Integra Lifesciences Holdings Corp (IART) 2015 Q4 法說會逐字稿

Good day, everyone, and welcome to the Integra LifeSciences fourth-quarter and full-year 2015 financial results conference call. As a reminder, today's call is being recorded. At this time, I would like to turn the call over to Ms. Angela Steinway, Global Head of Strategic Initiatives and Investor Relations. Please go ahead.

Thank you, Priscilla. Good afternoon, and thank you for joining the Integra LifeSciences fourth-quarter 2015 earnings results conference call. Joining me today are Peter Arduini, President and Chief Executive Officer; and Glenn Coleman, Chief Financial Officer.

Earlier today, we issued a press release announcing our fourth-quarter and full-year 2015 financial results, and providing 2016 full-year guidance. We also posted a presentation on our website, which we will reference during the call today. You can find this presentation at IntegraLife.com under Investors, Events and Presentations, in the file named fourth-quarter and full-year earnings call presentation.

If you would open that file up to slide 2, please reference our Safe Harbor statement covering the forward-looking statements we will make on today's call. As well, please reference the reconciliations of non-GAAP financial measures at the end of the presentation, beginning on slide 13.

And now I'll turn the call over to Pete.

Thank you, Angela, and good afternoon, everyone. Turning to slide 3, let me start with some of our financial highlights. In the fourth quarter, our sales were $241.2 million, representing an increase of 10% as reported and 12% on a constant currency basis over the prior year. Regenerative product portfolios in both our Specialty Surgical Solutions, and Orthopedics and Tissue Technology segments, once again drove the growth. Including TEI, regenerative sales in both segments increased to 42% of total revenues, up from 35% in the prior-year period.

Organic growth in the fourth quarter was 3.9%, set against a tough comparison in the prior year, as we previously communicated. Full-year organic growth of 6.7% came in at the high-end of our guidance, and is more representative of the growth we think we can sustain on a long-term basis. Our adjusted net income increased 7.2% from the fourth quarter of last year, driven by our top-line results and a 270-basis point improvement in adjusted gross margin, which reached a record high of 68.3%. In addition, our quality of earnings continues to improve, as evidenced by our full-year free cash flow conversion rate of over 67%.

Please turn to slide 4 for an update on our recent accomplishments. In the first week of January, we achieved another key milestone in our plans to enter the outpatient diabetic foot ulcer market, when we received FDA approval of our PMA supplement for Omnigraft. We're on track to our previously communicated commercialization plans, and expect a mid-2016 launch. We are well-positioned to execute on our 3 x 3 Wound Care Strategy that we outlined at our Investor Day meeting in November.

We will be the only Company that offers three technologies through three sales channels, with our engineered collagen matrix, [paid] cellular dermal collagen and amniotic allograft focused on addressing inpatient, outpatient and enterprise-level call points. This strategy, coupled with the additional commercial and clinical investments, is expected to drive our wound care business for years to come.

TEI was important addition to our advanced wound care business, and results are tracking as planned. We completed the majority of our integration efforts, and the legacy Integra and TEI sales forces are now fully aligned. The TEI wound care channel is now exclusively focused on outpatient wound care, and we look forward to launching Omnigraft through this channel in mid-2016.

The surgical sales channel, which sells SurgiMend into the hernia repair and plastic reconstructive surgery markets, is also fully integrated, and we anticipate introducing new products through this channel. We're also beginning to leverage our enterprise contracting capabilities to create access at the national, regional and local levels. We're scaling up manufacturing, and we have coverage from several of the Medicare administrative contractors. We look forward to providing you with additional updates as we get closer to commercial launch.

The integration of the Salto ankle is also progressing well, and we are seeing stabilization in the core user base. The majority of our sales channel is participating in clinical cases. And our leadership team and sales reps are engaged with the top surgeons and key opinion leaders who have been long-term users of this technology. Throughout the year, we will be coordinating medical education events at various industry conferences.

In December, we initiated our go-direct strategy in Italy with the acquisition of Tekmed, a long-time distributor of Integra's neurosurgery products. Tekmed, which has a four-year history of serving the surgical community in Italy, will accelerate our growth in Western Europe. Also in December, we received 510(k) clearance for our new Fin-Lock Anchor Peg Glenoid. The Fin-Lock allows for enhanced fixation, and will be the first launch in a series of new product introductions addressing complications in the shoulder.

And finally, I am pleased to report that our collagen manufacturing facilities here in Plainsboro, New Jersey, and Anasco, Puerto Rico, recently completed FDA quality inspections. Both facilities received clean reports, with no observations -- a credit to all the work our employees have put into quality improvements over the last few years.

And now, I'd like to turn the call over to Glenn to provide a more detailed review of our 2015 financial results and our outlook for 2016. Glenn?

Thanks, Pete, and good afternoon, everyone. Overall, we are pleased with our fourth-quarter financial performance, which was in line with the guidance we provided in November. And we're now even more optimistic about our financial outlook for 2016.

First, let me start with a discussion of our fourth-quarter reported sales, which were $241.2 million, up 12% on a constant currency basis. Our fourth-quarter organic growth of 3.9%, over a tough comparison in the prior year, was in line with our guidance. Full-year organic growth of 6.7% demonstrates the strength of our underlying businesses and the success of new product launches, which accounted for about a-third of the organic growth.

Please turn to slide 5. Reported fourth-quarter sales in Specialty Surgical Solutions of $153.1 million increased 2.6% on a constant currency basis, despite a challenging comparison with the fourth quarter of 2014, particularly outside the United States. For the full year of 2015, organic sales were up roughly 5.3% over the prior year, equally balanced between US and international markets. This increase was largely driven by sales in our Dural Repair franchise, which grew 9% over the prior-year fourth quarter, and 14% over the full year.

In addition, we saw continued momentum in our Precision Tools & Instruments franchise, which reports broader distribution of our instruments in Europe, and higher sales of Mayfield 2 in the United States. Organically, sales in this franchise accelerated throughout 2015, for a full-year growth rate of 5%, marketing a successful transition of our instruments franchise into Specialty Surgical Solutions.

Global tissue ablation in our critical care sales were down for the quarter and for the full year, in line with our expectations, due to a higher-volume capital equipment replacement cycle, and large international orders in both of these product lines in the prior year. International sales in this segment on a constant currency basis increased over the fourth quarter of the prior year because of the MicroFrance acquisition and growth in China and Australia. Both of these markets are now generating over $10 million in annualized sales, with growth in China above 40% in 2015. For 2016, we're expecting sales in Specialty Surgical Solutions to grow 3% to 6% on both an organic and reported basis.

Turning to slide 6, I'll now go through the results for our Orthopedics and Tissue Technology segment. Sales in the segment for the fourth quarter were $88.1 million, up almost 33% on a reported basis, driven by acquisitions and solid organic sales growth of 7.4%. On a full-year basis, organic sales in this segment grew 10.1%.

Sales of our regenerative products, which make up about 70% of the Orthopedics and Tissue Technology segment, grew mid-teens on a constant currency basis over the prior-year period, excluding the benefit of TEI. Our exclusive engineered collagen skin products drove organic growth in this segment, as we continued to see the benefits of the channel investments we've made, and greater acceptance of our advanced wound care solutions. TEI sales continued to track in line with expectations that we outlined following the acquisition.

Sales in our Extremities franchise were up over 20% in the fourth quarter, driven by the addition of the Salto ankle, which outperformed our initial expectations. Assuming the benefit of acquisitions, our Extremities sales in the fourth quarter declined low-single-digits. Our shoulder product line continued to do well, and our upper extremities products increased internationally, but declines in our legacy products offset this growth. We expect new product introductions to accelerate growth in the second half of 2016.

International sales in this segment increased 12% on a constant currency basis, driven by the TEI acquisition. For 2016, we're expecting reported sales growth in the Orthopedics and Tissue Technology segment of 25% to 30%, and organic growth of 10% to 14%. Our guidance includes approximately $15 million of sales for outpatient DFU products, including both Primatrix and Omnigraft.

If you turn to slide 7, I'll now walk through the components of our full-year 2016 revenue guidance. Based on the segment revenue that I just provided, we expect consolidated full-year 2016 revenues to be in the range of $975 million to $1 billion, representing growth of 10% to 13% of a reported basis. Included in this guidance range is organic growth of approximately 7%, slightly higher than we discussed at our November Investor Day, and at the midpoint of our recently raised long-term organic revenue target of 6% to 8%.

This reflects increased confidence in our growth outlook in Regenerative Technologies, and additional growth in demand we're seeing in our private-label business, that's now supported by the capacity expansion of our new collagen manufacturing center. We recently signed a 10-year contract extension with one of our key private-label partners, which should provide higher revenues in 2016 and beyond.

It's worth noting that our increased organic revenue outlook contemplates a more challenging selling environment outside the US in countries such as Brazil, Mexico and China. We're still confident in the investments that were making to expand our international infrastructure. We're tempering near-term expectations, given the macro economic environment for these markets.

Consistent with our previous comments on 2016, we expect see higher organic growth in the second half of the year, reflecting new product launches, such as Omnigraft, and the inclusion of TEI in our organic growth, whilst we move past the first anniversary of the acquisition. With respect to the first quarter of 2016, we expect reported revenues to be in the range of $229 million to $234 million, with organic growth of 5% to 6%.

Now, if you'll please turn to slide 8, I will review our fourth-quarter 2015 P&L performance and provide expectations for 2016. In the fourth quarter, [graph] gross margin of 62.7% increased 150 basis points from the prior year and adjusted gross margin of 68.3% reached a record high and expanded 270 basis points. These improvements largely resulted from payroll product mix, with regenerative technology products outperforming other franchises.

For 2016, we expect GAAP gross margin to be about 64%, and adjusted gross margin can be approximately 69%, which represents an improvement of 150 basis points over 2015. We expect the increase in gross margin to be driven by a full-year contribution from TEI, and continued favorable product mix, with our most profitable products growing faster than the rest of the portfolio.

Moving to operating expenses, our R&D expense increased 120 basis points to 5.7% of sales in the fourth quarter. For 2016, we're expecting R&D to be in the range of 5.5% to 6% as we continue to invest in a growing pipeline and increase our clinical studies to show differentiation of our products. We plan to initiate several clinical studies this year to support the Cadence two-piece ankle for total ankle arthropathy, and Primatrix for diabetic foot ulcer treatment, as well as the start of our PyroCarbon hemi shoulder study.

G&A expense was 45.5% of revenues in the fourth quarter of 2015, an increase of 330 basis points year over year on reported basis. On an adjusted basis, SG&A was up 370 basis points for the quarter to 42.4%, and up 60 basis points for the year to 42.7%. Sales and marketing expenses rose sequentially in the fourth quarter, as we integrated the Salto ankle and TEI acquisitions, and invested in the launch of Omnigraft, scheduled for mid-2016.

In 2016, we expect to reinvest the benefit generated by the two-year suspension of the medical device excise tax into new product introductions, licensing of new technologies, and commercial channel expansion. For 2016, we're expecting SG&A expenses to be in the range of 42% to 42.5%. However, we do expect this rate to be higher as a percentage of sales in the first half of the year, and trend down in second half.

Our adjusted EBITDA margin was 23.5% in the fourth quarter of 2015, and 22.2% for the full year. In 2016, we expect to continue to show EBITDA margin improvement, up to about 24%, which implies a 180-basis point increase over 2015.

Moving to slide 9, based upon our full-year 2016 outlook for revenue and expenses, we expect GAAP earnings per share to be in the range of $1.70 to $1.85, and adjusted earnings per share to be the range of $3.35 to $3.50, at current foreign currency rates. This represents growth of between 9% and 14% in our adjusted earnings per share versus the prior year. As a reminder, our 2016 share count will include a full-year share dilution from our August 2015 equity offering and therefore, our adjusted net income is expected to grow faster than EPS, in a range of 16% to 22% in 2016.

Consistent with my earlier comments that stronger organic revenue growth is expected to come in the back half of the year, we also expect earnings growth will be similarly weighted. We therefore expect first-quarter adjusted earnings per share to be in a range of $0.70 to $0.74. This EPS range implies double-digit net income growth.

Turning to slide 10, fourth-quarter cash flow from operations was approximately $25 million, a significant improvement over the prior year. Capital expenditures increased in the fourth quarter as we continued to upgrade manufacturing equipment, and introduced automation which would benefit production efficiencies. Our full-year cash flow from operations was approximately $107 million, driven by improved profitability and lower expenses on our ERP implementation. This resulted in a free cash flow conversion for the full year of nearly 68% -- in line with our guidance and a significant improvement over the prior year.

One item I wanted to point out for 2016 relates to the principal repayment of our December 2016 convertible notes, and how it's presented in our statement of cash flows. When these notes are repaid, the portion of the notes that represent the non-cash interest accretion is shown as a reduction to operating cash flow, instead of financing activities. This amounts to roughly $42 million, and will be excluded from our operating cash flow and adjusted free cash flow conversion guidance for 2016.

We expect operating cash flows, excluding this accreted interest payment, to be in the range of $125 million to $140 million. And capital expenditures to be between $35 million and $40 million, generating adjusted free cash flow conversion of between 70% and 80%.

Turning to slide 11, I'll wrap up with a quick update on our capital structure as of December 31, 2015. We have a net debt of $675 million, a borrowing capacity under our existing revolver of about $600 million, and a bank leverage ratio of 3 times. Based on our strong capital structure and expected improvements in cash flows in 2016, we remain confident in our ability to invest in our business and pursue strategic M&A opportunities to reach our new long-term financial targets.

And with that, I'll turn the call back over to Pete.

Thanks, Glenn. We exited 2015 with momentum across our business, and I want to take a few minutes to recap our key areas of focus for 2016. So if you would turn to slide 12. In November of last year we raised our key long-term financial targets, including organic revenue growth, by 100 basis points, to 6% to 8%. And adjusted EBITDA margins to about 25%, from 23% to 24% prior. The targets are long term, so while we may see some variability quarter to quarter, we expect to continue to execute and show progress towards these targets over the next three years.

A few minutes ago, Glenn outlined our 2016 financial guidance. Achieving 7% organic revenue growth, with double-digit EPS growth, is a top priority for the year. Improving execution has been an important theme for our business over the last several years, and we strengthen our operational foundation. From this stronger position, we are focused on accelerating growth. We have numerous opportunities, new products to launch, new markets to enter, and an energized team executing against these growth plans.

At our Investor Day last November, we provided details on our 3 x 3 commercialization strategy for Omnigraft. January PMA approval was the first for a diabetic foot ulcer treatment in roughly 15 years, and we take great pride in having accomplished something that will provide new solutions for this large and growing market. And we're executing on all aspects of the launch, and look forward to providing additional updates to you in the next couple of months.

In addition to the launch of Omnigraft in our Regenerative Technologies portfolio, our Extremities franchise is well-positioned for accelerating growth in 2016. The relaunch of Salto through the Integra sales team, and the introduction of Cadence, will add organic growth in the fourth quarter of 2016. And we also expect to gain share with some new product introductions in our Extremities franchise, such as the Fin-Lock Glenoid solution, [X-Fix], our new external fixation product, and a new version of Panta, our leadership product for internal fixation.

Internationally, we look forward to the expansion of market-leading products such Integra Skin, DuraGen, DuraSeal, and our Titan Shoulder, as we execute on new product registrations in new geographies.

In the United States, we announced a service lines agreement with PREZIO Health. PREZIO Health is a leader in perioperative services, repair, maintenance and management of surgical instruments. They will act as an authorized service provider for our leading surgical instruments portfolio in the United States. The agreement positions us to offer a more competitive, full-service solution that improves patient care and reduces costs.

Finally, we remain committed to pursuing strategic M&A in Specialty Surgical Solutions, and Orthopedics and Tissue Technologies.

And before I close, I'd like to thank all of Integra's employees for their hard work in 2015, and for their commitment to our brand promise of limiting uncertainty for caregivers, and our core vision of becoming a multi-billion-dollar medical technology company. We are confident that the accomplishments of the past year and the investments in our infrastructure and capabilities positions Integra for a successful 2016.

With that, operator, please open up the line for questions. In an effort to accommodate everyone, we ask that you limit yourself to one question and one follow-up, after which you may rejoin the queue. Operator, you may now open up the lines.

(Operator Instructions)

Travis Steed, Bank of America.

Good evening, Travis.

Thanks for taking my question. Originally, you gave guidance a few months ago at the Analyst Day, and raising your revenue a little bit, but you're widening out the EPS range a bit as well. So can you help us understand what you're seeing in the business that gives you confidence in raising the revenue growth but needing to widen out the EPS range?

Yes, I'll comment, and then maybe Glenn can jump in, Travis. I think as we take a look at -- as we mentioned in the prepared comments, I think our product launches that we have prepared for the year, we have better insights into what those estimates look like.

Our legacy portfolios, both in Specialty Surgical, including dural repair as well as we take a look at our regenerative products, our skin products and such -- we've got increased confidence that we could move to the higher end of that range. And as you recall, we talked about 6% to 7%.

I would say -- and I will have Glenn put a finer point on it -- at the same time, we are entering two new segments that we've never been in before, with ankle, as well as into the diabetic outpatient foot area. And just the amount of marketing, the amount of ramp-up, the amount of investments, we really decided to make sure that we put the adequate investments up front, so that we can accelerate our growth in the long term. And that is some of the investment that's there.

Glenn, you may want to add a little bit more on the profit.

You know, Travis, you're exactly right. I mean, we've taken our guidance up now to 7% organic growth for 2016. Previously, we talked about 6% to 7%. I think some of these new product launches could be higher than we initially thought potentially. So we're kind of giving ourself a little bit of cushion in our guidance range.

We're also more bullish just in general about our agenda portfolio and our skin products. So if you look at the momentum that we've got in our skin portfolio, I feel really good about what is happening there.

Even in our private-label business now, with some of the additional capacity we have in our new collagen manufacturing center, we see some potential opportunities to do better in our private-label business.

And as Pete mentioned, in the ankle space, we had a good start with the Salto ankle. It did better than we thought in the first quarter, out of the box. And we feel pretty bullish about our total ankle portfolio as we go into 2016.

So on the top line, we're feeling a little better about things, despite the fact we've got some headwinds in some emerging markets like Brazil, Mexico and China. But overall, we feel better than we did back in November, on the top line.

EPS-wise, we have a lot of moving parts. We know the first half of the year is going to have a lot of investment, with these product launches. So relative to how we see the year shaping up, expect the first half to be lower than the second half, just given the investments we're going to make in a lot of these product launches.

But relative to our guidance range, I think 335 to 350 is good range to go out of the year with. And if these products are successful and these are better than we think, we will probably end up in the mid to higher point of that range.

But we're giving ourselves a little bit latitude with respect to a wider range. And again, the range would give us the growth range of 9% to 14% year over year.

Okay, thanks. Just have a follow-up on the Extremities business. You said it was down low-single-digits. Can you parse out what upper and lower grew on a global basis or a US basis? And kind of what drove the weakness overall relative to the last two quarters?

Yes, Travis, I would just say, we don't break it out. But overall, upper has done well, shoulder continues to do well. As Glenn said, the first three months, or first quarter, that we actually had the ankle, which was in the fourth quarter of last year, it's continued to be impressive. And that will be an accelerant.

The area we had spoken about, which is our lower, our foot products primarily tied to some older product versions that we are upgrading. And we had that type of slowdown. It was actually little bit lower rate than in previous levels. We believe by midyear in 2016 that we'll be able to turn that tide around, specifically on those legacy products.

I mentioned on my prepared remarks some of the new products that are coming out in that area, as well as, we're kind of refreshing that whole line. And so there's two things. One is the refreshing of the lower, we believe, is going to make a difference for us in 2016.

Having the ankles gives you access to new customers that we really didn't have before, that use all of the rest of our lower portfolio. And then we've also done some things to focus and add to our channel.

And so that is kind of the three areas. But the being down, it's the same area that we've spoken to in the past, which is kind of in the forefoot, mid-foot, hind-foot area, at different areas. And we feel pretty good about our plans to turn the course of that mid-year 2016.

All right, thanks a lot.

Yes.

Larry Biegelsen, Wells Fargo.

Good evening, Larry.

Hey, guys, thanks for taking the question. Pete, maybe let's start with the diabetic foot ulcer launch. And just my questions are as follows.

Are you still comfortable with the $15 million this year for that franchise, that you talked about at the Investor Day? And maybe if you could talk a little bit -- I know it's early -- about what you're hearing from payers on that -- on Omnigraft, excuse me. Thanks. And I have a follow-up.

Yes, sure. So, Larry, across the board, we feel very good about where we are positioned with diabetic foot ulcer product-branded Omnigraft. I would say, our feedback from the FDA -- as many of you saw, a press release that the FDA actually put on the product itself, talking about how excited they are about what this can do for patient care. Our ramp-up and our overall packaging of our product -- we're in good shape.

And we are really commencing hitting the road here with payers, with a focus on being able to build up the amount of not only in the area of open-policy max, which is roughly about just over 25 million lives, but also the closed-policy max. So we've been working through that. And the private payers, which I would tell you, we are well on track to where we had hoped to be for mid-2016.

So I feel quite good about that. I think the initial feedback that we are hearing is extremely positive. As I mentioned, there's been a lot of products that have come to some of these payers that haven't had much data. So we bring the largest study that has been out there, with some very definitive data, what it can do for outcomes.

And then being able to show the amount of product that is actually needed to close a wound in this product, has been very exciting for folks to see. Ultimately, the rubber meets the road once we get it in clinicians' hands, and see how we can move from there. But I would say our initial feedback on the quality of the data, the quality of the study, the health economics and cost benefits, all being received well.

Thanks, that's helpful. And then one long-term EBITDA margin question. You are guiding to 24% EBITDA margin this year, which is a big improvement over last year. But your 2018 goal is 25%, which would seem conservative, given that you expect 6% to 8% organic growth. So Pete, can you talk a little bit about -- is that 25% something you see as being conservative? Thanks.

I would just say, and then Glenn can add some points to it, I think that we have opportunities to obviously outperform that potentially sooner. But I want to just kind of frame this up. We have, again, areas with some pretty formal competitors, that we plan to invest at a proper level, to do long [follow] studies, do the right types of investment to be able to compete.

And so a big chunk of our assumption is -- just to a view of your previous question -- we have 50 reps. Many of our competitors are going to be in the range of 100 to 150 reps. As we grow, those will take additional investments. And as we gave out those targets, we thought about some of the infrastructure and capabilities that need to be there.

So look, it's been going extremely well. Do we have an opportunity to do better than that? Sure, we do. But I think it is quite realistic at this point time to say, that's the type of target that make sense for us.

And Larry, the only other thing I would add is, keep in mind we have TEI in for full year in 2016, versus five months. It's a very profitable business, so we get the one-time benefit really in 2016. And then you have a recurring business for a full year thereafter.

So in addition to what Pete said, just keep in mind, TEI full-year helps us to get more of an impact in 2016. But still very bullish about what getting to those 25% EBITDA margins by 2018.

David Lewis, Morgan Stanley

Hello, this is actually Jon Demchick in for David. Thanks for taking my question.

Hey, John.

I wanted to start off a bit on earning quality. So it's been a large focus of our team -- seeing the large gap in guidance EPS versus adjusted EPS gave us a little pause. But I mean, I think that is largely related to the interest payments on the convertible debt, which you all pointed out.

Certainly there has been a lot of improvement over the years in earnings quality for you all. And I was wondering if you could maybe talk to some of that improvement on what drove it, and how sustainable that is, at these sort of 70% to 80% levels that you talked about, for this year moving forward?

Hey, Jon, this is Glenn. Let me take a crack at this, and Pete can add any additional color to it. When we look at our differences between GAAP and adjusted earnings, especially in 2016, as an example, the vast majority of those special charges are non-cash-related charges for acquisitions.

So intangible asset, amortization, inventory step-up. You mentioned the non-cash interest portion on the converts. Those are the big-ticket items. So when you look at our cash flow improvements, the fact that those are non-cash, you are seeing cash flow improvements in the business.

Part of it is also the ERP system cost coming down year over year. We had about $10 million or so of less cash outlays for the ERP in 2015, expect a similar-type improvement in 2016, and then going away.

And so yes, we are expecting more improvements in our cash flows. We're expecting the cash special charges to go down. And we're very confident we are going to get to a 95% cash conversion rate by 2018, as we previously said.

So we are on a good path. We made great progress in 2015. We're going to make more progress in 2016, and on a path to getting close to 95% or 100% by 2018.

Thank you. And just a quick follow-up on R&D guidance, actually. I was expecting that R&D would probably be moving a little higher than the 5.5% to 6% that we saw. And you mentioned -- called out a few different studies in ankles, shoulder and others.

Is this sort of 5.5%, 6% rate where you would expect it to be moving forward? Do you expect it to kind of move higher to fund some of the higher growth that the business is driving?

Jon, I think, again, obviously it's a percentage of sales on 7% growth. It's actually a pretty good step up in the actual investment dollars. So I think running towards that higher end of the range is probably where we see it.

There will be windows of time. We're starting out and using some of the investment dollars from [mid tech track] to start our tightened shoulder power carbon work that will happen this year and go into next year. So there will be windows of time when you actually have multiple studies going that may pop up in there.

But we think with the mix of businesses that we have, that running in that 6% range, and at times, going slightly above that, makes sense. And again, with the growth that we've had organically, just a few years ago, when we were only growing, say, 2%, 3%, obviously growing at a 7% level, it's been feeding our R&D, we think, at the right level and at the right clip.

Matthew O'Brien, Piper Jaffray.

Good afternoon, everyone. This is actually J.P. in for Matt. Thanks for taking the question.

Hey, J.P. Sure.

I had one on Omnigraft. I think once you got the FDA approval, you had, I think, coverage of around 50% of the max. And then you have to go and negotiate with the other half. I wondered if you could comment on some of those discussions thus far?

And then what's -- is there anything that could happen in terms of gaining more coverage decisions that could accelerate the launch maybe earlier than mid-2016? Or is that just kind of an internal making sure the team is ready and the marketing is ready, et cetera?

I would say, I really don't have a whole lot more to comment, other than I addressed on Larry's question. I think between the open-policy max, as well as the closed, we're calling on all. As you may or may not know, some of them have a process of when you have to submit the information. And there's windows of time you have to get there. So that dictates the time.

And then with the private guys, the Uniteds, and all those folks, there's a little bit more methodical -- Aetna's -- approach to go through. And some of those could even take up to a year.

But we are well on our way of having our meetings set up, and plans for reviews with those, with a walk-up on how we would see covered lives increasing. Relative to the launch and pulling it up, I would just kind of position it this way. There's really nothing with the payer side that I think inhibits anything happening faster. Obviously the more time that goes by, the more covered lives that we get in position.

We have our sales teams now fully staffed, and we've actually been commencing training. They are already starting to have discussions on the Primatrix product with customers within the space. So we'll be commencing having the discussions there. The $15 million that we had mentioned relative to the Investor Day, for including Omnigraft, including Primatrix, is still a number that we are forecasting here for 2016.

And some of the main items are, as you can imagine. We commence ramping up the product here quite soon, and you need to build up inventory. And you also need to build up the right level of product, so that you get your dating on the products, so that when you initially ship it, you have it out there. All that is factored into our mid-year launch.

So some of those are procedural things from a manufacturing thing that we look through. But obviously if we have the opportunity to go out sooner, we would take advantage of it. At this point, we just feel very good and confident that we can hit our mid-year 2016 date to launch.

Great, thank you. And one more, if I could. On the gross margin guidance for 2016, is it fair to say that the med device tax should add around 100 bps, 1%? And that you're looking for around organic gross margin expansion of around 50 bps? Is that math correct? And just given the new products you're launching in terms of total ankle, or the DFU products for higher margin, why that can't be more?

Yes, I'll take the first part, and maybe see if Pete has any additional comments on the second part. So relative to the medical device tax, keep in mind, that's a G&A expense for us. So that does not show up in our gross margins.

Overall, the impact is about 100 basis points. So you are right in terms of your math. But it's not in the gross margin line. And again, while it's coming out of our G&A expense line item, we're reinvesting in selling and marketing R&D.

So from an EBITDA perspective, we're ruling that as a neutral event. So that's how you should think about the impact of the medical device tax. And Pete, I don't know if you have any comments on the other piece?

Yes, I mean, I would say, on the products, again, as you're scaling up in their partial years, you're typically dealing not with full-production runs, as far as your cost. And so sometimes, your cost of goods on those products clearly aren't at the level of full production. That starts coming in at the end of this year or into 2017, is when you would see some of the benefits.

So we think that they are well-positioned. Again, if we were to have a faster ramp and we could get to some of those quantities higher, that would give us a better cost advantage. That's in the products.

And then one that we've talked about quite a bit, is how fast we fill up the new plant, also has an impact on actually reducing the cost of a some of our regenerative products, which would pass through at higher gross margins. But as of now, products coming out of that plant, and the estimates that we've given you right now, are really probably at their lowest position. Meaning, we have the highest burdens on it, because the plant is only producing 15%, 20% of its capacity.

So Glenn mentioned about private-label -- that's an interesting adder that can help across the board. Mainly because in the last five years, we haven't had the capacity to really do any additional private label, because our plant was maxed out, making products for ourselves.

And so we do have some opportunities there. And as they come into the facility, they can obviously be profitable products. But they can also help the overall capacity across for every product that is in that plant.

So there's a bunch of different things that we're looking at and thinking through. But I think how we would position it right now, it's pretty representative of how we think 2016 will finish up.

Yes, and again, it's a significant improvement over 2015. We're talking about 150-basis point improvement year over year. And so we feel really good about our plans, and continuing to drive increased profitability in 2016.

Jayson Bedford, Raymond James.

Good afternoon, thanks.

Hey, Jason.

Hey, Pete. Maybe just to follow along the last line of discussion there, you mentioned on your private-label business that you re-upped the contract. Just wondering, was that on the core legacy and Integra side, or was that on the TEI business?

Integra products that we actually made here in our older facility, that now enables us to actually make more capacity in the new facility.

And with this expanded production here, are you actively going out and looking for new private-label partnerships?

Yes. And I would say, not just anything, but we are looking for things that might actually help us to join R&D or work within some of our product platforms. That would be an area that we're not going to compete in. But actually, the enhancement could actually help across our product lines.

And so where those opportunities exist, we're very interested in. And as you could imagine, there's a reasonable amount of opportunity for scaffolds and structures, with the leadership position that we have.

(Operator Instructions)

Steven Lichtman, Oppenheimer.

Thank you. Hi, guys.

Hey, Steve.

Pete, you mentioned that the surgical sales channel with SurgiMend is integrated now. Can you talk about the opportunity you see there looking ahead here? And also what are the type of products you see as adding through that channel potentially?

Thanks, Steve. It's a good question. Again, when you think about this, to frame-up, we've never had a call point where we saw the reconstructive surgeon that did breast reconstruction or did hernia repair before.

So with the proper studies, we think our opportunity to go into the breast area for reconstruction is a really interesting opportunity. And with the right studies on the legacy TEI products, but also the work that could be done with our products such as flowable and other scaffoldings, there could be some really interesting opportunities for us.

If you go into the hernia area, we think that, with some focus that TEI had already commenced, there's a lot of interesting opportunities to increase products that have higher vascularization, other types of fits and stuff. So we're already working together closely, integrating the R&D teams to come up with some new products. So that's some interesting things.

And then I would say, with the channel structures we have now that go into that area of inpatient, into the OR that touches burn, into the OR that touches broader wound, and in the outpatient area. There's some interesting products that we could license, that we could fold into each of these channels. And I would say, they can range from everything from a synthetic-type product, all the way to a human tissue product, that could properly fit into those areas.

We obviously have an amniotic product today that we're talking about, [Wound]. But there's clearly derivatives thereof that could go into those other segments. And I'd say, we're looking at all those different areas. And I'd say, this year, we hope to be able to bring some of those into the fold that would most likely have benefits in 2017, 2018 and beyond.

Okay, great. And then just, can you talk a little bit more about advancements you're making in enterprise selling? Any comments overall on how that effort is going would be great.

Yes, I think we're starting to ensure hitting our stride. It starts with getting your own organization to embrace it. Meaning that you've got the systems now to look at a integrated delivery network as a integrated customer in P&L, if you will. And we can do that now, having the right types of analytic skills to be able to understand, when you bring X products together, does it make sense for the customer, does it make sense for us? We have that in place now.

And we're going much beyond just the GPO agreements, and actually setting up individual delivery network agreements. And I would say last year, our growth out of those account areas was significantly higher than our core growth. And we're pursuing quite a bit of those this year.

I would say, relative to things like the 3 x 3 strategy, we just don't know yet. We haven't gone down that route. But we do think that approach of bringing together products and capabilities in multiple channels, and bringing together, not a hunting license agreement, but literally an agreement that talks to a level of commitment -- a customer needs to buy this amount of product from us. Will be some of the type of agreements that we'll be able to write here in the latter part of 2016, once we get those products launched.

(Operator Instructions)

Okay, well, look, thank you all for attending the call, and all your questions today. I'd also like to just take a couple minutes here just to recap. We're very proud of how we executed the 2015 plan and delivered on our financial results. 2016, we'll focus on the following objectives and items that I highlighted in my prepared remarks, I just like to touch on again.

First of all, we're executing on our 2016 financial objectives, is a key area for us, including this organic growth of 7%, and double-digit adjusted earnings-per-share growth. Secondly is, entering the outpatient wound care market, we spoke quite a bit about. And implementing our 3 x 3 strategy, with the successful launch of Omnigraft mid-year, which we feel quite good about.

Third is continuing to drive the organic growth with new product introductions. And finally is, pursuing M&A within Specialty Surgical, Extremities and wound care, and staying very disciplined about those three areas. So again, thank you so much for listening, and we look forward to speaking with all of you in the near future.

Thank you.

This does conclude today's program. Thank you for your participation. You may disconnect at any time.