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Earnings Call: Q1 2023

May 9, 2023

Operator

Good afternoon, ladies and gentlemen. Welcome to Masimo's Q1 2023 earnings conference call. The company's press release is available at www.masimo.com. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. I am pleased to introduce Eli Kammerman, Masimo's Vice President of Business Development and Investor Relations.

Eli Kammerman
Vice President of Business Development and Investor Relations, Masimo

Thank you. Hello, everyone. Joining me today are Chairman and CEO, Joe Kiani, and Executive Vice President and Chief Financial Officer, Micah Young. This call will contain forward-looking statements which reflect management's current judgment, including certain of our expectations regarding fiscal year 2023 financial performance. They are subject to risks and uncertainties that could cause actual results to differ materially. Risk factors that could cause our actual results to differ materially from our projections and forecasts are discussed in detail in our periodic filings with the SEC. You will find these in the investor relations section of our website. This call will include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures.

In addition to GAAP results, these non-GAAP financial measures are intended to provide additional information to enable investors to assess the company's operating results in the same way management assesses such results. Management uses non-GAAP measures to budget, evaluate, and measure the company's performance and sees these results as an indicator of the company's ongoing business performance. The company believes that these non-GAAP financial measures increase transparency and better reflect the underlying financial performance of the business. Therefore, the financial measures we will be covering today will be primarily on a non-GAAP basis, unless noted otherwise. Further, we will also be referencing pro forma financial measures, which include historical results for Sound United prior to the acquisition date of April 11th 2022. In our presentation today, we will once again be referring to this business as our non-healthcare segment.

Reconciliation of these measures to the most directly comparable GAAP financial measures are included within the earnings release and supplementary financial information on our website. Investors should consider all of our statements today, together with our reports filed with the SEC, including our most recent form 10-K and 10-Q, in order to make informed investment decisions. In addition to the earnings release issued today, we have posted a quarterly earnings presentation within the investor relations section of our website to supplement the content we will be covering this afternoon. I'll now pass the call to Joe Kiani.

Joe Kiani
Chairman and CEO, Masimo

Thank you. Thanks, Eli. Good afternoon, and thank you for joining us for Masimo's Q1 2023 earnings call. We started the year with solid performance and are excited about the many new products coming out of our research and development pipeline this year. Our consistent focus on life-improving innovation continues to drive growth in our professional healthcare, consumer health, and consumer markets. Now, supported by the scale and infrastructure of our Masimo Consumer business, our health and healthcare innovation is going to reach people from all walks of life. Our consolidated revenues for the Q1 reached $565 million. We delivered healthcare revenues of $347 million and consumer revenues of $218 million. New customers in our pulse oximetry business and increasing traction for Rainbow and advanced parameter products strengthened our healthcare revenues this quarter.

In fact, this was the best Q1 in our history for new conversions of hospitals to Masimo. In addition to rainbow blood constituent monitoring, which has now become over 10% of our healthcare revenue, we have solid growth in our SedLine and O3 brain monitoring and NomoLine capnography and gas monitoring products. Robust growth for hearables led the performance of our consumer business, along with a strong market reception for some recently launched AV products. Despite many consumer-facing companies struggling post-COVID, our consumer business remains on track. Meanwhile, we're leveraging our unique combination of signal processing, physiological monitoring, audio, and automation technology capabilities to launch a series of new and innovative products to revolutionize consumer health.

On that point, later in the call, I'll update you on the recent launch of our Stork baby monitor and Opioid Halo, as well as some of the other new products planned for this year that we expect will contribute to our long-term success. With that, I'll pass it to Micah to review our Q1 results in more detail and provide an update on our 2023 financial guidance.

Micah Young
EVP and CFO, Masimo

Thank you, Joe. Good afternoon, everyone. For the Q1, we achieved consolidated revenue of $565 million and non-GAAP earnings per share of $0.87. For our healthcare segment, Q1 revenues were $347 million, representing 16% constant currency growth. Recall that our Q1 2022 revenues were adversely affected by supply chain challenges that produced a shortfall in that period and resulted in growth of only 3%, which was subsequently recovered in the Q2 of last year.

We shipped over 77,000 drivers in the quarter, and we are on track to ship over 300,000 drivers this year. At the end of the Q1, we estimated that our installed base has grown by 7% over our installed base at the end of the Q1 of 2022. As Joe mentioned, our healthcare revenue growth is driven by strong performance from our rainbow blood constituent monitoring, SedLine and O3 brain monitoring, and NomoLine capnography and gas monitoring products. For our non-healthcare segment, Q1 revenues were $218 million, representing an expected decline of 9% on a pro forma and constant currency basis.

This was in line with our guidance as this business faced a tough year-over-year comparison due to the fulfillment of back-ordered products in the prior year quarter that drove 22% constant currency growth right before the acquisition closed. Hearables, including headphones and earbuds, remain a key category for growth. Hearables sales more than doubled in the Q1 versus the prior year period, primarily driven by the Bowers & Wilkins headphone franchise. While we're pleased with the strong growth we're seeing in this category, we expect the launch of the Denon PerL AAT earbuds later this year to further elevate our hearables business as we bring truly differentiated technology to our consumer audio brands. Now moving further down the P&L. For the Q1 of 2023, we realized consolidated non-GAAP gross margin of 52%.

This includes gross margins of 62% for our healthcare business and 36% for our non-healthcare business. Consistent with our guidance, we expect to see gross margins steadily rise over the course of 2023 as our supply chain continues to stabilize. For our consolidated business, our non-GAAP operating profit increased 8% to $76 million, which was a solid result despite year-over-year currency headwinds and the elevated litigation costs associated with the trade secrets misappropriation trial against Apple. Our non-GAAP earnings were $0.87 per diluted share, which included an increase of $11 million in interest expense over the prior year period related to the debt incurred for the acquisition and share buyback. To summarize, we delivered Q1 results at the high end of our guidance as our healthcare business again realized steady gains in market share across the portfolio.

In our non-healthcare segment, we saw an impressive growth from our hearables products despite a difficult year-over-year comparison. We have an exciting lineup of new products rolling out this year that will help us advance our strategy, drive long-term growth, and improve lives, whether in the home or in the hospital. Now I'd like to provide an update on our 2023 financial guidance. For the full year 2023, we are maintaining our previous guidance ranges for consolidated revenue of $2.415 billion-$2.460 billion, non-GAAP operating profit of $400 million-$405 million, and non-GAAP EPS of $4.70-$4.80.

As we discussed last quarter, we are taking a disciplined approach to our product launches and leveraging Masimo Consumer's capabilities and channels to maximize the impact of the incremental 100 basis points of promotional investment we are making. For our healthcare segment, we are maintaining our previous revenue guidance of $1.45 billion-$1.465 billion, representing 8%-10% constant currency growth. For the non-healthcare segment, we are maintaining our previous guidance range of $965 million-$995 million, representing 2%-5% growth on a pro forma and constant currency basis. Please reference the earnings presentation on our investor website for further details.

In conclusion, our outlook for 2023 reflects solid growth in our business while incorporating prudent investments to support the new products we will launch this year. With that, I'll turn the call back to Joe.

Joe Kiani
Chairman and CEO, Masimo

Thank you, Micah. I'm delighted to report that we received De Novo FDA approval for Masimo Opioid Halo, a revolutionary product for the detection of opioid-induced respiratory depression in people taking opioids at home. Illicit opioid-related deaths are at an all-time high, and unexpected deaths from opioids, even in patients who are complying with recommended dosages, are a significant problem in the U.S. Over 80,000 people died due to opioid overdose. We intend to play an active role in reducing these deaths by alerting patients and their loved ones when opioid-induced respiratory depression occurs. The alarm functionality of Opioid Halo provides an early warning of depressed respiratory function that should result in vulnerable patients being woken up and saved from a terrible fate. If not, then an alarm with location is sent to the nearest ambulance.

On May first, we began marketing Opioid Halo to drugstores and addiction treatment centers. We are going to do our best to make sure there is awareness of Opioid Halo, as we believe if used, it could save people from opioid-induced respiratory depression. With the transition of naloxone brands to over-the-counter status, large retailers are creating display areas that promote opioid safety and awareness within their stores. We expect Opioid Halo, which has over-the-counter and prescription clearance, to become part of that initiative. On May third, we launched Stork at the 2023 Kids Expo in Las Vegas. We had very strong interest from major retailers, including one of Masimo Consumer's largest customers, which will carry Stork and give it a very prominent display location in stores.

We're currently selling different configuration of Stork on the MasimoStork.com website and expect to announce important retail channel presence as well as large online baby registries for Stork over the next six months. The marketing team at Masimo Consumer is doing an excellent job of gaining attention for Stork, both online and in traditional retail channels. These efforts should accelerate adoption of the product in the second half of this year. As one of our first consumer health product launches, Stork is creating a great template for how our teams can leverage our integrated global brand and marketing framework, which we will rapidly refine and replicate as we learn from the Stork rollout and launch more consumer health products. We will also soon launch our first hearables based on our Adaptive Acoustic Technology platform.

The AAT platform creates personalized listening profiles for each user, customizing the sound spectrum for each person's unique ear architecture and hearing sensitivities to ensure that no instrumental detail or sound subtlety goes unheard. These next generation earbuds will be marketed as the Denon PerL and PerL Pro to leverage Denon's heritage of world-class acoustics, and we have already received very strong interest from retailers that gives us confidence in a rapid sales ramp. Shifting to wearables, our W1 watch is gaining traction as Cambridge University Hospitals in the UK and Charité – Universitätsmedizin Berlin have expanded their telehealth programs with Masimo W1. Last but not least, Masimo Freedom smartwatch with Android operating system is slated for sale in the second half of the year. We showed Freedom at the BNP Paribas tennis tournament in March and have begun pre-sales on our e-commerce site.

In addition, Freedom Sleep Band will round out our portfolio of wearables, which addresses a range of distinct consumer health needs at various price points and can be displayed together in retail stores for marketing synergy, hopefully prior to the Christmas holiday season. We also continue to make progress building our home-based medical data ecosystem that connects our wearables and remote monitoring products and services to HEOS devices, allowing us to feed data from the wearables into our secure health cloud. We grew the number of HEOS connected devices by approximately 180,000 in the Q1. We intend to grow Masimo by making a real difference in people's lives in hospitals and home. We can't do that without the dedication and commitment of our team and support of our shareholders.

For the first time since we took Masimo public in 2007, we will be engaged in a proxy contest. We encourage all of our shareholders to vote. The outcome will be consequential for our company's mission, strategy, and guiding principles, which have been incredibly important to our success. With that, we'll open the call to questions. Operator?

Operator

At this time, I would like to remind everyone, in order to ask a question, press star, then one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Our first question comes from Marie Thibault with BTIG. Your line is open.

Marie Thibault
Managing Director and Senior Analyst, BTIG

Hi. Thank you so much for taking the questions. Congrats on a very strong start to the year.

Joe Kiani
Chairman and CEO, Masimo

Thank you, Marie.

Marie Thibault
Managing Director and Senior Analyst, BTIG

Yeah. I wanted to start here with just a basic question about the healthcare business. I think last quarter you mentioned that there had been some encouraging pricing trends and contract renewals. Just wanted to hear what drove some of the strength that you saw in healthcare. I know you mentioned some of the parameters, but wonder if there were other, sustainable trends that you can also point to.

Joe Kiani
Chairman and CEO, Masimo

I don't know if we're sustained as, but Q1 was our biggest quarter ever in converting hospitals to Masimo SET pulse oximetry, new customers. I think it was twice the rate that we normally do. That's very encouraging. Pricing has stabilized, cost of goods has stabilized. One of the other things that we're encouraged about is the traction that rainbow is getting, non-invasive hemoglobin, PVI, outside the US, ORI, and our capnography, O3, and SedLine businesses. We see that all really, really positive. The only thing is from the best, I guess the best estimate that we have, census has returned to 2019 level, but it hasn't grown. It's the 2019 level, where normally each year census and grows by 1% to 3%.

From the best we can see, we're finally back at 2019 level. If all bodes well, we hope that eventually, COVID-related deaths that affected a lot of elderly people that would use hospitals regularly in their last years of life, will go through and the new norm will begin. With the huge conversions we've had this quarter and the past couple of years, we think overall we'll be ahead of things. I hope that helps.

Marie Thibault
Managing Director and Senior Analyst, BTIG

Yeah, it does. Thank you. Sounds like it's heading in the right direction. Wanted to ask my follow-up here then on Opioid Halo. Congrats very much on getting through the FDA with that, and great timing with the naloxone going OTC as well. Wanted to sort of understand how you think about your go-to-market strategy. You mentioned that some drugstores will be offering Halo as part of the over-the-counter naloxone effort. Is there a plot to try to get reimbursement at some point? I think I recall out-of-pocket of $250, which is more than most people spend in the drugstore. Curious about the business model longer term here then.

Joe Kiani
Chairman and CEO, Masimo

Yes. Longer term, we do hope to get reimbursement, but that might take a few years. In the meantime, we are doing a multi-pronged sales approach from over-the-counter at drugstores to reaching out to the kind of physician offices that do surgeries in their offices and send people home with opioids to make them aware of it. We're reaching out to states that have received settlement money from the opioid companies that wanna use that money for the greater good of people that are potentially addicted to opioids already. I think hopefully with all of that, until we do get reimbursement, we should have strong adoption and sales.

Marie Thibault
Managing Director and Senior Analyst, BTIG

All right. That all makes sense, Joe. Thank you so much.

Joe Kiani
Chairman and CEO, Masimo

Thank you.

Operator

Our next question comes from Matt Taylor with Jefferies. Your line is open.

Matt Taylor
Managing Director and Senior Equity Research Analyst, Jefferies

Hey, thanks for taking the question and congrats on a good start to the year here. I guess I was hoping to ask a little bit about current state of litigation. Obviously, we saw the mistrials. I was hoping you could update us on what you think ultimately happened there, and maybe just remind us about what's coming up here with the ITC and the other trials you have in the future.

Joe Kiani
Chairman and CEO, Masimo

Sure, sure. Big picture, we have five separate litigations with Apple. It started off with the patent and trade secret lawsuit we filed here in Orange County, which got split into two, a trade secret case and a patent case that's supposed to resume post PTAB rulings and appellate court decisions. We filed the ITC case with the International Trade Commission to stop the importation of foreign manufactured products that infringe patents. Apple sued us in Delaware for patent infringement, and we countersued them in Delaware for patent infringement, antitrust, and unfair competition. With the first two things, of course, the ITC case, you know we won the first stage of that. We're waiting for the commission to rule. The commission delayed the ruling.

Right now, we expect middle of July to get a decision, and assuming it's favorable and President Biden doesn't stop it, we could see the exclusion of the Apple Watch with pulse oximetry in September timeframe. On the trade secret case we just had in Orange County, it was quite three to four week process. The evidence came in incredibly strong. The evidence came in that showed in 2012, Apple decided to make a watch. They quickly decided the most important feature of that watch would be health sensing with pulse oximetry. They realized they did not know how to do pulse oximetry, so they started a project called Rover to look at all the companies in the world that do pulse oximetry.

Quickly, they decided Masimo and Cercacor were the two standout pulse oximeter companies, both run by me and my trusted technical VP was Marcelo Lamego. They recommended, while they recruit some of my team, to Tim Cook to acquire Masimo. They thought Masimo would be a great acquisition, not just because of our technology and our people, but because I could take over their healthcare business. They also were shut down. Tim Cook said. This all came in in front of the jury. Tim Cook said, "We don't do acquisitions like this." They looked at doing maybe a joint development with us while still recruiting our people. Although their head of BD kept warning them, "This is not good karma. We shouldn't be doing this," but they were doing it.

Right around that time when they were looking at joint development, the CTO at Cercacor, Marcelo Lamego, they had identified as my confidant, finally responded to Apple and decided, "You know what? Yeah, maybe I will join you guys and bring all of this stuff to you if you give me a high-level technical executive role." Which at that time, it looks like that stopped their business development front with us. Instead, Steve Hotelling, who apparently had 3,000-4,000 engineers reporting to him and the watch, started a confidential project. To go one layer lower, they had Marcelo now, our CTO, they had Michael O'Reilly, our CMO, which, by the way, evidence came in, they both took our trade secrets to Apple.

They also, unfortunately decided to go one layer lower and attract our engineers and directors. They hired between 20 to 30 additional people. The jury got to see some of that evidence, they also got to see that Apple launched their pulse ox in 2020 knowing that it wasn't good enough to get FDA clearance. Because of the COVID chaos, they called it, they thought SpO2 would help them gain market share from Fitbit, which they launched it. You know, probably the worst thing is about 100 million people now have pulse oxes in the back of their watch that doesn't really work. Their goal was to just get two measurements on 90% of the people each day, they fell short of that. They got it 37% of the time, two measurements each day.

All of that stuff was in front of the jury. They saw how they took several of our trade secrets. Right before the jury went to deliberate, the judge, I think, believing we had a jury that was gonna go all the way with us, took away our business trade secret case, which we disagreed with, but we're gonna have to wait for appeal on that. Despite all of that, unfortunately, the jury hung up. It isn't as though it's been reported that it was 6: 1. I can't get into more details on that, but it wasn't like that. Unfortunately, we did hit that. At this point, I guess in life, you don't get many do-overs. We're gonna get another do-over.

We will be retrying this case, and hopefully, given how good the case came and how everyone assumed it would go, we expect next time we'll get very different results.

Matt Taylor
Managing Director and Senior Equity Research Analyst, Jefferies

Thanks for that great answer. Any thoughts on the timing of that coming back around?

Joe Kiani
Chairman and CEO, Masimo

No, we don't know. It's up to the judge. It could be two to three months to another year. We don't know.

Matt Taylor
Managing Director and Senior Equity Research Analyst, Jefferies

Okay, cool. Thanks very much for that answer.

Joe Kiani
Chairman and CEO, Masimo

Thank you.

Operator

Our next question comes from Mike Polark with Wolfe Research. Your line is open.

Mike Polark
Director and Senior Analyst, Wolfe Research

Hey. Hey, good afternoon. Thank you for taking the questions. Maybe a guidance question. I see the affirmation for the year on say. As I look through the deck, I see a modest reduction to the consumer gross margin input. That's the standout. I guess for Micah, any other twists and turns within the guidance affirmation we should be mindful of here?

Micah Young
EVP and CFO, Masimo

No. Michael, the only thing, we held of course, guidance on top line, bottom line EPS and operating profit. We did have, if you look at the slightly lower on the full year for the consumer business on gross margins, that just reflects in the Q1 where we saw some lingering spot buys that impacted that business. We really didn't change the outlook for the last three quarters, let that kind of flow through the year. We also, you know, we did a very good job of managing expenses in the Q1 to offset that. You'll see a little bit softer gross margins, also improvement on lowering operating expenses for the year, reflected in that guidance.

We're seeing, you know, overall, Michael, we're seeing, you know, stabilization of the supply chain. The trends that we're seeing exiting the Q1 are a good signal for us. We still expect a steady rise in gross margins throughout the rest of this year, with Q1 being the low point.

Mike Polark
Director and Senior Analyst, Wolfe Research

If I can follow up, another guidance question or modeling question. 2Q, any feel for 2Q modeling, specifically, I guess, both segments, but also kinda wanna make sure we're all understanding of the unusual year-on-year comps given kind of the supply chain snafu last year in 1Q and then getting all caught up in healthcare in 2Q.

Micah Young
EVP and CFO, Masimo

Yeah.

Mike Polark
Director and Senior Analyst, Wolfe Research

Sequentially, Micah, how do you think about revenue progression? Thank you so much.

Micah Young
EVP and CFO, Masimo

Yeah, absolutely. Great question. If you think about the first year, first half of the year last year, to your point is, there was a lot of, you know, supply chain disruption in those quarters, or on the consumer side, there was some improvements from the fulfillment of back orders. The way I think about it, you'll see the second half more normal comps, but, in Q1 last year, as I mentioned in my prepared remarks, the healthcare business grew 3%. Q2, it grew 19%. Traditionally, our healthcare business, based on seasonality and the non-healthcare both step back in Q2, and then you start to see progression in Q3 and our heavy, heaviest quarters in Q4. Just be aware that comp, the 19% growth comp in Q2 on the healthcare side.

We also saw comps for the non-healthcare business of 22% growth in Q1 last year, and then 10% growth in Q2, which is above trend line just because of the fulfillment of those back orders. I think the first half you'll see that we're up against some tough comps, and still up against tough comps in Q2, but then those comps should ease and normalize out in the back half of this year.

Operator

Our next question comes from Jason Bednar with Piper Sandler. Your line is open.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

Hey guys. Good afternoon. Joe or Mike, wanted to start on maybe some of the new products, that really as we think about Halo, Stork, W1. I know this is a funding year for a lot of these new products, really a building year to get these products off the ground. Can we talk about maybe the intermediate term economics from the hardware, help us with how you're thinking about margins and what volumes need to reach with Halo or Stork or W1 in order for those offerings to be break even? Then, you know, maybe from a timing perspective, you know, should we be thinking about break even in 2024, or is this more of a multi-year process to get that part of the business profitable?

Joe Kiani
Chairman and CEO, Masimo

Well, high level, we expect all the business to be profitable from the day we launch them. We're not seeing margin limitation despite manufacturing the W1s right here in Irvine. We expect good margin on those. Micah, do you want to add anything to that?

Micah Young
EVP and CFO, Masimo

I think, Jason, you know, we would expect, to Joe's point, I mean, those gross margins should be, or the margins on those products should be supportive of our overall, gross margins for the company. To Joe's point, we don't expect those to be dilutive. In fact, if we can start to see, you know, drive some subscription type revenues around some of those products as well over time, you know, we could see even steady improvement above the corporate average. But we are making some investments. I think I mentioned in my prepared remarks about 100 basis points of promotional investments this year and, you know, we're gonna be very prudent and thoughtful about that as we invest going forward.

We wanna see good results and, you know, we'll continue to make the right investments to grow that business.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

I guess just that as we think about, and maybe we're thinking about these differently in terms of how we're bucketing the profitability. You know, to say that they're profitable in year one, we're talking about like more than $20 million in revenue from these products this year, which I don't think is what you're saying, Micah. Again.

Micah Young
EVP and CFO, Masimo

No.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

I don't want to put words in your mouth, but... Sorry, go ahead.

Micah Young
EVP and CFO, Masimo

No, I don't think that's what we're saying. I think, what Joe's referring to is that it would be supportive of our gross margins. You know, in terms of break even, I mean, we're gonna have to see how that plays out, but we're, you know, we're making about 100 base points of investment this year and, you know, we have high expectations for these products, especially, you know, we think we'll see some meaningful revenues going into next year, that could drive some leverage in that business and, hopefully return profitability within the next, you know, year or so.

Joe Kiani
Chairman and CEO, Masimo

Yeah. I think also it's important to note that we've done advertisements before, and we've done them every year practically since we launched our product. When you advertise even for a certain product, it does lift all boats in other areas. You know, for example, during COVID, we were advertising our COVID product, and while the COVID product did well, it actually helped Masimo grow. Yes, I don't think we are looking at losing money with any of this.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

Okay. No, no, fair enough. I mean, again, I think the one thing that's really hard to tease out or tell right now is, you know, these are entirely new categories, that you're entirely new channels that you're marketing and selling into, which I think is why I'm just trying to gauge out the sensitivity around spending and then the uptake. It sounds like that's right now not expected to be an issue or a problem. Maybe shift into a different follow-up here.

Joe Kiani
Chairman and CEO, Masimo

Well, Jason.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

You know.

Joe Kiani
Chairman and CEO, Masimo

Maybe that's actually not a bad thing you're raising, is maybe there's confusion out there. Remember, that's why we bought Sound United. There's 400-500 salespeople at Sound United that were there when we acquired them that are gonna be helping these new products. While it is a new category for Masimo for the combined entity, we're not hiring people to support these launches. That's why we bought Sound United.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

Yeah. Understood. Yeah. I'll handle some more there maybe in follow-up line here. From, from a competitive perspective, I guess I'm just wondering if you're seeing any changes in practices or tactics, with your main patient monitoring co-competitor out there, evaluating some alternatives to its business. I'm not asking you to speak, you know, ill of a, of a, of a peer, but, you know, is there a distraction with that group, or have you seen them turn more aggressive? Just any shift in behavior there, just with that asset being up for potentially up for sale or, being spun off?

Joe Kiani
Chairman and CEO, Masimo

Well, it never helps to underestimate your competitors, but on the healthcare side, I think they've tried everything. They can't slow us down. I hope to one day say that about the consumer side.

Jason Bednar
Managing Director and Senior Research Analyst, Piper Sandler

Okay. Thanks, guys.

Operator

Your next question comes from Jayson Bedford with RJ. Your line is open.

Jayson Bedford
Managing Director and Senior Research Analyst, Raymond James

Good afternoon. Just a couple questions. I guess just on the pipeline here, where do you stand with the timing of FDA clearance for both W1 and Stork, then just walk through the decision to launch Stork without clearance?

Joe Kiani
Chairman and CEO, Masimo

We don't know, and we don't want to guess at when they're gonna approve things. We're delighted that we got Opioid Halo cleared, and we hope the rest will clear as well. The decision to launch Stork is because it's a baby monitor. If you notice, we are not making alarm monitoring claims or things like that. There's a significant business out there without making or needing to make those claims. We decided to begin the sales of these products, given that we were seeing the high interest of the retailers that we're talking to without making those claims. Of course, as soon as we get the FDA clearance, we will announce that, then I think it should help as well.

Jayson Bedford
Managing Director and Senior Research Analyst, Raymond James

Okay. Just off topic here or a different topic. Is there any way to parse out the incremental cost related to the Apple suit in 1Q and then just on the retrial from an expense standpoint, are most of these costs sunk, or would you expect a similar spend on round two?

Joe Kiani
Chairman and CEO, Masimo

You know, we're not new to defending our IP, but we are new to people just exercising the hell out of the court with motions. I think the number of motions Apple filed that was leading up to this trade secret trial were about three times what we're used to. It's funny you say that because I've been asking Micah, can we non-GAAP this extra stuff that's really related to Apple? It's not our standard stuff. Whether he gets comfortable with that or our auditors get comfortable with that, I don't know, but it is really not normal.

Jayson Bedford
Managing Director and Senior Research Analyst, Raymond James

Is there any way to quantify it?

Joe Kiani
Chairman and CEO, Masimo

I think we have. In the Wall Street Journal article, I think I mentioned-

Jayson Bedford
Managing Director and Senior Research Analyst, Raymond James

Okay

Joe Kiani
Chairman and CEO, Masimo

we've spent $55 million up until now on the Apple litigation. of course, it's not just a trade secret case, it's the ITC case and the patent case, there's a lot more to go. As I said, there's five cases. We've just begun on two of them. unfortunately, I think we're gonna spend over $100 million on these litigations.

Micah Young
EVP and CFO, Masimo

Jason, just to clarify, that's over since the inception of the cases, so it's over multiple years, about three years.

Jayson Bedford
Managing Director and Senior Research Analyst, Raymond James

Okay. Thank you.

Operator

Our next question comes from Mike Matson with Needham & Company.

Mike Matson
Senior Equity Research Analyst and Managing Director, Needham & Company

Yeah, thanks. I just had a few on the Freedom watch, and I guess the bands as well for that matter. You know, I checked out the website. It looks like it's got a $1,000 price tag on it. It seems pretty high compared to the competing products out there. Just wanted to get your take on that, especially since it's, I assume it would require a subscription as well. You know, what's, you said there was a lot of interest from the retailers in Stork. Have you seen, you know, what's the interest level been in the bands and Freedom?

Joe Kiani
Chairman and CEO, Masimo

Yeah. We have 3 price points when it comes to the wearables. The most expensive is Freedom at about $1,000. The next most expensive product is a W1 at about $500. The Freedom Band will probably be around $250. We'll have something that does biosensing, the exact same biosensing for everyone, I believe. It's just a matter of what features do they want, and are they willing to pay for those features. I've seen people get really excited about the privacy switch, which nobody else has. We'll have to see. As I've said before, our customers that we're targeting are people that have chronic illnesses and that need a serious monitor, that serious measurement, and they want it in a way that's unobtrusive.

you know, time will tell where we go. As you know, we are trying to manufacture these products in the U.S., which makes the cost of goods greater than if we were doing them in China. you know, we'll see how it goes.

Mike Matson
Senior Equity Research Analyst and Managing Director, Needham & Company

Okay. Thanks.

Joe Kiani
Chairman and CEO, Masimo

Unfortunately, due to our conservative financial officer, we haven't projected a lot of revenue for these things, so we'll see.

Mike Matson
Senior Equity Research Analyst and Managing Director, Needham & Company

Yeah. Yes. Fair point. Then just W1 in the healthcare setting, are you know, seeing any signs of traction there with that product and channel?

Joe Kiani
Chairman and CEO, Masimo

W1 right now is being really marketed by our hospital sales force outside the U.S. In the U.S., we're still waiting for FDA clearance. We had not begun putting W1 into the consumer channel, because we didn't want the consumers to think that is the watch we have in mind. We want them to first know Masimo as Freedom. That is a much more beautiful design, and has a lot more features. Now that we're have begun the pre-sales on Freedom, we're giving our consumer business team the ability if they want to begin selling W1 to their channel. That may start happening towards the H2 of the year.

Mike Matson
Senior Equity Research Analyst and Managing Director, Needham & Company

Okay. If I can just get one more in on the Q2. I know there was an earlier question, but I guess I wanna get more specific. The consensus I'm looking at, in fact, that's $591 million of revenue and $1.11 of EPS. Are you guys comfortable with that? Do you think the Street is... analysts have modeled it correctly for the Q2?

Micah Young
EVP and CFO, Masimo

Yeah. I think, Mike, when I look at the numbers right now, it looks like there wasn't consideration for the seasonality of both businesses where they traditionally step down in Q2. You know, the comps from last year, as I mentioned before, healthcare is up against a 19% comp on the growth rate last year in Q2, and non-healthcare is up against a 10% comp in Q2 last year. I think, you've got to look at that, consider that, you know, we still will see pretty heavy year-over-year currency headwinds as well, you know, similar to what we saw in Q1. Of course, you know, it starts to turn, I believe, into more of a tailwind in the back half on currency.

Make sure that you're thinking through that as well.

Mike Matson
Senior Equity Research Analyst and Managing Director, Needham & Company

Okay. Got it. Thank you.

Micah Young
EVP and CFO, Masimo

Yeah.

Joe Kiani
Chairman and CEO, Masimo

Yeah. We reiterated the full year guidance.

Micah Young
EVP and CFO, Masimo

Yes

Joe Kiani
Chairman and CEO, Masimo

the quarters might not be exactly the way you guys have put out there, we feel really good about the whole year.

Micah Young
EVP and CFO, Masimo

Yes.

Joe Kiani
Chairman and CEO, Masimo

I think that was our last question. We thank you for joining us today, and I know you guys are gonna be spending a lot of time with, Micah and Eli. Look forward to talking to you next quarter.

Operator

This concludes today's call. You may now disconnect.

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