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RTI Surgical Inc. (NASDAQ:RTIX)

Q4 2013 Earnings Conference Call

February 13, 2014 8:30 am ET

Executives

Brian Hutchison – President, Chief Executive Officer

Robert Jordheim – Executive Vice President, Chief Financial Officer

Roger Rose – Executive Vice President, North American Sales and Marketing

Carrie Hartill – Executive Vice President, Chief Scientific Officer

Wendy Crites Wacker – Executive Director, Global, Corporate and Marketing Communications

Analysts

Matt Hewitt – Craig-Hallum

Bill Plovanic – Canaccord Genuity

Jason Bedford – Raymond James

Chris Cooley – Stephens

Operator

Good day ladies and gentlemen and thank you for standing by, and welcome to the RTIX Fourth Quarter and Year-End 2013 Earnings conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions will follow at that time. Should anyone require assistance during today’s event, you may press star then zero on your touchtone telephone for a live operator. As a reminder, today’s conference may be recorded.

It’s now my pleasure to turn the floor over to Wendy Crites Wacker. Ma’am, the floor is yours.

Wendy Crites Wacker

Good morning and thank you for joining RTI Surgical for our fourth quarter and year-end 2013 conference call. Today we will hear from Brian Hutchison, President and Chief Executive Officer, and Rob Jordheim, Executive Vice President and Chief Financial Officer. Also joining this morning for Q&A are Tom Rose, Executive Vice President of Administration; Roger Rose, Executive Vice President, North American Sales and Marketing; Carrie Hartill, Executive Vice President and Chief Scientific Officer; and Robby Lane, Executive Vice President, Global Commercial.

Before we start, let me make the following disclosure about forward-looking statements. The earnings and other matters we will be discussing on this conference call will involve statements that are forward-looking. These statements are based on our management’s current expectations but they are subject to various risks and uncertainties associated with our lines of business and with the economic environment in general. Our actual results may vary from any statements concerning our expectations about future events that are made during the course of this meeting, and we make no guarantees as to the accuracy of these statements. Accordingly, we urge you to consider all information about the company and not to place undue reliance on these forward-looking statements.

Now I’ll turn the call over to Brian Hutchison.

Brian Hutchison

Good morning everyone. Thank you for joining us. Today I will start with an overview of the fourth quarter and then let Rob review our financial results. I’ll follow up with guidance for 2014.

As detailed in our press release issued this morning, we reported fourth quarter revenues of $60.5 million, a 36% increase over the fourth quarter of 2012. This includes $19.9 million of Pioneer Surgical Technology revenue in the fourth quarter. Revenue modestly exceeded our fourth quarter guidance of $59 million to $60 million. We achieved annual revenues of $198 million, an increase of 11% from 2012 and exceeding our annual guidance of $196 million to $197 million given at the beginning of the fourth quarter 2013. This includes $36 million of Pioneer revenue for the period of July 16, 2013 to December 31, 2013.

When reviewing each of our lines of business, fourth quarter spine revenues increased to 78% compared to fourth quarter 2012. The increase was related to the addition of revenue from the Pioneer acquisition. In October of 2013, we began cross-distribution of some of our allograft implants with our new direct spine channel. This group now has a complete line of allograft and synthetic bone graft substitutes available to go along with the portfolio of metal and synthetic spinal implant and instrumentation. In December 2013, we had a first spine surgeon symposium, which focused on biologics. We had a great turnout and a very positive response from the surgeon attendees.

Early results from these and other efforts have been impactful, as demonstrated by sequential monthly increases in the fourth quarter in average daily revenue. These initiatives, along with new product launches, will drive growth in spine over the next year. At this time, we are anticipating spine will grow in the mid-single digits for the full year of 2014, based off the fourth quarter 2013 annualized run rate.

Our sports medicine business decreased 14% compared to fourth quarter of 2012. As you know, the sports medicine team faced some challenges in 2013. We changed leadership in this business and in the fourth quarter we initiated cross-distribution opportunities resulting from the Pioneer acquisition. This team is intently focused on recovering and growing this business customer by customer and through a best-in-class portfolio of allograft and second generation synthetics, as well as excellent customer service. Initial signs of the sports business recovery were seen in the fourth quarter, as evidenced by sequential monthly growth in average daily revenue. We are anticipating that sports medicine will return to growth in 2014. At this time, we expect growth in the mid-single digits for this line of business.

Fourth quarter surgical specialty revenues increased 5% compared to fourth quarter 2012. The increase in revenues is due primarily to the higher than anticipated revenues in breast reconstruction offset by declines in hernia revenue from our commercial distributor. In mid-2013, we launched our direct surgical specialties team, completing their portfolio in the third quarter with the introduction of Fortiva porcine dermis. Our direct distribution force has begun to gain traction in the fourth quarter as we begin to gain acceptance from hospital value analysis committees.

In January 2014, we announced our agreement with Yankee Alliance, a group purchasing organization with over 14,000 members. The agreement covers RTI’s complete line of surgical specialty implants and was effective January 1, 2014 for a period of three years. We expect to receive CE mark for the Fortiva porcine dermis product in Europe in early 2014 and will expand distribution outside the U.S. At this time, we anticipate that the surgical specialties business will grow in the mid-single digits for the full year 2014, with most of that growth coming from direct distribution and breast reconstruction through our commercial distributor.

Fourth quarter BGS and general orthopedics revenues increased 19% compared to fourth quarter 2012. The increase in revenues for the quarter was due to the addition of Pioneer revenue resulting from the acquisition.

Many of you have been following the progress of our map3 cellular allogeneic bone graft. In October, we were excited to feature map3 at the North American Spine Society meeting. Following the initial implantations, we announced in the third quarter of 2013 we’d continue distributing map3 to targeted surgeons, and we have received very positive responses. We’re working to follow up on patient outcomes and recently received an update on our first case, which is now at the six-month time point. We’re pleased to share that the patient is progressing well with no leg or back pain, and x-rays showing progression of bony bridging posterior to the inner body and end plate incorporation.

The map3 implant contains the three essential elements for bone formation: osteoconduction, osteoinduction, and osteogenesis. Map3 is different than any other bone grafts with stem cells because it contains MAPC cells which have specific osteogenic and angiogenic properties. Additionally, a validated minimum number of viable MAPC cells or MAPC-class cells per CC are delivered at the time of implantation. Currently, we are focused on supporting the initial launch for spine and extremity indications. Over the course of 2014, we will strategically expand the distribution of our map3 implant. We anticipate that BGS/GO revenues will grow in the mid-single digits for the full year of 2014 based off the fourth quarter of 2013 annualized run rate.

Fourth quarter dental revenues decreased 2% compared to fourth quarter 2012. This is in line with our exclusive distributors contract minimums, which met our expectations. At this time, we remain conservative in our expectations for the dental business and we anticipate that dental revenues will grow low single digits for the full year 2014 per our contract with our exclusive distributor.

Fourth quarter revenues of ortho fixation were $7.8 million. In the third quarter, we launched the Tritium Sternal Cable Plating System for closure of median sternotomies following open heart procedures. The product has been well received by the market and will drive growth in 2014. At this time, we anticipate the ortho fixation will grow in the high single digits based off the fourth quarter 2013 annualized run rate.

At this point, Rob will provide some details on our financial results.

Robert Jordheim

Thank you Brian. The financial results for the fourth quarter include the financial results of Pioneer, including certain purchase accounting adjustments and transaction expenses related to the acquisition. Domestic revenues of $50.4 million for the fourth quarter of 2013 increased 36% compared to the fourth quarter of 2012. Our domestic revenues increased $18.2 million as a result of the acquisition of Pioneer. International revenues, which include exports and distribution from our German, French and Dutch facilities, were $6.1 million for the fourth quarter of 2013, an increase of 36% compared to the fourth quarter of 2012. Our international revenues increased $1.7 million as a result of the acquisition of Pioneer. On a constant currency basis, international revenues for the fourth quarter of 2013 increased 30% as compared to the fourth quarter of 2012.

On a GAAP basis, net loss applicable to common shares for the fourth quarter of 2013 was $8.5 million or $0.15 per fully diluted common share, based on 56.4 million fully diluted shares outstanding. This compares to net income applicable to common shares of $2.3 million or $0.04 per fully diluted common share for the fourth quarter of 2012, based on 56.3 million fully diluted shares outstanding.

As a result of the Pioneer acquisition, during the fourth quarter of 2013 the company recorded the following: a pre-tax inventory purchase accounting adjustment of $9.5 million, a pre-tax integration expense of $468,000, a pre-tax restructuring charge of $2.9 million, and a pre-tax acquisition expense of $167,000. Excluding these charges, the company reported a $0.01 loss per fully diluted common share for the fourth quarter of 2013.

Gross margin for the fourth quarter was 35% as compared to 49% for the fourth quarter 2012. The decrease was primarily due to the accrued pre-tax inventory purchase accounting adjustment of $9.5 million. Excluding this charge, gross margin for the fourth quarter was 51%. For 2014, we expect that gross margin will be negatively impacted in the first quarter by one more quarter of purchase accounting adjustments.

During the quarter, marketing, general and administrative expenses totaled $26.1 million, an increase of $10.9 million or 71% higher than the fourth quarter of 2012. The increase in expenses was primarily due to the Pioneer acquisition and includes marketing, general and administrative expenses from Pioneer. As a result of the Pioneer acquisition, marketing, general and administration expenses includes amortization of intangibles of $911,000 and one-time integration costs of $468,000.

Research and development expenses totaled $4.1 million for the fourth quarter of 2013, an increase of $1.1 million or 37% higher than the fourth quarter of 2012. This increase in expenses was primarily due to the research and development expenses from Pioneer.

During the fourth quarter, the company incurred a pre-tax $2.9 million restructuring charge for severance payments and a facility closure related to the Pioneer acquisition. We expect approximately $5 million in annualized cost savings as a result of this effort. In addition, during the fourth quarter of 2013 we accrued a pre-tax expense of $167,000 for certain fees related to the Pioneer acquisition. Lastly, our tax rate for the fourth quarter of 2013 reflects a tax benefit of 36% compared to a tax provision of 38% in the fourth quarter of 2012.

Turning to the balance sheet, our cash position at the end of 2013 was $18.7 million compared to $49.7 million at the end of 2012. The decrease was primarily due to cash used to partially fund the acquisition of Pioneer. For 2014, we anticipate being cash flow positive from operations. We are confident that with current cash balances and available debt, we have adequate liquidity to support our future operations and meet our financing obligations.

Inventories of $106.1 million, including a $9.5 million write-up related to purchase accounting adjustments, increased $29.6 million primarily due to the acquisition of Pioneer as compared to the end of 2012. More specifically, at the end of 2013 unprocessed donor tissue and raw materials increased $5.5 million to $31.5 million, tissue and work in process increased $11 million to $39.4 million, and final donor tissue and finished goods increased $13 million to $33.1 million.

Working capital at the end of 2013 totaled $135.4 million, an increase of $6.3 million compared to the end of 2012. At the end of 2013, we had $69.1 million of debt and approximately $13.4 million available under our revolving credit facilities.

With that, I will turn the call back over to Brian.

Brian Hutchison

Thank you, Rob. 2013 was a year of significant change for RTI as we transformed the company from a biologics provider into a global player for surgical implants through the acquisition of Pioneer. We’re greatly encouraged by the progress we’ve made in the past quarter and enthusiastic about the opportunities in front of us to drive growth in the business in 2014 and beyond. Our key growth initiatives for 2014 are to continue to execute and recovery of direct spine and sports medicine that began in the fourth quarter, gain traction in our direct surgical specialties business, and launch key new products for our direct distribution organization.

We have an exciting line-up of new products launching in the coming months and anticipate more than 20 new products or product enhancements in 2014, with more than half of them coming in the first half of the year. As we do these launches, we will have a ramp-up period but should start to see an impact on revenues in the second half of 2014.

Turning to guidance, in our press release this morning we outlined expectations for revenue and EPS for the first quarter and full-year 2014. For the first quarter of 2014, we expect revenues to be between $58 million and $59 million. This would results in a 45% increase in revenues compared to Q1 last year at the midpoint of our guidance. The increase is primarily due to the addition of Pioneer revenues.

In the first quarter of 2014, we anticipate that the timing of orders from our commercial distribution will offset continued traction in our direct businesses. On a non-GAAP basis, we expect net income per fully diluted common share for the first quarter of 2014 to be approximately break-even. We expect full-year revenues to be between $245 million and $250 million, an increase of 25% at the midpoint of our guidance compared to 2013. On a non-GAAP basis, full year net income per fully diluted common share is expected to be in the range of $0.06 to $0.08 based on 57 million fully diluted common shares outstanding.

We hope to see some of you this quarter as we’ll be presenting at the Canaccord Genuity Musculoskeletal Conference on March 11 in New Orleans.

At this time, let’s open up to questions.

Question-and-Answer Session

Operator

Thank you, sir. [Operator instructions]

It looks like our first phone question will come from the line of Matt Hewitt with Craig-Hallum. Please go ahead. Your line is now open.

Matt Hewitt – Craig-Hallum

Good morning and thank you for taking our questions. First one for me – you got the all-clear letter from the FDA in the fall, or late fall I should say. I’m curious if you could give us an update on how the customers are responding. Have you been able to bring them back into the fold, and how much of a contribution can you anticipate, at least in the first part of this year?

Brian Hutchison

Matt, Roger Rose is here. We’re going to ask him to address that question.

Roger Rose

The marketplace has reacted very favorably, and many of the accounts that we were blocked from were now back in doing business, and we’ll continue to see improvement there as the year unfolds. Our objective, as Brian stated earlier, is to get back what we lost, and we’re well on our way to doing that.

Matt Hewitt – Craig-Hallum

Is there the possibility that you could—I mean, part of the thesis going into last year was that you were one of the first companies to receive that warning letter, would likely be one of the first ones out, and as a result you should not only recapture lost share but should be able to pick some up. Do you still, or should we anticipate that that is still an opportunity for you?

Brian Hutchison

Matt, this is Brian, and I’ll say this and have Roger tack on. I think we tried to be clear here – we did lose a little bit of business to competition, but what we really lost business to was the alternative procedure, which is autograft. So we’re now going back to these same accounts and converting these doctors and hospitals back from autograft to allograft, which was the first time we did that years ago and we’re having to do that again. So it’s not so much—we did lose some to competition, but for the most part when all the warning letters began to pile up, hospitals just kind of ran away from allograft and went back to autograft.

Matt Hewitt – Craig-Hallum

Okay, but I would assume that given the pushback on reimbursement for readmissions, and obviously with autograft there is a greater risk of that – you’re talking about two surgery sites – that it should be much easier to convert those accounts back to allograft under those circumstances, correct?

Roger Rose

Yes.

Matt Hewitt – Craig-Hallum

Okay. All right, and then maybe just one different line of thought from me and then I’ll hop back into queue. As far as the new products are concerned, porcine dermis, how much of a contribution should we anticipate from that this year? I mean, are we talking a couple million dollars to the top line, or how will that impact growth?

Robert Jordheim

Yeah Matt, this is Rob. We’re not going to give specifics on the new products, but I will tell you it will be meaningful and it will be in the single digit millions of dollars.

Matt Hewitt – Craig-Hallum

All right, thank you.

Operator

Thank you, sir. Our next phone question will come from Bill Plovanic with Canaccord. Please go ahead. Your line is open.

Bill Plovanic – Canaccord Genuity

Thanks, good morning. Can you hear me okay?

Brian Hutchison

Yes, Bill.

Bill Plovanic – Canaccord Genuity

Great. So a couple questions – first, just trying to parse this out, just looking at the growth in the spine business. Pioneer was $19.9 million and you did $7.8 million in the trauma businesses, at least $12.1 in spine and biologics. I’m just trying to find out, figure out if the growth you saw in your spine was pure Pioneer, or kind of tease out what your core old partner spine business was doing.

Robert Jordheim

Bill, this is Rob. The growth you’re seeing is really pure Pioneer. From a commercial standpoint in the spine area, those results were essentially flat.

Bill Plovanic – Canaccord Genuity

Okay, so the core was flat and the Pioneer was the balance in that business.

Robert Jordheim

Yeah.

Bill Plovanic – Canaccord Genuity

Okay, and then secondly, just looking forward, ongoing purchase price adjustments on a quarterly basis, what exactly are we going to see and where in the P&L?

Robert Jordheim

Bill, what you’re going to see in Q1 of 2014 is one more purchase accounting adjustment, and it’s going to be in the cost of sales line and it’s related to the amortization of the purchase of the inventory write-up. That number is going to be roughly $5 million.

Bill Plovanic – Canaccord Genuity

And then that’s the last of it?

Robert Jordheim

Yes.

Bill Plovanic – Canaccord Genuity

So as we go into Q2, 3 and 4, it will be pure GAAP earnings that we’ll be working off of?

Robert Jordheim

That’s correct.

Bill Plovanic – Canaccord Genuity

Okay. And then just finally, as the new products come out, is there anything as you look at these products, are these all incremental improvements or will we see some major product contributors as you ramp into 2014?

Brian Hutchison

Bill, Carrie Hartill is here. I’m going to ask her to address that.

Carrie Hartill

Hi Bill, this is Carrie. Good morning. So it’s essentially a mix. Some of them are extensions to some of the existing legacy kind of spine lines that are significant in rounding out those lines, so while they could be viewed as incremental they really allow full penetration of specific surgical indications. Then others are basically brand-new products coming into the pipeline, some on the cardiovascular side, others on the spine side as we go through the year.

Bill Plovanic – Canaccord Genuity

Is there anything you’d like to call out specifically?

Carrie Hartill

Probably the most significant as we go out through the year will be completing the launch of our map3 portfolio, which will include the strips which are ahead of schedule, and so we believe that they will have an impact.

Bill Plovanic – Canaccord Genuity

And is that in current year guidance, the major incremental or step-up type of products?

Robert Jordheim

Bill, yes it is. I would like to add that we are launching two systems in hardware for our spinal business, a cervical plating system and an MIS system.

Bill Plovanic – Canaccord Genuity

Great, thank you very much.

Operator

Thank you, sir. It looks like our next question will come Jason Bedford with Raymond James. Please go ahead. Your line is open.

Jason Bedford – Raymond James

Good morning, and thanks for taking the questions – I’ve got a couple. I may have missed this, but what’s your expectation for gross margin in ’14, absent the purchase accounting adjustment?

Robert Jordheim

Jason, this is Rob. Expectations are that it’s going to be in the low 50%, and what you should see throughout the year is sequential improvement quarter over quarter.

Jason Bedford – Raymond James

Okay. On the surgical specialty, you mentioned the Yankee GPO. Are you more actively pursuing other GPO contracts and do you expect any new ones here in 2014, and can you maybe comment on generally the pricing environment out there?

Brian Hutchison

Jason, this is Brian. We’re going to ask Roger to answer that question.

Roger Rose

We do have a lot of activity in the GPO and large IDN area. It is not our intention to just go out and contract with these folks unless we see value, and those that can drive compliance are where we typically see value – the HCA, the HPGs. But we’re in communication with most of the large groups to get in the queue as to when their contracting period’s back into play, and we are active in that space. As I’m sure you know, a lot of these products require that you’re in some way playing the game with those guys, but it is not our preference where we don’t need to.

Jason Bedford – Raymond James

Okay, and maybe another question just for Roger. Getting back to the sports business, can you give us an idea of the number of customers ordering product pre-warning letter versus post, meaning did you have 10, 15% of the customer base stop ordering, and do you expect to recoup all of that here in ’14?

Roger Rose

Yeah, I’d say the overall percentages are pretty close to accurate, and I think we’re going to pick up a fair share of it. As in any competitive space, there’s some customers that just aren’t going to come back to you, but along the way we’re gaining new customers; so while we may have seen some departure of some people, we’re seeing a pick-up on the other side. As Brian mentioned earlier, the biggest opportunity for us is autograft, and that’s where people headed when they couldn’t get non-irradiated grafts, and we’re the only company in the space that’s providing non-irradiated grafts. It’s a significant advantage for us and the surgeons and the patients that receive our products.

Jason Bedford – Raymond James

Helpful. And then just lastly from me, on Map3, how do we gauge your performance in ’14, meaning what are your goals, whether it be patients and docs using the technology, revenue? What are your goals for that category?

Roger Rose

Well I don’t think we’re going to give specific numbers for the year, but I will say that enthusiasm in two separate selling organizations is very high, and the spine group has been out in the marketplace and is very active right now. As we continue to put inventory on the shelf, they’ll continue to put it into hospitals, and our expectation is every month it’s going to grow and it’s going to be a big benefit to the company long term.

Jason Bedford – Raymond James

Thanks.

Operator

Thank you, sir. Our next question will come from Chris Cooley with Stephens. Please go ahead. Your line is open.

Chris Cooley – Stephens

Can you hear me now?

Operator

Yes, sir.

Chris Cooley – Stephens

Okay, super. Good morning all. Thanks for taking my questions. Maybe first for just Brian and Rob, can you help us a little bit with just—when we think about the growth throughout the course of the year, you’re launching 20 new products or product enhancements here in the first half. Does this alter how we think about the historical progression of revenue growth through the year, the split between first half-second half? Just trying to make sure I heard your comments right, so I think you may have mentioned that that was contributing more in this second half of the year. I just want to get some clarity on that and then I have a quick follow-up.

Robert Jordheim

Yeah Chris, this is Rob. That’s exactly right. What you’re going to see is a steady sequential increase in growth throughout the year on a normalized basis. Obviously the growth is going to be higher in the first half of the year because of the comparable issue, but once we start normalizing those comparables, the growth rate is going to be in that high single-digit area.

Chris Cooley – Stephens

Understood. And just from an execution standpoint, you’re now post-Pioneer. Maybe just a two-point question here – you mentioned back at the end of the third quarter the cross-distribution initiatives, both in sports and spine had gotten underway. How would you characterize that at this current state? Is it steady state now? Do we need a couple more quarters for that to hit stride? I’m just trying to get some level of an assessment of where you are in that integration. And then the follow-up that I had to that, and then I’ll get back in queue, is you did unfortunately lose some customers – obviously they were from Pioneer. When you think about the total base that you had at the time of the acquisition, how would you kind of characterize the—let’s call it the surgeon base that use those products now after you’d had a chance to rebuild some of the lost docs here post-that transaction? Thanks.

Brian Hutchison

Chris, we’re going to have Roger address those questions.

Roger Rose

I think in the spine space, we’ve got a solid base of business that we’re going to expand and grow by adding additional biologic solutions to those that are using metal. We’re also upgrading the talent, and we’ve got a number of distributors that are wanting to now carry our products. We’ve also gotten some surgeons back that had left us when they’ve seen that we’re true to our word and what we’re going to do from an education perspective in the marketplace, so we’re very bullish here in that we’re seeing month-over-month growth, as Brian alluded to earlier, and that’s going to continue on through the year.

We have just launched into our sports group, nanOss Bioactive, and they’re pretty fired up to get that into the foot and ankle and trauma marketplace direct through our own channel. Our expectations are there again that month-over-month, that will improve and it will grow. Both selling organizations have just been retrained in that product as well as in our stem cell product, so our expectation is that that cross-pollination, if you will, is going to be effective and it’s going to ramp, and as Rob and Brian alluded to, it’s going to take throughout the whole year for everybody to see the full results, but quarter-over-quarter, month-over-month it’s going to continue to grow.

Chris Cooley – Stephens

Understood, thanks.

Operator

Thank you, sir. And presenters, at this time I’m showing no additional phone questions in the queue. I’d like to turn the program back over to Brian Hutchison for any additional or closing remarks.

Brian Hutchison

Thank you all for joining us. We look forward to talking to you at the end of first quarter.

Operator

Thank you, sir. Again ladies and gentlemen, this does conclude today’s call. Thank you for your participation and have a wonderful day.

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