Resmed Inc (RMD) — Q1 2022 Earnings Call Transcript

Great. Thank you, Kevin. Hello, everyone, and welcome to ResMed's first quarter fiscal year 2022 earnings call. We thank you for joining us. This call is being webcast live and the replay will be available on the Investor Relations section of our corporate website later today, along with a copy of the earnings press release and presentation, which are both available now. With me on the call today are ResMed's Chief Executive Officer, Mick Farrell; and Chief Financial Officer, Brett Sandercock. During the Q&A portion of our call, Mick and Brett will be joined by Rob Douglas, our President and Chief Operating Officer; Jim Hollingshead, the President of our Sleep & Respiratory Care business; and David Pendarvis, Chief Administrative Officer and Global General Counsel. During today's call, we will discuss some non-GAAP measures. For a reconciliation of the non-GAAP measures, please review the notes in today's earnings press release or the appendix of the earnings presentation. And as a reminder, our discussion today may include forward-looking statements, including, but not limited to, expectations about ResMed's future performance. We believe these statements are based on reasonable assumptions; however, our actual results may differ. You are encouraged to review our SEC filings for a discussion of the risk factors that could cause our actual results to differ materially from any forward-looking statements made today. With that, I'll turn the call over to Mick.

Thanks, Amy, and thank you to all of our stakeholders for joining us today as we review results for the September quarter, our first quarter of fiscal year 2022. Our first quarter results demonstrate strong performance across our business, buoyed by extremely high demand for our sleep and respiratory care devices as well as the continuing recovery of many markets from COVID-19. We achieved double-digit growth at both the top and bottom line metrics of our business. I want to be clear that achieving these results has not been easy this quarter. We are dealing with an unprecedented, what I would call perfect storm of elements, including the COVID recovery, but also including a competitor recall, a recall that's ten-fold higher than any in the industry to date, and supply chain constraints that are impacting not only our industry but multiple industries worldwide. I'm incredibly proud of ResMedians across our global teams, many of whom are working 24/7 to get our products and solutions into the hands of patients who need them most. Despite these extraordinary efforts, we know that we have not been able to meet all of the demand. As the market leader, our competitor, that is in the number two market share position, announced a recall mid-June that has created unprecedented dislocations in the market. In effect, we are facing the challenge of providing the volume for our own number one market share position and also trying to meet as much of their number two market share position as possible around the world. Given the supply chain crisis, our suppliers have been allocating components to us on the inbound side. We have, in turn, been forced to allocate our products on the outbound side to our customers. We have been clear on the guiding principles for that allocation of our products, namely that we are giving priority for production and delivery of our devices to meet the needs of the highest acuity patients first. The allocation conversations that I have with our customers are the same ones that I am having with my suppliers and their suppliers and so on up the supply chain. As an example, during the quarter, I was on a Zoom call with one of our suppliers' suppliers' suppliers' suppliers' suppliers' suppliers, and I'm not kidding. We achieved our goal with that manufacturer. And we received increased allocation from that manufacturer. But then we face the challenge and are still facing it of working with the five customers of theirs, all the way down that chain to get to us to ensure that the agreed-upon increased allocation of that component actually gets to ResMed, gets manufactured into ResMed products and then sent to ResMed customers and ultimately to patients. That's just one example of the high degree of difficulty we’re facing in our supply chain team. The supply chain analysis and negotiations are ongoing, and the situation is very fluid, changing day by day, week by week, and month by month. We have an incredible Six Sigma Black Belt-laden team of supply chain specialists working on these issues 24/7. In short, supply bottlenecks continue to restrict our access to critical electronic components, especially semiconductor chips that ultimately limit our net production output. In addition to component supply issues, the ongoing challenges of sea freight and air freight from manufacturing facilities to distribution warehouses and ultimately, the customers are increasing our costs and further impacting our ability to respond as rapidly as we want to the huge demand for ResMed products. The combination of component shortages and transportation bottlenecks makes providing a steady and smooth flow of products to the market very difficult. We are working incredibly closely with our global supply chain partners, doing everything we can to gain access to additional supplies of the critical components that we need to further increase production of our medical devices. We will continue to coordinate with all stakeholders as the situation develops. We understand that this is a difficult situation for all of our customer groups, including physicians, home medical equipment providers, payers, and the most important customer, the patient. Our number one priority will always be patients, doing our best to help those who need treatment for sleep apnea, COPD, asthma, and other chronic respiratory diseases as well as critical out-of-hospital care. Our goal is to ensure that patients get the therapy that they need, where they need it and when they need it. Let's now discuss the overall market conditions in our industry. We are seeing a steady ongoing recovery of demand in the countries that we operate in. They remain at various stages of the post-COVID peak recovery process in terms of new patient flow. We are still seeing a divergence in total patient flow and sleep lab capacity from 75% to 95% of pre-COVID levels in some countries, up to 100% plus of pre-COVID levels in others. These metrics will continue to ebb and flow as vaccines and boosters roll out globally and as new variants of the coronavirus arise and cause temporary perturbations. Our global ResMed team remains committed to working with national, state, and city governments as well as local health systems, hospitals, and healthcare providers to supply the ventilators, the masks, and the training for acute care and the transition home for affected patients. Let me now update you on our three strategic priorities as we pivot back to grow our core business. These three are: one, to grow and differentiate our core sleep apnea, COPD, and asthma businesses; two, to design, develop, and deliver world-leading medical devices as well as digital health solutions that can be scaled globally; and three, to innovate and grow the world's best software solutions for care delivered outside the hospital and especially in the home. In August, we launched our next-generation device platform that we call AirSense 11 into the United States market. In short, that launch has been very successful. We will be introducing the AirSense 11 into additional countries very soon. Our market-leading R&D team accelerated the launch of this amazing innovation. First, by expanding the controlled product launch to additional customers, and then accelerating to an earlier full product launch date to bring this product to market faster. Globally, we continue to sell our market-leading legacy platform, the AirSense 10, to maximize the total volume of CPAP, APAP, and bi-levels available for customers. Clearly, the ongoing adoption of both the AirSense 10 and the AirSense 11 platforms remains very strong. It's still early into the AirSense 11 launch, but initial customer feedback, combined with the detailed responses to our controlled product launch, tells me that the AirSense 11 is another success for ResMed. Physician, provider, and patient feedback are all very positive. I was able to attend the California Sleep Society meeting in person during the quarter, and I was able to observe firsthand the responses to the latest innovations on the AirSense 11, such as the personal therapy assistant, care check-in, and the incredible rate of uptake of the patient-centric app called myAir, which has been upgraded for AirSense 11. The uptake on that is almost double that of what it was for the myAir app on AirSense 10. What's clear to me is that this platform, the AirSense 11, benefits not only patients and their bed partners, but in addition, the device and software combination benefits physicians, it benefits providers, and it benefits payers as well as entire healthcare systems with more data, more insights, and better outcomes. As a two-way digital health comms platform with many technical features that represent significant therapeutic advances, AirSense 11 is not only easy to set up and use, but it also offers a very rich patient-centric experience. All AirSense 11 devices are 100% cloud connectable with upgraded digital health technology that can increase patient adherence to improve clinical outcomes and deliver proven cost reductions within healthcare providers and physicians' own health systems. We are engaging with patients in their therapy digitally like never before in the industry. This is a critical part of the ResMed 2025 strategy, as presented at our Investor Day, which we held virtually during this last quarter. Another key aspect of our long-term growth is linked to the awareness and the increasing flow of sleep apnea patients. With 936 million sleep apnea sufferers worldwide, this work is critical to our mission. COVID-19 has advanced awareness, adoption, and acceptance of digital health and remote care, including home-based sleep apnea tests. We want to support seamless and cost-effective approaches to sleep diagnostics. We want to scale technology that in our consumer markets enables an easy-to-use device experience and technology that, in our reimbursed markets, can be a low-cost, clinically reliable screening tool for sleep apnea. In this vein, on October 1, we closed a transaction to acquire EctoSense, a leader in cloud-connected home sleep apnea testing technology from Belgium. We believe EctoSense's digital and easy-to-use solutions in the hands of both physicians and sleep lab technicians, as well as consumers, can help significantly increase sleep apnea diagnosis rates, as well as general sleep awareness. EctoSense will operate within our sleep and respiratory care business unit, and we're excited to bring this innovative technology to more global markets as we move forward. Let me now turn to a discussion of our respiratory care business, focusing on our strategy to better serve the 380 million COPD patients and the 330 million asthma patients worldwide. Our long-term goal is to reach hundreds of millions of patients with our respiratory care solutions, including non-invasive ventilation and life support ventilation, as well as newer therapeutic areas such as cloud-connected pharmaceutical delivery solutions and high flow therapy offerings. Demand for our core non-invasive ventilation and life support ventilation solutions for COPD and beyond was strong throughout the quarter, especially in markets outside the United States where physicians and providers shifted focus to support the most severe highest acuity patients. This demand aligns with our strategy to ensure priority for manufacturing and delivery of the devices that meet the needs of those patients, specifically those that need life support ventilation or non-invasive ventilation, including bi-level support first. We are balancing the growth in the respiratory care demand with the supply of ventilators that made it to market throughout the coronavirus pandemic, as well as customers as they balance their inventory with ongoing acute and chronic ventilation patient needs. We continue to see rapid adoption of the AirView for ventilation software solution that we launched in Europe a little over a year ago, and we continue to expand this technology to regions around the world. The value being provided through AirView for ventilation has been very helpful to physicians not only during COVID, but it is increasingly valuable on an ongoing basis for them and the health care systems that they operate in. In the not-too-distant future, I can see AirView becoming the standard of care for patients on home-based ventilation protocols in many health care systems. Let me now review our Software as a Service business for out-of-hospital care. During the quarter, our SaaS business grew in the mid-single digits year-on-year across our portfolio of markets, including home medical equipment as well as facility-based and home-based care settings. The continued growth of home-based care is providing tailwinds for our home medical equipment and our home health products, and we continue to grow with customers as they utilize our software and data solutions, including Brightree and Snap ReSupply to improve and optimize business efficiencies and patient care. The COVID-19 pandemic has been challenging for some verticals in our SaaS business, particularly skilled nursing facilities. However, we are seeing positive trends as census rates of patients improve across SNFs and other facility-based care settings. We will continue to watch this closely as COVID cases ebb and flow at slower rates around the country. We expect there to be pent-up demand for technology investments in these SaaS verticals, which provides opportunities for us to increase our new customer pipeline as COVID restrictions continue to ease. As we look at our portfolio of software solutions, we expect SaaS revenue to accelerate, increasing from mid-single-digit growth to high single-digit growth by the back end of this fiscal year. As always, our goal is to meet or beat these market growth rates as we continue to innovate and take market share. We are the leading strategic provider of SaaS solutions for out-of-hospital care, and we provide mission-critical software across a broad set of very attractive markets. We are uniquely positioned, and we have created differentiated value for ResMed with our SaaS portfolio. We are set up for sustainable growth through ongoing innovation investments, commercial excellence partnerships, and future acceleration through strategic M&A as well as selective tuck-in M&A opportunities. Looking at the portfolio of ResMed's business across sleep and respiratory care as well as our SaaS solutions, we remain confident in our long-term strategy and our pipeline of innovative solutions. Our patient-centric, physician-centric, and provider-centric approach, combined with our unique ResMed culture, means that we are well positioned to continue winning in the vastly underserved respiratory medical markets of sleep apnea, COPD, asthma, and other chronic diseases. We are transforming out-of-hospital care at scale. We are leading the market in digital health technology. With over 10 billion nights of medical data in the cloud and over 15.5 million 100% cloud connectable medical devices on bedside tables in 140 countries worldwide, we are unlocking value from this data to help patients, providers, physicians, payers, and entire health care systems. Our mission and goal to improve 250 million lives through better healthcare in 2025 drives and motivates me and ResMedians every day. We again made excellent progress toward that goal this quarter. Before I hand the call over to Brett for his remarks, I want to once again express my sincere gratitude and thanks to the more than 8,000 ResMedians for their perseverance, hard work, and dedication during these ongoing and unprecedented times. You, our ResMed team, have helped save the lives of many hundreds of thousands of people around the world with COVID-19, with those emergency needs these last 18 months. And you are now and you have now already pivoted back to provide ongoing support for all of our customers during some of the most challenging industry dynamics that we've seen in the industry. Thank you. With that, I'll hand the call over to Brett in Sydney, and then we'll open the call up for Q&A.

Great. Thanks, Mick. In my remarks today, I will provide an overview of our results for the first quarter of fiscal year 2022. As noted, all comparisons are to the prior year quarter. Group revenue for the September quarter was $904 million, an increase of 20%. In constant currency terms, revenue increased by 19%. Revenue growth reflected increased demand for our sleep and respiratory care devices, driven by both sleep patient flow recovering from the COVID-19 impacted reduced levels experienced in the prior year quarter and by increased demand in response to the recent product recall by one of our competitors. In the September quarter, we estimate the incremental revenue from COVID-19-related demand was approximately $4 million compared to $40 million estimated incremental revenue from COVID-19-related demand in the prior year quarter. Excluding the impact of COVID-19-related revenue in both the September 2021 and September 2020 quarters, our global revenue increased by 25% on a constant currency basis. Looking forward, we expect negligible revenue from COVID-19-related demand. In relation to the impact of our competitors' recall, we estimate that we generated incremental device revenue in the range of $80 million to $90 million in the September quarter. Taking a look at our geographic revenue distribution and excluding revenue from our Software as a Service business, our sales in US, Canada, and Latin America countries were $491 million, an increase of 22%. Sales in Europe, Asia, and other markets totaled $315 million, an increase of 23%, or an increase of 21% in constant currency terms. By product segment, US, Canada, and Latin America device sales were $276 million, an increase of 40%. Masks and other sales were $215 million, an increase of 5%. In Europe, Asia, and other markets, device sales totaled $218 million, an increase of 24%, or in constant currency terms, a 22% increase. Masks and other sales in Europe, Asia, and other markets were $97 million, an increase of 21%, or in constant currency terms, an 18% increase. Globally, in constant currency terms, device sales increased by 31%, while masks and other sales increased by 8%. Excluding the impact of COVID-19-related sales in both the current quarter and the prior year quarter, global device sales increased by 44% in constant currency terms, while masks and other sales increased by 10% in constant currency terms. Software as a Service revenue for the September quarter was $98 million, an increase of 6% over the prior year quarter. For the balance of fiscal year 2022, we expect several factors will drive demand, including the general recovery of the global sleep market from COVID-19 impacts, the ongoing launch of our next-generation AirSense 11 platform into additional markets and geographies, and share gains during our competitors' recall. However, as reported last quarter, while we are working hard to increase manufacturing output, we will not be able to meet the expected demand resulting from our competitors' recall, primarily because of significant and ongoing supply constraints for electronic components. As Mick discussed earlier, we're operating in a very dynamic supply chain environment. Based on the latest information available, we continue to expect component supply constraints will limit the incremental device revenue resulting from our competitors' recall to somewhere between $300 million and $350 million for fiscal year 2022. This includes the device revenue we were able to generate in Q1. In particular, we now do not see any improvement in our component supply position until our fourth quarter of FY 2022. During my commentary today, I will be referring to non-GAAP numbers. We have provided a full reconciliation of the non-GAAP to GAAP numbers in our first quarter earnings press release. Our non-GAAP gross margin decreased by 270 basis points to 57.2% in the September quarter compared to 59.9% in the same quarter last year. The decrease is predominantly attributable to higher manufacturing and freight costs, ASP declines, and unfavorable currency movements, which have been partially offset by a positive product mix, particularly in relation to strong growth of our higher acuity devices. Moving on to operating expenses. Our SG&A expenses for the first quarter were $177 million, an increase of 11%, or in constant currency terms, SG&A expenses increased by 10% compared to the prior year period. The increase was predominantly attributable to an increase in employee-related expenses. SG&A expenses as a percentage of revenue improved to 19.5% compared to the 21.1% we reported in the prior year quarter. Looking forward and subject to currency movements, we expect SG&A as a percentage of revenue to be in the range of 20% to 22% for the balance of fiscal year 2022. R&D expenses for the quarter were $60 million, an increase of 10% on a constant currency basis, an increase of 9%. R&D expenses as a percentage of revenue was 6.6% compared to 7.3% in the prior year quarter. We continue to make significant investments in innovation because we believe our long-term commitment to technology, product, and solutions development will deliver a sustained competitive advantage. Looking forward and subject to currency movements, we expect R&D expenses as a percentage of revenue to be in the vicinity of 7% for the balance of fiscal year 2022. Total amortization of acquired intangibles was $19 million for the quarter, and stock-based compensation expense for the quarter was $17 million. Our non-GAAP operating profit for the quarter was $281 million, an increase of 18%, underpinned by strong revenue growth. During the quarter, we finalized the deed of settlement with the Australian Taxation Office, or ATO, covering transit pricing audits for the years 2009 through 2018, and also agreed on transfer pricing principles for the future. In anticipation of this settlement, we had previously estimated and recorded an accounting tax reserve of $249 million, net of credits and deductions in our FY 2021 financial results. In relation to the conclusion of the settlement in the current quarter, we recorded an additional GAAP tax expense of $4 million associated with lower tax credits, which were driven by foreign currency movements. On a GAAP basis, our effective tax rate for the September quarter was 21.3%, while on a non-GAAP basis, our effective tax rate for the quarter was 20%. Looking forward, we estimate our non-GAAP effective tax rate for the fiscal year 2022 will be in the range of 19% to 20%. Non-GAAP net income for the quarter was $222 million, an increase of 20%. Non-GAAP diluted earnings per share for the quarter were $1.51, an increase of 19%. Our GAAP net income for the quarter was $204 million, and our GAAP diluted earnings per share for the quarter was $1.39. We had negative cash flow from operations for the quarter of $66 million due to the payment of $285 million to the Australian Taxation Office associated with the deed of settlement. After adjusting for this payment, our operating cash flow for the quarter was $219 million, reflecting robust underlying earnings, partially offset by increases in working capital. Capital expenditure for the quarter was $27 million. Depreciation and amortization for the quarter totaled $39 million. During the quarter, we paid dividends of $61.2 million. We recorded equity losses of $1.4 million in our income statement in the September quarter associated with the Primasun joint venture with Verily. We expect to report equity losses of approximately $2 million per quarter through the balance of fiscal year 2022 associated with the joint venture operations. We ended the first quarter with a cash balance of $276 million. At September 30, we had $806 million gross debt and $530 million in net debt. Our debt levels remained modest. And at September 30, we had almost $1.5 billion available for drawdown under our existing revolver facility. In summary, our liquidity position remains strong. Our Board of Directors today declared a quarterly dividend of $0.42 per share, reflecting the Board's confidence in our operating performance. Our solid cash flow and low leverage provide flexibility in how we allocate capital. Going forward, we plan to continue to reinvest for growth through R&D. We will also likely continue to deploy capital for tuck-in acquisitions such as acquisitions like Health and EctoSense, an acquisition we made on October 1. And with that, I will hand the call back to Amy.

Great. Thanks, Brett, and thanks, Mick. Kevin, I'd like to now turn the call back over to you to provide instructions and then run the Q&A portion of the call.

Good afternoon, and I hope everyone is doing well. Mick, the first question is how do you ensure that your devices are going to new patient fits versus a replacement device for Phillips?

Thanks, Matthew. In markets where we are fully vertically integrated, such as Germany, South Korea, Australia, and New Zealand, we can directly engage with patients and doctors to facilitate our processes. However, it's more challenging in markets like France and the US where we collaborate with providers. Our competitors have made it clear that they are focusing on getting people to register their devices and plan to spend the next year just on replacing those devices. This approach is more of a theoretical obligation for them. Our goal is to address the demand we see directly from patients in integrated markets as well as through distributors. We believe that the overwhelming majority of our devices are allocated to new patients. While some may be going to replacement patients looking for quicker options than the Philips process, most are indeed for new patients. The challenge we face is becoming the top player while also addressing the demand from the second-place competitors. We have reached the limit of critical components coming in, which prevents us from fulfilling all new patient demand due to supply chain issues.

Thanks for taking my question. Look, Mick, I know when you set the guidance of $300 million to $350 million for the recall, you were sort of unable to quantify masks and reluctant to do so. I was just hoping for an update today on whether you are seeing, in fact, any associated benefit on your mask sales due to the significant increase in CPAP that you've seen in the quarter?

Thank you, Chris, for your question. We don't typically provide detailed guidance, but we have shared some estimates due to the varying sell-side expectations for incremental revenue. Last quarter, we mentioned rough guidance of $300 million to $350 million related to devices. This estimate is not precise because it entails predicting over a 12-month period in an uncertain environment. As Brett noted, we are maintaining that guidance, especially since we expect $80 million to $90 million from this quarter. The remaining amount will be pursued over the next nine months. On the mask side, the situation is complex with many factors at play. Our global mask growth was 8% this quarter, while in the US, it was around 5%. Challenges arise since our second competitor is not taking on as many new patients as they should, affecting our ability to meet all the demand, leading to fewer new patients being set up. Despite this, ResMed has a strong uptake rate of over 50% for masks on new devices, regardless of the manufacturer, which is a disadvantage for us if new patients aren’t receiving therapy. Conversely, when a ResMed device is involved, there’s a higher likelihood of success due to their compatibility. Doctors and therapists often prefer our brand, leading to good uptake rates. However, the challenge remains that if a competitor does not provide a device, mask sales also suffer. Therefore, US mask growth is limited to around 5%, while the industry struggles to address the increasing upfront demand. It’s a complicated situation for us to model at both customer and country levels, which I understand presents challenges for analysts on the sell-side too.

Thanks. Mick, if I could just get you to touch on the guidance, the $300 million to $350 million. I mean, given we've seen $80 million to $90 million come through this quarter. Could we just talk a little bit about how you expect this to be phased through the rest of the year, given the supply side constraints, please?

Yes. Thanks, David. And as I said in the prep remarks, there's a perfect storm hitting the industry. And so there's so many dynamics impacting us that I'm going to call this afternoon working on this. I'm shifting my attention, which usually focuses purely on customers and governments and making sure the demand is there for this is an amazing industry that we serve and sleep apnea and asthma, and I'm spending a lot more time with suppliers. So with that, our best reading of the future flow of components is that you look at it, and as Brett said in the prepared remarks, that we actually had reasonably good flow, some through inventory and working through that in the quarter of $80 million to $90 million here in the first quarter. It's going to be very difficult here in the December quarter with component shortages and very difficult in the March quarter with component shortages. I do think the components, as we are getting some increased signals and actually doing some great engineering to work around different suppliers and to design in new components. I feel much more confident about the June quarter 2022, so our Q4 fiscal year 2022. And so that's sort of qualitative guidance to it. We're not modeling it out. We've got the $300 million to $350 million. You can subtract off the $80 million to $90 million and model it. But if I was looking at it, it would be tougher in December and tougher in March right now and then freeing up in the June quarter and then September quarter, even more so as some of our new designs and new components get to roll in and we get that flow going. But look, it's changing day by day, week by week. I'm looking forward to my call this afternoon to potentially impact that. But even if I get agreement with someone today, it takes quite a while, as I explained sort of with that example of the five levels deep in the supply chain to get that to flow through from a foundry, to a chip manufacturer, to our factory, to a product, to the warehouse to then be able to sell it to a customer. So I know that's not a specific quantitative guidance, David. It's probably the best I can give you in terms of color for fiscal year 2022. And the hope we have in Q4 and Q1 2023, as we start to see those components really start to free up.

Hi, Mick. I hope everyone is safe and healthy. Hey, Mick, specifically, on the Philips recall, if I could, could you walk us through the dynamics in the U.S. versus OUS? How sticky are these share gains? And unless our math is wrong, it almost comes across like there is some sort of mix and match on the masks versus the devices. Just give us some additional color. And really what we are trying to understand is, okay, you get $350 million, $400 million, whatever million incremental, how sticky are these? And how do you all plan for this? Thank you for taking my questions.

Thanks for the question, Suraj. And since I've answered the first three, I'll just correct that our guidance was $300 million to $350 million, not $350 million to $400 million, what you just said, but $300 million to $350 million for the fiscal year. But Jim Hollingshead, you run this business. Do you want to give as much as you can on the color to Suraj?

Sure. Thanks, Suraj, for the question. I think it's a very good question. And I'm just going to back up to what we're trying to do in the business, independent of the recall and then talk about the context of the recall. With the launch of AirSense 11, our aim is to put in place a product that once again significantly improves the patient experience and significantly improves workflows and lowers costs for providers and also puts us in the position midterm, long-term to improve outcomes. So AirSense 11 is a device that we put on market anticipating long-term share gain. And we have internal goals for that number. And we don't talk about that number publicly, but our plan was to take share with that device. We're launching that device now into a situation where the number two player in the market is out of the market for new patients. And so obviously, we're going to take quite a lot of share as we can put that product into the market. And we have the two best products on the market in AirSense 10 and AirSense 11. So your question is how sticky will that share be? Our goal is to make it quite sticky. But obviously, we have good competitors in this market, and we don't anticipate landing at 100% share when they recall clears, but we want to have a number that's higher than what it was before we launched AirSense 11, and we're pretty confident we can do that. And just to cap on that, the answer is probably already too long, but to cap on that, I will say that we've managed to take a few points of mask share during the recall as well, and our aim would be to keep some of that share as well. So I think we will emerge from this stronger than when we entered it. And our offerings are clearly the best offerings on the market.

Thanks. Good morning, everyone. Just on U.S. masks, I just wanted to touch a little bit more on that, given that it did disappoint slightly versus expectations. So has there been any change to the Resupply dynamics in the U.S. market in the quarter?

Thanks, Gretel. I'll have a go and maybe Jim can join in as well. But I get the Resupply is actually very strong. We have Brightree Resupply. We also have Snap technology that has been incorporated into our Brightree platform that has driven incredible Resupply. If you remember, that really was going strong throughout 2020. So we have some incredibly high comps when you look at the percentage growth rate of masks from this quarter a year ago, even despite COVID hitting this time a year ago, our mask Resupply and maybe because of that somewhat with the HMEs focusing on it, our mask Resupply was through the roof this time of a year ago. And even with those comps, we're still achieving some very good rates in Resupply. As I said, there are headwinds in it when we're not taking care of all new patients, and ResMed gets well over 50% of all masks, some new patients, no matter whose device it is, in the global market. That's a headwind that we're dealing with while this recall continues. But the tailwinds of Resupply are actually well incorporated into those figures. And I think if you look outside the U.S. market, look at Europe, Asia, and the other 140 countries we operate in, you saw pretty strong 18% double-digit growth in masks in those areas and global growth of around 8%, which is very strong given the headwinds of new patient setups. But Jim, any further color on the U.S. or beyond?

Yeah. I would just say, probably end up repeating some of the key points, but we had a very large comp. And there was a tailwind created by COVID, which is patients, we've talked about this before over the last three or four quarters, but patients are more focused on having clean masks. I mean COVID has created a mentality if I want a new mask; I want a fresh mask for patients. And then our HME customers in the U.S. have been focused on driving resupply into their installed base of patients. And I actually think that within the context of the Philips recall, driving revenue out of the installed base of patients has once again become quite an important emphasis for our HME customers. And then there are headwinds. The headwinds of the whole market is not being served, so new patient starts are down. And because we had slower new patient starts during the span of COVID overall, because labs weren't open, there's a little bit of headwind on Resupply because the installed base didn't grow during that period the way we might have anticipated it to. So it balances out. The dynamic inside of the installed base is quite good. So the installed base of patients continues to be resupplied at a very healthy rate.

Thanks. Just the question for me was on the different regions, which are trending below pre-COVID levels and which ones are above. Could you just give any color which different markets are and in which category? Thanks.

Thanks for the question, Craig. I'll hand that to Rob Douglas, our President and Chief Operating Officer.

Yes. Thanks, Craig. The issue really is that all of our markets are performing very strongly. The actual recall impacts it globally. So we're seeing that really excess demand. And just with different dynamics, as Mick said before, you saw that very strong in the mask on all of it. I actually couldn't call out any particular region and say it wasn't doing really well. There are specific countries, and sometimes it's local when there's a lockdown, there might be a shortage of diagnosis capacity, and you'll see that. But our teams really run through that and manage around that. And as I said, just to recap, the strong performance was across all countries.

Yes. And I'll add on maybe just a little bit of color there, Craig. I mean it's hard to say, because you said, what regions, and as Rob said, we can't say what regions. And even if you would ask a more specific question, what countries. It'd be difficult to say there, because in the U.S., there are 50 states with all different regulations, and some of them are 100% plus capacity and some are at 75%, 80% within the state level. And then cities going up and down, and China is not just there. It's different regions there as well. So there are ebbs and flows on a daily, weekly, monthly. But what we can say is on aggregate, it is getting better and better. And it's nice to see some cities, some states, some countries at 100% plus that they're getting through it, they're finding ways to embrace digital health, home sleep apnea testing, and remote setup, so that we're able to get the flow of patients going through. Then the challenge we have right now is that we don't have the components of those patients with prescriptions come through to meet all that demand, which is the real critical rate limited right now as well. Thanks for your question, Craig.

Thanks very much. Good morning, Mick and Brett. Just as part of the recall, ResMed is going to be getting more exposure through the patient referral network. I'm just wondering if you've had any feedback or observations from physician, DMEs, patients in relation to ResMed's product offering. Just wondering if there's any observations from that group that may have used ResMed less frequently before.

Yes, David, it's a good question. I think everyone had exposure to ResMed products. We're the market leader; everyone knew the brand name. Everyone had tried it, and we get a large percentage of the prescriptions and actually the share in the 140 countries we operate in. But as you said, there are some doctors who liked a particular aspect or a technical aspect or an emotional aspect really or a workflow aspect of some of our competitors' devices or software systems. And to your question, they are getting, if you like, forced exposure, because it's the only one available for new patients, to ResMed's amazing innovation on the device, the software, the systems and the flow. And if they had some form of prejudice of a device from the '90s that they tried or something and have been stuck with the brand, they're now trying a new brand. And I do think, to Jim's point earlier, that some of that brand-new share of somebody who was in another brand's componentry area says, wow, this actually is great. My prejudice was wrong. And I think we will get a lot of that share that we'll maintain forever. And I think certainly, the exposure of patients to the brands and to understand that has increased. I mean, the Net Promoter Score for ResMed amongst patients is rising, and the knowledge about the brands, for better or for worse, through this awful recall is they're getting to know what device they have. And that awareness is actually good for the whole industry because I think physicians and providers and technicians have always been aware of the brands and had prescription biases and others that we absolutely influence through our really strong commercial, clinical sales teams. And now we're getting that brand name to new customers as well. So I mean, the short answer to your question is yes, we've got exposure to new consumers, new physicians, new providers. And we think a lot of that will be sticky because of the value we provide. The brand is the brand that represents a 50% lower labor cost if you're setting up a patient when it represents three less clicks to get a report, when it reflects an API that can link into your Epic or your Cerner or your National Health Trust system really efficiently, it becomes really part of your day-to-day workflow. And that's the type of share that we think is part of the ResMed brand and will maintain our strong growth for a long period to come through for this period.

This is Maggie Boeye on for Margaret. I wanted to ask one on gross margins today. I would say that the gross margins for the quarter came in a little bit better than expected, although still contracting. Can you talk about some of the dynamics within that and how you are leveraging the increase in cost given the supply constraints and the freight issues today? And how you are looking at future gross margins specifically in the upcoming quarters? Thanks.

Yes. Brett, I'll hand that question to you.

Yes, thanks, Mick. Hi, Maggie. The gross margin is fairly consistent with where we were in Q4. The main factor impacting us is the significant freight costs, which remain a considerable challenge. Additionally, we've been dealing with some foreign exchange impacts this quarter. However, there was a slight benefit from the product mix, particularly with higher acuity devices, like the Astral sellers and ASV devices, which helped improve the total product mix and contributed positively to the gross margin. Despite this, we still face challenges and pressures regarding freight and component costs that we need to monitor. Overall, I am quite pleased with how the gross margin turned out for the quarter.

Thank you. Good morning, Mick, and good morning team. Great numbers. Mick, I understand you usually don't discuss what you've noticed regarding pricing or product mix for the quarter. However, you've mentioned supply constraints, yet you have still delivered the device numbers. Could you help us understand what you've observed about the price and volume mix during the quarter? Thanks, Mick.

Thank you for your question, Sean. You’re right that we don’t go into details about pricing. However, these are unprecedented times with respect to costs. As mentioned in Brett's previous response regarding gross margin, freight costs are high. Currently, there are more than 100 ships waiting just two hours north of me on the I5 stack near Long Beach. This backlog means that sea freight inventory is piling up and coming through at the highest costs we've seen. We have even chartered planes to fly our products from Singapore to Los Angeles and Atlanta to meet this demand. These actions significantly increase our costs. While these are consumer planes, they are only transporting ResMed devices, which has also affected our expenses. With the launch of AirSense 11, we are implementing a price premium due to the exceptional innovation it brings; it is not only the best product we have offered in eight years, but arguably, the best in the market overall. This innovation justifies a price premium. We are also working with customers to adjust discounts and rebates that are no longer applicable. This is a daily discussion with our commercial team, tailored customer by customer and region by region. While we cannot absorb all the increased costs, we are actively finding ways to address this with our customers over time, ensuring we take care of every patient that comes to us. This commitment was evident in the last quarter.

Hey, guys. This is Frank on for Anthony. Two questions from our side. Number one, what's the reception to Philips' recent US clearance of the replacement abatement among US DMEs? And then a follow-up. We're hearing a lot on US hospital staffing shortages. Is there a potential tailwind for Matrix Care, or what are some of the dynamics there looking ahead for the rest of the year?

Thank you for the questions, Frank. I really don’t have insight into what customers think about the replacement phone compared to our competitor's replacement devices. That's something for them to handle. If I were a patient, I would prefer to replace a device rather than a phone. However, I cannot speak to that. There has been a notable lack of strong communication on this issue publicly, and I have no additional information to provide. Regarding the US hospital situation, as I mentioned in my prepared remarks, we are observing a rise in census rates at skilled nursing facilities as more patients are filling beds. We believe there is pent-up demand for technology to assist with this. Rob, do you have any additional insights on MatrixCare and Brightree home health and hospice?

Absolutely. A fundamental aspect of our SaaS strategy has been the ongoing challenge of recruiting and retaining the right staff, along with managing the training costs, to ensure that there is a high-quality patient experience. This is an issue faced by all care providers, not just hospitals. We believe our technology solutions improve the working environment for staff, making it easier for them to perform their duties, facilitating training, and increasing retention rates, while also enhancing efficiency. Therefore, staffing challenges are a key factor in our strategy, similar to how Jim mentioned that concerns about cleanliness and respiratory health influence our core sleep strategy. The difficulties related to staffing are a long-term driver of our SaaS strategy and will ultimately benefit the business. Despite many short-term challenges, we are witnessing improved performance, particularly within skilled nursing facilities across our SaaS businesses.

Thanks. Good afternoon Mick. I just wanted to ask, I imagine it's quite difficult to differentiate what sales of devices are relating or going into the Philips opportunity versus the organic growth of your business. But if I do strip out the $90 million out of your device revenues for this quarter and then strip out the $40 million of vent sales in the PCP, you're getting in excess of 20% growth. Is that how you characterize what's going on with the new patient starts?

Steve, thanks for the question. And yes, good morning to you there in Australia. I think you're not wrong that we would have very strong double-digit growth. And that actually makes sense and has traditionally happened when we launch a new product like the AirSense 11 as our first platform launch in eight years. And as I said in my prep remarks, I mean, I'm blown away by things like the personal care system, watching the care check-in personal therapies or watching the sleep technicians and sleep doctors live at that California Sleep Society engage not just with the presentation from the marketing teams, but then sitting down with the clinical teams and walking through this device, I think it's a device that deserves to take double-digit growth and take a lot of share. And so I think your calculations there are spot on in terms of this is double-digit growth time for ResMed in the device space irrespective of this competitive recall, irrespective of the comps that we had around COVID and vents and the tailwinds of vents and headwinds of sleep apnea patients coming in a year ago that we're seeing really strong growth of the sleep space. And as Jim said earlier, our goal is to entrench people in these amazing workflows that have lower costs and better outcomes and drive therapy to patients in ways never seen before. The part that I'd highlight is this huge take-up of patients signing on to Mya and having a personal relationship with their therapy through the smartphone with Mya is at unprecedented levels. I'm talking double the uptake of AirSense 10. That's one of the highlights that I think has been missed through this. So, Steve, thanks for the question and the opportunity to highlight that.

Thank you. I was just hoping to get a little more color on where you think the sleep testing capacity is in the market. Are we back to pre-pandemic levels? So just give us a little more color on new patients and where you think that is kind of trended over the last couple of quarters.

Great question, John. I'll hand that to Jim Hollingshead.

Thanks, John. As mentioned in Mick's remarks, testing capacity is largely back to normal. In the US market, we are mostly back to normal, and there may even be some upside as home sleep testing has been more widely adopted by sleep labs during the COVID crisis, which might not have happened otherwise. While there are likely still a few fewer people going to labs, the use of home sleep testing has broadened significantly. Overall, testing capacity in the US is back to normal, possibly slightly improved, even though the structure of it looks a bit different. Additionally, the situation varies quite a bit depending on developments with the Delta variant and the status of health care systems. Generally speaking, new patient starts in Europe are approaching pre-COVID levels, although there are some variations by country. Some health systems may still be somewhat backed up, particularly hospital-based ones, where the diagnosis may have caught up but the capacity to initiate therapy could be a bottleneck. There is pent-up demand and similar issues, but in general, we are nearly back to normal. I’d also like to mention that one reason we chose to proceed with the acquisition of EctoSense is to simplify the process for patients to determine if they have a sleep issue. In some markets, EctoSense will serve as a screener, while in others, it is currently used as a diagnostic tool. The technology provides a very straightforward and easy patient experience, and we are leveraging this acquisition to further enhance access.

Good morning, everyone. Thank you for taking my question. I just wanted to talk about inventory levels a little bit, both at ResMed and also at the distributors. So in your balance sheet, I see higher inventory levels compared to last quarter. Can you talk about what that might mean for device sales going into the second quarter? But then also, if we look at the different regions you're operating in, from our perspective, we're seeing greater bottlenecks at set up in the United States than in Europe. So do you have a sense of what inventory levels are like with your distributors between the United States and Europe?

So that's a great question, Lyanne, and quite detailed. I'll hand the first part of the question about ResMed's inventory and what's been happening with the build-up there to Brett. And then I'll hand the second part about the inventory at the HMEs, HCPs, and distributors, as they call them in Europe, between the US and Europe to Jim Hollingshead. So Brett, over to you first, and then Jim.

Thank you, Mick. Hi, Lyanne. Regarding the inventory, a significant portion relates to the raw materials in our stock. This situation has arisen mainly due to the elongation of supply chains along with the bottlenecks and congestion we are experiencing. We're aiming to support production in anticipation of increased demand for electronic components. Therefore, we have several components ready to deploy once we receive the electronic parts. We're being quite intentional about this and looking to boost safety stocks in response to the supply chain disruptions. Additionally, the increased lead times for sea and air freight have extended up to two to four weeks, which has resulted in us carrying more inventory. Many companies might face similar challenges due to these logistics delays, which are leading to increased stock in transit. Furthermore, we're currently operating the dual AS 10 and AS 11 platforms to meet market demand, which is somewhat atypical for us. These various factors are contributing to a slight rise in our inventory levels. However, our inventory days remain reasonable, and the main goal is to support overall production when we receive the necessary components.

I'll just add to Lyanne's question by saying that our customers and distributors currently have very little inventory and are operating with unusually low levels. When you remove the second largest manufacturer from the market and fail to meet demand, it creates a very challenging situation. We are reporting what we believe is a strong quarter, but we are working hard to increase our manufacturing supply and deliver products to the market. The manufacturers in our industry are not meeting demand, which has placed our customers in a tough position, and we recognize their frustration. We are doing everything we can to produce and deliver products as quickly as possible because we understand that the market is undersupplied, which is putting significant pressure on our customers.

Thanks very much, guys. Apologies if the line's a bit crackly. But Mick, just a quick question on SaaS, you mentioned growth increasing to the upper single digits by the end of fiscal 2020. Can you just talk to what the drivers of that increase are, what the key drivers of that uplift are likely to be, give you that confidence?

Thank you. I'll start and pass it to Rob for additional details. We have Bobby Ghoshal as our new President of the SaaS division, and he has made significant progress in his first five weeks. We are seeing promising opportunities for growth acceleration. The issues I mentioned earlier about skilled nursing facility census are improving, leading to increased demand. Our pipeline is strengthening, which is positive for the SaaS business since a growing pipeline typically leads to conversions and eventually revenue. We have good visibility for growth over the next three to nine months, and I'm confident that as census rates improve, the MatrixCare business will begin to grow rapidly. Additionally, Brightree and Snap are seeing strong adoption of new resupply tools and innovations from the Brightree R&D team, with Bobby’s previous experience as COO contributing valuable insight. I believe that momentum will continue throughout the fiscal year. Rob, with the eight verticals we have, what other factors do you see that could further enhance this business?

I think you've covered many of them, Mick, but also there's a real execution focus on the team, and we're really confident that they're driving execution. Mick mentioned the innovation. There's a strong innovation mentality in that team. And we've got great new offerings and great new ideas coming to market as well as really streamlining our focus. And a lot of it's also execution on the sales front and having the sales team being able to build the pipelines and then increasingly doing face-to-face visits in getting these deployments underway as things ease up. So we've got a lot of confidence in that business.

Good morning. Thanks very much. Just looking at the fourth quarter, you guided to this $300 million to $350 million. And at that time, you were quite explicit that we should not expect the uplift until the second half. And now today, you're suggesting uplift comes in the first quarter and fourth quarter, and you delivered almost, what, 30% of that total up 54% in the first quarter alone. So – and on top of that, Brett just said you've got the small material inventory build. So can you explain what has – what's changed since then? And why – what mechanics of this drop off in second, third quarter would be? Thanks.

Yeah. Thanks, Dan. So look, it's a complex and moving dynamic. But the rate-limiting step here is electronic components and specifically the semiconductor chips from a particular manufacturing and a supply chain that, I know the names and the people and I'm talking to them to try and get this supply. The trouble is that there are multiple other industries. And demand for semiconductor chips that are through the roof. And obviously, everyone on this call follows many other industries. You've heard this, we're not alone in the medical device industry; automotive industry, consumer communications industry, even consumer products are often cloud connected now and have these limitations. So look, things haven't gone better these last 90 days in terms of supply. They've got very difficult. And our visibility, as I look at the June quarter, I feel very confident in the semiconductor chips coming through. But in December and March, it's hand to mouth of these devices and chartering planes and working with redesigns to make sure the semiconductor chips go so much in. And so our best reading of the dynamics, even though we feel in aggregate, that $300 million and $350 million, which is a pretty broad range in itself and has some plus or minus on the top and the bottom end of it, that we feel stronger on that June quarter with the supply that we see coming through, whereas it's not as strong. I'm closer to the December one now, and I know it's going to be tough and March as well. But look, things can change on a day-by-day, week-by-week, month-by-month. And what we're doing is we're being as open as we ever have around supply chain as open as we ever had and transparent about sort of the variability, if you like, of the flow of these components that come in. I can tell you though, we get one more chip, it goes into one more device and goes to one patient. And that's the truth. There is no stockpiling of this inventory. It goes all the way straight through to production. And we have an incredibly efficient plan in Singapore and also in Sydney and also manufacturing in Atlanta, Georgia, and we are not constrained on our internal capacity. As soon as that part comes in, that rate-limiting bottleneck part, it goes on to a product, gets to a customer. And that's what we are focused on. And I'm giving as much color as I can qualitatively around that.

Well, thanks, Kevin, and thanks again to all of our shareholders for staying on an extra five to seven minutes here and joining us on this call. I'd also like to thank once again the 8,000 ResMedians, many of whom are also shareholders who listen to this call for their dedication and hard work, helping people breathe better, sleep better, and live better lives outside the hospital in 140 countries. Thanks for what you do today and every day. Thanks especially to our ResMed heroes on the front lines during this crisis, patient care, technical service, sales teams working with customers every day, but I'd like to add a special call-out to our amazing teams on the front lines of supply chain, management production, distribution. All of you are heroes. Every chip you get is a patient's life change. So, I look forward to talking with you all again, all of our stakeholders here in 90 days. Thank you. I'll turn the call back to Amy to close out.

Great. Thanks, Mick, and thanks, everyone. We appreciate your interest and your time. If you have any additional questions, please don't hesitate to reach out directly. This does conclude our first quarter 2022 call. Kevin, you may now close this out.