Earnings Labs

Orthofix Medical Inc. (OFIX)

Q4 2015 Earnings Call· Mon, Feb 29, 2016

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Transcript

Operator

Operator

Hello and welcome to the Orthofix Fourth Quarter 2015 Earnings Conference Call. Today's call is being recorded. I would now like to turn the call over to Mr. Mark Quick, Director of Business Development and Investor Relations. Please go ahead, sir.

Mark Quick

Management

Thanks, operator and good afternoon, everyone. I'd like to welcome you to the Orthofix fourth quarter 2015 earnings call. Joining me on the call today is our President and Chief Executive Officer, Brad Mason; Chief Financial Officer, Doug Rice; and Chief Strategy Officer, Mike Finegan. I will start with our Safe Harbor statements and then pass it over to Brad. During this call we will be making forward-looking statements that involve risks and uncertainties. All statements other than those of historical fact are forward-looking statements, including any earnings guidance we provide or any statements about our plans, beliefs, strategies, expectations, goals or objectives. Investors are cautioned not to place undue reliance on such forward-looking statements as there is no assurance that the matters contained in such statements will occur. The forward-looking statements we make on today's call are based on our beliefs and expectations as of today, February 29, 2016. We do not undertake any obligation to revise or update such forward-looking statements. Some factors that could cause actual results to be materially different from the forward-looking statements made by us on the call include the risks disclosed under the heading risk factors in our 2015 Form 10-K, as well as additional SEC filings we make in the future. If you need copies, please contact my office at Orthofix in Lewisville, Texas. In addition, note that on today's call we will refer to certain non-GAAP financial measures in which we exclude certain items from our U.S. GAAP financial results. We believe that in order to properly understand our short-term and long-term financial trends, investors may wish to review these matters as a supplement to financial performance measures determined in accordance with U.S. GAAP. Please refer to today's press release announcing our fourth quarter and full year 2015 results available on our website for reconciliation of these non-GAAP performance measures to our U.S. GAAP financial results. At this point, I'll now turn the call over to Brad.

Brad Mason

Chief Executive Officer

Thanks, Mark and good afternoon, everyone. I will start by giving you an update on our fourth quarter and full year 2015 performance after which Doug will walk you through the financial results that we reported today. I will then follow up with a few thoughts about our expectations for 2016 before opening it up for Q&A. Overall we exceeded our expectations in the fourth quarter with a very strong finish to a transformational year at Orthofix. Our Q4 results further validate our strategy, momentum and the strength of our businesses. Additionally, we believe there's significant opportunity to continue to improve our performance going forward which I will discuss in a few minutes. I will give a few financial highlights for the fourth quarter. Net sales grew 7.6% for the quarter on a constant currency basis. Excluding a benefit from a revenue recognition accounting change in Q3 of 2013, the fourth quarter was our highest quarterly year-over-year growth rate in the last six years. The BioStim Strategic Business Unit or SBU, in particular had another exceptional quarter growing net sales by 13.2% in constant currency over prior year. The Biologics SBU continued to show consistent topline growth with Q4 increasing net sales by 5.2% in constant currency. The Extremity Fixation business net sales declined by 2.2% in constant currency in the quarter but achieved a modest 1% growth for the full year in the phase of continuing international challenges particularly in Brazil. And not to be overshadowed by the other SBUs, despite fixation business achieved year-over-year growth in the fourth quarter of 11.9% in constant currency which highlighted a notable turnaround to this business in 2015 as we had expected and communicated at the beginning of the year. Adjusted EBITDA for the quarter was $19.3 million or 18.4% of net…

Doug Rice

Chief Financial Officer

Thanks, Brad and good afternoon, everyone. I'll start with providing details into our net sales and earnings results and then discuss some of our other financial measures. Total net sales in the quarter were $104.6 million, up 4.3% from the fourth quarter 2014 total net sales of $100.3 million. On a constant currency basis, net sales increased by 7.6%. Now, I'll talk about each strategic business unit in more detail. Starting with our BioStim SBU, 2015 fourth quarter net sales were $45 million, up 13.2% versus the same period in the prior year. The increase was primarily due to our sales force expansion and an increase in the number of spine procedures. I would also note that approximately $1.7 million of the growth was a result of one-time program that accelerated backlogged orders. Turning to our Biologics SBU, 2015 fourth quarter net sales were $16 million, an increase of 5.2% versus the same period in the prior year, primarily driven by our increased number of sales representatives and an increase in the number of spine procedures. Moving on to our Extremity Fixation SBU, 2015 fourth quarter net sales were $23.9 million, a decrease of 13.5% in comparison to the same period in the prior-year largely due to an unfavorable foreign currency impact of $3.1 million. On a constant currency basis, the SBU declined 2.2% due primarily to continued international challenges, including weakness in Brazil and the timing of cash collections. Since we recognize revenue from a large portion of our stocking distributors only on cash collections, we believe the constant currency trailing 12-month revenue growth gives our investors the best measure of the performance of this business. At the end of the fourth quarter, the trailing 12-month growth rate in constant currency was 1%. And lastly, our Spine Fixation SBUs…

Brad Mason

Chief Executive Officer

Thanks, Doug. With 2015 now in the books, this is a great time to reflect on the successful transformation of Orthofix over the last several years. In 2014 we created a vision to become a highly respected orthopedic and spine Company, that delivers exceptional value to our stakeholders. This vision is beginning to be realized and we are on the right path to fully realize our potential in the next few years, as we focus on business fundamentals including our key 2016 objectives. Our first objective for 2016 is to grow our sales in each of our businesses faster than the growth in our respective markets by expanding and optimizing our sales force while launching new and innovative products. Specifically, this year we expect to accelerate our new product cadence with 10 new product launches and 7 line extensions. The most important of these launches will be our next generation bone growth stimulation products at year end, a novel hip fracture system at Extremity Fixation, and in Spine Fixation, our FORZA PTC and PTC PILLAR line of proprietary interbody products, Firebird NXG, a significant upgrade and enhancement to our Pinnacle screw system, and Sentra, a new anterior cervical plate. Our second key objective is to expand margins through improved operating leverage and SG&A expense reductions. We expect to make good progress in 2016, and this will continue to be a focus area for us in the years ahead. And lastly, our third objective is to continue to invest in meaningful clinical research particularly for our regenerative technologies to ensure the long term success of the Company. In 2016 we will continue to work on a variety of clinical studies that are currently in progress both to support the existing products as well as to investigate new indications for the use…

Operator

Operator

[Operator Instructions] And we'll take our first question from Raj Denhoy with Jefferies.

Raj Denhoy

Analyst · Jefferies

Hi, good afternoon. Wonder if I could start a bit on the expenses in the quarter. Most of the leverage in the quarter came on the gross margin line, and your comments around 2016 suggest that you're still aggressively spending on sales and marketing R&D. So the question is when you think you can start to find more extensive leverage in those expense lines.

Brad Mason

Chief Executive Officer

Raj, it's Brad, how are you today?

Raj Denhoy

Analyst · Jefferies

Good, thanks.

Brad Mason

Chief Executive Officer

Good. So we do expect to make some progress in our G&A this year looking for 2% to 3% decline in G&A spending for the year and we may make a slight amount of progress in our sales and marketing but actually on the R&D side we’re actually going up a bit which is what we are trying to do last year we got a little behind in some of our studies and some of our enrollment. So, I’m a big believer in spending R&D for the future of our company. So you are going to see some in G&A this year we expect and sales and marketing roughly flat and maybe down slightly but that's generally how it’s going to flow out. The one thing that I would really speak to is the cadence of it for the year with our - I kind of think about our year in three pieces, our first quarter then our second and third quarter which are roughly equal and then our fourth quarter and our first quarter always drops quite a bit over Q4 and then we lose some - we lose a lot of absorption in that Q1. So, from a percentage basis it's going to be a little bit off from one quarter to next particularly in Q1 and then probably in Q4 will be other way a bit. So, but overall we should see a decline - marginal decline for the year in our operating expenses.

Raj Denhoy

Analyst · Jefferies

On one point, you noted that the U.S. sales force, I think you noted you increased it by 20% in 2015. That's a big number. And so I'm curious how you think about the cadence of adding additional salespeople, and at some point I imagine that investment starts to become a pretty good source of leverage, and when do you think that starts to kick in?

Brad Mason

Chief Executive Officer

That's a good question Raj. So I think about - I always think about things differentially between the different business unit. So, Brad Niemann as a President of our BioStim business got a little bit of a head start on expanding the sales force in 2014, a little bit before some of the other businesses as partly why you saw the increase in Q3 and Q4 for our BioStim business is it’s about a year for that - for new sales people who come on board to really contribute to the topline So you are seeing that in our BioStim business, you saw in Q3 and Q4 and then also now you will see a more of that in 2016 for both our biologics, as well as our Spine Fixation business. We have not added quite as many in the Extremity Fixation business yet, but it will roll out over a period of time. So you saw part of it in 2015, you will see more of it in 2016 and even beyond, because we will continue to expand our sales force, but yes we have got some opportunity coming up.

Raj Denhoy

Analyst · Jefferies

Okay. And just one last on product question. You did mention Extremity Fixation, you did note that you expected positive growth I guess in all the lines, so you are expecting a turn there. So couple of questions, it sounds like it is predominantly what you are seeing in international markets, but you have also launched TrueLok Hex in United States, which I think there was quite a bit of excitement about. So perhaps you could just give us a little bit in terms of what we should expect from Extremity overall as we look into 2016?

Brad Mason

Chief Executive Officer

Yes. I think -- if we'd be thinking in the low to mid-single digits for the year, we would be happy if we get into the mid-single digits. We think we have great opportunity with leveraging both our TrueLok Hex as well as our Galaxy product line outside the U.S., but we also have to confirm in Brazil and some other areas of the world. We think the U.S. will be a good market and a good business for us this year. I think Brazil is we feel it's probably is bottomed out, it's on its way back, but there is still some uncertainty in the business. So we are not as aggressive as we might otherwise be in our forecasting -- in our projections for the year.

Raj Denhoy

Analyst · Jefferies

Okay, I will leave at there. Thank you.

Operator

Operator

We will take our next question from Jim Sidoti with Sidoti & Company.

Jim Sidoti

Analyst · Sidoti & Company

Two questions. First, what was the legal settlement in the quarter that you took the charge for?

Brad Mason

Chief Executive Officer

The legal settlement had to do with going back to 2012 and the issue that we had in Mexico and we settled all that with the U.S. and then Mexico wanted to get their piece of the pie as well. We actually -- that's an interesting settlement, because if there were some cash involved, but it was also we had the opportunity to work directly with the government down there which was great experience for us. And we are going to be giving some of that settlement in product and training and we of course for accounting purposes, we book that at the fair value of it, but our cost of -- when we do that when we actually supply those materials and products will be less than that. So we have some opportunity to recover some of that. But more importantly, it really gives us a great relationship with the Mexican government where we can now deal directly and sell directly to IMSS there, which is great for compliance and it is great for us all around. And I think it's going to be a little bit of a model as to how other companies might work in Mexico. So we are very excited about that.

Jim Sidoti

Analyst · Sidoti & Company

All right. And then my second question, you gave an adjusted EPS number for 2016. Is the primary adjustment going to be the project Bluecore expenses or was there something else there in that $1.25 to $1.35?

Doug Rice

Chief Financial Officer

Jim, this is Doug. Now, the adjustments will be the same adjustments that we have used around share-based compensation, FX, any strategic investments that we've traditionally done. But there will be some Bluecore as I mentioned a few minutes ago, we expect some OpEx impacts that we will adjust for there. So those are the primary items.

Jim Sidoti

Analyst · Sidoti & Company

All right. And can you give me what you estimate the EPS impact of Bluecore and the share-based adjustments is?

Doug Rice

Chief Financial Officer

The OpEx impact of Bluecore will be less than a $1 million for the year. So the EPS impact based on roughly 18.7 million shares. I don't have math in front of me, but that will be around -- could be about $0.05.

Jim Sidoti

Analyst · Sidoti & Company

And how about for stock-based expense?

Doug Rice

Chief Financial Officer

Share-based compensation, we expect to be roughly the same as we had in 2015. So I'll leave at that -- we'd have to do a little math at that, Jim.

Jim Sidoti

Analyst · Sidoti & Company

All right, thank you.

Operator

Operator

We will take our next question from John Gillings with JMP Securities.

John Gillings

Analyst · JMP Securities

All right, great. I'm hopping back and forth between a couple calls so I apologize if anybody's asked about this already, but I just wanted to follow up quickly on the options you guys have on eNeura. We're about a year into the 18 month period that you have on that option. And just wanted to get a sense if you could give us some color on the topic of milestones that you guys will be watching for over the next six months to help decide if you want to pull the trigger on that. Thanks.

Mike Finegan

Analyst · JMP Securities

Hi John, Mike Finegan here. Thanks for the question. So with eNeura they continue to make very good progress on a number of different fronts. We continue to evaluate their progress. One, notice that they are behind in generating cash flows as they really concentrated on clinical and label expansion planning as opposed to commercial launch. They have launched commercially, but it's effectively been delayed. And so the cash flows are essentially delayed by a year compared to what our expectations had been. Given that it's probably on balance less likely that we exercise the option, but we have six more months effectively to go and we will continue to keep actually little bit more than six months. And we will continue to keep a careful eye on it as we go.

John Gillings

Analyst · JMP Securities

Okay, that is helpful. Thanks guys. Appreciate it.

Operator

Operator

[Operator Instructions] We'll take our next question from Imran Zafar with SunTrust.

Imran Zafar

Analyst · SunTrust

Hi, good afternoon everybody. Thanks for taking my questions. I had a couple of topline questions to start. First, on the Biologics business, you had another nice quarter there and I just wonder how much of that strength is coming from penetration of the spine market versus inroads in foot and ankle? I know you had some nice clinical data published recently. If you can qualitatively talk about where you're seeing that growth come from. Thanks.

Mike Finegan

Analyst · SunTrust

Mike - Imran, Mike Finegan here. I would say that we have growth in both parts of the business; however, the growth in spine is better. And even against the reported number that we gave from biologics within that of course we have non-Trinity biologics as well. And so if you look at the Trinity performance, the Trinity performance is even stronger than the collectively biologic to itself. If you look at that and focus on that it is almost 8% growth for the quarter. So we continue to see good results there and good uptake of the product and a lot of opportunities.

Imran Zafar

Analyst · SunTrust

Okay. And then on the BioStim business, obviously another good quarter there. Can you talk about what's been driving that growth in the last couple quarters in terms of competitive gains, better market? What's driving the uplift there? Thanks.

Brad Mason

Chief Executive Officer

Sure Imran. Yes, it's Brad again. Couple of things. So their growth percentage is little misleading. We are coming up, we have some little bit lower comps, but overall we are very, very happy with that business. And with -- we are getting some of the growth from just the expansion of spine procedures, we estimate that -- our estimate to be about 3% or so of those procedures. We get – we get a percentage of those procedures and so we're getting some growth from that. We also are benefiting from the addition of the sales force that we put in 2014. It really started to kick in 2015 in the second half of the year. So we will see some of that continuing going forward. We think overall, that business is still a low to mid-single digit growth business and we have had a couple of good quarters. We had one of the issues, one of the -- not issues -- one of the things that we did in Q4 that we talked about a few minutes ago was we had a backlog of orders that were being held by some of our sales force so we gave them an incentive to bring those in and reduce that backlog which we did. That has contributed about $1.7 million or so in the quarter which was about 4% of that 13.2% growth. So overall we are very, very pleased with the business. We are still doing things in the business to streamline the processes so we can move the claims through faster, we get a higher percentage of claims paid, those sorts of things. And we are really excited about in the fourth quarter, our limited market release of our whole new line of Physio-Stim, Cervical-Stim and Spine Stim products with some really, really good features. So we are very, very happy about that business and expected to do well this year.

Imran Zafar

Analyst · SunTrust

Okay. And then lastly, can you just remind us what your topline exposure is to Brazil and Puerto Rico and also what your assumptions are on the 2016 guidance vis-à-vis these two markets? Thanks.

Brad Mason

Chief Executive Officer

Sure, Brazil has declined over the last four years or so, four or five years. So the exposure is in - between $10 million to $15 million is our top line down there. Now we don’t give it specifically but I will give you kind of a range on it. And then for Puerto Rico we did approximately $5 million in revenue there last year and this year we got - we are not counting on any because of the financial situation in Puerto Rico that concerns us, so we are not guiding to anything budget for that so Puerto Rico this year. That’s all upside we do expect to get some, but we don’t know how to quantified is just we’re going to take a little more prudent approach with that. So that’s all upside for us in the numbers – in the guidance that we have been given you so far.

Imran Safar

Analyst · SunTrust

Excellent, that's it from me. Thanks very much.

Operator

Operator

At this time it appears there are no further questions in the queue. Mr. Mason, I’d like to turn the conference back to you for any additional or closing remarks.

Brad Mason

Chief Executive Officer

Thank you, Operator and thanks for everybody joining us on the call today. I look forward to updating you on the progress as we go through the year. We’re excited about the year and hopefully I will see some of you down in Orlando later this week. Take care and have a great rest of your day.

Operator

Operator

That concludes today's presentation. Thank you for your participation.