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Executives

Cindy McGee - Vice President, IR and Alliance Management

Jack Lief - President and CEO

Craig Audet - Senior Vice President, Operations and Head, Global Regulatory Affairs

Robert Hoffman - Chief Financial Officer

Dominic Behan - Chief Scientific Officer

Bill Shanahan - Chief Medical Officer

Analysts

Cory Kasimov - JPMorgan

Lee Kalowski - Credit Suisse

Steve Byrne - Bank of America

Ted Tenthoff - Piper Jaffray

Thomas Wei - Jefferies

Alan Carr - Needham & Company

Marko Kozul - Leerink Swann

Jason Butler - JMP Securities

Arena Pharmaceuticals (ARNA) Q4 2012 Results Earnings Call March 4, 2013 8:30 AM ET

Operator

Good day, everyone, and welcome to Arena Pharmaceuticals’ fourth quarter and full year 2012 update. This call is being recorded. At this time, for opening remarks and introductions, I would like to turn the call over to Arena’s Vice President of Investor Relations and Alliance Management, Ms. Cindy McGee. Ms. McGee, please go ahead.

Cindy McGee

Welcome, and thank you for joining us. On today’s call we will provide a corporate update and review our fourth quarter and full year financial results. Prepared remarks will be provided by Jack Lief, our President and Chief Executive Officer; Craig Audet, our Senior Vice President of Operations and Head of Global Regulatory Affairs; and Robert Hoffman, our Chief Financial Officer. Dominic Behan, our Chief Scientific Officer; and Bill Shanahan, our Chief Medical Officer, are available to address your questions.

During this call, we will make forward-looking and other statements about our vision, views, goals, plans, expectations and future activities and events, including statements about BELVIQ and our drug candidates, including with regard to efficacy, safety, potential and future research and development; current and future collaborations; the regulatory process; commercialization; and other statements that are not historical facts. Such statements may include the words plan, will, expect, believe, may, could, would, or similar words.

You are cautioned to not place undue reliance on these forward-looking statements, which are only predictions and reflect the company’s beliefs, expectations, and assumptions based on currently available information and speak only as of the time they are made. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995.

Risks and uncertainties that could cause actual results to differ materially from those described in our forward-looking statements include the timing, results, uncertainty and cost of research and development; the regulatory process; manufacturing and commercialization; data and other information related to drug and drug candidates may not be as expected, favorable, or sufficient for further development or commercialization; activities and results related to our current collaborations, and our entry into additional collaborations; and other risks identified in our SEC reports. For a discussion of these and other factors, please refer to the Risk Factors in our SEC filings.

I will now turn the call over to Jack.

Jack Lief

Thanks, Cindy. 2012 was a great year for Arena, with the FDA approval of BELVIQ, our novel product for chronic weight management. While we are excited about this [announcement], we are not content to stop there. Our focus at Arena is to build on this success in 2013 and beyond, as we further our commitment to bring novel treatments to physicians and patients and greater value to our stockholders.

Our first step in building on this accomplishment is BELVIQ’s U.S. launch, which will be handled by Eisai. Arena and Eisai believe that BELVIQ will be the market-leading compound for chronic weight management. Eisai’s experience in building markets, gaining reimbursement coverage, and creating value for patients is compelling.

Specifically, regarding the upcoming launch, Eisai sales representatives have now been trained on BELVIQ’s safety and efficacy profile and are ready to go. Approximately 200 representatives are located strategically across the country in regions with high numbers of targeted physicians and patients.

In addition, Eisai has more than 50 specialists who are working with key insurance companies to expand reimbursement for BELVIQ and, after extensive research, Eisai has established a wholesale price for BELVIQ that they believe properly reflects the product’s unique value to patients. The wholesale acquisition cost is $199.50 for 60 10 mg tablets, which equates to $6.65 per day. The actual cost to patients will depend upon various factors, including their insurance coverage.

Words cannot convey how excited we are that BELVIQ will soon be available to patients in the United States. It’s a time of great pride at Arena, with BELVIQ representing the first of what we expect will be many novel treatments resulting from our validated research and development approach.

On today’s call, Craig will provide updates on additional BELVIQ efforts, and Robert will review our financials. After this, I will outline plans to advance our pipeline of novel drug candidates and review our upcoming milestones.

Craig?

Craig Audet

Thanks, Jack. As Jack mentioned, we’re working with Eisai to prepare for the U.S. launch of BELVIQ, which will follow the completion of DEA scheduling. Late in 2012, the DEA proposed that BELVIQ be placed in Schedule IV of the Controlled Substances Act, and the 30-day public comment period was completed mid-January. Once the scheduling designation is effective, BELVIQ will be available by prescription in retail pharmacies throughout the United States.

With regard to our [post-marketing] requirements, the three protocols required by the FDA this year related to to cardiovascular outcomes trial and the pediatrics studies have been submitted for comment. We plan to provide additional details on the design of these studies once these protocols have been finalized with the FDA.

Beyond the United States, we are progressing with additional marketing applications. With respect to the European Union, we are nearing the end of the MAA review process. In January, we received the CHMP’s Day 180 list of outstanding issues. I’m pleased to report that we have submitted our response to the outstanding issues, and now look forward to working with the CHMP and their experts as we advance through the remainder of this process. We continue to expect a decision on our E.U. application in the first half of this year.

With respect to Switzerland, Swiss Medic recently provided their initial assessment regarding our BELVIQ MAA in the form of a list of questions, which include major objections that are similar to those identified with our European application. We are in the process of preparing a response to those questions.

In addition to our efforts to obtain marketing approval in the E.U. and Switzerland, we are assisting Eisai with the BELVIQ applications that are planned for this year in Mexico, Canada, and Brazil. Likewise, we are helping Ildong with their planned submission in South Korea. We will keep you updated on these applications as they progress.

We look forward to the opportunity to bring this important treatment option to physicians and patients in the U.S. through our collaboration with Eisai. Further to that, the global obesity pandemic and the lack of new medicines to address it is a strong impetus for us to do the same in other parts of the world.

Robert will now provide you with a financial update.

Robert Hoffman

Thanks, Craig. I will focus my comments on highlights of financial performance for the fiscal year ended December 31, 2012, compared to the full year ended December 31, 2011. I also refer you to today’s financial news results earnings release, as well as the 10-K we filed on Friday.

For the following financial results, 2012 will refer to the full year ended December 31, 2012 and 2011 will refer to the full year ended December 31, 2011. We recorded revenues of $27.6 million for 2012, compared to revenues of $12.7 million for 2011. 2012 revenues included a $20 million milestone payment from Eisai for the inclusion of the BLOOM-DM data in the FDA-approved prescribing information for BELVIQ.

Research and development expense for 2012 decreased to $54.1 million from $58.7 million for 2011. R&D expenses for 2012 included $1.8 million in noncash share-based compensation expense, compared to $1.9 million for 2011.

General and administrative expenses totaled $26.2 million for 2012 compared to $24.2 million for 2011. G&A expenses for 2012 included $3.2 million in noncash share-based compensation expense, compared to $1.7 million for 2011.

We recorded interest expense of $9.1 million for 2012, compared to $14.3 million for 2011. This $5.2 million decrease is primarily attributable to reductions of the principal on our note payable to Deerfield. In May 2012, we repaid the remaining balance on this note. We recorded a noncash loss on extinguishment of debt of $6.3 million in 2012 related to the principal repayments on our note payable to Deerfield.

We also recorded a noncash loss of $13.4 million in 2012, primarily related to the revaluation of common stock warrants that are classified derivative liabilities. This loss is primarily due to the increase in our stock price over 2012.

Our net loss [electable] to common stockholders decreased to $88.3 million for 2012, compared to $111.5 million for 2011. Cash and cash equivalents totaled $156.1 million at December 31, 2012, compared to $57.6 million at December 31, 2011.

Cash and cash equivalents at December 31, 2012 did not include a nonrefundable up-front payment of $5 million less 5% withholding taxes which were received in January 2013 that was due in connection with entering into the BELVIQ agreement with Ildong.

At December 31, 2012, we had approximately 217.5 million common shares outstanding, warrants to purchase 3.4 million shares of our common stock with an average exercise price of $6.23 per share, stock options to purchase 13.8 million shares of common stock at an average exercise price of $4.44 per share, and restricted stock unit awards of 165,000 shares of common stock. None of Deerfield’s former warrants to purchase shares of our common stock remained outstanding as of December 31, 2012.

The total cost to operate our Swiss manufacturing facility is currently about $15 million. Of this, we expect the cost of manufacturing BELVIQ to be approximately $12 million annually. These costs will, in general, be capitalized in inventory and will be expensed to cost of goods sold as product sales of BELVIQ occur, appropriately matching revenue with expenses.

Prior to FDA approval on June 27, 2012, we had on hand [APIs] of nearly half a billion tablets of BELVIQ and the cost to purchase this API had been expensed as a period cots to R&D expenses when purchased. Any purchase of API after FDA approval will be capitalized into inventory and such costs would be in addition to the current $12 million annual run rate.

With regard to 2013 guidance, in addition to revenue from BELVIQ sales, we expect to record revenues of $65 million in milestone payments from Eisai following the DEA’s final scheduling of BELVIQ, approximately $6 million from amortization of up-front payments from existing collaborations, and approximately $3 million from manufacturing services revenue from Siegfried. We also expect to receive a $500,000 milestone payment for each regulatory submission in Mexico, Canada, and Brazil under our expanded Eisai agreement.

We expect full year 2013 R&D expenses of approximately $70-78 million, including noncash expenses that total approximately $7 million. This guidance includes the advancement of our programs and our share of the expenses related to to cardiovascular outcomes trial in pediatric studies.

We expect full year 2013 G&A expense of approximately $28 million to $34 million, including noncash expenses of approximately $6 million. We will continue to monitor our overall spend, and will adjust as appropriate based upon factors such as timing of DEA scheduling and sales of BELVIQ.

With our current level of cash, upcoming milestone payments including the $65 million following the final DEA scheduling, and cash flows from the sales of BELVIQ, we continue to believe we are well-financed, and have no plans to raise additional cash through the sale of equities.

I’ll now turn the call back over to Jack.

Jack Lief

Thanks, Robert. In addition to BELVIQ’s activities, we’re also advancing our pipeline of internally discovered drug candidates. In regard to APD811, in October we initiated a multiple ascending dose Phase I clinical trial. This compound is an orally available agonist of the prostacyclin receptor and intended for the treatment of pulmonary arterial hypertension, or PAH.

PAH is a progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure strains the heart, which can limit physical activity, result in heart failure, and reduce life expectancy. There is an estimated five-year survival rate of 57% from diagnosis.

The ongoing Phase I trial is intended to evaluate safety, tolerability, and pharmacokinetics, and optimal titration schedule of multiple ascending oral doses of APD811. We now have interim data, and are pleased to report that we continue to believe in the potential of this program.

The adverse event profile to date is similar to that observed in the completed single ascending dose trial. The most common events were consistent with the expected pharmacology of the compound. Next month we plan to initiate an additional cohort in the Phase I program to optimize the dosing regimen prior to potentially initiating a Phase II clinical trial.

In addition to our work in PAH, we are researching and developing S1P1 receptor agonists as potential oral treatments for a number of conditions related to autoimmune diseases, including multiple sclerosis, psoriasis, and rheumatoid arthritis. We plan to initiate a Phase I clinical trial of our lead compound, APD334, in the next few months.

We’ve also recently entered into a codevelopment and license agreement with Ildong for Temanogrel. Temanogrel is our internally discovered inverse agonist of the serotonin 2A receptor intended for the treatment of thrombotic diseases. Under this agreement, Ildong will fund and conduct the next two planned clinical trials in this program, an additional Phase I trial in healthy volunteers, and a Phase IIA proof of concept trial in patients. This collaboration with Ildong enables us to further Temanogrel’s development while conserving internal resources.

Here at Arena, we are energized every day by the opportunity to deliver new, best-in-class treatments to physicians and patients. BELVIQ is the first product resulting from our vision to discover novel medicines that selectively target GPCRs. Much like 2012, this is a year of significant opportunity.

Our milestones include the upcoming U.S. launch of BELVIQ, decisions on BELVIQ applications for approval in the European Union and Switzerland, updates on BELVIQ submission Mexico, Canada, Brazil, and South Korea, updates on our BELVIQ, APD811, APD334, and Temanogrel development plans, and the potential for additional collaborations for BELVIQ and other drug candidates in our pipeline.

We thank you for your support of our efforts, and look forward to keeping you informed on our progress. We will now open the call for questions. Operator?

Question-and-Answer Session

Operator

[Operator instructions.] Our final question comes from Cory Kasimov of JPMorgan. Please go ahead.

Cory Kasimov - JPMorgan

I wanted to follow up on the pricing of BELVIQ. I’m curious on any potential additional detail you can possibly provide on the rationale that went into it, whether or not this was based off of discussions with payers. It certainly seems like, from what we’ve seen so far, with Qsymia’s launch, that this is a very price-sensitive market, at least until reimbursement gets more ramped up than what it is today. So I’m wondering if you believe that’s not the case, or if you have an idea from payers that reimbursement is going to ramp up faster for BELVIQ than it has so far for Qsymia, or if there’s something else there that you can comment on.

Jack Lief

Combination of things to address your question. The first is obviously Eisai has done extensive market research on the pricing, both with patients as well as payers. Eisai has more than 50 specialists who are working key insurance companies to expand reimbursement for BELVIQ. And we believe that the price properly reflects the product’s unique value to patients.

The actual cost to patients will depend upon various factors, including insurance reimbursement coverage. And of course when you launch into a self-pay market, Eisai has said that they’re going to have the appropriate coupons and other rebates in place to allow patients to use this compound. So we’re really excited about the price, as well as the opportunity to bring this really new agent, a new way of looking at weight management, to the market.

Cory Kasimov - JPMorgan

And Jack, a quick follow up for you or Craig. Any comments you can give us on updated plans for combination studies for BELVIQ? I guess in particular I’m interested in what you’re thinking of with phentramine?

Craig Audet

We’re still in the process of finalizing our development program with Eisai for combination. We’ve drafted our meeting request for the agency. So we’re getting there. Our main focus right now is trying to get BELVIQ launched in the U.S. So that’s really what we’re looking at right now in terms of the milestones we need to get past. But we continue to work on the combination as well.

Operator

Our next question comes from Lee Kalowski of Crédit Suisse. Please go ahead.

Lee Kalowski - Crédit Suisse

One question on R&D. For the guidance for 2013, does that assume some expenses for the CVOT? Can you say if the trial budget with Eisai has been approved? Does that assume some expenses for that in the year? And as we look at the increase, is that something, as we move from 2012 to 2013, that we think is going to be steady, or more back end loaded? Anything you can say about that?

Robert Hoffman

The budget hasn’t been approved by Eisai at this point in time. Having said that, we have included some expenses in there. Recall, Eisai pays for 90% of that. We pay for 10% of that. As Jack had mentioned, we do have a pretty promising pipeline moving forward as well, although the expenses are included in there. So it just depends on how our pipeline performs in terms of what’s spent going forward. But for 2013, it includes not only that, it includes life cycle management for BELVIQ, our pipeline, as well as the COVT and pediatric studies.

Lee Kalowski - Crédit Suisse

And just as far as where things stand in Europe, can you say, have you gone through an oral hearing? Is that something that is going to happen down the road? Or is that something that’s already happened? And as far as the list of 180-day questions, prior to that, had you given the CHMP essentially all of the same information that you had given FDA as part of their review process?

Craig Audet

We have not been to an oral explanation. We have been invited to one, though. But it is still proposed at this time. The day has not been set, and it’s not definite that that will happen or not. So we have to wait until the CHMP has done a little bit more of an assessment, and then they’ll let us know whether they want us to come and speak to them.

In terms of the 180 day, we have given the CHMP the same information that we’ve given to the FDA, so they have the same information in order to make their determination in terms of safety and efficacy.

Operator

Our next question comes from Steve Byrne of Bank of America. Please go ahead.

Steve Byrne - Bank of America

Will there be a 30-day waiting period after the DEA scheduling has been finalized? Or has that been waived?

Craig Audet

Eisai has requested that the DEA waive that period. They have not heard back yet. The DEA will assess that when they assess all the other comments and questions that they received through the public hearing process.

Steve Byrne - Bank of America

And Robert, just another question on your R&D guidance. Is there any assumption of a combo study in that guidance to start up before year-end?

Robert Hoffman

There is some expenditure in there for life cycle management, which would include a combination or other indications, yeah.

Steve Byrne - Bank of America

And another one for you, Robert, on taxes. You have a 10-year holiday in Switzerland. I assume that’s from [the cantin]. And you have NOLs from Switzerland. Which of those two are more meaningful to you?

Robert Hoffman

The tax holiday.

Steve Byrne - Bank of America

And then relative to the NOLs in the U.S., which jurisdiction do you think you’re more likely to have cash taxes in the foreseeable future? In Switzerland or the U.S.?

Robert Hoffman

We’re going to do a lot of work around our tax situation over the current year. Our NOL in the U.S. is over $600 million, and for the state it’s over $700 million. So we certainly have a lot of NOLs to go through, but having said that, we’ll wait and see how all the work we have goes through. We also have to do some 382/383 studies, as well as some transfer pricing studies. So stay tuned.

Steve Byrne - Bank of America

And any risk on that 382 level of erosion on your NOLs?

Robert Hoffman

It’s always possible. Our stock trades a lot, and so it has to do with some ownership changes. Again, we’ll work through it, and we’ll let you know as soon as we know. But having said that, it is also based upon market cap, and so if we did have an ownership change now, the impact would be less burdensome.

Operator

Our next question comes from Ted Tenthoff of Piper Jaffray. Please go ahead.

Ted Tenthoff - Piper Jaffray

Just picking up on the questions on DEA scheduling, with the 30-day comment period and with Eisai requesting to waive the 30-day waiting period, what specifically, just so that we discuss it out in the open, do they still have to do, and what is the process remaining between now and launch, so that we can understand that?

Craig Audet

Eisai doesn’t have to do anything. It’s all up to the DEA right now. So the way this works is that after the close of the public comment period in January, the DEA then has to go through each of the comments they receive and respond to those, not directly, but they’ll respond to them in their final register notice when they put the final scheduling in. And they even said, in their own words, that they received quite a few comments comparatively.

So they’re in the process of going through those comments now. They have to also take into consideration Eisai’s request to waive that final 30 days. What’s left is they will finish their review of the comments. They will determine the final scheduling. They will post that in the Federal Register, and then that’s when that 30-day limitation period either kicks in or doesn’t kick in depending on how they deal with Eisai’s request.

Ted Tenthoff - Piper Jaffray

I know in public forums you’ve been discussing some of the preparation that Eisai’s been doing, both in terms of sales force, but also on the reimbursement front. And you’ve discussed the supply that you have. Can you give us any sense in terms of preparation around marketing and just sort of what the overall message is going to be for BELVIQ as you and Eisai get ready to launch the product?

Jack Lief

Well, for competitive reasons, as you can imagine, we don’t want to get too specific in terms of the messaging that we’re addressing. I think our label, basically, as an adjunct to diet and exercise, for chronic weight management, addresses the major need of patients and physicians as far as managing their weight. And we certainly expect that that’s going to be well communicated from a variety of different perspectives.

Operator

Our next question comes from Thomas Wei of Jeffries. Please go ahead.

Thomas Wei - Jefferies

On the combination development strategy, I know you’ve talked before in the past about proposing to the FDA something that would be significantly fewer patients than the original BELVIQ approval package. Is that still the plan in this proposal that you’re drafting for the agency right now?

Craig Audet

Yes, that is still our plan.

Thomas Wei - Jefferies

And is it fair to say that given the fact that you’ve put in the design for the cardiovascular outcomes study already, that that does not include combination BELVIQ and phentramine? Or is there some way that the CVOT allows you to study that as well?

Craig Audet

We’re still waiting for FDA to give us their final comments on the CVOT, so we’re not at liberty to discuss that. I’m sure you can understand, considering the fact that the agency is still looking at that.

Thomas Wei - Jefferies

And then on the work to determine what should be done for the combination strategy, are you the party who is solely responsible for determining that and negotiating that with the agency? What is Eisai’s involvement in combination strategy?

Craig Audet

Well, we certainly want to do it in partnership with Eisai. Although, contractually, we have the final say on all BELVIQ development, we see that as a partnership with them moving forward. So we’re working with them very closely to make sure that both sides are aligned. And when we go to the FDA, they will come with us.

Thomas Wei - Jefferies

And then just the last question, on these coupons or rebates, or eventually copay assistance programs for those patients who have reimbursement, could you just confirm for us that, in the contract with you and Eisai, that’s part of the growth to net adjustment on revenue? Or does Eisai book those costs separately as part of their own cost of goods sold or SG&A? I guess I’m just curious, what are you actually getting your sales royalty on?

Jack Lief

We won’t get it on the sample, but having said that, we’ll get cost of goods on the sample.

Thomas Wei - Jefferies

But if Eisai were to give a coupon for those patients who need some financial assistance to pay for BELVIQ, you’re paid on the net revenue?

Robert Hoffman

Yeah, so that will get deducted and then we’ll add back whatever cost it is, and then we’ll get reimbursed for that. So it will get deducted, but then we’ll turn around and we’ll invoice them for the cost of that sample.

Jack Lief

So just to clarify, whatever discounting Eisai does have will be deducted from their gross price, and becomes net price. We receive between 31.5% and 36.5% of that number.

Operator

Our next question comes from Alan Carr of Needham & Company. Please go ahead.

Alan Carr - Needham & Company

Can you give us an update on your design for the CVOT trial and timing there? And then could 371 move into the clinic this year?

Craig Audet

I’ll give you the update on the CVOT. As I just mentioned, the FDA is in the process of reviewing that. We have to have a final protocol with them by the end of March. So we’re in the final throes of those negotiations. So it’s a little premature for us to discuss publicly what the final design of that will look like.

Alan Carr - Needham & Company

Can you give us a sense of a perspective on scale and that sort of thing, whether there’s been any changes from when you were approved, and your commentary on it back then?

Craig Audet

No, no changes.

Jack Lief

And you had a question about 371?

Alan Carr - Needham & Company

Yeah, might that one move into the clinic this year?

Bill Shanahan - Chief Medical Officer

371 is still in the preclinical stage, but we hope to perhaps file an IND by the end of the year. But we’re still looking at that.

Jack Lief

Just as background, that’s our CB2 pain compound, and that’s potentially also very exciting, but because it’s not at IND stage yet, it wasn’t included in my prepared remarks. But we’re still excited about that too.

Operator

Our next question comes from Marko Kozul of Leerink Swann. Please go ahead.

Marko Kozul - Leerink Swann

I wanted to ask a follow up to earlier BELVIQ combination questions. Does your current draft include a Phase I combination dose finding trial? Or do you think you can move straight into a Phase II study? And what might that look like?

Craig Audet

A little premature to talk about that design as well, since we’re in the final discussions with Eisai on the development program design. And then we still need to go to the agency and get their feedback as well. So it would be premature for me to tell you anything, because it’s subject to change at this point.

Marko Kozul - Leerink Swann

I appreciate that. Eisai, on its recent third quarter [ECS] call, suggested it would engage in meaningful sampling. I was wondering if you could help us understand what that might mean.

Jack Lief

Well, given that launch is pretty soon, I think we’ll just have to wait and see how meaningful that might be. But they’re committed to ensuring that patients have access to therapies, so we’re excited about that.

Marko Kozul - Leerink Swann

Just a quick last one here, Eisai’s 50 reimbursement specialists and three healthcare economists, have they already started working? Or are you waiting for final approval before they get working on negotiating reimbursements?

Jack Lief

No, they’ve been working on this, and there’s a lot of progress being made, but we’ll see how that all works out once we launch the drug.

Operator

Our next question comes from Jason Butler of JMP Securities. Please go ahead.

Jason Butler - JMP Securities

Just wanted to follow up on the European approval process. Since you got the 180-day LOI, have you reached out or had any interaction with your rappoteurs or advice from scientific experts in Europe?

Craig Audet

Yes, we’ve had some discussions with the co-rapporteur regarding the questions and the strategy for responding to those questions.

Jason Butler - JMP Securities

And is there any insight you can give us there in terms of the issues that you outlined previously that EMA is still looking to address?

Craig Audet

It’s hard to talk about that. We’re in the midst of this assessment with the CHMP. So really, we’re going to have to wait until that comes to a conclusion.

Operator

I’m showing no further questions at this time, and would like to turn the conference back over to Ms. Cindy McGee for any closing remarks.

Cindy McGee

Great, thank you. Thanks to everybody for joining us today. We are planning to present at a number of upcoming investor conferences, and also medical meetings, so we look forward to seeing many of you there. Thanks for joining us.

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