting scheme that we can apply to both TOLAMBAtm it should be successful and flu which we expect to be successful. So we – moving forward it was a primary focus on taking these a progress forward on our own, and then to find the appropriate commercialization partners value inflection point that would then have to reach to get flue valuation for those program. So, I would like to thank you for participating in the call today, and we look forward to updating you on our progress throughout the year. Thanks.

Operator

That concludes today’s conference call. We appreciate everybody’s participation. And have a good day.

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