Amgen's Management Presents at 2013 Deutsche Bank dbAccess Health Care Conference (Transcript)

| About: Amgen Inc. (AMGN)

Amgen Inc. (NASDAQ:AMGN)

2013 Deutsche Bank dbAccess Health Care Conference

May 30, 2013 9:20 am ET


Arvind Sood - Vice President, Investor Relations


Robyn Karnauskas - Deutsche Bank Research

Robyn Karnauskas - Deutsche Bank Research

Good morning everyone. My name is Robyn Karnauskas, I'm one of the Deutsche Bank biotechnology analysts, and it's my pleasure today to have Amgen at our conference, and with us we have Arvind Sood, Vice President of Investor Relations. For those of you who are listening to the webcast, I have been taking questions over email and our app called Yorn. Over email, just shoot me an email at and I'll make sure that Arvind answers your question anonymously.

Arvind Sood

Thank you very much, Robyn, and I will do my best to answer your questions. Good morning, everybody. So what I'd like to do over the next few minutes as a part of my prepared comments is to kind of tee up some key topics that we can engage in a broader discussion when we get into the Q&A session, and as a matter of fact, most of the topics that I have noted here in terms of our key areas of focus for this year and beyond are really topics that we have laid out at our Business Review that was held a few months back, and it goes without saying that much of what we are doing in terms of our growth initiatives going forward are really focused on positioning the Company for long-term growth.

So I'll spend a few minutes today talking about some of the advancement, some of the progress that we have made with our pipeline, our foray into biosimilars, I'll highlight the six products that we have decided to develop biosimilars against, and some of the steps that we're taking to expand our global footprint, and just over the past few days actually we have announced two deals, one with a small company in China, a company called Beta Pharma, through this we're going to co-commercialize the product called Vectibix, and just yesterday we also announced a transaction with Astellas in Japan and that's also a transaction that I will spend a few minutes discussing.

Attractive near-term earnings growth, of course we are going to fund many of these growth initiatives that I've highlighted in terms of pipeline development, biosimilars and international expansion through operating efficiencies that we expect over the next few years, but near-term, we have significant operating leverage because of a change in our profit-share agreement on Enbrel with Pfizer. This agreement comes to an end at the end of 2013 and we have a significant contribution to operating income that we are expecting beginning the 2014.

Our commitment to continue to return capital to shareholders remains very much intact. Since the time that we initiated a dividend towards the end of 2011, we have actually increased the dividend twice and the average increase has been about 30%. That's not to imply that going forward that's what the increase will be but just stating the fact. And of course we will continue to repurchase our shares. We concluded our $10 billion share buyback program towards the end of last year and we have an authorization for an additional $2 billion worth of shares and we have about $1.6 billion outstanding or remaining as a part of that program, and those share buybacks will carry us through the end of 2014, but again it's a point that I will come back to in just a few minutes.

So what is our near to long-term outlook? I think we have been fairly explicit in the guidance that we have provided for 2013. We expect revenues in the range of $17.8 billion to $18.2 billion and we expect earnings per share above the midpoint of the range of $7.05 to $7.35. Again over the next couple of years, we believe that we can deliver attractive earnings and dividend growth as I outlined before, but longer-term, it's all about accelerating this growth through the growth initiatives that I outlined before, notably the pipeline launches, biosimilars, and expanding our global footprint or international expansion.

So let me address each of these in some detail. You know when we look at our – now this is just a portion of our pipeline but this highlights some of the key opportunities that we have, and as a matter of fact between now and 2016, we expect that there are eight innovative programs that are going to yield pivotal results between now and 2016, and let me kind of start towards the bottom of the chart with Romosozumab which was previously known as AMG 785. This is our sclerostin antibody that we are developing for the treatment of postmenopausal osteoporosis. We have two studies which are ongoing. There is a registrational study comparing Romosozumab to placebo and there is another study comparing this product to alendronate, and both of these studies are expected to read out by 2015.

Just looking at this chart, I think it becomes very obvious that the data flow in 2014 is going to be significant. AMG 145 which is a very interesting opportunity that we have in our pipeline is our PCSK9 antibody which is being developed for the treatment of hypercholesterolemia, and again in just a few minutes I'll outline some of the key trials that are expected to read out in 2014.

Brodalumab, our AMG 827, is our IL-17 antibody which is being initially developed for the treatment of psoriasis and we have three studies ongoing, one is a placebo-controlled study, and there are two other studies comparing Brodalumab to an active comparator, Stelara or ustekinumab, and these studies are also expected to read out in 2014.

Velcalcetide, AMG 416, is an intravenous version of the calcimimetic that we believe is going to serve as an important successor to Sensipar down the road. Again we expect that data next year. And Blinatumomab is a product that we acquired through a company called Micromet, and this is a BiTE or bispecific T-cell engager antibody that is initially being developed for ALL or acute lymphoblastic leukemia, and again we expect to get the pivotal Phase 2 data on this product next year as well.

Let me kind of come back to the top of the chart because we expect some data flow from those two products that I've noted this year. Talimogene, otherwise known as T-VEC, we have already top-lined the durable response data, the durable response rate of the primary endpoint, and this data is going to be discussed in some detail at the upcoming ASCO, and Trebananib, our AMG 386, we also expect to get the PFS or the progression-free survival data this year with the overall survival data next year.

So let me embellish these two products a bit. Talimogene or T-VEC, again this is the pivotal study that we have conducted and it demonstrated that the durable response rate in patients was 16% in the T-VEC arm as compared to 2% in the GM-CSF arm. This is a very interesting product and it works actually two ways. You have localized tumor lysis because it's injected directly into the tumor, but it also stimulates the immune system to produce a systemic effect, and of course the overall survival data is going to be key and we expect to get that in the second half of this year. There was a trend towards overall survival based on the initial data that we recently publicised, and again, this is going to be discussed in some detail at the upcoming ASCO.

The other product that I would note is Blinatumomab, and as I've mentioned before, this is a so-called BiTE or a bispecific T-cell engager antibody, and again the mechanism of this product is very interesting because it essentially directs the cytotoxic T cells to tumor cells that express the surface protein called CD19 which is implicated in leukemias and lymphomas, and again as I've noted before, we expect to get the pivotal data on Blinatumomab next year.

As I've noted before, I think one of the principal opportunities, one of the key opportunities that we have in our pipeline is our PCSK9 antibody, AMG 145, and we have four Phase 3 trials ongoing incorporating almost 3,000 patients. There is obviously a study with AMG 145 as monotherapy, there is a study ongoing with AMG 145 in combination therapy, there is a large study in heterozygous familial hypercholesterolemia, and then we also have a study ongoing in statin-intolerant patients. Each of these Phase 3 studies are expected to read out in 2014.

So let me switch gears and talk a little bit about another growth initiative that we have embarked on, and that is the whole biosimilars arena. Now we have a lot of capabilities which we think are going to be critical to succeed in this business. Unlike small molecules or pills, we think that getting into the biosimilars business is going to require manufacturing capabilities, regulatory capabilities, commercial capabilities which are going to be very specific to this business, and to a large extent the guidelines which have been in place in Europe we think are also going to serve as an effective proxy to succeed in this business. To that extent, we have identified six molecules that we intend to develop biosimilar products against or biosimilar molecules against. Four of these are oncology antibodies, Avastin, Herceptin, RITUXAN and ERBITUX, and for these particular products, we actually have an agreement with what was previously known as Watson and is now known as Actavis, and we have two other products that we are developing biosimilars against and those are HUMIRA and REMICADE.

Now often we get questions that, hey, since you guys have Enbrel, since you have the leading share with Enbrel, why would you want to develop a biosimilar version of HUMIRA. Well, several reasons. First of all, we believe that to be able to offer kind of a complete alternative to patients, not every patient is treated with Enbrel, HUMIRA generates a significant amount of revenues, so clearly there is a need for a biosimilar version of this product on the road, and also our rights to Enbrel extend just to the U.S. and Canada. So we feel that this is going to also serve as a very effective alternative outside the U.S.

The third growth initiative that I've highlighted again in very briefly was the international expansion. Again as I've noted before, we have already made some strides. We struck this agreement with a small company, Beta Pharma in China, to commercialize Vectibix, and just yesterday we announced an alliance with Astellas, and I would suggest thinking about this alliance in three specific components. The first is a collaboration which includes co-developing and co-commercializing five compounds, four of these are antibodies and the fifth is actually a small molecule MET inhibitor for the treatment of gastric cancer, and gastric cancer by the way there is a tremendous amount of unmet need in many of the Asian markets including Japan towards this particular indication.

The second component of this alliance will be a capability build phase, and doing this phase, Astellas is going to contribute a certain number of sales representatives, R&D personnel, other personnel to a joint venture which is going to be majority owned by Amgen, we'll own 51% and Astellas is going to own 49%. As early as 2020, we will have the right to purchase the stake in this joint venture that we don't own, this 49% that is going to be currently owned by Astellas, which will essentially give us a feet on the ground presence in this important market. Japan as you know is the second-largest pharmaceutical market and we think that this venture, this alliance can allow us to develop the presence in this important market.

Again as I've mentioned before, we are committed to returning capital to our shareholders, we are committed to returning on average more than 60% of our net earnings to shareholders over the next few years, and in as much as share buybacks are going to moderate over the next few years, we continue to keep our commitment intact in terms of raising the dividend.

So let me just conclude my prepared comments and then I'll be happy to engage in a dialog with you on any questions that you might have. So let me kind of conclude with where I began. Near-term attractive earnings growth, obviously many of the growth initiatives that I've highlighted are going to be funded through the operational efficiencies that we expect to extract between now and 2015. You will see a fair amount of leverage on the P&L because of the expiration of the Enbrel profit share agreement that we have with Pfizer. As a matter of fact, we have quantified that this is going to add about $800 million to our operating income beginning the 2014.

So again attractive near-term earnings growth, ongoing commitment to return capital to shareholders, but most importantly, we are taking some concrete modified steps to continue to position the Company for long-term growth and those steps will emanate from our commitment to developing the pipeline, getting into the biosimilars business which we think is going to represent a multi-billion dollar opportunity, and also international expansion by getting into some of the attractive markets where we don't have a significant presence today.

So I will stop there and if you have any questions, be happy to address those.

Question-and-Answer Session

Robyn Karnauskas - Deutsche Bank Research

Any questions from the audience?

Unidentified Participant

Could you just talk about your strategy in China, how you're going to develop other products, whether it's going to be with Beta Pharma or with other partners?

Arvind Sood

So our strategy in China is really going to be a multipronged strategy, and what I mean by that is we need to establish an R&D presence in the Chinese market. So that's one of the initiatives that we are going to be working towards. You know biosimilars I expect it to play a significant role in the Chinese market, to again establish a framework through which we can commercialize biosimilars in the Chinese market, is another prong of that strategy. And then through the alliances or through the types of alliances that we just announced with Beta Pharma, we'll continue to seek those types of alliances to commercialize our products there.

Now, this alliance with Beta Pharma of course is very specific to just one product, our EGFr inhibitor Vectibix, but down the road, Rilotumumab, this is a product that we are developing for the treatment of gastric cancer, and this is an important indication in the Asian markets including China. So this is another product that we would look towards as being a significant contributor in the Chinese market as well. So again a multipronged strategy and what we have seen in terms of the initial alliance that we've struck with Beta Pharma is just the first step.

Robyn Karnauskas - Deutsche Bank Research

One question I get from investors a lot, they ask you keep raising the dividend significantly, but I'd like to ask at what point would you raise it in line with pharma, because a lot of investors believe if your dividend was in line with pharma, they would be even extremely comfortable owning you given your long-term growth prospects in your pipeline, so I guess why not raise the dividend in line with pharma and at what point would you revisit your strategy of returning 60% to shareholders?

Arvind Sood

So thanks for the question, Robyn. Several thoughts. First of all, we are not necessarily trying to correlate our dividend with the average large-cap pharma companies for one simple reason, if you assess the profile, the growth profile of Amgen as compared to again an average large-cap pharma company, there are differences. Our expected growth rate is attractive. Again I won't comment on what the expected growth rates are for large-cap pharma, but they are pretty modest in terms of both revenues and earnings. We have provided the guidance of course for 2013, but longer-term through a combination of pipeline expansion, biosimilars and international expansion, we truly believe that we can accelerate this growth rate. So point number one that our view is that the growth profile that Amgen offers is better than what you would get with an average large-cap pharma company.

Now as far as the payout is concerned, the fact that we embarked on a fairly aggressive share buyback program, our pay out over the last couple of years was actually considerably higher than the 60%, it was over 100%. So going forward, of course our view is that the share buybacks are going to moderate but we will continue to increase the dividend. And one of the underlying messages that we also wanted to convey is the sustainability of the cash flows. We generate about $5 billion to $7 billion in free cash flow on an annualized basis. So it gives us a fair amount of flexibility but by paying a dividend, hopefully what we've also gotten across to the investment community is the fact that we expect these cash flows to be sustainable going forward.

Robyn Karnauskas - Deutsche Bank Research

Have you ever considered a special dividend, and as far as your strategy goes, how do you make these decisions, how often do you revisit your guidance and your business plans as far as returning cash to shareholders?

Arvind Sood

Yes, I mean this is something that is evaluated by the senior leadership team and by the Board on an annualized basis and we feel that considering where we are in terms of our growth profile, that again a 60% payout through a combination of share buybacks as well as dividends over the next few years offers an attractive return to shareholders.

Robyn Karnauskas - Deutsche Bank Research

Got it. And guidance was updated at the last Business Review Meeting or R&D Day, so I just want to know when you might give even longer-term guidance, is that something we could see in the 2014 timeframe given that we'd be one year away from that guidance filing?

Arvind Sood

I guess the last time that we provided long-term guidance was actually back in 2011. We had a Business Review Day in the first half of 2011 and we gave guidance going out to 2015. There were some very specific reasons as to why we needed, why we felt that we needed to provide the long-term guidance at that time. There was a tremendous amount of uncertainty. Our product EPOGEN, which is used in the kidney dialysis setting, was being subjected to a bundled payment system and the patent on Enbrel was due to expire in 2012. So again there was a lot of uncertainty in the investment community regarding the expected growth trajectory of the Company. And frankly we felt that there was a bit of a disconnect in terms of how we foresee the growth profile of the Company and how the investment community was looking at the growth profile of Amgen. So we felt that it was important at that time to kind of draw a line in the sand and to provide this long-term guidance.

When we held our Business Review Meeting in February of this year, we felt that we were in a very different position. We have a new patent on Enbrel that actually goes out to 2029. The base business actually has held up very well. If you look at the erythropoietin business, if you look at our filgrastim business, Enbrel is doing great, if you look at the other products like Vectibix, Prolia, XGEVA, again the marketed products, the in-market products are doing very well. So in light of that, we felt that it was no longer necessary to provide kind of the false precision by giving longer-term guidance. And yet it was really important to convey, to provide a strong sense of conviction in terms of our future growth drivers. The pipeline has become increasingly visible. As I've noted before, there are several products that are going to yield pivotal data between now and 2016. So we felt that this was an important message to convey to the investment community.

Biosimilars, a lot of people have questioned that why would a company that has historically focused on innovative branded products, why would you want to get into the biosimilars business? Again, if you use the European proxy or the European experience as a proxy, we feel that this could be a significant opportunity for a company that has those capabilities, as I've noted before, the manufacturing capabilities, the regulatory capabilities, the commercial capabilities, and lastly the global footprint. To a large extent, we are still a U.S.-centric company. We derive about 80% of our sales in the U.S. So it is important for us to diversify the global footprint. And today we conduct business in about 56 different markets, 56 different countries, and our objective is to expand that to about 75 different countries over the next few years.

So again in light of all of these growth initiatives, we felt that by providing or updating or giving long-term guidance, it could just be false precision. And yet it's important for the investment community to know that near-term over the next couple of years we plan on delivering attractive earnings growth and of course dividend growth, but longer-term based on these growth initiatives we expect to accelerate that growth.

Unidentified Participant

A question on your mature products that you mentioned that did pretty well, how do you see the scope for you to get more out of them in the future by increasing price, maybe you could be a bit more specific on EPO for instance where you probably have seen the worst in terms of the volume bit and still limited competition overall, what would be your thoughts there in this regard for your pricing strategy?

Arvind Sood

So the pricing strategy is one that's really defined by the value proposition and the competitive dynamics of the products that we have, our in-market products that we have. So let me give you a couple of examples. On Enbrel, last year we took a couple of price increases. There was one that we took in January, then we took another one in July, and the price increases, both the price increases were above 7%. Part of the reason we took the second price increase is because one of the principal products that we compete with, which is HUMIRA, took a price increase of about the same magnitude in July. This year we took one price increase on Enbrel and we'll just see how kind of the dynamic evolves for the rest of the year.

On EPOGEN, historically we have been somewhat constrained in terms of taking price increases because largely it's used by Medicare population. From the time that a patient is diagnosed with end-stage renal disease, they become Medicare patients, and we just took a price increase on EPOGEN, the price increase was around 5% but we haven't taken a price increase on EPOGEN for some time. You're right to a certain extent, the market dynamics for EPOGEN has changed. It's difficult to say for how long it's going to remain that way. There was a competing product that had been launched, a product called Omontys that had been launched by a company called Affymax. That product has since been withdrawn. So we most likely will recapture the share that we have lost to Omontys, which wasn't huge. We exited 2012 with about 96% share with EPOGEN, so we have lost about 4 percentage points of share to Omontys. So we tend to recapture that in the near term. But the competitive dynamic for EPOGEN is going to continue to evolve.

There is a product by Roche that may potentially get launched in the U.S. market next year, it's a product called Mircera, and then beyond that, our patent, post our patent expiration on EPOGEN, you may also see biosimilar products that may get launched in the 2015 time frame. So we are well aware of that dynamic. I can tell you this much that with EPOGEN we have a strong foundation now of safety and efficacy, the dialysis centers are certainly very comfortable in terms of their experience with EPOGEN, so we'll continue to commercialize this product based on those scenarios.

Robyn Karnauskas - Deutsche Bank Research

I guess I'll ask a little bit more around the EPO franchise. So you could face upside surprises this year as some of these competitors don't impact your base business as much as the street thing. So the first one, Omontys, with it being off the market, can you help us understand what was happening in the first quarter before it went off the market, what are some of the changes that occurred as far as pricing or contracting going into marketplace where they don't compete with you?

Arvind Sood

Sure. So in the EPO business, Robyn, first of all we have a long-term contract with DaVita. As a matter of fact, the duration of the contract is seven years, and DaVita accounts for about 30% to 35% of the dialysis business. We also have a nonexclusive contract, this was a three-year contract that we had established with Fresenius. So Omontys for the most part was running pilot programs. They had a pilot program with Fresenius through which they treated about 18,000 patients. There were no mass conversions to Omontys because it's a big undertaking to convert all the dialysis protocols to a new product. So it is understandable that they would run these pilot programs. And of course, as I've noted before, that Omontys got pulled off the market. So our first priority was to make sure that first of all there was uninterrupted supply for the patients who are being treated for kidney dialysis. Number two, we have also been very busy communicating the conversion protocols to convert these patients back from Omontys to EPOGEN.

Number three, I think there was some expectation in Q1 that since Omontys was withdrawn off the market, that we would immediately see an incremental benefit for EPOGEN. But keep in mind that the dosing of Omontys was once a month and this product was pulled off the market towards the end of February. So for those patients who were dosed on Omontys towards the end of the month, we would have to wait at least four weeks before they are converted back to EPOGEN. So of course as we get into the second quarter, I'm not going to provide specifics, but we would expect to see some improvement in the EPOGEN trend. But again I would just note that the portion of the share that was lost to Omontys was small, it was only 4%. As I've noted before, we exited 2012 with a 96% share. So again, our commitment remains to ensuring that these patients are able to come back to EPOGEN, that the conversion protocols are communicated very effectively to them.

And the last point that I would note is that in terms of the overall use of erythropoietin, we have felt for some time that we would see a stability in the overall average hemoglobin levels, and the overall average hemoglobin levels tends to have stabilized at around 10.7. Our view was that if hemoglobin levels decline much below 10.5, you would see an exponential rise in transfusions, which of course is not a very efficient way to treat these patients.

Robyn Karnauskas - Deutsche Bank Research

Helpful. And what kind of impact are you seeing from generic Zometa on the marketplace as far as the impact on XGEVA?

Arvind Sood

So, so far there are five generic versions of Zometa that have been launched and we have not seen a discernible impact so far, although we have called out the issue or the concern that you could potentially see an impact, because having the generic version of Zometa on the market does create a financial incentive for the oncology community because of the way the ASP methodology works. The ASP or the average selling price is calculated over a full quarter period but then there is a two quarter lag. So this impact can lap for some duration of time, it can be anywhere from 12 to 18 months, again because of the way the ASP methodology works. But so far we have not seen a discernible effect.

Now, I think there are a couple of factors that should be borne in mind. First of all, with XGEVA we have demonstrated unequivocal superiority over Zometa in two of the clinical trials that we have conducted to secure approval for XGEVA. So in our communications with the medical community, I mean that's one of the key points that we have emphasized, that again XGEVA has demonstrated superiority over Zometa.

The second point is that the route of administration is different. XGEVA is given subcutaneously and Zometa of course is given intravenously. So for a patient who is doing well on XGEVA, I think it would be awkward for the physician to say, hey, by the way we are going to transition you to a product that we are going to have to give you intravenously. Clearly there is going to be some resistance on the part of the patient with that type of a switch. So again, it's a trend that we are observing very carefully, but so far so good.

Robyn Karnauskas - Deutsche Bank Research

That's great, that's actually really helpful. Then lastly the third component, essentially (indiscernible), a lot of investors are concerned about generic NEUPOGEN and potentially a generic competitor to Neulasta, not really generic but a competition of a similar drug, how do you market against a competitor, what kinds of messaging do you use to emphasize the importance or the advantages of continuing to use NEUPOGEN and Neulasta, and who uses NEUPOGEN, like is that a sticky market, that would be the first drug to face competition?

Arvind Sood

So Robyn first of all I'm glad you noted that the expected change is not really generic competition but competing products that may get launched in this market. Teva has a product, it's just called Tbo-filgrastim, that has been approved that they can potentially launch post November of this year. They have also developed two longer acting agents which they have submitted with the FDA, and again I can't comment specifically on the approvability of those products. But I would view this as more of a competitive change rather than biosimilar competition against our products down the road.

Now for NEUPOGEN, we fully expect that Teva will launch their approved short-acting product post November of 2013, but again I would just note that NEUPOGEN represents only about 20% of our sales of the overall filgrastim franchise. Neulasta represents 80% and our exclusivity on Neulasta actually extends out to 2015.

In terms of who uses these products, obviously they are used in the oncology setting. Clinics account for much of the use, in excess of 50% of the use for Neulasta. Clinics account for about 25% of the use of NEUPOGEN. So bulk of the use for NEUPOGEN is already in the hospital setting.

Robyn Karnauskas - Deutsche Bank Research

Alright, that's helpful. Then we also have done a survey recently regarding the impact of biosimilar HUMIRA on Enbrel, and doctors were very conservative as far as their initial use of the drug, something like 5% uptake at peak, potentially 25% if there was a significant pricing erosion, (indiscernible) HUMIRA impact on Enbrel. What are your thoughts on that because it looks like that would be a different dynamic than what we have seen in Europe which is more a slow uptake?

Arvind Sood

So with Enbrel, first of all I would note that we continue to retain leadership in terms of our segment share, both in rheumatology where our segment share is about 31% and in dermatology where our segment share is about 38%. The market dynamic is very strong. If you look at the segment growth both within rheumatology and dermatology over the last couple of years, there has been a very good resumption of growth in these two markets. The fact that we have had Enbrel on the market for several years, we have developed a very strong foundation of safety and efficacy and our view is that that is something that should serve us long.

And the last point, Robyn, that I would note is that this kind of this new lease on life that we have now on Enbrel, the fact that we have a patent that extends out to 2029, we are continuing to reinvest in this brand, we are reinvesting from an access standpoint to continue to improve access, we are reinvesting from a commercial standpoint, we have been running this direct-to-consumer campaign with Bill Nicholson that many of you may have seen, and we feel that the return on investment on this particular campaign has been very good. Enbrel is already approved for a fairly broad roster of indications, so I can't necessarily point to any substantially new indications for Enbrel, but again it's the strong foundation of safety and efficacy that we believe will continue to serve this brand well.

Robyn Karnauskas - Deutsche Bank Research

One last question. On generic HUMIRA, when you get a generic approved, would it just be for one indication, so would there be portions with a market that would still be branded, or would this be for all indications where HUMIRA has approval?

Arvind Sood

Again, I don't want to address specifically what the biosimilar strategy would be against a product against HUMIRA. I believe that it may be an indication specific. But again I would just note that these products are different, and unlike small molecules, these products are going to be biosimilar not bioequivalent. So the dynamic is going to be very, very different. For one, clinical trials would have to be done to get these products approved. These products would have to be established based on their own distinct trade names. I think the FDA and their draft guidelines have certainly alluded to the fact that interchangeability is not going to be permissible in the earlier phases of the launch of these products. So again, I would view a biosimilar version of HUMIRA as more of a competitive change rather than a true generic equivalent to a product.

Robyn Karnauskas - Deutsche Bank Research

Okay, thank you very much.

Arvind Sood

Thank you.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to All other use is prohibited.


If you have any additional questions about our online transcripts, please contact us at: Thank you!