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Haemonetics Corporation (HAE)

Q1 2018 Earnings Call· Mon, Aug 7, 2017

$59.96

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Q1 2018 Haemonetics Corporation 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. As a reminder, this conference is being recorded. I would like to introduce your host for today's conference, Mr. Gerry Gould, Vice President of Investor Relations. Sir?

Gerry Gould - Haemonetics Corp.

Management

Thank you, Vince. Good morning. Thank you for joining us for Haemonetics first quarter fiscal 2018 conference call and webcast. I'm joined today by Chris Simon, President and CEO; and Bill Burke, CFO. Please note that our remarks today will include forward-looking statements. Our actual results may differ materially from anticipated results. Additional information concerning factors that could cause results to differ materially is available in the Form 8-K we filed today and in our latest Form 10-K filing. This morning we posted our first quarter fiscal 2018 earnings release to our Investor Relations website. We also posted two tables with information that we will refer to on this call. Today, Chris and Bill will discuss our strategy and business performance, trends in our commercial markets and elements of financial performance, then we'll take your questions. Before I turn the call over to Chris, I would like to mention the treatment in our adjusted results of certain items, which, by their nature and size, affect the comparability of our financial results. Consistent with our past practice, we've excluded certain costs and charges from the adjusted financial results, which we'll talk about today. In the first quarters of fiscal 2018 and fiscal 2017, we excluded restructuring and turnaround charges from adjusted earnings as well as deal-related amortization expense. Also, in fiscal 2018, we excluded the gain we realized upon sale of our SEBRA line of benchtop and hand sealers. Finally, we excluded the tax effects of excluded items. Further details of first quarter fiscal 2018 excluded amounts, including comparisons with the same period of fiscal 2017, are provided in our Form 8-K and have been posted to our Investor Relations website. Our press release and website also include a complete P&L and balance sheet and a summary statement of cash flows as well as reconciliations of our reported and adjusted results. With that, I will turn the call over to Chris.

Christopher Simon - Haemonetics Corp.

Management

Thank you, Gerry, and good morning, all. At our Investor Day on June 19, we introduced our new management team, provided a comprehensive overview of our strategy and set expectations for growth in fiscal 2019 and beyond. So, this morning, our comments will focus on the first quarter's results and major milestone attainments. We'll leave ample time for your questions. Our first quarter results met our expectations and were consistent with what we anticipated at the outset of fiscal 2018. First quarter fiscal 2018 revenue was $211 million, up 0.5% as reported and up 1% in constant currency. We had 4% Plasma revenue growth, 7% overall growth in our Hospital revenues and our Blood Center business substantially stabilized, declining 7%. On an adjusted basis, we earned $17.5 million or $0.33 per share, 32% above the first quarter a year ago as we are benefiting from our ongoing cost-savings initiatives. We generated $29 million of adjusted free cash flow further demonstrating the ongoing strong cash generating capability of our business and providing flexibility for the investments we are making. As announced last week, our PCS 300, plasmapheresis device, now branded NexSys PCS, received the U.S. FDA regulatory clearance on July 25. We are pleased with this very positive release and we are encouraged by this major milestone achievement in the context of our broader plans for the new product platform. This clearance is fully consistent with our anticipated timelines and allows us to move forward as planned and communicated previously. Our development strategy purposefully separated the FDA submission for the NexSys PCS device from the other components of our new collection system. The system consists of the device and its embedded firmware. NexLynk DMS, our next-generation proprietary donor management software, our disposables and our technical service support. As discussed at our…

William P. Burke - Haemonetics Corp.

Management

Thank you, Chris, and good morning, everyone. Please refer to the two tables we posted to our website with the link in our earnings release. We provided specific revenue and income dollar amounts that derive the percentages I will refer to in my comments. In the first quarter, strong result in Plasma continued. Plasma revenue was up 4% in constant currency, including a 1% negative impact from the disposition of the SEBRA product line. North America Plasma disposables revenue was up 6% in the first quarter of fiscal 2018. Growth continue to be driven by strong end-market demand for Plasma-derived biopharmaceuticals, and we remain highly confident in the continued market growth underlying our commercial Plasma Collection business. We had 7% constant currency growth in our Hospital business on the strength of Hemostasis Management, which remained on our projected growth trajectory. TEG revenue was up 17% in constant currency in the first quarter, accelerating over its fiscal 2017 full-year constant currency growth rate of 14%. The TEG 6s product offering once again accounted for the majority of Hemostasis Management growth in the first quarter of fiscal 2018. The U.S., Europe and China contributed to accelerating growth. Also, within our Hospital business, cell salvage and transfusion management revenue grew 2% in constant currency over the prior year first quarter as OrthoPAT and Cell Saver decline were more than offset by improving growth in BloodTrack and other hospital software products. Blood Center revenue was down 7% in constant currency, a considerably moderated rate from the decline of 14% in fiscal 2017. Platelet disposables revenue decreased 3% in constant currency. This muted decline is considered an anomaly and entirely attributable to customer order timing in Japan, which made the first quarter of fiscal 2017 unusually low on a comparable basis. Approximately 28% of collections,…

Operator

Operator

Thank you. Our first question is from Brian Weinstein of William Blair. Your line is open. Brian D. Weinstein - William Blair & Co. LLC: Hey, guys. Good morning. Thanks for taking the question. Chris, I was hoping you can give us a little bit more detail on the rollout of NexSys. How should we think about it in terms of modeling? How are you guys thinking about it in terms of what's embedded in your guidance on both the top line as well as some of the spending that's going to be required?

Christopher Simon - Haemonetics Corp.

Management

Yeah. Look, Brian, I appreciate the question. We spent a good bit of time going through this during our Investor Day. And I would direct you to the materials that are posted on the website there for the details. We're delighted to have received a timely and overwhelmingly positive release from FDA for the NexSys PCS device. That's really the platform that we're operating off of, and we're rapidly ramping production. We have the initial wave of products on hand to begin our customer experience programs. That'll start in earnest now. We'll progress from those experienced programs to limited and then later full market release, all of which has been laid out. So, we're in full ramp mode. I think the approval substantially derisked the timeline as we communicated it previously and we'll build accordingly. Brian D. Weinstein - William Blair & Co. LLC: Okay. And then on the Plasma market, you guys reported 4% FX and North American disposables I think you said were up 6%. That's a little bit lower than what we would have thought given some of the results we heard from some of the competitors and what we're hearing in the marketplace. Can you just talk about what that end market looks like now? And with respect to your result, were you guys a little bit lighter than your internal projections or were you in line there? Just any commentary there. Thanks.

William P. Burke - Haemonetics Corp.

Management

And so – it's Bill. On the Plasma results, just remember the impact of the SEBRA divesture. So, Plasma, yes, it was 4.3% and we had a 1.2% impact from the SEBRA divestiture, so we're upwards of 5.5% in the Plasma business, which was in line with our original guidance. But as far as the end market goes, we haven't seen any changes from what we've had communicated earlier at Investor Day and even before that, so the market still remained strong and the Plasma business is doing very well. Brian D. Weinstein - William Blair & Co. LLC: Okay. Thank you.

Operator

Operator

Thank you. Your next question is from Anthony Petrone of Jefferies. Your line is open.

Anthony Petrone - Jefferies LLC

Analyst

Thanks and good morning. And maybe just a housekeeping on selling days impact in the quarter. I know, last quarter, in fiscal 4Q, there was a headwind. I'm not sure if there was a tailwind this quarter, so any help there is appreciated. And then in terms of NexSys, I know at Analyst Day there were some analytics that were thrown out there from sort of beta testing, early testing of some units down the field. Can you give us an update on just some of those initiatives? When do you expect to have maybe some in-center data from other beta test initiatives? Thanks.

William P. Burke - Haemonetics Corp.

Management

Hi Anthony, it's Bill. I'll answer the days question. The selling days in our Q1 were comparable to prior year, so there's not a comparison issue for us prior year. If you are looking versus Q4, it's comparable against our Q4 for FY 2017, although, as you remember, Q4 FY 2017 versus prior year had the comparison problem with the extra week. But this year there's no issues on selling days year-over-year.

Anthony Petrone - Jefferies LLC

Analyst

Okay. Great.

Christopher Simon - Haemonetics Corp.

Management

Anthony, it's Chris. In terms of NexSys, at the core of our system offering, I'd just go back to some of the material we presented. We are working on with customers in these customer experience programs and will be part of our limited market release, is really to quantify the benefit associated with those four broad pillars. It's the improved quality and compliance. This is minimizing risk of operator errors, avoiding over and under draws, which are costly and inconvenient and just giving them a documented paper trail for compliance purposes. We'll drive center-wide productivity in terms of the connectivity and a much more simple guided operation, and our support needs to be business optimization. We will continue to push the frontier on yield attainments, which is something that I think we're quite excited about. And overall, between the combination of the hardware and the software, a better donor experience, minimize wait times and donor inconvenience and a bunch of things that help improve the quality of the staff/donor interaction that we think will have real benefits to our customers. As we define those and quantify those with customers, we'll be more transparent. But I want to be clear, we're not going to be – we're not going to disadvantage ourselves competitively or in the price negotiations to come.

Anthony Petrone - Jefferies LLC

Analyst

Right. And then just last one from me would be how many customers at this point are going through this testing phase? Thanks again.

Christopher Simon - Haemonetics Corp.

Management

Yeah. Thanks, Anthony. We haven't finalized the exact number that we're going to put through the process. It will be multiple. I think early on I probably made the comment that I thought this was one where no one would want to go first, but everybody wants to go second. I guess, thankfully, I've been proven wrong because we now have a good base of our existing customers who are saying we'd like to be in the initial wave to this. We're trying to find ways to accommodate as many of those touch points as possible. The staged rollout gives us the benefit of learning how to implement. We're confident in the system but how to implement the system in the hands of our customers, and I think a broader touch point there is beneficial to our customers.

Anthony Petrone - Jefferies LLC

Analyst

Thanks.

Operator

Operator

Thanks. Your next question is from John Hsu of Raymond James. Your line is open. John Hsu - Raymond James & Associates, Inc.: Good morning. Thanks for taking the questions. Maybe if we could start on Hemostasis Management, it looks like the revenues came in a little bit less than we thought (23:14). Could you give us any color on that and specifically any updates on timing for the U.S. trial indication?

William P. Burke - Haemonetics Corp.

Management

Yeah. John, as far as the results, Hemostasis Management was 17% better than the prior year. That met our expectations internally. I can't comment on the numbers that you had in your model. But we see the continued strength in the business, the growth rates are improving even versus last year. And based on the guidance we've issued, we expect the business to at least deliver what it delivered in the first quarter and hopefully higher in the next three quarters.

Christopher Simon - Haemonetics Corp.

Management

Yeah. John Hsu - Raymond James & Associates, Inc.: Okay. Great. And then – I'm sorry. And then on Plasma, I just want to be clear. I think, in the release, when you got the FDA clearance, congratulations on that by the way, that you talked about some additional enhancements. And specifically, one of the things that you were talking about at the Analyst Day was kind of a yield enhancement. And I just wanted to be clear, is that already cleared as part of the NexSys approval or is that one of the additional pieces that you might need further clearances for?

Christopher Simon - Haemonetics Corp.

Management

Yeah. Thanks, John. It's Chris. The way I think about this, we're doing something that's less common I guess in the industry in terms of disrupting ourselves with a new platform and it's no small feat. I think you'd get a handful of these over the course of a career and we're quite excited about it. But I think the other thing we intend to do in parallel is the incremental but nonetheless meaningful innovation that is kind of the dot 1, dot 2, dot 3 on a new platform. So, we're running that in parallel. We've already introduced yield enhancing benefits into the marketplace on our existing PCS 2 platform with the new device, the NexSys, we have the potential to take that, that much further. It will involve changes to the embedded firmware, which is something we're in dialog with FDA about. We also think there's meaningful advances that we can bring forward in our NexLynk donor management software, which is a proprietary software. The actual firmware and the device itself is open architecture or work with anything. But when you work with our NexLynk, it's that much more powerful. I think the combination of those items is what's really going to drive all four areas of benefit yield included. John Hsu - Raymond James & Associates, Inc.: Okay. Great. And then last one from me, R&D spending was down nearly $3 million year-over-year. So, how do we think about the appropriate run rate and some of the factors that kind of drove it down? Do you expect to be kind of closer to 4% of sales? I know you're a little bit higher in (26:01), so maybe you could just speak to that?

William P. Burke - Haemonetics Corp.

Management

Yeah. So, I'll speak to the quarter results. So, on a GAAP basis, we were down $3 million. $1.5 million of that reduction was because of restructuring activities related to our advanced engineering group from the prior year. The other $1.5 million is strictly, and Chris actually mentioned it in his opening comments, the review of the product portfolio within R&D. And as we make our way through all the projects in R&D, obviously, the Blood Center isn't one of our focus areas and that's the reduction in our Q1. Just not spending on these low-profit projects related to Blood Center. And as far as, going forward, John, I think that the – I mean, obviously, we don't guide to R&D line in particular. But, for the year, we will be lowering R&D versus FY 2017. John Hsu - Raymond James & Associates, Inc.: Okay. Thank you.

Operator

Operator

Thank you. Our next question is from David Lewis with Morgan Stanley. Your line is open. David Ryan Lewis - Morgan Stanley & Co. LLC: Good morning. I just have one for Chris and then a couple of follow-ups for Bill. But Chris, I want to understand the regulatory strategy on PCS 300 a little better. Are you going to pursue specific claims for specific enhancements? Can you get those claims through a traditional 510(k) process? And do those claims matter prior to having pricing conversations with your customers?

Christopher Simon - Haemonetics Corp.

Management

Yeah. So, they do but they probably matter less than the actual experience that customers have and what they believe is the true value associated with our system. So, obviously, NexSys PCS, the PCS 300 device, is the big substantial review. We purposely follow the strategy where we submitted that device with software that was deemed by the FDA to be substantially equivalent to the software that we use in our PCS 2 devices. That expedited the review and allow for a very favorable and very timely outcome. Many of the enhancements to the embedded firmware are as simple as letter to file. There will be those that are incrementally more meaningful and/or change the nature of the donor experience, and we'll obviously pursue a 510(k) release for those. But where we sit today, we feel that this has been substantially derisked and reaffirms our confidence around the timeline that we've laid out previously including at our Investor Day. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay. So, no PMA level claims for the product and you don't think you need to have these claims prior to having pricing conversations with customers?

Christopher Simon - Haemonetics Corp.

Management

There are absolutely no PMA submissions involved in this. Additional 510(k) will be very targeted and the customer discussions around the benefit have already begun in earnest as you can imagine. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay, very helpful. And then Bill, just two quick financial questions for me. One, gross margins were a little below our expectations. Maybe you can talk about the impact of Plasma mix and/or currency. And then on CapEx, I'm still not entirely clear. CapEx is pretty in line, free cash flow much better yet you're not changing expectations for CapEx for the remainder the year. So, I'm just trying to kind of understand the free cash flow guidance for the remainder of the year in light of the stronger start to the beginning of the year and your guidance not really being changed. Thanks so much.

William P. Burke - Haemonetics Corp.

Management

All right. So, David, let me address the capital first. So, cash flow, in general, was really strong in the quarter. It's obvious. We determined that we did not want to raise our $35 million to $55 million guidance as the bulk of the investments that we had spoken about, the build of the PCS 300 in particular and other investments that are P&L related will be backend loaded this year. As we move through the year, if we see that some of that timing of spending is slipping, then we will raise guidance accordingly. But it was a very, very strong quarter. It was in line with our expectations and, again, it comes down to this last nine months and particularly the last six months of capacity expansion, and also the PCS 300 on NexSys PCS build.

Christopher Simon - Haemonetics Corp.

Management

Okay?

William P. Burke - Haemonetics Corp.

Management

You okay with that one? David Ryan Lewis - Morgan Stanley & Co. LLC: Perfect.

William P. Burke - Haemonetics Corp.

Management

All right. And then on gross margin, we did have a benefit. I think everyone is expecting the benefit from the $3 million recall charge that we took in the prior year. And without that repeating, you would have expected an uptick in gross margin. There's really three things impacting margins this quarter. One was we had some unfavorable FX in the quarter. Two, we had a lot of benefit from our manufacturing sites last year, and that benefit just slowed a little bit in Q1. And again, there's no problems there, it's just some timing issues. And then third, we're working through some delays in the expansion of production capacity regarding liquid solutions. And we incurred some incremental costs related to those delays in the capacity expansion. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay. And Bill, (31:35) in line, can you just give us an update for currency assumptions for the year that may be helpful?

William P. Burke - Haemonetics Corp.

Management

Our currency assumptions are based on the most current exchange rate as of a couple of weeks ago. It's like June 28 or something like that. So, we don't – our major currencies that impact us are the yen, the yuan and the euro. And we – first, what we had guided originally, we don't see large changes in foreign currency that would require us to adjust guidance in any manner. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay. Thanks so much.

William P. Burke - Haemonetics Corp.

Management

Okay. You're welcome.

Operator

Operator

Thank you. Your next question is from Jim Sidoti of Sidoti & Company. Your line is open. James P. Sidoti - Sidoti & Company: Good morning. Can you hear me?

Christopher Simon - Haemonetics Corp.

Management

Yes, Jim. James P. Sidoti - Sidoti & Company: Great. On SG&A, that expense was also a bit lower than I expected in the quarter. Is that something you think kicks up as you get further along in the year with the product launch?

William P. Burke - Haemonetics Corp.

Management

So, on SG&A, we had originally, at Investor Day, been pretty clear about what the productivity for this year was going to be. We had $0.30 to $0.40 of productivity, some of that being new initiatives in FY 2018. Other part of the savings is the carryover from last year, and that particularly would influence the Q1 results. I made that clear in my opening comments. It was a good quarter for savings. Do we anticipate more savings going forward? The answer is yes. We're still within that $0.30 to $0.40 range and it's a big savings number that we absolutely think that we can hit for the year. James P. Sidoti - Sidoti & Company: All right. Thank you.

William P. Burke - Haemonetics Corp.

Management

You're welcome.

Operator

Operator

Thank you. I see no other questions in queue. I'll turn it to Mr. Simon for closing remarks.

Christopher Simon - Haemonetics Corp.

Management

Thank you. So, in closing, I want to thank our customers and our shareholders for their continued trust in us and our business partners and our employees for their continued dedication. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone, have a great day.