Pfizer's CEO Discusses Q4 2013 Results - Earnings Call Transcript

Jan.28.14 | About: Pfizer Inc. (PFE)

Pfizer Inc. (NYSE:PFE)

Q4 2013 Earnings Call

January 28, 2014, 10:00 am ET

Executives

Chuck Triano - Senior Vice President of Investor Relations

Ian Read - Chairman of the Board, Chief Executive Officer

Frank D'Amelio - Chief Financial Officer, Executive Vice President - Business Operations

Albert Bourla - Group President of Vaccines, Oncology and Consumer Healthcare

John Young - Group President, Global Established Pharma Business

Doug Lankler - Executive Vice President, General Counsel

Geno Germano - Group President, Global Innovative Pharma Business

Mikael Dolsten - President, Worldwide Research & Development

Analysts

Tim Anderson - Sanford Bernstein

Gregg Gilbert - Bank of America

Mark Schoenebaum - ISI Group

Jami Rubin - Goldman Sachs

Chris Schott - JPMorgan

Steve Scala - Cowen

Alex Arfaei - BMO Capital Markets

John Boris - Suntrust

Vamil Divan - Credit Suisse

Andrew Baum - Citi

Tony Butler - Barclays

Seamus Fernandez - Leerink

David Risinger - Morgan Stanley

Damien Conover - Morningstar

Operator

Good day, everyone and welcome to Pfizer's fourth quarter 2013 earnings conference call. Today's call is being recorded.

At this time, I would 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 thanks for joining us today to review Pfizer's fourth quarter 2013 performance. I am joined today by our Chairman and CEO, Ian Read, Frank D'Amelio, our CFO, Albert Bourla, President of Vaccines, Oncology and Consumer, Mikael Dolsten, President of Worldwide Research and Development, Geno Germano, President of Global Innovative Pharma, John Young, President of Established Pharma and Douglas Lankler, General Counsel.

The slides that will be presented on this call can be viewed on our home page pfizer.com, by clicking on the link for Pfizer Quarterly Corporate Performance Fourth Quarter 2013 which is located in the Investor Presentations section in the lower right hand corner of this page.

Before we start, I would 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 the forward-looking statements. The factors that could cause actual results to differ are discussed in Pfizer's 2012 Annual Report on Form 10-K and in our reports on Forms 10-Q and 8-K.

Discussions during this call will also 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 28, 2014.

With that, I will now turn the call over to Ian Read. Ian?

Ian Read

Thank you, Chuck and good morning, everyone. We finished 2013 with a solid fourth quarter and the overall financial performance of the year was strong. Looking at the quarter, we delivered good operational performance, revenues in the emerging markets grew 9%, established products revenues grew 6%, oncology revenues grew 29% and consumer healthcare grew 2%.

We also had strong quarterly revenue performance operationally from key inline products such as Lyrica which grew 14%, Celebrex which grew 9% and Enbrel, outside of North America, which grew 8%. We continue to see positive progress of our recently launched products, Eliquis and Xeljanz. For Eliquis, in the last two quarters of 2013, we saw definitive momentum across key metrics resulting from the actions that we implemented together with our partners BMS.

While we are starting from a small base, the trend we are seeing on sales growth for Pfizer is significant. Specifically we saw a 124% increase in sales globally in the fourth quarter of 2013 compared to the third quarter and TRX volume in the US for Eliquis increased 68% from the third to the fourth quarter of 2013. For Xeljanz, we continue to see a steady increase in U.S. scripts, over 28% growth in TRX volume in the fourth quarter compared to the third quarter of 2013. Physician feedback continues to be positive. To date, nearly 3,500 ACP have prescribed Xeljanz and nearly 80% have repeat prescribers.

Now turning to highlights for the year. We met or exceeded every element of our financial guidance. We drove operational growth in key products including Lyrica, Enbrel outside of North America. Looking at how our business performed operationally, emerging markets reported solid single-digit growth of 6%, oncology grew 29% and consumer health business grew 5%.

We saw advancement in our pipeline across the portfolio. We achieved approval in the U.S. for DUAVEE for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis. We expect to launch next month and the FDA approved a prior approval supplement for Embeda extended release capsules.

We initiated a Phase 3 program which include includes pivotal and several outcomes studies for bococizumab the proposed generic name for our PCSK9 monoclonal antibody to lower LDL cholesterol. We initiated two Phase 3 studies of Palbociclib on advanced breast cancer and began enrolling patients in the third Phase 3 study with a German Breast Group in patients with early breast cancer at a high-risk of recurrence. We initiated a Phase 3 program with our partner Merck for ertugliflozin, our SGLT2 inhibitor, for the treatment of Type II diabetes.

We concluded a Phase 2 study for our staph aureus vaccine which showed encouraging signals that our vaccine elicits positive immune response. We expect to present this data at a medical conference this year. We completed the Phase 2a proof of concept study of a novel PDE5 inhibitor in diabetic neuropathy, which showed encouraging clinical profile warranting further exploration in Phase 2b. We conducted Phase 1 proof of concepts on biosimilars of rituximab and infliximab which concluded with positive outcomes on the relevant study endpoints.

For Xeljanz in Europe, where we received a negative opinion last year for our rheumatoid arthritis indication, we will continue to registration on active and engaging discussion with regulators and the development of additional data to support a refilling, although we continue to expect this will result in a several year delay.

We reduced our total adjusted cost of sales, SI&A and R&D expenses on an operational basis by approximately 3% which is about an $850 million reduction versus 2012 levels. We completed the separation of Zoetis and generated approximately $17.3 billion in after-tax value. We returned nearly $23 billion to shareholders in dividends and share repurchases and we put in place and are operating in our new commercial structure. Each business has strongly leadership in place and we believe that by having a sharper focus we can to better maximize the performance of all our businesses. In terms of financial transparency, we will provide a management view of profit and loss for each business starting with the first quarter results this year.

To sum up the year, we strengthened our innovative core by advancing key R&D programs, create significant value for shareholders through disciplined capital allocation and our commercial businesses have performed well during a time of transition and difficult market dynamics. Three years ago, we laid out the priorities and strategies for how we will create value for each of our businesses and address R&D productivity challenges. Over the course of last three years, our priorities and our strategies have not changed and I believe it's showing strong results.

Again, in 2014, you can expect us to remain intensely focused on maximizing the opportunities within each of our commercial businesses, continue to advance science, innovation and our pipeline and prudently deploying our capital. We see distinct opportunities for each of the commercial businesses this year. The Global Innovative Pharma Business will focus on accelerating the uptake trajectory of newly launched products, Xeljanz and Eliquis, and driving growth for major inline brands like Lyrica Enbrel outside of North America, Viagra in the U.S. and Chantix.

The Vaccines, Oncology and Consumer Healthcare Business, respectively, will capitalize on the Prevnar 13 franchise, concentrate on the recently launched oncology products, Xalkori, Inlyta and Bosulif and launch over-the-counter Nexium in Europe and in the U.S. provided it receives FDA approval.

The Global Established Pharma Business will focus on maximizing key Peri-LOE brands, namely Celebrex, Lyrica in the EU and Zyvox. It will support continued growth from important legacy old patented brands such as Lipitor and Norvasc in emerging markets, build on local partnerships like those with Mylan, Teuto and Hisun and advanced growth opportunities with the sterile injectables by some of those portfolio.

Building on the pipeline advances achieved in 2013, there are several potential milestones in 2014. We expect to report in the near future the topline results for Phase 2 study of Palbociclib in patients with post-menopausal, ER-positive, advanced breast cancer. The results for the CAPiTA trial for Prevnar 13 in adults age 65 and older are expected to readout during this quarter and if supportive we expect to discuss the data with the advisory committee on immunization practices, ACIP, in the U.S. and other regulatory authorities.

Along with our partner, Bristol-Myers Squibb, we are seeking approved for Eliquis VTE prevention in orthopedic patients in the U.S. and VTE treatment in the U.S. and Europe. We have two pivotal trials in the Xeljanz Phase 3 oral psoriasis program that anticipates to readout in the second quarter. For the staph aureus and meningitis B vaccines, we anticipate sharing results from Phase 2 studies at medical conferences this year, while advancing the late stage development of both assets.

Last week, we announced the topline Phase 3 results for ALO-02, an investigational agent, called oxycodone hydrochloride and naltrexone. It met the primary efficacy endpoints in patients with moderate-to-severe chronic low back pain demonstrating a statistically significant difference compared to placebo.

Yesterday, we announced topline results for two Phase 3 studies, BR.26 and ARCHER 1009, that evaluated dacomitinib in two different populations of previously treated patients with advanced non-small cell lung cancer. While we are disappointed that neither study met its primary endpoints, we will continue to evaluate the full dataset from both trials to understand that molecularly defined subgroups of patients may derive benefit from dacomitinib. In order to continue development of a robust pipeline of highly differentiated molecules in vaccines that has the potential to be either first or best in class such as the therapeutic I just noted, requires ongoing R&D investment.

In 2014, we will continue to be prudent towards how we allocate capital and we will balance these incremental R&D investment with the need for delivering overall shareholder return. As we have done in the past, we will continue to use business development opportunities as enabler of strategies to create value for our shareholders.

In summary, we start 2014 with a sound strategy and a strong business. We will build on our performance in 2013 by continuing to create a sustainable high-value pipeline and establishing strong commercial businesses. By executing on our new product launches, growing key in-line products, delivering on the potential at all phases of the pipeline and effectively deploying our capital, we will further strengthen the whole of our businesses. Our top priority and commitment is to develop and to bring to patients innovative medicines that meet their needs and together with our actions we will generate an enhanced shareholder value.

Now I will turn it over to Frank to take you through the details of the quarter and our financial guidance for 2014.

Frank D'Amelio

Thanks, Ian and good day, everyone. As always, the charts I am reviewing today are included in our webcast. I want to remind everybody that as a result of the full disposition of Zoetis on June 24, 2013 the financial results of the Animal Health business are reported as a discontinued operation in the consolidated statements of income for full-year 2013 and fourth-quarter and full-year 2012.

Now let's move on to the financials. Fourth-quarter 2013 reported revenues were approximately $13.6 billion which decreased 2% year-over-year and reflect operational growth of approximately 1%, driven mainly by the strong performance of Lyrica, Celebrex, Inlyta and Xalkori globally, Enbrel outside of North America and Xeljanz and Eliquis primarily in the U.S. These were more than offset by the unfavorable impact of foreign exchange of approximately $397 million or 3%, the expiration on October 31, 2013 of the collaboration agreement for Enbrel in North America, continued erosion for branded Lipitor in developed Europe and certain other developed markets, the ongoing expiration of the Spiriva, collaboration in certain countries, other product losses of exclusivity in certain markets and decreased government purchases of Prevnar in certain emerging markets among other items.

Adjusted diluted EPS of $0.56 increased 22%, primarily due to the operational decrease of adjusted SI&A and R&D expenses and increase in other income, due primarily to the sale of a portion of our in-license generic sterile injectables portfolio to Mylan, a lower effective tax rate on adjusted income and substantially fewer weighted average shares outstanding due to our continued share repurchases and the impact of the Zoetis exchange offer.

Reported diluted EPS was $0.39 compared with $0.85 in the year ago quarter, driven by the significant negative impact of the non-recurrence of income from discontinued operations attributable to the Animal Health and Nutrition businesses including the gain on the sale of the Nutrition business in the year ago quarter. In addition to the previously mentioned factors, reported diluted EPS was favorably impacted by a lower effective tax rate, primarily due to favorable audit settlements, lower charges related to asset impairments and legal matters and lower acquisition related expenses.

During the fourth quarter, biopharmaceutical revenues in the BRIC-MT markets increased, driven primarily by strong volume growth in China, especially for Lipitor. In these BRIC-MT markets, volume growth of 6% was partially offset by foreign exchange of 3% versus the year ago quarter. Revenue from all emerging markets increased 9% operationally in the fourth quarter with China growing approximately 19% operationally. If you exclude the portfolio of products whose rights were transferred to our joint venture in China with Hisun, in the fourth quarter we would have had operational revenue growth of 10% in our overall emerging markets business, 9% in the BRIC-MT markets and 27% in China compared with the year ago quarter.

Foreign exchange negatively impacted fourth quarter revenues by $397 million or 3% and positively impacted adjusted cost of sales, adjusted SI&A expenses and adjusted R&D expenses in the aggregate by $251 million or 3%. As a result, foreign exchange negatively impacted fourth quarter adjusted diluted EPS by approximately $0.01. As you can see, in 2013, we met or exceeded all components of our financial guidance including exceeding our adjusted diluted EPS guidance.

Now I would like to comment specifically on a few of the elements of our 2014 guidance. First, we expect adjusted revenues to be in the range of $49.2 billion to $51.2 billion. I want to point out that this range reflects an anticipated $3 billion negative impact due to declining alliance revenues specific to 2014 notably the Enbrel collaboration in North America and the ongoing expiration of the Spiriva collaboration in the U.S. and other developed markets and the loss of exclusivity of certain products in several geographies, including Viagra in the EU, Japan and Australia, Detrol in the U.S. and Aricept in major developed markets.

I also want to point out that our 2014 adjusted revenue guidance also reflects an additional $1.4 billion negative impact due to the year-over-year difference in actual foreign exchange rates in mid-January of 2013 compared with mid-January of 2014, mainly driven by the movement of the Yen against the U.S. dollar. So, had we applied the rates from mid-January of '13 to our 2014 guidance, the adjusted revenue range would have been $1.4 billion higher.

We expect cost of sales as a percentage of revenues to be in the range of 19% to 20%, an increase from the 18% we recorded in 2013 driven by the significant decrease in alliance revenues. It's important to remember that these alliance revenues were recorded at 100% gross margin because there is no associated cost of sales. Consequently the significant decrease of these revenues will also negatively impact our cost of sales as a percentage of revenue in 2014.

We expect adjusted SI&A expenses to be in the range of $13.5 billion to $14.5 billion which reflects spending in support of key product launches as well as the benefit of our continued cost reduction and productivity initiatives. We expect adjusted R&D expenses to be in the range of $6.4 billion to $6.9 billion to support Phase 3 studies initiated in late 2013 and early 2014. We also expect adjusted other deductions to be approximately $100 million. I want to remind everyone that the recognition of profits from the Enbrel collaboration in North America has shifted from alliance revenue to other income as we have moved to a royalty structure.

We expect our tax rate on adjusted income to be approximately 27%. Finally we expect adjusted diluted EPS to be in the range of $2.20 to $2.30. This range includes anticipated share repurchases of approximately $5 billion this year which will more than offset some expected dilution related to employee compensation programs.

It's important to note that our 2014 adjusted diluted EPS guidance absorbs an $0.08 negative impact resulting from the previously mentioned difference in actual foreign exchange rates from mid-January 2013 compared with mid-January 2014. As always, we will continue to monitor foreign exchange fluctuations and we will update the potential impact, if any, on our 2014 expectations.

So moving on to key takeaways, we achieved or exceeded all elements of our full year 2013 financial guidance in a continuing challenging environment. In 2013 we completed the separation of our Animal Health business and created a new commercial structure that was successfully implemented at the beginning of this year. We provided full-year 2014 financial guidance which reflects the negative impact of $3 billion due to declining alliance revenues and expected product losses of exclusivity. In addition, our guidance for adjusted R&D expenses reflects our investment in several Phase 3 studies initiated in late 2013 and early 2014. We will continue to mitigate the impact of product losses of exclusivity and declining alliance revenue with growth of certain other products as well as expense discipline and share repurchases.

We continue to create shareholder value through prudent capital allocation. In 2013 we repurchased $16.3 billion or 563 million shares. Overall in 2013, we returned almost $23 billion to shareholders through dividends and share repurchases. Over the past three years, we have returned almost $53 billion to shareholders through dividends and share repurchases. In 2014 we expect to repurchase approximately $5 billion of our common stock. Finally we remain committed to delivering attractive shareholder returns in 2014 and beyond.

With that, I will turn it back to Chuck.

Chuck Triano

Thanks, Frank, and Ian as well. With that, operator, please if we could now poll for questions.

Question-and-Answer Session

Operator

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

Tim Anderson - Sanford Bernstein

Hello. Thank you. A couple of questions, please. You have, no doubt, seen various analysts reports predicting what the financials for the three divisions will look like, and I know you are planning on providing those details on your Q1 call, but can you give us your preliminary thoughts on what you are seeing thus far from the street. Do you think we will end up being surprised by how the numbers fall out between the different divisions or do you think the analyses you have seen look reasonable?

Then on Palbociclib, any updated perspective on the likelihood of being able to file on the final Phase 2 results? I know that it is approaching. I would imagine you have already had some discussions with the agency or at least at a minimum have some thoughts on the matter?

Ian Read

Okay. Thank you, Tim. I will ask Frank to answer the question that you posed on the financial divisions and when you will see the results and then I would ask Albert Bourla to comment on Palbociclib.

Frank D'Amelio

So, Tim, clearly we have looked at several models that have been put together relative to what the new businesses will look like. I think the rhythm of those numbers is directionally correct. Just how I would describe it. Obviously we will come out with our numbers for our first quarter 2014 results, but I think directionally correct is how I would describe it. I don't expect what we will publish will create any big suprises.

Albert Bourla

Thank you, Frank. Tim, on palbo, as you alluded, our discussions with FDA are productive and they are ongoing and this is particularly true, given the breakthrough therapy designation we have received from them. Now, these discussions will continue after the Phase 2 analyses becomes available. Therefore the exact regulatory path forward has not yet been determined. Now having said that, we can envision a scenario where depending upon the strength of the final Phase 2 data there may be a pathway to file with the FDA based upon these Phase 2 results. However as you know, the acceptance of an filing is ultimately an FDA decision.

Ian Read

Thank you, Albert.

Chuck Triano

Thanks, Albert. Next question please, operator.

Operator

The next question comes from Gregg Gilbert from Bank of America.

Gregg Gilbert - Bank of America

Thanks. Just sticking with the palbo theme, could you comment on the competitive landscape in light of Novartis and Lilly's progress and what differentiation you could speak to at this early stage?

For Frank, can you put a little more meat on the bone on the gross margin commentary? What are the drivers for lower gross margin in '14 and whether those items are trends or blips? Thank you.

Ian Read

So, Albert, palbo again.

Albert Bourla

Yes. As you are aware, there is very limited information in the public domain on these compounds from these companies. So its really difficult to differentiate palbo at this point until we see some more efficacy and safety data from them. On palbo, on the contrary, we have seen data and we are encouraged by the magnitude of the clinical activity we have seen in our patient population. So we are really looking forward to our final Phase 2 results.

Ian Read

Thank you, Frank?

Frank D'Amelio

Yes. So, Gregg, on the gross margin, let me walk through this and I am going to bridge this because I think it will be helpful. So let me run the numbers first. We printed 18% for the full year 2013. We are providing guidance for next year of 19% to 20%. So now let me build a bridge.

If we remove foreign exchange, the positive impact of foreign exchange we had last year on cost of sales because it lowered cost of sales, that 18% becomes 18.5%. So 18% to 18.5%. Then if you did the accounting for Enbrel in '13, the way we were going to do the accounting for it in '14, which is don't show it is alliance revenues but show it as royalties, that 18.5% would become 19%. So now 18% between 19% and then that 19% to 20% in 2014 is really a result of the other alliance revenue declines, primarily Spiriva and then some of the product LOEs, and one key point to make here is the big decline year in alliance revenues is in 2014.

So that's the way to think about the rhythm of the numbers.

Chuck Triano

Thanks, Frank. Next question please, operator

Operator

The next question comes from Mark Schoenebaum from ISI Group.

Mark Schoenebaum - ISI Group

Hi, guys. Thanks a lot for taking my question. Also congratulations on great P&L management in '14. I know a lot of people were nervous about the alliance revenue lines and everything. So well done. I just want to ask a question that you probably get a lot, but I thought I would ask it on a call. And that is, is there a scenario that you can envision, Frank or Ian, where you might sell your established products or at least your generics unit in some kind of a tax advantage the way prior to 2017?

Then just the only other question I had, if I might, is if my calculations are correct, R&D plus SG&A crept up a little bit as a percentage of revenue at the midpoint versus 2013. I was just wondering, I know you are not going to give guidance beyond 2014 but in general, are you comfortable where analysts models are or should we expect that trend to continue as at 2014 blip? Thanks a lot.

Ian Read

Thank you. I think on the R&D, our R&D spend has been responsive to late Phase 3 assets that we have a high confidence than anyone to invest in and have a Phase 3 with (inaudible). So I think we will fund, well, you expect us to fund Phase 3 assets to the extent we see great opportunity for them and we will continue to do that, that we will continue to manage our overall P&L as we do that.

On the potential sale of our established products business, you know, we are managing all three businesses to create value for the company and I think the immediate focus of this is to get these businesses which have very strong management teams which they have, put focus on the different ways of delivering value and to drive value for Pfizer shareholders. There are also several data requirements which restrict our ability to enter into any transaction even if some of we wanted to at this stage and I will ask Frank to talk about that.

Frank D'Amelio

Yes. So Mark, it is Olympian, but let me try to rip through this which is, it depends on the type of transaction. So if it's a public transaction, so what's a public transaction. A partial spend, complete spend, a reverse Morris Trust, a partial IPO, a partial IPO followed by spin or a split, three years of audited financials are required. That's a requirement.

If it's a private transaction, a partial sale of the business, a complete sale of the business, formation of a joint venture where we have a minority, where we have a majority interest, no audited financials are required. However a significance test is required, the results of which may require audited financials.

Let me rip through these significance tests. There is three tests that make up this significance test. There is an asset test, an income test and an investment test. Basically it's the target's results for each of those test as a percentage of the acquirer's results. So think about income, it would be the target's income as a percentage of the acquirer's income.

Now the way the results work or the test work is if all three tests are less than 20%, no audited financials are required. If any one test is greater than 20% and lower than 40%, between 20% and 40%, one year of audited financials is required. Between 40% and 50% in any one test, two years of audited financials. Any one test greater than 50%, two years of audited balance sheet, three years of audited P&Ls, cash flows, other comprehensive income and shareholders' equity statements.

So that's basically what's required and why it's required. That's a summary.

Ian Read

Thank you, Frank. As you can see, Mark, we have a lot of asset issues, and I would say that we want to create optionality and the best way to create optionality is having strong results and transparency on these results over the next few years, and that's what we are focused this on. Thank you.

Chuck Triano

Thank you, Ian and thanks, Frank, for the detail there. Next question please, operator.

Operator

The next question comes from Jami Rubin from Goldman Sachs.

Jami Rubin - Goldman Sachs

Thank you. Just to follow-up on that. Ian, if you could talk about the value business, which is what we are all focused on here, the emerging markets and established products business, that's a huge part of the overall Pfizer story, and while we appreciate that you are going to focus on driving value to each of these businesses, maybe you could talk about how you think about the margin and growth potential of this business? What are the true durable earnings performance that you seek from this business? Because, from what we see, the growth of established is really just coming from shifting products that go generic into that business, and then the emerging markets space is obviously very difficult to predict. So maybe if you can provide your view on how you see this business as a standalone performing over the next three years or so?

Then just as a follow-up to the breakup scenario, Frank, you said three years of financial audit information is required. So if we get this, before showing the data in the first quarter this year, does that then mean that the earliest you could contemplate a full breakup would be end of 2016? Thanks.

Ian Read

Thank you, Jami. Well, obviously as I said, the established products business is not a homogeneous business. It is heterogeneous business with many different opportunities. We have very strong management teams in all our businesses. So I am going to ask John Young to answer your good questions over how we will manage the established business to grow. And on the last point, I think yes, we are indicating that we would have three years financial by the end of '16.

John Young

Okay. So thanks for the question, Jami. So maybe just to say a little bit about what this business is. I think certainly we believe that this is not only a very large business unit, to your point, about its contribution to Pfizer overall, but actually a very attractive, a very diverse and a very profitable business with actually some unique opportunities across different portfolios and geographies. So let me just walk you through a little bit, what this business really comprised of.

Broadly, we think it as in four buckets. There is a Peri-LOE business in developed markets. It includes some of the major brands that currently are pre-LOE such as Celebrex, Zyvox, Lyrica in the EU. Certainly, we are going to be very focused in that segment on maximizing the profitability of those brands, both sides of the LOE spectrum and leveraging some of the capability from EP that we think has really done a pretty good job with some of the recent LOEs such as Lipitor compared to market proxies.

The second segment of that business is really a legacy EP business that comprises mature off- patent products in developed markets. That business is declining but we are very focused on maximizing profitability through targeted investments in certain brands in that portfolio that present opportunities for growth.

The third piece of the business is really what comprises probably a little more than 70% of the emerging market business today and that business is growing pretty strongly. You have seen the results from the fourth quarter for the emerging market business overall. we believe that portfolio and actually the think of the mature products in Global Established Pharma portfolio is a great fit, actually for a lot of the healthcare needs that we see in some of the key emerging markets such as China and Brazil and Mexico. That is growing today and we envisage that that will continue to grow in the future.

Then the last component of this business really is what we think of as growth opportunities. Now some of those growth opportunities will be medium term growth opportunities such as the biosimilar portfolio. We think we have one of the leading biosimilar portfolios in the industry with five assets in different stages of development. But we actually have a number of other opportunities too, through areas of growth such as some of the partnerships that you are already aware of with Teuto, Hisun, Mylan, all the way through. We are very pleased with them. They are performing well and we are going to be very active in looking for additional partnerships in targeted markets where we think there is an opportunity to drive shareholder value, opportunities for continued growth of sterile injectables and some targeted opportunities in certain markets for some reformulated branded generic products as well.

I think probably the last point to make is, this is really not a commodity generic business. In fact, less than 10% of our revenues would come from what you traditionally think of as being a generic business. So there is no doubt that we will see some pressure on revenues over the next few year driven by some of the LOEs that everyone is well aware of from some of those Peri-LOE brands. Actually this is a business where we believe in the medium-term that it will plateau and we believe that we can then have a number of significant opportunities for growth with this business in the medium to longer term.

Ian Read

Thank you, John. Frank, you want to make a comment?

Frank D'Amelio

Yes, real quickly. Jami, I just want to punctuate what Ian said, which is three years prospective financials as I have said previously. So that would be '14, '15 and '16 financials and then obviously the '16 10-K wouldn't be done until the end of February 2017. So optionality, if we decided to do so, it will be sometime in 2017.

Chuck Triano

Thanks, Frank. Operator, next question please.

Operator

The next question comes from Chris Schott from JPMorgan.

Chris Schott - JPMorgan

Great. Thanks very much. Just staying on the established products side, recognize the near-term focus in that business is kind of walking on the performance but when you consider the long-term options for that business, I guess first of all, would you agree with the statement that this is the division where a larger merger could make the most sense for Pfizer? And following on that, can you walk through the pros and cons of a larger merger for that division as you consider your options relative to either running the business on your own or looking at tuck-in deals?

Then my second question is, just as we are thinking about capital deployment, is there any changes in the way you are thinking about share repo versus higher dividend payout or other opportunities in light of the new business structure? Does that change at all or just you want to have either more cash available as these business units work out their various options as you consider new structures, etcetera? Anything we should be thinking about there. Thanks very much.

Ian Read

So Chris, I think on the established products business, our focus is the creation of value. So we do have a quite impressive portfolio and a geographic presence across the emerging markets. And your question is, will further scale be useful? I think it depends very much on the opportunities that arise and we have to be opportunistic about that. Clearly if we can broader portfolio and specific scale in some of key countries, we would be interested in, which is why we have doing on JVs on a country-by-country basis and would be open to other alternatives as we always are that would create shareholder value. But clearly, we are going to focus right now on running that business, producing the value and open to various BD alternatives to create more value.

On the second question, the capital structure, I think you know as we have seen over the last few years, our capital structure and the we manage our capital has been focused on ensuring we produce the best return for our shareholders. We continue to manage that mix and I would ask Frank to make some more specific comments.

Frank D'Amelio

Chris, I think the short answer is our priorities have not changed. Maybe I will embellish a little bit. So clearly dividends, buybacks continue to remain important parts of our capital allocation. Investing in the business, you see that in '14 with our capital deployment for R&D, for launch costs and support of our new products and obviously business development remains a priority. So priorities haven't changed and you look at what we did with our dividend in December, we increased the dividend from $0.96 to a $1.04, an 8.3% increase. We just announced another $5 billion in repurchases of our shares. So the priorities have not changed. They remain the same.

Ian Read

I would just add to Frank's comment there. As I think we see ourselves in a position of well-balanced optionality in many directions, given our capital structure. Thank you, Frank.

Chuck Triano

Thanks, Ian. Operator, next question please.

Operator

The next question comes from Steve Scala - Cowen.

Steve Scala - Cowen

Thank you. Two questions. First, I believe there is a pending court decision. So does your 2014 guidance bracket a scenario where generics to Celebrex launch in May of this or do the guidance elements not consider the scenario?

The second question is, I know FDA was aware of CAPiTA's design very early on. But what discussions have you had with ACIP on the design of CAPiTA? And are they comfortable that it did not compare Prevnar to Pneumovax? Thank you very much.

Ian Read

So Doug, do you want to comment on the Celebrex situation?

Douglas Lankler

Sure. Obviously, so we have our reissue patent on Cele that takes us through December 2015 and our trial to defend that patent is scheduled to commence on March 19 of this year.

Ian Read

Frank, you want to add anything to that?

Frank D'Amelio

Yes. Our guidance assumes we have a full-year of Celebrex.

Ian Read

Thank you, Albert, on discussions with ACIP?

Albert Bourla

Yes, as you can imagine, once we have the results, we will determine the best approach to present the data to ACIP and request a recommendation. We have been in discussions with the CDC and members of ACIP to ensure their understanding of the protocol and the potential outcomes. So when they have the data they can move quickly. The ACIP meets three times per year. I cannot speculate in which meeting they will make a vote.

As regards your question for how would they compare it with Pneumovax. Again I cannot speculate on that, but if you look at current practice, in immunocompromised adults, age 19 years and older, that there is recommendation, ACIP has recommended routine use of Prevnar 13, administered in addition to Pneumovax.

Ian Read

Thank you, Albert.

Chuck Triano

Excellent. Next question please, operator.

Operator

The next question comes from Alex Arfaei from BMO Capital Markets.

Alex Arfaei - BMO Capital Markets

Good morning. Thank you for taking the questions and congratulations on your performance. I was wondering if you can provide us more color on the powering assumptions for CAPiTA and do you believe there is still enough residual disease among U.S. adults, given that Prevnar 13 has been available for four years and is probably significant herd effect?

Finally on palbo, is the Phase 2 sufficiently powered to detect a significant difference, statistically significant survival difference between the two arms? Thank you.

Ian Read

Thank you for that question. I believe the CAPiTA design was powered for three endpoints and it would have been designed well aware the herd effect. So I would ask Albert just to talk through the three endpoints of CAPiTA. You know, really, the response of ACIP will depend on those endpoints and that's why we have to wait for the trial to readout but I believe that it was very well designed trial, powered to achieve, show the results of the product's performance as we expect and then on the Phase 2, Albert, could you discuss the powering vis-à-vis overall survival?

Albert Bourla

Yes, well, I would say, CAPiTA is a lot complex trial. We have 85,000 health volunteers and the three endpoints are a primary endpoint to demonstrate the efficacy of the product in prevention of first episode of pneumococcal cap community, acquired pneumonia, of course, for the vaccine type. The secondary endpoint is to demonstrate the same efficacy in the first episode on non-bacteremic non-invasive cap and in invasive pneumococcal disease. As you said, the study is very well designed taken in consideration everything that study was post registration, post approval obligation which the FDA. So we have consulted with them for the protocol.

Ian Read

Thank you. On the Phase 2, do you want to that, Mikael?

Mikael Dolsten

I just had one comment on the herd effect that Alex asked about. Actually, in 2013, there has been some very useful publications from U.K. and U.S. that have studied, the epidemiology of various pneumococcal strains and have clearly shown that in the adult, and particularly the older adult population that is highly vulnerable to pneumococcal, there is a number of Prevnar 13 strains still occurring linked to disease and actually even Prevnar 7 strains are occurring.

So its just that the older population is more prone to pickup those strains and interesting is some strains that are not causing disease in younger population can cause substantial disease in the older population where we also see a substantially increased morbidity and also fatal outcomes. So we do believe that the recent data will favor the view of an existing unmet need in this population, and as Albert alluded to, pending the readout of CAPiTA, and this would be that all available study of this size that would show an effect in this population.

Ian Read

Thank you, Mikael. It's good questions and good to speculate. We will know at the end of the quarter and then we can discuss it in more detail. Albert, on the overall survival of palbo?

Albert Bourla

Yes. Data for overall survival is event driven. So therefore it is difficult to predict when the final overall survival data will be complete. Apparently the study is well-powered to cut any differences. We do anticipate preliminary overall survival data that could be presented at a medical conference in the first half of 2014 together with the other data.

Ian Read

Thank you, Albert.

Chuck Triano

Next question please, operator.

Operator

The next question comes from John Boris from Suntrust.

John Boris - Suntrust

Thanks for taking the questions. I just have two. Just on Prevnar 13, you indicated that there is three times that ACIP meets. What's the earliest meeting and have you asked the ACIP yet for to be a part of the agenda at anyone of those three meetings yet?

Then secondly on Palbociclib. If you look at your binding affinity for CDK4 and CDK6, most notably on cyclin D1, D2 for CDK4, its 11 and 9 and cyclin D6, IC50 is 15 which suggests high degree of affinity, hence strongly correlated to efficacy. Is there anyway you might be able to contrast that to the activity of the Novartis and Lilly compounds?

Then the second part of that question on palbo is, there some off target effects that occur on greater than 30 other kinases. Has the FDA asked you to try and characterize any of those off target effects on palbo? Thanks.

Ian Read

Thank you John. Prevnar, ACIP, I think there are three meetings. One in February, one in June and one in October. I would find it doubtful we would make the February date and then when have the results, we will immediately engage with ACIP so they can review the results at the earliest point possible and one would expect their willingness to do that will depend on the results, in many ways. Mikael, do you want to comment on John's very scientific question there on palbo?

Mikael Dolsten

Yes, John. First with your detailed understanding of this kinase inhibitor and as you very well articulate that we have designed an inhibitor that would have potent activity against both kinases, which I do think is somewhat unique for Palbociclib. All kinases have some off target activities but we do believe that the therapeutic window for Palbociclib favors the on target profile, and if you look at efficacy and tolerability we have seen so far, the main adverse events related to neutropenia that has been well manageable is very much compatible with on target effect for these type of drugs.

Ian Read

And we don't really have enough detail on the competitive products to make any comparisons. Is that correct?

Mikael Dolsten

Yes. We tend not to comment on other products and that's why I used the term that you inhibitors are well balanced and has a unique profile in that sense, and I think at this stage of clinical development, as Albert very well alluded to, we need to understand more from the competitive product as they advance in development.

Ian Read

Thank you.

Chuck Triano

Our next question please, operator.

Operator

The next question is from Vamil Divan from Credit Suisse.

Vamil Divan - Credit Suisse

Yes, thanks for taking the questions. I have two on the pipeline. For palbo, excited by your studies outside of breast cancer and where the most of the focus has been. Can you just talk at this point where you see palbo having the most potential outside of the lead breast cancer indication?

Then second on the PCSK9, just any comments there. You are going into Phase 3. Obviously it's a very large study. A lot of investment really needed there. Given some of the changing guidelines, maybe less of an emphasis on LDL and HDL target levels. How do you see the value of a PCSK9 program and would you consider maybe partnering that with someone, just given the amount that you would need to invest there? Thanks.

Ian Read

So, good questions. Palbo, Albert, outside of breast cancer, you may want to discuss a little bit of what we are doing there? Then Geno will do the PSK9 reply.

Albert Bourla

Yes. Vamil, expanding palbo beyond breast cancer is a top priority for us. Given the potential of this franchise, we are very focused on progressing in other few more types, as melanoma for example. There is an ongoing Phase 1/2 study of palbo with Zelboraf and this is conducted by the National Cancer Institute of France and this is for BRAF mutations.

Also in addition, I am sure you have seen a recent announcement. We are working with GSK to evaluate palbo with their MEK inhibitor in metastatic melanoma, this time without BRAF mutations. This trial should begin in the first half of the year of 2014.

Now, if we look beyond melanoma, we are working with academic centers including the Dana-Farber Cancer Center to evaluate palbo in non-small cell lung cancer and to have numerous other collaborations and programs in other tumor types, including squamous non-small cell lung cancer and head and neck cancer.

Ian Read

Thank you, Albert. Mike, sorry, Geno, PCSK9?

Geno Germano

On PCSK9, we have initiated our Phase 3 program. It's a broad program, as you can imagine, with multiple lipid-lowering studies and we have decided to go into two fairly large outcome studies as well with the intent to provide the broadest base of data of any of the PCSK9 program in the patient populations that we believe can benefit from the therapy.

We believe that outcomes, trials and the results of the outcomes trials are going to determine the place for these agents in management of patients with cardiovascular risk factors and high cholesterol levels. Our programs are designed to read out in a similar timeframe of the competitive programs as well. So we are excited about the program. We are often running with our Phase 3 program and we are at this point going in alone.

Ian Read

Thank you, Geno.

Charles Triano

Next question please, operator.

Operator

The next question comes from Andrew Baum from Citi.

Andrew Baum - Citi

Good morning. First on palbo. Should I assume that in the absence of any significant OS benefit from the Phase 2, you would not file under accelerated approval? Then in addition, you made some comment about the manageability of the neutropenia. Actually I have seen that's still the case and the profile hasn't changed from the early patient experience.

Then finally, you retained the rights to both tremelimumab and your anti-CD40 together with use with vaccines. Do you have any vaccines close to entering clinical development in combination with either these two assets? Thank you.

Ian Read

Thank you, Andrew. Look, on palbo, I don't think we can assume anything on the path forward until we see the results and then we will be in conversations with the FDA. As you say, overall survival is event-driven and may take a longer time, but we will just have to wait for the results and have in-depth discussion for the FDA. Mikael, do you want to talk about profile vis-à-vis neutropenia and also then discuss the tremelimumab and the CD 40?

Mikael Dolsten

Yes. So the type of profile we have reported, which is very well compatible with what you will see with these type of drugs has been very well manageable in the clinic and it seems to be much more tolerable than previous experience with the drugs in use in solid tumors when it relates to a hematological suppression. So we feel very comfortable with the profile and look forward, as Ian alluded, to see the final results. Clearly, at this stage of development, it's progression-free survival that will be the dominant endpoint to look for.

In the vaccines area, you are right, we retained use for tremelimumab. Particularly, I would like to underline that that antibody is part of the platform we are exploring together with unique prostate vaccine antigens and a very comprehensive delivery method of the vaccine to boost the immune response. Our initial focus is on prostate cancer and we aspire to be in human studies by 2015. At that time point, we would like to see a number of Pfizer cancer immunotherapy approaches move forward based on a panel of different molecular antibodies.

Ian Read

Thank you, Mikael.

Charles Triano

Thanks, Mikael. Next question please, operator.

Operator

The next question comes from Tony Butler from Barclays.

Tony Butler - Barclays

Thanks very much. Good morning. Just a brief question. As you, late last year, made references to splitting out the units into three different business units, you focused on Oncology and Vaccines, claiming that there was the need for laser-like focus on these areas because they are clearly growing substantially above the corporate rate. That's clearly understandable. You included consumer at the time and as I seem to recall it was either Frank or you, Ian, made the reference that it was because the manager of the Consumer business would then be the manager of both. Now, that Albert is head of that, does it not now make sense that consumer be split apart, again, because of this laser-like focus on Vaccines and Oncology? Thanks very much.

Ian Read

Thanks, Tony. I think the structure is important, but not overriding. What's overriding is having really good leaders running the Oncology and the Vaccine business, having transparency on their results, having somebody good running Consumer and then having an overall President who has done tremendously good work in the Established Products and the value business and somebody who is a seasoned leader. So I don't really think it's important vis-à-vis, small tweaks in the structure because of the changes in leaders. But thank you for the question.

Charles Triano

Thank you. Next question please, operator.

Operator

The next question comes from Seamus Fernandez from Leerink.

Seamus Fernandez - Leerink

Thanks a lot. Thanks for the questions. Frank, thank you for the incredible detail on the P&L structures. That was great. But separately, you mentioned the staph aureus showing some preliminary evidence of efficacy. Can you just give us maybe a little bit of color as to what you were looking for in terms of the quality of the immune response? So should we anticipate some threshold of real evidence of opsonizing antibodies actually showing, since it's my understanding that that's what's necessary to really eradicate or fight the disease?

Then separately, as we think about some of the products in earlier stages of development, would you mind just maybe giving us a little bit of color as to the products in Phase 2, outside of the products that were mentioned on the call today that might be particularly exciting, particularly as we think about the prospect for combinations in your cancer portfolio? Thanks a lot.

Ian Read

Okay. Thank you. Really good questions. So Mikael, you are a popular man today.

Mikael Dolsten

Okay. So thank you very much for the interest in staph aureus vaccine. That's based on some various source of science that we invested in over the last couple of years and we identified four different antigens and both polysaccharide and proteins that we have shown elicit high level of antibodies in each relevant individuals. As you discussed, these induced antibodies, will both induce what you call opsonization, clearance of the antibody by the immune system, but also they will interfere with the bacterial function which is based on some unique science that we have done for this particular vaccine.

We saw very nice levels of induced antibodies, rapid onset with really the profile you would like to see before you vaccinate individuals to go into a surgical environment where there may be threatened with difficult infection. I would like to underline that antibodies cross react with a large majority of staph aureus strains including the multiresistant strains that can cause devastating outcome of hospitalization. So we are very encouraged by the data and we have shared it with both European and U.S. regulators and we are now in dialogues around a Phase 2b study that we will invest in to show event reduction of infection in a pre-surgical population.

Concerning the interest in our Phase 2 pipeline, I would like to underline that we have a rich pipeline with a lot of momentum behind the kind of near-term excitement around Palbociclib and adult vaccine. Just a few highlights. We have started multiple Phase 2 for our smooth inhibitor in blood cancers and related blood disorders, an area that we are very excited about. We are also moving our gamma-secretase inhibitor into triple negative breast cancer where we have seen some very interesting and favorable profile so far.

In the Xalkori space, we are now dosing patients with a full-on drug that is targeting all non-mutations and we think can have a very exciting profile. We have already moved one antibody drug conjugate into the clinic and we have several more that will move into the clinic this year.

In inflammation immunology, we have readouts in this year of our best-in-class IL-6 antibody across numerous immune conditions similar for our Med Chem antibody and also for our small molecule dissociated glucocorticoid receptor. Then in vaccine, we also have noticed favorable Phase 1b data with (inaudible) and then moving forward with one of our formulations towards Phase 2 initiation this year.

And Ian alluded briefly in his introductory remark to some extent that work we are doing into renal diseases, where we have seen a positive Phase 2a data of our novel PDE5 inhibitor. We also have moved a second CCL25 dual inhibitor into diabetic nephropathy and diabetic macular edema underlying the important opportunity, medical and commercial, we see in this disease.

You may also note in some other highlights, including a dual acting inhibitor of uric acid for gout therapy, that we recently acquired through a licensing agreement with Kissei. So I think you will continue to see great momentum with internal and external partnership in this area. Thank you for your interest.

Ian Read

Thank you. Of course, on top of that, we do have Phase 3 Bococizumab and the Xeljanz data coming out and MeningB. So I think it's a strong pipeline across all phases. Thank you, Mikael.

Charles Triano

Next question please, operator.

Operator

The next question comes from David Risinger from Morgan Stanley.

David Risinger - Morgan Stanley

Thanks very much. Frank, I appreciated all the detail that you provided. I just wanted to follow-up, though, on some potential acquirers of the Established Products business. You have implied or suggested that Pfizer can indeed retroactively audit going backwards. So could you just sort of settle the debate, could you talk about why Pfizer cannot retroactively audit going backwards and just explain whether there is an any gray area there, that would be great. Thanks so much.

Ian Read

Sure.

Frank D'Amelio

So Dave, I mentioned before that three years audited financials and I used the word prospective. The reason I used the word prospective was, if not prospective, then it would have to be some portion of retrospective. Remember, if we are doing something retrospectively, it's not just an income statement, it's also a balance sheet, it’s a cash flow statement and these are businesses that in their new construct didn't exist previously to 2014. So it's the complexity involved in there not existing and the full suite of financial statements required which is why I said prospectively.

Charles Triano

Thanks, Frank, and our last question please operator.

Operator

Your final question comes from Damien Conover from Morningstar.

Damien Conover - Morningstar

Thanks for taking the questions. Just two quick questions. First on Eliquis, the Lancet in December published a mid-analysis that looked at the different anticoagulants and really showed little differentiation among them. Obviously, better than warfarin, but I want to get your sense of the marketing efforts and if you are finding ways to market Eliquis and get a better response over Xarelto and Pradaxa?

Then secondly, just a question on the potential breakup of the company. If you look forward to patent losses beyond the breakup, just trying to get an understanding of how assets might stay within companies or shift companies? For example with Lyrica, I think the patent loss is 2019. How would something like that, would that stay with the branded company or would it shift to the established company? I am just trying to get a sense of how that strategy might play out? Thanks.

Ian Read

Thank you. So I will take the second question first and then I will ask Geno to comment on the differentiation and the confidence one can have in mid-analysis and compared to randomized prospective trials. So look, I think the way you see we have set up our divisions now and the transfer of assets is probably similar to what we would do if there was a separation, but it would depend upon what type of separation it was and clearly you have to operate to maximize the value, initially of Pfizer's shareholder at that time and then it either will be commercial considerations on how you ensure that continuing LOEs get well managed by an organization that is capable to maximize it.

So I think your questions is, is all hypothetical this time without knowing exactly how we would, if we do, do any type of break-up with separation. Whether it would be selling to another company or a spin, that would clearly change the nature of the transactions, etcetera, etcetera. So in both your cases, we will be focused on doing what is right for our shareholders and ensuring maximum value.

Geno, do you want to add any comments on?

Geno Germano

Yes. Just a comment on our datasets. Our Eliquis dataset is really an outstanding dataset, a randomized prospective controlled clinical trial demonstrating superiority across three important efficacy and safety endpoints is a extremely strong database. Frankly, having randomized trials with those results is the strongest form of evidence that we could possibly have. What we are doing with that, that's really helping us in a competitive field, is taking it to, frankly, the clinicians that can understand and appreciate the data the best, and that's the specialist, the cardiologist.

We have increased substantially our medical education, our focus on the cardiologist and as a result, we have seen a nice response. In fact, we use as a leading indicator, new-to-brand prescriptions and we are watching new-to-brand prescriptions. This is prescriptions where a patient is getting a new brand. Across all of the business, we are now over 25%, and among cardiologist, we are about 30%, and we have surpassed Pradaxa and we are growing at a more rapid rate than Xarelto. So we think we have got some good momentum going here and it's on the back of the excellent dataset that we have.

Ian Read

Thank you.

Charles Triano

Thank you. Thank you this morning for everyone's attention. Thanks.

Ian Read

So long, everybody. Thank you.

Operator

Ladies and gentlemen, this concludes the Pfizer's fourth quarter 2013 earnings conference call. Thank you for participating. You may now disconnect.

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