Haemonetics Corporation (HAE) Earnings Call Transcript & Summary

September 15, 2020

New York Stock Exchange US Health Care Health Care Equipment and Supplies conference_presentation 30 min

Earnings Call Speaker Segments

David Lewis

analyst
#1

Well, good morning, everyone, and welcome to day 2 of the Morgan Stanley Healthcare Conference 2020. My name is David Lewis, medical device analyst at Morgan Stanley. It's my pleasure to start off this morning with Haemonetics. As many of you know, Haemonetics, under the leadership of Chris Simon in these last few years, has really gone through a significant transformation from both a growth technology and cost perspective. We're going to talk about some of that this morning. And then there's been some recent debates on Haemonetics we're also going to focus on as well. Before we begin, as I've said time and time again, please go to the Morgan Stanley website under Research Disclosures, morganstaley.com/researchdisclosures to see all of my disclosures. And with that, we're going to get right into it with Chris this morning.

David Lewis

analyst
#2

So Chris, I want to start sort of with the key debate of the hour. We've talked about COVID-19 recovery across all of our corporates so far in day 1. Your business is a little different admittedly, but I want to give you the opportunity as we talk about the dynamics of COVID recovery. You said plasma volumes were down 25% or 30%. A lot of companies saw recovery. It wasn't clear based on your last quarter, whether or not the company had seen recovery. Can you maybe talk to us about what you're seeing in the channel? We heard from Grifols yesterday. They are talking more about recovery suggesting that maybe collections are down more like 10% now versus a trough that could be 25% to 30%. So broad open-ended questions. So far COVID-19 recovery, what have you seen here in the intermediate term these last few months?

Christopher Simon

executive
#3

David, thanks for the time today. Delighted to be here talking with you and your investor base. Brief disclaimer upfront. Please be aware, as I know you are, that statements made today may be considered forward-looking. And refer to SEC filings that discuss risks and uncertainties that could cause results to differ from those that are projected here today. But so as it pertains to plasma collection, as you point out, it differs meaningfully from many other medical device segments, including our own hospital business. Volumes are not tied to hospital access or procedures. And for our own hospital business, it hit its trough back in April and then began a meaningful recovery through May and June, consistent with what you see in other med tech segments. So conversely, plasma collection stayed low because of the dynamics impacting collection center and donors. And there's a lot of noise in daily, weekly and even monthly collection trend data. So we don't think it's necessarily predictive in this current environment. And instead, we strive to look at structural, attitudinal and meaningful customer factors to forecast the recovery. And if I might, let me just touch upon a few of those. Structurally, donor traffic, particularly along the Mexico border, remains limited. And newly opened centers across the country continue to struggle to build donor loyalty in this environment. Many, but certainly not all, college students have returned to campus. And public transportation in most cities is running, albeit with reduced service and significantly reduced ridership. All the centers have now adapted to social distancing. And it's not currently a rate-limiting factor, although we clearly watch that going forward. I think in parallel is the attitudinal issues. And don't want to lose sight of the reality that COVID-19 hit our donor population communities disproportionately hard, heightening concerns about safety and risk. Concurrently, right, we -- many would-be donors received federal stimulus. And now COVID case counts appear to be falling in the hardest-hit areas, federal stimulus checks and unemployment benefits are hung up in Congress. So the donor attitudes appear to be shifting and we're watching that closely. I think the third dynamic is with our customers. Fractionators now have an opportunity to better understand the root drivers and take targeted action to encourage donors to return to their collection centers. What's really important through all of this is the end market demand for plasma-based pharmaceuticals has not changed due to the pandemic, in fact, if anything, it's increased. And our customers are acutely aware of this. They've stated repeatedly that they do not intend to incur drug shortages. So we fully expect collection volumes will rebound and go, in fact, beyond pre-pandemic levels. They must enable -- in order to enable our customers to rebuild their inventories and build back and replenish their safety stocks. So the big question is timing and extent. And that has everything to do with the confluence of these factors. And we're watching carefully and doing our part to help where we can. We'll be prepared to talk more explicitly about results in the second quarter earnings call.

David Lewis

analyst
#4

Okay. But there's no reason to believe, Chris. If Grifols is seeing some improvement in collection volumes, at some point, you have to be a derivative to that. So if they're seeing an improvement, it seems to be -- it's rational that you have seen some type of month-over-month improvement.

Christopher Simon

executive
#5

Yes. Again, we don't talk about individual customers, there are always puts and takes. As I said, it's a major factor. Our customer response to this. There are clearly regional and local differences that play out in terms of COVID hotspots previously, for example, but the interplay of structure and the donor attitude and the plasma fractionator response, we look at as cautiously optimistic that volumes will build as we appropriately address COVID factors.

David Lewis

analyst
#6

Have you seen -- not speaking on specific customers, but fractionators in general, you have seen them take action either an either -- it could be promotional activity, it could be donor fee activity, but you have seen a proactive response from fractionators to get collections up. Has that begun?

Christopher Simon

executive
#7

Yes, absolutely. Our customers are taking a variety of actions. I won't comment on the specifics, but what we are seeing is they've reconfigured, they've instituted new safety protocols. I feel quite confident in the assertion that these collection centers present a very safe environment for our donors. And we now see the companies coming forward with meaningful advertising campaigns, et cetera. We developed something called the Donor 360 app, which we've made available regardless to the entire industry, which will help safely facilitate donor track through the centers, it allows the donor to go online remote and complete their medical survey and then they can work on queuing capability that allows them to wait outside the center at a safe distance for their appointed time. So I think there's a bunch of good things going on that really will lay the foundation for the eventual success here.

David Lewis

analyst
#8

Okay. And you said look, near-term maybe environment is recovering, but it still remains sort of choppy by region. But one of your companies or one of your fractionator customers has said is we think collection volumes could be up 30% next year if you just do some comp-adjusted math, it sort of implies that they expect to get back to that underlying 8% to 10% like plasma growth in a year. And that sort -- it supported what you're saying is that short term will evolve, although we have every confidence the business gets back to normal in the intermediate term. Just kind of confirm me, is a year from now, in your mind, a fair estimate to when this business can get back to that trend we'd expected, which is 8% to 10%?

Christopher Simon

executive
#9

Again, we feel very confident in 8% to 10% as a long-term forecast for IG demand in the market and our ability to deliver against that. I think there's a series of good things going on. It really comes back to the progress against the COVID and the pandemic. We're not going to guide for '22. We haven't provided guidance for '21 and given the confidence factors here. But I will say that the back-of-the-envelope math is not wrong in order to return to high single or low double-digit growth, you would need to see about 30% improvement off of what we put forth in the first quarter. So in that regard, it's directionally correct for sure.

David Lewis

analyst
#10

Okay. Do you think it's too soon this [ quarter, Chris, for M&As ] to guide for the year? Is that likely to be too soon? Or is it a possibility?

Christopher Simon

executive
#11

We're going to watch the trends carefully. I do get nervous about the vagaries. When you think about these attitudinal factors, August was really the first month where we had no additional stimulus in the market and that cleared the way for our customers to respond more directly to donor attitudes. And I think we're watching and waiting. And as we see that play out, there's a set of externalities that could factor in here. But from our vantage point, it feels like there's been meaningful progress. And we'll continue to observe and see how it plays out. But it's too early to call. Again, we strongly desire to be transparent and will be wherever we can. I don't want to try to be certain about things that are inherently uncertain.

David Lewis

analyst
#12

Yes. Look, the stimulus is sort of resolving a little bit. It sounds like that's had an impact in August, fractionators are taking efforts as well. You talked about this fear factor, Chris? We've heard this due diligence as well on the specific donor population and the fear of COVID. Does that mean that the vaccine, in your mind, is a very important catalyst for your business? Or do you think you could have improvement regardless to the vaccine?

Christopher Simon

executive
#13

I think we need broad-based control and to date, there are a lot -- more folks more knowledgeable than this -- than I, but the epidemiology of COVID-19 would suggest the vaccine is a major part of getting this under control in a lasting fashion. So yes, that's a -- that is the most powerful lever. Can we do other things? Do we see other things in other markets? Absolutely. For example, and some of our customers have talked explicitly about this in some of our European markets, where the outbreaks have been well controlled for a longer period of time. We do see meaningful improvement in foot traffic back into the centers.

David Lewis

analyst
#14

Yes. Okay. So one of the things this has raised is the NexSys technology platform like a lot of clients call me and they say, look, they have a technology that increases utilization, increases plasma per patient if fractionators having trouble getting plasma, why isn't NexSys now sort of front center? So in your minds, I'm kind of curious, why do you think centers or fractionators have not adopted, certain customers have not adopted NexSys that the value proposition is so clear? And how do you think those dynamics change in line of COVID?

Christopher Simon

executive
#15

Again, look, it's multifactorial. We're in negotiations with all of the customers who have not yet adopted. And I think with greater than 11 million YES collections now yielding in excess of 250,000 incremental leaders of plasma, we're more confident than ever in the 4 pillars of the NexSys value platform, right, yield, cycle time, e-compliance and donor sat continue to be our hallmark. And I think to your point, the pandemic has exacerbated the importance of these, certainly, safety and reliability concerns as inventories windle is an important factor. And so we've taken extra steps to demonstrate both the value prop and our ability to safely and reliably convert centers to NexSys. So the discussion is ongoing and we feel good about the value proposition and the message that that's delivering.

David Lewis

analyst
#16

Would you agree with the statement that given the dynamics that are going on inside fractionators adopting NexSys today in immediate term, 1 to 3 months, that's more challenging but over the -- sorry, that's the near term, over the intermediate term, let's say, 6 to 18 months, the value proposition has gone up, so it's hard to adopt NexSys today, but in 6 to 12 months, the rationale for NexSys has gone up fairly dramatically because of COVID?

Christopher Simon

executive
#17

I think it's probably more true at the outset of the pandemic. I think folks were understandably concerned. You didn't want to, in any way, compromise the safety of the center and then I think as collection volumes diminished, the reliability and the importance of not missing a beat for the donors that we're turning up, became critical, I think we're beyond that. I think we have demonstrated in the midst of the pandemic our ability to safely convert centers and I feel like we asked an answer to that question with demonstrated results in our conversion activity.

David Lewis

analyst
#18

Interesting. So the safety issue is answered. They were just out to the dynamic of getting more plasma, which would certainly argue for NexSys conversion, at least in my mind?

Christopher Simon

executive
#19

Particularly given the yield enhancement and the cycle time, perhaps the most valuable will ultimately be the donor satisfaction, donors like the NexSys platform. It's a more donor and user friendly environment.

David Lewis

analyst
#20

Okay. So we all know about the YES technology and sort of the FDA labeling, we've seen some recent data from studies on PPN, right? So it's a different way of sort of calculating these nomograms. How much of a game-changer, Chris, in your mind is sort PPN relative to the YES technology?

Christopher Simon

executive
#21

So we're really excited about PPN. We think it's, first and foremost, a testament to our team's growing data and analytic capabilities. Brief definition, PPN was essentially a calculation that uses body mass and hematocrit in combination to enable a more tailored collection target for each individual donor, it's very different than the current industry-wide nomogram, which was established back in the early '90s, which is based solely on donor's weight. So you're referring to, David, is the IMPACT study, which we announced back in early August. It's a multicenter perspective, double-blinded randomized controlled trial, 3,400 donors, over 23,000 donations and we compared our NexSys PCS with YES technology to NexSys PCS with PPN enablement on top of it and talked about the results. But we're very excited by it. And I think it's a meaningful advance forward for us and the industry at large.

David Lewis

analyst
#22

Sure. So we -- the whole nature of our operator to the stock tiers you gave us tied to some of the YES technology and the value of NexSys. And we thought you could extract some of that value in terms of enhanced pricing. If I think about the potential opportunity of PPN versus YES, it's obviously increased value to the customer, how do you think about the pricing algorithm for customers in line with PPN data and pending approval?

Christopher Simon

executive
#23

Yes. Our work to date has been focused on the clinical trial and preparing for a successful regulatory submission, which has really been our focus, right? We've put the press release out there to be transparent where we could. It is very early days in our customer discussion. What I would say is they are genuinely excited to learn about safely increasing plasma yields. And again, YES was roughly a 3% improvement. PPN will be 8% additional on top of that or better as we continue to advance the individual nomogram characteristics. So our customers are keen to understand that. And that's where we're really focused. We're not in a position to talk about pricing at this point.

David Lewis

analyst
#24

Okay. But it seems likely that you would you try to get some value for enhanced technology. That was always the platform NexSys, as you said, multiple software iterations over time, the software feed business model that you adopted with NexSys allows you to offer new solutions at new pricing?

Christopher Simon

executive
#25

Yes. We are very committed to innovating the NexSys platform. As you've heard me go on about in the past because it's kind of our favorite child here. But we want to continue to advance the device itself. It's a completely new offering, 90% new components. The embedded software is where our YES and PPN capabilities are embedded along with a series of monitors and controls. So it's exciting stuff. And we think there's more room to go with that. Clearly, our DMS, donor management software, is a proprietary offering. It's -- none of the other competitors in the space have proprietary software. So it's a meaningful differentiator for us and I think in many ways is the tie that binds. We are advancing against our disposable kit, which is essentially the same kit that's been out there in the market for several decades. It's great, it's reliable, it's trusted. We have technology. We have data analytic insights from running those 11-plus million collections with NexSys. We know we can make our software better -- or make our disposable sets better, faster, more reliable, capable of further enhancing yield, all of which we're committed to. And then I think we're increasingly wading into this space, which is one part software as a service; one part data and analytics; one part tech support where we increasingly are able to help our customers optimize their center performance and the donor experience within them.

David Lewis

analyst
#26

Okay. And investors have asked me, what does this mean for fractionators that haven't yet converted? And it's either 1 or 2 things. It's either PPN, that's an existing technology that makes it more likely fractionators convert gets [indiscernible] and they do convert. The question is, are you more focused in using PPN as a strategy to get them to convert or a strategy of getting them to convert at frankly higher pricing is really the question?

Christopher Simon

executive
#27

Yes. Again, I don't want to talk about price. We think it's a meaningful advancement. The existing nomogram's in place and has served the industry exceptionally well. It is safe and it works. We think PPN is an opportunity to take that nomogram to the next level, using our proprietary technology to advance and incorporate the data and analytics to make that individual donor contribution that much greater. We think it's the right way to do it and we intend to roll that out across the board. So we're excited. We think it clearly strengthens the NexSys value proposition and our offering more broadly. So next step is FDA release and we'll go from there.

David Lewis

analyst
#28

And when are you expecting FDA approval? My sense would be, certainly before the end of the year, probably it could be 3 months away. What are you thinking about timing?

Christopher Simon

executive
#29

So we're following the standard 510(k) process and we submit it back earlier in the summer. So broad strokes, we're looking at fall.

David Lewis

analyst
#30

Okay. Great. Makes perfect sense. So look, we kind of talked about 2 pieces already and my sense is we're getting some COVID-19 collection recovery. The NexSys value proposition has probably moved higher so what is holding investors back from sort of buying the stock? And that's probably -- some of these factors we talked about, but also this pharmaceutical risk has been a new -- well, kind of new debate, Chris. We've been talking about it for a couple of years, but people are very focused on risk to plasma demand over a 3- to 5-year period of time. Maybe just share with us your perspective when thinking about companies like argenx and their data, Momenta and the recent J&J acquisition, how are you feeling about 3- to 5-year plasma demand?

Christopher Simon

executive
#31

Yes. So I think we are fully aware of potential new treatment alternatives targeting the autoimmune segment. And we are monitoring those developments closely. None of this was a surprise to us, and it's important that you're going to continue to see meaningful innovation and efforts, biopharmaceutical and otherwise, underway here in the space to treat these patients as appropriate. So we're monitoring it. We're paying close attention to it. We feel quite confident all things considered that, that 8% to 10% long-term growth rate is fully sustainable. And that's predicated upon our belief that the underlying demand for IG for plasma-based therapies will remain roughly at that 8% rate over time. So we can talk about the details within that, but there's nothing we've seen or in the most recent developments that give us pause around 8% growth in IG and 8% to 10% growth in collection volume to support it.

David Lewis

analyst
#32

Yes. So I think, Chris, when you say stuff like that, it makes sense because the plasma industry is growing 8% to 10% here recently, but the average investor says, look, it was growing 8% to 10%. I have big companies focused on some of these indications in [indiscernible] gravis or CIDP, how can you possibly sit there and say it's still going to grow 8-ish when it was growing 8-ish and now you're going to see some incremental competition? And what -- are there specific indication specific trials, things you're aware of in the demand side of the equation that geographic expansion into China for IG, who knows. But are there specific things you're thinking of that give you confidence that the industry can weather what could be in a salt to some of the key indications you relied upon?

Christopher Simon

executive
#33

Yes. And I think it's -- at some point, we may delineate between anti-FcRn and hyper-sialylated IG therapy. But there are 5,000-plus trials underway for plasma-derived pharmaceuticals. And I think the success of those trials gives us confident that over the long term, that growth rate will stay largely interrupted. When we look at what's out there in the market, I think there's a series of hurdles that the drug candidates will need to clear before they can take meaningful share in the space. There's nothing magical about this, right? They've got to demonstrate meaningfully improved patient outcomes versus the current standard of care, which is IG. And it may be easier to do that, candidly, in a 5% market opportunity like MG, where IG is not the ideal therapeutic. It will be much harder as we push into CIDP and ITP, for example, which are well treated with IVIG. And candidly, without a meaningfully better efficacy and/or pricing profile, it's not clear that neurologists will have a strong incentive to actively convert off of IVIG, provided we and the industry are able to make that IVIG fully available to them.

David Lewis

analyst
#34

Okay. So your view is if it's not therapeutically better, it just comes down to different mechanism, different drug delivery, it comes at a higher price, the conversion is going to be more measured?

Christopher Simon

executive
#35

Yes. I think that's right. And you mentioned J&J, look, J&J is a world-class company. Their acquisition of Momenta clearly validates the potential therapeutic benefit. It is interesting that they chose to acquire Momenta when they have preexisting collaboration, research collaboration with argenx, which, on certain indications, appears to be ahead based on what they've released publicly. From our perspective, the announcement doesn't change the competitive landscape. It validates, but the hurdles still remain. And from our experience, I think when a larger, more established company like J&J takes over an emergent therapeutic, they tend to review time lines carefully and invariably, things slow down. Larger companies typically are going to command a premium for pricing, and they're going to shun off-label use to ensure a fair and uninterrupted return on their investment. For us, that buys time for some of these additional plasma trials to come to fruition. And candidly, I think it gives us confidence that we can both meaningfully advance as an industry collectively to care on these horrific diseases while not diminishing that 8% to 10% growth. I think from where we sit today, time may be on our side.

David Lewis

analyst
#36

Okay. Interesting. Would you say you are more concerned about FcRn or sort of more concerned about hyper-sialylated. What is the bigger threat in your view?

Christopher Simon

executive
#37

They play out very differently, right? Anti-FcRn essentially beats the body of IG, all IG, right, depending on dosing and response, et cetera. So there -- it's an interesting dynamic and that it clearly will reduce demand wherever it is used. On the other hand, there may be a need to infuse additional IG in response to anti-FcRn therapy paradoxically. Hyper-sialylated is different in that it enhances and strengthens the underlying IG, so it doesn't directly displace it. It may reduce the volume -- collection volumes required. It's also earlier. In many ways, it's more novel and more interesting, but I think it's just too early to call at this point.

David Lewis

analyst
#38

Yes. Okay. So we got a few minutes left, Chris. I mean we -- I started off my conversation this morning saying how your role in transforming Haemonetics. Now the world is being transformed by this thing COVID-19. I was sort of curious, where do you see the Haemonetics transformation here kind of coming out of COVID?

Christopher Simon

executive
#39

We're excited. We've outlined a 3-pronged strategy, 5-year turnaround, we are well into year 5 of that turnaround with every intent to complete successfully the turnaround this year and embark on accelerated growth, transformational growth going forward on the other side of COVID. We talked pretty much exclusively about plasma today. That's half our business. The other half of our business is split between hospital and the blood center and both of those businesses have done a fantastic job of responding and recovering and we see that in our actual results. So we think that bodes well for growth going forward. We have meaningful programs underway. We didn't talk about operational excellence, but that's a big driver of further improving our gross margins. As you highlighted, 4 years ago, when I joined the company, our operating income margin was in the very low teens, 12% or 13%. Prior to the onset of COVID, we actually were in the low 20s. We actually touched upon 23% in the fourth quarter of last year. So we see every reason to believe post-COVID that we will be back on that trajectory with more room to run. And some of that will be operational excellence, some of that will be just the beneficial effects of renewed top line growth, sustainable, profitable growth. So I think it's a challenging environment. I'm proud of the work that our team has done to stay fully operational and respond to customer needs across all 3 of our businesses. There's nothing easy about it. There's nothing straightforward about it. I'm sure there'll be fits and starts and such as we go. But I think within Haemonetics, we are very optimistic about our ability to pivot the transformational growth that we get on the other side of this virus.

David Lewis

analyst
#40

Chris, a lot of our companies that had ongoing transformations, whether it was Teleflex or Invista didn't really matter who it was, if you had an active cost restructuring program you have been able to take COVID and extend that program. I think about the $80 million to $90 million of OEP savings through fiscal '23, what is the opportunity to accelerate those plans, frankly, in light of COVID, some of the middle-income statement flexibility that may have come as a result of pandemic?

Christopher Simon

executive
#41

Yes. I think operational excellence for us is primarily oriented in improving our gross margins by driving down our cost of goods sold while simultaneously raising product and service quality levels. I feel like we're fully on track to do that. COVID has been a challenge. Our first priority was to stay operational and keep our people safe while we preserve cash. We've done that. We continue to make the through-cycle investments. We'll deliver fully against that program in the time line that was originally outlined. So we feel very good about that. We've taken steps to minimize from the outset our cash outflow, but I don't feel like we have meaningful additional opportunity from where we sit to pull forward. But candidly, we also want to be mindful of the investments we're making. We're still building out our commercial capabilities. We're making meaningful investments in R&D and you see things like PPN as a result of it. And then I think we've -- as part of OEP, we've taken a series of steps. We sold off one of our facilities down in Puerto Rico, that's associated with the manufacturing of whole blood filters. That's -- those type of transactions will continue to allow us to make step-wise progression despite the pandemic.

David Lewis

analyst
#42

And just lastly, just the last piece of transformation. We've seen some small tuck-in divestitures out of the company and some small acquisitions but the opportunity of something getting out of the blood business or making a more material acquisition, are you comfortable making a material $100 million to $300 million acquisition now? And what are the prospects of maybe getting out of some lower-growth businesses of the company?

Christopher Simon

executive
#43

Yes. So look, we are excited about portfolio moves, as we describe them, large and small. We are committed to sustainable profitable growth. So as acquisitions present themselves that we can act on in the near to intermediate term, certainly within the range that you just described, we feel good about our ability to do that. I think the most likely candidates will fall in our hospital sector, probably in close adjacencies to our rapidly growing TEG business. So think of trauma, think of cardiovascular applications where we can convince ourselves in short order. We can be an natural owner and drive disproportionate growth. We're definitely in the market. We have the balance sheet to support it and we're committed to investing in growth in all forms.

David Lewis

analyst
#44

Great. With that, Chris, we're out of time. Thank you so much for being here this morning and kicking us off for day 2. I appreciate you being here and good luck with your meetings during the day.

Christopher Simon

executive
#45

Thanks, David. My pleasure. Bye-bye.

David Lewis

analyst
#46

Mine too. Thank you.

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