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Celgene Corporation (NASDAQ:CELG)

Goldman Sachs 35th Annual Global Healthcare Conference

June 8 2014 13:00 AM ET

Executives

Bob Hugin - Chairman and CEO

Patrick Flanigan - Vice President - Investor Relations.

Analysts

Terrence Flynn - Goldman Sachs

Terrence Flynn - Goldman Sachs

Great. Thanks everyone for joining us. Good morning, I'm Terrence Flynn, one of the Biotech Analyst at Goldman Sachs. We are very pleased to have Celgene with this morning. From the company we have Bob Hugin, Chairman and CEO and Patrick Flanigan, Vice President of Investor Relations. Thank you, very much gentlemen for taking the time for this conference this morning. May be I'll turn it over to Bob first just make some brief opening remarks and then we will launch into questions.

Bob Hugin

Thanks very much for having us. For me personally it's been 10 years since I have been in this conference. And it's sort of been amazing 10 years since then. But it is great time to have this discussion the format is great, we get into as much detail on topics you like to discuss about Celgene. We are very excited about where we are today. We think we have tremendous operating momentum in our core businesses which is critical because that's really what creates the opportunity for the future. And we are much as excited about where we are headed but we really see increased opportunities to accelerate what we are doing. Even the operating side-- I was in New Jersey, the headquarter on Monday, we had sort of semi annual portfolio review. And even in the near-term drivers we are seeing some good areas where we think we can accelerate things in the existing portfolio above and beyond the very exciting trajectory that we have. And we spent a lot of time on the pipeline as to where we are headed, what we invested in and we are just more energized about the potential the pipeline, both our internal pipeline and our external pipeline, and we really do believe over the next 12 to 24 months, we have the potential for multiple, multiple approve of concepts and new disruptive technology. So it is a very exciting time to be here. We are having good discussion on any topic that relate to Celgene or otherwise and thanks for having us.

Question-and-Answer Session

Terrence Flynn - Goldman Sachs

Great, well, thank you very much. May be just to start I know you have been intimately involved with the Board of the Pharma industry organization and so you obviously have some views on ACA and exchanges. I was wondering may be just there if you could provide us with your view of kind of the changes that health care system in a future and any impact I guess your business model specifically and how you expect to evolve going forward given the changes?

Bob Hugin

Yes. Frankly, the Affordable Care Act hasn't and even when it was enacted, it got reduced in scope as to what its objective turned out to be. And of the some very positive aspect of it and others that are really problematic and are not achieving the goals of the program certainly expanding Medicaid to 1.38x poverty was a positive step for getting people covered. And that's positive thing. The program design to increase access to insurance for people the sort of 2.5x to 7x of poverty level has really turned out to be based on the structure of the program to really not do that at all. In fact that the sort of (inaudible) low premiums was just high deductible and high co insurance is really made it extremely difficult for the working poor, patient groups like AIDS community, every single AIDS drug in some of the formularies or some of these program are on high specialty tiers which really discriminate against that population may be cancer patients in some areas the same way. And the working poor basically being discriminated by so I think we will see dramatic, we will have to see very significant changes if it is going to have the kind of positive effect, impact it was designed to have. So after November election they will be on the both side of the aisle very significant proposal to modify. And we have been working with everyone to provide construction proposal to make the system work better. The bottom line for us I think and companies that have focused on innovative therapies to help patients' life, there is really no imminent challenge or threat to the operating model as we see it. Though that's proposition when you are dealing with government, you always have to be careful and make sure that they are making good policies but we got lot of work to do. There are things down the road that could be problematic, iPad and other thing. But in the near-term I think you will see a fundamental change in anybody's business model, okay based on that.

Terrence Flynn - Goldman Sachs

Okay, great. What I guess just another in a big picture question that we have been getting lot just the recent management promotion and addition. May be you could just provide us your perspective there and kind of what drove those decisions and then the second follow up is just, do you think this is going to have an impact on your capital allocation strategy and/or your business development strategy which I think is pretty differentiated there.

Bob Hugin

Let me answer the second one first in terms of capital allocation, capital structure strategies and business development. We have taken a long time to evolve the company and produce the kind of organization that we have. And I think we have a strong integrated team, yesterday, today, and tomorrow, some of the way we look at it and our strategies on those key issues are something that we collaboratively come to a decisions on with the Board on those kind of issues. And I would not foresee any change to the way we collaboratively look the environment, our prospects, look at value proposition or on the decision that we should make to assertively manage our capital structure and balance sheet and to be an aggressive player in building a pipeline and relationships that really give us synergy and leverage to build campaigns on technologies against our disease et cetera. So I do think we have a somewhat unique focus and strategy towards how we think about research and development in a collaborative sense to really build again these campaigns and these franchises both with internal and external assets starting with internal expertise. So I don't think any of these changes do anything but to strengthen our team, we surely added to it with the addition of Peter Kellog and given Mark and Jackie opportunities to take on new challenges to build new skills to be more valuable in the future. All of the changes to your first part of the question are designed to be what a dynamic organization should be. And dynamic organization should be an organization that anticipate the environment, to the saying how do we think the world is going to be three years from now on a restructured in a way that produce the best results over three years. Are we at the same time developing our people and giving them the challenges and opportunities to have maximum impact today but also the stronger and better leaders in the future. And so all of the changes that we announced one that were internally driven, no -- there were no pressure from the Board. It would just say, how can we make our company have the highest -- best prospects, highest competitive success over the next two or three years and develop people in a way that will increase their impact and increase their long-term potential. So I think it is very exciting for the people. We are fortunate to now building a great team that works very collaboratively. And I'm very excited about the long-term prospects. It's certainly for better or worse -- it is certainly no signaling about my plan. I have never been more energized or more engaged on what's happening it is Celgene and I am not planning and going anywhere so let me disappoint some people but I am very excited about what we're doing and this is designed to help us make stronger as we go forward.

Terrence Flynn - Goldman Sachs

Okay, great. May be touch on the base business before we move to the pipeline. But just first the REVLIMID front line filings are obviously and you guys announced on your last call. And may be just reminding us of the growth opportunity there both U.S. and Europe. And then what are the potential outcomes that you see for the European label? I know that something you have been trying to kind of frame the book ends there?

Bob Hugin

In EU it is very different market by market as you imply. In the U.S. we have been physicians and patients have made sure this access to new REVLIMID for new diagnosed patient from the U.S. but we don't promote it, we can't promote, we shouldn't promote it. But when we get the approval to it we will aggressively promote it because we do believe when you see that is coming out in combination therapies with POMALYST antibodies, REVLIMID antibodies second and third line therapies are going to be more impactful. And so the whole prospect for myeloma patient is getting brighter and brighter. But that is with REVLIMID as an upfront therapy as the backbone and it is backbone across the myeloma treatment. So we do think we have significant upside in the U.S. in terms of market share impact from having the approval and being able to help physicians and patients sequence structure the all different lines of therapy most effectively. That's one. Obviously outside the U.S. it is most dramatic where the potential can be--since we are sort of single digit, mid single digits market share in some market and virtually no market share and no diagnosed, again we can't promote it, not reimburse outside the U.S. so that approval really opens big market and let's us really be more effective in the second and third line therapy sort have been developed now with IMNOVID outside the U.S. POMALYST and the combination that are developed. So we are very excited about it. So the U.S. is being more straight forward. It is MM -20, in Europe, because of the history MM-15 filing, it will be part of that process and we believe we've got great data in all of the aspect of it. But we will work with the regulators and I don't know exactly, we have to get the label and we are confident it will be good label but we got to do that over the next six or eight months.

Terrence Flynn - Goldman Sachs

And can you comment about the -- I mean your-- I am guessing your initial -- the label you love would be a newly diagnosed label just very broad but then the other analyst spectrum is more the transparent and eligible label, is that the --we think about the different.

Bob Hugin

I mean actually goes even broader that in some market. We pursue the treatment of myeloma and so market as you go for, you will say listen, they don't want to give you transplant patient so you go for the transplant or some market might be able to do both. So I think in some markets we end up with treatment of myeloma. Others will end with only transplant ineligible but we think the data is powerful across the spectrum and we will push aggressively but in the end will be practical and hopefully negotiate the right the best outcome.

Terrence Flynn - Goldman Sachs

Okay. And the other thing I guess Hugin update for just material survival data from the Phase 3 CALGB and ISM trial, that's in the transplant set later this year. Just wondering if you look forward and how will that data be incorporated into the future labels?

Bob Hugin

Yes. We are big believer that your label should include much data as possible so that the kind of dialogue you have not just for medical affair or scientific perspective but on commercial perspective is broad base as possible. So every time we have definitive data that can be submitted to agencies we work hard to get that. So we looked to broaden label completely. And that is very, very important to us in the concept of where growth can come above and beyond the baseline growth that we are targeting. There are really two themes of REVLIMID and POMALYST growth that are critical to us. And we are seeing continuing success on both of them. One is the whole maintenance which is really the two trials that you referenced are really focused on maintenance therapy. That is some of the best, best value of the IMiDs platform where did not only brings great induction result to the patient to stop the progression of disease but the continued therapy allows for the continued suppression of the disease. And it is the continued therapy the maintenance that really makes the difference in patient's life. And so what you looked at our continuum trial on COL, the relevance study in NHA that validating and demonstrating the maintenance paradigm is something critical to patients and provides above the base line growth opportunities for Celgene. That combined also with the look this gone for a long time, is never gone as fast as you like the combination of IMiDs and antibody. That will also have the potential for long-term, durable maintenance treatment with combinations like that in the second and third line. And will really change the disease and potentially change the duration of therapy even in second and third line which is again above a base line growth driver for us over the next four -five years that we are very much invested in and are committed to maximizing that opportunity.

Terrence Flynn - Goldman Sachs

Okay. May be that's a good segway into the next topic is just additional indication of REVLIMID or beyond myeloma. I guess you guys going to have obviously CLL, the regular lymphoma diffused large B-cell lymphoma. May be walk us through some of the readout we can expect over the next 12 to 24 months. And just where you have the most and least confidence in those data set that are coming out over the next foreseeable future?

Bob Hugin

Yes, I mean I think when you do Phase 3 trial you generally are-- have a relatively high degree of confidence that you are investing Phase 3 is the most expensive part of the development paradigm. So we are following on the remark study in diffused large B-cell is fully enrolled and that's be an event driven kind of outcome. So anytime over the next 6-12 months we could see data but it's hard to do that. We have the relevance study fully accrued in the coming month or the end of the year, continuum among the CLO maintenance areas is going forward very expeditiously and we are optimistic that's kind of a big impact. And I think overall when we talk about maintenance and look at minimal residual disease that's a big area focus for us to be able to say target the high risk population, target those that are being okay treated but have potential, higher potential progression to really focus on those. So I think these probably half dozen --studies that we are expecting readout on. There are several Phase 2 study that continue to accrue and should be able to general data at ASH and other meeting over the next 12 to 18 months. So we just initiated another series of Phase 3 study specifically into diffused large B-cell that actually have a companion diagnostic but those won't readout for another couple of years.

Terrence Flynn - Goldman Sachs

Okay. And which companion diagnostic is it?

Bob Hugin

GCB, non GCB.

Terrence Flynn - Goldman Sachs

Okay.

Bob Hugin

And now we have other program in the Phase 3. We are always deciding both as MDS stand now and as a -- and there is event here in -- it is an epigenetic therapy as a priming mechanism but the MDS and AML are in Phase 3.

Terrence Flynn - Goldman Sachs

Okay. One other area not that you guys have spent some time in the past looking at the potential pyramids in solid tumor. May be just give us an update on your thought there and any data we might see once again over the near term data that we should be focused on.

Bob Hugin

The whole platform what I guess today is called protein homeostasis IMiDs platform. The learning that is happen is just real the biology is really accelerated over the past couple of years. And understanding the differentiated impact in solid versus hematological cancer. We are on the two prong front looking for combination therapies that look at the immunotherapy aspects of REVLIMID and looking combination therapies in solid tumors and then really that the pipeline of looking at 122 and other compound that are coming out of that are more directly targeted to solid tumors. And my own view on solid tumor is having gone down that road we had a Phase 3 study in prostate cancer REVLIMID that did not work. We did not pursue patient subtypes but we are going back to look at some of the subtypes where we saw now that we understand more about the biology of both the disease but also of our own product of the biologic impact. They were looking back, they are say other areas of opportunity for us to pursue. And I think until we see proof of concept at least in control Phase 2 study I would not raise people's expectation with that.

Terrence Flynn - Goldman Sachs

Okay. Maybe the last one REVLIMID and obviously I know you are not going to comments specifically on ongoing patent litigation with Actavis and NATCO, but just wondered if you can give us any high level commentary and your view on post the market ruling that came out couple of weeks ago and then the second part of that question just are all options on the table with respect to the path forward here.

Bob Hugin

I mean just put in context. The intellectual property state around REVLIMID which is now 20s of patents, 22 I guess will be litigated has been developed over a long period of time with the world's best experts of assistance on the outside and internal. We have patents now that has been issued in the last few years, that have all of the litigation and the allegation, litigation available to the patent office even before the issuance of the so-- this is a diverse, highly refined, high quality patent of state with multiple types of patents. And we will vigorously defend them. We believe that these patents are going to win. So that is the basic view. And so we feel very good about it. The Markman hearing itself and we thought went extremely well, produce the two areas that we were concerned about, the outcomes are very favorable to us that have could have an impact on trial. The rest of the outcomes really have little impact even on the one that the five that were --being contested, they were agreed by them the night before to just hour of claim construction. We don't seen issue that Markman hearing will be dispositive in anyway to the outcome of the trial. So we feel very, very good about the quality and the process of both prosecuting the patents and defending them. That being said, we are going to be practical and pragmatic of what's the best outcome for us. But we have recognized we have invested more than a decade of work in building this patent portfolio, so very good about it. But we are going look for the right outcome but we are prepared to litigate and win.

Terrence Flynn - Goldman Sachs

And so that I guess trial would start sometime in next year. Is that typical?

Bob Hugin

Yes. There are certainly some complications that there are patents that had not been certified that have to be litigated, will that be a separate trial or in the same transfer issue that have to be resolved by I think the conventional wisdom that we would see a trial next year.

Terrence Flynn - Goldman Sachs

Okay. And may be moving on to the rest of base business. So POMALYST is obviously been extremely strong launch out of the gate. Your guidance is the drug would exceed a billion dollars but I think one of the outstanding questions is just how far upstream will this drug move and what is that mean for treatment duration? So you can give us kind of your latest views what you have been seeing now as the drug has been out there in the market both in the U.S. and Europe for a number of quarters now?

Bob Hugin

Yes. Things are going very, very well. It is really finding its place in the third line and second line setting and the question is overtime what combination will enhance it. But we are still in the early stage of that launch. So we are really benefiting and we will benefit for the next couple of years as growth will benefit from three different factors that will drive -- we are just adding month by month, quarter by quarter more countries reimbursements. So we still have a very significant addition of geographic area that will add to the growth of POMALYST, IMNOVID around the world. Secondly, even within the countries where we reimburse we are seeing increasing market share quarter-by-quarter, month-by-month into that. So and the third one is that already the duration has exceeded our expectations from where we are. But what we are learning both in combination in model therapy, we expect to see continue duration grow so all three drivers and in all market are give us the optimism. And it is not like we didn't have a good strong launch. It is just had -- it exceeded our expectations certainly in the first year of launch now that we are moving into the second year, things continue to be a very positive and again it's like REVLIMID, we just got to keep focused on the geographic expansion, getting reimbursement, the right kind of pricing and so far we have been very fortunate where we met or exceeded our goals in terms of the pricing target that we have been able to achieve in the market that have been reimbursed. So that trend is very positive, the acceptance in market share desired to find combination to even enhanced in second and third line has been very encouraging. And again the duration has been very positive. So again takes time but things are going in right direction. We are very encouraged by it.

Terrence Flynn - Goldman Sachs

And may be a follow up just as you work though those pricing reimbursement negotiations in Europe. Is there any synergy between your potential future conversation on REVLIMID or is this completely independent conversations with the reimbursement body in your particularly.

Bob Hugin

Every province or sick fund versus federal government, this is -- it is -- there are so many different one. But the general theme is that it's a different indication, it is a different drug and there are always over arching discussion but for the most part so far it has been very focused on this specific drug and this specific indication and the value proposition has been incredibly well received. It received every place where it is reviewed, the highest level of innovation analysis that is awarded into it. So we have been very coverage in Germany and France and places where they can use the valuations to diminish but the clinical benefit have been recognized and valued and so far that's been worked in our interest. And just other part of your question where it would go. I think that it is going to go second line, third line where it is, where it is building. I don't think you will see it go beyond that because there is not data that demonstrate so from a clinicians' point of view and patients point of view if you have evidence that one drug works after another drug, we don't have evidence of the other drug works after other drug. You put the patient at risk and the physician not having the potential to have another therapy after initial therapy. So I don't think we will see it advance beyond where it has been headed to now.

Terrence Flynn - Goldman Sachs

Okay. And I guess one other question just multi myeloma landscape obviously touched in briefly in the beginning it is just that the introduction of potential antibodies, two IMiDs , the anti C-38 antibody, you guys have one with Morphosis, but how do you see those really been swatted into the treatment paradigm. It seems to be it is obviously great for patients, they have lot more options now but seems like the market is going to become more segmented as we go forward, but may be just talk to us first about antibodies, how you expect those to be important then may be future segmentation of market.

Bob Hugin

I think the power of the combination has been very clear where you have something that is very synergistic in many cases where you have an antibody that does not seem to have a lot of single agent activity and when you combined it, and we will see ASH data. I think that we are committed to myeloma and myeloma patients. And we are going to invest in research and development in myeloma for as long as the disease is not fully cured. Every little patient subtype that does not as well treated as others but I think it will be very difficult in a few years from now to get new drugs approved in myeloma because when you see the combination of IMiDs and antibodies in the second and third line, the kind of trial that somebody would have to do, the duration of those trials could be 18 years. And so we are focused on is really the segmentation of where this high risk disease, where is this minimal residual disease so we can take the well treated patient, they can get 10 or 15 years diagnosed at 65 with the life expectancy of 15 and if we can get to that then we will look at the subset of patients and how do we ensure that every patient gets to that type of outlook. Then we will be pretty happy. But it will be tough for others to do trials in the patent life of a drug if the trial takes 10 years to do and take several years before you get into the trial and you got that-- the patent will be gone before you even get the drug approved or reimbursed. So it's going to be -- it is a promising time for myeloma patients. It's not where we wanted to be but we are committed to continue to push on that front. And we will even if we get out to longer and longer survival terms.

Terrence Flynn - Goldman Sachs

And how about your latest news on immunoncology, I mean coming out of ASCO, obviously lot of excitement in solid tumor side. We saw Bristol get breakthrough designation for Hodgkin lymphoma, a couple companies are running some trials in myeloma, may be how do you see that evolving over the --

Bob Hugin

Yes. As really having been in the immunoncology company from beginning, if you look at what REVLIMID does, its activity is really hiding and made immunity and is big part of the activity and something that we believe strongly and especially -- talk about ABRAXANE in a minute, we are partnering with virtually every company and every PT-01, PDA-01, every opportunity to really combined those to really produce the maximum patient benefiting in the wide range of solid tumor cancer. We haven't yet seen the pathway in the hematological cancer much but we are looking for opportunities to partner and combine drugs to have the impact. But the impact that you will see with antibodies and IMiDs are going to make it tough for anything to be able to come into that space because it is -- the impact is pretty significant but there is no doubt, all the therapy out cycle, I mean therapies are critical one and we think we have a great program to ensure that ABRAXANE in a wide range of indication in combinations with known immunotherapies but other combination therapies also that -- we made a risk decision to buy Abraxis BioScience and invest in ABRAXANE we believe that it would have a positive impact in pancreatic and that's been the case. But we are not just sitting there and saying, okay, let's just capitalize on this and make it x whatever revenues but we are looking at how do we really impact pancreatic cancer, how do we look at lung cancer, breast cancer and other cancers that we really think in combination ABRAXANE can be foundation for improved care for multiple, multiple solid tumors.

Terrence Flynn - Goldman Sachs

Okay, great. May be just in interest of time, I am just going to touch on the couple of more topics and then anyone audiences questions in last minute or so we go there but just on OTEZLA, obviously its launch is underway, congratulation on the approval there diversification of the business out to another area beyond cancer. I just wondered if you have any commentary you can share on your perspective on the early days of launch and we will learn some more on your next earnings call in July but may be just your perspective on from talking and on the field and what you are seeing and hearing?

Bob Hugin

Yes. I think from an investor point of view, I think what I would be focused on is to say, it is something we've talked about over the last couple of years. And there has been I think increasing acceptance, and that's my opinion of in the outside world of the value of efficacious, safe, oral compound in advance of biologics. That building that market place is the question that I would think if I was an investor, but I won't answer that question. And our insures, our payers recognizing that as a valuable patient opportunity clinically and how does it fit in manage care of how you do that. And that is the key component. Then you -- so there have been people who are skeptical about that. I think there are still people skeptical about that. And that's certainly fair. But that's separate question and those of OTEZLA fit that capability of helping build that market of an oral pre biologic place. So first let say we will have market place development and OTEZLA will help, so those are thing that focus on, I would tell you from our initial observations and discussing the clinical profile with the medical leaders or payers and so we are very, very encouraged about the opportunity of building that market place. If we build that market place we will far exceed the targets for the product. If we don't build that market place, it will be challenge we will still can -- we still be able to do it but it is going to more of a challenge. So that's where we are focus on to make sure that are we building the kind of access that will have the opportunity for dramatic impact. We have -- we only launched for psoriatic arthritis in the U.S., we have September 23 PDUFA date in the U.S. We are very optimistic that things are on track for that and we will get that, we will be prepared with -- that which is a multiple of the psoriatic arthritis size market to do that. Outside the U.S., in Europe, we are on track for CHMP decision towards the end of the year, end of the year beginning of the first quarter that kind of timeframe. That's the combined filing of psoriasis and psoriatic arthritis. We had hoped Canada would be before that -- before Europe but they decided they wanted 52 week data which an end of positive because the data continues to look good and we are going to have the supplemental application once we get psoriasis approved in the U.S. to get the 52 week data and label so we can actually promote that because I see the more powerful for us so and we are going forward in Australia and other markets where we think we can build the mark the OTEZLA, so again this is going to take time and we got to build the market place but the other thing beside manage care that in terms of access to the product that I would spend a lot of time on is the people. And the quality of the team, Scott and Terry Karen and Mark Kersten and [Pete Taylor] are building is world class team. So it will not be -- we are not going to look back two years now and say, we have the right people and they are doing a great job and so take its time but we are very optimistic about where we are heading and where we are going to end up.

Terrence Flynn - Goldman Sachs

Okay, great. May be just last question and may be just on your business development strategy and may be just we saw the recent deal for GD31 from Nogra, may be just provide some perspective on that deal and how does that fitting your overall strategy of the kind of assets that you are guys are looking for?

Bob Hugin

Yes. I think that deal to me represents what tells you and should be, Celgene should be a company that takes risks with the potential of having a dramatic transformation of the way patients are treated and outcomes for patients and that we think that's an area fits with us, million patients of significant unmet need, an area where disruptive therapies are really needed that could change the course of that disease. And we have found a compound here that what we saw in Phase 2 does that in space and we could not be more excited about the opportunity here. That's where we should be investing our money where we have a chance of not making incremental change in patients' life, we had some thought leaders in the U.S., top, top thought leaders help us to the diligent and look at the data, and one of the very, very top thought leaders in the U.S. said, if the Phase 3 data is half as good as the Phase 2 data, I don't understand how you one of a 100% market share. The safety profile, again 166 patients doesn't -- we got to do Phase 3, the data will be presented and we expect in Europe in beginning of the first quarter, it has been submitted for payer review publication so people then will have a chance to say, is this optimism, this enthusiasm grounded in the fact, we have been on a tremendous diligence about it, and we are excited about it. And that's where Celgene should be. all of our business development deal should be targeted towards building a relationship of collaboration that we learn from the partner learn from but with the intention of the disruptive technology having a meaningful impact on the lives of patients and that's in the end the value proposition of Celgene. If we make a difference in patients' lives, Celgene will be highly valued for that. And that's where we invest our money. And that's where we should invest our money.

Terrence Flynn - Goldman Sachs

Okay, great. I think we are out of time but thank you very much. Gentlemen, really appreciate it.

Bob Hugin

Thanks for having us, glad to be here.

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Source: Celgene's (CELG) CEO Bob Hugin Presents at Goldman Sachs 35th Annual Global Healthcare Conference (Transcript)

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