Zimmer Biomet Holdings, Inc.
Q2 2013 Earnings Call Transcript

Published: 25 Jul 2013

[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.

[Robert J. Marshall:]

Good morning, and welcome to Zimmer's Second Quarter 2013 Earnings Conference Call. I'm here with our CEO, David Dvorak; and our CFO, Jim Crines. Before we start, I would 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 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 Dvorak. David?

[David C. Dvorak:]

Thank you, Bob. Good morning, everyone. This morning, I'll review our second 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 I'll discuss all earnings results on an adjusted basis. Turning first to global market conditions. In the second quarter, musculoskeletal markets demonstrated stability with modest improvements over the first quarter. This was in line with trends from the previous several quarters, as well as our expectations for the full year. Against this backdrop, Zimmer delivered strong sales results in the second quarter, driven by contributions from our innovative new products across the portfolio, as well as accelerated performances in key geographic regions. This top line performance represents the company's strongest sales growth in several quarters and validates our belief that there are significant opportunities for innovation and growth within the musculoskeletal space. We, again, delivered against our financial commitments and returned value to our stockholders in the quarter. For the balance of 2013, we'll continue to drive our top line through the ongoing commercialization of innovative new products. We'll also remain focused on our business transformation programs, which continued to enhance the effectiveness and efficiency of our global organization. We expect the continued benefits from our expanding portfolio, combined with our commitment to operational excellence and a strategy of disciplined capital deployment, will allow us to capture further value creation opportunities in 2013. Consolidated net sales for the quarter were $1.17 billion, an increase of 5.5%. And our earnings per share were $1.43, an increase of 6.7% over the prior-year period. In the second quarter, Americas sales grew by 7.6% year-over-year, while Europe, Middle East and Africa increased by 0.5% and the Asia Pacific region grew 6.9%. The quarter was highlighted by the achievements of key milestones on the ongoing commercialization of several new offerings, which the company has recently developed or strategically acquired. These products and technologies have strengthened our core reconstructive franchise, as well as our emerging businesses. With respect to pricing, we experienced price pressure of negative 1.3% in the second quarter. Price pressure tempered relative to the first quarter due mainly to the anniversary-ing of the biannual price adjustments in Japan and slight moderation of price pressure for large joint reconstruction in the United States. Turning now to the results of our product categories. Knee sales for the second quarter increased 4.7%, reflecting positive volume and mix of 6.1% and negative price of 1.4%. Our Americas segment reported a sales increase of 5.0%, while Europe, Middle East and Africa grew sales by 0.4% and the Asia Pacific region delivered 9.8% growth compared with the previous year. We continue to be excited about the ongoing commercial release of Persona The Personalized Knee System. Persona has revolutionized the standard of care by eliminating the compromises inherent in competitive platforms, offering patients a more natural feel, fit and normal function postoperatively. With Persona, we pushed the boundaries of implant design and engineering, resulting in the highest fidelity and anatomically accurate implants ever developed. These components also leverage Zimmer's proven Trabecular Metal technology and VIVACIT-E, our vitamin E-infused advanced-bearing material. Our next-generation intelligent instruments make Persona more accurate and intuitive for surgeons to implant, and the feedback from our customers continues to be extremely positive for the unmatched flexibility and surgical precision of this system. We look forward to further expanding the market penetration of this truly differentiated need. Knee growth in the second quarter also benefited from promising sales of Gel-One, Zimmer's single-injection hyaluronic acid treatment. Gel-One is a key component of our expanding portfolio of early intervention and joint preservation solutions, including DeNovo NT and Chondrofix. In the quarter, Zimmer acquired U.S.-based Knee Creations, including products and technologies used in their advanced proprietary early intervention treatment, Subchondroplasty. The first procedure of its kind, Subchondroplasty is a minimally invasive outpatient treatment for bone defects associated with chronic bone marrow edema. Subchondroplasty is a unique joint preserving solution that addresses an unmet need for patients between early interventions, such as NSAIDs and joint arthroscopy and knee replacements. These treatments, along with the industry's leading portfolio of personalized knee solutions and intelligent instrumentation, demonstrate our ongoing commitment to delivering quality outcomes for patients, their surgeons and healthcare institutions. Our hip business delivered steady performance in the second quarter, with overall sales growth of 1.7%, reflecting positive volume and mix of 3.8% and negative price of 2.1%. Sales increased by 3.4% in the Americas; decreased by 2.0% in Europe, Middle East and Africa; and increased by 3.9% in the Asia-Pacific region. Our performance in the quarter was supported by the Continuum Acetabular Cup, which features the company's proprietary Trabecular Metal technology, as well as solid contributions from VIVACIT-E liners and ceramic head offerings. We've also seen encouraging traction with the U.S. rollout of the Avenir hip stem, a product we believe has a promising future given its compatibility with the increasingly popular Anterior Supine surgical approach. We'll continue leveraging this comprehensive portfolio for sustained growth in our global hip business in the second half of 2013. Extremities recorded impressive growth of 14.6% in the second quarter. All geographic regions reported above-market performances, led by the continued success of the Trabecular Metal Reverse Shoulder System. Meanwhile, ongoing commercialization of the Trabecular Metal Ankle has been promising with positive clinical feedback. Also in the quarter, we announced the acquisition of Germany-based NORMED, which adds to Zimmer's offerings in the foot and ankle market. This investment represents our ongoing commitment to expanding our portfolio to other anatomical sites. Dental sales decreased by 0.6% in the quarter. We continue to market our differentiated dental portfolio in order to maximize opportunities in a challenging global marketplace. Continuing softness in international dental markets was partially offset by positive growth in the Americas, driven principally by higher implant sales. We're confident that our advanced technologies position Zimmer Dental for growth as markets recover over time, such as our proprietary Trabecular Metal Dental Implant, custom-milled Zfx, CAD/CAM, Digital Dentistry Solutions and the value-based offering designed in the P-I Brånemark philosophy for the Brazilian market. In the second quarter, Zimmer Trauma increased sales by 2.7% over the prior year, with sales in the Americas decreasing by 1.4%; increasing by 6.3% in Europe, Middle East and Africa; and increasing 7.5% in the Asia-Pacific region. Competitive pressures, most notably in the United States, slowed our Trauma growth for the quarter, but were mitigated by the company's consistently strong performance in overseas markets. Notably, the Zimmer Natural Nail family delivered solid sales for another quarter, and we continue to see a steady incremental uptick of the XtraFix External Fixation System. Our recent acquisition of NORMED, which I noted earlier, also offers Zimmer an entry into the global hand and wrist trauma market, which we expect will complement our clinically robust Trauma portfolio, as well as enhance our global competitiveness. Our Spine business increased sales by 3.9% compared to the prior year. Zimmer Spine's growth rate represents a noteworthy turnaround from recent quarters with significant performance improvements from all geographic regions. Zimmer Spine's return to growth has been lead by a focus on our core fusion solutions, such as the inViZia Track Anterior Cervical Plate Systems, as well as the TM Ardis and TM-S Interbody Fusion devices. Backed by our dedicated spine sales force, we plan to build upon this improved performance in future quarters. We're also encouraged by early results from the recent introduction of the APEX Spine System, which will expand our portfolio into a broad range of degenerative deformity and complex spine conditions. Zimmer's surgical and other business drove exceptional growth across all geographic regions in the second quarter, with an outstanding 27.6% sales increase over the year prior. Of note, our Americas segment reported a 42.6% sales increase. Our growth in the quarter was driven primarily by the Transposal fluid waste management system, a clinically relevant product that addresses a wide range of surgical cases and enhances Zimmer's presence in the operating room. The performance of our Universal Power System surgical equipment, particularly in Europe, Middle East and Africa, contributes to our bullish outlook for this offering as we continue its introduction in the United States. As in previous quarters, the Asia-Pacific region delivered a solid sales performance by capitalizing on the strength of our core surgical products portfolio. Overall, the acceleration of surgical's top line in the quarter resulted from a strategic focus on capturing market opportunities, both with organically developed technologies and strategically acquired products. With that, I'll now ask Jim to provide further details on the second quarter and our updated guidance. Jim?

[James T. Crines:]

Thank you. I will review our second quarter performance in more detail and then provide additional information related to our 2013 sales and earnings guidance. Total revenues for the second quarter were $1,169,000,000, a 5.5% constant currency increase compared to the second quarter of 2012. Net currency impact for the quarter decreased revenues by 1.6% or $18 million. The negative currency impact for the quarter related principally to our Japanese yen denominated revenues. Accelerated growth in our emerging businesses and markets has impacted our gross margin profile. Our adjusted gross profit margin was 73.3% for the quarter. The margin ratio declined 170 basis points compared to the second quarter of 2012. In the quarter, a higher mix of lower margin product and geographic revenues, as well as inventory charges and a slight year-over-year decline in price, outweighed foreign currency hedge gains and cost savings from our operational excellence and transformation programs. In the quarter, significant growth in sales of the capital component of the Transposal fluid waste management system, along with certain other new products which have gross margins below the company average, drove our gross margin ratio lower when compared with the prior year. Additionally, a shift in the country mix of revenues within our Europe, Middle East and Africa operating segment, favoring emerging markets, weighed on the gross margin ratio in the quarter. We would expect these headwinds to diminish over time as our surgical product's revenue mix move toward higher-margin, single-use disposables utilized with the capital component of the fluid waste management system and as developed markets within our Europe, Middle East, and Africa operating segments stabilized. The company's R&D expense decreased 3.8% on a reported basis to 4.7% of net sales when compared to the prior year. As noted in the prior quarters, the decrease in R&D expense continues to reflect the natural decline related to the completion of a number of large projects, as well as the efficiency benefits of transformation initiatives implemented in this function. Selling, general and administrative expenses were $458 million in the second quarter, and that 39.2% of sales were 110 basis points below the prior year. In the quarter, savings from our transformation initiatives were partially offset by increased selling, marketing and distribution costs associated with the commercialization of a number of new products, as well as direct sales integration in certain key markets. Special items amounted to $87 million in the quarter. Included in special items are costs related to our global restructuring and transformation initiatives, certain litigation and integration activities connected with recent acquisitions. In the quarter, we increased our provision for certain claims related to the Durom Acetabular Component by $47 million before taxes. This reflects an increase in the total estimated liability for projected worldwide claims related to Durom, offset by anticipated insurance recoveries. Adjusted operating profit in the quarter amounted to $344.7 million or 29.5%. Our adjusted operating profit ratio -- profit-to-sales ratio was 20 basis points lower than the prior-year second quarter. Net interest expense for the quarter amounted to $14.4 million, which was flat compared to the prior-year quarter. Adjusted net earnings were $243.4 million for the second quarter, an increase of 3.3% compared to the prior year. Adjusted diluted earnings per share increased 6.7% to $1.43 on 170.7 million average outstanding diluted shares. These adjusted earnings per share are inclusive of approximately $0.05 of share-based compensation. At $0.89, reported diluted earnings per share decreased 27% from the prior-year second quarter reported EPS of $1.22. Our adjusted effective tax rate for the quarter was 26.4% and was flat when compared to prior year. Our reported effective tax rate for the quarter was 22.6%, as the majority of the certain claims and special items charges are incurred in higher tax jurisdictions. During the quarter, we repurchased 0.9 million shares at a total purchase price of $69 million, enabling us to return increased value to stockholders. Approximately $554 million of authorization remains under our repurchase program that runs through December 31, 2014. The company had approximately 169 million shares of common stock outstanding as of June 30, 2013, down from 174.6 million as of June 30, 2012. Operating cash flow for the quarter amounted to $189.7 million, a decrease of 18.1% from $231.5 million in the second quarter of 2012. The decrease is driven by the ongoing build-out of pipeline inventory in support of new product introductions as well as the impact of the medical device excise tax. Net inventories were $1,053,000,000 at the end of the second quarter, an increase of $14 million from March 31, 2013. Adjusted inventory days on hand finished the quarter at 284 days, a decrease of 22 days compared to the prior-year quarter. As of the end of the second quarter, net receivables increased to $942.5 million from $906.7 million in the second quarter of 2012 or 4% over prior year. Our trade accounts receivable days sales outstanding finished the quarter at 69 days, a decrease of 3 days when compared with the prior year. Depreciation and amortization expense for the second quarter amounted to $91.4 million. Free cash flow in the second quarter was $109 million, $59 million lower than the second quarter of 2012. We define free cash flow as operating cash flow, less cash outlays per instruments and property, plant and equipments. The decrease in free cash flow reflects the ongoing investments in our new product pipeline inventory and the deployment of instruments to support the full release of Persona and other new products. Capital expenditures for the quarter totaled $81.2 million, including $58.8 million for instruments and $22.4 million for property, plant and equipment. I'd like to turn now to our guidance for 2013. In our earnings release this morning, we increased our sales guidance, noting that the company expects full year 2013 revenues to increase between 4% and 5% constant currency when compared to 2012. Previously, we had estimated full year revenues would increase between 2.5% and 4.5% constant currency. We now expect foreign currency translation to decrease our reported 2013 revenues by approximately 2% for the full year. Therefore, on a reported basis, our revenues are projected to be between 2% and 3% above 2012 results. Previously, we had estimated foreign currency translation will decrease revenues by approximately 1.5%. Our earnings release also indicates that our full year 2013 adjusted diluted earnings per share guidance has been narrowed to a range of $5.70 to $5.80. To arrive at our anticipated reported GAAP earnings per share, you should subtract total charges for inventory step-up and other inventory and manufacturing-related charges, certain claims and special items of $250 million, pretax, or approximately $1 per share on an after-tax basis. Our gross margin ratio is now expected to be at or slightly above 74% for the full year. R&D is now expected to be approximately 4.5% for the full year. We anticipate SG&A as a percentage of revenue will be at or slightly below the low end of our prior guidance of 39.5%. We expect interest expense for the full year to be approximately $56 million. Moving down the income statements, we continue to expect the 2013 full year effective tax rate to be around 26%. Our average diluted share count for the year is expected to be around 171 million shares. Taking into account the effects of year-over-year differences in billing days and normal seasonality across our geographic segments, third quarter revenue growth on a constant currency basis is expected to be in line with the constant currency revenue growth reported for the second quarter. Third quarter adjusted diluted earnings per share are expected to be in the range of $1.20 to $1.25. Finally, please note that our guidance does not include any impact from potential acquisitions or other unforeseen events. David, I will turn the call back over to you.

[David C. Dvorak:]

Thanks, Jim. In the first half of 2013, Zimmer advanced the commercialization of several differentiated new products, which have broadened and enhanced our portfolio. We're encouraged to see these new offerings make a meaningful contribution to an accelerated top line in the second quarter, which we believe demonstrates our potential for further expanding our leadership within the musculoskeletal market. As we've communicated in previous quarters, our relentless commitment to lean and efficient business practices helps to support the foundation of our future success. In the second quarter, our ongoing commercial and operational excellence programs continue to deliver cost savings in line with long-term targets. Furthermore, we remain committed to a disciplined model of capital deployment. In keeping with that strategy, we have continued to pursue prudent external development within the musculoskeletal space, as well as returned value to our stockholders through our dividend and share repurchase programs. As we enter the second half of 2013, we're confident that promising sales from our new products and above-market performance in several of our core franchises and geographic regions position Zimmer for continued success. And now, I'd like to ask Montserrat [ph] to begin the Q&A portion of our call.

[Operator:]

[Operator Instructions] First question comes from the line of Matthew Taylor with Barclays.

[Daniel Sollof:]

It's actually Dan in for Matt. Just wanted to start with pricing. You guys noted a slight moderation of pressure in the quarter. Part of that was Japan, but you also referenced the moderation of the large joint market as well. So I'm just wondering, to what extent does that surprise you guys? And would you go so far to suggest any potential change in trend? Or is this more of just like a quarter-to-quarter variation and year-over-year pressure?

[David C. Dvorak:]

Well, I think that the biggest contributor -- Dan, as you pointed out, the biannual price cuts anniversary-ing out in Japan. Beyond that, we saw a little bit of price pressure increase in Europe. But again, as you mentioned, a positive change in -- from Q1 to Q2 in the Americas. So it's round numbers, I think, 30 basis points for us in the Americas; and it was about 80 basis points improvement sequentially from Q1 to Q2 in each of knees and hips. As far as extrapolating out and forecasting whether or not that's the beginning of a trend, I think it's too early to do that. I do think that it's fair to characterize pricing as stabilizing. And quarter-over-quarter, we've got to -- tend to be getting, hopefully, what becomes a positive trend in that regard.

[Daniel Sollof:]

Great. And then 1 quick follow-up on guidance. You took up the constant currency revenue expectation by about 100 basis points. So you said the general market seems stable. So is that really incremental confidence or more visibility to benefit from new products? Or -- just kind of want some color there.

[David C. Dvorak:]

I think that, generally, you can interpret the top line guidance, Dan, as being of view that the market is performing in a manner that's consistent with our expectations going into the year, and we're making the progress that we expect to make on the new products. And it's really the latter that is driving the increase in the top line forecast as we get further and further into the launch of these new products. And these products are going to find traction at different stages just by the nature of the launches across the various product categories. But we're tracking quite well in all respects. And what you see, in a way, of the updated forecast is a reflection of our confidence as to what we're going to be able to do in the second half of the year and going forward.

[Operator:]

Next question comes from the line of Larry Biegelsen with Wells Fargo.

[Craig W. Bijou:]

It's actually Craig on for Larry. First quick question, I wanted to get your thoughts on Europe. It looks like performance ticked down a little, adjusting for selling days compared to Q1?

[David C. Dvorak:]

Yes. And I think that Europe continues to be a challenging market. I don't believe that it sequentially got worse from Q1 to Q2. I think that our heavy emphasis in particular countries -- and we have significant market share in the developed markets in Europe. By way of example, it's probably, as much as anything, our revenue mix within countries that have shown a significant slowdown over the last several quarters that you see reflected in our performance. So we continue to be very optimistic about what we're going to be able to do, continue to believe that we're outperforming the general market in EMEA. But it's a challenging market, and we have a lot of market share in countries that have seen significant step-downs including a market like Germany.

[Craig W. Bijou:]

And 1 quick follow-up. Just on the SpineCraft, NORMED, Knee Creations agreements and acquisitions, I wanted to see if you would provide the expectation for the contribution that it will have for 2013 growth?

[David C. Dvorak:]

Well, it's going to contribute -- all of those external development projects, Craig, are going to contribute to 2013 growth. But they're going to contribute to 2013 growth because of what we're going to be able to do with those products and technologies through our distribution channel. I'd like to clarify that the accelerated top line that you see us reporting in Q2 is not by virtue of acquired revenues. It is the case that the external development projects that we've been doing fairly consistently over the last several years contributed positively to that uptick. But I would tell you that the acquired revenue run rate effect on Q2 is probably a bit less than $5 million, so not at all substantial. Now that said, several of those products that we've acquired over time are ramping up as we launch them and execute our sales and marketing strategies. So we're seeing significant contributions, but not by virtue of having acquired the revenue, rather by virtue of acquired -- acquiring an appropriate technology or product line that's a fit for our distribution channel and our overall strategy.

[Operator:]

Your next question comes from the line of Bob Hopkins with Bank of America Merrill Lynch.

[Robert A. Hopkins:]

So quickly -- I have a question on operating margins and then a question on knees. First, on operating margins, it looks like your guidance really isn't changing overall from an operating margin perspective, but gross margin is obviously coming down by a little over 1 point, it looks like. So my question on gross margins is, Jim, can you kind of break down the components of the change in a little bit more detail and, more importantly, maybe comment on, as we look forward, do you think your business -- relative to the mix that you expect, can you as a company get gross margins back over 75% as you look out into next year?

[James T. Crines:]

Okay. Bob, I'll take a stab at that. As you know, coming out of the first quarter, we were, at the time, thinking gross margin ratio would be coming around 75% to even 75.5% for the full year. That, of course, was predicated on anticipated hedge gains based on the currency assumptions we have for the top line at that point in time and lower unit cost from a combination of higher volumes associated with our new products, as well as efficiencies gained from improvements in our manufacturing processes. And then, of course, offsetting those positive effects on ratio, we also anticipated negative price and the medical device excise tax would impact on the ratio in the second half. We were not, at that time, anticipating the strength in surgical product sales that we realized in the second quarter or the effect that would have on our gross margin ratio. We were also not expecting that excess in obsolete inventory charges would be as high or that the changing mix for geographic revenues would have, again, as much of an impact as we experienced in the quarter. So with taking all of that now into account, we have adjusted our outlook for the ratio for the full year to now be at or slightly above 74%. We, as you pointed out, have also raised our outlook for top line updated guidance for operating expenses, the net effect of which lead us to our bottom line adjusted diluted earnings per share expectation of $5.70 to $5.80 for the full year. Now that as -- between the various sort of things that I've touched on, the product mix, the geographic mix, the inventory charges, I would say the product mix, the inventory charges accounted for most of the, sort of, step-down in the gross margin ratio in the quarter relative to the prior year. Geographic mix had a less of an impact. And as we get into the second half of the year and even next year for that matter, I think we feel, for a lot of reasons, that we can anticipate a bit less pressure on the margin ratio from excess and obsolete inventory charges. We get those in the normal course, but they -- as they have over the first half of the year, they could be more significant as we launch new systems and we begin to cannibalize out the legacy products. So we've had more significant pressure from those charges in the first half of the year than we're either anticipating for the second half of the year, and we still have work to do to to fill up our operating plans for next year than I would expect we'll see going into next year. We also expect more favorable hedge results coinciding with the change in the currency outlook, as well as expect the shift towards higher-margin revenue as we get deeper into the launch of Persona, and our surgical product sales reflect the better balance of revenue as between the capital equipment and single-use disposables. And I think both those trends should continue on into next year. I'm not going to attempt to give guidance on the gross margin ratio for 2014. We'll certainly be prepared to talk about that in more detail after we've gone through our development of our operating plan and provide guidance for 2014 on our fourth quarter call.

[Robert A. Hopkins:]

That's very helpful. So it sounds like there's a couple of things that will get better from here, and we'll have to see how the mix plays out as we look to next year. And then, on knees, 2 things maybe for David. I was wondering if you could just comment on the contribution from Gel-One, given that that's now reported in knees. I have assumed that it maybe would be $5 million to $10 million this quarter. And then, also, David, maybe give a sense for just where you think you are with Persona? Any metrics in terms of the rollout? Is it -- any metrics that we can track as to where you think you are right now relative to your original set of expectations?

[David C. Dvorak:]

Bob, we're tracking consistent with expectations. With respect to the Gel-One rollout, first of all, it is in the range that you suggested, but probably closer to the lower end of that range than the higher end of the range for the quarter that you framed out. We are doing everything on schedule with respect to the Persona release, and the feedback has been very, very positive. So our instrument deployments is one of the key metrics. We're on plan with respect to the instrument deployment. You can obviously see that in our reinvestment numbers, with respect to the CapEx for the last couple of quarters. I would tell you that the receptivity among competitive surgeons is quite good at this point. But as you would anticipate, notwithstanding the positive reception to the Persona System -- and I would tell you, if anything, I think, at this point, the anecdotal evidence has exceeded our expectations -- or reasonable expectations, as optimistic as we were going into the year. So it's going to be a very, very strong product line for us. And it clearly already is helping to reinvigorate our knee sales, and you see that in the step-up from Q1 to Q2 in our growth rate. But those systems take longer to get full traction. And so in the first half of the general release, which is what Q1 and Q2 of 2013 represent, that still is very early stage. All of the leading indicators that we track, as I said, are positive and I'm quite confident that this system is going to be a big winner for us.

[Operator:]

[Operator Instructions] Your next question comes from the line of Mike Weinstein with JPMorgan.

[Kimberly Weeks Gailun:]

It's Kim here for Mike. So a couple of questions. I guess, as we think about the constant currency guide here for the rest of the year, Europe is a little softer in the quarter. And you guys touched on some of that, highlighting Germany. I'm just curious how you're thinking about Europe playing out for the rest of the year. And then, in addition, you saw kind of the step-up in the quarter in the fluid waste management business. Is that something you're looking forward to be sustainable in the back half of the year, and how does that play into that kind of 4% to 5%?

[David C. Dvorak:]

Great. I'll respond to each of those questions. With respect to Europe, first of all, I think that Europe will continue -- we think that Europe will continue to be a challenging market. But what I would tell you is if you look back at the second half of 2012, we really started to see a step-down in the growth rate and procedure rates within many of the developed markets in Europe, and that's really what I think is affecting the overall growth rate of the EMEA market. So in the very least, there should be some positive effect to the anniversary-ing out of that step-down in procedure rates in some of those developed markets, and we have significant businesses in those markets. And so I think that bodes well for, at least, stability in Europe, if not some potential improvement, even without a more fundamental beginnings of a recovery. And so, that's how we are thinking of the European market at this point in time.

[Kimberly Weeks Gailun:]

Okay. Great. And then, the second question was just on the waste management side.

[David C. Dvorak:]

Sure. And the surgical business, we continue to believe, will be a terrific opportunity for us in the second half of the year. That said, you can see by the growth numbers in the U.S., in particular with the fluid waste management system, that we're at a pretty torrid pace in Q2. And so, 40-plus-percent growth rate in the business category -- or the product category for us in Q2 is one that we'd love to be able to sustain, but that's probably on the high end of what anyone could consider a reasonable expectation. That said, we're going to continue to go after the opportunity that we have there and believe that we're going to continue to grow that category at very attractive rates.

[Kimberly Weeks Gailun:]

Okay. And then, just 1 follow-up on Gel-One is just kind of any anecdotal feedback from how that launch is going for you guys, what you're hearing from surgeon customers just in light of broader industry guidelines and how the surgeons are thinking about prescribing patterns and behavior?

[David C. Dvorak:]

Yes, no negative effects on that development. At this point in time, obviously, for us, it's a smaller product category because it's a recent launch. But we haven't seen any callback on the usage rate. It's probably a question that would be posed, and maybe you'll get a more comprehensive response from someone who's been in the market for an extended period of time relative to us. But we don't see that creating any immediate headwind, and our launch is tracking at or in front of the pace that we contemplated in the plan. I would tell you, we continue to get terrific feedback on the product itself. The lower volume -- the great track record on lack of any kind of pseudo-sepsis response with that product has made it one that our customer base has been very receptive to integrate it into their practice.

[Operator:]

Your next question comes from the line of Matt Miksic with Piper Jaffray.

[Matthew S. Miksic:]

So generally, obviously, pretty impressive step-up in knee growth. Can you talk about -- 1 question on that, and then I have a follow-up for Jim on margins. Just on the knee side, what's -- can you talk about what sort of dialogue you've been having around the premium for the product? That was the question at the rollout, you obviously wanted to be able to get paid for the development and research that's gone into the system. Environment's a little tougher maybe than the last large knee launch that we've seen, and we'd love to hear what the response has been and how you've been able to capture some of that value. And as I mentioned, a follow-up for Jim.

[David C. Dvorak:]

Sure, Matt. The response that we've received to date has been very positive. And I would say, if anything, probably on the upside, within the range of our expectations going in as to what we thought we could get to stick from a price standpoint. And the core value proposition there is one that speaks to the broader audiences that we're involved in and selling such a product and technology at this point in time as compared to a decade ago as you referenced to a prior knee system launch. So we're getting a great response from the surgeon community on the personalized implants. These things -- the implant design allows for better fit, feel and function and very anatomically accurate. Terrific feedback on the anatomically designed tibia, the coverage with that tibia and what that leads to as far as performance and rotation. The bone-conserving nature of the implant system is another area. And then, the shape and sizing options to do as precise of a patient matching as is possible, both preoperatively and intraoperatively, have all been value propositions that have resonated with the surgeon base. Also with the surgeons, we've received very good feedback on the instrumentation. So the design of these instruments are catered in a fashion that leads to a nice efficiency opportunity for the hospital, and so it can reduce sterilization cost. And so, that's a message that resonates with that stakeholder in the discussion, and it's meaningful economically for them. And then, the ergonomically designed instruments speak very well to the surgeons and help with the precise implantation of a system. And then, finally, when we're talking about the performance long term of the product and some of the differentiated technologies, we're incorporating our VIVACIT-E Highly Crosslinked bearing surface into the Persona System, and that one's a premium and we have great evidence scientifically to prove why that's a better bearing surface. And so that's led us to successful discussions in that regard. And then, ultimately, a cement-less knee is a coming attraction what Trabecular Metal technology incorporated in. So we're doing really well in these discussions, Matt, and finding a lot of interest among our legacy surgeons, competitive surgeons and finding nice success in the pricing discussion of the system to date.

[Matthew S. Miksic:]

That's great. On the margins, Jim, I wanted to -- I know you got into this a little bit already and went through some detail, but I just wanted to clarify. It sounded like the delta in gross margins in the quarter and going forward, we have sort of an OSP-related mix hit. We have a geography-related hit on mix, delta and FX hedging and some E&O [ph] charges. And, first, does that -- are those the basic points for this quarter and going forward? And second, if you could talk maybe -- I don't know if you hit on proportions of what those are and maybe what -- how we should expect the trends to go the rest of the year, if that might be asking too much?

[James T. Crines:]

Those are the right elements, Matt. And as I indicated, we are anticipating less pressure from excess on obsolete inventory charges on the back half of the year. As well, we're expecting more favorable hedge results as well as a more favorable shift toward higher-margin products, as we get deeper into the launch of Persona. And the mix of revenue within the surgical business shifts more towards, sort of, a better balance as between the capital sales and disposable sales. As far as the -- what those sort of various pressures, those various components that I spiked out were -- in terms of how they were impacting in the second quarter, I've, without getting too detailed, just indicated that the product mix and inventory charges accounted for the majority of that pressure in the second quarter and geographic mix less -- had a negative impact, but less of an impact than the other 2 components.

[Matthew S. Miksic:]

And just -- so to color on the OSP-related, I mean, is this a matter of you've launched the product and you're sort of loading, if you will, accounts with the capital side of the razor side of the razor blade, if you will. And as the blade consumption, kind of, picks up across these accounts, the margins will kind of start to pick back up? Is that the thinking?

[David C. Dvorak:]

Yes, generally, that is the dynamic. I mean, the capital equipment margin is a lower margin than the annuity that flows from the disposables. So as you place those units, your mix of revenues will rebalance over time and the higher margin will become more prominent.

[Operator:]

Next question comes from the line of David Lewis with Morgan Stanley.

[Steve Beuchaw:]

It's Steve Beuchaw here, stepping in for David. I just had 1 for housekeeping question first and then a couple on the markets. Jim, I wonder if you could give us any sense of whether there was a material impact anywhere of any selling day irregularities year-on-year and, maybe, if you could, any sense for which geographies or product lines where they might have been more impactful?

[James T. Crines:]

Okay. So the -- yes, I think we pointed this out on our last call. We did have an extra selling day in the quarter, and we'll have an extra selling day in the third quarter as well, but not across all geographies. So to the extent it was not across all geographies, in our case, it only contributed less than 1 point, somewhere between 0.5 points to 1 point within the quarter.

[Steve Beuchaw:]

And then, David, on the U.S. ortho market, one of your competitors not only made comments that are pretty similar to yours, indicating more or less that markets are steady, if not slightly improving on an underlying basis or went so far as to say it doesn't seem like we are seeing in 2013 the summer slowdown in the U.S. that we've seen over the last 2 or 3 years. Would you echo those views about what's going on in U.S. hips and knees?

[David C. Dvorak:]

Well, I think, from what we saw in Q2, it's a performance in the market that I think is pretty consistent with general trends over the last several quarters. I mean, there are blips, up or down, from quarter-to-quarter as we've discussed in the past. We saw a bit of a step-up in Q4 of 2012, and then it looked like, at least in the case of knees within the U.S., a bit of a step-down in Q1 of 2013. And then, that looks like it strengthened by 100 basis points from Q1 to Q2. But then, that just lands you back in what has been a pretty consistent range of a couple to 3% growth rate across the last many quarters. And I think that's the right way to think about the market.

[Steve Beuchaw:]

That's very helpful. And then, the last one on Europe, maybe putting a more positive spin on it. But if you follow the macro headlines, the consensus view seems to be that for Europe, broadly speaking, that austerity is probably not, and this is a broad generalization, probably not what that -- the continent wants to be doing with regard to policies around, let's call it, Spain, Portugal, Italy or maybe some of the peripheral countries, so maybe we'll get some relief of austerity. Some of our survey work would suggest that you're already seeing the signs that the things are bottoming out. I mean, in your view, is there a case to be made here that some of these peripheral countries that were early drags on growth in Europe could start to reverse over the next 12 months? And if so, what should we be looking at as the leading indicators?

[David C. Dvorak:]

Well, I think that what you pose is quite possible, Steve, but it's -- it really is speculation to say that the macroeconomic conditions are going to trend in one direction or another. And there are people that have backgrounds and spent a lot more time studying and providing those forecasts than us. I would tell you, as it relates to the musculoskeletal market, the reason that I think we believe it's going to show some level of stability. It's just -- you can only push back on those on the procedure demand and defer those cases for so long before there's going to be some political unrest within the population base [ph]. So the aging population is what it is, that hasn't change. Yet the procedure rates started to tick down because there was a pullback in the allocation of resources to do those cases last year. I think, as we get deeper into 2013, there has to be some leveling off of that because those patients don't have other solutions. So just -- the core drivers for these markets don't melt away. They're still there. And at some point, there'll be enough of an active population base seeking knee solutions that have proven results to where -- the market will come back a bit. So especially in these developed markets, it looks like they stepped down pretty significantly as we got to the back half of 2012. I think that we'll see some stabilization in the second half of this year.

[Operator:]

Question comes from the line of Kristen Stewart with Deutsche Bank.

[Robert Wisniewski:]

It's Rob in for Kristen. I wanted to touch on -- you saw a nice turnaround in Spine this quarter, a nice uptick in growth sequentially. Can you speak to the dynamics there and how much is that a Zimmer phenomenon and how much is that a market?

[David C. Dvorak:]

Yes. I think that, for us, we've seen sort of stabilization as it pertains to price, and I think a market that hasn't changed dramatically. The big difference maker is we're putting new products out the door, and that's fueling the improvements in our top line performance. And it's been a good number of quarters in the making. But the team there has been very focused, innovating in a relevant way, concentrating on the core fusion market, which is the lion's share of that $8 billion, $9 billion market that exists and delivering solutions that are responsive to what customers are seeking. So we're getting -- are blocking and tackling down and executing and starting to see the positive benefits of that with the right products coming out the door, a nice pipeline of future launches. I would also tell you that I think our commercial execution on the sales side is -- these guys have worked very hard, and we're finding traction and improving, and they're building the tailwind out within that network. So it's just the beginning of what we believe should be a positive trend in our performance, and it's the case across the globe. We had step-up in performances with more of the right products in the bag, o U.S. as well as within the United States, and saw sequential improvement in all 3 geographic segments.

[Robert Wisniewski:]

Great. That's helpful. And looking at the U.S. trauma business, growth ticked down there sequentially. There's obviously a number of moving parts given Synthes [ph] and J&J. Can you just speak to the performance of that business and the dynamics in that market?

[David C. Dvorak:]

Yes. Well, we've had a very strong run for multiple quarters now, and our performance has been on a positive track and all 3 geographic segments continued on a positive track in the o U.S. segments. It's a product portfolio that we've built out over the last handful of years, and we feel like we have a very competitive offering at this point in time, only further short of by virtue of the NORMED acquisition. So there was a market opportunity that was somewhat unique in Q1. We shared in some of that opportunity, obviously. That kind of melted away in Q2, and we had some other Zimmer unique issues that we'll resolve and get back on track in the U.S. in the coming quarters. So it's a market that we think is quite attractive. We've made a lot of progress in building out the product portfolio and bringing emphasis to the sale of those products across all 3 geographic segments. And I think we just have more work to do in the U.S. jurisdiction, and we just want to continue the momentum o U.S. But we're going to be in good shape going forward in trauma.

[Operator:]

Next question comes from the line of Bill Plovanic with Canaccord.

[William J. Plovanic:]

Just on the med device tax, could you quantify what the impact was in the quarter for that?

[James T. Crines:]

As we pointed out before, we are anticipating somewhere in the order of $10 million to $15 million of charges, hitting cost of sales. I would -- and as we've also pointed out, the way we're accounting for that is as the tax gets paid, it gets capitalized in inventory and then will get released into the P&L if that inventory is sold. So there was virtually no impact in the P&L on the first half of the year. So neither the first or second quarters will -- as that inventory sort of works its way through the system, we'll begin to see some charges in the back half of the year.

[William J. Plovanic:]

Great. I just wanted to clarify that. And then, on the hip business -- I mean, that was a nice turnaround. That business in the U.S. has been up a little past couple of quarters, down a little last quarter and you had a good quarter this quarter. Anything specifically driving that either in the U.S. or Asia-Pac?

[David C. Dvorak:]

No. We have a competitive offering on the hip side and, generally, doing a pretty good job in all 3 jurisdictions. I think that we need to pick up the pace and improve in some of the big markets in Europe, but those are the markets that have been hit with the kind of across-the-board slowdowns. And so I'd expect us to be able to continue the overall performance, at least, at market growth rates and, hopefully, as the European market stabilized, to benefit from that because of our geographic mix within hips. But the technologies that we're driving are the right technologies. We're doing really well with the Continuum Cup. We got a broad stem offering. We like the prospects of the Avenir stem and are seeing really nice traction, particularly from surgeons that are interested in the Anterior Supine approach. And we have a nice pipeline coming too. So we're in good shape with respect to hips, as well as opportunities for intelligent instruments in that category.

[William J. Plovanic:]

And are you concerned at all with the sales force focused on knees and the Persona that you can maintain continued growth in the hip?

[David C. Dvorak:]

We'll be able to maintain it. I mean, our core channel is focused on large joints. And so, you're right to be sensitive to it, and we will be sensitive to it. But we're going to look to ensure that we drive balance in those sales. Those are our 2 largest franchises. And so, much of the business is built around knees and hips.

[Operator:]

Your next question comes from the line of Jeff Johnson with Robert Baird.

[Jeffrey D. Johnson:]

David, I wondered if we could just look at the dental business for a second. Growth maybe slowed down a couple of hundred basis points sequentially. You came up against a slightly easier comp. Is that just European market more than anything? Is there anything competitive in there? Just any color you could give would be helpful.

[David C. Dvorak:]

Well, o U.S. market and not just Europe in that case, Jeff. I think that Japan in particular and what's happened as far as a bit of transformation within the marketplace in Korea has contributed to that as well.

[Jeffrey D. Johnson:]

All right. And the Japanese headwinds have been going on for, what, now 3 or 4 quarters? Are we almost through most of those -- at least, anniversary-ing through those? Is that base of business down to kind of a defensible area here for you and probably the whole market?

[David C. Dvorak:]

We keep looking for that. These have been challenging markets and probably markets that we talked about with price pressure and some of the different product categories and geographies in which we operate. I'd tell you, as it relates to dental, there had been some more fundamental transformations going on with deeper penetration by the value providers. And so, that's some of what you see in addition to the procedural pullback. And when you layer that dynamic on top of procedural pullback that's driven by the fundamental macroeconomic conditions, you'll start to be able to reconcile the growth rates across that market.

[Jeffrey D. Johnson:]

Understood. And then, just as a follow-up question, on the acquisition front, I just want to understand kind of, with NORMED, with Knee Creations and Dornoch will anniversary after this quarter. But in the quarter itself, maybe -- I think you talked about a $5 million run rate from acquisitions. Is that about what you're expecting the acquisition contribution in the back half of the year as well? I'm just trying to reconcile, kind of, relative to your updated guidance.

[David C. Dvorak:]

I'd say it will be in a similar range because I think we get into Q4 before the Dornoch acquisition anniversaries out as opposed to Q3. So -- but you're talking about a couple of million dollar difference, one way or another, dependent upon when you snap up the line and they're looking for the revenues to anniversary out. None of those acquisitions are substantial in the way of acquired revenue run rates. They're all substantial by way of the opportunity and sort of the accretive nature if we execute them well. And to date, we have done just that.

[Operator:]

Your next question comes from the line of Bruce Nudell with Crédit Suisse.

[Matthew Keeler:]

This is Matt in for Bruce. I just wanted to clarify, in response to an earlier question, I think you said Gel-One was closer to $5 million than $10 million. I'm just wondering, inclusive of all the items that were reclassified from surgical and other, is that around $10 million that went into the Americas knees in the second quarter? Or is it a little more? A little less?

[David C. Dvorak:]

Yes. We're not going to start parsing million dollar sections, Matt, of our -- it's our largest franchise. And so, any of those movements are not substantial in the context of our knee business, which is, round numbers, 40% of our overall business. So not substantial by the way of absolute revenue dollars. And the biggest contributor on year-over-year growth was Gel-One. And as I characterized that in response to the question of -- thinking of it as a range of $5 million to $10 million, I said that's the right range, and just between those 2 numbers, it's closer to the lower end of that range than the upper end of that range in Q2. But we're going to be cautious about getting into quarterly report-outs of single-digit million dollar revenue numbers. I hope you understand.

[Matthew Keeler:]

Sure, sure. And then, I guess, just on Knee Creations, can you maybe share your thoughts with us on the market opportunity for that product longer term, and when that could start to be a significant revenue generator?

[David C. Dvorak:]

This is really an interesting technology and one that we're very excited about. I think that we obviously are looking at unmet clinical needs across our business, and knees is our largest business. And the satisfaction rates within knees, notwithstanding the terrific clinical performance as measured by lack of revision as an endpoint clinical marker, total knee replacements are going to continue to be very much in demand. But we're of a view that there are going to be opportunities to move upstream in the disease state, catch opportunities to provide a terrific patient solution earlier in the disease stage. And in that continuum of care, these early intervention strategies that we're putting together can be very, very meaningful in providing us a great benefit to patients in a cost-effective way. And as you can see, we've been assembling a portfolio of these solutions, including Gel-One, including DeNovo, including Chondrofix. And now, with the pick-up of Knee Creations and the Subchondroplasty technique and technologies and products, we believe it can be a big difference maker because the bone marrow edema pathology is one that we think is underestimated in the effect that it has on patients, and we need to build out the clinical proof points for that to ramp up, and that's likely to take some number of operating periods going forward. But this could be a very, very significant solution that ends up reshaping how some of these patients in earlier disease states are treated. So we're excited about it, and we'll look to make further investment to build out the clinical proof points to be able to pursue the expansion of that solution and offering to surgeons and patients globally.

[Operator:]

Next question comes from the line of Joanne Wuensch with BMO Capital Markets.

[Joanne K. Wuensch:]

In order for gross margins to improve throughout the year, do you need the OSP uptake to slowdown?

[James T. Crines:]

So we don't -- no, no, we don't need it to slow down at all, and we'll be more than happy to have it continue at the same pace we saw it at the second quarter. We, as you can understand, Joanne, were more than happy to have the absolute number in terms of gross margin growing at pace with the kind of top line growth we're seeing in the surgical products business. And if that weighs on the ratio, that's okay, to the extent that we're getting significant growth -- absolute growth in gross and -- gross margins and operating profit. It's just the case that -- that's why I pointed out we do expect this -- the mix to change a bit going forward. We were -- there were sort of very significant new customer capital installations that occurred over the course of the second quarter. And over time, as we get these this customer set up and the capital installed, naturally, we're going to be selling more of the higher-margin, single-use disposables relative to the capital.

[Joanne K. Wuensch:]

And then, the acquisitions you've been making lately have been what we would call the small tuck-in variety. Have you changed -- or could you refresh us on your M&A viewpoint?

[David C. Dvorak:]

Sure, Joanne. I think our M&A viewpoint has not changed over time. We have rigorous return metrics that we apply to evaluate in any opportunity. And it just so happens that we've been able to identify and successfully execute on some of the smaller, kind of bolt-on and tuck-in acquisitions with products and technologies that have build out our portfolio and addressed anatomical site scenarios that we felt like we could further strengthen our portfolio and offerings. We would have an appetite, obviously, to do bigger transactions, but we're going to be very disciplined about the evaluation of those opportunities. And to the extent that we can identify a medium-sized or even a larger transaction that satisfies the return metrics that we apply to evaluating those opportunities, then we would put energy towards doing such a transaction. But I think that we would look at -- continue to at least to have a constant cadence of the kinds of deals that we've been doing for the last couple of -- 3 years on the M&A front.

[Operator:]

And your final question comes from the line of Jason Wittes with Brean Capital.

[Jason Wittes:]

I wanted to ask about your pricing strategy with knees. There's quite a bit of differentiation in terms of, I guess -- I'd say, modularity in terms of whether that be Trabecular Metal or VIVACIT-E cups. But how does that play against a hospital that has capitated pricing? Does that mean that you just end up with more implants at the higher end of the spectrum, or are you able to sort of offset some of that capitation?

[David C. Dvorak:]

Well, I mean, it -- we just, as they are, are doing a value analysis in those discussions. And so, there are going to be instances where, by virtue of the volume that's driven and the service requirements and the instrument deployments, which are not inconsequential on this business, all of those are factors that go into what price point we're going to take those kinds of technologies into a particular system or individual facility. But there's obviously a structure and a rationale to how we position our systems and the technologies, and we have the benefit, frankly, of having a broad enough portfolio to where we're able to position our products and systems in a way that they can address about any customers' wants, needs and desires in that regard, Jason.

[Jason Wittes:]

Okay. So in other words, there are some negotiations that still happens, and you're able to sort of come to the table with both an increased service offering plus, it sounds like, some clinical backing to some of the differentiation in your knees. Is that fair to say?

[David C. Dvorak:]

That's exactly right. There will continue to be negotiation in those discussions. And I think that the onus is on us, as we've described in the past, increasingly to provide empirical proof of the superiority of any new technology or system that we're launching as well to innovate in a way that is helping those customers address their concerns for delivering excellent patient outcomes in a very cost-effective way. So that is something that is embedded in any R&D project that we scope out to ensure that we're delivering value on multiple fronts.

[Jason Wittes:]

Okay. And then, just quickly, in terms of the knee rollout, I assume that your -- there's still more to go in terms of rolling out. I mean, my understanding going through the year was that you'd start to see it this quarter, but it's really next 2 where you'd see a more -- the new knee in the hands of more surgeons. Is that the right way to think about it?

[David C. Dvorak:]

It is. And I guess, I'd ask you to -- or encourage you to take a step back even further from that. This type of a system launch is a multi-operating period launch as opposed to just a multi-quarter within an operating period launch. So this is the first full year of the launch, and there will be several years of instrument deployments in the U.S. and o U.S. markets. And then, there are going to be phases of technologies in addition to that system to take place over multiple operating periods too. So it's one of the reasons, frankly, that we're so excited about the receptivity that we saw in the limited release last year in the general release as we broadened this year, is we just feel like we're on a terrific track at this point in time for multiple operating periods to go after competitive business and do great things for patients and take share. And that's what we're out to accomplish within the knee category. So I'd like to thank everyone for joining the call today and your continued interest and support for Zimmer. We look forward to speaking to you on our third quarter conference call, which is scheduled for 8 a.m. on October 24. And with that, I'll turn the call back to you, Montserrat [ph].

[Operator:]

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