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Pfizer Inc. (NYSE:PFE)

Q4 2012 Earnings Conference Call

January 29, 2013, 10:00 AM ET

Executives

Ian Read - Chairman and CEO

Frank D’Amelio - EVP and CFO

Olivier Brandicourt - President and General Manager, Emerging Markets and Establish Products

Mikael Dolsten - President, Worldwide Research and Development

Geno Germano - President and General Manager, Specialty Care and Oncology

Amy Schulman - General Counsel and Business Unit Lead, Consumer Business

John Young - President and General Manager, Primary Care

Chuck Triano - SVP, Investor Relations

Analysts

Tim Anderson - Sanford Bernstein

Chris Schott - JP Morgan

Jay Olson - Goldman Sachs

Mark Schoenbaum - ISI Group

Andrew Baum – Citigroup

Gregg Gilbert - Bank of America Merrill Lynch

Alex Arphe - BMO Capital Markets

Mark Goodman – UBS

Tony Butler - Barclays Capital

Seamus Fernandez - Leerink Swann & Company

David Risinger – Morgan Stanley

Catherine Arnold - Credit Suisse

Stephen Scala - Cowen & Company

Michael Tong - Wells Fargo Securities

Kim Vukhac - CLSA

Operator

Good day everyone, and welcome to Pfizer’s Fourth Quarter 2012 Earnings Conference Call. Today’s call is being recorded. At this time, I’d like to turn the call over to Mr. Chuck Triano, Senior Vice President of Investor Relations. Please go ahead, Sir.

Chuck Triano

Thank you, operator. Good morning and thank you for joining us today to review Pfizer’s fourth quarter and full-year 2012 performance.

I’m joined today by our Chairman and CEO, Ian Read; Frank D’Amelio, our CFO; Olivier Brandicourt, President and General Manager of Emerging Markets and Establish Products; Mikael Dolsten, President of Worldwide Research and Development; Geno Germano, President and General Manager of Specialty Care and Oncology; Amy Schulman, General Counsel and Business Unit Lead for our Consumer Business; and John Young, President and General Manager of Primary Care.

The slides that will be presented on this call can be viewed at our home page at pfizer.com by clicking on the link for Pfizer quarterly corporate performance, fourth quarter 2012 located in the Investor Presentations Section in the lower right-hand corner of this page.

Before we start, I’d like to remind you that our discussions during this conference call will include forward-looking statements and that actual results could differ materially from those projected in forward-looking statements. The factors that could cause actual results to differ are discussed in Pfizer’s 2011 annual report on Form 10-K and in our reports on Forms 10-Q and 8K.

The discussions during this call will include certain financial measures that were not prepared in accordance with generally accepted accounting principles. Reconciliation of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in Pfizer’s current report on Form 8-K dated today, January 29, 2013.

In addition, we will offer some brief comments regarding the potential IPO of a minority stake in our Animal Health business, Zoetis. As I’m sure you’ll understand we’re not going to be able to respond to questions on that subject in light of the quiet period imposed by the securities laws.

With that, I’ll now turn the call over to Ian Read.

Ian Read

Thank you, Chuck and good morning, everyone. During my remarks this morning I will briefly recap the progress we made in 2012 improving the performance of our innovative core and in creating value for our shareholders. I’d also discuss our focus 2013.

2012 was a year of very strong operational financial performance especially given our LOE challenges. We drove operational growth in many of our key products in the patent protected portfolio including Lyrica, Enbrel, Prevnar 13, Celebrex and Sutent. Operationally Emerging Markets grew 12%, animal health grew 6% and the consumer business grew 8%.

Also during 2012 we executed on our plans allocating capital in ways that it enhance shareholder value. We reduced our total adjusted cost of sales SI&A and R&D expenses on an operational basis by approximately 10%, which is nearly a $4 billion reduction versus 2011 levels.

We realized significant value for our shareholders through the sale of our Nutrition business to Nestlé for $11.85 billion, and we’re on track subject to market conditions to unlock value from our Animal Health business by completing our IPO Zoetis in the near future, and we returned nearly $15 billion to shareholders through dividends and share repurchases.

Our focus on creating and productive and sustainable innovative course is yielding results. Our fourth quarter was highlighted by two important product approvals, Xeljanz in the U.S. and Eliquis in the U.S, Canada the EU and Japan. Along with our time at Bristol-Myers Squibb we’re looking forward to launching Eliquis in the U.S. shortly, and believe its strong clinical profile can establish this medication as an important new treatment option in the high need area of stroke prevention for patients with nonvalvular atrial fibrillation.

Our Specialty Care business is in the initial phase of launching Xeljanz in the U.S., a first-in-class compound with a compelling clinical profile and oral dosing. We believe these factors will position us competitively within the moderate to severe rheumatoid arthritis market.

We are prepared to invest in both of these products at competitive levels to support their launches. In addition to Xeljanz and Eliquis, during 2012 we received approval for three additional new medicines in light of advanced renal cell carcinoma in the U.S., the EU and Japan, Bosulif for CML in the U.S. and Eleyso for Gaucher disease in the U.S.

During the year, we also advanced our early and mid-stage pipeline most notably in oncology and vaccine areas. We move forward in Phase 3 studies with dacomitinib for non-small cell lung cancer and inotuzumab for aggressive non-Hodgkin's lymphoma.

We reported encouraging Phase 2 data from our CDK 46 inhibitor for advanced breast cancer. This asset formally known as PD-332991 is now palbociclib. We commenced a Phase 3 study for inotuzumab for acute lymphoblastic leukemia and we began a Phase 3 study for meningitis B vaccine for individuals aged 11 to 25. I believe we are entering 2013 with one of the most robust pipelines in the company's recent history.

The actions we set in motion early in 2011 to improve R&D productivity are starting to bear results and we look forward to additional progress June 2013. We have a pipeline that I believe includes high-value assets at all stages of the development continuum across our key therapeutic areas.

As of late last year, our pipeline contained a total of 78 programs including 59 new molecular entities. There were 17 programs in Phase 3 clinical testing and eight in registration. Throughout 2012, we concentrated on advancing our pipeline, reducing our cost structure and returning value to our shareholders. I believe that through the dedication and focus of Pfizer colleagues, we have delivered on each of these goals.

Turning to 2013, as I've discussed with you on previous calls, we have two distinct operating models within the developed markets. One model supports our innovative driven business; primary care, specialty care and oncology. The second model supports our value-driven business that comprises the off patent products within our Established Products unit.

In terms of the Emerging Markets, our operational model has a geographic focus that supports both, the innovative driven and the value driven business. This is working well in these high growth geographies. That said, as these markets evolve, we will evaluate if our Emerging Markets operating model should more closely mirror the two distinct approaches we have for developed markets.

The Consumer Healthcare business continues to be important as we pursue Rx to OTC Switch opportunities. We believe these are the right models for achieving the best performance for Pfizer over the next several years. During this time, we will be able to focus on the market success of our new products, advance our early and mid-stage pipeline, drive continued growth in Emerging Markets in both our innovative and all patent portfolio.

Additionally, we'll have put behind us our most significant LOEs. We will also continue to use business development opportunities to supplement both our research and internal product efforts. Our primary focus remains both on acquisitions that are projected to meet or exceed the return on investment of share repurchases.

More specifically in 2013, you will see us focused on continuing to maximize the value of our in-line portfolio including key in-line assets such as Lyrica, Celebrex, Enbrel, Viagra and Prevnar 13; maximizing the performance of the products approved in the last two years; continuing to advance the mid-to-late stage pipeline in vaccines, oncology, cardiovascular information; focusing on the high-growth, high-margin off-patent opportunities; focusing opportunities in key growth markets such as China, Brazil, Russia, India, Turkey and Mexico; continuing to work on managing our expenses and driving ongoing efficiencies within our manufacturing network so we have a lower and flexible cost base that allows us to respond to pricing pressures and our upcoming LOEs; and continuing to return capital to shareholders through dividends and share repurchases.

In summary, our results in 2012 demonstrated that we’re focused on the right areas and are making visible progress towards sustained value creation. In 2013 we must maintain our momentum by continuing to execute by delivering on the potential within our pipeline and by demonstrating fiscal responsibility in how we use our capital. We are committed to helping patients by delivering innovative medicines and creating value for our shareholders.

Now, I’ll turn it over to Frank, for additional details on the quarter and our 2013 financial guidance.

Frank D'Amelio

Thanks, Read, and good day everyone. As always, the charts I’m reviewing today are included in our webcast. I want to again remind you that the Nutrition business is presented as a discontinued operation in consolidated statements of income for all periods presented. As you know, discontinued operations are excluded from adjusted financial results consequently throughout 2012 until its sale on November 30th. The results of the Nutrition business have been excluded from adjusted results.

Now let’s move on to the financials. Fourth quarter 2012 revenues of approximately $15.1 billion decreased 7% year-over-year reflecting a 2% negative impact from foreign exchange an operational decline of approximately 5% driven mainly by the loss of exclusivity of several key products in certain geographies notably Lipitor in all major markets.

Adjusted diluted EPS of $0.47 decreased 4% primarily due to the previously mentioned decrease in revenues, which was partially offset by an aggregate operational decrease of 9% and adjusted cost of sales, adjusted SI&A expenses and adjusted R&D expenses primarily resulting from cost reduction and productivity initiatives, and fewer weighted average shares outstanding due to our continued share repurchases.

Reported diluted EPS was $0.85 compared with $0.19 in the year-ago quarter, in additional to the factors previously mentioned. Reported diluted EPS was favorably impacted by the gain on the sale of the Nutrition business to Nestlé and lower overall cost, which were partially offset by the negative impact due to loss of exclusivity of certain products and several geographies and higher restructuring charges.

Foreign exchange negatively impacted fourth quarter revenues by 2% or $271 million and unfavorably impacted adjusted cost of sales, adjusted SI&A expenses and adjusted R&D expenses by $161 million or 1%. As a result, foreign exchange negatively impacted fourth quarter adjusted diluted EPS by approximately $0.05.

In the fourth quarter of 2012 Emerging Markets biopharmaceutical revenues were approximately $2.7 billion which reflects operational growth of 20% and the negative impact of foreign exchange of 3%. The revenue growth in Emerging Markets this quarter was driven primarily by strong volume growth in China, overall Emerging Market growth as well as the timing of government purchases of Enbrel in Brazil and Prevnar 13 in Turkey compared with the year-ago quarter.

Volume growth of 22% in Emerging Markets was partially offset by price reductions of 2% resulting in the 20% operational growth. Of the fourth quarter Emerging Markets biopharmaceutical revenues approximately 42% which generated by Established Products, 34% by specialty and oncology products and 24% by primary care products.

Fourth quarter biopharmaceutical revenues in the BRIC-MT markets were approximately $1.2 billion which reflects operational growth of 26% and the unfavorable impact of foreign exchange of 4%. Of the fourth quarter BRIC-MT biopharmaceutical revenues, approximately 46% was generated by Established Products, 29% by specialty and oncology products and 25% by primary care products.

During the fourth quarter, biopharmaceutical volume growth of 30% in the BRIC-MT markets was partially offset by price reductions of 4% resulting in operational revenue growth of 26%. Full-year operational growth in the BRIC-MT markets was 60% versus the year-ago period, reflecting volume growth of 20% partially offset by price reductions of 4%.

As you can see in 2012 we met or exceeded most components of our financial guidance including achieving the top-end of our full-year 2012 revenue guidance and exceeding our just diluted EPS guidance. Our 2012 adjusted R&D expenses of $7.3 billion reflect opportunities to accelerate investments and promising late stage pipeline assets including palbociclib and advanced breast cancer.

However, I want to point out that we expect full-year 2013 adjusted R&D expenses to be in the range of $6.5 billion to $7 billion. And as I previously mentioned, reported diluted EPS was primarily favorably impacted by the gain on the sale of the nutrition business.

Now moving on to our 2013 financial guidance, which incorporates the full-year contribution from Zoetis, I'd like to comment specifically on a few elements of the guidance. First, we expect reported revenues to be in the range of 56.2 billion to 58.2 billion. I want to point out that this range includes the absorption of an anticipated $4 billion negative impact due to the loss of exclusivity of certain products in several geographies and to the near-term expiration of certain co-promotion agreements.

In addition, it's important to note that approximately 200 million of 2012 revenues associated with products that Pfizer is contributing to the Pfizer-Hisun joint venture in China announced in 2012 will not be recorded as Pfizer revenues in 2013. The results of the joint venture will be recorded in other income.

We expect 2013 SI&A to be in the range of 15.6 billion to 16.6 billion, the midpoint of which is less than the 2012 actual spending level. This range includes spending and support of key product launch opportunities such as Eliquis, Xeljanz and Prevnar 13 Adult.

These are significant product opportunities and we intend to appropriately fund and support these launches to be competitive. In addition, we plan to essentially offset those incremental expenses through our cost reduction initiatives.

We also expect our 2013 tax rate on adjusted income to be approximately 28%, which among other items includes the federal R&D tax credit renewed by Congress under the American Taxpayer Relief Act for both 2012 and 2013.

Finally, we expect adjusted diluted EPS to be in the range of $2.20 to $2.30. This range includes a $0.02 unfavorable impact for certain ongoing costs associated with the potential separation of Zoetis, including the interest expense on Zoetis debt, certain duplicative costs for corporate support and manufacturing functions and other costs, as well as a $0.02 negative impact reflecting the difference in actual foreign exchange rates in 2012 compared with the mid-January 2013 exchange rates. As always, we will continue to monitor foreign exchange fluctuations and will update the potential impact if any on our 2013 expectations.

I want to point out that with all other things being equal, the inclusion of the $0.02 of cost related to the separation in Zoetis and the $0.02 impact of recent foreign exchange movements has negatively impacted our 2013 adjusted diluted EPS guidance range by $0.04. Excluding these items, our adjusted diluted EPS guidance range would have been $2.24 to $2.34.

Now moving on to key takeaways, we achieved the top end of our full year 2012 revenue guidance and exceeded our adjusted diluted EPS guidance. Our initial 2013 financial guidance includes the full-year contribution from Zoetis.

We recently completed a 3.65 billion offering of Zoetis senior unsecured notes and remain on track to complete a potential initial public offering of up to a 19.8% ownership stake in Zoetis in the near future.

In November, we completed the sale of our Nutrition business to Nestlé for $11.85 billion. During the fourth quarter, we received U.S. regulatory approvals for Xeljanz and Eliquis. We continue to create shareholder value through prudent capital allocation.

In 2012, we repurchased 8.2 billion or 349 million shares. As of December 31, 2012, we had 11.8 billion of authorization remaining under our current repurchase programs. Overall, we returned almost 15 billion to our shareholders in 2012 through dividends and share repurchases.

Finally, we remain committed to delivering attractive shareholder returns in 2013 and beyond.

With that, I'll turn it back to Chuck.

Chuck Triano

Great. Thanks for the commentary, Frank, and operator at this point if we could please poll for questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Your first question comes from Tim Anderson from Sanford Bernstein.

Tim Anderson - Sanford Bernstein

Thank you. On your tax rate guidance in 2013, can you say what it would be without (indiscernible) accounting and the R&D tax credit? And you had a one-time -- actually at the time of the Wyeth merger suggested a longer term rate of maybe 30%. Seeing what Bristol-Myers had done on lowering its tax rate remarkably, I'm wondering if you have any ability to restructure any of your legal entities as well. And then a second question, its obviously one that you get asked about a lot, but can you give us your latest thoughts on potentially carving up the drug side of business and the truly separate companies like you’re doing with Zoetis. You’ve been alluding this for -- for those possibility for quite sometime now, but I think investors don’t really know it's sort of hard to assign to it, so when you say its higher probability, is it (indiscernible) size or is it lower probability?

Ian Read

Thank you, Tim. I will ask Frank to take care of the tax rate guidance and explain the 30% tax rate and any other comments you want to make on tax.

Frank D’Amelio

Sure. So, Tim on the 28%, which is down from 29.3% in 2012. That even if we didn’t have this, I will call it the double benefit of the R&D tax credit in 2013, our tax rate would be closer to 28% and to 29%. So that’s the way to think about it. What will happen in 2013 is we recorded the 2012 benefit in Q1 and then 2013 benefit we record throughout the year, just in terms of the accounting mechanics of the R&D tax credit. In terms of legal entity restructuring the way I think about that is our tax planning. We do tax planning all the time. If you look at our tax rate over the last couple of years, it’s gone from 30% to last year’s slightly higher than 29% and our guidance for this year is approximately 28%, we’ll obviously continue to do tax planning. But the one thing I will say is, trying to project tax rates beyond 2013, given everything that’s going on and with the uncertainty which is corporate tax reform I think is not approved in thing to do.

So our current guidance is approximately 28% and obviously we’ll do everything we can to meet or achieve – or exceed that guidance.

Ian Read

Tim on your additional question on the business models, I think I’ve been talking some time now when discussing this with investors, that I see that we have two models or two businesses within Pfizer today, major segments. One being the innovative core and one being what we call value, which is basically post or pari – post-LOE products. And we have made that operational separation in the developed markets, in the U.S. and in Europe and Japan and Australia or in Korea and places like that. We haven’t made that separation in Emerging Markets where we run it from a geographic basis. Although in the major markets we’re moving towards creating units within those geographies that specialize in oncology or primary care or Established Products.

I believe that at some point the markets will separate globally and there will be an innovative market distinct from an established market and I think Pfizer will continue to evolve into being managed that way. So, I hope that answers your question. Right now, as I think I said in my opening comments, Emerging Markets is working well, structure in the developed markets is working well, we’re focused on the new launches, the pipeline, our capital allocation, expense discipline and we’ll continue to evolve our model as we see value opportunities.

Chuck Triano

Great. Thank you, Ian. Our next question please, operator.

Operator

Your next question comes from Chris Schott from JP Morgan.

Chris Schott - JP Morgan

Great. Thanks very much. Just two questions here. Maybe one just kind of following upon on Tim’s questions, and I think you’ve talked about, as the Emerging Markets evolve that, we might see the business model evolve. Just following up on that, does it make sense for Pfizer to keep both a value and innovative core under the same umbrella if we get to a point with the Emerging Markets that structured us and that the current regional structure does not make sense? And the second question is, coming back to the bolt-on acquisitions, can you remind us how large a bolt-on acquisition you considered – you would be considering at this point? What are the priorities for you and when the Company, if a larger deal were to come along with the right fit, is that an opportunity for Pfizer or is that really not in the cards as we consider a capital deployment over the next couple of years? Thank you.

Ian Read

Thank you, Chris. Going back to the possibilities of [EM] and why would it make sense for Pfizer that to have those two businesses, I think it is not really a lot of point on speculating over this. Today we have both businesses certainly in an innovative side, need to be careful that you have – it tends to be more volatile and the Established Products allows you to take short-term movements in volatile in the business. But that being said, we will look at it, we will I believe move towards a separate management. And at that point, we'll be able to evaluate with the shareholders would prefer to have the option to invest in two distinct companies or not. I don't think that is a short-term priority right now for us. The priority is to evolve our internal model and measure how successful those businesses are and what management and leadership they require and are they distinct enough to go further.

On the bolt-on acquisitions, we've said that we are focused on generating shareholder return and I'm going to make a few comments and ask Frank to add to it if he wants to. So, we look at bolt-on acquisitions as a way of adding high value businesses or intellectual property to Pfizer that can generate positive returns to shareholders above what we see as opportunity to share buybacks. Bolt-ons, I don't want to give you precise number, we did King that was 3.7, so what's a bolt-on? Middle multiples of that number, you pick it where our market cap's 180 billion what we do consider bolt-on for that size of company.

Now as regards larger opportunities, we look at everything from a point of view of does it add value to Pfizer's shareholders? If it adds value, we never say never, we consider opportunities, but right now we continue to be focused on running our internal business and looking for bolt-on opportunities.

Frank D’Amelio

I'll just add maybe three items to Ian's comments. I think first the way we think about this (indiscernible) in general is it's not a strategy in and of itself, it's an enabler of our strategy. So that would be point number one. I think the second thing in terms of bolt-ons, I think Ian sized it perfectly. King was several billion dollars. We viewed that as a bolt-on, the way we think about that. In terms of the priorities, which is something you asked, no changes. I think our priorities remain on focus therapeutic and disease areas, including the Emerging Markets. That's clearly where we've been biasing and I think that's where we'll continue to bias. Then in terms of the large deals, just to punctuate what Ian said, there's no new news here. We always say we never say never but our focus has been and continues to be on bolt-on acquisitions.

Ian Read

Well, continues to be on bolt-on acquisitions and those acquisitions that add value to our shareholders.

Chris Schott - JP Morgan

Thank you.

Chuck Triano

Thank you. Our next question please operator.

Operator

Our next question comes from Jami Rubin from Goldman Sachs.

Jay Olson - Goldman Sachs

Hi. This is Jay Olson on behalf of Jami Rubin. A couple of questions. First off, with the focus on optimizing both your innovative and your value-based businesses, and we appreciate the significant progress being made in the innovative side with new product launches and pipeline progress. We wonder if you could elaborate a little on some of the initiatives you're taking to optimize the value-based business. And second of all, I understand your comments may be restricted, but could you help us understand what might be a fair timeline for your potential decision to monetize the remaining 80% of Zoetis and would a share exchange be something you would consider if Zoetis' shares traded a premium to Pfizer? Thank you.

Ian Read

Thank you, Jay. I'll ask Olivier who runs the Established Products business and Emerging Markets if he can comment on the work we're doing to grow what we call a value business. And then Frank will answer the question and I will help.

Olivier Brandicourt

So thank you for your question. What we're trying to do in the Establish business division is to maximize the performance of those products in the LOE space and supporting their lifecycle, potentially with line extension and (indiscernible) product formulation. We also have recently built on the opportunity to quickly provide very reliable source of product in shortest situations. And we've been very active on the U.S. market in that space. We made also a move on sterile injectable. We think it's a high value space for the post LOE market. And in the space of differentiated formulation, I don't know if you've seen recently but we launched Quillivant XR in January. It was the first and only product which is in liquid formulation, an extended release for kids between 6 and 12 years old, with ADHT and we think we’re going to be prove that, enhance and better formulation very competitive in that marketplace. So just providing few examples of what we’re doing.

Ian Read

Thank you, Olivier. I will probably add to that we also have an active program in biosimilars, which would – I would consider probably in the post-LOE space.

Olivier Brandicourt

Sure.

Ian Read

Frank?

Frank D'Amelio

So on Zoetis, I just want to reiterate what Chuck said at the beginning of the call, which is we’re in a quiet period, so I’m very limited in what I can say. So, what I can say is, we remain on track to complete a potential IPO for up to a 19.8% stake in Zoetis in the near future and the road show is taking place and relative to beyond the IPO, we’re assuming one is completed, we will have a number of alternatives that are available to us for distributing and the remainder in to remaining shares and obviously we’ll do what’s best from an after tax return to our shareholders.

Chuck Triano

Great. Thank you, Frank. Next question please, operator.

Operator

Your next question comes from Mark Schoenbaum from ISI Group.

Chuck Triano

Hello, Mark.

Mark Schoenbaum - ISI Group

Sorry, can you hear me?

Ian Read

Yeah Mark, loud and clear.

Mark Schoenbaum - ISI Group

Apologies for that. Maybe I can ask couple of pipeline and product related questions. Number one on PD-991, I think this is the first earnings call since the fantastic data a month or two ago, just wondering if you can clarify your plans in terms of filing timelines and also if you can help us understand the market opportunity for that, that would be great. Then also, two major product launches this year, Pfizer arguably the highest profile launches in all biopharmas with Xeljanz and Eliquis. I would love it if you could give the investment community any advice or wisdom, when we think about those launches and maybe compare and contrast. Thank you.

Ian Read

Thank you. So on PD-991, palbociclib, I would ask Geno to comment on that and on that I can say outstanding data we got in the first of the Phase 2 trial. And then perhaps Geno would make some comments on how we see the evolving launch of Xeljanz and then John Young could make some comments on the launch of Eliquis. Thank you.

Geno Germano

Okay. So for palbociclib, as you mentioned, we had some really terrific data that we were able to present in San Antonio last year that trial continues into this year. There are two patient cohorts. The one first patient cohort has completed, and the second patient cohort will complete later this year, and we’re expecting to present data -- full-fledged data by the end of the year. And as the data emerges we will continue to discuss the data with the agencies around the world and determine the best pathway to bring this product to patients.

Our current focus is on the ER-positive, HER2-negative advanced breast cancer patient population. We expect to initiate a Phase 3 trial in this population that confirms the results that we saw on Phase 2 in the very near term and we’re anxious to proceed with that program. We also have plans to initiate additional Phase 3 programs in other breast cancer patient populations and then to explore the utility of the drug in tumors outside of breast cancer as we go through the rest of this year.

With regard to the Xeljanz, we’re off to a very good start. We’re very pleased with the execution of the launch plans so far. It is early days, but the response’s from physicians has been very favorable. They’re particularly pleased with the second line indication and the ability to use Xeljanz without the need for Methotrexate. These are kind of recurring themes that we’re hearing. We did expect that the majority of initial trial will be in the post-TNF patient population, and we think that, that’s reasonable going forward although we are hearing physicians trying the drug in both the post-Methotrexate and the post-TNF patient population.

Most physicians are putting a hand full of patients on the drug and want to see if the patients come back to evaluate them, and we’re pretty optimistic that when they see those patients return that they will be pleased with the results given the outcome of our Phase 3 trials and in particular the feedback from patients on patient reported outcomes which were actually very favorable in our Phase 3 programs. So, we’re on track, we feel good about Xeljanz – sorry, and I guess, with that I’ll turn it over to John Young.

John Young

Thanks, Geno and thanks for your question, Mark. So obviously we are very excited about the opportunity that we have with Eliquis along with our partners BMS and I think clearly since the last call and a little more than six weeks, Eliquis received back-to-back approvals in the U.S., the 27 countries of the EU, Canada, Japan, South Korea for reducing the risk of stroke and some systemic embolism in patients with nonvalvular atrial fibrillation. So we've already launched in the UK, Germany, Denmark and the launches will progress in the EU over the coming months.

In terms of the profile, which you know very well, clearly Eliquis is the only oral anticoagulant that's demonstrated superior risk reduction versus warfarin in the three critical outcomes of stroke prevention, major bleeding and all-cause mortality in patients with nonvalvular atrial fibrillation. So as a result, we certainly believe it offers a compelling profile for cardiologists and primary care physicians as reflected in our approved labels.

We expect Eliquis to be widely available in most U.S. pharmacies by the end of January. Our U.S. sales teams from Pfizer and BMS are at the internal launch meeting as we speak. I will be on the road speaking to physicians on Monday next week. And overall, we really believe Eliquis differentiated profile combined with the extensive experience that Pfizer and BMS bring to the cardiovascular commercial markets certainly positions us well to succeed. Given the strength of the Eliquis data, the superior risk reduction versus warfarin and those three critical outcomes of stroke prevention, we believe that peers will certainly want to ensure that patients with nonvalvular atrial fibrillation have access to this clinically important medicine. And we expect steady progress as we penetrate this market over the course of 2013 and beyond.

Chuck Triano

Great. Thank you, John and Geno. Next question please, operator.

Operator

Your next question comes from Andrew Baum from Citi.

Andrew Baum - Citigroup

Thanks. Three questions. First, Ian, do you see opportunities for the industry to remove excess capacity, the infrastructure from within EM and established market products through a reorganization consolidation of distribution channels? Second, for Mikael -- for Frank, I'm interested in how tax positioned you think your existing EM and Establish Products business is? And how much would alternative business structures potential enable you to optimize that? And then finally for Geno, apologies, could you just talk to where there's a preplanned interim analysis for your recently initiated first line PD-991 trial? Thank you.

Ian Read

Thank you, Andrew. Excess capacity in Emerging Markets, I think right now probably if you go back to the U.S. market in the '90s, most companies are focused on trying to get as large as a share as they can in these quickly growing economies. So, I don't think people are focused right now on taking out infrastructure. However, I do agree with you that just like we saw in the U.S. and Europe that clearly will be at some point opportunities to rationalize infrastructure in those geographies.

As the second question, I didn't really understand, EP and Emerging -- I didn't really understand I'm afraid Andrew. Perhaps you can come back and reposition it. Geno, could you comment on palbociclib.

Geno Germano

Yeah. In the Phase 3 program, again, we're in ongoing discussion with the agency and our focus is really on finding the best way forward to reveal data that will enable the best decisions on making the drug available to patients. So, we will discuss interim analysis as part of that assessment.

Frank D’Amelio

Yeah, perhaps I could just say on Emerging Markets and EP, we have a clear vision of both businesses. We're getting what we believe are strong results. In EP, you could see the successful switch of Lipitor, you could see the [Coban] launch, focus on sterile injectables, focus on major markets. And in Emerging Markets, we have strong geographic based organizations that are driving value in both our innovative and our post LOE products. Olivier, do you want to add anything to that?

Olivier Brandicourt

I think there is a strong integration of EP products into EM and as we said very valuable. It represents basically about 45% of our revenue growing very strongly this quarter as you've seen that 21% and very often that is a result of combining innovative and EP products into the same sales force. For instance, cardiovascular sales force have this Lipitor and Norvasc, and in many geographies Lipitor is still (indiscernible) where Norvasc is not, but you do optimize the two brands that way. So, there are plenty of synergies to build on.

Andrew Baum - Citigroup

Thank you.

Chuck Triano

Great. Thanks, Olivier. Next question please.

Operator

Your next question comes from Alex Arphe from BMO Capital Markets.

Ian Read

Alex?

Chuck Triano

Alex?

Ian Read

Seems to be an issue.

Chuck Triano

We’ll move on to the next question please, operator.

Operator

Your next question comes from Gregg Gilbert from Bank of America Merrill Lynch

Ian Read

We must be having a problem with the phones.

Chuck Triano

Gregg?

Ian Read

Will give a second to see if it’s a technical issue that people can’t get through. Oh yeah, okay. Who is on?

Gregg Gilbert - Bank of America Merrill Lynch

Can you hear me?

Ian Read

Yes.

Gregg Gilbert - Bank of America Merrill Lynch

It’s Gregg Gilbert. Thanks. First question is on Emerging Markets growth in 4Q, I realize that could be a lumpy growth line. So, perhaps you could set the bar with a reasonable growth vehicle would be annually in ’13 and possibly beyond? My second question, along the lines of maximizing value for the value business, the strategy so far for the developed market portion seems to be focused on Pfizer brands that lose exclusivity coupled with alliances with generic companies that do generic R&D. So going forward, could the strategy also include one internal development of small molecule generics and/or to outright acquisitions of companies in that space? Again, I’m thinking more about developed markets than the emerging piece. Thanks.

Ian Read

Okay. Olivier, could you take the fourth quarter and also refocus the comments on the strategy in the developed markets with the [piece]?

Olivier Brandicourt

Right. Thank you, Gregg. So you’ve seen – we posted 20% operational growth and that is a result actually of very good results across geographies. BRIC-MT have actually posted 26% operational growth, about 30% in volume and offset by pricing, but very strong across geographies and portfolio. Specialty is running at 45% growth this quarter, and as I mentioned before Emerging Market at 21%.

Now having said that, you have a lot of one-time items this quarter, all right, especially Enbrel in Brazil and Prevnar in Turkey and Mexico and if you exclude those one-time items you get to 16% growth for the quarter. And there are still volatility quarter-to-quarter in Emerging Markets and we remain committed to grow our Emerging Market division by high single-digit growth into coming years. So, that’s the first question.

Gregg Gilbert - Bank of America Merrill Lynch

Yeah, and then on the Established Products to maintain the developed markets, what are the key strategies to grow the business such as sterile injectables and launches of Quillivant et cetera?

Olivier Brandicourt

Right. So, we remained focused on Established Products, to your point. We are not focusing in generic – and the generic portfolio outside the U.S. where we have a strong position with as you know with Greenstone. Outside the U.S. it's mainly emerging products – Established Products, and we’re looking to bring sterile injectable and as I mentioned before new and differentiated formulation of Established Product.

Ian Read

Yes, so I suppose in the developed market, we would say that, business is a combination of Greenstone a quality supplier that closes market gaps with quality product. We’ve done that also in the oncology space. We bring important and sterile injectable products. We’re trying to launch innovative formulations and as distinct from Established Products in the Emerging Markets where it's still a primary care business, its field forces, its selling quality and it's selling the brand name of the products in Pfizer. Thank you.

Chuck Triano

Thank you. Next question, operator.

Operator

Your next question is from Alex Arphe from BMO Capital Markets.

Alex Arphe - BMO Capital Markets

Good morning. Can you hear me?

Chuck Triano

Yeah, we got your back Alex.

Alex Arphe - BMO Capital Markets

Okay, great. Sorry about that. A question on Zoetis and its impact on Pfizer. We know from the information that's available that the Zoetis business is a lower margin business. If you were to proceed with full separation, how should we think about the margin expansion for Pfizer? And then on the CAPiTA trial, we know it's expected this year, I'm just wondering if you have a narrower timeline for it and if you could provide us any insights as to how we could quantify the adult opportunity? Thank you.

Ian Read

Frank, if you could take the first part and Geno the second.

Frank D’Amelio

Yeah, so on the impact of Zoetis on our numbers and once again, I'm limited to what I can say. But the intent here is assuming we were to complete an IPO, we would issue – we would revise our guidance in early April after Zoetis has filed its 10-K which would be at the end of March. So at that time, we would revise our guidance byline item and then therefore you could see the impact that it would have on our numbers.

Ian Read

Geno?

Geno Germano

With regard to CAPiTA, the program, the trial continues to accumulate patients. As you know, it's an event-driven trial so we really don't know what the date would be when the final event has been identified. Once we have all the events approved, we will complete the assessment, do the analysis and report the data. We expect that to happen later this year.

With regard to the magnitude of the opportunity, assuming positive results, we think that having a vaccine with demonstrated ability to prevent non-bacteremic pneumococcal pneumonia would be a valuable asset. There are over 300 million adults over 50 years of age in the developed markets and I think the number expands to over 700 million on the global marketplace. So we think that the opportunity is substantial.

Alex Arphe - BMO Capital Markets

Thank you, Geno.

Chuck Triano

Thanks, Geno and Frank. Next question, please.

Operator

Your next question comes from Mark Goodman from UBS.

Mark Goodman - UBS

Yes, good morning. Geno, maybe you can give us some color on some of the oncology launches, how they're going? Second of all, Olivier, I'm curious in the Emerging Markets, given all the cost cutting going on in the overall company, I was curious how much investments are occurring in the Emerging Markets where we invested significantly more for 2013 versus '12? And then maybe we could just get what the key Phase 2 readouts are for 2013 for data? Thanks.

Ian Read

All right, so Geno oncology; Olivier, if you could make some comments on the question there and Mikael, will you do the Phase 2.

Geno Germano

So for oncology, just a couple of comments about Xalkori. We got a full year now in the U.S. Xalkori achieved $100 million from sales in 2012 primarily in the U.S. It's now approved and launched in the U.S., Europe, Japan and several other smaller markets. Sales are continuing to grow as adoption and molecular testing continues to expand. We started out with about a 10% testing rate. Now the testing rate is over 60%.

We think in the past year, we captured about a quarter of the potential patients in the U.S. We're also seeing an expansion in the duration of treatment as we're identifying patients earlier in their disease. So, we're happy with the progress of Xalkori and looking forward to expansion in new markets around the world.

Inlyta has also gotten off to a very strong start in the U.S. where it's already established the leading share in second line. In Japan, it's the second most prescribed drug for metastatic renal cell carcinoma and with a 10% share and 40% in the second line setting. So, in general, we're seeing good growth of Inlyta, continued progress with Xalkori and now we're just getting started with Bosulif.

Ian Read

Thank you. Olivier?

Olivier Brandicourt

All right. So for Emerging Markets definitely represent an important growth opportunity, so we have been investing quite significantly in this market in recent years. We continue to invest to remain competitive, however, we are putting transformation programs to ensure that we are optimizing our sales force and we have the best potential deployment, especially in support of new products which are going to be very important for Emerging Markets and the new launches, in addition to putting in place go-to-market models when it comes to brand marketing. So, while we’re investing, we’re also beginning to get positive leverage from those investments.

Chuck Triano

Thank you, Olivier.

Mikael Dolsten

Yeah, so we have a very exciting Phase 2 cohort reading out more than 10 studies over the next 12 months. I’ll share a couple with you. Immunology, we have our best-in-class aisle 6 antibody with data coming in Lupus and also in Crohn’s disease. We have a Med-Chem antibody for Chron’s disease, a small molecule (indiscernible) oral inhibitor for COPD. In diabetes we have pancreatic glucokinase activator with a really unique profile, reading out in diabetes and glucose control. And we also have a Novel PDE5 inhibitor for diabetic nephropathy. In vaccines, we’re expecting data from Staph aureus. Our F-14 biosimilar are starting to move very nicely. We recently had positive data on Trastuzumab, which is exploring plans to go into Phase 3 while this year we expect data from our second biosimilar rituximab after [finalization] of Phase 2.

In some small areas we’re strengthening our portfolio in rare diseases and have a readout on a GMI-1070 in sickle cell crisis. Also pieces Canine had a positive readout that we’ve reported last year and we have a Phase 2b data coming, which underpins then our path forward to Phase 3.

Chuck Triano

Thank you, Mikael. Next question please.

Operator

Your next question comes from Tony Butler from Barclays.

Tony Butler - Barclays Capital

Thanks very much. Just sticking with the pipeline, (indiscernible) if possible, you actually get the read out of the Phase 3 study ARCHER with dacomitinib this year. And then second, I guess, for Geno going back to Xeljanz, some doc feedback to us, and again its limited, has suggested that patients do not actually know about the drug. Is patient awareness important at this early in the launch? And as a DTC campaign actually in the carts? Thanks very much.

Ian Read

Thank you. Mikael, are you going to talk to the …

Mikael Dolsten

Yeah, so I can mention, we're very excited about dacomitinib. As you know it's a pan-HER inhibitor irreversible binding and it did very well in our Phase 2 data against Tarceva. The ARCHER trial that you referred to is event driven and we expect to date probably more during the first half of 2014 to have accrued the number of ends required to close the trial. In addition to that trial where we go against Tarceva as we did in our Phase 2, we also have another partner trial against refractory non-small cell lung cancer. So, its run by the National Cancer Institute of Canada, so it's a nice study set behind dacomitinib and we look very much forward to see that data come for possibly a new generation of EGFR inhibitors.

Chuck Triano

Thank you. Geno.

Geno Germano

So with regard to awareness on Xeljanz, fortunately within the first few weeks of launch we are near 100% awareness among the prescribing community which is terrific. And as I mentioned before a lot of enthusiasm for the drug. Patient awareness is much lower, and we haven’t done a lot of work with consumers, but we expect to roll out a consumer program around the middle of this year in keeping with the pharmaceutical guidelines to hold off on direct-to-consumer advertising for the first six months of launch. But we do think that consumer communication will be an important driver. We know that consumers are excited about the idea of having an oral option and also excited about the potential to have an effective therapy without the need for Methotrexate.

Tony Butler - Barclays Capital

Thank you.

Chuck Triano

Thanks, Geno. Moving on to next question please, operator.

Operator

Your next question comes from Seamus Fernandez from Leerink Swann.

Seamus Fernandez - Leerink Swann & Company

Thanks for the question. So, first for Ian. Ian, can you just maybe clarify your comments in terms of the separation of the management. Are you planning to actually tighten down the management from the multi-tiered organizations to now officially providing reporting at some point around the structure of the two businesses as you described them, the innovative core and the value business? And then separately, Geno, can you just help us understand back when Prevnar 7, there was a decision at Wyeth way back when to not continue forward with Prevnar 7 in the adult setting in large part because of herd immunity that is created by dosing infants. How do you see herd immunity influencing the adult indication for Prevnar 13 and is it just really more a timing related issue as we think about the impact of herd immunity with Prevnar 13? Thanks a lot.

Ian Read

Thank you, Seamus. What you were really talking about was segment reporting. Right now we have the management split and the responsibility split in the developed markets. We don't have that split in the Emerging Markets, so it's really I think premature at this stage to look at segment reporting. But we'll continue to review that so as to give shareholders the transparency they need with that.

Geno Germano

Seamus, just regarding Prevnar, my recollection is that we choose not to go forward with the adult indication on 7 because we were so focused on advancing and broadening the serotype coverage and getting to 13 ahead of our competition. Once we achieve the formulation for 13, we were anxious to proceed to the adult vaccine.

With regard to herd immunity, we know there is some herd immunity with the vaccination of children. There are a variety of epidemiologic studies that show different rates of herd effect. There are surveillance programs as well underway to identify the herd effect. And what we see is that there is a residual disease burden that we think that the adult vaccine will help prevent in the adult patient population and the opportunity remains significant.

Chuck Triano

Thank you, Geno. Next question, please.

Operator

Your next question comes from David Risinger from Morgan Stanley.

David Risinger – Morgan Stanley

Thanks very much. I have some questions on Xeljanz and then on Emerging Markets future growth prospects. So with respect to Xeljanz, we're going to try to benchmark the prescription trend ramp and I just wanted to understand your sampling program because on the one hand I understand that you are giving 30-day samples, but on the other hand for virtually all drug launches, drug companies give samples, so I don't know if your sampling program is unusually strong relative to other product launches such that we should expect unusually low reported prescriptions?

And then with respect to the once daily Xeljanz which is entering Phase 2 in 2013, could you help us understand whether Pfizer plans to run bridging studies to shorten the timeline to filing and when do you plan to file that once daily for approval?

And then changing gears to Emerging Markets, the operating performance growth was 12% in 2012 including a huge fourth quarter which seems to be driven by some anomalies and I know that you're sticking to your high single digit growth target operationally for Emerging Markets. But is that too conservative because you reported 12% in 2012 and it looks like high-single digits growth going forward would be below market growth or should we think about potential upside to that target for high single digit Emerging Market growth going forward? Thank you.

Ian Read

Thank you. Geno, could you answer the Xeljanz issues..

Geno Germano

With regard to the sampling program on Xeljanz, there's really two components and one is we have a patient support program to help patients access the reimbursement and to go through that process, which is very similar to any of the other drugs that they would be using in rheumatology. So there's a 14-day supply that we make available to patients to ensure that they can start therapy as soon as possible while they're going through that reimbursement process.

In addition to that, we identified a group of rheumatologists who we wanted to have access to drug right away so that they gain experience immediately and we gave 30-day supply bottles to that identified population of rheumatologist to use, to gain that early experience. Now whether we’ll continue to add program into the future or not is unknown at this point, but the very initial impact of these two sampling programs will range from fairly short period of time. And with regards to the once a day program, we’re going to want to have the once a day have adequate labeling to enable use across all of the indications that we’re pursuing. So the program is a robust program and we’re still in discussion actually with the agency on the exact protocol.

Ian Read

Thank you. David, on the Emerging Markets, I would agree with you that most multinationals are growing at slower than the overall market rate as these markets are very local in their healthcare delivery and there are strong local competitors who given the lack of intellectual property in the last 25 years have brought portfolios and add to those portfolios very fast. So, I don’t think it’s reasonable to expect the multinational will grow the marketplace. That being said, we have had accelerating growth, I was very pleased with the growth in the fourth quarter. However, I still believe that it’s appropriate and aggressive to maintain a high single-digit growth rate in the Emerging Markets.

Chuck Triano

Thank you. Next question please, operator.

Operator

Your next question comes from Catherine Arnold from Credit Suisse.

Catherine Arnold - Credit Suisse

Thanks very much. I wanted to ask you a few things. First of all, could you comment on your strategic interest in the eye business for the right price and also tell us when we’re going to hear about your dry AMD program? And then just a nuance on the CDK, I don’t think we got you is the part two study comes out as positive or directionally in the same as you’re seeing for part one with your – of your ER negative, ER positive HR negative study which you presumably go to FDA for an accelerated approval path? Thanks.

Ian Read

Eye interest – I don’t believe that the eye is a stated strategic disease area for us, so that would probably answer that one. On macular degeneration, could you comment on that?

Geno Germano

Yeah. So, you know we have more opportunities efforts in ophthalmology based on scientific spin of opportunity. The particular program we have RN6G is an antibody against amyloid that we made some findings seem to in a models play role in dry AMD. The study is up and running, but we’ll not have any data coming this year.

Ian Read

And on palbociclib which is the CDK 4/6, I think Geno, has commented on this, I’ll just reinforce it. We have great data in the first trial. We have a second trial running which is a different cohort of patients. We expect to be able to give you the results of that trial in the second half of this year. And as the data revolves we will continue to work with the FDA in our agencies, and we will clearly try and work with the regulators to bring this product to patients as fastest as it’s appropriate given the data we have.

Chuck Triano

All right. Thanks for the context, Ian. Next question please.

Operator

The next question comes from Steve Scala from Cowen.

Stephen Scala - Cowen & Company

Thanks. A couple of follow-ups. First, has the strong flu season increased the event rate in capita and has it changed the timing from the Q3 conclusion which I think is what the Company has said previously. And secondly, has the decision by many payers to pay for Xeljanz post-TNF failures been mostly dictated by price, by lack of real world experience or by some other factor? Thank you.

Chuck Triano

Thank you, Steve. Geno.

Geno Germano

So, I mean it has been a robust flu season this year, and generally that is associated with a higher number of events. I can’t confirm or deny whether or not there has been an acceleration of events in the trial. Clearly the sooner the events accumulate to the target the sooner we’ll have results. So, we’ll let you know as soon as we know something there. And with regard to reimbursement for Xeljanz, actually the reimbursement rates -- reimbursement coverage has been very favorable. Most of the plans are reimbursing out of the gate and we’ll conduct category reviews over time.

Chuck Triano

Great. Thank you, Geno. Next question, please.

Operator

Your next question comes from Michael Tong from Wells Fargo Securities.

Michael Tong - Wells Fargo Securities

Hi. Just a quick question with regard to your biosimilar strategy, when do you expect a first biosimilar product to get onto the market? And within 18 months of that, how many more would you think you'd be able to get through?

Ian Read

Michael, we have – I think we're focusing on five molecules initially. We have two in sort of active development and three that were – are further back. I really can't give you the – we don't give timings, but the lead candidate in biosimilar is in phase – Mikael, you indicated phase…?

Mikael Dolsten

Yeah. We just completed successfully with our first biosimilar. I briefly mentioned earlier trastuzumab which is the name for Herceptin, completed Phase 2 and/or exploring plans for a Phase 3 opportunity this year. The second that Ian alluded to rituximab is going to complete in this year a Phase 2 study. So you can see its good momentum. We're using the deep skills in biopharmaceuticals and manufacturing in Pfizer to provide quality data.

Ian Read

And so far we're very encouraged by the Phase 2 data and our ability in this area.

Chuck Triano

Thank you, Ian and Mikael. We have time for one last question please, operator.

Operator

Your final question comes from the line of Kim Vukhac from CLSA.

Kim Vukhac - CLSA

Thank you. Just a quick question. With regard to the guidance, can you talk about what your share repurchase assumptions are for the year? In addition, speak to the, maybe the timing of the buyback, has it weighted more the first half versus second or more? Should we assume evenly spread out throughout the year?

Ian Read

Thank you. I think Frank can give you the numbers on that.

Frank D’Amelio

Yeah. So Kim, the assumption is mid-teen billions relative to buybacks. And in terms of the rhythm, I think the way to think about that is throughout the year. So no heavy weighting one area or the other just kind of throughout the year and mid-teen billions.

Chuck Triano

Thank you, Frank. Thank you everybody for your attention this morning.

Ian Read

Thank you. Have a good day.

Operator

Ladies and gentlemen, this does conclude today's Pfizer's fourth quarter earnings conference call. You may now disconnect.

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