Good day, and thank you for standing by. Welcome to the Outset Medical Q1 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. And I would like to turn the conference over to your speaker today, Jim Mazzola, Head of Investor Relations. Please go ahead.

Okay. Thank you, and good afternoon, everyone. Welcome to our first quarter 2024 earnings call. Here with me today are Leslie Trigg, Chair and Chief Executive Officer; and Nabeel Ahmed, Chief Financial Officer. We issued a news release after the close of market today, which can be found on the investor pages of outsetmedical.com. This call is being recorded and will be archived on 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 of Outset's public filings with the SEC, including our latest annual and quarterly reports. One quick note before we get started, Nabeel is feeling a bit under the weather today, so I'm going to cover the financial section in our prepared remarks. Nabeel is here with us and will handle Q&A as normal. So with that, let me turn the call over to Leslie.

Thanks, Jim. Good afternoon, everyone, and thank you for joining us. With our most challenging recent headwind now behind us with the FDA clearance of TabloCart, demand for Tablo that has never been higher, 12 consecutive quarters of gross margin expansion, a strong recurring revenue model that represents more than 50% of our total revenue, tipping point adoption in the acute, strong home growth with an industry-leading patient retention rate and significant decisive steps now taken towards reaching cash flow breakeven without needing additional capital, Outset's outlook and conviction in its future has never been stronger. Earlier this week, we announced the receipt of FDA clearance for TabloCart with Prefiltration ahead of our guidance for clearance during the second half of the year. I want to thank the incredible cross-functional team here at Outset that accomplished this milestone. TabloCart provides another unique differentiator to Tablo's ecosystem, and we look forward to the impact we expect it will have during the remainder of the year. In terms of quarterly performance, we delivered revenue of $28.2 million in the quarter, which was lighter than we had originally anticipated due primarily to ongoing headwinds from the TabloCart ship hold and some associated orders again being postponed out of the quarter. With the clearance of TabloCart, this factor is now behind us. Additionally, several customers experienced disruption from the Change Healthcare cyberattack which slowed reimbursement payments and resulted in several of our customers deferring both treatment and console purchases until their cash flow normalized. We believe this factor is now behind us as well. As evidenced by treatment ordering in April, rebounding to expected levels. Taking a step back, over the past quarter, we reflected on the complete alignment between our desire and that of shareholders to reach cash flow breakeven more quickly and…

Thanks, Leslie. Hello, everyone. Revenue for the first quarter was $28.2 million. While below our expectations, revenue was aligned with the quarterly build for 2024 that we guided to during the third and fourth quarter 2023 calls. The decrease was driven by a decline in product revenue, which was $20.4 million in the first quarter, a $2.5 million decrease from the fourth quarter. Service and other revenue increased $7.7 million, up slightly from the $7.6 million we recorded in the fourth quarter. Console revenue was $9.2 million and consumables revenue was $11.2 million. As Leslie has already discussed, we believe the drivers of this shortfall relative to our expectations, the impact of the TabloCart regulatory hold and the Change Healthcare cyberattack are now behind us. We were encouraged to see our counsel ASP remains strong across all care settings as a result of our disciplined pricing and strong uptake of Tablo Pro Plus offering with acute customers. Following the end of the quarter, we saw a strong April month for treatment sales and cartridge utilization over time continues to perform in line with our expectations. Before moving to gross margin and operating expenses, I want to highlight the initiative we undertook during the quarter to restructure our 2024 and longer-term spending budgets with the goal of reaching cash flow breakeven without the need for additional capital. Included in our GAAP results is a net charge of $2.5 million that we took in the first quarter associated with the restructuring. This charge is comprised of severance and related benefits offset by the reversal of bonus accruals related to impacted individuals. We have outlined the impact of this charge across our P&L in the tables that accompany our earnings release. I encourage you to review the reconciliation of GAAP to non-GAAP measures,…

[Operator Instructions] The first question that we have today will be coming from Rick Wise of Stifel.

Good afternoon, everybody. Let me start with, I think, Tablo -- I'm sorry, with TabloCart. And I'm going to ask just a multipart aspects that you've touched on it a little bit. specifically the -- as Jim or Jim-Nabeel, will hyphenate his name now said, it's going to take some time to reengage and there's work to be done to install. But Leslie, maybe you can talk to us about are there orders in hand? Are you ready to manufacture and ship to meet those orders? And in the second half, can you quantify at all, I mean, is the upside from having TabloCart in hand, TabloCart sales specifically? Or no, it freeze conversations and it's going to pull with it TabloCart as well -- Tablo as well if you follow what I'm getting at. Sorry for the multipart question.

No worries. Yes. I will -- I'm happy to answer all of those, and let me know if I overlook any section of your question. So let me -- I think the first part was our orders in hand. Taking a quick step back when we decided to effectuate the ship hold, we had to pause all sales, all marketing, all contracting and any of the sort of back office order taking or support activities. And that's exactly what we did. So all of that needs to be reestablished. What are -- to give you the next level of resolution on that, what does that look like? Those are activities like generating new quotes, reviewing existing sales agreements, in some cases, getting new POs generated. And of course, there's a time factor for that. None of this is difficult, by the way, that's the good news, but it does take a bit of time. I think another factor too is just customer budgeting. In some cases, we expect customers will have to rebudget for it. They might have had the funds allocated and approved several quarters ago and need to go back into their internal organizations and get those funds redeployed and approved. And again, that's not difficult either, but will take a little bit of time. So I'm very confident we will have all these steps well, well underway. I do expect that to take us through the remainder of Q2. But again, the good news is hey, we're ready for the back half, right? And we had originally expected TabloCart approval right around the midpoint of the year. And I think that the main benefit here of the early approval is it just gives us time to get prepared earlier than we expected. Get all the pieces ready…

Got you. No, I appreciate all that. Lot to unpack. And just as a follow-up, I think it'd be helpful to hear a little more about the lighter-than-expected first quarter. I mean, just based on your commentary and all the surrounding comments, I mean in a sense, it's -- it sounds like it was actually a better period than maybe the optics, the initial optics might suggest. Can you help us better understand when you mentioned, I think you said Tablo a delayed or delayed orders and the cyberattack impacts now resolved. But how do I think would -- so would first quarter sales have been $1 million higher, $5 million higher? I mean can you help us understand the pieces and like whether that delayed order will come back in the second quarter, et cetera.

Yes, Rick, it's Nabeel. The first quarter really played largely as we had guided. We had expected a soft first quarter and then recovery in Q2 and really ramping in the back half of the year. That's kind of the guidance commentary we gave entering this year and back in Q1. So we'd always said the first half of this year will look more like the back half of last year because, again, in both periods, we didn't have Cart. Having -- so Q1 performed largely as we expected. Having said that, in Q1, specifically, we did see the continued deferral of console sales and cart sales, which now is behind us with the cart's approval. And we did also experience a little bit from this change healthcare slowdown, which, again, we believe is also behind us. So Rick, Q1 really played largely as we expected, a little bit softer. But again, we believe we haven't lost any deals, and we believe, again, that we're now going to ramp Q2 for a strong second half of the year, again, as we had originally guided.

Let me -- I'll just add 1 more thing just to reiterate, 2 things that I think are important to mention. One is the treatment revenue and the treatment orders in April have really come back and they were very strong, and we're very -- again, we're very bullish about the direction for Q2 and the remainder of the year there. And then you had embedded in your question, Rick, asked something about he any of these orders come through on the console side, and the answer to that is yes. Actually, 1 of the orders that was deferred right out of Q -- toward the end of Q1 because of the change healthcare situation actually was an order that was placed in April for the record there.

And our next question will be coming from Shagun Singh of RBC Capital Markets.

A quick follow-up here. I was just wondering if there's a way to quantify the backlog what was outstanding is waiting for TabloCart to get approval on restructuring. Is there any way you can provide the cadence for that $20 million savings in '24 and just what are you saying on the profitability time line? I know you said a few quarters ahead, but anything more specific. And then, I guess, a big picture question for you, Leslie. Can you just spend some time elaborating on your commercial organization? Like just trying to understand if you have the leadership in place, the feet on the street, if you will, how are you really looking to reengage these customers.

Sure. Maybe, Nabeel, you want to start off, and I'll take over in a minute.

For sure. Shagun, maybe let me sort of lay out how we are thinking about the second half of the year, the full year really from a guidance perspective, right? And so let me go back to sort of we expect the first half of this year to look largely like the back half of last year. Again, because we haven't had cart in any of those periods. So our guidance for Q2 is for revenue in the low $30 million zone, as Leslie pointed out, we'd ramp back on cart with prefiltration. Now Shagun, as we think of the second half of the year, there's really 2 components I would point you to. So first of all, we will have the recurring revenues on our larger installed base. This is the consumables and the service revenues which will be roughly half of kind of our implied 2H revenue, if you will. If you take that and then sort of the remainder -- the remaining console revenue after you sort of take the second half, roughly half is recurring. The remaining console revenue is roughly in line with what we did in the first half of 2023 when we had cart to be able to sell. So that's how we kind of thought about the back half of the year. Moving on, Shagun, your second question with respect to the savings, a little over half of the savings were from R&D and ops groups kind of R&D, more broadly speaking. And again, Leslie talked about the projects that were sort of, again, deferring or that we took a second look at. The rest or half is R&D and ops. The other half is just across the P&L. And again, it's things like spans of control, layers of management programs and projects that didn't have payback within our LRP horizon. So that's number two. Number three, from a profitability time line perspective, let me first maybe talk a little bit more about the savings we've generated. So in total, we are saving through the actions we have undertaken over $100 million over our LRP period. Roughly $20 million comes out of $24 million. As we talked about, that annualizes to about $30 million in '25 and a little bit more than $30 million in '26 and '27. So if you propel that math through the model, our initial expectation was that we'd get to breakeven exiting '27, you can see how, again, if you take kind of $30 million, a little bit over $30 million out of the out years, you can see how that will pull profitability forward by a few quarters.

Maybe I'll pick up on the commercial org. I think was your last question and do we have adequate coverage out there to rapidly educate customers about TabloCart and other. And the short answer is yes. We are covered actually in all 50 states. Just as a quick reminder, we have a capital sales team. We have a clinical sales team, and we have a national accounts team. All 3 of those teams cover both acute and sub-acute of course, and also home. And so we continue to get a lot of operating leverage out of this team. And I think we've talked about that in past calls. That continues to be true, but we do have sales coverage in all 50 states, and I am not worried at all about the speed with which our sales team will be sharing the news with both current customers and our potential new customers.

And our next question is coming from Marie Thibault of BTIG.

Wanted to start here with a pretty high level one. I know that 1 headwind you've talked about in the past is a longer selling cycle and environment being a little bit tougher. I wanted to hear how that's changed since you last spoke with us publicly? Has that gotten worse? Has it gotten better? Has it stayed the same? Any detailed commentary you can give on that would be helpful.

Yes, sure. I would say on the capital spending environment, it's been really stable, which has been a good thing. So we have not seen any material changes in the capital spending environment. We are also advantaged because Tablo and in-sourcing does have a very rapid payback period typically inside of a year for a hospital that makes the conversion. And that certainly helps ensure that Tablo rises to the top of those capital budgeting prioritization list. But setting that aside, in general, we saw a lot of stability in the capital spending environment. No changes to speak of.

Okay. That's great to hear. And then my follow-up here on gross margins. You just continue to exceed expectations there, nice to see another increase. On maintaining the guidance there, I mean you are already starting the year in the low 30s and we're expecting to have low 30s for the full year, exit midyear -- mid-30s to exit the year. Should we just expect smaller incremental improvements? Was this kind of a onetime leap, and we should expect a little tick down? How should we think about the cadence for the rest of the year?

Yes. Marie, it's Nabeel. We -- so we are really pleased with our team's ability to deliver our 12th consecutive quarter of gross margin expansion. And look, we think it is going to be linear from here to that mid-30% exiting the year on our way to 50%. So a really good performance. And again, we just expect to continue down the path.

Our next question is coming from Kristen Stewart of CL King.

I was wondering if you could just expand a little bit more on the U.S. Renal Care announcement. And just in terms of when we could start to see an impact from that really materializing?

Yes, sure. Well, U.S. Renal Care has been a good partner to us and continues to be a good partner to us. And our initial home programs with them were very successful. As I mentioned, it's 1 of the largest of these midsized dialysis organizations. They manage roughly 36,000 patients across the United States and increasing their home population and growing home is really central to their mission looking forward. I think what they were able to confirm for themselves is a much faster training time with Tablo, which made it easier to convince patients to adopt home. Our training time, our average duration despite a much wider and wider and wider demographic of patients adopting home it still remains remarkably consistent at under 10 sessions, roughly 2 weeks or equivalent of PD. So that's been a real selling point that I think has been recognized by many provider organizations and really this retention rate has been key. It is so much higher than other alternatives out there. And that's really the point. The point isn't to train as many people as you can to go home. The point is to keep as many patients as you can at home. That's really where the economics bloom and of course, the clinical outcomes manifest themselves. And so we view U.S. Renal Care, like all of our other partnerships within this MDO segment as really critical to our own home growth, and we're privileged to be able to be a strategic weapon in their hands as well as they try to grow home.

And our next question is coming from Suraj Kalia of Oppenheimer.

Leslie, Jim, Nabeel. Can you hear me all right?

Yes.

Perfect. Leslie, a lot of commentary provided. If you could quickly the 90-day 90% retention rate, if I were to extrapolate those curves at the 1-year time point, do you have visibility into what the retention rates are? And also specifically on workforce reduction, Leslie, was there any reduction in the sales and marketing division.

Sure. Yes. So let me speak to that. I'll talk about the patient retention rate, now I'll go to your second question. The -- yes, we do have data on the 1 year and -- we -- it is also markedly higher at 1 year on Tablo compared to the legacy Home Hemo system. So we've been really pleased at the 1-year retention as well. And actually, I'll make another remark, it has been very, very stable. So not only has it been much, much higher. It's been really stable. And Suraj, we've offered in the past that at 1 year, what we call our controllable attrition. There's the uncontrollable attrition, which is out of our hands unfortunately, that's death and transplant. And then there's what we call the controllable attrition, which is the patients just opting off. They want to go back in center, let's say, or something in their life changes. We should be able to affect that. We challenge ourselves to effect that. And so we really focus on doing a great job as an organization in the controllable attrition rate. And for us, that controllable attrition rate at 12 months has remained very stable at about 10% despite our pretty significant growth in the denominator of patients at home on Tablo. So those results, Suraj, they definitely are holding between 90 days and a year. Regarding the reduction of our team, we -- the lion's share of the people as well as programs and CapEx and other forms of OpEx, we're in, as Nabeel said, work in the operations and the R&D area with the remainder of those reductions spread across the organization. When we thought about the approach here and the philosophy around reducing our spend, we really had 2 non-negotiables, they are sort of sacred cows in mind. Our core tenets were, number one, we have to preserve the patient and the customer experience that is what is driving Tablo's adoption growth; and two, we have to ensure that we continue to deliver on our gross margin expansion initiatives, which continue to pay off. So we very, very, very carefully planned our cost reduction to avoid affecting those areas.

Our next question is coming from Stephanie Piazzola of Bank of America Securities.

I appreciate the color on the guidance you've given and how we should think about the first half versus the second half of the year. But just wanted to follow up a little bit, I guess, as Q1 coming in a little late and not changing the outlook for the second half. Is there anything getting better maybe in the second half to offset Q1 versus previous expectations and maybe any difference in how we should think about the low versus the high end of the guide now?

Stephanie. So with respect to Q1, again, it came in largely as we guided a little softer. Q2, we'd always expect it to be a ramping quarter for lack of a better word. Again, for all the reasons that Leslie talked about in terms of getting customers reactivated with TabloCart with prefiltration. So we do expect Q2 to step up a little bit in that low $30 million zone, as we said. Now when we think about the back half, a couple of things. So one, we will have TabloCart with Prefiltration for the full half because we expect to be ramped and are working to be ramped in the second quarter so that we're fully sort of ready in the second half. And then let me talk a little bit about the second half and some more specificity. And really, Stephanie, it's 2 components. So one, we do have our recurring revenues, consumables and service of a larger installed base as we enter the second half. And if you assume kind of at even the low end of guidance that half of our 2H implied revenues come from recurring revenues. The other 50% coming from consoles is the same -- roughly the same amount of console revenue as we did in 1H 23, which was the last half year when we had TabloCart with Prefiltration, does that make sense?

Yes. Thank you.

And then Stephanie, we will get to this part one. And then as you think about moving through the guidance range, we've always had the same performance levers, right? So we can place more consoles in both our large home or acute end markets. We have ASP. We have Tablo Pro Plus penetration or sales. And of course, we have TabloCart sales both to our existing installed base and to new customers. So those are kind of how we think about guidance.

I can add just a few points that came to mind what you're talking. I think in addition to TabloCart, which is the big -- again, the big propellent heading into the second half, but I will also reiterate we did see very significant pipeline expansion in Q1. And we have talked before about our sales cycle being in the 9 to 12 months. Some deals come in earlier than 9 months and other deals go a bit longer than 12 months. But generally speaking, it's 9, 12 months. So with this significant pipeline expansion, I think, I mentioned, I want to reiterate it, a higher percentage than ever of our deals in the pipeline are over $1 million in size each and over half are from potential new customers. So this pipeline is looking a little different to us in a very, very good way. And so that's another kind of tailwind for -- excuse me, second half. And then, of course, the third tailwind, which is related is that lapping of the sales cycle from Q3, Q4 of 2023 coming online in that second half of '24. So that's how I think about the 3 tailwinds kind of propelling us to this growth trajectory through the back half of this year.

Okay. Thanks, Stephanie. Next question, operator.

And the next question is coming from Joshua Jennings of TD Cowen.

I was hoping to just get an update on the Tablo enhancements that have been brought forward over the past 12 to 18 months. It sounds like the CTO departed as part of the restructuring. I imagine there's a deep bench there, but any plans to replace that head of that group? And then anything we should be looking for in terms of technology enhancements on the Tablo system as we move through this year.

Yes. Sure, Josh. Happy to answer that. One of our, if not our CTO's greatest gift and legacy to Outset is the team that he put in place here, and he's leaving us with. We have an absolutely stellar Vice President of Software, very, very deep bench strength on cyber and data analytics and EMR operability. As we noted in the script, we have spent the last many number of years making very significant enhancements and investments in all dimensions of software, data, data transmission, cyber and EMR interoperability. And now is our moment to harvest those investments. And as I said, kind of really maximize the Tablo that we have today. We do have an advantage in this market, which is we are light years ahead. We have a very, very meaningful technology advantage, both hardware and software. And I know this has been pointed out to us by investors and shareholders that, hey, you guys have an incredible, incredible lead should you just be maybe taking a pause and really selling and marketing what you have. And I think that there's a lot of merit to that, and we reflected on that a lot. We will never stop being -- sort of the imaginative ambitious people that we are, I can't change the personality of the organization. However, we do have an advantage and the lead that we already have, both software and hardware, it will be our focus for the -- over the course of this LRP period to make the best use of that. But no, we are not going to stop dreaming. And as I mentioned, we are just going to probably more pace investments in the future, better aligned to the time line at which they might pay off, which is probably maybe towards the end of the LRP period or beyond. Hopefully, that helped.

Definitely. And then just thinking about the evolution of the Tablo system and as we think about the LRP, what are the pricing assumptions both on the capital and on some of the disposables. Should we be thinking about price increases year-over-year or is stable pricing is the name of the game within that LRP guidance?

Yes, Josh. I mean we've -- so look, we've always talked about Tablo, about our ability to protect our pricing on the low end. And then offering these value-added accessories, including Tablo Pro Plus and now back with TabloCart with Prefiltration. So again, that's how we think about pricing broadly now and over the LRP period.

Okay. Thanks, Josh. Operator, any further questions for us.

At this time, there are no more questions in the queue. I'd like to go ahead and turn the call back over to Leslie for closing remarks.

Great. Well, I would like to thank everybody again for joining us this afternoon, and wish everybody a very good evening. Thank you.

This concludes today's conference call. Thank you for joining. You may all disconnect.