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AbbVie, Inc. (NYSE:ABBV)

Q1 2013 Earnings Call

April 26, 2013, 9:00 a.m. ET

Executives

Larry Peepo – VP of IR

Richard A. Gonzalez – Chairman of the Board, CEO

William J. Chase - EVP and CFO

Laura Schumacher – EVP Business Development, CSO

John M. Leonard - SVP and CSO

Analysts

Jami Rubin – Goldman Sachs

David Risinger – Morgan Stanley

Jeff Holford – Jefferies & Company

Greg Gilbert – Bank of America

Chris Shad - JPMC

Marc Goodman – UBS

Michael Tong – Wells Fargo

Alex Arfaei – BMO Capital Markets

Damien Conover – Morningstar Investment Services

Operator

Good morning and thank you for standing by. Welcome to the AbbVie first quarter 2013 earnings conference call. (Operator Instructions)

I would now like to introduce Mr. Larry People, Vice President of Investor Relations.

Larry Peepo

Good morning and thanks for joining us. Also on the call with me today is Rick Gonzalez, Chairman of the Board and Chief Executive Officer and Bill Chase, Executive Vice President of Finance and Chief Financial Officer. Joining us for the question and answer portion of the call are Laura Schumacher, Executive Vice President of Business Development, External Affairs and General Counsel and John Leonard, Senior Vice President and Chief Scientific Officer.

Today, Rick will discuss AbbVie's results from the first quarter as well as highlights from our commercial portfolio and pipeline. Following Rick's comments, Bill will give a more detailed review of the quarter and then provide an overview of our outlook for 2013 and the second quarter. Following our comments, we'll take your questions.

Before we get started, some statements may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words believe, expect, anticipate, project, and similar expressions among others generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.

Such risks and uncertainties include but are not limited to challenges to challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, Risk Factors, in our 2012 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

On today's conference call as in the past, non-GAAP financial measures will be used to help investors understand AbbVie's ongoing business performance. These non-GAAP financial measures are reconciled with the comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website at www.abbvieinvestor.com.

So with that, I'll now turn the call over to Rick.

Richard A. Gonzalez

Thank you, Larry. Good morning everyone and thank you for joining us for AbbVie's first quarter 2013 earnings conference call.

Today, we're pleased to report strong results in our first quarter as an independent company with adjusted earnings per share of $0.68 exceeding our guidance range for the quarter. We delivered this strong performance despite the decline in TriCor sales due to generic competition.

During the quarter, we executed on AbbVie's key priorities. We drove continued growth of HUMIRA with more than 17% global operational growth. We advanced our pipeline with continued progress across our mid and late state R&D programs. This includes our Phase III HVC program, which is well underway and enrolling rapidly. And we delivered return to our shareholders through a strong dividend.

As we said before, 2013 is a year of transition as we absorb the impact from the loss of exclusivity of our lipids franchise. But 2013 is also a year of execution across both our commercial portfolio and our pipeline. And we're off to a strong start on all fronts.

As I mentioned, we continue to see strong momentum from HUMIRA, particularly robust growth in dermatology and GI. Our global launch of UC is going well with strong uptake in both the U.S. and Europe. Beyond UC, we continue our development efforts for HUMIRA with several new indications currently in late stage trials. We expect a cadence of data, registrations, and regulatory approvals over the next few years. This includes our U.S. regulatory application for (Axiospa), which is currently under review. And we also expect to submit our U.S. regulatory application for pediatrics' Crohn's disease in the coming months.

HUMIRA currently offers the broadest label in the category. Several of the new indications we are pursuing will be unique, unique to our label and will help us further differentiate from competitive products and add to the sustainability and future growth of HUMIRA. All told, we expect new indications including those approved in 2012 to add roughly $1.5 billion in incremental global sales.

As we track new product entrance, performance continues to be in line with our expectations with HUMIRA continuing to gain or hold market share across all indications. Bill will talk more about HUMIRA and our other product performance in the quarter as well as our expectations for the year. But it's fair to say that HUMIRA is off to a strong start this year, well on track to achieve our sales growth outlook for the product in 2013.

Now moving to our pipeline, as a bio-pharmaceutical company, advancing our pipeline is paramount to our long-term success. We're focused on delivering innovative therapies to address the most pressing areas of unmet clinical need. And we're encouraged with our progress. Over the past year, we've advanced two promising programs into Phase III development including our Interferon free HVC program, which I'll discuss in more detail here in a moment.

We also expect to advance seven additional programs into late stage clinical trials over the next 12 to 18 months. For example, Atrasentan, our newly discovered compound in development with diabetic kidney disease. We'll present results of our Phase IIB study at the European renal association meeting next month. And we're on track to initiate the Phase III program in the first half of this year.

ABT-199, our next generation BCL-2 inhibitor in development in partnership with Roche Genetech has shown strong activity in hematological malignancies. Earlier this month, we presented Phase I data showing patients with chronic lymphocytic leukemia treated with ABT-199 experienced rapid tumor reduction. We'll present additional data at the upcoming ASCO and EHA meetings in June.

As discussed on our last quarterly conference call late last year, we paused dose escalation and recruitment in several ABT-199 studies as we worked to refine the dosing and monitoring approach for patients at risk for tumor lysis syndrome. We recently proposed an amended study protocol for ABT-199 in CLL. Upon approval by the FDA, dose escalation and new patient recruitment will resume.

It remains our goal to initiate Phase II and Phase III studies in relapse or refractory CLL patients this year. We continue to have a high level of enthusiasm for this compound, which we believe holds promise in a number of hematological malignancies.

ABT-888 is another compound within our oncology pipeline poised to advance into Phase III in early 2014. ABT-888 is a PARP inhibitor. It has shown promise in enhancing the effectiveness of common cancer therapies such as chemotherapy and radiation. It's currently in Phase IIB for bracket deficient breast cancer and other cancers.

ABT-126 is our alpha-7 NNR agonist, currently in Phase IIB trials for Alzheimer's disease. And cognizant impairment associated with schizophrenia. Data from our Phase IIA proof of concept study in Alzheimer's disease will be presented at the Alzheimer's Association International Conference in July. And we'll present results from the schizophrenia study in 2014. Provided our Phase IIB clinical work is successful, we'll initiate Phase III trials in both indications in 2014.

ABT-719, our novel investigational compound for the prevention of acute kidney injury. Additional confirmatory Phase IIB study is currently ongoing. And we'll enable Phase III initiation in early 2014.

Elagolix is compound with a unique profile currently in development for endometriosis and uterine fibroids, both prevalent conditions with few treatment options. Our Phase III program for endometriosis is ongoing. And we recently initiated a Phase IIB study in uterine fibroids. Again, pending success in our mid-stage trial, the fibroid program is also poised to advance to Phase III next year.

So as you can see, we have a number of exciting programs on track to advance to Phase III development over the next year or so. In addition to these assets, we have several other promising compounds already in late stage development. This includes Daclizumab, which is in Phase III development in partnership with Biogen, for relapsing remitting multiple sclerosis. Data from the first of two registrational trials, the select study, were recently published in the Lancet. And results of the second year extension of that study called Selection were recently presented at the American Academy and Neurology meeting. We expect results from the second pivotal study in 2014.

And finally, a central program within our late stage pipeline is our Interferon free HCV combination. All the Phase III studies that will be included in our initial registration are now underway and enrolling very well. In fact, ahead of expectations. As we said before, the primary focus of our program is on delivering Interferon free treatments and offer patients the best chance for cure. Our approach is to maximize SBR rates across various patient types from naïve patients to the most difficult to treat with the simplest possible therapy.

Earlier this week at the ESO meeting in Amsterdam, we presented data from our large Phase IIB Aviator study showing that conditions with reduced response to Interferon base therapies, such as the level of fibrosis or IL28B genotype do not impact response to our Interferon free therapy. We expect our Phase III study to begin to read out later this year and into 2014. Reporting registration submission in mid-2014 given that our compounds have been granted fast track status by the FDA, we expect market entry in early 2015.

So in summary, we've delivered a strong first quarter. And we continue to drive strong performance with our flagship product, HUMIRA as well as other products in our specially focused portfolio. And we continue to make notable progress in advancing our pipeline, which we believe includes a number of exciting programs that have the potential to address significant medical need. For a company of our size, the potential sales projections in our late stage pipeline represent an opportunity for meaningful revenue growth beginning in the 2015 timeframe.

With that, I'll turn the call over to Bill.

William J. Chase

Thank you, Rick. Today, I'll spend some time talking about our first quarter performance. I'll then turn to our outlook for the remainder of 2013.

As Rick said, we're very pleased with the strong first quarter we delivered. Total sales increased 5.1% on an operational basis excluding an unfavorable 1.4% impact from foreign exchange.

Excluding TriCor/Trilipix due to loss of exclusivity, sales increased 8.6% on an operational basis.

The first quarter adjusted gross margin ration was 76.2% excluding intangible amortization and other specified items in line with our expectation for the quarter. This reflects both the loss of exclusivity within our lipid franchise as well as the effect of unfavorable foreign exchange on the ratio.

Adjusted SG&A was 27.9% of sales in the first quarter including continued investment in our growth brands and the incremental costs of becoming an independent company. This level of investment was in line with our expectations for the quarter. And we remain on track for a full-year adjusted SG&A of around 26% of sales.

Adjusted R&D was 14.6% of sales in the first quarter reflecting funding actions in support of our emerging mid and late stage pipeline and the continued pursuit of additional HUMIRA indications.

Net interest expense was $66 million in the first quarter. And other income was $18 million. The adjusted tax rate was 22.2% in the quarter.

First quarter adjusted earnings per share excluding non-cash intangible amortization expense and specified items were $0.68, which exceeded our previous guidance range. On a GAAP basis, earnings were $0.60 per share.

Turning to product sales in the quarter, HUMIRA delivered global sales of more than $2.2 billion, up more than 17% on an operational basis. In the U.S., HUMIRA sales increased nearly 24% driven by continued market expansion and share gains in the (duram) and gastro segments.

Internationally, HUMIRA sales grew 13% on an operational basis and nearly 11% on a reported basis as a result of strong market growth and some modest benefit from tender timing. As we look to the second quarter for international HUMIRA sales specifically, we would expect a modest negative impact from tender timing in some markets, particularly Brazil. On a global basis however, we expect low double digit sales growth for HUMIRA in the second quarter in line with our full year outlook.

AndroGel sales were up low single digits in the quarter following strong 2012 performance. AndroGel continues to maintain more than 60% share of the testosterone replacement market.

Growth in the quarter was impacted by a moderation in the rate of overall market growth as well as the year-over-year impact of rebating actions implemented in mid-2012. Based on current trends, we're forecasting AndroGel sales growth in the mid-single digits for 2013.

Global sales of Lupron were approximately $180 million in the first quarter. For the full year 2013, we expect Lupron sales to be roughly in line with 2012.

Moving onto our lipid franchise, TriCor/Trilipix sales were $128 million in the quarter, down roughly 50% due to the entry of generic Fenofibrate in November of 2012. U.S. sales of Niaspan were $186 million in the quarter, down 2.6%. As a reminder, we're forecasting 2013 sales of less than $1 billion for our combined lipid franchise, reflecting a decline of roughly $1.2 billion, which will be exhibited more acutely in the second half of the year. We plan to offset our lipid franchise decline through growth of key marketed products including HUMIRA.

Moving onto Snythroid where U.S. sales were $119 million in the quarter. Synthroid maintains strong brand loyalty and market leadership despite the entry of generics into the market many years ago. For the full year, we expect to see Synthroid sales growth in the mid-single digits.

U.S. sales of Creon were $90 million in the first quarter, up more than 32% compared to the first quarter of 2012. Creon maintains market leadership in the pancreatic enzyme market where we continue to capture the vast majority of new prescription starts. This quarter, we received FDA approval for a new dosage strength of Creon. The new 36,000 lipase unit dose is the highest available, which may help to reduce pill burden for some patients. This approval further strengthens our leadership position because we are able to offer patients the broadest range of dosage strengths in the class. In 2013, we expect U.S. Creon sales to grow at a low double-digit pace.

Duodopa, our therapy for advanced Parkinson's disease performed well in the first quarter with growth of more than 8%. Duodopa is currently approved in Europe and other international markets. We completed registrational studies last year. And are in the process of pursuing regulatory approval in the U.S.

Turning now to our full year 2013 outlook, we are confirming our adjusted earnings per share guidance of $3.03 to $3.13. This guidance continues to contemplate sales somewhat above $18 billion reflecting growth from key brands offsetting the expected decline in lipids. Included in our sales guidance is an estimated negative impact from exchange of slightly less than 1%.

We're forecasting a gross margin ratio of around 76.5% for the full year excluding non-cash amortization. This forecast reflects both the impact of loss of exclusivity events and the effect of unfavorable foreign exchange.

We anticipate R&D expense to be approximately 14.5% of sales reflecting funding actions in support of our emerging mid and late state pipeline and the continued pursuit of additional HUMIRA indications. And we expect SG&A to be around 26% of sales.

We're forecasting net interest expense of approximately $300 million for the full year. And we expect an adjusted tax rate of approximately 22% in 2013.

Our adjusted earnings per share guidance range excludes $0.37 per share of non-cash intangible amortization expense and certain specified items primarily associated with separation related costs and ongoing restructuring activities. Earnings per share would be $2.66 to $2.76 on a GAAP basis. We're still in the process of quantifying certain one-time costs related to the separation. And we will look to further refine our forecasts of these specified items as the year progresses. Finally, we expect approximately $6 billion of operating cash flow in 2013.

Regarding our second quarter outlook, we expect adjusted earnings per share or $0.78 to $0.80. This excludes roughly $0.12 of specified items and non-cash amortization resulting in a second quarter GAAP EPS of $0.66 to $0.68.

Our second quarter outlook reflects sales growth in the low single digits on a reported basis including a modest impact from negative exchange. We expect the gross margin ratio for the quarter to be somewhat above our full year guidance. And we expect R&D and SG&A as a percentage of sales to be in line with our full year outlook.

So in conclusion, we're pleased with our first quarter performance as well as our outlook for the remainder of the year. With that, I'll turn it over to Larry.

Larry Peepo

Thanks, Bill. We'll now open the call for questions. Elan, we'll take our first question.

Question-and-Answer Session

Operator

(Operator instructions). Our first question today is from Jami Rubin from Goldman Sachs.

Jami Rubin – Goldman Sachs

Thank you. Just a couple of questions. First, can you hear me okay?

Richard Gonzalez

We can.

Jami Rubin – Goldman Sachs

Great. So on HUMIRA, sales were up 17% on an operational basis. Bill, you talked about tendering that could impact international sales, but still, your guidance for the full year of low double digit growth does assume a, you know, decline in the pace of growth throughout the year. I’m just wondering if you could talk about why you expect such a slowdown or if it’s just too early in the year to make adjustments to your forecast?

And secondly, if John Leonard is on the phone, I just wanted to ask a question on ABT-199. It sounds like you’re making progress with the FDA in refining the trial so that you can remove the pause, but what gives you confidence that the tumor lysis syndrome is based on a dose response mechanism and not based on the drug mechanism itself? Thanks very much.

Richard Gonzalez

Thanks, Jami.

John Leonard

Jami, it’s John Leonard. I will go first. Thanks for the question. Just for everybody on the phone, let me remind you, we had, at the very end of last year some instances of tumor lysis syndrome in some of our early studies with ABT-199.

We voluntarily paused enrollment in some of the studies that we were doing and with the FDA, went on a partial clinical hold for the CLL studies. In the last couple of months, we’ve very carefully gone back retospectfully looking at all those patients to understand what might be any risk factors for TLS and now we’ve been working with the FDA. So let me give you a sense of exactly where we are.

We’ve identified risk factors that we think are clearly related to the tumor burden itself. In other words, those patients that had experienced any evidence of POS all had large tumor burdens associated with it. And with that, we have taken that into consideration going forward.

So I’m pleased to report that in the instances of multiple myrloma and non-Hodgkin’s lymphoma, we’ve resumed enrollment, that site is actively going on. And we’re in the very final stages of working with the FDA to resume enrollment in the CLL studies.

Essentially what’s going on is some final work to refine the actual prophylactic regiment for handling some well-known side effects of TLS.

I think to your question, Jami, we’re pretty confident that one can step through dosing in a graded fashion and have tumor dye at a controlled rate and well-known, well-characterized prophylactic measurements – or measures. We believe that we should be able to readily handle TLS.

Richard Gonzalez

Jami, this is Rick. So let me answer your HUMIRA question. Certainly, we’re off to a strong start. Now, one of the things that Bill pointed out in his remarks is we did have some tenders move from second quarter into first quarter, so first quarter is, you know, slightly up and we’ll see that reverse in second quarter. But all in all, still overall, if you looked at the average, we have very strong growth. We’re also only a quarter into 2013, so it’s probably a little early to change any projects that we have for the product. But I – suffice to say, we’re confident with the performance that we’ve projected for HUMIRA and we’ll just have to see how the rest of the year plays out.

Jami Rubin – Goldman Sachs

Thank you.

Richard Gonzalez

Thanks, Jami.

Operator

Thank you. And our next question is from David Risinger from Morgan Stanley.

David Risinger – Morgan Stanley

Thanks very much.

Richard Gonzalez

Good morning.

David Risinger – Morgan Stanley

I have three questions on separate drug candidates. First, and, you know, I don’t think it’s worth going into a lot of detail because there would be too much ground to cover on HCV, but if you could hopefully just frame, as you see it, the timing of launch for your all-oral regimen and if you could position that relative to Gilead’s timing, that would be helpful in terms of the all-oral regimen.

And then second, with respect to ABT-199, I’m just curious about whether there’s any risk of the lower dosing constraining the efficacy? I.e. yielding lower efficacy. And then finally, with respect to ABT-126, I noticed in the press release that you’re hoping to start Phase III trials next year. Could you just talk about the timing of news flow for ABT-126 for Alzheimer’s and also for cognition and schizophrenia? Thank you.

John Leonard

Okay, I’ve been scribbling notes with your questions. :Let me take them in reverse. So ABT-126, let me give you a sense of where we are, David. We’re doing Phase IIb work as we speak and that’s meant to extend the proof of concept, call it 2a work that was done with modified studies and limited dosing. So what we want to do is more fully flush out what the efficacy curve might look like and with that, characterize even higher doses that we were not in a position to test when we did our first study.

Two different indications, you’re correct. Alzheimer’s disease as well as cognitive disorders, so schizophrenia or CIA as it’s now called.

With respect to the news flow, we will share the data from that first 2a study in Alzheimer’s disease in July at the Alzheimer’s meeting and our plans right now for the CIS data would be in 2014. We haven’t chosen a venue yet, but as we have that, obviously, we’ll share that with you.

Let me move onto 199. It’s sort of an extension, I think, of Jami’s earlier question. The premise of your question, I think, is a little incorrect if I understood it. I took it to imply that what we’re doing is giving lower doses on a continuous basis of the patients, and therefore, the higher doses that we might want to get to may not be reached and therefore, efficacy might be constrained a bit. That’s not what we’re doing. Essentially what we’re doing is a walking up doses and we’re convinced that as tumor dies the risk of tumor lysis syndrome will recede because there’s less material from the tumor to be dealt with and therefore you can get to those higher doses that have been associated with the outstanding activity that we’ve observed today.

So it may take a little bit longer to get there, which is what we’ll be working out here as we go, but in terms of being able to deliver what we want to deliver for these patients, we’re very confident we’re going to be able to get there.

And then finally HCV was the first question, launch timing. I mean, it’s no secret that we’re all working as fast as we can. It’s a very competitive space. We have an excellent team on that. They’re working flat out. We’ve communicated along the way that we would expect a very early 2015 launch. We’re confident that we will meet that and we’ll see where Gilead is with respect to that timing as well.

David Risinger – Morgan Stanley

Thank you.

Richard Gonzalez

Thanks David.

Operator

Thank you. Our next question is from Jeff Holford from Jefferies.

Jeff Holford – Jefferies & Company

Hi, good morning. Thanks for taking my question. I just got two really. First off, on the additional HUMIRA patents that you have submitted to the patent office already, I think they’re mainly manufacturing and formulation patents, can you give us any update on any expected timing of when we might see some more news on those? And also, just around that as well, when you might begin to flush out how the new formulation work around HUMIRA and when we’ll get some more visibility on that too.

And then the second question is just some dated thoughts really from you if you have any on the competitive positioning of your Hep C cocktail following these updates from Gilead and in particular, Bristol Myers as well. Thank you.

William Chase

Thanks, Jeff. I’ll take the HUMIRA patent question and the reformulations and I’ll let Dr. Leonard or Rick go with the latter question.

You know, certainly we do have a number of patents that we have submitted at this point in time. You’re right to characterize those as process manufacturing, etcetera. You know, obviously, this is very competitive space and you know, we’re not going to provide a lot of granularity around what those look like and the timing, but it’s safe to say that we do have a fairly significant and robust portfolio of applications in right now. Obviously trying to do as much as we can to protect HUMIRA in the event that bio-similars do find a pathway to market.

In terms of reformulation, again, a similar story. You know, we’ve talked about opportunities to enhance the product both from a delivery mechanism as well as the product itself. We’re not going to be very specific in terms of what that looks like and the timing, but again, we are working on those. We have a window here, our patents don’t expire until later in the decade and we’re putting forth as much effort as we can right now to enhance the products such that if someone is working towards a bio-similar of today’s product, that may not be the product that exists down the road.

So I think I’ll leave it at that, Jeff. Hopefully that’s helpful.

Jeff Holford – Jefferies & Company

Thank you.

Richard Gonzalez

Jeff, this is Rick. So on the competitiveness of the HCV, you know, as I said in my comments, you know, our goal is to basically deliver therapy to the marketplace. It gives patients the greatest opportunity to be cured. And we want to do that as broadly as we possibly can across [inaudible]. We want to be able to do that for naïve patients and we want to do that for even the very difficult to treat and all those fibrotic patients, et cetera.

I think as we look at our data and the data we just presented last week at EASL, I think we’re demonstrating that. You know, you look at the fibrosis data and the aisle 28b data that we presented at that meeting and I think we have outstanding performance, right. It doesn’t degrade at all. So I think we feel very good about the competitiveness of our program based on the objectives that we have for it and we feel good about the timeline that we’re operating against.

And so, I think we have a high level of confidence in our HCV program.

Jeff Holford – Jefferies & Company

Thanks very much.

Richard Gonzalez

Thanks, Jeff.

Operator

Thank you. Our next question is from Greg Gilbert from Bank of America.

Greg Gilbert – Bank of America

Thank you, good morning. A couple quick ones. First, is there any color on HUMIRA outside the U.S. you can offer in terms of lumpy order patterns or tenders as we progress through the remaining quarters of the year?

Secondly, I was curious if you’re willing to quantify your royalty burden on the product and how that changes over time?

And third, for John, I wanted your take on your strategy for – and sort of your take on overall the breakthrough status versus fast-track status that is available to the industry and how that might apply to your novel portfolio. Thanks.

John Leonard

It’s John. The regulatory question of breakthrough status, you know, it’s an avenue that the Food and Drug Administration has opened up that we think is a valuable one in that it permits more access and more opportunity to discuss data as it emerges and to have good planning. It doesn’t necessarily predict a regulatory outcome, however, or accelerate the review. So we filed for breakthrough status on some of our products and we’re looking forward to hearing from the FDA so that we can, as always, welcome additional interaction with them.

But I think in terms of planning for review status and all that, I would treat it essentially the same way that we always have until now.

William Chase

And Greg, it’s Bill Chase. On the – on your HUMIRA tender question, as you know, tenders occur fairly choppily throughout the year. If you look at Q1 in international, even if you exclude those tenders, international still had double digit HUMIRA growth. The tenders actually gave it about a 3% lift. We’d see that basically coming out of Q2 and then the second half of the year, a little difficult to call at this point in time, but it does have a tendency to move around a little bit on us and we’ll certainly give you visibility as that occurs.

Greg Gilbert – Bank of America

Okay, so a few percentage points in a given quarter is a decent way to think about it?

William Chase

Yeah, I think that’s the right way to look at it.

Greg Gilbert – Bank of America

Okay. Thanks.

Richard Gonzalez

And Greg, this is Rick on the HUMIRA royalties. You know, we don’t provide product level P&L detail, so we’re not going to go through the royalties in any level of detail. What I would say is there have been reports put out, Jami’s report in particular that came out recently. I think the premise behind that report, we would feel is accurate, is appropriate. And the range that was characterized in that report of 5 to 10%, if you looked at it across on a global basis I think is a reasonable range to think about it. So I think that should give you some clarity around the royalties and the expiration of those royalties.

Greg Gilbert – Bank of America

Thanks.

Operator

Thank you. Our next question is from Chris Shad from JPMC.

Chris Shad - JPMC

Great, thanks very much. Just a couple questions here. The first is, just with the negative opinion from [inaudible] last night in Europe, just mention any thoughts you might have of kind of what that means to the dynamic impact to the HUMIRA business, et cetera.

The second question, just coming out of EASL, I think there was some comments in the company that they would consider looking for partners in the [inaudible]. I just wonder if you could elaborate a little bit on that and talk about any priorities there.

And then finally on the oral [inaudible] programs, just update where we are there maybe as you’re considering that, just maybe longer-term, how important do you see having an oral agent in the portfolio and maybe second, how much differentiation you believe you believe you’re going to see between the various jacks that are out there. Thank so much.

John Leonard

Thanks for the question, it’s John Leonard. Let me start with the EASL comments. Scott’s comments were taken out of context and are not accurate. We’re very confident in the work that we have with our first generation program. We’re also extremely excited and confident about the elements of our second generation program. We’ve not been actively looking for partners. I think the story was essentially a distraction.

With respect to Jack, the importance of having an oral jack, we’ve shared our longer-term strategy in the immunology space is to try to enhance the overall benefit risk profile and I think we’ve seen some evidence of how important that is. Our goal is to take some of the learnings that have come from the jack space and try to tease that apart and build that into our own oral program with the intention of getting to higher levels of efficacy than achieved in the space. That’s our primary goal and of course, that’s what we’re striving for.

With respect to where we are, you undoubtedly know that we have a relationship with Golopogas, they’ve shared some early information on their compound, which we think is very, very exciting and they’re moving into 2b work the middle of this year. That will be dose ranging that will test q.d. and b.i.d regimens. We’re very excited about its profile, particularly with respect to what we think is a very attractive adverse event profile and the efficacy, oh well, based on small patient numbers for a short duration, we think is definitely intriguing and worth pursuing.

Our own internal jack program goes for great specificity to select out the jack 2 activity, which we think has been dose limiting in some of the first generation compounds and that’s well into its Phase I program and progressing well.

Richard Gonzalez

All right, Chris, this is Rick. I’ll cover the Pfizer comment. I mean, basically we don’t know much more about the Pfizer situation than you do, than what’s been publically reported. So you know, I think as far as the dynamics are concerned, our projections would have been a relatively modest impact in 2013 anyway in Europe, based both on the timing and how difficult this market is to break into. I think you’re seeing that in the U.S. launch today. The challenge is that any competitor coming into this market tends to face. I don’t think it has any dramatic impact on what we had forecast and we’ll just have to see how it plays out longer term as Pfizer continues to pursue approval of that product in Europe.

Thanks, Chris.

Operator

Thank you. Our next question is from Marc Goodman from UBS.

Marc Goodman – UBS

Yes, first on Duodopa, which we haven’t talked about yet, can you just give us the sense of what are the major countries that it’s doing well in in Europe and just flush out how you’re doing on the new delivery system that you’re working on?

John Leonard

With respect to Duadopa’s launch, primarily in Europe, and it’s used most in the Nordic countries, I think that’s where it’s getting most of its use.

Thanks, Marc.

Operator

Thank you. Our next question is from Michael Tong from Wells Fargo

Michael Tong – Wells Fargo

Hi, good morning. I actually want to ask an AndroGel question. You made the comment about a slowdown in the growth of that market. Do you think that’s temporary or is that permanent and are you surprised that the market growth has actually decelerated with a couple of new entries or, you know, recent entries into the marketplace?

And then second question is, from Bill, if you can remind me your CapEx expectations for 2013? Thanks.

Richard Gonzalez

Michael, this is Rick. On AndroGel, you know, we have seen the markets slow down. You have to remember, this is a market that grew very rapidly in 2012, so if you look at the average in the first quarter, I think it’s down around high-single to 10% kind of range. You know, I think that’s probably a reasonable expectation to think about going forward from a market growth standpoint, that this market will grow roughly in the high-single digits kinds of ranges going forward. I don’t think that surprises us that much. You know, every market tends to slow down over time and I think if you look at the fundamentals of this market, that’s what we would expect going forward.

And so that – our planning assumptions are now built around that kind of market growth going forward for 2013.

William Chase

And Michael, it’s Bill. On a CapEx, this is a business that runs pretty lean on CapEx. We are, over the next couple of years, obviously going to have to separate from Abbott, which will increase CapEx somewhat, but this year we’re anticipating about 500 to $600 million.

Michael Tong – Wells Fargo

Thank you.

William Chase

Thanks, Michael.

Operator

Thank you. Our next question is from Alex Arfaei from BMO Capital Markets.

Alex Arfaei – BMO Capital Markets

Good morning. Thank you for talking the questions. Just a follow-up on HUMIRA. I was wondering if I could ask a higher-level question. We’d love to get your insight about some of the trends you’re seeing in different geographies, for example, are things getting better in Europe? You know, if you could elaborate a little bit more on emerging markets. We know there are a few smaller biosimilars in a couple of emerging market countries, if you see that a, you know, what your outlook is with that in general. Just an overall picture on, not just so much for arthritis but also different indications. Thank you.

Richard Gonzalez

Alex, this is Rick Gonzalez. So I think if you look at Europe and you’re seeing this for a number of years now, we continue to see good strong robust growth in Europe in this particular area. I think one of the things that Europe has really adopted and valued is the ability to be able to put the disease in remission and be able to hold it in remission for long periods of time. So you know, we continue to see market growth in the double digit range in that market. When you look at the penetration rates across all three major areas, the penetration rates are still relatively low and so we would expect that we’ll continue to see that growth going forward in the programs that we have I place I think have been demonstrated to be very effective at both helping market growth as well as driving improvement in share, growth in share in the indications particularly [inaudible] as I indicated. But also we’re continuing to hold our own from an RA shares standpoint. And so I think we feel good about the dynamics in Europe. You know, there’s still problematic countries in Europe, for sure, but I think overall, if you look at Europe in general it’s performing within our expectations and I think it’s a market that we think is a good market for products like HUMIRA.

As far as the emerging market, I think one of the things that’s important to remember is that, you know, the majority of our business is still in the developed markets, roughly 85% of our revenues come from the developed markets. There are some emerging markets like a Brazil that are relatively large markets for us but there are also a number of markets that are relatively small. And so we have not seen any material impact from any biosimilar competition in the emerging markets or anything what we would perceive to be any kind of an issue for the business going forward in those emerging markets.

Alex (Arfaei) – BMO Capital Markets

Great. Thank you very much.

Larry Peepo

Thanks, Alex. We have time for one more question today.

Operator

Thank you. Our final question today is from Damien Conover from Morningstar Investment Services.

Damien Conover – Morningstar Investment Services

Hey, good morning. Thanks for talking my question. Just two questions. One on HUMIRA sales in the U.S.A., very strong growth, but in the press release, rheumatoid arthritis wasn’t really called out for the support of that growth. I was just wondering if you could talk through some of the dynamics there.

And then secondly, when you’re looking at the hepatitis C market in a broad picture, as these next generation of [inaudible] come to the market with very strong efficacy and lower side effects, I was wondering if you could share your thoughts on the expected treatment rates for this space given that it’s very low right now, just so to take a look at the overall market growth. Thank you.

Unidentified Company Representative

On HUMIRA U.S. sales, you know, on RA we called out the more rapid growers and that would be gastro and dermatology. Certainly we do still see growth in RA, it’s certainly more modest than those other two areas, call it mid-single digit growth for the market, maybe a little bit stronger for us. And again, holding share despite new entrance into the RA space, but certainly a lot of our growth continues to come from dermatology and gastro, derma on the low end of penetration rates, we continue to see a lift in penetration rates, which, as you know, are still only in the single digits at this point in time in dermatology. So we called up the two biggest growers but RA continues to grow and we’re holding share in that space.

Richard Gonzalez

And Damien, this is Rick. On the HCV question, you know, as we look at this market, we do expect to see some acceleration, significant acceleration in market growth. I mean, I think to frame the size of the market and give you some perspective on it, you know, today if we look at geno-type 1 and the G7, we would estimate somewhere around 2.5 million people are currently diagnosed as being infected with the disease. If you go back to 2011, roughly 175,000 patients were treated. And so there is some clinical capacity constraints that exist today with the current therapies. As we bring these next generations of products to the marketplace in that 2015 timeframe, there’re obviously simpler protocols to be able to administer from a physician’s standpoint and the side effect profile is dramatically improved from the generation of products that exist today.

So you would expect that you would be able to increase the number of patients who are treated at that point. We’re estimating that that number could grow to the 350 kind of thousand range per year.

As far as the patient types, I think, you know, our perspective on it is, this is a disease that progresses very slowly and as these new therapies come to market, we think that healthcare systems and physicians will prioritize those patients that need the therapy the most and I think particularly if you can bring a therapy to market that has a 90% plus kind of mature rate for those patients, which hasn’t been seen before with the current therapies that exist today, there’ll be motivation to go treat those patients. And so we think in the early parts of the launch, the first few years, that we should see a significant number of those patients being treated. Obviously, that makes us feel good about our particular therapy. Thank you.

Operator

That concludes today’s conference call.

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