Portsmouth Square Q4 2023 Earnings Call Transcript

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Provided by Quartr
February 28, 2024

There are 14 speakers on the call.

Operator

Good day, and welcome to Enari Medical's 4th 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.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Welcome to Inari's conference call to discuss our Q4 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 fact 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 Limflo are based on Enari's current expectations, forecasts and assumptions, which are subject to inherent uncertainties, risks and assumptions that are difficult to predict.

Speaker 1

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 ks 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.

Speaker 1

Please refer to today's press release for a 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 anarenemedical.com. A recording of today's call will be available on our website by 5 P. M. Pacific Time today.

Speaker 1

With that, I'll turn the call over to Drew.

Speaker 2

Thank you, John, and thank you for joining our call today. We are thrilled with our Q4 and full year 2023 performance. In the 4th quarter, we achieved record revenue of more than $132,000,000 driven by strength in our core VT business, strong growth from our emerging therapies portfolio and continued traction from international expansion. For the full year, we generated revenue of over $493,000,000 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 LimbFlo acquisition.

Speaker 2

I would like to thank Denari 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 DBT 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 to new patient populations included the acquisition of Lymphlo, which we announced and closed in Q4. Lympho'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.

Speaker 2

I'll have more to share about our progress with Finflo later in the call. Going forward, we will begin providing a new revenue breakout that we believe better aligns with the 3 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 break out U. S. And international revenue.

Speaker 2

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 2 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 IBC, a life threatening situation. After consulting with her physicians, she decided to undergo thrombectomy.

Speaker 2

First, her physicians used the new ClotTriVer XL catheter to effectively remove all the clot in her IBC as it was purpose built to do. The protrude sheet was also used adjunctively to protect against the risk of clot embolization. Next, 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 DBT and PE.

Speaker 2

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 3 growth pillars, starting with VTE, which we believe represents a $6,000,000,000 TAM in the U. S.

Speaker 2

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 account penetration, as the pace of new territory adds continues to moderate, we've started to see some nice corresponding productivity gains.

Speaker 2

Looking ahead, we remain confident in 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 and the development of VTE programs. The goal is analogous to the programs that have been created in stroke, STEMI and TAVR.

Speaker 2

As we execute BT 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're now seeing TAM penetration rates above 50%. Most importantly, we believe VT 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.

Speaker 2

In fact, we just completed patient enrollment for PURELESS, our trial randomizing FLOWTRUER to castimab directed thrombolysis. We were able to fully enroll this study in just over 2 years, a considerably faster pace than other currently enrolling RCTs. We look forward to the data readout in the second half of twenty twenty four. Enrollment for Defiance and Peerless II are also tracking in line with our expectations. Currently across the industry, there are no fewer than 7 actively enrolling RCTs, each studying different aspects of VTE.

Speaker 2

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 3 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.

Speaker 2

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 T16 curve, Klotriever XL and Klotriever Bold Gen 2. The Flotriever and Klotriever systems are 4th and 3rd generation platforms respectively, benefiting from 6 years of continuous iteration and improvement. However, we remain committed to further innovation within VTE.

Speaker 2

Next, I'll provide some updates across our portfolio of emerging therapies, our 2nd growth pillar. This segment consists of 4 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 $4,000,000,000 TAM in the U. S. Alone we are just getting started in each.

Speaker 2

Beginning with chronic venous disease, we continue to be encouraged by the initial commercial traction of Revcor, the first mechanical thrombectomy device to treat venous stent thrombosis. Between incidence and prevalence pools, we believe the addressable for Revcor totals nearly 50,000 patients, representing a US500 $1,000,000 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. Enthrill continues to build commercial traction over the past several quarters.

Speaker 2

Enthrill 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 $1,000,000,000 market opportunity. Turning to CLTI, since closing the Limflo acquisition in mid November, we've made important progress in beginning to integrate the business into Inari, while also executing the early U.

Speaker 2

S. Launch. We have successfully established the initial lympho organization through a combination of LimbFlo and Ennard 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.

Speaker 2

S. Launch is proceeding in line with our expectations. We are successfully navigating back approvals and the completed initial series of commercial cases. We held our 1st 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 an NTAP, which would go into effect in October.

Speaker 2

Taken together, we continue to view 2024 as a foundational year focused on physician training, back approvals, thoughtful patient selection and deliberate wound care follow-up. Lympho 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 $1,500,000,000 U. S. TAM.

Speaker 2

Our last emerging therapies category is acute limb ischemia, a $600,000,000 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 2nd generation ARDICT system to market later in 2024.

Speaker 2

Finally, I would like to discuss our 3rd pillar, international. In Q4, we continue to see strong growth led 1st 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 $8,000,000 in Q4, up more than 130% versus the prior year. Looking forward, we recently received favorable incremental reimbursement in France.

Speaker 2

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 our 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 and 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.

Speaker 2

We announced our 3rd 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 toolkits into new disease states with significant unmet needs. We also announced, closed and began to integrate Lympho, 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 3 growth pillars in 2024 and for many years to come.

Speaker 2

With that, I'll now turn the call over to Mitch.

Speaker 3

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 clotriever and flowtriever product families globally. Emerging therapies includes our portfolio of products addressing on a global basis chronic venous disease, dialysis accidents management, chronic limb threatening ischemia and acute limb ischemia.

Speaker 3

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 4th quarter and full year 2023 results.

Speaker 3

Inari revenue in the Q4 of 2023 was 132,100,000 dollars up 23% over the same period of the prior year. On a year over year basis, VT drove more than 85% of the growth and emerging therapies accounted for roughly 15% of the growth. Gross margin was 87.1% for the Q4 of 2023 compared with 87.8% in the prior year period. Operating expenses were $124,400,000 in the Q4 of 2023 compared with $100,500,000 for the same period of the prior year. R and D expense was $22,900,000 in the Q4 of 2023, up 12% compared with $20,400,000 for the same period of 2022.

Speaker 3

The increase in R and D expense was primarily due to increases in professional fees and clinical and regulatory expenses. SG and A expense was $101,500,000 in Q4 of 2023, up 27% compared with $80,100,000 for the same period of the prior year. The increase in SG and A expense was primarily due to increases are primarily attributable to the acquisition of Limflo. 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.

Speaker 3

Going forward, legal and associated expert expenses related to this matter will be recorded in our SG and A expense. Eni recorded a GAAP operating loss of $9,300,000 in the Q4 of 2023 compared with a GAAP operating loss of $5,900,000 for the same period in the prior year. On a non GAAP basis, which excludes acquisition related expenses and acquired intangible asset amortization, the 4th quarter operating loss was just $300,000 There were no non GAAP adjustments related to our 2022 operating loss. Net loss for the Q4 of 2023 was $4,700,000 compared to a net loss of $5,800,000 for the same period of the prior year. The basic and fully diluted net loss per share for the Q4 2023 was $0.08 based on the weighted average basic and fully diluted share count of 57,600,000.

Speaker 3

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 53,600,000 for the same period of the prior year. Shifting to full year 2023 results, we reported revenue of $493,600,000 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 $448,600,000 for the full year 2023, up 22% compared with $367,100,000 for the full year 2022, including one time expenses related to the LYNPLA acquisition.

Speaker 3

R and D expense was $87,500,000 for the full year 2023, up 18% compared with $74,200,000 for the full year 2022. Increase in R and D expense was primarily due to increases in personnel related expenses, materials and supplies, clinical and regulatory expenses and software costs and depreciation in support of our growth pillars. SG and A expense was $361,100,000 for the full year 2023, up 23% compared with 292,800,000 dollars for the full year 2022. The increase in SG and A expense was primarily due to increases in personnel related expenses and professional fees largely associated with the acquisition of Lympho. GAAP operating loss was $14,000,000 for the full year 2023 compared with $28,100,000 for the full year 2022.

Speaker 3

On a non GAAP basis, which excludes acquisition related expenses and amortization of acquired intangible assets, operating loss was $2,400,000 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 $1,600,000 compared to a net loss of $29,300,000 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 56,800,000. 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 52,800,000 for the full year 2022.

Speaker 3

Moving on to the balance sheet. Our cash and investments at the end of the 4th quarter totaled 116,100,000 dollars Our cash flows provided by operating activities were $35,900,000 in 2023 compared to cash flows used in operating activities of $14,000,000 in 2022. Turning to our 2024 outlook, we are reiterating our full year 2024 revenue guidance of $580,000,000 to $595,000,000 reflecting growth of approximately 17.5% percent to 20.5 percent over 2023. Our guidance reflects contributions across all three of our growth pillars: VTE, Emerging Therapies and International. For Lympho, we continue to view 2024 as a foundational year and expect a modest revenue contribution.

Speaker 3

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.

Speaker 3

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 twenty twenty five. With that, I'll turn the call back to the moderator for questions. For the Q and A segment, Drew, John and I will be joined by Doctor. Tom Tu, Enari's Chief Medical Officer.

Operator

We will now begin the question and answer session. Our first question comes from Travis Steed from Bank of America. Please go ahead.

Speaker 4

Hey, thanks for taking the question. I wanted to ask about the DOJ investigation you mentioned, Mitch. I guess the list of question I'd have on that is, how broad is the investigation? When did it start? What are the next steps?

Speaker 4

How long do you expect it to last? And do you expect it to have any impact on customers or revenue in 2024?

Speaker 2

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.

Speaker 2

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.

Speaker 2

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 ks. It's a couple of very specific areas related to healthcare professional relationships.

Speaker 2

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 quarters.

Speaker 4

Okay. Thanks for that. And then a question on the 2024 guidance. I'm curious how you're seeing the core in that 17.5% to 20.5% guide. And when you look at the core for 2023, it was around 25%.

Speaker 4

So just curious why you're assuming such a slowdown in the core business in 2024, if it's just conservatism or anything else you'd call out on that?

Speaker 2

Yes, I think in general, I'd probably start with reiterating what our philosophy is around guidance. And you know 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 $5.80 to $5.95 that 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.

Speaker 2

We anticipate continued strong growth there from commercial expansion, from taking share from lytic based interventions, from TAM expansion via our market development efforts, new data innovation all of that factored into the anticipated growth in the VTE pillar. In 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, in entril, new products coming with Ardix and as you've heard us describe a modest contribution from Lympho. And then finally, we're factoring in continued growth and strength internationally led 1st 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.

Speaker 2

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 Mater from Piper Sandler. Please go ahead.

Speaker 5

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 pick up in their business in Q4, I think in the late November timeframe.

Speaker 5

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.

Speaker 2

Yes. Thanks for that, Em. 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.

Speaker 2

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.

Speaker 2

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 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 lympho along the way there as well. And then obviously, some nice traction continuing internationally with Europe leading the way. More geographies contributing more meaningful ways and still on track in both China and Japan for treating patients in those two markets. So, so far so good.

Speaker 2

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.

Speaker 5

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 entrants on the DVT side

Speaker 6

of things? Thanks for taking the questions.

Speaker 2

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 $6,000,000,000 market, 6% penetrated our focus primarily historically and today remains on market growth and making the investments we believe are necessary to change the standard of care for this patient population.

Speaker 2

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 entrants. We factor that into our guidance. We started 2023 as the clear market leader.

Speaker 2

We exited 2023 as the clear market leader and we would absolutely expect to continue to be the market leader in 2024. That confidence and 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 caleb Titchmarch from Morgan Stanley. Please go ahead.

Speaker 7

Thanks for taking the question. I think one for Mitch here. Just on the gross margin side, I think 87.1% in the 4th 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?

Speaker 7

I guess, are you still comfortable remaining in that mid to high 80% range longer term? Thanks a lot.

Speaker 3

Sure. Yes, thanks for the question, Talam. 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 Lympho acquisition, even though that was just in the picture for about 45 days. We continue 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 DTE products that we've historically been selling.

Speaker 3

So that's kind of a couple of 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.

Speaker 3

We expect it will continue to have that. 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.

Speaker 7

Great. Thanks a lot.

Operator

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

Speaker 8

Hey, good afternoon. Thanks for taking the question. Drew, historically you've said the core U. S. VTE market was a 20% growth 20% plus I think growth market?

Speaker 8

What are you seeing now and what are your expectations for 2024?

Speaker 2

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 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.

Speaker 2

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 $6,000,000,000 market in the earliest phases of transitioning from conservative medical management to frontline therapy with Flotriever and clotriever.

Speaker 8

Thank you. And to help us understand the emerging technology and international lines better, can you talk about what's assumed for ARDEX? And what's assumed for Japan and China? And any color on those market

Operator

Thank you.

Speaker 2

Yes. So relative to Arteryx, we've been working almost back 1.5 years 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.

Speaker 2

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's 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.

Speaker 9

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.

Speaker 9

S? Or are there some emerging therapy treatments doing being done internationally?

Speaker 3

Yes, Marie. There's a it's primarily U. S. Revenue when we're looking at the emerging therapies. So for example, if you look at the table, this is the back of the press release.

Speaker 3

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.

Speaker 9

Okay. That's helpful. And then let me ask I guess a 2 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.

Speaker 9

And then similarly, the path to profitability in first half of twenty twenty five on operating profitability. What do you need to do kind of operating leverage wise? And what gets you to that goal?

Speaker 3

Yes, Marie, thanks for the question. In the prepared remarks, I commented on kind of a 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 in the second half of the year.

Speaker 3

So that would give you a sense for the overall revenue profile. From an operating leverage and path to profitability point of view, 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 Linflo one time costs, the OpEx grew by 15%. So really nice progress there in Q4.

Speaker 3

And then looking at the full year numbers, revenue growth of 29%, OpEx growth of 22% and then if we exclude the Winflo one time step about 19%. So we've taken this challenge of operating leverage seriously as a company. It's something 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 twenty twenty four versus the second half of twenty twenty four. So less basically operating losses we move through the course of the year and then moving towards sustained operating profitability in the first half of twenty twenty five.

Operator

The next question comes from Bill Plavonic from Canaccord. Please go ahead.

Speaker 10

Yes, I'm here. Thanks for taking my questions. To 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 number on the VTE business, you grew just under 20%.

Speaker 10

You've had some solid growth internationally, which puts the U. S. More into the mid to high teens. Expecting in 2024 in terms of this?

Speaker 2

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.

Speaker 2

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.

Speaker 2

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 3rd, 4th generation platforms at this point.

Speaker 2

We have a very capable and well established commercial presence and field team that are doing good work day in, day out. We've got a mountain of high quality clinical evidence getting bigger every day and we'll continue 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.

Speaker 2

Anything you want to add to that, Mitch?

Speaker 3

Yes. Just, Bill, from the point of view of the VPE growth, so I'm 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'm just looking at the sequential revenue growth, let's say, of Q4 over Q3, so just over 4% there. And then when I look at the year over year number for VTE, about 19.5% revenue growth comparing 2023 to 2022. So I think those numbers are pretty attractive from a growth perspective and we feel pleased with the progress and the performance of the business during 2023.

Speaker 3

And for all the reasons you heard from Drew, very optimistic about 2024 as well.

Speaker 10

And then, just you mentioned, Mitch, on the profitability of the business you subtracted out the Blimpela acquisition cost. I'm sure there's some when you did that, is it just the acquisition or is it also the ongoing Lympholla cost 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?

Speaker 3

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 $9,000,000 in Q4 and then $11,700,000 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 interested in that.

Speaker 3

From a Q4 perspective, I think the one time costs in Q1 will 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 dissipate as we move through the year and then this purchase price amortization thing that we I talked about the amortization of the acquired intangible asset. So happy to talk further about that, but hopefully that's helpful with some at least some directional feeling on that.

Speaker 10

Yes. So you're seeing another $9,000,000 in Q1 and then we'll see about $2,500,000 to $3,000,000 a quarter from the amortization in Q2 through Q4. Is that how to think about it? Yes.

Speaker 3

That amortization number stays pretty consistent through the course of the year around $2,500,000 The total one time stuff in Q2 through Q4 is more in the $4,000,000 to $5,000,000 range because there's still some transaction costs involved.

Speaker 10

Great. Thank you. Thanks for taking my questions.

Speaker 3

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. I just want to make sure everybody is clear on that.

Speaker 10

Thank you.

Operator

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

Speaker 11

Thanks. Just one quick one on the quarter. Any color on the VTE mix between FlowTriever and CloudTraver in 4Q?

Speaker 3

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 flow trigger family and the clot trigger 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're 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.

Speaker 11

Okay. That's fair enough. And then just a couple of questions on Peerless. So it's completed enrollment. It's short follow-up.

Speaker 11

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? What percentage of patients are getting CBT today and could shift thrombectomy if that data is really compelling?

Speaker 8

Great questions, Chris. Thanks for bringing them up. So, firstly, as regards to the timing of the PURELIS 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.

Speaker 8

And you can imagine towards the back half of the year what possible beatings 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 pulmonary embolism, although there are still people who consider that as a 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.

Speaker 6

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 $4,000,000 to $5,000,000 per quarter number versus the $2,000,000 or so in Q1.

Speaker 6

So I'm wondering, 1, if that is kind of the right way to start off thinking about emerging therapy contribution in as early as, I guess, the Q1 of 2024. And then I'm curious what the maybe the biggest kind of contribution segment or product in that $4,000,000 to $5,000,000 per quarter that we've seen and whether or not that's been steady throughout those 2 to 3 quarters in the back half of twenty twenty three or if there's any movement around some of those new products having a bigger contribution on a quarterly basis?

Speaker 2

Yes, David, I'm happy to get started on that and 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 Nthrill. So you're 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.

Speaker 2

We will be bringing a new product into the CBD toolkit alongside Revcor. We talked about that in the prepared remarks. There'll be some incremental growth hopefully from that. New product introduction will have continued traction with Enthrill. Lympho is included obviously in the CLTI component of emerging therapies.

Speaker 2

We've only factored in a modest contribution from lympho, but that will be ramping as we move through 2024 and the U. S. Launch progresses. And then finally, we will get started on Ardex if all goes to plan later in the year. And that will be incremental growth in the 4th and final segment of emerging therapies.

Speaker 3

And David, the thing I would add quickly is I think the in the anabergentine therapies is likely to be a little bit lumpy, I guess I would call it. And that's both due to the fact that we have in some quarters a new product that's been introduced and you can kind of see that looking at the numbers for 2023 actually back to 2022 as well. And then also due to kind of the way these products are moved through the back approval process and timeline with the hospitals and that takes X number of months typically for that to get through. And so the way those actually begin to impact the revenue line, it tends to be a little bit lumpy as opposed to really smooth.

Speaker 6

Okay. So would it be fair to say that maybe all of these segments on a go forward basis and thus far are contributing to the growth and that doesn't really appear to be a clear winner among the core products that are in your view is there maybe clear winner product so far?

Speaker 2

So I do think all 4 will contribute on a go forward basis. On a relative basis, Ardex is, of course, going to start from 0 as we relaunch. So that will be pure incremental. Across the other three, I think they will grow as we move through the year. And to Mitch's point, you might see some lumpiness driven by some of the new product introductions and the VAC approvals coming through across those respective new products.

Operator

Our next question comes from Richard Newitter from Truist Securities. Please go ahead.

Speaker 12

Hi. Thanks for taking the questions. And thanks for providing the revenue disclosure. Maybe just on kind of the pieces of the disclosure that you provided as they roll up to 24%. I'm just trying to get a sense directionally.

Speaker 12

Can you tell me if I'm directionally close? I'm getting to the midpoint of your guidance. Thinking about the core U. S. VTE in kind of the mid to high teens, I'm assuming international about 5% to 6% of revenue and that implies the leftover being the emerging therapies.

Speaker 12

I guess, are those a directional component understanding you strive to outperform the initial outlook. Are those a reasonable directional components of how to get to the midpoint of your guidance for now? Specifically, you could comment on that international as a percent of total in that 5% to 6% range?

Speaker 3

Yes, Richard, thanks for the question. I think we closed out the year with international at 6%. That's something it's going to continue to make progress. I think there's potentially some step up as we move through the year, as we continue to get more traction in the more developed markets. As well we may have some additional products for sale at some point in these markets.

Speaker 3

I mentioned earlier during the call that we're still pursuing regulatory approval for many of the new product things that we've launched. As Drew mentioned, we think that the international contribution from China and Japan is likely to be very modest and probably more back end kind of loaded in terms of thinking about 2024. From the point of view of the other pieces of the puzzle, in terms of your revenue build, I think you're kind of headed in the right direction there in terms of how that's how that certainly how we close out the year 2023 and then how we'll kind of think about 2024.

Speaker 12

Okay. And just to be clear, so maybe international, even though you have incremental emerging therapies contribution, international as a percentage of sales, still will gravitate higher than the 6% than 23%.

Speaker 2

Yes.

Speaker 3

Yes. That's what we expect.

Speaker 12

Okay. Thank you very much.

Speaker 3

I think Drew has talked about that longer term growing into a 20% type factor, but certainly that's going to be a multiyear build to that level.

Speaker 12

Thank you.

Speaker 2

Sure.

Operator

Our last question comes from Mike Matson from Needham and Company. Please go ahead.

Speaker 13

Yes, thanks. So just wanted to ask one on lympho. So you mentioned this NTAP opportunity. So I assume it's been applied for, but you don't know whether or not you're getting it yet. Is that right?

Speaker 13

And how critical is that to driving adoption of the product in your view?

Speaker 2

Yes. Great question, Mike. I'm happy to get started on that. So far so good with LimbFlow. We closed in November.

Speaker 2

We made some really nice progress on the integration front. And we've also made some nice progress on the initial U. S. Launch. We obviously don't have access to the NTAP today.

Speaker 2

But if you look at the existing reimbursement, inpatient reimbursement today at our target first group of limb salvage centers, it is in the neighborhood of $30,000 So it is a positive contribution margin procedure even today with the existing reimbursement. We have applied for NTAP and are confident we will receive it. It will go into effect in October and that will add incrementally about another $16,000 in incremental reimbursement on top of the existing DRG. So it obviously provides a lot of incremental economic value to the hospital at that point. But even today, in advance of the NTAP, we are gaining back approvals and beginning to do initial cases in the U.

Speaker 2

S. And I think the economic value proposition is broader and ties back into limb flow being a really important part of any limb salvage center armamentarium and some of the broader economic considerations I think are helping fuel the growth here and the traction even in advance of the NTAP, which again we anticipate coming online in October.

Speaker 13

Okay, thanks. And then, I know there's a lot of focus on competition from Penumbra, but I just want to ask if you had seen any sort of impact from BOST Scientific's real PE study. I think that it was presented at TCT kind of in the fall. Did that drive any kind of pickup in their eco sales or I mean that you could see your share gains from you guys?

Speaker 2

Yes. I think Tom might have some perspective to share on that data set and the impact.

Speaker 8

Yes. Thanks for the question, Mike. So, first of all, to call the real PE data set a trial, I think is maybe overstating its value. It really was a kind of an exercise in electronic medical record assessment. And what it showed is that when you retrospectively look at who got FLOWTRIVOR, you times saw patients who were too sick to get any other therapies.

Speaker 8

You got patients who are actively bleeding, who got the only therapy that really was appropriate for somebody who cannot get lytics and that would be mechanical thrombectomy. So I think it was a nice exercise in selection bias. I think

Speaker 2

the vast majority of

Speaker 8

physicians see it for bias. I think the vast majority of physicians see it for what it is. We're excited about Peerless because Peerless is actually high quality randomized data. And I think that the community can't wait to see the results of that. We really have not seen any commercial impact from that data release.

Speaker 13

Okay, got it. Thank you.

Speaker 3

Thank you, Mike.

Operator

This concludes our conference call. Thank you for attending today's presentation.

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Earnings Conference Call
Portsmouth Square Q4 2023
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