Inari Medical, Inc. (NASDAQ:NARI) Q4 2023 Earnings Call Transcript

Inari Medical, Inc. (NASDAQ:NARI) Q4 2023 Earnings Call Transcript February 28, 2024

Inari Medical, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good day and welcome to Inari Medical’s Fourth Quarter and Full Year 2023 Conference Call. At this time, all participants are in a listen-only mode. At the end of the company’s prepared remarks, we will conduct a question-and-answer session. As a reminder, this call is being recorded and will be available on the company’s website for replay shortly. And now I will turn the call over to John Hsu, Vice President of Investor Relations. Please go ahead.

John Hsu: Thank you, operator. Welcome to Inari’s conference call to discuss our fourth quarter and full year 2023 financial performance. Joining me on today’s call are Drew Hykes, President and Chief Executive Officer; and Mitch Hill, Chief Financial Officer. This call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements, including statements related to Inari’s estimated full year 2024 revenue, operating loss or profitability expectations, and the expected operating performance and potential strategic benefits of LimFlow are based on Inari’s current expectations, forecasts, and assumptions, which are subject to inherent uncertainties, risks, and assumptions that are difficult to predict.

Actual outcomes and results could differ materially from any results, performance or achievements expressed or implied by the forward-looking statements due to several factors. Please review Inari’s most recent filings with the SEC, particularly the risk factors described in our latest Form 10-K for additional information. Any forward-looking statements provided during this call, including projections for future performance, are based on management’s expectations as of today. Inari undertakes no obligation to update these statements, except as required by applicable law. On today’s call, we will refer to both GAAP and non-GAAP financial measures in announcing our Q4 and full year 2023 results. Please refer to today’s press release for reconciliation of the non-GAAP measures discussed on this call and referred to in the press release.

The press release and the slides accompanying this call are available on our website at inarimedical.com. A recording of today’s call will be available on our website by 5:00 p.m. Pacific time today. With that, I’ll turn our call over to Drew.

Drew Hykes: Thank you, John, and thank you for joining our call today. We are thrilled with our Q4 and full year 2023 performance. In the fourth quarter, we achieved record revenue of more than $132 million, driven by strength in our core VTE business, strong growth from our emerging therapies portfolio, and continued traction from international expansion. For the full year, we generated revenue of over $493 million, reflecting 29% growth for the year. We also made meaningful progress on our path to profitability, positioning Inari for sustained operating profitability in the first half of 2025, despite the incremental operating deficit support associated with our LimFlow acquisition. I would like to thank the Inari team for their hard work to make this year a success by every measure.

We are succeeding on our goal to drive strong adoption of our market-leading PE and DVT therapies, while also executing on our plans to expand internationally and diversify commercially into sizable new patient populations that are underserved by today’s standard of care. This expansion into new patient populations included the acquisition of LimFlow, which we announced and closed in Q4. LimFlow’s purpose-built system allows for the transcatheter arterialization of the deep veins and is indicated to treat patients with chronic limb-threatening ischemia, or CLTI. This technology addresses a spectacular unmet need for these patients, providing new hope and an important new treatment option. I’ll have more to share about our progress with LimFlow later in the call.

Going forward, we will begin providing a new revenue breakout that we believe better aligns with the three growth pillars of our business. Specifically, we’ll report revenue from our global VTE portfolio and from our global emerging therapies portfolio, while also continuing to breakout U.S. and international revenue. Mitch will have more to share about this new framework in his remarks. Before turning to these growth pillars, I wanted to share, as we always do, a story about the incredible impact our technology has on patients. Recently, a 30-year-old woman, just two weeks postpartum, presented to an ER in Louisiana with severe trouble breathing and leg swelling. As a complication from her recent pregnancy, this young mom was diagnosed with both a pulmonary embolism and a clot in her inferior vena cava, or IVC, a life-threatening situation.

After consulting with her physicians, she decided to undergo thrombectomy. First, her physicians used the new ClotTriever XL catheter to effectively remove all the clot in her IVC, as it was purpose-built to do. The ProTrieve sheath was also used adjunctively to protect against the risk of clot embolization. Next, her pulmonary embolism was successfully and efficiently treated using the T24 catheter. After a short hospital stay, the patient was able to return home to her newborn baby and family. Her successful outcome was made possible by the skill of her treating physicians and the breadth and depth of Inari’s purpose-built toolkits across both DVT and PE. During 2023, we surpassed 130,000 cumulative patients treated globally, including this young mom.

This was a humbling milestone for our organization. But despite all our success to date, much more work remains, and we believe we’re in the earliest phases of the impact we can have on patients globally across multiple disease states. I will now provide an update on each of our three growth pillars, starting with VTE, which we believe represents a $6 billion TAM in the U.S. alone. Our growth strategy in VTE continues to focus on commercial expansion, market development, high-quality clinical evidence, and continuous innovation. Commercially, we remain committed to our high-touch approach. We continue to split territories, adding reps selectively at a measured pace in areas with the greatest need. Given our high level of national count penetration, as the pace of new territory adds continues to moderate, we have started to see some nice corresponding productivity gains.

Looking ahead, we remain confident in the ability of our world-class commercial team, the largest VTE-focused sales force in the industry, to drive significant growth. Turning to market development, we’re increasing penetration within existing accounts via VTE Excellence, our comprehensive market development program. VTE Excellence is a series of playbooks and activities that we systematically execute to help support hospitals in the development of VTE programs. The goals analogous to the programs have been created in stroke, STEMI, and TAVR. As we execute VTE Excellence, our penetration into the TAM at the account level increases and we are encouraged by the progress we are making. Today, in many of our most advanced accounts, we are now seeing TAM penetration rates above 50%.

Most importantly, we believe VTE Excellence is scalable and repeatable. On the clinical evidence front, we remain steadfast in our commitment to produce the highest quality clinical data to drive awareness and ultimately change the standard of care in VTE. This commitment is reflected in the significant progress we continue to make across all three of our randomized controlled trials. In fact, we just completed patient enrollment for PEERLESS, our trial randomizing FlowTriever to catheter-directed thrombolysis. We were able to fully enroll this study in just over two years, a considerably faster pace than other currently enrolling RCTs. We look forward to the data readout in the second half of 2024. Enrollment for DEFIANCE and PEERLESS 2 are also tracking in line with our expectations.

Currently across the industry, there are no fewer than seven actively enrolling RCTs, each studying different aspects of VTE. This represents an exciting new era of investment and shared commitment to change the standard-of-care for this huge underserved group of patients. But make no mistake, Inari continues to be the clear leader in this effort. Taken together, we will study over 2,000 patients in our three RCTs, more than those conducted by all other sponsors combined. We believe this high-quality clinical evidence will ultimately enable us to treat a significant portion of the 700,000 U.S. patients suffering from VTE each year. Finally, we continue to innovate across our best-in-class toolkits to protect and extend our leadership position.

Over the past 12 months, we commercialized multiple new products to augment our VTE franchise, including T16Curve, ClotTriever XL, and ClotTriever BOLD Gen 2. The FlowTriever and ClotTriever systems are fourth- and third-generation platforms, respectively, benefiting from six years of continuous iteration and improvement. However, we remain committed to further innovation within VTE. Next, I will provide some updates across our portfolio of Emerging Therapies, our second growth pillar. This segment consists of four distinct patient populations outside of VTE, where we have identified an unmet need we believe we can address by leveraging our core competencies. Taken together, we believe these markets represent a $4 billion TAM in the U.S. alone, and we are just getting started in each.

Beginning with chronic venous disease, we continue to be encouraged by the initial commercial traction of RevCore, the first mechanical thrombectomy device to treat venous stent thrombosis. Between incidence and prevalence pools, we believe the addressable market for RevCore totals nearly 50,000 patients, representing a $500 million U.S. TAM. Looking ahead, in 2024, we plan to launch the second purpose-built tool within the CBD toolkit, further augmenting our portfolio and unlocking another portion of this significant TAM. Turning to dialysis access management, InThrill continues to build commercial traction over the past several quarters. InThrill is a thrombectomy system designed for small vessels, including AV fistulas and veins in the upper extremities and below the knee.

The combined total addressable market is 250,000 procedures per year in the U.S., representing an incremental $1 billion market opportunity. Turning to CLTI, since closing the LimFlow acquisition in mid-November, we’ve made important progress in beginning to integrate the business into Inari, while also executing the early U.S. launch. We have successfully established the initial LimFlow organization through a combination of LimFlow and Inari personnel and a small number of external hires. We’ve undertaken important work to stabilize and build capacity across the supply chain, while also beginning to integrate corporate support services. Commercially, the U.S. launch is proceeding in line with our expectations. We are successfully navigating back approvals and have completed initial series of commercial cases.

We held our first training summit in late January and had great engagement and feedback from the event. We anticipate building momentum throughout the year, highlighted by incremental reimbursement via NTAP, which would go into effect in October. Taken together, we continue to view 2024 as a foundational year focused on physician training, VAC approvals, thoughtful patient selection and deliberate wound care follow-up. LimFlow offers new hope and new options to the 55,000 no-option CLTI patients. We are encouraged by the progress we’ve made to date in accessing this $1.5 billion U.S. TAM. Our last emerging therapies category is acute limb ischemia, a $600 million U.S. TAM characterized by tremendous unmet needs and a lack of purpose built tools.

In fact, roughly 50% of ALI patients today must undergo an open surgical procedure to successfully remove their clot. We remain committed to better outcomes for these patients and continue working to bring our second generation Artix system to market later in 2024. Finally, I would like to discuss our third pillar, international. In Q4, we continue to see strong growth led first and foremost by our European franchise. Alongside Europe, we continue to gain incremental product approvals and are now commercial in over 30 countries globally. Overall, international revenue was nearly $8 million in Q4, up more than 130% versus the prior year. Looking forward, we recently received favorable incremental reimbursement in France. Also, we remain on track to treat patients in both China and Japan this year on a commercial basis.

While international sales are just 5% of our total revenue today, given the spectacular unmet need and the investment we’ve made in establishing an international commercial footprint. We expect international sales to account for at least 20% of revenue over time. In closing, we’re pleased with how the business performed in Q4 in 2023. For the year, we generated record revenue and strong growth of nearly 30%, driven by crisp execution across our growth pillars. Our field team continued to drive patients toward frontline treatment with our therapies while working to support the development of VTE programs. We announced our third RCT and built meaningful momentum across new product launches, and we saw another record quarter and strong growth from our international business.

In addition, we laid the foundation for strong sustained revenue growth via expansion of our purpose-built toolkit into new disease states with significant unmet needs. We also announced closed and began to integrate LimFlow, our first acquisition. Finally, we delivered meaningful operating leverage while continuing to invest in burgeoning parts of the business. Going forward, I’ve never been more confident in the health of our business and our ability to generate meaningful revenue growth across our three growth pillars in 2024 and for many years to come. With that, I’ll now turn the call over to Mitch.

Mitch Hill: Thanks, Drew. Before I begin, I want to share additional color on the revenue breakouts Drew described. We’re pleased to be introducing additional visibility to our growth pillars by sharing the revenue contributions of our VTE and our emerging therapies products. VTE includes sales of the entire ClotTriever and FlowTriever product families globally. Emerging therapies includes our portfolio of products addressing on a global basis, chronic venous disease, dialysis access management, chronic limb-threatening ischemia, and acute limb ischemia. In our press release, we have provided quarterly historical revenue for these growth pillars going back to the start of 2022 to provide a sense of the strong growth and adoption we are seeing in all areas of the business.

Please note that we will also continue to provide U.S. and international revenue splits as we have done historically. Turning to the fourth quarter and full year 2023 results, Inari revenue in the fourth quarter of 2023 was $132.1 million, up 23% over the same period of the prior year. On a year-over-year basis, VTE drove more than 85% of the growth and emerging therapies accounted for roughly 15% of the growth. Gross margin was 87.1% for the fourth quarter of 2023, compared with 87.8% in the prior year period. Operating expenses were $124.4 million in the fourth quarter of 2023, compared with $100.5 million for the same period of the prior year. R&D expense was $22.9 million in the fourth quarter of 2023, up 12%, compared with $20.4 million for the same period of 2022.

The increase in R&D expense was primarily due to increases in professional fees and clinical and regulatory expenses. SG&A expense was $101.5 million in the fourth quarter of 2023, up 27%, compared with $80.1 million for the same period of the prior year. The increase in SG&A expense was primarily due to increases in personal related expenses from increased headcount, increased commissions due to higher revenue, and professional fees, which are primarily attributable to the acquisition of LimFlow. Also in December 2023, we received a civil investigative demand from the Department of Justice requesting information primarily related to meals and consulting service payments provided to healthcare professionals. We are cooperating with this investigation.

Going forward, legal and associated expert expenses related to this matter will be recorded in our SG&A expense. Inari recorded a GAAP operating loss of $9.3 million in the fourth quarter of 2023, compared with a GAAP operating loss of $5.9 million for the same period in the prior year. On a non-GAAP basis, which excludes acquisition related expenses and acquired intangible asset amortization, the fourth quarter operating loss was just $300,000. There were no non-GAAP adjustments related to our 2022 operating loss. Net loss for the fourth quarter 2023 was $4.7 million, compared to a net loss of $5.8 million for the same period of the prior year. The basic and fully diluted net loss per share for the fourth quarter 2023 was $0.08 based on the weighted average basic and fully diluted share count of $57.6 million.

This compares with a basic and fully diluted net loss per share of $0.11 based on the weighted average basic and fully diluted share count of $53.6 million for the same period of the prior year. Shifting to full year 2023 results, we reported revenue of $493.6 million, up 29% over the prior year. VTE accounted for over 85% of the growth, while emerging therapies contributed nearly 15% on a year-over-year basis. Gross margin was 88% for the full year 2023 compared to 88.4% for the full year 2022. Operating expenses were $448.6 million for the full year 2023, up 22% compared with $367.1 million for the full year 2022, including one-time expenses related to the LimFlow acquisition. R&D expense was $87.5 million for the full year 2023, up 18% compared with $74.2 million for the full year 2022.

The increase in R&D expense was primarily due to increases in personal related expenses, materials and supplies, clinical and regulatory expenses, and software costs and depreciation in support of our growth pillars. SG&A expense was $361.1 million for the full year 2023, up 23% compared with $292.8 million for the full year 2022. The increase in SG&A expense was primarily due to increases in personal related expenses and professional fees largely associated with the acquisition of LimFlow. GAAP operating loss was $14 million for the full year 2023, compared with $28.1 million for the full year 2022. On a non-GAAP basis, which excludes acquisition related expenses and amortization of acquired intangible assets, operating loss was $2.4 million for the full year 2023.

There were no non-GAAP adjustments related to our 2022 operating loss. Net loss for the full year 2023 was $1.6 million, compared to a net loss of $29.3 million for the full year 2022. The basic and fully diluted net loss per share for the full year 2023 was $0.03 based on the weighted average basic and fully diluted share count of $56.8 million. These compared with a basic and fully diluted net loss per share of $0.55 based on the weighted average basic and fully diluted share count of $52.8 million for the full year 2022. Moving on to the balance sheet, our cash and investments at the end of the fourth quarter totaled $116.1 million. Our cash flows provided by operating activities were $35.9 million in 2023 compared to cash flows used in operating activities of $14 million in 2022.

Turning to our 2024 outlook, we are reiterating our full year 2024 revenue guidance of $580 million to $595 million reflecting growth of approximately 17.5% to 20.5% over 2023. Our guidance reflects contributions across all three of our growth pillars: VTE, emerging therapies and international. For LimFlow we continue to view 2024 as a foundational year and expect a modest revenue contribution. We currently anticipate sequential revenue growth of approximately 4% for Q1 of 2024 relative to Q4 of 2023. For 2024 from a phasing perspective we expect strong revenue growth momentum in the back half of the year. Turning to profitability we are continuing to invest on our growth pillars while positioning the business to achieve sustained operating profitability.

In 2024 we expect to see greater operating losses in the first half of the year than in the second half of the year. And as we shared early in the year, we continue to forecast reaching sustained operating profitability on a consolidated basis in the first half of 2025. With that, I’ll turn the call back to the moderator for questions. For the Q&A segment Drew, John and I will be joined by Dr. Tom Tu, Inari’s Chief Medical Officer.

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Q&A Session

Operator: [Operator Instructions] Our first question comes from Travis Steed from Bank of America. Please go ahead.

Travis Steed: Hey, thanks for taking the question. I wanted to ask about the DOJ investigation you mentioned Mitch. I guess the list of questions I’d have on that is, how broad is the investigation? When did it start? What are the next steps? How long do you expect it to last? And do you expect it to have any impact on customers or revenue in 2024?

Drew Hykes: Yes, thanks for the question, Travis. This is Drew. I can get started on that. So, as you likely understand from some of the precedent examples of other companies navigating these same waters, we’re not going to have a lot of additional background. We’re going to be able to share beyond what’s in the disclosure. We got the CID back in December, so it’s still relatively early. We are cooperating with the DOJ. We take compliance seriously. Today we always have at every step of our commercial activity here in the U.S. going back to 2018. We do not expect that this will have any impact on our ability to execute commercially. The focus of the CID is described in the 10-K, it’s a couple of very specific areas related to healthcare professional relationships. Going forward, we’ll update you as we can, but again based on the precedent I think the timeline is most likely going to be measured in years as opposed to months and quarters.

Travis Steed: Okay, thanks for that. And then a question on the 2024 guidance, I’m curious how you’re seeing the core and that 17.5% to 20.5% guide. And when you look at the core for 2023, it was around 25%. So just curious why you’re assuming such a slowdown in the core business and 2024, if it’s just conservatism or anything else, you’d call out on that?

Drew Hykes: Yes. I think in general, I’d probably start with reiterating what our philosophy is around guidance. And historically when we put out a number, we want to be highly confident in being able to deliver on that number. That’s been our historical practice, and that was certainly consistent with how we approach guidance here last month for 2024. We feel really good, very comfortable and confident in that guidance range of 580 to 595. The factors growth in across all three of our growth pillars. Certainly, VTE will be the majority of the growth and the revenue still in 2024. We anticipate continued strong growth there from commercial expansion, from taking share from analytic based interventions, from TAM expansion via market development efforts, new data innovation all of that factored into the anticipated growth in the VTE pillar.

Emerging therapies we’re factoring in growth across all four of those new patient populations that we’re beginning to do work in. Certainly continued traction in CBD and InThrill, new products coming with Artix, and as you’ve heard us describe a modest contribution from LimFlow. And then finally, we’re factoring in continued growth and strength internationally, led first and foremost by Europe, but also factoring in contributions from some of the other geographies as well. So we’ll have an opportunity to discuss guidance again here in 60 days or so on the formal Q1 call but in the meantime, we’re going to continue to focus on execution that we’ve always taken great pride in.

Operator: The next question comes from Adam Maeder from Piper Sandler. Please go ahead.

Adam Maeder: Hi. Good afternoon. Thank you for taking the questions. Wanted to start with a Q4 question, and apologies for the granularity here. But I was hoping you could give us some color on Q4 in terms of kind of how that played out in terms of monthly progression and commercial momentum. Your competitors talked about a pickup in their business in Q4, I think in the late November time frame, wondering if you have any reaction to that comment, and then just any early commentary that you can give us on your business thus far year-to-date in Q1. Thank you.

Drew Hykes: Yes, thanks for that, Adam. So we saw a nice momentum building in Q4 particularly in the tail end of the quarter, and we saw that momentum carry over here into the beginning of this year. As you know, we don’t normally provide detailed intra quarter commentary, but what I can tell you is that that momentum did carry over nicely into the beginning of this year. January was a step up, actually a nice step up from what we saw in December, and that momentum has continued here. So, taken together, we’re feeling really good about how we’re positioned here at the beginning of the year. We like the plan. The team is executing really crisply, really consistently. We’re seeing nice growth across all three of those growth pillars.

And looking ahead from here, we see some really nice catalysts shaping up for the remainder of the year across those pillars. New territories and new data, driving continued traction in VTE. New products and new markets that we’ll be getting started in with emerging therapies, contributions from LimFlow along the way there as well. And then obviously, some nice traction continuing internationally with Europe leading the way, more geographies contributing in more meaningful ways, and still on track in both China and Japan for treating patients in those two markets. So far, so good, we’re feeling very confident in how we’re positioned here, not only in Q1, but as we look out from here through the remainder of the year.

Adam Maeder: Thanks for the color there, Drew, and I guess for the follow up. I’ll ask a question on competition as it relates to 2024. The last, Travis, was asking about your outlook for 2024, but was curious kind of what you’re baking in from a competition standpoint, competitive standpoint for your guidance in 2024, both from your primary competitor and then any new market entrance on the DVT side of things? Thanks for taking the questions.

Drew Hykes: Yes. So competition and competitive dynamics are clearly incorporated into our guidance. This is an attractive market. We are going to see competitive entrants, become active in this market. Keep in mind it’s a $6 billion market. 6% penetrated our focus primarily historically, and today remains on market growth, on making the investments we believe are necessary to change the standard of care for this patient population. That’s where we have focused on training and education, on innovation, on high quality evidence. All those areas you’ve heard us describe before, all of them designed to drive market growth, that’s where the real opportunity is. We’re going to see competitive entrance. We’ve factored that into our guidance.

We started 2023 as the clear market leader. We exited 2023 as the clear market leader, and we would absolutely expect to continue to be the market leader in 2024. That confidence in leadership comes from the performance of our products, the undisputed, solid clinical data that we have, the new innovation, the way our team is executing, all that gives us confidence we’re going to continue to be the leader in this market. And that is despite what will undoubtedly be new entrants. Maybe the last point I’d make is to the extent we do have new entrants that can help participate in the market development work, that’s obviously going to be constructive for everyone and ultimately constructive for patients.

Operator: Our next question comes from Kallum Titchmarsh from Morgan Stanley. Please go ahead, please guys.

Kallum Titchmarsh: Thanks for taking the question. I think one for Mitch here. Just on the gross margin side, I think 87.1% in the fourth quarter was a bit below where the Street was. So just keen to understand how we should be thinking about the setup for this in 2024 and maybe just some color on how you expect gross margins to trend longer term with these emerging products coming through, I guess, are you still comfortable remaining in that mid- to high-80% range longer term? Thanks a lot. Sure.

Mitch Hill: Sure. Yes. Thanks for the question, Kallum. And in terms of the Q4 gross margin we saw some impact from the acquisition. There’s a portion of the gross margin decline that related to the LimFlow acquisition, even though that was just in the picture for about 45 days, we continued to see some margin impact due to the internationalization of the business, as well as the new – some of the emerging therapy products have a lower gross margin profile than the kind of the VTE products that we’ve historically been selling. So that’s kind of a couple different factors that affected the change in gross margin from Q3 to Q4. As we think about the gross margin in 2024, I would say we’re going to likely have another quarter or so of margin kind of in the low 87% range, and then we probably actually look for some margin pickup in the second half of the year.

And then longer term, we’ve messaged and we still feel confident in our messaging about the gross margin kind of in the mid-80s. There’s a lot of different factors that kind of go into the stew when we put that together. But overall, we think this business has a premium gross margin profile. We expect it will continue to have that, and we’ve kind of accounted for all the different factors in there as we kind of forecast that mid-80s percent gross margin over time.

Kallum Titchmarsh: Great. Thanks a lot.

Operator: The next question comes from Larry Biegelsen from Wells Fargo. Please go ahead.

Larry Biegelsen: Hi. Good afternoon. Thanks for taking the question. Drew, historically, you’ve said the core U.S. VTE market is a 20% growth – 20% plus, I think, growth market. What are you seeing now, and what are your expectations for 2024?

Drew Hykes: Yes. We still see this as a massive market in the earliest stages of penetration. We’re making the investments to drive that market growth, and we’re continuing to see a very robust backdrop of market growth. We have every expectation that that’s going to continue as we look out from here, certainly in 2024. So, no change in our view of the underlying strength of the market growth. Month to month, quarter to quarter, there may be fluctuations here and there, just given how early we are in penetrating this market, but the trend line is unmistakable. This is a $6 billion market in the earliest phases of transitioning from conservative medical management to frontline therapy with FlowTriever and ClotTriever.

Larry Biegelsen: Thank you. And to help us understand the emerging technology and international lines better, can you talk about what’s assumed for Artix and what’s assumed for Japan and China and any color on those market opportunities and your confidence in Artix the second time around here that you’re going to be successful? Thank you.

Drew Hykes: Yes, so relative to Artix, we’ve been working almost a back – a year and a half now to reset that platform and do the development work you’ve heard us describe coming out of the first gen LMR. We’ve been hard at work. We are cautiously optimistic that we’ve improved the product in terms of the effectiveness and ease of use that you’ve heard us describe before. But until we actually execute the LMR, we’ll need to be a little cautious about what kind of contribution we’re going to be describing. We’ve taken that into account in the guidance. It’s a relatively modest component of our guidance as a result. Similarly with China and Japan, we’re confident we’re going to be able to treat patients in those two markets this year, but there is some uncertainty around when the exact approvals will take place as well as how quickly the initial ramp will take place.

And as a result of those uncertainties, we’ve also factored in a pretty modest contribution from both China and Japan into that 2024 guidance.

Operator: The next question comes from Marie Thibault from BTIG. Please go ahead.

Marie Thibault: Hi, thank you for taking the questions. I wanted to ask a quick clarification on the emerging therapies revenue breakout. Am I fair in assuming most of that’s out of the U.S., all of that’s out of the U.S., or are there some emerging therapy treatments being done internationally?

Drew Hykes: Yes, Marie, there is a – it’s primarily U.S. revenue when we’re looking at the emerging therapies. So, for example, if you look at the table that’s at the back of the press release, those are almost exclusively in the U.S. For the reasons you’d imagine, we’re in the process of pursuing regulatory approval for many of those products for international markets, probably initially focused on Europe and then we’ll kind of roll those out in other parts of the world, but we’re still kind of going through the process.

Marie Thibault: Okay, that’s helpful. Then let me ask, I guess, a two-part question, largely on cadence and sort of the path to think about this year. Cadence for the sales guidance throughout this year, if I’m recalling correctly, Q2 was just a slight sequential step up from Q1, so I’d like to try to understand that for modeling purposes. And then similarly, the path to profitability in the first half of 2025 on operating profitability, what do you need to do kind of operating leverage-wise, and what gets you to that goal?

Mitch Hill: Yes, Marie, thanks for the question. In the prepared remarks, I commented on kind of the Q4 target, sorry, a 4% target in terms of sequential growth from Q4 to Q1 as we move into 2025. Past couple of years, we’ve seen some seasonality softness in Q2. We’re still not sure about that, if that’s a real thing in our business or not, different reasons and theories around that. But then I did mention in the script that we would expect accelerating revenue sort of in the second half of the year. So that would give you a sense for kind of the overall revenue profile. From an operating leverage and kind of path to profitability point of view, I am glad you asked about that. I was just thinking in Q4 of – in terms of our Q4 numbers, with 23% revenue growth, OpEx grew by 24%, but if we exclude the LimFlow one-time costs, the OpEx grew by 15%.

So really nice progress there in Q4. Then looking at the full year numbers, revenue growth of 29%, OpEx growth of 22%, and then if we exclude the LimFlow one-time stuff, about 19%. So we’ve taken this challenge of operating leverage seriously as a company. There’s a lot of buy-in across the company to looking at all the areas of the OpEx spend and making sure that we are seeing some nice productivity of our investments there. That’s contributing to our confidence as we think about the progress of the business from a profitability point of view in the first half of 2024 versus the second half of 2024, so less basically operating loss as we move through the course of the year, and then moving towards sustained operating profitability in the first half of 2025.

Operator: The next question comes from Bill Plovanic from Canaccord. Please go ahead. Hi, Bill…

Drew Hykes: Hi, Bill. Are you there?

Bill Plovanic: Yes, I’m here. Thanks for taking my questions. Let’s start off with, can you help us understand just any commentary regarding competitive trialing, share gain/loss, where are you seeing the biggest impact, DVT, PE? I think as we look at these numbers on the VTE business, you grew just under 20%. You’ve had some solid growth internationally, which puts the U.S. more into the mid to high teens. I guess what I’m trying to get at is how much of this is behind you, and what are you expecting in 2024 in terms of this?

Drew Hykes: Yes, so I’m happy to answer some of that, Bill, and Mitch may want to pile on as well. We’ve been pretty clear about the competitive dynamics as we move through 2023. I think much of the competitive trialing was front-end loaded on the year, but we did see it kind of splash over into Q3 and Q4. You’ve heard us describe those are cases that we would have had. That’s revenue that we would have generated. And due to the competitive trialing, we don’t have access to it. So it has definitely had an impact. At the same time, again, we began the year as the market leader. We’re exiting the year as the market leader. We are very confident in continuing to be the market leader. This is an attractive market. There are going to be new entrants that come.

Where we compete head-to-head, we like our chances. We like the way our technology is performing, third, fourth-generation platforms at this point. We have a very capable and well-established commercial presence and field team that are doing good work day-in and day-out. We’ve got a mountain of high-quality clinical evidence getting bigger every day, and we’re continuing to innovate on the technology as well. On top of that, a very differentiated approach to market development. So you take all that together, we’re very confident in our ability to continue to lead in this market. And to the extent new entrants can help develop the market, after all, that’s where our focus is, that’s where the real value is on a patient front as well as a value creation front.

Anything you want to add to that, Mitch?

Mitch Hill: Yes. Just, Bill, from the point of view of the VTE growth, so I am kind of looking at some of the revenue aggregation that’s in that table we disclosed in the back half of the press release. I am just looking at the sequential revenue growth, let’s say, of Q4 over Q3, so just over 4% there. Then when I look at the year-over-year number for VTE, about 19.5% revenue growth comparing 2023 and 2022. So I think those numbers are pretty attractive, you know, from a growth perspective, and we feel pleased with the progress and the performance of the business during 2023. And for all the reasons you heard from Drew, very optimistic about 2024 as well.

Bill Plovanic: And then, just you mentioned, Mitch, on the profitability of the business, you subtracted out the LimFlow acquisition costs. I’m sure there’s some – when you did that, is it just the acquisition, or is that also the ongoing LimFlow costs when we kind of looked at that from the core, was that like a core business look in terms of your answer to a prior question?

Mitch Hill: Yes, the answer to the prior question, I was just looking at the 2023 Q4 numbers and also the full-year numbers, and then just backing out the one-time costs which are identified in the press release, essentially that was $9 million in Q4, and then $11.7 million for the full year. Happy to share some commentary, if you’d like in terms of how that looks in 2024 as well. I think we would expect the one-time costs if you’re kind of interested in that, from a Q4 perspective, I think, the one-time costs in Q1 would be about the same as Q4, and then potentially drop into about half of that for the remainder of the year. And that’s made up of both the transaction costs, which dissipated as we moved through the year, and then this purchase price amortization thing that I talked about, the amortization of the acquired intangible asset. So happy to talk further about that, but hopefully that’s helpful with at least some directional feeling on that.

Bill Plovanic: Yes, so you’re seeing another $9 million in Q1, and then we’ll see about $2.5 million to $3 million a quarter from the amortization in Q2 through Q4, is that how to think about it?

Mitch Hill: Yes, that amortization number stays pretty consistent through the course of the year, around $2.5 million. The total one-time stuff in Q2 through Q4 is more in the $4 million to $5 million range, because there is still some transaction costs involved.

Bill Plovanic: Great, thank you. Thanks for taking my questions.

Mitch Hill: But, Bill, just to make sure I’m clear, when I was talking earlier about the company’s profitability, we’re speaking about GAAP profitability, so I’m not talking about this non-GAAP number that we have in the press release, so I just want to make sure everybody is clear on that.

Bill Plovanic: Thank you.

Mitch Hill: Yes.

Operator: The next question comes from Chris Pasquale from Nephron Research. Please go ahead.

Chris Pasquale: Thanks. Just one quick one on the quarter. Any color on the VTE mix between FlowTriever and ClotTriever in 4Q?

Drew Hykes: The overall mix, Chris, still has been pretty consistent. I think you’ve kind of seen historically, you can look back for several years, actually, for us, and you can see the breakdown in terms of product-wise, revenue-wise between the FlowTriever family and the ClotTriever family. So I would say that’s pretty consistent. That’s one thing that, as a part of this new revenue aggregation as we move forward we are not going to talk specifically about that. But I think you’ve got a pretty good flavor for it based on how the business has operated historically.

Chris Pasquale: Okay, that’s fair enough. And then just a couple questions on PEERLESS. So, it’s complete enrollment, it’s short follow-up. You talked about data being presented in the back half of this year. It seems like you might know what it looks like before then, just given the timing here. So, are you targeting a particular venue for that? And how would you frame the impact positive data could have? You know, what percentage of patients are getting CDT today and could shift to mechanical thrombectomy if that data is really compelling?

Drew Hykes: Great questions, Chris. Thanks for bringing them up. So, firstly, as regards to the timing of the PEERLESS data release, we’re really excited about the completion of enrollment in this study. I think it’s a testament to the level of interest of clinical investigation in this space, as well as the execution of the clinical team. We are targeting a major cardiovascular meeting for the release of the data, and you can imagine towards the back half of the year what possible meetings that might be. I think this being a groundbreaking study deserves the kind of platform that that might provide. So, that’s as much as timing. As far as the potential impact, we know that CDT has been progressively diminishing as a treatment for pulmonary embolism. Although there are still people who consider that as therapy, and I think this data set is going to go a long way towards targeting conversion of CDT therapy to definitive mechanical thrombectomy.

Operator: Our next question comes from David Rescott from Baird. Please go ahead.

David Rescott: Great. Thanks for taking the question. Good afternoon. I wanted to start on the emerging therapies bucket and some of the prior year-over-year – prior data that you provided. When we look at, I think, maybe Q2 through Q4 of 2023, it looks like there is a pretty significant step up, at least closer to that $4 million to $5 million per quarter number versus the $2 million or so in Q1. So I’m wondering, one, if that is kind of the right way to start off thinking about emerging therapy contribution as early as, I guess, the first quarter of 2024, and I am curious what maybe the biggest kind of contribution segment or product in that $4 million to $5 million per quarter that we’ve seen and whether or not that’s been steady throughout those two to three quarters in the back half of 2023, or if there is any movement around some of those new products having a bigger contribution on a quarterly basis.

Drew Hykes: Yes David I am happy to get started on that, Mitch may want to add some additional thoughts as well. So as you look back over the course of 2023 across the emerging therapies portfolio, keep in mind these are still relatively small numbers, but you’re seeing the impact of some of the new product introductions that we made earlier in 2023, specifically RevCore and InThrill. And so you are seeing the impact of those product launches and some of those step ups. Looking ahead from here, we absolutely would expect the emerging therapies portfolio to grow on a relative basis quite a bit faster than VTE, but obviously off a much smaller base. We will be bringing a new product into the CVD toolkit alongside RevCore. We talked about that in the prepared remarks.

There will be some incremental growth, hopefully, from that new product introduction. We’ll have continued traction with InThrill. LimFlow is included, obviously, in the CLTI component of emerging therapies. We’ve only factored in a modest contribution from LimFlow, but that will be ramping as we move through 2024 and the U.S. launch progresses. And then finally we will get started on Artix if all goes to plan later in the year. And that will be incremental growth in the fourth and final segment of emerging therapies.