Vanda Pharmaceuticals' (VNDA) CEO Mihael Polymeropoulos on Q4 2015 Results - Earnings Call Transcript

| About: Vanda Pharmaceuticals (VNDA)

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA)

Q4 2015 Earnings Conference Call

February 10, 2016 4:30 PM ET

Executives

Jim Kelly - SVP and CFO

Mihael Polymeropoulos - President and CEO

Analysts

Jason Butler - JMP securities

Josh Schimmer - Piper Jaffray

Difei Yang - Brean Capital

Stefan Quenneville - Morningstar

Operator

Welcome to the Q4 2015 Vanda Pharmaceuticals Earnings Conference Call. My name is Anna, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded.

I will now turn the call over to Jim Kelly, Vanda’s Senior Vice President and Chief Financial Officer. Mr. Kelly. Please go ahead.

Jim Kelly

Thank you, Anna. Good afternoon and thank you for joining us to discuss Vanda Pharmaceuticals' fourth quarter and full year 2015 performance. Our fourth quarter and full year 2015 results were released this afternoon and are available on the SEC EDGAR system and on our website, www.vandapharma.com. In addition, we’re providing live and archived versions of this conference call on our website.

Joining me on today’s call is Dr. Mihael Polymeropoulos, our President and CEO. Following my introductory remarks, Dr. Polymeropoulos will update you on our ongoing activities. Then I will comment on our financial results before opening the lines for your questions.

Before we proceed, I’d like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These risks are described in the risk factors and Management Discussion &Analysis of financial condition and results of operations sections of our annual report on Form 10-K for the fiscal year ended December 31, 2014 and on our subsequently filed quarterly reports on Form 10-Q, which are available on the SEC EDGAR system and on our website. We encourage all investors to read these reports and our other SEC filings.

The information we provide on this call is provided only as of today and we are under no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events or otherwise except as required by law.

With that said, I would like to now turn the call over to our CEO, Dr. Mihael Polymeropoulos.

Mihael Polymeropoulos

Thank you, Jim. Good afternoon, everyone. And thank you very much for joining us. In the fourth quarter, we experienced strong revenue growth leading to full year 2015 total non-GAAP net revenue of $109.9 million which was consistent with the upper end of our earlier financial guidance. HETLIOZ revenue grew by 30% as compared to the prior quarter to $15.1 million. The majority of new patient demand was generated from our opt-in database which is continuing to grow primarily through our effective DTC campaign.

More than 17,000 individuals have opted in to date, the majority of which are self identified likely patients. We believe the fundamentals of our HETLIOZ business are strong and have provided net product sales guidance for 2016 of between $73 million and $78 million as compared to $44.3 million recorded in 2015. In the European Union, we are currently focusing our efforts on pricing and reimbursement activities with HETLIOZ in key countries as well as beginning systematic efforts to increase non-24 awareness. Our immediate goal is to prepare for HETLIOZ launch in Germany in the third quarter of 2016.

Fanapt was again a significant revenue contributor for Q4 with $16.7 million which is in line with a similar result in Q3. In late Q4, we completed the launch of a 50% Fanapt dedicated sales force which is promoting Fanapt primarily to psychiatrists across the US. Our goal is to stabilize the unit demand for Fanapt with this effort. We are currently in various stages of litigation on our expanded Fanapt patent portfolio against the number of Paragraph IV genetic manufacturers.

A four-day trial against Roxane, the generic manufacture on patents 198 and 610 is scheduled to begin on February 29. In December of 2015, the FDA accepted for review our sNDA supplemental new drug application for Fanapt for the maintenance treatment of schizophrenia. An FDA PDUFA date has been set for May 2016. Additionally, we have submitted an application for the approval of iloperidone for the treatment of schizophrenia in the EU and that review is ongoing. We expect to have receive some superior opinion by yearend regarding this regulatory filing.

Beyond our commercialized products we are also progressing on our clinical pipeline. On HETLIOZ, we are making progress on our programs including the following. Smith-Magenis Syndrome. An observational study has been completed and then open label interventional study is underway. We expect to initiate a Phase III in the second half of 2016. Jet Lag Syndrome. An observational study was conducted in the fourth quarter of 2015 and the data are presently been analyzed. Pending results from this observational study we expect to initiate the Phase III study in the second half of 2016.

Pediatric non-24. Pharmacokinetic study and subsequent efficacy study are expected to begin in the first and second half of 2016 respectively. On Tradipitant, our neurokinin receptor antagonist we conducted a pharmacokinetic study that has been now completed and analysis is ongoing. We've also initiated a Phase II proof of concept study in chronic pruritus, results of which are expected in the first half of 2017. On Trichostatin A, an HDAC inhibitor, we plan to file an IND application for various oncology indications in 2016.

Finally, on AQW051, our alpha7 nicotinic agonist, we continue to evaluate some potential clinical development test.

I'll now turn the call to Jim.

Jim Kelly

Thank you, Mihael. You will see in our press release that Vanda is offering non-GAAP financial information. We do so because we believe the non-GAAP information can enhance the overall understanding of our financial performance when considered with GAAP figures. When describing the fourth quarter and full year 2015 financial results I'll be making comparisons to 2014. As a reminder the Vanda fourth quarter and full year 2014 financial statements reflect the impact of the settlement agreement with Novartis announced on December 22, 2014. Vanda recorded $77.6 million gain on arbitration settlement during the fourth quarter of 2014. For this reason, I will focus my commentary on the non-GAAP results.

Vanda Non-GAAP net loss excludes Fanapt licensing agreement revenue stock based compensation, intangible asset amortization and the gain on arbitration settlement. On a Non-GAAP basis during the full year 2015, Vanda recorded a Non-GAAP net loss of $18.9 million as compared to a Non-GAAP net loss of $80 million for the full year of 2014. During the fourth quarter of 2015 Vanda recorded a Non-GAAP net loss of $10 million compared to a Non-GAAP net loss of $13.5 million in the same period in 2014.

Vanda Non-GAAP total revenues exclude Fanapt licensing agreement revenue, Non-GAAP total revenue adjustments are specific to 2014, and for 2015 GAAP and Non-GAAP total revenues are the same. Non-GAAP total revenues for the full year 2015 were $109.9 million compared to $19.4 million during the prior year. This result was consistent with Vanda's full year 2015 total revenue guidance of between $100 million and $115 million. Non-GAAP total revenue for the fourth quarter of 2015 was $31.8 million, a 12% increase compared to $28.3 million in the third quarter of 2015 and 319% increase compared to $7.6 million in the fourth quarter of 2014. This is a result of significant growth in the year to date sales of HETLIOZ in the US and the acquisition of the Fanapt product right at the end of 2014.

HETLIOZ net product sales grew to $44.3 million for the full year 2015, a 246% increase compared to $12.8 million in 2014. HETLIOZ net product sales grew to $15.1 million in the fourth quarter of 2015, a 30% increase compared to $11.7 million in the third quarter of 2015 and 152% increase compared to $6 million in the fourth quarter of 2014. As of December 31, 2015 the specially pharmacy channel held less than two weeks of inventory as calculated based on growing demand, we did see a return to normal stocking levels in the fourth quarter of 2015 as compared to the prior quarter.

Fanapt sales of $65.6 million for the full year of 2015 compares to $65 million in 2014 as reported by Novartis. Fanapt net product sales of $16.7 million in the fourth quarter of 2015 compares to $16.7 million for the third quarter of 2015.

On a Non-GAAP basis, for the full year of 2015, Vanda recorded Non-GAAP operating expenses, which exclude cost of goods sold, stock-based compensation and intangible asset amortization of $105.7 million compared to $98 million in 2014. This result was consistent with Vanda's full year 2015 guidance for Non-GAAP operating expenses of between $100 million and $110 million.

On a Non-GAAP basis for the fourth quarter of 2015, Vanda recorded Non-GAAP operating expenses of $35.7 million compared to $26.4 million in the third quarter of 2015 and $20.4 million in the fourth quarter of 2014. The $9.4 million sequential quarter increase in Non-GAAP operating expenses was driven by an increase in commercial activities which included the fourth quarter 2015 HETLIOZ US Non-24 awareness campaign. The HETLIOZ EU launch preparations and the expansion of the US field force from 12 to 50 representatives.

Vanda’s cash, cash equivalents and marketable securities as refer to as cash as of December 31, 2015 were $143.2 million, compared to $144.3 million as of September 30, 2015. Full year 2015 increase to cash of $13.4 million benefited from the receipt of Fanapt royalty payment and the timing of payments for the Fanapt gross-to-net liabilities. We expect approximately $10 million of the benefit related to gross Fanapt liabilities to reverse over the course of 2016 and 2017.

Vanda expects to achieve the following financial objectives for 2016. Net product sales from both HETLIOZ and Fanapt of between $143 million and $153 million. HETLIOZ net product sales of between $73 million and $78 million. Fanapt net product sales of between $70 million and $75 million.

Non-GAAP operating expenses excluding cost to good sold of between $125 million and $135 million. The primary drivers of the expected increase over the prior year are investment in the US Fanapt and European HETLIOZ commercial businesses. Non-GAAP operating expenses also excluded intangible asset amortization expense of $10.9 million and stock based compensation of between $9 million and $11 million. Year end 2016 cash is expected to be between $123 million and $143 million.

I'll now turn the call back to Mihael.

Mihael Polymeropoulos

Thank you, Jim. At this time, we lock in up to line for questions. We will be happy to answer any questions you may have.

Question-and-Answer Session

Operator

[Operator Instructions]

And we have a question from Jason Butler from JMP securities. Please go ahead.

Jason Butler

Hi. Thanks for taking my questions. Just first one on the HETLIOZ guidance. Can you just give us any color on whether your guidance includes any expected price increases in 2016?

Mihael Polymeropoulos

Thank you very much, Jason. The guidance does not include any price increases. So the guidance and the growth implied is unit growth only.

Jason Butler

Okay, great, helpful. And then given that you now have several quarters of experience of HETLIOZ in the marketplace. Do you think you have a good working understanding of the appropriate level of investment in the commercial effort and ultimately do you think you now have handle on what level of revenue it will take to get to profitability for the franchise?

Mihael Polymeropoulos

Certainly. I want to point out that while we are now about seven quarters in the launch, it is still a launch period and we are learning a lot. A few key lessons are here is that DTC continues to be very effective and continues to drive the input to our new patient demand generation. As I said earlier in our script, 17,000 individuals have now opted in from the beginning of this campaign in the last seven quarters or so. This of course is generated by -- are systematic now national DTC campaign. And I would say that the levels of investment into DTC campaign have settled. And what you have seen as a general spend in Q4 it is more likely to continue going forward. We are also evaluating continuously ways that we can improve efficiency of generating new patient demand. And that means looking very carefully in our data of the 17,000 individuals, the majority of which are self identified likely patient and trying to understand ways that we can improve both the percent of conversion to treated patients, but also the time to conversion. Other areas that we seek to improve efficiency and our recent work in Q4 suggests that we are improving significantly are the time and percentage of dispensing after an intake or the script has been received. We've talked in the past that on average about half the script received are completed and dispensed is about 12 week. And while this maybe an okay number in general for orphan drugs, we believe we can do better and we have in turn initiatives now towards that in the early result suggest that we can improve those metrics. So in summary we believe we are investing well in the Fanapt launch now. We can certainly improve processes but we do not believe that any additional investment that we need are going to be far outside of what we are doing today.

Jason Butler

Great. That's really helpful. And I just have two real quick questions. One, does your earlier guidance include any sales in Europe? And then two in the opt-in program how many patients do you have in there or family members of pediatric patients do you think you have identified?

Mihael Polymeropoulos

On the first question the guidance for HETLIOZ, the $73 million $78 million does not breakout US and Europe. It is a global number. However, just to point out the European number will be miniscule this year. The expectation is we are launching in Q3 in Germany and we are going to expect of course very few patients, I mean on treatment and contributing on revenue. Your next question was in the opt-in database how many of these opt-ins could likely be parents of kids with below the age of 18. We do not know this answer but we do know that about 30% or so of the opt-ins in the database have identified themselves as friends and family. But we do not know the age breakdown. Now in the course of our pediatric non-24 program. We intend to have a specific registry where we will develop a database of parents alongside their children under the age of 18 that would be interested in the clinical program. And that will form the nucleus of the potential pediatric Non-24 registry for the future.

Operator

Our next question is from Josh Schimmer from Piper Jaffray. Please go ahead.

Josh Schimmer

Thanks for taking the questions. First maybe you can help us understand what you are looking for in the observational study in Jet Lag and Smith-Magenis Syndrome that will inform further development.

Mihael Polymeropoulos

Yes. I'll start off with a Smith-Magenis Syndrome. Just for a background Smith-Magenis Syndrome is a rare genetic disorder due to chromosomal deletion on human chromosome 17. One of the cardinal features of the disorder which is alongside other developmental and skeletal deficit that these individuals may have is a significant aberration of sleep-wake cycle which has been described in the literature but not in a way that one can conduct controlled clinical studies on. So what we are looking in the observational study is to one, better characterize the sleep deficit in a way that can be translated in an end point, understanding both the biomarkers underlying the deficit but also the measurement of the deficit in a controlled manner that will inform discussion with regulatory agencies leading to the end point of the study. So it is both characterizing the disorder but also optimizing the end point. On the Jet Lag study, observational study goals are again very similar. One is characterize what is it the measurable effect of transatlantic flight that move patient into range of five to eight time zones and characterize that especially on their sleep week cycle with objective and subjective parameters. And second better understand potential end point. And what are interesting here in the Jet Lag as well there are a lot more knowledge and the literature about the effect of Jet Lag on people's sleep and wake cycle in contrast to Smith-Magenis Syndrome. We are identifying quite a few interesting new phenomenons that have not been fully described in the literature. And that actually will create interesting opportunities to optimize the protocol and inform our discussions with regulatory authorities.

Josh Schimmer

Got it. What ultimately how should we be thinking about operating margin after once you have a few years to execute on the HETLIOZ launch and you also pass through some of the royalty obligation on Fanapt?

Mihael Polymeropoulos

I am not sure I heard well the first part of your question. You said operating something I didn't hear it.

Josh Schimmer

Margins

Mihael Polymeropoulos

Operating margins, okay. So the question is our outlook for operating margins on HETLIOZ and then Fanapt in the future. I will start with Fanapt; pass on to Jim to talk about HETLIOZ. On Fanapt just the clarity on the royalty. Today's royalty obligation combined to two entities that receive this royalty is 23% of net. That royalty is due at this level up until the expiration of NCE patent which expires in November of this year 2016. After that and based on the new agreement we reported with Sanofi, the royalty will go effectively to 9% for the following three years. And then it will go to 6%. Jim on HETLIOZ?

Jim Kelly

Sure. So and just to confirm here Josh what I believe you are asking is as we reach cash flow positive and net income positive just what might our operating margins looks like or net income as a percent of revenue, is that correct?

Josh Schimmer

Correct.

Jim Kelly

Right, fantastic. So I think Mihael did a nice job talking about how our gross margins going to improve. I mean right now our gross margins looking at about 18% to 20% and when you factor in some of these favorable adjustments to Fanapt that's going to decrease from 18% to 20% to the 11% to 13% rate. So I mean that's a spectacular improvement I think in sort of our gross margin. Then as we move forward of course I think the key feedback we are giving to all is that we expect to be a cash flow positive company. We expect to deliver earnings, the EBITDA positive. That's our expectation. And so while we do not show that in our guidance for 2016, it's certainly our expectation as we move beyond that point to reach that at some point. All right. So one of the key components we can talk about today. I think the first one is we've got a fairly matured SG&A cost structure for our US business for both HETLIOZ and for Fanapt. In the fourth quarter we brought online our full 50 for Fanapt and we are seven quarters in the launch of HETLIOZ. So what we are looking for in the US now is to create operating leverage to drive revenue with the OpEx in a manner consistent with what you see generally consistent with what you see in the fourth quarter. So that's an important first piece of the puzzle. As you look at the increases over time you will see that as we continue to launch HETLIOZ in Europe you will see some additional SG&A come online. And so we'll talk you about that as we seek to launch in those different market. The last piece of the puzzle therefore becomes R&D. I can speak for now for 2016. Our expectation of R&D is going to be approximately flat year-over-year. So I know I am not giving you a specific profile for the out year, hopefully that gives some of the building blocks.

Josh Schimmer

Got it. Very helpful. And then sorry, did you have remark on that discussion --

Mihael Polymeropoulos

No, that's it.

Josh Schimmer

Okay, great. Just one last question. Have you begun discussions with countries in Europe regarding HETLIOZ reimbursement rate? And if so what kind of ballpark do you expect that will be in?

Mihael Polymeropoulos

Well, we've begun our activities towards reimbursement, the first emphasis is in Germany and just to remind there are several processes and cycles you go through. Our expectation is that with our launch in Q3 we will have approximately a full year of pre-pricing that we set and during that year there will be negotiation of the price that actually we will be reimbursed at. That is -- that will be very important milestone. And getting set the tone for other countries as well. Although discussions with other countries will proceed in an independent manner. For example soon in parallel with Germany negotiations we expect to be involved in reimbursement activities in France and potentially Italy. And with these three first countries -- these three first countries will form the focus of our thinking. Just to give more color though as a philosophy we believe that the drug is priced properly in the US and we believe a similar pricing will be sought for in Europe. However, we do know that there a lot of idiosyncrasies in the European reimbursement system and while we may request flat pricing, the chance of having exactly flat pricing are not very high. And in fact discount is expected in different markets. But we will wait and see and we'll negotiate as good as we can.

Josh Schimmer

And just to remind myself, melatonin is not available in Europe. Is that correct?

Mihael Polymeropoulos

Melatonin as we've discussed before day, it is a supplement that maybe available in the some European countries, not in others but in no country is melatonin or any form of it approved and available for treatment of Non-24.

Josh Schimmer

Which countries do you know do not have access to it?

Mihael Polymeropoulos

I cannot tell you, no.

Operator

And our next question is from Difei Yang from Brean Capital. Please go ahead.

Difei Yang

Thanks for taking my questions. Just a quick few. The first question on if you look at SG&A Q4 versus Q3 there was an increase of $10 million. Would you give us a little bit color how the $10 million was allocated to you Fanapt versus HETLIOZ?

Jim Kelly

Hi, Difei. Thanks for the question. And I would -- I had highlight that is a couple of different items on Fanapt and HETLIOZ. It is -- the HETLIOZ awareness campaign the Q3 versus Q4, there was the continued investment in Europe in preparation for our HETLIOZ launch. And then finally the third component was bringing the Fanapt 50 onboard. We went from 12 to 50 within the quarter. And of course everything else surrounding their efforts. We haven't been offering the detail. You know the break up of those different items but I think the important thing to share is that the spending that you see in our SG&A is representative of maturing of our SG&A. Now I'll tell you it was slightly more than I expected in the fourth quarter but that's because we executed so well get in the Fanapt folks onboard .We are actually really thrilled with the quality of folks we are able to find for our field force and getting them going. But as you look forward what you are seeing is mature SG&A and from that you are going to see us build up operating leverage as we continue to drive the business.

Mihael Polymeropoulos

And the full 2016

Jim Kelly

SG&A, well the full 2016 a non-cash OpEx guidance is $125 million to $135 million and that compares to the $105.7 million that we put up for 2015. And that increase is representative of sort of the full year run rate of on the maturing of Fanapt US investment in sales and marketing. And the remaining component is the launch in Europe. So what you are seeing is a continued and maturing investment in our commercial business.

Difei Yang

Okay, thank you. That's very helpful. And so moving on to HETLIOZ awareness campaign, DTC campaign. Would you walk us through from the time you start the DTC campaign then what happens and then how does that process turned into HETLIOZ prescription then revenue. What's that sales cycle look like? How long does it take?

Mihael Polymeropoulos

Yes. We have not shared a lot of details on conversion rate or time to conversion. But of course you can back into it and quickly realize that we have under 1,000 patients, we are not discussing patients or treatment number either and we have 17,000 people who have opted into database. And therefore that tells you that the conversion so far is a small number. But what are more important are two things. One is that regardless of how long somebody has been opted into database these patients continue to have the potential of becoming treated patients. So if for example some patients opted into database three years ago, they still have the potential to move on to the group of patients or being treated. And what drives that is a number of things. One is awareness and deepening of awareness that you can achieve with the repeated DTC. Our discussion through case management directly with these patients and finally the complex behavioral decision making for every patient, their families and their doctors. So this is what eventually causes complexity to answer the question what is the average time of converting and what is the percent. Important thing is that we continue to believe that a number of patients in the 17,000 database will continue to convert over time. The second piece which is very important and very encouraging is that despite having run the DTC campaign on and off for the last seven quarters, and despite the fact that 17,000 individuals have opting the database, we continue to see a very flat rate of dollar spend per opt-in which suggest that we have not yet saturated the interest of pay sensitive potential patient that can come to this database. So DTC remains a very effective way of identifying potential new patient and continue to grow this registry.

Difei Yang

Thanks, that is very helpful. And let me try to change the question slightly from a different angle. So what you're saying is that despite the DTC campaign being intermittent, that the growth of the prescription is fairly constant or gradual, rather than you see a spike then it comes down, basically in sync with or slightly delayed from DTC. Is that the right way to look at this?

Mihael Polymeropoulos

Yes. So there are two different forces here. The first part is how does the opt-in rate changes with intermittent DTC and the second one is how do new RXs change with intermittent DTC? The answer to the first one is there is an absolute correlation between opt-in and DTC. So the weeks we don't run DTC, we have much fewer opt-ins. The weeks that we run DTC, we have much higher opt-ins. On the correlation between intakes and intermittent DTC, there you see a flat that new RXs are relatively flat with little variation from week to week regardless if there is a DTC in the background. And this you would expect given the fact that it takes a significant longer time for one to from opt-in to intake script. And the fact that patients were treated today is a very small percent as compared to the far bigger registry of opt-in.

Difei Yang

Yes, great. That makes perfect sense. That leads to my last quick question on Q3. What was the ending inventory, wholesale inventory level?

Jim Kelly

Yes. What we said is that we have in both Q3 and Q4 was less than two weeks but what happens sequentially in Q3 as compared to Q2 is inventory went down. That was just stocking and it was the first time since launch that we saw any destocking. Well that reversed itself in the fourth quarter. So there is some benefit in the fourth quarter when you look at the 30% growth sequentially from Q3 to Q4. There is a small amount that was representative of the normalization. And it's in the range of 2,000 or so.

Difei Yang

Oh, yes, it is very minor. Okay, thanks. Thanks, that's all. Congratulations for a great Q4.

Operator

And our last question is from Stefan Quenneville from Morningstar. Please go ahead.

Stefan Quenneville

Hi. Thanks for taking my question. I just have a question about your pricing strategy for HETLIOZ going forward. Obviously the drug fulfills a very unique niche in the marketplace, and I was wondering what the scope is for price increases going forward. And what your strategy is going to be going forward, thinking about pricing increases.

Mihael Polymeropoulos

Yes. Thank you very much. So as I said before we believe that HETLIOZ at this time is properly priced for two things. The benefit that we understand provides to patients and the audience number of patients that are being addressed by it. At this time, there is no planned price increase that is included in our guidance of revenue.

Stefan Quenneville

And maybe a bit longer term beyond this year -- and obviously this would be a very good year to not try and push through an aggressive price increase, given the scrutiny on a lot of drugs recently. But sort of longer term, what do you feel the scope for pricing power is?

Mihael Polymeropoulos

Well, as I said before our pricing decision is done based on the benefit that we believe drug gives to patients and how many patients are there to be treated. And that is for a very specific reason of making sure that we can recover the investments that we made in developing this drug especially HETLIOZ; we have been working on it since 2004. And of course been able to make appropriate investment in our R&D organization. So again all I can say for now is that after having gone through our first seven quarters and understanding both benefits, the growth of the audience and the size of the audience. And of course we understanding the investment we have made to get here through the R&D organization and what will it take to recoup that investment; we think we are appropriately priced.

Mihael Polymeropoulos

Well, thank you very much for joining us on our Q4 call. And we'll be talking to you soon.

Operator

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.

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