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Dendreon Corporation (NASDAQ:DNDN)

Bank of America Merrill Lynch 2012 Health Care Conference

May 16, 2012 8:00 PM ET

Executives

Rachel McMinn – Bank of America Merrill Lynch

Greg Schiffman – EVP, CFO and Treasurer

Rachel McMinn

Good day. And thanks for sticking around for the last presentation of the session. I’m Rachel McMinn, Biotech Analyst here at Bank of America Merrill Lynch. And it’s my pleasure to introduce Greg Schiffman, CFO of Dendreon with the latest update. Thanks.

Greg Schiffman

Thanks very much Rachel. And we’d really like to thank Rachel and the team of Bank of America for having us on the conference here. We’ll remind you this presentation does include forward-looking statements subject to risks and uncertainties. And to find out more about our specific risks, please reference our SEC filings.

We’ll go through our (inaudible) quick presentation and then open it up for some Q&A. So, Dendreon is completely focused on oncology advancing the war on cancer, breakthrough form of therapy. It’s really the first large scale personalized therapy harnessed into patient’s immune system by actually taking their cells, processing in our factory and re-infusing the cells back into the patient. Benefits that bring short duration of therapy of 30 days, favorable safety profile with a meaningful survival benefit.

We had Q1 revenues of $82 million, about 6.5% increase over Q4. We had a very solid launch in last year, not in line with the expectation that the company had originally set but if we look at our relative to oncology launches we’re still within the top 10 launches if you look at full year revenues. We’ve seen good uptick in terms of physician interest, confidence in PROVENGE. We’ve continually signed on new accounts. We have about 570 accounts. We’ve targeted around 1,000 accounts getting us access to about 80% of all the patients. And so, we’re about 60% penetrated.

However the focus has increased in the utilization of the accounts. We currently have seen the accounts prescribing PROVENGE but really in a very early low-penetration, putting a patient on and sort of waiting for reimbursement, getting comfortable with the environment. Definitely a large commercial opportunity when you look at prostate cancer and the market potential for the drug.

This is the Kaplan Meier curve we issued a 4.1-month median survival benefit. Substantial benefit in the metastatic phase, I think you’ve only seen for the drugs that’s partially better survival benefit. But what’s most important is it does have a long tail. And as you talk about survival, 4.1-month median, it’s difficult for a patient, it’s difficult for a physician to totally, have a dialogue and understand when half the men have passed away.

So, if you start looking at survival over time, you can see that over time, you see it’s increasing at three years out, almost 40% more patients are alive on the treatment armed in the placebo arm. This is the one that’s really exciting from a patient’s standpoint because of the short duration therapy very favorable side-effect profile, but a much greater probability of being alive, years later.

When we look at the safety profile, it’s typical adverse events, tilts, fatigue, fever, back-pain, typically of a low-grade lasting one to two days after an infusion, and so, again short-duration therapy, very meaningful survival benefit and very favorable safety profile.

Prostate cancer landscape is definitely one that we continue to see evolving. And I think we’ll continue over the next couple of years. It’s a very exciting time if you are a physician in this space. And I think a time with a lot of promise if you’re a patient. And we think that this is really great for a patient.

PROVENGE, when you look at the course of therapy and where it’s targeted, in the continuum, you know, men that are diagnosed are going to go in for some primary therapy feeds in plantation or surgery. Large percentage, 70 plus percent are cured. Those that are not are going to go on to some formal hormonal therapy. If you live long enough, so you don’t die of the prostate cancer, you will eventually become hormonally prostate resistant or hormone refractory. That’s what PROVENGE is targeting for front line therapy, its metastatic hormone refractory.

But currently the drug in the space along with Docetaxel Taxotere chemotherapeutic regimen, and you’ve seen Jevtana has been approved as Zytiga for the chemo refractory. I think that you will see Zytiga data coming out and we do expect to see that approved in our label. And you have a couple of others I think Medivation is the other drug that we do here but we also expect to see positive news coming into the label.

And as we look at that, we really think that becoming an opportune time as you look at patients and physicians the real question is how do you appropriately use these therapies that are coming in, what’s the right sequences for those therapies and last year that we started to do some clinical activity.

We see PROVENGE is a very logical frontline it’s a meaningful survival benefit. Its therapeutic approach or how it works is completely different than these other two therapies that are entering this space and you’re done in 30 days. The belief in general is that if you have a lower tumor burden, if a patient is a healthier patient, they’re actually seeing a better result, get that locked in and get it done. And after 30 days you can move forward with any other therapy for these patients. Next, the direction we’re positioning, it’s certainly what we hear a lot of. And we think it makes a lot of sense.

Three key areas that we’re focused on is increasing the utilization of PROVENGE, cost of goods sold, so making it more efficiently and then expanding both the pipeline of data and the product on a global basis. We’ll go through those quickly. Reimbursement is probably the biggest discussion topic we’ve had. PROVENGE is unique in that. The price point forward I think is in line with metastatic prostate cancer treatment, its in-line with the new product. Certainly Zytiga at least as it’s priced in chemo-refractory space. And its price-point as you look at it’s entering our space.

We believe it’s going to be right in line with what PROVENGE set about $93,000 or it is $93,000 for the full course of therapy. The difference is its not systemic course of therapy, you won’t take it for a year to year and half as $93,000 has incurred in a month.

From a physician’s standpoint, that does create a situation that they are basically buying the product, we get financing in terms we not have to pocket the cash, but they do have a liability to payback and they’ve wanted to be very confident that this has been reimbursed per label. And from that, because if it isn’t they’re out in the $93,000. So, on that basis, we’ve seen physicians getting comfortable reimbursement, it is working very smooth.

On average to be paid in less than 30 days, electronic reimbursement through Medicare, we went through a national coverage analysis with a uniform decision that it does to get reimburse per label, doctors getting comfortable there.

We’ve been optimizing marketing we’ve certainly made changes within the marketing structure, both from a headcount standpoint, some of it on the messaging. We watched the Urology business grow from about 5% of our business the middle of last year to 28% until end of last quarter. It has been the fastest growing segment of our business. We’ve seen good growth in the community practices both oncology and urology but urology the fastest growing.

In addition, we’ve structured an account management team specifically focused on urology, looking at managing these on a national level. And we’re working closely with a lot of key opinion leaders along with other companies. I think you’re seeing this with AMJ. You’re going to see this with other drugs entering into our space getting urologists start to look to screen patients earlier.

Traditionally, there was no therapy available for a man that failed to use hormonal refractive or metastatic resistant other than chemo. Patients wouldn’t go on and tell they started to experience symptom-logy, and that point, only half the patients ever opted for it. So, urologists didn't start scanning at low PSA levels, they didn't start scanning when the patient’s felt because there wasn’t anything that they would do based on the data. You’re look at this point to have them scan, the moment that they see biochemical failure on these hormonal agents.

And so, that’s the push that we’re getting out there but you see the same from AMJ, and I think you’re going to see the same from Zytiga, so, J&J when it comes out eventually from Medivation echoing this message.

The last thing that we’ve started is we’ve launched a program called PROPEL which is the branded patient education series. We provide materials for physicians who are actually presenting at local support group meetings, talking about prostate cancer specifically PROVENGE, how that fits in the continuum, how it works and educating the patients. We’ve received very favorable feedback for (inaudible) as well as the patients.

And I guess, last is, as we look at the sales force effectiveness, we’ve really been focusing on penetrating within accounts getting much broader reach, making sure we’re talking to all the physicians in the accounts. And if we look last quarter, I think we had what I consider, a major milestone from our sales cycle. Historically all of our major accounts were academic.

From a reimbursement standpoint, they’ve behaved very different than the community practices because the doctors actually do not sign a credit out, they don’t have a practice that is financing it. Not putting anything at risk. It really is the institution, so back office finance organization. We’ve seen them comfortable to reimbursement and they’ve been putting on large amounts of patients.

For the first time, last quarter we saw community based accounts both urology and oncology, small number but important that went from being small accounts treating sort of a half a patient a month, one patient every other month to becoming the largest accounts we’ve ever had as a company. And I think these are accounts we expect to continue to see ramp, they have in therapy sale.

And so, we have for the first time see the community accounts in the small number ramp up to become large accounts. Our focus is continuing to penetrate, we’ve got a large number of accounts but they’re all acting at this point really cautiously as they’re getting over the reimbursement hurdle and then comfortable with putting this broadly into their practice.

From a cost to goods sold, we’ve been focused for the last six months on reducing cogs, prior to that it was really building out the infrastructure. We’ve already isolated a lot operational efficiencies. If you look from Q3, if you include our start-up cost, SG&A but we’re just labor and other costs associated with manufacturing. We’ve gone from over 100% to 73% in about six months. So, we’re showing dramatic improvement in our costs of goods sold.

We have specific efforts going forward outside of general efficiencies that we expect to continue to find. One of them is electronic packed records, which will go in this year and other electronic systems. We’ve been working on these for about a year and half, and we expect to get a lot of efficiency there. We’re automating the test environment and we expect that to be implemented next year. And we’re looking to automate the environment in terms of our manufacturing of the hood.

And through all of these, we would expect to see our cost of goods sold continually improve, eventually reaching a cost of goods sold between 20% and 30% and that’s what we’ve had as a target really for the last four years. We would expect to see them improve from where we’re at now, to about 50%, where we were at 73% last quarter, 50% of revenue as we move from where we’re at $82 million to about $125 million in revenues. So, again, you should see fairly substantial improvement over the next several quarters.

We’ve got a sequencing study, it’s looking at PROVENGE and Aberaeron and so what is the right sequencing. Abby, does use Prednisone in a very low dose, and the question is how long do you have to wait after treating with PROVENGE? Since it’s an immunotherapy, it’s harnessing immune system to start treating a patient. People feel comfortable in about two months.

This study is going to look at patients starting them on Aberaeron actually at the point in time after they’ve had their first salt collection procedure. We’ll be taking getting PROVENGE and we’ll compare it patients that wait until six weeks after their final dose. The data that you’re looking at, the primary data will be immune response monitoring data, it’s all gathered, it’s part of our manufacturing process, since this (inaudible).

We see a lot of shifts in immune response monitoring from dose one two, to three. We see things like CD54 up regulation, our potency metric that’s correlated close with survival. And we’re going to see if there are any difference between these two arms, you really have to delay, and if so, how long.

We’ve filed for Europe at the end of last year and we will get our 120-day questions at the end of this month. I mean, there is no surprise in the feedback we get. We believe we’re on track for a regulatory decision at some point in the middle of next year. We think it’s a large market opportunity and the dynamics of it really match that that we see in the US.

It is – PROVENGE is based on a platform technology by changing the antigen, we can go after other indications. We’ve got a study now in bladder cancer that we’re using, so using here two new, it’s the DN24-02 study that started, the phase II study looking at new edge in studying in bladder.

We have two other antigens that we’ve done pre-clinical works in, CA-9 and CA, and our goal is certainly to expand the pipeline. We can leverage the technology, the manufacturing and the other infrastructure that we’ve been investing in. In addition, we will look at moving PROVENGE into earlier phases of the current disease and they can probably begin a large Phase III study at some point next year.

We’ve finished last quarter from a balance sheet and financial perspective with about $560 million of cash in the balance sheet as cash, cash equivalents and other investments. We had revenue of about $82 million, we had a cash usage of about $59 million, down from $75 million the quarter before and we would expect to see cash usage drop as revenues grow, looking to achieve a breakeven at around $125 million in revenues. We believe we have the cash on hand that will get us to a cash flow breakeven. And are not looking there would be any additional financings required.

And with that, we will stop and open up for questions.

Question-and-Answer Session

Rachel McMinn – Bank of America Merrill Lynch

Questions in the audience? Okay, well, maybe we’ll start on the cost side of things and then maybe move back to revenues. But I guess one question I have is with the growth rate of PROVENGE being a bit more modest I think than we would have expected at the current time. How do we – how should we think about costs of goods sold, if volumes are kind of growing in the kind of range that we’ve seen – the guidance that you have for 2Q low single digits?

Greg Schiffman

Sure. So, costs of goods sold, there really is a volume component that is certainly important but there is also a time component. And I think that’s where we’ve guided that at $125 million, our costs of goods sold, we expect to see around 50%. If you continued at that level and did not see revenue grow at all, you would see your costs of goods sold, continue to improve.

And that – if we look at the operations that we discussed, putting in things like an electronic batch record, putting in things like the automation – the test and automation of the hood, continuing and making more efficient. And so, from that standpoint, there is both a volume base as well as a time based component with cogs. In addition, other areas that we will see with cogs that are volume based is price reductions associated with the raw material components.

We do have volume based on the Apheresis our two large raw materials would be the Antigen and the Apheresis. Those are both ones where we would expect to see improvement in our cost over time as we ramp up and produce Antigen in larger volume and Apheresis we expect to see those come in next year.

And so, from that, I think you know, we’re on track with the metrics we’ve set operationally. I think it is important to look at what the company has done. We’ve – probably over the last four years, you know, it does in different metrics we’ve put up for manufacturing, bringing plants up, cost structure associated with them. We have hit every single – hit or beat ever single metric we’ve put up as far with that team.

Rachel McMinn – Bank of America Merrill Lynch

So, just to go back to quantifying it though, again if volume growth is limited, it will improve from here but can we get to the 20% to 30% target or does that really require significant volume growth from here?

Greg Schiffman

Sure. So, getting between 20% and 30%, we certainly are expecting volume growth as a part of that. I don’t know at $82 million and say it never grew. We’ve certainly, given the dynamics we’re seeing is not consistent with anything in the market. But where you get exactly, you know, my guess, you start getting to a $500 million rate with all of the automation and things. I doubt we’ll stay between 20 and 30, but you’re probably closer with a three-handle in front of it, closer to 30 than 40.

But we need to see where we actually get, there is a lot of noise in a lot of areas that we’re working with. But there is, regardless of volume a tremendous amount of efficiencies and savings that we will see happening over time.

Rachel McMinn – Bank of America Merrill Lynch

That’s really helpful. And just in terms of you know, again the run rate and how we should we be thinking about capacity, you know, part of the issue is that this is so much underutilized capacity. So, is it possible to keep all of these plants open but just sort of shutter pieces of it so that you can maintain the kind of benefit of having in various locations with them?

Greg Schiffman

Yeah. So, I think as we – we’ve had a lot of discussions around manufacturing itself, are you going to close the facility or rather. I think the discussion you had is a really valid one. There is a lot of alternative between fully shuttering a facility. When we look at what we know today and this is where the world really has moved a lot over the last couple of years as you look at potential automation and self-processing.

We will not speed our manufacturing cycle in terms of an individual dose. But we’re looking at you know, potentially being able to decrease the footprint with which it’s required to make the product, as you look at lot of this automation, enabling you to get a lot more capacity per facility. And from that standpoint, where today, we can probably do about $1.6 billion, $1.7 billion out of our three plants, you could see that number grow a lot.

We’ve got a lot more capacity and that based, the question is how do you get the most efficiency out of it? And you can look at things, anything from complete shuttering a facility to shuttering portions of a facility and picking up a lot of the savings. And I think we’re looking today at the cost side of it. We’ve had a lot of attention there. I think equally right now is we’re looking at a final answer of what we will do, you’re understanding from a customer standpoint, service levels and the impact of ramifications you could have because you don’t want to affect sort of the top-line growth and the customer in any meaningful way.

Rachel McMinn – Bank of America Merrill Lynch

Right. So, at this point, it sounds like there is a lot of things you can do longer term but you just need to make sure that there is no slip-up from a manufacturing perspective to position to restarting these that have based on that experience?

Greg Schiffman

That’s the biggest key. We know that we can service majority of the US from New Jersey, we were doing that, all right. We were servicing California from New Jersey when it was our only facility available. The service level won't match, I mean, that’s one of the reasons we created the three facilities we’ve got. I can current service physicians across the US with getting the product to them, you know, in the morning at the timeframe when the majority would like to see you deriving.

If you go down to a single facility, you’re looking at something that gets delivered but it could get delivered in the afternoon and that’s the only option. And so, from that standpoint, three facilities, given the logistics of it, gave us a lot of effectiveness, a lot of service levels, you really want to understand the ramifications and who are those customers that would be impacted.

Rachel McMinn – Bank of America Merrill Lynch

And then, it will impact the revenue side of things, but maybe you couldn’t just breakout these various buckets for us. But it sounds like there is a certain proportion of physician’s who use the product initially and had a bad experience with the reimbursement. And do you consider those bridges burns that those physicians are just sort of – they’re just not going to be amendable to using PROVENGE for a while?

Greg Schiffman

And so, I mean, if I look at the physician base, we’ve clearly got a range there. I don’t think the reimbursement, I’m never going to pay that it was a terrible reimbursement paradigm, but it was one that they would submit and you often saw a kick-back a couple of times. I don’t think that’s unusual for miscellaneous J-code where it goes in and you don’t have the same person processing it over and over. It was frustrating with physician’s that was one of the feedback we got as they didn't spend far more time getting the reimbursement for the product and they did with other drugs. And I think that was the price point and the quick period that was incurred.

On the other hand, if we looked over the last six, seven months, reimbursement particularly from a Medicare standpoint, if you got an electronic code in place, it’s happening in 30-days or less than average, we have not heard issues or things that are rising from it. And I think it’s working well.

We did not see many accounts start with PROVENGE and stop. I’m not going to say there is none, because you’re always going to have a very small percentage. But if I think of that on that basis, we’ve seen them using it in a steady but low basis, really getting the reimbursement. I do think some of the accounts that have never had a kick-back, may get comfortable reimbursement quicker than the accounts that we’re the early adopters.

And the other area that I think is important with it is when we were going through the NCA process, CMS was not reimbursing for the label. They included all of our clinical enrollment criteria and different Medicare regions were using different enrollment criteria, things like e-cogs, status zero to one, PSA greater than 5, no visceral mass. Other criteria, I mean, getting the docs (ph) comfortable that knew that CMS was looking at that criteria, they now go to the label where it can be any med there is no PSA level.

I think again, Docket (ph) never had those requirements in place. That’s the way they started bringing it into their practice, the others, you’re working with them to explain them look you no longer have to narrow that subset of patients.

Rachel McMinn – Bank of America Merrill Lynch

So, when you go to – you’ve mentioned that there are these community based physicians the one that being really tiny accounts, being your most important accounts. Do you have enough time under your belt to feel comfortable that the volumes there aren’t going to be sort of like the finish once they’re done or are those going to be more sustainability of revenue generation from those accounts?

Greg Schiffman

So, the discussion we’ve had – I can say I’ve had with sales on one of those accounts that happened fairly recently was the discussion within that they’re still in a large ramp base. And they are quite a ways from hitting their peak. And so, if I looked at it, you know, I don’t know that – I can't say there is (inaudible) from the discussions with the docs looking at practices, I think there were very few accounts we’ve ever had that have really gone in, treated the prevalence pool let alone the incident rate that there has been come in.

Rachel McMinn – Bank of America Merrill Lynch

And then, can we – any questions from the audience? Can we go back to expenses on the SG&A line? Do you think that that line is optimized it seems high to me, even when you take out the start up cost. How should we think about that line over the next couple of years?

Greg Schiffman

You bet. So, SG&A itself I can characterize some of it similar to what we’ve seen with manufacturing. And if I look at the accounting organization, the one that I’d be close to, at this point in time, we do not get much leverage from the systems that we use. There is a lot of activity and a lot of people involved with making things work because two years ago, I didn't have to book revenues that standards for cogs a lot of activity. That’s true in many of these functions.

Now we would expect to see efficiencies and operational improvements over time as the next couple of years, we’re really focused on how do, we make lot of the administrative functions more efficient. The last two years has been focused on manufacturing from a system standpoint and we’re about to realize those benefits.

On top of that though, I think when John came on board, the first thing we were extremely focused in on was cost of goods sold. We wanted to get him comfortable with the plan and where we’re going. We equally at this point are looking at what are the areas with SG&A over time that we could see improvements in savings. And I think it’s an area that we’re closely looking at. I think, across the board we would expect to see SG&A improving not just as a percentage of revenue but long-term, improving just as an absolute level as you get more efficiency in some of the structures.

There is, not a lot of companies that are doing what Dendreon is, which is going from a biotech that had no infrastructure to one that’s operating in commercial enterprise. Even though the volumes today are not large compared to biotech, they’re still relatively large revenue for a company that two years ago had nothing and you’re having to manage and run the business while you’re putting the structure them to do that.

Rachel McMinn – Bank of America Merrill Lynch

So, if I’m interpreting your comments without putting words in your mouth. Do you feel like there is room from I don’t know whether it’s from a selling side or the G&A side, but it sounds like there is actually room to lower dollar on dollar SG&A expenses?

Greg Schiffman

Yeah. I think that there is a lot of work and whether, you know, we also have a lot of work with consultants, a lot of work with others that are helping to augment. And I would say longer-term, we should be able to be much more efficient as an operation, yes.

Rachel McMinn – Bank of America Merrill Lynch

Yes, please.

Unidentified Analyst

On the European side, you mentioned you expect approval next year. Could you comment on the operational side in you’re open?

Greg Schiffman

You bet. So, from a European standpoint we will approach things different than what we’ve done in the US. I think our decision to build out manufacturing is the absolutely right decision here. Three years ago, when we had discussions with investing communities, there wasn’t a belief that we would ever be successful in scaling up manufacturing and delivering the product. And I think on that side we’ve been extremely successful.

However, you’ve demonstrated the success, you can transfer that success and the knowledge that we have to Europe and we’ll work with the contract manufacturing. So, our cost of goods sold, will never match what they were in the US in terms of being over 100%.

They started at a much lower you’ll be able to grow them more in line. You won't have the capital cost. We spent to close to $400 million, $200 million at our facilities and $200 million associated with labor and other expenses, starting those facilities up. It’s a very expensive process. You have to have everybody trained. And then let the FDA know you’re ready and then they come in, they inspect it and you got a 4-month waiting period while all these employees are trained and capable and they’re doing work but they’re not creating product. Europe you won’t go free.

We are in active discussions with potential contract manufacturers, it would be too early to sign a deal because we need to get closer to the roll-out strategy and plan and a piece of that you actually do want to get to see the 120-day questions with Europe. So, we filed at the end of last year. We’ll get sort of a first written feedback on that filing shortly.

From a commercial standpoint, I think we will have discussions with potential partners if we can get the right partnering deal. I think we’re extremely open to it. You’re not going to partner it if the economics don’t make sense and the focus there is really we are working towards the cash flow breakeven. I think there are things that we’re doing here to help drive and get that. Looking at being able to, if you do go yourself, financing it out of the cash flow that you generated, you will not have the large initial bonus because you’re up a point of approval you do not have reimbursement in all the countries and so it does roll out in a more gradual fashion.

Rachel McMinn – Bank of America Merrill Lynch

And just a follow-up on Europe. I guess if you have a contract manufacturer, and that’s not new information of course. But I’m just thinking through that a little bit, you really do – I think with control of some of that service level that you – talked about being important in the US. How do you balance that, because if you’re lowering the cost it’s obviously?

Greg Schiffman

Yeah, I mean, you lose control in that and it doesn’t directly report in through a management structure. But I guess if I looked at my career and what I’ve done, I’ve worked with contract manufacturers for large grids of time, a large amount of other companies do. Antigen is made by a contract manufacturer. These people are in the business providing good service because that’s how they keep their business going.

And I think you do – you don’t – I don’t know that you really lose control or you just manage it in different way as you’re working with the third party. I think what’s important with it is you have a third party that’s responsive to your needs. You have contracts and structure that align your interest. And if you do that I think I’ve always seen great results from the third parties we’ve worked with.

Rachel McMinn – Bank of America Merrill Lynch

But presumably from a cost of goods sold perspective you couldn’t have better than the 20% to 30%?

Greg Schiffman

Yeah. I would say from a cost of goods sold, assuming the same price in Europe and the US, your cost of goods sold would be higher in Europe. So, if I’m looking at 20% to 30% here, it’s going to be – if I hit 20%, it’s going to be more than 20% in Europe. It’s not substantially more. These aren’t organizations that look or are able to say we want to get 50% margin on our work. There is a return that they make but they don’t have the R&D, it’s not high at risk type to cost to capital and they make the return on their value added cost.

And so, it would be slightly higher. But it’s one that – as you look at it, it still is going to generate a very solid margin, far more profitable early on, a little less profitable later. You do maintain the optionality if you wanted to buy them out and bring it back in-house, which you could do at some point in the future if you wanted.

Rachel McMinn – Bank of America Merrill Lynch

Okay. I think we’ll leave it there. Thank you very much.

Greg Schiffman

Thank you very much.

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