Outset Medical, Inc. (NASDAQ:OM) Q2 2023 Earnings Call Transcript

Outset Medical, Inc. (NASDAQ:OM) Q2 2023 Earnings Call Transcript August 2, 2023

Outset Medical, Inc. misses on earnings expectations. Reported EPS is $-0.92 EPS, expectations were $0.73.

Operator: Good day, and thank you for standing-by. Welcome to Outset Medical Q2 2023 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advice that today’s conference is being recorded. I would now like to hand the conference over to your first speaker today, Jim Mazzola. Please go ahead. Jim, if you could go ahead and unmute yourself please.

Jim Mazzola: Okay. Good afternoon, everyone, and welcome to our second quarter 2023 earnings call. Here with me today are Leslie Trigg, Chair and Chief Executive Officer; and Nabeel Ahmed, Chief Financial Officer. During the call, we will discuss our second quarter 2023 operational and financial results and host a question-and-answer session. We issued a news release after the close of market today and updated our investor presentation, both of which can be found on the Investor Relations pages of outsetmedical.com. This call is being recorded and will be archived in the Investors section of our website. It is our intent that all forward-looking statements made during today’s call will be protected under the Private Securities Litigation Reform Act of 1995.

These statements relate to expectations or predictions of future events, are based on our current estimates and various assumptions and involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied. Outset assumes no obligation to update these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section about the public filings with the Securities and Exchange Commission, including our latest annual and quarterly reports. With that, I will now turn the call over to Leslie.

Leslie Trigg: Thanks, Jim. Good afternoon, everyone, and thank you for joining us. We are pleased to share our second quarter 2023 results, which were marked by accelerating quarter-over-quarter revenue growth, further margin expansion and continued commercial traction across our business. On the acute side, we’ve been encouraged to see more customers recognizing Tablo’s strong economic value proposition and makes the decision to in-source inpatient dialysis with Tablo. We also continue to see improvement in the broader macro selling environment with both current and prospective customers. On the home front, we achieved our goal to sign agreements with the majority of large midsized dialysis providers and initiated the first Tablo Home program with one of the country’s largest health systems with plans to expand to multiple US sites.

With the first half of 2023 now behind us, we retain our strong conviction in the fundamentals of our business with confidence grounded particularly by a healthy pipeline and backlog with interest in and demand for Tablo’s strong and growing. Before I go through the details of the quarter, I’d like to begin by providing an update regarding the warning letter we received from FDA in early July. As many of you are aware, we previously disclosed that our San Jose facility was inspected for the first time in the company’s history by FDA in late January of this year. We were pleased overall with the inspection process, which concluded in February, and resulted in four observations that were communicated to us via Form 43. Each of those observations related to internal process improvements with none related to safety or efficacy concerns.

We responded rapidly to FDA with a comprehensive work plan, and our team remediated all four observations internally at the end of the second quarter. The July warning letter noted two additional observations that were not part of the original inspection finding. The first observation pertains to content on our website that referenced continuous renal replacement therapy or CRRT a modality not currently included in Tablo’s indications for you. To be fully reflective of our most recently cleared indications for use, we’ve removed these materials. We believe our action plan has addressed this finding and expect no impact with customers from this remediation. FDA’s second observation related to TabloCart with prefiltration requiring 510(k) clearance.

Although we had evaluated TabloCart with prefiltration prior to marketing and distributing the product and concluded that no marketing authorization was necessary, we’ve made the decision to submit 510(k) and cause its distribution until clearance has been granted. We’ve been in dialogue with FDA, and we intend to submit the 510(k) by the end of this month. I want to emphasize that neither of these two additional observations pertain to safety, efficacy or quality and importantly, the letter did not place any restrictions on the made the decision system itself. While we were surprised by the warning letter, our intent is always to innovate in lockstep with an adherence to the highest quality and regulatory standards and that is exactly how we’ve approached our response to the warning letter.

We believe the actions we have taken are the right steps towards resolving these observations and further strengthening our competitive position. Turning now to a more detailed review of the quarter. Our performance in Q2 once again demonstrates our ability to consistently deliver strong top line results as well as our commitment to profitability and steady gross margin improvement. Revenues in the quarter were $36 million, representing approximately 44% growth year-over-year and approximately 8% growth sequentially. Gross margin expanded again for the ninth consecutive quarter by a little over 2 percentage points thanks to our continued execution against our consistent gross margin drivers. In terms of end market performance, beginning with acute care, we were pleased to see strong comp flow growth once again driven predominantly by momentum with in-sourcing initiatives.

Through 2023, we have seen more and more customers recognizing the cost savings associated with bringing Tablo in-house, and this continues to be a driving factor for health system administrators. In the second quarter, we again signed new in-sourcing agreements with a large number of hospitals, and I’m encouraged by the pipeline of similar opportunities as we move through the second half of the year. One such example during the quarter came from a large IDN with Tablo already deployed to multiple facilities in their network. This customer wanted to expand their in-source dialysis service line to new network hospitals and ordered nearly 70 additional consoles to fulfill this seed. And while nationwide, we still remain low double-digit penetrated.

With this new order, Tablo is now deployed in over 90% of this particular health systems facilities, demonstrating meaningful and continued progress with our land and expand strategy. For those customers who are considering insourcing but are also sensitive to dialysis nursing availability, our Bridge program has remained an attractive offering that provides customers the confidence to move forward while they complete the process of hiring their own permanent staff. As in Q1, we found that in situations where we sold the bridge program during the quarter, customers were able to staff their program faster than they initially expected, enabling us to operate the program cost efficiently. While those customers proceed without needing to purchase bridge, particularly as we continue to see stability in hospital staffing constraints, it remains an important tool that sets outside of part and highlights our commitment to service.

Beyond the traditional acute setting, we continue to see strong momentum during the quarter with subacute providers. These providers are an essential bridge for patients between acute care and ultimately receiving care in the home or in center. We now have master sales and service agreements signed with all of the top 10 sub-acute providers. One example of our success in this market is Encompass, which operates nearly 160 hospitals in 40 states. With more than 60 of its facilities using Tablo today, Encompass has reported a 50% reduction in its dialysis costs, a measurable reduction in readmission and reports that patients feel better following dialysis with Tablo. As Encompass continues to expand in-sourcing with Tablo, the drivers for them are clear: cost reduction and better clinical care.

We saw continued strength during the quarter in ASPs across both consoles and consumables. Similar to Q1, our ASP benefited from better-than-expected uptake of our 24-hour software feature, which we branded Tablo profile. From an innovation perspective, we recently improved our integration of Tablo with the hospital electronic medical record, a key benefit for providers, particularly those managing a growing fleet of Tablo systems. This offering is off to a strong start, including planned implementations at 7 sites of a large regional IVN. While early, it is another example of the type of innovation we seek to deliver, providing new value to customers with new sources of revenue margin for outset. Turning for a moment to the macro environment.

We’ve been encouraged to see a consistently improving environment relative to last year with the stabilization in hospital staffing dynamics we reported in Q1, carrying through the second quarter. For those health systems still grappling with staffing issues, temporary programs like Bridge continue to prove successful in helping our commercial team address gap and concerns upfront. Similarly, capital spending, which can sometimes affect the timing of yields, also has not been a meaningful headwind for us today, due in large part to Tablo’s economic value proposition and demonstrated ability to lower hospital dialysis cost by 50% to 75%. Now an update on the home front. As we’ve communicated in the past, our strategy for home is twofold and follows the proven land-and-expand model we have successfully deployed in the acute setting.

In the short-term, we’re focused on driving the patient census in each established health program higher than historical standards by sending more patients home. And over the longer term, our strategy entails expanding the home dialysis provider universe by working with hospitals and other healthcare providers to stand up their own home program. As it relates to this strategy, our measurable home goals for 2023 include landing the majority of the largest midsized dialysis operators known as MVOs and initiating home programs with two the largest health systems in the country. In the second quarter, I am pleased to report that we have achieved the first goal. We are in the majority of MVOs and made good progress on our second goal by securing a commitment from one of the largest health systems in the country to roll out a comp program.

Equally important, we are gaining traction with individual hospitals setting out their own home program. During the quarter, we closed multiple agreements on this front, and I’m pleased with the additional opportunities we see for similar agreements in the second half of the year. Key to success in the home setting is our retention rate, which we believe continues to be a central advantage of Tablo and a primary driver for further profitable expansion in the Home segment. Through the first half of this year, our retention rate continued to perform well with Tablo’s patient operate consistently hovering in the 10% range, which we believe is roughly half of the historical rate associated with the incumbent home hemodialysis device. We are proud of data like this and believe it underscores why Tablo maintains an edge over competitive devices.

As we continue to grow the number of patients at home on Tablo, it is also our goal to maintain our markedly higher retention rate. Finally, we are still a few months away, but I want to highlight our plans for the American Society of Nephrology Annual Meeting coming up in early November. Multiple abstracts have been submitted that reinforce Tablo’s value across market segments, including the results from a quality improvement effort by an ICU customer. In this case, the provider demonstrated a 43% reduction in mean dialysis treatment hours per patient ICU stay and a more than 50% reduction in dialysis treatment cost per hour while achieving a roughly mid-teens percent reduction in the patient’s overall IT like this day with no change in mortality.

These economic and clinical benefits are representative of what we now consistently see and what we look forward to presenting more information at ASN, including early insight from our National Home Registry. The conference begins on November 2, and we’re planning to host investors at our booth on the morning of November 3. We look forward to sharing more information as we get closer to the meeting. In tandem with solid progress in both end markets, our team also continues to make strides operationally which resulted in another quarter of consecutive gross margin expansion, enabling us to deliver a non-GAAP gross margin of 22.5% in Q2 and up over 6.5 percentage points above our Q2 2022 gross margin. As we continue to grow the top line, the principal drivers of margin expansion remain unchanged, and our consistent performance over the last nine quarters illustrates our ability to capture this margin expansion opportunity.

As we look ahead, we remain committed to reaching our next mile marker of 50% gross margin. I’d also like to provide a brief update on our Tablo Cartridge in-sourcing initiative. Cartridge production at our Mexico manufacturing facility, which began in the fourth quarter of 2022, has continued to ramp well against our expectations, and we are pleased with the throughput and quality we’re seeing. We continue to expect the majority of the cartridges we produce to come from our plant in Mexico by the end of the year. With that, I will now turn the call over to Nabeel to review our financials and provide an update on our expectations and key drivers for the back half of 2023.

Nabeel Ahmed: Thanks, Leslie. Hello, everyone. Our second quarter revenue increased 7.7% sequentially and 43.8% year-over-year to $36 million. The year-over-year change was driven primarily by higher console placements and the associated pull-through of consumables used for each Tablo treatment. Product revenue was up 5.6% from the prior quarter and increased 49.5% year-over-year to $29.3 million. Console revenue grew 4.4% from the first quarter and increased by 48.8% year-over-year to $19.7 million. We had strong console placements in both our acute and home end markets. As Leslie indicated, ASP remained high during the quarter, driven by mix, disciplined pricing and the substantial majority of acute console shipping with our Tablo Pros+ [ph] software.

We believe that these three factors mix pricing and software sales will continue to be the primary drivers for ASP during the second half and for the longer term. Consumable revenue was $9.6 million, up 8.2% from the prior quarter and an increase of 50.9% versus the prior year as our installed base grows. Treatment revenue and cartridge utilization performed well and in line with our expectations. We saw invoice treatments in the acute setting between four and five treatments per week and just above three in the home setting. Service and other revenue of $6.7 million was up 17.9% from the prior quarter and higher by 23.4% compared to the prior year, driven by the growth of our installed base and offset by the planned expiry of the HHS agreement.

As a reminder, the third quarter of 2022 saw the expiry of the final components of our HHS agreements. Moving to gross margin and operating expenses. I will highlight our non-GAAP results. I encourage you to review the reconciliation of GAAP to non-GAAP measures, which can be found in today’s earnings release. Our second quarter gross margin was 22.5%, a sequential improvement of 221 basis points and an improvement of just above 6.7 percentage points versus the prior year period. As expected, service margin increased sequentially to 14.3%, and our expectation remains that it will continue to improve throughout the year. On a year-over-year basis, service margins declined in the quarter due to the HHS agreement that increased service revenue in the second quarter of last year.

As Leslie pointed out, this progress marks 9 consecutive quarters of consistent and substantial gross margin expansion. And once again demonstrates our commitment to reaching our next milestone at 50% gross margin. The same three key drivers that get us to our 50% gross margin milestone have enabled this track record of margin expansion. They are: one, our console cost-down programs; two, the pull-through of software and consumables; and three, service leverage. Operating expenses of $41.5 million in the second quarter were roughly flat sequentially and up 3% versus the prior year period, showing leverage by growing at a lower rate than revenue. We reported second quarter GAAP net loss of $44 million, resulting in a net loss of $0.90 per share compared to a net loss of $43.8 million or $0.92 per share for the prior year period.

Non-GAAP net loss was $33.9 million or $0.69 per share compared to a non-GAAP net loss of $36.4 million or $0.77 per share for the same period in 2022. We ended the quarter with approximately $226.1 million in cash, cash equivalents, restricted cash and investments, including $100 million of borrowings under our term loan. We continue to have access to up to an additional $200 million of capital under our SLR debt facilities. We used $26.4 million of cash during the second quarter down from approximately $38 million in the first quarter. This progress demonstrates the strengthening leverage in our model and our continued commitment to delivering on our profitability objectives. Moving now to our full year 2023 outlook. We are reiterating our 2023 revenue guidance of $144 million to $150 million.

Given the pause in shipments of TabloCart with pre-filtration we now expect to be at the low end of this range. Our guidance assumes that we do not get clearance on our 510(k) in 2023. We had expected a modest revenue contribution from TabloCart with prefiltration in the low single-digit million dollar range that we now expect to be deferred out of the second half. Guidance also contemplates the potential impact of some Tablo orders being deferred until this 510(k) is cleared. Based on the visibility we have in our pipeline and backlog we expect the impact to disproportionately affect the third quarter, which we believe will be roughly flat to the second quarter before growing again on a sequential basis in the fourth quarter. I want to point out a couple of important things.

First, we do not expect to lose deals as a result of this pause on TabloCart with prefiltration. Second, our scale and clear value proposition in diverse end markets gives us the ability to accommodate disruptions such as this and enables us to maintain our guidance range with confidence in our ability to execute through the second half of the year. I also want to reiterate our 2023 gross margin guidance to be in the roughly low-20% range and that we expect to exit the fourth quarter in the roughly mid-20% range. And finally, on OpEx, we continue to expect OpEx growth for the full year to be significantly lower than our rate of revenue growth with OpEx growth in the low double-digit percentage zone. We are on track and continue to expect that we will burn less cash in 2023 than we did in 2022.

In summary, we are pleased with the strong performance during the first half of 2023 and believe we have the momentum and visibility we need as we would to continue executing through the second half of 2023. We look forward to providing another update on our third quarter progress during our next earnings call. With that, I’ll turn it back to Leslie, for closing remarks.

Leslie Trigg: Thanks, Nabeel. We remain well positioned to execute against our full year strategic goals across both the acute and home segments and look forward to advancing our commercial and regulatory initiatives and lock staff in the months ahead. Recent trends, combined with our expectation for ongoing stability in the broader macro environment, give us greater confidence in our near-and longer-term growth opportunities, particularly given Tablo’s differentiated value proposition, our large and growing end-markets and the positive macro tailwinds, which continue to fuel our business. So with that, I think we are ready for Q&A. Operator, please open the line.

Q&A Session

Operator: Thank you. We will now conduct a question-and-answer session. [Operator Instructions] Our first question is from Travis Steed with Bank of America Securities.

Travis Steed: Hi. Thanks for taking the question. I guess I just, wanted to follow-up on the decision to say, the lower end of the guidance range given you guys beat by $1 million this quarter, its only low single-digit millions you have embedded in the guidance. Just curious, why there was a reason that you can’t kind of offset that within the guidance range and also understand like why would Tablo orders actually be deferred here when they can probably upgrade to get the Cart, post the approval?

Leslie Trigg: Yeah. Maybe I’ll just take Travis. I’ll start with the second part of your question. So we originally developed TabloCart for customers that are in areas of the country with truly bad like anomalously bad water, where they found themselves replacing the filters inside the Tablo consoles more frequently than desired. And so we designed TabloCart as an optional accessory that, they could use to extend the life of the filters inside Tablo. So as we look at the second half, we’re just thinking about, hey, if there are any new customers in these really bad water areas, they might choose to push back their console purchase until TabloCart is available and so for that reason, we contemplated that in the guidance that we talked about today.

Nabeel Ahmed: Hey Travis, just a couple of other things on guidance, so first of all, when we think about the pause on TabloCart with Prefiltration, we did defer the revenue in the low single-digit million dollar revenue associated with TabloCart with Prefiltration itself. And then we also contemplated the potential deferral of some of these Tablo console sales that Leslie talked about. Importantly, based on the visibility we have as we enter the second half, we believe that the low end of our guidance range is our floor, and we’re going to work hard to work our way up from that. But again, based on the visibility we have, we do believe we’ll be

Leslie Trigg: I will add — oh, sorry, go ahead, Travis.

Travis Steed: No, no, go ahead, Leslie.

Leslie Trigg: I was just going to say that I will add that we — I mean, we really did a fantastic quarter in Q2 and a really, really strong first half. I think we all feel very bullish about our ability to execute in the second half. And the entire team here is very focused and motivated to kind of work our way up through that range. as we move through time here between now and year-end.

Travis Steed: And just to confirm, just saying that the only thing that’s really changed here versus 3 months ago is the Tableau cart. And I don’t know if there’s a way to kind of parse out how much of this was the actual delays that you’re factoring in, if that’s like half of the guide to the lower end of the guidance range? And the build, can you kind of go over the Q3 commentary as well. I just want to make sure we got the message on Q3 modeling — and I’ll jump back in queue.

Nabeel Ahmed: Yes, Travis. So guidance for us is always based on a couple of things. One, it’s based on the visibility, right? And as I mentioned, we took the low single-digit million associated with Cart and sort of deferred that out of 2023. And then we took an estimate for Tableau deferrals, again, for the reasons that Leslie talked about. That is the only thing. As we were entering the quarter, Leslie talked about the strong performance. We saw console placements do exactly what we want — we saw treatments behave the way we expect, right in line with our expectations. Service renewals remain high. So we had all of the ingredients, if you will, Travis, to have a really strong print and give really, really good commentary with respect to the back half of the year falls notwithstanding.

So hopefully, that helps, again, we do — we are guiding to the low end of our range as the floor. Now with respect to the quarters, given the recency of this event, we believe that the third quarter will be more disproportionately impacted. We have to now go out and work with our customers on alternate plans. Those customers in bad water jurisdictions. We have to go work on alternate plans and help them with how we can work with them. So we believe the third quarter will be more impacted and that it will be roughly flat to the second quarter. And then that we will grow in 4Q as again, we get some of the momentum out of 3Q and then some of the deals from 3Q that may be deferred land in 4Q

Leslie Trigg: I’ll just punctuate what Nabeel said at the beginning of your question, Travis, is that nothing else has changed and nothing — I think importantly, nothing structural has changed here. Yes, this is an unforeseen curveball and we will be able to manage it within the current guidance range. But all of the other leading indicators in acute and home are performing exactly as I hoped they would. So I think with regard to the performance of the business at large, both near term and long term, our bullishness has remained unchanged.

Travis Steed: Very helpful color. Thanks a lot.

Leslie Trigg: Sure.

Operator: One moment for our next question. Your next question comes from Rick Wise with Stifel.

Rick Wise: Good afternoon, everybody. Leslie, I don’t want to dwell on Tableau. I mean it’s clear the business is in excellent shape, and you’re making a lot of positive progress. But — just to make sure I’m understanding everything. It didn’t seem like — and maybe I’m wrong in remembering, but it didn’t seem like you were going to — or you felt the necessity to file a 510(k) how was the decision made in conjunction with the FDA? Was this your initiative? And maybe just help us think about a potential time line to resolution? I know there’s no perfect answer, but can you just add to some more clarity around that point?

Leslie Trigg: Of course, absolutely. Happy to. So first and foremost, we are doing at the run volition. As we talked about, I think, in early July, the warning letter did not require or request that we stopped selling or distributing Tableau or the Tableau system. Our goal — I mean, job number one is to fully remediate the warning letter as quickly and smoothly as possible. And so as we had more time on the clock, I mean, we’ve received the warning letter in July 6th I think and we disclosed on July 7th. So with the benefit of more assessment and analysis time we determined that the fastest path towards kind of a smooth and expeditious resolution was to file and pause. I just think it’s the right thing to do. Again, in the spirit of job number one is resolve the warning letter as quickly and smoothly as possible.

Related to the 510(k) itself, taking a step back, the decision-making around Tableau Card’s this regulatory approach obviously occurred some time ago. While this recent action may not reflect it externally, we really have substantially deepened our expertise and capabilities in this area and I do feel we are well positioned moving forward to scale quality and regulatory at the pace that our high growth rate is requiring. We have taken a lot of time, both internally and also with external experts to develop an and implement a multitude of initiatives to continue to scale and bolster quality regulatory from people to senior leadership to process these procedures. We have upgraded and expanded the breadth and depth of our talent. And at this point, we have examined every facet of our quality and regulatory management systems strengthening along the way.

So I feel that moving forward. And let me add one more point. While we were surprised by this warning letter, we actually really have had a quite strong track record of successful 510(k) submissions and clearances noted in the fact that we’ve received at least one 510(k) clearance every year for the last five years and more prior to that. I do think as a result of all of this cumulative regulatory experience and also the byproduct of our intent to continue to innovate, we are amassing very valuable expertise about how to meet the expectations of regulators in ways that I believe we believe are creating competitive advantages that will be quite durable and valuable over time. Lastly, let me touch on the — your — part of your question related forward timing.

Our immediate focus is on producing the clearest and most comprehensive submission that we can that’s critical to enabling a timely FDA review. And so our entire team is focused on doing that by the end of August. Obviously, as you know, 510(k) typically do follow a faster path that we’ve compared to PMAs. But there’s always a lot of factors at play. And so we’re assuming that review will take us through the end of the year, which, again, is also factored into our guidance. But our focus and our strategy at this point is to provide an incredibly thorough and incredibly robust submission into the agency for review.

Rick Wise: Great. That’s a — very appreciate the thorough answer. Two last questions. I’m going to answer — ask them rather together. I think I’m correct in saying it that I was intrigued to see that despite moving to the lower end of your sales range guide unchanged, but the low end and thinking about losing revenue or possible revenue from TabloCart accessory sales, which I imagine must be higher margin, highly accretive margins to the overall company. I mean how does gross margin stay intact when you move to the low end? And the second question there is just talking about all these — your significant progress in landing the midsized accounts and you hinted at one very large account and another one to come. When — how do we imagine that starts to get factored into the sales sort of your thinking on sales is — is it — it’s going to potentially benefit fourth quarter, or no, it’s going to take three to six months for some reason?

I’d just like to know how that all plays out? Thanks so much for both.

Leslie Trigg: Sure. Nabeel, do you want to hit the margin question first?

Nabeel Ahmed: Yes, for sure. So Rick, TabloCart with prefiltration was and when it gets back, it expected to be margin accretive to us. Having said that, we only launched the product late last year. And again, Rick, this is a product that is really only serving customers and jurisdictions where the water is really bad. So we never expected it to be in all of our console sales or even the majority of console sales. The drivers for us of margin expansion really are unchanged. It’s continued cost down on the console. It’s continued pull-through of our consumables, it’s service leverage. And then just to double-click on ASP, while TabloCart with prefiltration certainly was a component, the other drivers of ASP strength have been number one, our disciplined pricing, which really hasn’t changed since we’ve been commercial.

And number two, it’s been our sale of Tablo Pros, the 24-hour software which in the second quarter was in the substantial majority of our acute consoles. And so we have a lot of other margin drivers right that continue to give us conviction in our gross margin objectives both through the back half of this year and then to our ramp up to that 50% milestone.

Leslie Trigg: I’ll pick up on the home piece, Rick. So we started the year here in January, or planning for the year, last December, we had those two goals in mind as we thought about our forecast and our expectations for where we wanted to land the plan on home by the end of 2023. And so we assumed — we are prone to assuming victory and reaching it, no matter what obstacles in our way. So we had assumed victory on, hey, we are going to get contracts with the majority of these midsized MDOs by the end of the year. And we will have, through the largest health systems, our contracted to set up home program. So I — while it would be difficult to say, hey, we’re going to start to see impact in this quarter versus that quarter, we certainly planned for some benefit in 2023, which we’re already starting to see.

Rick Wise: Thank you so much.

Leslie Trigg: Of course.

Operator: One moment for our next question. Our next question comes from Shagun Singh with RBC Capital Markets.

Shagun Singh: Hey, thank you for taking question. I was just wondering that with Q3 sequential growth is flat, what is driving your confidence in the significant step-up that you’re modeling for Q4?

Nabeel Ahmed : Shagun, it’s really just the visibility that we have into the business. Remember, we’ve always run a high-visibility business just under half of our revenues, our recurring revenues, these from consumables and service, and then with our strong pipeline and backlog, we have a good forward visibility into console placements. So again, it’s really just visibility, which is what we always anchor guidance on that tells us both that we will achieve the low end, at least the low end of our guidance range and that we believe 3Q will be roughly flat to 2Q

Leslie Trigg: I would also add everything to do that. I would only add from my vantage point and probably more editorial than anything. I mean, we have never had a bigger pipeline than we have today. And I think we’ve really been aided with the benefit of some time as more and more and more health systems have adopted Tableau for in-sourcing and seeing the cost reduction benefits and the clinical care benefits and the operating benefits there’s a network effect that starts to emerge. And so I’ve been present myself for a number of conversations between health system executives sort of sharing and swapping success stories. And so I think that I can sincerely say that the flywheel, particularly in acute is firmly underway. And so those are some of the factors that give me the confidence more editorially about the back half of this year.

Shagun Singh : Got it. And just as my second question, in the acute care setting, you called out strong demand from hospitals due to cost savings. I think you also referred to some data out there. That seems pretty positive. Just in that setting, I guess a two-part question. Are there any economic or outcomes analysis that you’re focused on presenting data from? And then in the acute care setting, how are you thinking about utilization versus continuing to and so within our land and expand strategy? Thank you.

Leslie Trigg: Yes. Maybe I’ll start, Nabeel you can. On utilization, I’ll just touch on that. It’s not an or, it’s an and. And our — we have a commercial team that is very focused both on expanding the number of customers, expanding the number of facilities inside those customer networks through console sales. And then we have a large percentage of our team in the commercial organization focused on expanding utilization as the tenure of the Tableaus and those accounts mature. So it will never be in work for us. It will always be in hand. In terms of the economic analysis, some of that actually will be presented in greater length at the — or more detail, I should say, at the ASN Annual Meeting here in early November. And in addition to that, we continue to see customers publishing white papers sharing their own experiences.

There are a number of other conferences, et cetera, that will take place into early 2024 and it will be in my expectation. I think that we’ll continue to see more of this economic data being shared in those venues as well over time as more and more of it is recognized and accumulated.

Shagun Singh : Thank you.

Nabeel Ahmed : Next question.

Operator: One more for next question. Our next question comes from Suraj Kalia with Oppenheimer & Company.

Suraj Kalia : Can you hear me all right?

Leslie Trigg: Yes.

Suraj Kalia : Perfect. So Leslie, I remember last year in your comments, there was this notion of home being approximately 15% contribution in FY 2023, at least I vaguely recall that number and it was triangulating to like $20-plus million in contribution. I appreciate the qualitative commentary, Leslie, maybe can you give us some guidepost on where home hemo is currently relative to your expectations, relative to patients?

Nabeel Ahmed: Yeah. Hey, Suraj, it’s Nabeel. Our comments were with respect to 2022, we had expected for the full year 2022 to drive home revenue to roughly 15% of our total revenue, and we surpassed that. We actually got home revenues to be roughly 20% of our 2022 revenues for the full year last year. And we will update you with our installed base annually. We do consultations annually that break out home and acute, and we’ll update that when we print our 4Q results.

Operator: One moment for our next question. And our next question comes from Josh Jennings with TD Cowen.

Josh Jennings: Hi, great. Thanks for taking the questions. I was hoping, Leslie and Nabeel, you could just help us think about drivers for 2042 drivers that will be sustaining the revenue growth you’re delivering in 2023 or accelerating, some soft-ish comps from the recovery earlier in the year for the ship hold and then now with TabloCart and just a very, very minor, I guess, disruption here in the second half of 2023. But outside of soft comps sounds like the pipeline is plus, any other drivers you would have a think-through as forecasting after post 2Q results?

Nabeel Ahmed: Yeah, Josh, hi. It’s Nabeel. So look, for 2024, as Leslie pointed out earlier, structurally, nothing has changed for us. Tablo demand for both our acute and home-end markets remains and we entered the second half with a lot of momentum in both of those end markets, and we’re really setting up — we had a good print and we’re still setting up for a strong back half of the year. Now none of the hiccup that we’re facing here, none of that demand goes away. As we’ve talked about our expectation is that sales of both TabloCart with prefiltration will resume once we get our clearance and that any Tablo orders that may defer will also come back once we get our 510(k) clearance. So as we think about 2024, nothing has structurally changed.

Now we’re in the middle of 2023 here, and it’s — in any year, it would be early for us to give any specific commentary on 2024. Our focus is now really executing to get to the low end of our guidance range for 2023 and then to work hard to get above that, and we’ll come back and update you on 2024 as we get more visibility as we normally would.

Leslie Trigg: I agree with all that. I’d only add maybe at a more qualitative level, the drivers of demand, which will underpin, obviously, our performance in 2024, the drivers of demand on the acute side are strong and only getting stronger. Hospitals need to, want to, must reduce costs, hospitals want to need to must provide the best possible clinical care that they can for their patient community. And increasingly, hospitals are facing challenges with discharge. Their inability to find a dialysis chair in the outpatient, dialysis clinic continuity is causing some really significant headaches and cost pain points with length of stay. The hospitals cannot find a chair in that community to discharge a patient who, they must continue to dialyze that patient in the inpatient setting for which they are not reimbursed.

And so we are seeing a pretty material uptick in traction, interest, activation amongst both smaller hospitals and large health systems in standing up their own home programs. And I do anticipate that to be a major driver in 2024 as well.

Josh Jennings: Great, thanks for that detailed answer. I also wanted to just ask about, I mean, I guess, a potential headwind would be in the acute channel just the competitors having a stronger response. And our anecdotal check suggests that some of the dialysis providers that provide that outsourced inpatient dialysis are rolling over and it’s been giving up. I have — is there — have you seen anything on the — in the marketplace with a stronger competitive response from those dialysis providers, or do you expect one going forward? Thanks.

Leslie Trigg: Yes, sure, Josh. Short answer, no. We haven’t really seen a significant change. What has been happening and continues to happen. And this is just giving you some color on what we hear from health system executives is that they are continuing to receive higher pricing and lower service levels on those outsourced contracts. And so yes, I mean, that activity does continue to be a tailwind for us is that obviously provides additional ammunition and motivation to in-source and sort of take back control of that service line. kick out of controlling their own destiny, both on cost and also clinical care. So that does continue to be a tailwind for us.

Josh Jennings: Understood. Thank you.

Operator: [Operator Instructions] Our next question comes from Drew Ranieri with Morgan Stanley

Drew Ranieri: Hi, Leslie and Nabil. Thanks for taking the questions. Maybe just to piggyback off Josh’s last question there — or first question, but I know that we like previously talked about home being more of a gradual type of adoption curve versus like an inflection point, but maybe just to build on your answer to Josh, but is there anything in the environment and home from a provider or maybe even a patient standpoint, that’s getting easier in terms of your ability to drive Tableau home adoption or just even shifting care to the home from the clinic. I mean you’re just talking about the discharge issues. But is there a point where you think you just kind of hit critical mass, where mean adoption just because it becomes much more easier and maybe doesn’t flaunt?

Leslie Trigg: Yes. I’m happy to talk about that. That has homes my favorite topic as everybody at out that note. I do think that the — the what’s new, again, in the last kind of couple of quarters, so what’s new are these discharge issues. What remains a strong tailwind in on the financial side, are the one, the availability of Medicare Advantage for dialysis patients, which is new since 2021. And the estimates that we’ve heard from providers is that already at least 40%, if not a bit more, of their dialysis patient census is already on Medicare Advantage. That’s a tailwind because that does have an associated higher reimbursement rate than pure Medicare. So that’s helping a lot. And then the second thing is the ETC program.

And that has got a long runway running through 2027. Those carats and those decks are starting to get deeper as we move into 2024 through 2027. So we do continue to see that as a motivator probably more so with sort of the midsized operators than the health system because the health systems just have a completely different cost structure. So I think all of those financial headwinds — or excuse me, tailwinds remain. If there’s anything new, I think the Tablo economic value proposition has become more and more clear to providers as they understand that whether it’s a Medicare patient or Medicare Advantage or commercial patient, the economics of Tablo on a per treatment basis make a lot of sense. And so I think we’ve had greater success through in sort of what’s new I think we’ve been more successful in our ability to show people that through financial ROIs and walk people through that story.

And I think as the providers gain more and more experience in supporting patients at home, that’s the last piece. I think that continues to change in a positive way. As they say, seeing is believing and every time a new customer starts seeing patients preferentially choose Tablo start seeing patients actually really train inside of 10 days regardless of their age, education or skill level and as they see their own patients stay on home for a much longer period of time than their experience has led them to believe with other devices in the past, that, that word is getting out. And yes, it will not be overnight. And yes, we still anticipate a gradual climb. But in those respects that again, I’ll use the flywheel analogy, the flywheel is beginning to turn here.

Drew Ranieri: Got it. I appreciate the color there. And maybe one for Nabeel. Just as we look at your gross margins, versus the prior year period, a significant step-up in product revenue margins step down in service and others. You just talk about maybe some of the factors there for service. Was it just the leasing agreement coming off, but anything that we should be focusing on as we think about a build up in our gross margin lines?

Nabeel Ahmed: Yes. Drew, on the service margin line, you are spot on. It’s really just the expiry of the HHS agreement. So Q3 of 2022 was the last quarter of that deal. And it will be behind us here in a quarter even from a comp perspective. Now if you look at our progress Q1 of this year to Q2 of this year, you’ll see kind of a linear step up. And that linear step-up in service margins will continue into the future. Every once in a while, we’ll have to make investments in people and programs, but again, over time, you will absolutely see a linear step up in service margins. And the product margin is really our cost down efforts as well as, again more consumables shift — more consumables revenue as the mix shifts from growth in the installed base.

Drew Ranieri: Thanks for taking the questions.

Operator: I’m showing no further questions at this time. I would now like to turn the conference back to Leslie for closing remarks.

Leslie Trigg: Great. Thank you. Well, I’d just like to thank everybody for attending and wish everybody a very good evening. I do want to close by thanking the entire Outset team I see every day a relentless determination and a really deep belief in restoring agency and autonomy to patients and providers. And for that, I and others here are deeply grateful. So thank you again to the team, and thank you all for joining today, and have a great evening.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.