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Healthcare - Medical - Devices - NYSE - US
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2014 - Q3
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Executives

Bob Marshall - VP of IR David Dvorak - CEO Jim Crines - CFO.

Analysts

Bob Hopkins - BofA Merrill Lynch Matt Miksic - Piper Jaffray Mike Weinstein - JPMorgan Matt Taylor - Barclays Capital Joanne Wuensch - BMO Capital Markets David Roman - Goldman Sachs Kristen Stewart - Deutsche Bank Derrick Sung - Sanford C. Bernstein & Company David Lewis - Morgan Stanley.

Operator

Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call..

Bob Marshall

Thank you, Britney and good morning everyone. Welcome to Zimmer's Third Quarter 2014 Earnings Conference Call. I'm here with our CEO, David Dvorak and our CFO, Jim Crines. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements.

Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures.

Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmer.com. With that, I'll now turn the call over to David..

David Dvorak

Thank you, Bob. Good morning, everyone, and welcome to our earnings call for the third quarter of 2014. This morning, I'll review our third quarter financial results, providing commentary on the year's progress to date and highlights from our performance. Jim will then provide additional financial details.

I'll state all sales in constant currency terms and all earnings results on an adjusted basis. Zimmer drove solid topline growth across several key product categories and geographies in the third quarter notably, accelerating U.S. knee sales over a strong performance in the prior year.

Consolidated net sales for the quarter were $1.11 billion, an increase of 3.1% and our earnings per share were $1.35, an increase of 8% over the prior year period. In the third quarter, Americas sales grew by 1% year-over-year, while Europe, Middle East and Africa increased by 5.7%, and the Asia Pacific region grew 6.9%.

These results reflect focused execution amid a stable global market for musculoskeletal solutions, with some modest acceleration in certain geographies.

With respect to pricing, we experienced price pressure of negative 2.2% in the third quarter, increased global market penetration of new products, positive long-term clinical validations of our legacy products in key international markets and the natural cycle of contract renewals and renegotiation in the United States all contributed to a sequential improvement and negative price trends by 60 basis points and thanks to the ongoing success of our operational excellence initiatives in the quarter, we once again expanded operating margins and accelerated earnings growth.

We also made progress with integrations planning for our pending combination with Biomet. We continue to be excited about the compelling strategic and financial rational, underlying this combination.

In addition to commercial and operational synergies, our combined entity will posses enhanced capabilities and resources for research and development, allowing us to more rapidly and efficiently bring a broad portfolio of musculoskeletal products, technologies and services to market.

We remain focused on integration planning efforts around the transaction, which we expect to close in the first quarter of 2015. Turning now to our product categories, Knee sales for the third quarter increased 6.3%, which we believe was an above-market performance, reflecting positive volume and mix of 9.2% and negative price of 2.9%.

Our Americas segment reported a sales increase of 5.7%, while Europe, Middle East and Africa grew by 9.8% and the Asia Pacific region delivered 3.8% growth compared to the prior year period.

Throughout the quarter, our focused execution drove solid sales of our next gen knee replacement system in European markets and supported the achievement of milestone sales for Persona, the personalized knee system, which has now surpassed the total of 100,000 implantations since its commercial introduction.

As we've communicated in previous quarters, the Persona system offers unprecedented level of anatomic fidelity and next generation features and is supported by Zimmer's intelligent instrumentation systems, including patient-specific instruments, the iASSIST Personalized Guidance System and the eLIBRA Dynamic Knee Balancing System.

We also continue to be excited about the steady growth of our joint preservation portfolio, including our single injection Gel-One Cross-linked Hyaluronate treatment and the Knee Creations' Subchondroplasty procedure.

Earlier this month, we strengthened this growing biologics portfolio of differentiated treatments early joint disease through the acquisition of Cambridge Massachusetts-based ETEX Holdings, Incorporated and its innovative line of solutions.

Zimmer's hip business recorded a sales increase of 2.7%, reflecting positive volume and mix of 5.2% and negative price of 2.5%. These results include a 0.2% sales decrease in the Americas; a sales increase of 2.8% in Europe, Middle East and Africa; and an impressive 9.7% increase in the Asia Pacific region.

We continue to position a comprehensive hip portfolio, for long-term growth opportunities and in the quarter, we achieved above market performances in several key overseas markets. Global sales were led by premium solutions such as our Continuum Acetabular System and BIOLOX delta Ceramic head offering.

We also delivered steady growth in the Americas with our M/L Taper and TM Primary Stems as well as the Avenir Müller Hip Stem in the European markets. Our legacy hip portfolio continues to demonstrate excellent performance as evidenced by an impressive level of clinical and scientific validation.

Zimmer continues to achieve favorable ratings by the United Kingdom's Orthopedic Data Evaluation panel with 10 of our major hip brands having now obtained a Class A 10-year rating.

Additionally, in ongoing extensive laboratory testing, Zimmer's Vivacit-E Vitamin E Highly Crosslinked Polyethylene liners have been evaluated for more than 90 million cycles of wear testing.

We believe this to be the first and only hip replacement technology to demonstrate long-term wear resistance, surpassing the number of walking steps a patient will typically take during their life time following total hip replacement surgery. Turning to extremities, Zimmer recorded a sales increase of 2.5% in the third quarter.

Competitive pressure continue to present a headwind for our shoulder business in the U.S., which somewhat offset our double-digit growth in the Europe, Middle East and Africa and Asia Pacific regions.

We'll continue leveraging our differentiated shoulder portfolio including the Trabecular Metal Reverse Shoulder and the Patient Specific Instrument shoulder system and innovative surgical platform that further enhances our position in this rapidly growing segment of the shoulder arthroplasty market.

We'll also continue to drive sales contributions from our more recently introduced products in our extremities portfolio such as the Trabecular Metal Total Ankle system and the Nexel Total Elbow, both of which feature advanced proprietary bearing technologies. Zimmer dental sales decreased by 2% in the third quarter.

Our stabilizing performance in the Europe, Middle East and Africa region was offset by challenging year-over-year sales comparisons for our Asia-Pacific business and regenerative portfolio.

We expect that these headwinds in the quarter will normalize in future operating periods and will continue to focus on leveraging our comprehensive dental portfolio for improved growth.

Zimmer trauma sales decreased 0.6% in the third quarter with an impressive 9.4% sales increase in the Asia Pacific region, offset by a 5.5% sales decrease in the Americas and a 0.7% decline in Europe, Middle East and Africa.

Although we faced challenge in prior year comparisons in Europe, Middle East and Africa, we continue to achieve encouraging growth in the Asia Pacific region and steady adoption of our core offerings, including rising sales of the Zimmer Natural Nail family.

In building on the recent launch of the Distal Radius Plating System in the United States, in the third quarter we introduced this versatile fracture system in certain European markets.

We intend to position our differentiated trauma offerings for improved growth in the future as we continue expanding our footprint in major trauma centers around the globe. Zimmer spine delivered 6.4% sales growth over the prior year, which we believe is an above market performance.

The growth of this global business continues to validate our efforts and focus on core fusion solutions.

As we execute on an innovative and increasingly competitive spine portfolio, released in the second quarter of 2014, the Virage OCT spinal fixation system has already succeeded in expanding our footprint in posterior fixation surgeries, while supporting volume and mix growth for other Zimmer spine products used in the same procedures.

We've also been pleased with the ongoing commercialization of the Optio-C interior cervical system. Our next generation modular cervical device, which in the third quarter received an additional 510-K clearance from the FDA for its allograft application. Sales for Zimmer's surgical and other category decreased by 4.4% in the quarter.

We continue to face challenging sales comparisons in the U.S. stemming from the exceptional performance in capital sales of our differentiated Transposal fluid waste management system in the prior year.

However, we drove noteworthy sales across a number of major product lines, including consumable and wound debridement products as well as skin graft solutions. We also continue to achieve healthy growth in capital sales of the A.T.S.

family of Automatic Tourniquet Systems, which feature advanced proprietary pressure sensing technology designed to achieve higher levels of safety, reliability and convenience. We look forward to continuing to drive this differentiated portfolio for growth in future quarters.

With that, I'll now ask Jim to provide further details on the third quarter and our guidance.

Jim?.

Jim Crines

Thank you, David. I will review our third quarter performance in more detail and then provide additional information related to our updated 2014 sales and earnings guidance. Before I start, I would like to note that our results reflect the same number of billing days in the current year quarters than the prior year.

Our total revenues for the third quarter were $1,106,000,000, a 3.1% constant currency increase compared to the third quarter of 2013. Net currency impact for the quarter decreased revenues by 0.2% or $2 million.

The negative currency impact for the quarter related principally to our Japanese yen-denominated revenues, partially offset by positive currency translation associated with our euro-based revenues. Our adjusted gross profit margin was 73.4% for the quarter. The margin ratio declined 10 basis points compared to the third quarter of 2013.

In the third quarter, we recognized approximately 80 basis points of charges related to the medical device excise tax.

This headwind, along with ongoing but more moderate price pressure was effectively offset by manufacturing efficiencies, as well as modest incremental gains from our cash flow hedging program and reduced year-over-year excess and obsolescence changes.

The company's R&D expense decreased 6.7% or $3.3 million to 4.2% of net sales when compared to the prior year. The decrease in R&D expense continues to reflect focused efforts on our quality and operational excellence initiatives and related dedication of resources.

Selling, general and administrative expenses were $443.5 million in the third quarter and at 40.1% of sales, were 70 basis points below the prior year. The continuous improvement in this ratio reflects our ongoing commitment to administrative and operational excellence.

Our global strategic sourcing initiative as well as go-to-market and distribution optimization efforts continue to drive improved productivity and year-over-year savings in certain spend categories.

In the quarter, the company reported pretax charges of $66.9 million in special items; $3.8 million in cost of products sold pertaining to global restructuring, quality and operational excellence initiatives and recent acquisitions; and $10.5 million of interest and upfront financing cost associated with the pending Biomet transaction.

Adjusted third quarter 2014 figures in the earnings release exclude the impact of these charges. Adjusted operating profit in the quarter amounted to $321.9 million or 29.1%. Our adjusted operating profit-to-sales ratio was 100 basis points higher than the prior year third quarter.

The continued expansion of operating margin demonstrates the organization's commitment to create value through the achievement of operational efficiency goals along with the growth and capital allocation dimensions embedded within our value creation framework.

Net interest expense for the quarter amounted to $13.3 million, which was flat when compared to the prior year quarter. Adjusted net earnings were $232.6 million for the third quarter, an increase of 7.8% compared to the prior year. Adjusted diluted earnings per share increased 8% to $1.35 on a 171.7 million average outstanding diluted shares.

These adjusted earnings per share are inclusive of approximately $0.05 of share-based compensation. At $0.96, reported diluted earnings per share increased 6.7% from the prior year third quarter reported EPS of $0.90.

Our adjusted effective tax rate for the quarter was 24.7%, which is 70 basis points favorable when compared to the prior year due to a favorable change in estimate associated with certain income tax returns that were finalized in the quarter.

Our reported effective tax rate for the quarter was 27.3%, due mainly to certain non-deductible expenses connected with the pending Biomet merger. The company had approximately 169.3 million shares of common stock outstanding as of September 30, 2014, a decrease compared to the 170.5 million as of September 30, 2013.

Operating cash flow for the quarter amounted to $255.7 million, a decrease of 12.6% from $292.7 million in the third quarter of 2013. The decrease was driven primarily by higher tax payments relative to the same period prior year as well as increased inventory investments in support of higher field consignments in global new product launches.

Net inventories were $1.2 billion at the end of the third quarter, an increase of $30.3 million from June 30, 2014. As I just noted, the increase is connected with the ongoing global commercialization of new product offerings, as well as the effects of placing more inventory into distributor and hospital consignments.

Adjusted inventory days on hand finished the quarter at 348 days as compared to 284 days at the prior year quarter end. As of the end of the third quarter, net receivables increased to $947.6 million from $898.9 million in the third quarter of 2013 or 5% above the prior year.

Our adjusted traded accounts receivable days sales outstanding finished the quarter at 71 days, two days improved when compared with the prior year. Depreciation and amortization expense for the third quarter amounted to $90.9 million. Free cash flow in the third quarter was $172.5 million, $33.5 million lower than the third quarter of 2013.

We define free cash flow as operating cash flow less cash outlays for instruments and property, plant and equipment. The decrease in free cash flow was driven by decreased operating cash flows, as I've just noted as well as increased instrument investments in support of the ongoing launch of new products.

Capital expenditures for the quarter totaled $83.2 million, including $50.9 million for instruments and $32.3 million for property, plant and equipment. I'd like to turn now to our guidance for 2014.

In our earnings release this morning, we updated the company's expectation for 2014 revenues and now forecast revenues to increase approximately 2.25% constant currency when compared to 2013. We now expect foreign currency translation to decrease our reported 2014 revenues by approximately 0.75% for the full year.

Therefore, on a reported basis, our revenues are projected to be approximately 1.5% above 2013 results.

As we anniversary through the recognition of medical device excise tax during the fourth quarter, coupled with ongoing savings from our operational excellence programs we would expect the gross margin ratio for the year to remain between 73% and 74%. Our guidance for R&D, SG&A and interest expense for the full year also remains unchanged.

However, as you refine your models for the fourth quarters, please consider the seasonally lower expense ratios typically experienced in the fourth quarter. Moving down the income statement, the estimated full year tax rate is now between 25% and 25.5%.

The previously guided fully diluted share count of 172 million shares to 173 million shares is more likely to be toward the lower end of that range as exercises some employee stock option are lower. In the fourth quarter, we would expect fully diluted shares to be just above 172 million shares.

Full year 2014 adjusted diluted earnings per share guidance has been updated to approximately $6.05, taking into account our updated expectations for full year revenue growth.

As indicated in our earnings release, to arrive at our anticipated reported GAAP earnings per share, you should subtract total charges for special items and certain claims of $250 million and $70 million of Biomet transaction-related expenses on a pretax basis or approximately $1.40 per share.

Before I finish, I would like to make a few modeling comments relating to our proposed combination with Biomet. I want to reiterate that the previously announced guidance regarding accretion and adjusted cash earnings per share applies to the first 12 months following the closing of the deal.

With that in mind, we continue to expect accretion and adjusted cash earnings per share to be $1.15 and $1.25 on approximately 207 million fully diluted shares.

To arrive at this fully diluted share count, and the 32.7 million shares comprising the equity portion of the consideration for the deal through our projected pending diluted share count of approximately 173 million as well an additional 1.3 million shares anticipated to the issue pursuant to our employee equity programs.

Finally, please note that our guidance does not include any impact from any unforeseen events. David, I'll turn the call back over to you..

David Dvorak

Thanks, Jim. Zimmer's third quarter was highlighted by solid sales across key products and geographies.

Our performance continues to be driven by innovative systems such as the Persona need, which incorporates premium technologies that we leverage across our differentiated portfolio, including Trabecular Metal technology in the Vivacit advanced bearing material.

For the balance of 2014 we'll be committing significant energy to the ongoing integration planning for our pending combination with Biomet, while continuing to deliver a compelling value proposition, the patients providers and healthcare institutions in the 45 billion musculoskeletal market.

And now I'd like to ask Britney to begin the Q&A portion of our call..

Operator

Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) Our first question comes from the line of Larry Biegelsen with Wells Fargo Securities. Please go ahead..

Unidentified Analyst

Hi guys, it's actually Craig on for Larry..

David Dvorak

Hello Craig..

Unidentified Analyst

Just I guess, I'll start with the implied -- the implied growth by my math is about 2% in Q4 and I just wanted to know and it seems like a bit of a slowdown, especially some of the -- given some of the acceleration you saw in re-con and then some of the seasonality trends that we expect.

So I just wanted to know what headwinds or what factors make that number seems conservative to us at least?.

David Dvorak

Well I think that you point out the seasonality trends and I think that's the thing to focus on. We wouldn’t expect our performance to fall off relative to the market and these categories the positive trends will continue by product category and by geography and we look to continue to improve the sales execution in the Americas in particular.

But as you reflect back on the fourth quarter of 2013, it was a pretty significant procedural shift into their quarter and that really was the area that one has to be careful about as we look to project Q4 market growth rates within the United States on the large joint side in particular..

Unidentified Analyst

Okay. Thanks. And if I can as a follow-up just ask on pricing, obviously you guys -- pricing improved during the quarter and I appreciate the color on some of the timing of contracts, but other competitors have seen pricing pressure increased during the quarter and throughout the year.

So I just wanted to get your sense of how we should look, how we should look at that going forward?.

Jim Crines

Sure Larry, this is Jim..

Unidentified Analyst

Craig..

Jim Crines

Craig, sorry..

Unidentified Analyst

We have a problem..

Jim Crines

Yes, yes. First of all we're really pleased with the sequential 60 basis point improvement in negative price in the quarter. We continue to believe our commercial teams are doing a good job with managing the pressure. As David indicated, there are a number of factors contributing to the [rate] (ph) we saw in the trend.

As an example, as we establish higher market penetration with new products, including most importantly the Persona knee system, we tend to see more stability in prices because these new platforms are being introduced with tighter price bands compared with our more established legacy products.

As you know we're operating in a market environment that does not allow for the kind of variations we might have experienced in the past. With regard to contract renewals, we have had to deal with our fair share of demand letters from our U.S. based hospital customers.

In our case the total value of price concessions by quarter across all contract renewals has come down sequentially from one quarter to the next beginning with the second quarter.

Now we may see an increase in demand letters in coming quarters, we certainly expect price pressure is going to continue in this market, but still a positive trend in this quarter and one we believe is helped by increased market penetration of new products.

And then lastly, I would just point out that we saw improvement in all geographic segments in the quarter as compared with the second quarter and in this context, we believe the continued positive long-term clinical validation supporting our legacy products, which is demonstrated in registry data, is helping us in key international markets..

Unidentified Analyst

Great. Thanks guys..

David Dvorak

You're welcome, Craig..

Operator

Thank you. Our next question comes from the line of Bob Hopkins with BofA Merrill Lynch. Please go ahead..

Bob Hopkins - BofA Merrill Lynch

Thanks and good morning..

David Dvorak

Good morning..

Bob Hopkins - BofA Merrill Lynch

So, on the Biomet transaction, thanks for the detail, I just wanted to ask two things.

First sort of qualitatively I was wondering David, if you could comment on how the integration is going generally or how the early part of the integration is going generally? Are you having good conversations with the distributors? Just your confidence level and then may be Jim more quantitatively I appreciate your comments on the synergies and the share count and frankly that's the kind of thing that I think a lot of people are modeling and as I see the street consensus for 2015 on a cash basis, assuming that Biomet closes in Q1, is in the high $7 area, $7.80, $7.85 somewhere in that range.

And I was just wondering if you could comment on is that a number that you are -- is that a range that you're relatively comfortable with at this point, given the -- given what you're seeing in the business today..

David Dvorak

I'll pick up with the first part of your question Bob. This is David. We're very, very pleased with the integration planning as it relates to the combination. I'll tell you that the chemistry of the Group has been terrific. The energy level has been extremely high.

We've had opportunities and part of this is enhanced by the sort of the co-location benefit of the headquarters, but I would tell you globally leaders have set a very good tone, a very constructive tone of the integration planning work and that's cascaded down as these teams have expanded.

At all levels of the organization I think that part of that is just a credit to the leadership and the Biomet leaders in particular, I want to applaud their efforts.

It's very commendable the approaches they take, but I would tell you that the other element of it that one can't fake at some level, is just the underpinnings and premises for the deal are unmistakable to folks as they get into the planning and look at the benefits of combining these portfolios, combining the R&D efforts, the strength of the combined distribution channels and on and on, one can clearly see that this is going to be a leadership position that can make a big difference for all stakeholders involved.

And that is establishing the positive tone in combination with the approach that the leaders are taking.

So we're right on track if not ahead of the planning efforts relative to what we were anticipating or looking to achieve going back to the announcement date in April and on the distribution side in particular, that you referenced/ I think that's not really well because at the sales level they can see the benefits of the combined portfolios and they can understand the logic to the combined R&D efforts and what a difference that can make in the environment that we're going to be operating in and the differentiated opportunity that we're going to have to provide better solutions to enhance patient outcomes and to do that in an increasingly cost efficient for the customers and help shape how those solutions are delivered to the marketplace.

So all is on track if not ahead of schedule and then I would tell you that the tone and the attitudes are even more positive than what I had hoped for..

Jim Crines

And Bob, this is Jim. Understanding that we have not provided top and bottom line guidance for calendar year 2015, we'll do that the closing of the deal for the combined enterprise. Ahead of that, we would plan to continue to provide guidance on Zimmer on a standalone basis.

I will say that we understand there is a wide range of estimates that are out there for the combined enterprise, some of which may assume that the closing takes place early in the first quarter, other that may assume the closing take place later in the first quarter and that range will certainly tighten as we provide more specific guidance.

I am not at all uncomfortable. I think by and large the analyst community has taken the $1.15 to the $1.25 in accretion and cash earnings per share and build that into the assumptions that they're making at this stage..

Bob Hopkins - BofA Merrill Lynch

Okay. So there is nothing that you would point out that would things that we would need to consider as modeling in that sort of a range.

Do you think we're missing any major piece as it just comes down to the timing of the close and so I am just trying to get a sense from you, are there things that you think we're not considering that we should be?.

David Dvorak

Well again, the timing of the close is a pretty big assumption of whether or not you assume it's going to be at the beginning or the end of the first quarter and we provided a bit more detail on average shares in my scripted comments.

It's not something we had done earlier and are doing that in an effort to provide as much sort of detailed support as we can at this stage..

Bob Hopkins - BofA Merrill Lynch

Okay. Great. I'll leave it at that. Thanks very much..

David Dvorak

You're welcome, Bob..

Operator

Thank you. Our next question comes from the line of Matt Miksic with Piper Jaffray. Please go ahead..

Matt Miksic - Piper Jaffray

Thanks for taking the questions. One, a couple, just one clarification and then one follow-up. You talked a little about pricing in the quarter, and some of the trends that sort of affected this year so far. And I think Craig mentioned some of the other commentary that we've heard throughout the year.

But I'd love to get your sense as to, is the stability that you're seeing with, I'm assuming Persona, some of your new products, and sort of the -- I don't know, maturation of the hospital networks in the U.S.

and their cost control strategies that we've seen evolve over the last years, is that something that you expect to be converging downward from where the pricing pressure that you're seeing? Or is this low 2% pricing pressure something you see as sustainable? I know it's kind of a difficult thing to predict, but maybe just in terms of new activity, changes in the way hospitals are buying, is there anything that you're seeing that would indicate that this is not a sort of sustainable range over the long term? And then I have one follow-up..

David Dvorak

We would see that the current trends as being stable and nothing environmentally changing in a material way Matt that would cause us to at this point believe that the future shorter and intermediate term will look materially different.

If you reflect back on the guidance that we came into the year in our January call, we said that we were expecting 2% to 3% negative price in the year and Q1 was minus 2.3%, Q2 was minus 2.8%, Q3 minus 2.2%.

So very tight within that band and more importantly and substantively to your question, the activities that surround those dynamics are consistent with expectations.

So holding to that same band for the balance of this year, will give you some specific guidance and color as we get into next year and provide 2015 guidance, but nothing that we see right now would cause us to believe that the environment is going to change dramatically..

Matt Miksic - Piper Jaffray

That's great. Thank you, David. And a follow-up for Jim, if I could. You mentioned a few, it sounded like a handful of sort of positives in the gross margin line. But the margin was in fact down a touch year over year.

If you could just maybe help us understand how those factors kind of added up to a slight decline, and what we can expect kind of heading into the end of the year?.

Jim Crines

Sure, well understand coming into the year, we're taking into 80 basis points of headwind associated with the medical device excise tax.

So the positive things that I mentioned that efficiencies, we're getting out of our operational excellence initiatives the slightly higher gains on hedge contracts as well as lower excess and obsolescence starters in the quarter -- third quarter this year compared to the third quarter of last year all helped to offset that 80 basis points of headwind, so that the gross margin ratio was only down 10 basis points compared to the prior year..

Matt Miksic - Piper Jaffray

And then heading into the end of the year, any seasonal expectations you can sketch out for us..

Jim Crines

Well I would tell you we're obviously taking -- we've increased our guidance with respect to the currency headwind for the fourth quarter. That does typically result in somewhat higher gross margin ratio as we realize gains on hedge contract and a lower topline on -- reported topline on our international revenues.

That together with what we were just talking about in terms of more moderate price pressure, I would tell you sort of contribute to gross margin expectation for the fourth quarter that would put us toward the high end of the range of what we're guiding to for the full year..

Matt Miksic - Piper Jaffray

Got it. Thank you, Jim. Thank you, David..

Jim Crines

Welcome. .

David Dvorak

You're welcome, Matt..

Operator

Thank you. Our next question comes from the line of Mike Weinstein with JPMorgan. Please go ahead..

Mike Weinstein - JPMorgan

Thank you. Let me start with the 2% to -- sorry, the 2.25% revenue guidance for the year. Maybe just give us your thoughts, and obviously you're not guiding yet, but if you think about the Company pro forma for Biomet. Biomet grew just this last quarter organically if you adjust for their acquisition, slightly faster than that.

Can you just talk about how you think about revenue growth at this company pro forma? And then I was hoping you could spend a little bit of time on the money you're setting aside to lock in distribution. If you could tell us a little bit more about that, and how expensive it will be, that would be great. Thanks..

Jim Crines

Sure. Mike, this is Jim. I would just go back to the guidance we provided when we announced the deal and expectation that in the short term, the combined enterprise we would expect to be growing in line with market understanding that there could very well be some disruption.

The sales channels are getting integrated, but just believe that we have significant opportunities with respect to cross selling that can offset any revenue loss that we might experience as the sales channels are being integrated.

Now as what the market growth will be globally in 2015, we'll provide some color on that when we come out with 2015 guidance somewhere in the range of low to mid single digits, but will be more specific about that when we come out with that guidance in January..

Mike Weinstein - JPMorgan

And then on the money set aside, I think in the proxy, Jim or David, whoever wants to take this. I think there was $87 million set aside for what I think it was classified as distributor and management retention.

Can you just talk about how extensive basically the pay-to-stay will be, and the agreements that you are coming to with some of the distributors? What is the one-year agreements, two-year agreements? If you could give us some visibility on that, that would be great?.

David Dvorak

Sure, and all integration planning is ongoing at this point in time Mike. I think that the disclosure that you're referencing the plans that were put in place by Biomet and so that disclosure is a specific I guess there's anything that is out there publically.

Those were programs that were designed really pursuant to the negotiation process and the diligence process and we were very supportive of, but Biomet management and Board's decision to put those programs in place, I think that they continue to serve that entity well from whatever we can see within the market place.

The balance of the cost of those integrations are just lumped up at this point in time and the best estimates that we had at the time of the announcement Mike is what the integration cost would be and just -- we put that out there as just being a certain multiple of the anticipated net synergy benefits.

But we will be able to firm up those numbers as we lock down the plans and I would be really confident that by the time the closing rules are around, we're going to be able to give you a really specific guidance as to what the all-in integration numbers are going to look like and the pace of retrieving the benefits of the synergies etcetera..

Mike Weinstein - JPMorgan

Okay. I would just say that as you guys get closer to it, if you could try and give the street just some visibility into the types of agreements you're reaching with the distributors and that would obviously help us gain some comfort in the synergy risk that everybody's been talking about..

David Dvorak

Yeah. Noted Mike we'll do that consistent with the lockdown of those plans okay..

Mike Weinstein - JPMorgan

Perfect. Thank you, guys..

David Dvorak

Thank you..

Operator

Thank you. Our next question comes from the line of Matthew Taylor with Barclays Capital. Please go ahead..

Matt Taylor - Barclays Capital

Hi. Thanks for taking the question. I wanted to ask one just about the integration and the performance this quarter. So I guess one of the trends in the quarter and recently, is some of those non-recon businesses that you have, have been growing more slowly. The hip and knee businesses had a pretty good quarter this quarter.

But you referenced before you see a lot of cross-selling opportunities, and I guess can you talk about the differences that you see between combining the large recon business versus combining some of those other ones? Do you expect more commercial synergies at those other businesses that may be sub-scale at Zimmer and Biomet?.

David Dvorak

Yeah that’s a great question. I would tell that if you look at the portfolios, there are significant opportunities in all product categories Matt. I think that the complementary natures within large joints might from the outside world appear to be a bit more nuance because both of these companies have fairly comprehensive portfolios to begin with.

But those nuances can make a big difference to the sales force as well and I’ll tell you some of the product fares that we've had consistent with the diligence and integration planning have revealed opportunities that have the sales forces on both sides very excited within the large joint side.

It really takes on a bit of different dimension when you get into the smaller business that your reference however because those businesses for each company have been challenged by scale historically and when you bring the product portfolios together on day one, you have some really significant enhancements whether material gaps that get filled.

But then very, very importantly there are kind of couple of big benefits to the combination as it relates to those business that include the capability to have much more scale or R&D pipeline so the cadence of what's going to come out of the development effort is going to be much, much more regular for those smaller business.

We're going to be able to get to the point where we have scale very competitive portfolios and then we were reinvesting in those portfolios and keeping the sales force engaged, excited, and getting out of ahead rather than filling gaps, which is kind of the trap the end up stuck within subscale. So I think that dynamic changes in a very material way.

And then secondly, the thing I would point you to just the capability to build out specialized sales forces at the rep level for instance in those different product categories, which again historically because of the scale challenges has been difficult for either company to do fully.

But we really do see our way towards being able to build out specialized sale forces of the rep level wherever that makes sense wherever that customer call point justifies that kind of an investment. So that's going to put us in a much stronger position. The combined product bag and the focused sales force is going forward..

Matt Taylor - Barclays Capital

Thanks. And just a follow-up on price. I think everybody assumes that pricing will stay down, or potentially get a little bit worse in the future. Do you see any scenario where in large joint recon, for example, pricing could get better because of either new products and mix, or because pricing has been down for the last five years..

David Dvorak

Well I think that you could see some evidence of some anniversarying out of some of those trends that have created the pressure. I just think it's premature to project things going into positive territory.

I think that the stability message is the one that we would use or refrain at this point in time, but the scenario that you put out there is a possibility of some point in the future..

Matt Taylor - Barclays Capital

Okay. Thanks a lot..

David Dvorak

You are welcome..

Operator

Thank you. Our next question comes from the line of Joanne Wuensch with BMO Capital Markets. Please go ahead..

Joanne Wuensch - BMO Capital Markets

Good morning. And thank you for taking the question. You had some really outsized growth rates in certain regions, if you could just comment on that. In hips it was up almost 10% in the Asia-Pacific region, in knees, EMEA up almost 10% also.

What's going on there?.

David Dvorak

Those teams are really doing a great job Joanne with sales execution. So largely the same portfolio, same competitors, the local dynamics can be a bit difference, but I don’t think those should be categories as being material.

Those sales teams are just doing an excellent job on the execution side and that is in the first quarter that we have seen that. In Q2 you saw the same very strong knee performance coming out of Europe, Middle East and Africa as well as the very strong hip performance coming out of Asia Pacific.

So those cross earnings are the types of things that we wanted to transfer back to other markets and I think the big positive that one should take away from that and this is what we communicate internally to the teams is you have the portfolio necessary to compete effectively.

But look, some of the trends that you saw within the United States Market sequentially from Q2 to Q3 show some important improvement in these categories as well, a pretty significant step up in knees for example and slight improvement in hips.

So we are going to keep working forward and try to post some numbers on the broad that look consistent with that high-end performance for Asia Pacific on hips and the high end performance for EMEA on knees..

Joanne Wuensch - BMO Capital Markets

And then in terms of the merger, could you remind us of when the deadlines are for various regulatory rulings? And then if there's any way to give us some qualitative update on how those conversations are going that would be appreciated. Thank you..

David Dvorak

Sure. The timelines that we put on and updates publically are what there is to say about that formally. You know there is a bit more of a formalized chronology that's been put out between now and the coming weeks and through the month of March even in the case of the European filing. The U.S. process is ongoing a little bit more of a rolling basis.

We're making a good progress and I think I would just say by way of general characterization is that process is tracking absolutely consistently with the diligence that we did prior to announcing the deal and what we are articulated at the time of the deal announcement back in April.

So everything is running on course and from a timing prospective consistent with our expectations leading us to just reiterate that we have the belief that we will close the deal in first quarter of 2015..

Joanne Wuensch - BMO Capital Markets

Thank you..

David Dvorak

You're welcome..

Operator

Thank you. Our next question comes from the line of David Roman with Goldman Sachs. Please go ahead..

David Roman - Goldman Sachs

Good morning, everybody. And thank you for taking the questions. I was hoping to start with the spine business because that was, if I look across the drivers of the acceleration this quarter, knees was certainly a call-out, but spine also was a very nice pick-up.

David, if I go back to your comments on the success you're having with Virage and the pull-through you're getting, could you maybe just put that in a little bit more context about where you are and sort of the full building out of your spine product portfolio? And whether you're at a point that the product bag is competitive, and we can see this type of trajectory continue?.

David Dvorak

Sure David. First when we just say we're thrilled to get a question this quarter on spine. We're really proud of the team. This is the team that’s been together for several years. They are the ones that develop a very intelligent strategy and approach to running that business and importantly to what they were going to focus on by way innovation.

Largely that team has been focused from a development effort on the core fusion market and they’ve just been methodically and dogged in executing those plans and at the same time strengthening the distribution channel. So I believe that what you saw in Q3 is a shape of things to come by the spine division.

And we're probably in the mid innings of building that portfolio out at this point David and you're seeing just the beginnings of the benefits of them executing that strategy with these products rolling out. We have about a dozen product launches this year.

So a really robust pipeline that has been a combination of pure internal and some mix of external development through licensing and distributional arrangements, but the primary drivers have been the internal projects that include projects like Virage and the benefit of those systems is obvious, right.

You strengthen the outer body and it shores up you capability to get the inner body device within those procedures and increasingly that team is positioning itself to become much, much more competitive in sought of the teaching institutions and academic centers because we are shoring up our deformity and conflicts in trauma offerings.

That will continue and I would say that over the course of the next 12 to 24 months those programs will continue to produce very important launches that will complete round up the core fusion line.

So I think we're in a really good position to start posting consistently positive above market growth numbers and I think it's just going to get stronger in the next 12 to 24 months..

David Roman - Goldman Sachs

That's helpful. And then maybe just a follow-up on sort of the broader macro. At least the analysis that we've looked at on your core business would suggest that the volume growth that the industry and you have posted over the past couple years is probably below what you would think the normal demographic trends would support.

And I understand that there's some hesitancy to call out a broader turn in utilization, but as we look at the data points that have surfaced this quarter, whether it's your numbers, your key competitors, some of the hospitals, etcetera, the environment does look to be getting better.

So I was just hoping to get your perspective on what it would take to get you more constructive on a sustainable turn whereby we can start to see volume growth reflect more of the demographic nature of the categories you serve?.

David Dvorak

Yes and I think that you could certain see that in what we articulated happened and we were able to drive within the market on the knee side for instance David within the quarter.

I think some of the hesitancy on that is understand from everyone’s prospective just the seasonality shift that may be going on primarily within the United States market, but even though U.S. where there are national healthcare systems that are either dialing up or down procedure rates because of our security measures or disciplines in that regard.

You get a little bit of lumpiness. So that said, we've had really consistent and good performance in the OUS markets. So I think that the underlying procedural demand for the solutions is just unmistakable and may be a topic that hasn’t come up in this call, but you can certainly see that in the emerging markets.

We continue to perform very, very well in the emerging markets and those penetration rates are low growing classes of folks that are going to be future patients within those markets expanding infrastructure that deliver those solutions and so we're going to be big part of providing those solutions to customers going forward in the important emerging markets.

So I think that the dynamics are all positive and I just think it’s a matter of stringing some quarter together from a market growth rate that allows people to become increasingly comfortable that the aging population, the fact that per late stage osteoarthritic patients this is the only solution out there and it works really well and its cost effective for the systems.

All of that lines up well for the continued health within these markets that we serve..

David Roman - Goldman Sachs

Okay. I appreciate all the prospective. Thank you very much..

David Dvorak

You're welcome.

Operator

Thank you. Our next question comes from the line of Kristen Stewart with Deutsche Bank. Please go ahead..

Kristen Stewart - Deutsche Bank

Hi, thanks for taking the question. I was wondering if you guys could update us on just -- I guess it's a two part question, the FDA outstanding warning letters, where do we stand with that? And then kind of as a parallel to that, the special items that you guys are reporting.

If I look back to the last couple years, it's steadily increased from $75 million to now you're expecting $250 million.

How much of those, I guess, special items are really going towards resolving some of the FDA warning letter issues? And maybe just some more clarity on how should we think about that number going forward, since the trend is seemingly increased over the last couple years?.

David Dvorak

So I’ll pick up on the first part of the question, Kristen this is David. The reference to warning letters, pleural, is incorrect. We have a pending warning letter out of the Ponce Puerto Rico facility. We're putting a lot of effort into addressing those concerns.

Any of the follow-up inspections that take place that result in Form 43 inspectional observations are the top priority for the company as it relates to our quality and operational excellence efforts. And we have a lot of focus and good work that's been done there.

We're communicating that progress to the FDA on a very regular basis and I am quite optimistic that we're on a very positive track towards resolving any of those outstanding issues going forward. I think importantly beyond the reference to the warning letter is just -- this is a core value for the company.

It is the top priority to ensure that we have the right quality systems at the foundation of our business and we've made tremendous progress in the last couple of years in particular on that front. And that really is going to be enabler going forward for continued not only quality, but operational excellence improvement.

It's going to support the financial returns ultimately, but it has remained every aspect of our business and I think that we have the right level of focus and the right effort underway to not only resolve that, but get the company up with the right kind of foundation for the future..

Jim Crines

And Kristen this is Jim. With respect to the actual spending as you point out, we coming into the year indicated that we anticipated spending around $250 million on quality and operational excellence initiatives as well as some ongoing spend associated with certain of improved initiatives.

Slightly more than half of that spend is connected with the quality and operational excellence efforts across all of our manufacturing sites.

So although as David pointed out, the warning letter is connected with a single facility where taking the approach to upgrade our quality systems across all dimensions of our quality system, production and process control, design controls, controls around design transfer across all of our facility. So it’s a very significant effort, a large project.

We've got a very capable leader who is a member of our operating community who is overseeing the entire effort and expect that spend will begin to taper off towards the end of 2015. So it will carry over into 2015, but begin to taper off towards the end of 2015..

Kristen Stewart - Deutsche Bank

By taper off, does that -- I assume it doesn't go away. So we should expect some continued costs, I guess, looking you out for the next couple years? Is that fair or….

Jim Crines

I think it's fair to say that it will be reduced significantly by the end of 2015 going into 2016..

Kristen Stewart - Deutsche Bank

Okay. Thanks very much..

Jim Crines

You're welcome.

Operator

Thank you. Our next question comes from Derrick Sung with Bernstein Research. Please go ahead..

Derrick Sung - Sanford C. Bernstein & Company

Hi, thanks for taking my questions. I think we're all trying to get kind of a sense of the industry landscape and what that will all look like post consolidation. One of the perspectives that we haven't heard too much from is, what's the hospital customers are thinking and telling you about the impending consolidation.

And so I was just wondering if you could maybe share some color on your conversations with the hospitals and the hospital administrators, and what they would say about the impending merger that you're going to be undergoing.

David Dvorak

Yeah I think that the conversations we've had in that regard have been positive at this point. We probably have had more conversations at the surgeon level or I’ve been involved in more conversations at surgeon level and necessarily the administrative level.

But here is the thing that the administration and increasingly as time progresses the surgeons care a lot about providing better solutions to the patients but finding a way to do that in an increasingly cost effective way and I'll tell you the message that resonates with the administration side deeply is how can we develop deeper and deeper partnership than we had historically to bring those solutions about an increasingly cost effective way.

The broad musculoskeletal portfolio and innovation within system but as well comprehensive solutions and integrated services is of high interest to the administrative leaders within those institutions.

And that's an area where I think we're going to be able to put a lot more effort and a lot more resources behind and look to collaboratively construct solution and service offerings that can achieve objectives on both of those fronts.

Provide better patient solutions and do that in an increasing cost effective way and it just makes sense when you think about some of the reforms that are taking place, pick a market around the world but here in the United States, the reforms that are being driven by the ACA with the delivery model changes whether it's ACO or bundling give these administrators much more of a reason to become in tuning advance of readmission charges and complications coming back to impact their P&Ls.

And I think that this is a good thing. I think it's going to be a good thing for patients because it's going to allow us to come in these more comprehensive partnerships to provide the solutions and to work towards a common goal of getting it right for that patient in short, medium and the long term..

Derrick Sung

Great. Thanks. That's helpful. And as a follow-up, just wanted to put your views of the global market trajectory in the context of the accretion from the Biomet deal that you're guiding to.

So I guess Jim, how sensitive is that accretion guidance that you're providing to whether the global markets end up growing in the low single digits versus the mid single digits? And maybe just any additional color you can provide to us on your global view of the markets would be helpful. Thanks. .

David Dvorak

Sure. We said with the announcement I pointed out earlier our expectation is that combined enterprise will be able to grow in line with market in the short term and again will give sort of more specific color on what we think that is in our fourth quarter call towards the end of January.

If this is a market although we would acknowledge that this is a market that has grown and you know as we've said in a range of low to mid single digit. As you will know this is a high margin business.

There is certainly opportunity as you're growing at the higher end of that range for the accretion to be at the higher end of the range that we guided to.

But I would tell you that within that range, we're very comfortable with $1.15 to $1.25 accretion and adjusted cash earnings per share because at the end of the day it's really a function of the acquired operating earnings as offset by the interest cost on the financing and the dilution associated with the additional shares that are getting issued in connection with the transaction.

So as long as Biomet continues to perform the way that they have into the close and the acquired operating earnings are somewhere in line with what we sort of expect them to be as we put that model together and we've no reason to believe at this point that they won't be.

I think Derrick, I would tell you we continue to have a high degree of confidence around the guidance that we've provided on accretion..

Derrick Sung - Sanford C. Bernstein & Company

Okay. Thanks Jim. That's helpful..

Jim Crines

You bet..

Bob Marshall

Britney, we have time for one additional question..

Operator

Thank you, sir. Our next question comes from the line of David Lewis with Morgan Stanley. Please go ahead..

David Lewis - Morgan Stanley

Good morning. Maybe just two quick questions. First Jim just a question on margins. If you look at this quarter it's been five consecutive quarters of EBIT margin improvement. So I just wonder what's the sustainability of that trend and sort of your ability to complete your cost program as you head into Biomet.

And a related to that margin question, I've a follow-up for David as well. The gross margin has not been a source of upside to you, but given the pricing environment, is flat GM is sort of the best we can hope for. So those two questions on margins and then I've a follow-up for David..

Jim Crines

Sure. We're going to continue to drive hard on the operational excellence initiative side.

There is still a lot of work to do I would tell you David and then a lot of opportunity in front of us and if nothing else, those programs, specifically those associated with manufacturing have to offset the impact of any price erosion that we continue to experience on the topline.

And we have confidence that they will, but we believe that the opportunity could very well go beyond that to the point where particularly as we see more stability in pricing trends, we could potentially see some expansion of the gross margin.

With respect to operating cost, some of what we're doing, some of what we had planned in the way of innovating improvement initiatives to drive towards the $400 million of savings by 2016 as a standalone enterprise we will get -- we will get incorporated into and added on to the synergy targets that the teams are driving across for the combined enterprise.

So we have as we pointed out I think at the time of the announcement, I think good visibility to exactly where we will be going into the close and good visibility into where those additional opportunities around what we need to do to drive towards more efficiency in the administrative functions as well as in the operating functions..

David Lewis - Morgan Stanley

Okay. And then David, just a quick question on FTC, over the last several years the FTC you’ve become increasingly coordinated, but they obviously are independent entities, but you’ve been clear in this first quarter '15 close, no change in timeline, but I think a lot of investors are sort of focused on what we're going to hear this year.

So what's the likelihood would we hear something from the FTC before we hear from the EU in the first quarter on any possible remediation. Thank you..

David Dvorak

Yes, I think they were just -- the process, the way that it has worked from the point of initiation just naturally sets up a circumstance where the U.S. process is ahead of the EU process and so it's more likely that we will progress to the point of clarification in the U.S.

than the European side of things as far as the forecast between now and the balance of the year, but obviously we'll keep you posted as we make progress.

Again things are cracking very consistently with our original analysis and nothing has changed in the many months that we either were evaluating this area of the deal or executing our plans to seek those clearances. So we're very optimistic that we're going to land where we need to land and in getting the deal closed in the first quarter of 2015..

David Lewis - Morgan Stanley

Great. Thank you very much..

David Dvorak

You're welcome. And with that, I would like to thank everyone for joining the call today and for your continued interest and support for Zimmer. We look forward to speaking to you on our fourth quarter conference call, which is scheduled for 8:00 AM on January 29, 2015. I'll turn the call back to you Britney..

Operator

Thank you, sir. And thank you again for participating in today's conference call. You may now disconnect..

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