Hello, and thank you for joining us. We appreciate you joining in for our second day of our virtual conference. Sorry that we're not in Snowbird, Utah, on the slopes, so I thought I'd bring up the background here so we could all remember how beautiful it is there, but we are here today with Eli Kammerman from Masimo, and I am so pleased to be able to have some time with him to chat about what Masimo has been up to. I do want to note here that they do have a Q4 earnings call coming up pretty soon, so there may be some topics we can't discuss, and I'm sure Eli will tell me if I've stepped out of bounds here, and just before we start the chat, I do want to urge investors to use the Q&A function on the webcast.
If you have any questions you want to send to me, I will be sure to ask them. But Eli, let's start right away by discussing the 2021 revenue guidance, $1.2 billion or so. That implies, by my math at least, about 5% year-over-year growth on a reported basis, about 3% or so after we think about LiDCO and constant currency. So the question I've been getting is, after such a strong 2020 performance, what gives you confidence that Masimo can continue to grow the top line from here?
Okay, sure. Thank you very much, Marie, for inviting Masimo to your conference this year. We're glad to participate in any way, shape, or form. Even though we're not in the snow, just having a chance to participate in the forum is a very welcome occasion for us. Looking to the 2021 guidance, firstly, to put things in perspective, for 2020, Masimo's revenues grew by 22%. So there's no question we are facing a quite difficult comparison. The fact that we're guiding to growth this year, we see as a significant achievement. Our confidence to generate that growth is based on a number of items, including firstly a rebound in elective surgeries.
As we move through the first half of the year, we believe that in the second half we'll be back to a normal 100% volume elective surgery schedule, and this will have a positive impact on all of the different types of sensors that we sell for all the different parameters, such as pulse oximetry, the Rainbow sensor for total hemoglobin measurement during surgery, capnography, cerebral oximetry, and of course, brain function monitoring. We have a firm outlook for shipments of our technology to drivers, to our OEM customers, at a minimum for the first quarter because we get our confirmations in the first month of each quarter. And then we've had continuing dialogue with our OEM customers, such as Philips, GE, or Nihon Kohden, getting insight into their forecast for the full year. We think we'll be back to that typical run rate of about 60,000 drivers per quarter.
As hospitals refocus on an equipment replacement cycle this year, rather than just expanding monitoring coverage last year due to COVID, we also see a ramp-up in sensor utilization of recently installed monitors. There's about a six-month lag between the time that we ship a board to an OEM customer and the time that board gets out and starts consuming sensors. So the boards we shipped in the second half of 2020 are expected to be productive the first half of this year. Secondly, we're also looking forward to gaining traction once again for our hospital automation sales effort. Those system sales were put on pause due to the disruption of COVID, and now that we see COVID fading into the background, we think we'll have better hospital access to promote those enterprise-wide related suites to handle all of the information coming from all of the devices around.
Then finally, we urge investors to look at our two-year stack rate up against the 2019 result, and if you calculate a CAGR out to the end of 2021, you'll see that it's 13-14% per year based on our guidance this year, which is pretty respectable.
That's great. That's great. And Eli, I hate to point this out, but it seems like we're getting a little bit of lag. I wonder if you could switch to phone audio. Maybe if you go over and click the microphone and hit switch to phone audio and hit the call me button, we might get a little more smoothness. We're just dropping the last part of all of your sentences.
All right.
And we'll hold off.
How's that coming through now?
That's a lot better. Are you feeling? Does that sound okay?
Yeah. Coming through just fine.
Okay. All right. Perfect. It's the new virtual world we're living in. So great. You pointed out a lot of the topics that I want to hit on throughout our discussion today. Maybe we'll take it one by one. The 60,000 shipped boards and monitors, Masimo has been pointing to that as an expectation. You started to talk about why you felt that was the right number, and it sounds like part of that comes from the insight you hear from our customers. Can you get into that in a little bit more detail for us, Eli?
Yeah. What we see for board shipments is essentially a resumption of the replacement cycle, and that will provide positive comparisons in that specific type of activity. In 2020, we think that hospitals were more focused on getting more beds with monitors next to them, and they were putting that replacement cycle on hold. So we're looking at some mixed comparisons as we move through the year, but based on our dialogue with the OEMs, we do have confidence that we'll be able to get back to trend line.
Keep in mind that last year our driver shipments for OEM customers and for Masimo brand monitors combined were 470,000. So just getting back to trend line is something that we see as a good achievement, and we're confident that the combination of equipment replacement as well as new hospital construction in developing areas will get those driver shipments on track. Does that address the question?
Yeah, it absolutely does. And I would say I typically hear more sort of how do you get back to the 60,000 as opposed to is 60,000 too low, given how many systems sort of went into the field last year. So it's good to hear some of that insight into where that 60,000 comes from, kind of getting back to that replacement cycle. As we think about 2021, and I know nobody has a precise answer here, but how is Masimo thinking about the cadence for recovery throughout 2021? I guess asked another way, what's built into the $1.2 billion in terms of that guidance and the cadence that comes with it?
Yeah, sure. Firstly, from a macro perspective, we see elective surgery volumes standing at 90%-95% of normal in the first half and then getting back to 100% in the second half. So that's one aspect of it. Then going into more detail, the comparisons for overall revenue growth vary by quarter. Generally speaking, they're somewhat tough when you compare the growth last year to our trend line growth of 9-11%. And the reason these comparisons are important is because they're mixed with regard to the contribution from hardware versus sensors. And so as the hardware comp flips to negative, we expect the sensor comp to switch to positive. So there'll be an offset there. In the first quarter, overall growth was 17%, and there was similar growth for sensors, whereas equipment was essentially in line with trend line, meaning that 9-11% level.
In the second quarter, overall growth was 30%, strongly boosted by hardware sales, meaning Masimo monitors and boards, but there was actually a year-over-year decline in sensor sales, so that's a very easy comparison for sensors in the second quarter. The third quarter, overall growth was 20%, once again strongly boosted by hardware, and there was a rebound to modest sensor growth in the third quarter. For the second and third quarter, the hardware growth was really, honestly, off the charts at about 175% and 150% year-over-year, so there's no question we're going to see declines related to that, but as I mentioned, with sensors being the bulk of our business and getting back to trend line or better, we think that that will help to offset the hardware comparison.
And then finally, in the fourth quarter, as we just put out in our pre-announcement, overall sales growth was 19%, again boosted by hardware with sensor growth essentially in line with the third quarter. So a relatively easier comp for sensor growth. So our take is that the tough comps are for equipment, but they're pretty easy for sensors. We think the recovery means a return to trend line growth for boards, and overall, we're confident in generating mid-single-digit growth for this year.
Okay. Yeah, that makes a lot of sense. That's a lot of great color on sensors and sort of the growth we should expect there. But how should we think about utilization, given how much the installed base expanded? I guess, asked another way, is there a way to kind of characterize what portion of the installed base is likely to keep being utilized?
We expect the entire installed base to be utilized over the long term. That's because when hospitals get new monitors, they keep them next to the beds that they were intended for. Now, there is a difference in utilization between the critical care setting, which is our core market, and the general floor setting, where we believe a lot of these extra monitors will wind up after hospitals reserving them for COVID patients this year, this past year. As COVID fades into the distance, we expect the installed base to be fully utilized within the low acuity general floor setting, mainly due to the strong evidence that supports continuous monitoring for post-surgery opioid recipients. Those monitors will remain in place. They won't be put into storage closets or sold off as surplus equipment. They'll be there on a contingency basis.
If there's a patient who's getting IV morphine or IV fentanyl or even oral opioids, those patients should be monitored. We've got great data supporting both the life-saving benefit of that as well as the cost-saving benefit. And the sensor utilization will really depend on the protocols that hospitals adopt in terms of standardized procedures. We think about 60% of the 25 million surgeries per year are highly invasive, resulting in significant postoperative pain, and that yields an addressable patient population of 15 million for continuous monitoring. That's really significant. And now that those monitors are out in the field, they should be put back into availability for the general populace in the hospital, and we think that the utilization will gradually ramp up with that availability.
Okay. Okay. You actually predicted my next question was going to be, I know Masimo has long talked about expanding into the general floor and some of these lower acuity areas of the hospital. Where do you think now? And I know it's hard. It's a moving target, but where are we in that kind of journey or progress toward that?
For the general floor, we started 2020 with about 10% monitoring coverage of the beds from all companies and all brands. We think that that coverage has gone up very significantly with these significant purchases of monitors throughout last year and that we ended 2020 with the potential for 20-30% of beds to be covered by monitors. Now, that raises the potential for the perception of a tipping point because it becomes much more obvious that some beds have monitors and others don't, which creates a perception of inequity in the healthcare that's available for patients. Consequently, we think that the coverage now has a much higher chance of becoming universal versus that potential at the beginning of last year.
That 20%-30% coverage is based on our assumption that the driver sales and the Masimo monitor sales we achieved last year were predominantly put into the field for contingency planning for an anticipated surge in COVID patients. Now that the reserved nature of those monitors is no longer necessary, they become available, and they all go to the general floor because there was already 100% coverage in the critical care area. Monitoring of the oxygen saturation in critical care, ICUs, and ORs is a standard practice across all hospitals. So the monitors were there for that setting, and then likely they flow to the general floor setting where they have value for the types of patients I just mentioned.
Yeah. That's very helpful. Some great numbers around there, and I appreciate all the clarification, Eli. I guess last question for you here on things related to hardware and installed base. What would you say has taken place on the market share side? If I recall, before all of this, I would say that it was a duopoly between you and Medtronic Nellcor. Any insight into how that has shifted throughout the pandemic?
Yeah. We think we put more distance between us and Medtronic throughout 2020, mainly as a result of being more nimble and responsive to hospitals' urgent need for equipment. We were able to get into hospitals even that weren't our customers to provide them with the extra monitors they need in response to the COVID crisis. So for 2020, we think our share grew meaningfully. If you look at the history of Masimo, you'll see that we've built our share quite meaningfully over the past 22 years or so with the company commercializing its products in 1998. And we believe our share continues to rise over the 40% level. At the same time, the main source of that share for us has been Medtronic because of the duopoly nature of the market. We think we're putting more distance between us and them, and we think that that trend will continue.
Okay. Great. And while I have you on the topic of Medtronic, Nellcor, I think it was just last week they released a press release talking about a post-op study in newborns, and they were comparing their technology against Masimo. Clearly, you know that Medtronic is trying to be a little more vocal about their competitive stance in all their markets, but I'd love to hear Masimo's reaction to that study and what you would say in response.
This reaction may surprise you because the answer is a very solid answer, but the basis of it is somewhat under the radar because it goes pretty far back in history. The study described in the article did not use Masimo's current technology that we developed in response to a 2015 update from the American Academy of Pediatrics Newborn Resuscitation Protocol, or NRP, to address the measurement condition during the first few minutes after birth. Based on that revised NRP, Masimo released a new newborn sensor with accompanying software in 2016 that provided accurate pulse rate readings earlier. It's not really a valid study from our perspective because it didn't use our currently available product.
Very helpful. Good point. Good thing to point out there. Okay. Well, I want to move us into the new parts of the business, and it's extensive. I guess maybe we can start with LiDCO. The acquisition was completed a few weeks ago. Remind us of what we might see from the LiDCO business in 2021 and the TAM for that hemodynamic monitoring business.
Yeah, sure. Well, when we're talking about TAM, you have to consider whether the market is mature, existing, realized market, or whether you're talking about market potential. And those two figures for the LiDCO hemodynamic monitoring technology are quite different. We see the realized market today is $250 million, but it's got very good potential to expand to 10 times that level based on the shallow adoption of hemodynamic monitoring today in both surgery and ICU patients. What we think LiDCO brings to the table is a more attractive value than its main competitor, the Edwards HemoSphere system, utilizing the FloTrac sensor. The FloTrac sensor is a proprietary disposable that's quite expensive, and the LiDCO technology can use a standard off-the-shelf commodity-type pressure transducer that is considerably less expensive by a factor of close to 90%.
Consequently, we expect LiDCO to gain significant share with Masimo's marketing power behind it. They had great success in the U.K. but were significantly underinvested in the U.S. with only a handful of reps here. Now that that technology will be plugged into the quite large Masimo hospital sales force, we think it has great potential to spread to many more hospitals. Numerically, we think LiDCO can contribute roughly 1% to revenues this year, and that number really can grow to be much more substantial as we look two to four years out.
Yeah. Absolutely. And what is it that gets the penetration or expands the market? You mentioned 10 times that 250 million. Is it really the access and kind of ease of use and the off-the-shelf componentry, or is there something more to it?
Yeah. The expansion of hemodynamic monitoring really is based on the perception of the high value of two different practices in the hospital. Goal-directed therapy, which refers to the practice of optimizing fluid volumes in patients, and ERAS, enhanced recovery after surgery, which refers to maintaining cardiac output and the appropriate blood pressure throughout the surgical procedure, which avoids bloating or hypovolemia to lower volume in patients, which can result in organ damage. Both of those conditions lead to a longer-than-necessary recovery in both the OR recovery room as well as the overall length of stay. So with goal-directed therapy and ERAS coming more to the fore, we think that that can result in significantly higher adoption rates for hemodynamic monitoring, such as cardiac output, stroke volume, stroke volume variation.
Yeah. Makes sense. I'm going to skip ahead here then to Opioid Safety Net. We got that MCIT rule, which is obviously a positive for a breakthrough device like Opioid Safety Net. So what have you heard from the FDA lately on that, and how are we thinking today about the market and the business model there?
Sure. Masimo Safety Net-Opioid is a very exciting product for us that's a representation of our hospital-to-home monitoring strategy. It utilizes a wearable wireless sensor that sends oxygen saturation levels to a home hub, which will then trigger an alarm if saturation drops below a dangerous threshold as a result of a patient suffering from respiratory depression, a common side effect of opioids. The product is still under review at the FDA. We think it'll be approved sometime in the first half of this year. And we see the market opportunity for the Masimo Safety Net-Opioid at $4.5 billion based on targeting 25 million patients just in the U.S. who are taking prescription opioids for either postoperative pain or chronic pain. We're pursuing sales coverage of the high prescribers for these drugs, which includes surgeons as well as pain specialists.
The business model involves the sale of a kit that has two disposable sensors, which provide eight days of monitoring coverage. As far as the sales dynamic, we think that distribution through pharmacies, pain clinics, or DMEs, durable medical equipment providers, are all possible, but we have not yet finalized our decision on which one of those routes we're going to pursue.
Okay. That's a lot of great detail, and we're expecting to hear a bit more about that throughout the year, so that's great. And in our last couple of minutes here, tough to choose, but I would love to hear a little bit more about TNI Medical. That was another acquisition last year, high-flow respiratory support. What's ahead in 2021? Are we going to see that in the home setting? Have you pushed that out in a big way in the hospital setting? Where are we with that?
The TNI Medical product, which provides high-flow respiratory therapy as a valuable type of therapy for patients with respiratory illness, has been sold in Germany only to date. We're expecting to launch that product in the U.S. by mid-year. It's already approved or cleared by the FDA in the U.S. We've been working on refining the product and building inventory for it. That introduction is on the horizon. As far as the home use, that's a second-stage selling strategy. It's been successfully executed in Germany, and we think there's good potential for home use in the U.S. for patients with chronic diseases such as COPD. That is something that will materialize later in the process.
Great. I have a lot more for you, Eli. We will have to wait for the Q4 earnings. But I think one last one to just sort of wrap it up. Masimo has so many new market opportunities, new monitoring parameters, the expanded installed base. If you could size for us, how has the company's TAM grown, or what does the company's TAM look like at this point?
When we talk about the TAM, as I mentioned before, we have to differentiate between existing markets and market potentials. We see the TAM as having grown significantly as a result of adding high-flow respiratory therapy, hemodynamic monitoring technology, and hospital-to-home monitoring products. The sum total growth of the existing TAM for those categories, plus their potential in aggregate, adds up to over $5 billion, which would more than double our targeted markets today that exist for our sensor parameters. So we think that $5 billion is the minimum value, and it has the potential to rise to $8 billion with expanded adoption, as we just discussed. The high-flow respiratory market we see as roughly $300 million today, with potential to exceed $1 billion if broad home use materializes, as well as expanded hospital use across more categories of patients.
We see the hemodynamic monitoring market as a realized market of $250 million today, with potential to exceed $2 billion if broader adoption in the OR and ICU materializes. And finally, regarding potential markets, we just talked about the hospital-to-home opportunity with Masimo Safety Net-Opioid, as well as Radius T for monitoring body temperature. Another aspect of the expansion of the TAM, which we're barely scratching the surface for, is something that we had already been targeting before 2020, which is the hospital automation opportunity, which we estimate at $1.5 billion, and where we bolstered our potential for success in that segment with an acquisition last year of the Connected Care division from NantHealth. So significant potential here to more than double our total addressable markets with the combination of realized sales in those markets today, as well as market potential expansion.
Very exciting. A lot of evolution happening at Masimo. Well, Eli, we have to wrap it there, but I want to thank you so much for joining us. Really enjoyed today's discussion, and investors on the webcast really appreciate your time as well. Thank you. Take care.
Thanks, Marie. Take care. Bye.
Bye-bye.