Q1 2024 Inari Medical Inc Earnings Call

Operator: Good day, ladies and gentlemen, and welcome to the Inari Medical, Inc. First Quarter 2024 Earnings Conference Call. All participants will be in a listen-only mode.

Good day, ladies and gentlemen, and welcome to the NRG Medical Inc. First quarter 'twenty 'twenty four earnings conference call.

Operator: 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. I would now like to turn the conference over to John Hsu, VP, Investor Relations. Please go ahead.

All participants will be 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.

I would now like to turn the conference over to John <unk> VP Investor Relations. Please go ahead.

John Hsu: Thank you, operator. Welcome to Inari's conference call to discuss our first quarter 2024 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 Security 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 LinFlow.

John: Thank you operator, welcome to <unk> conference call to discuss our first quarter 2024 financial performance.

John: Joining me on today's call are drew hikes, President and Chief Executive Officer, and Mitch Hill, Chief Financial Officer.

John Hsu: These statements 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, and Inari undertakes no obligation to update these statements except as required by applicable law.

This call includes forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 statement.

John: Statements made on this call that do not relate to matters of historical fact should be considered forward looking statements, including statements related to estimated full year 2020 for revenue operating loss or profitability expectations and the expected operating performance and potential strategic benefits of the inflow.

John: These statements are based on <unk> current expectations forecasts and assumptions, which are subject to inherent uncertainties risks and assumptions that are difficult to predict.

John: 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.

John: Please review and <unk>, most recent filings with the SEC.

John: Particularly the risk factors described in our latest Form 10-K for additional information.

John: Any forward looking statements provided during this call, including projections for future performance are based on management's expectations as of today.

<unk> undertakes no obligation to update these statements except as required by applicable law.

John Hsu: On today's call, we will refer to both GAAP and non-GAAP financial measures in announcing our Q1 2024 results. Please refer to today's press release for a reconciliation of the non-GAAP measure discussed on this call and referred to in the press release. The press release and 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 p.m. Pacific time today. With that, I'll turn the call over to Drew.

John: On today's call, we will refer to both GAAP and non-GAAP financial measures in announcing our Q1 2024 results.

Please refer to today's press release for a reconciliation of the non-GAAP measure discussed on this call and referred to in the press release.

Andrew J. Hykes: The press release and slides accompanying this call are available on our website at <unk> medical Dot Com a recording of today's call will be available on our website by five P. M Pacific time today with that I'll turn the call over to drew.

Andrew J. Hykes: Thank you, John, and thank you all for joining our call today. We're pleased with our performance in the first quarter, achieving record revenue of more than $143 million, reflecting over 23% growth. Our performance was driven by consistent, crisp execution and strong contributions across the Inari portfolio. I would like to thank the team for driving strong adoption of our market-leading PE and DBT therapies, executing on our plans to diversify into sizable new patient populations, and continuing to expand internationally.

Andrew J. Hykes: Thank you John and thank you all for joining our call today, we're pleased with our performance in the first quarter achieving record revenue of more than $143 million, reflecting over 23% growth. Our performance was driven by consistent crisp execution and strong contributions across the portfolio.

Andrew J. Hykes: I would like to thank the team for driving strong adoption of our market meeting PE and DVT therapies.

Andrew J. Hykes: Executing on our plans to diversify into sizable new patient populations and continuing to expand internationally.

Andrew J. Hykes: In addition to strong top-line growth, we continue to make progress on our path to profitability, and we are reaffirming our expectations to reach sustained operating profitability in the first half of 2025. As we look ahead, we are as committed as ever to the strategic objectives that support our continued strong growth. These objectives reflect the ethos and goals that have long been core to Inari's culture and have guided our commercial and operational progress.

Andrew J. Hykes: In addition to strong topline growth, we continue to make progress on our path to profitability and we are reaffirming our expectations to reach sustained operating profitability in the first half of 2025.

Andrew J. Hykes: As we look ahead, we are as committed as ever to the strategic objectives that support our continued strong growth. These objectives reflect the ethos Angola that have long been core to <unk> culture and have guided our commercial and operational progress.

Andrew J. Hykes: Our first objective is to continue to scale the adoption of our highly differentiated purpose-built toolkits across large, attractive markets. This year, this includes our plans to drive deeper adoption within our existing U.S. account base via our VT Excellence Initiative, gain access to new accounts across our emerging therapies portfolio, and expand internationally, including commercially, into Japan and China. In addition, we remain committed to ongoing portfolio expansion to address unmet patient needs in venous and other diseases. These initiatives have yielded strong growth, as reflected by the rapid adoption of our emerging therapies portfolio in the first quarter. This early success follows years of purposeful investment.

Andrew J. Hykes: Our first objective is to continue to scale the adoption of our highly differentiated purpose build toolkits across large attractive markets.

Andrew J. Hykes: This year. This includes our plans to drive deeper adoption within our existing U S account base via our VT Excellence initiative.

Andrew J. Hykes: Gain access to new accounts across our emerging therapies portfolio and expand internationally, including commercially and to Japan and China.

Andrew J. Hykes: In addition, we remain committed to ongoing portfolio expansion to address unmet patient needs in venous and other diseases.

Andrew J. Hykes: These initiatives have yielded strong growth as reflected by the rapid adoption in our emerging therapies portfolio in the first quarter. This early success follows years, a purposeful investments.

Andrew J. Hykes: We are encouraged by the progress we are seeing across emerging therapies and see huge opportunities to continue to drive meaningful growth. As always, our innovation strategy is to target unmet patient needs with purpose-built tools, and in conjunction with that, to protect our leadership by leveraging our strong and comprehensive IP portfolio. Next, we'll continue to lead the way with high-quality, market-impacting clinical data. To that end, we remain on track to showcase our peerless data in the second half of the year.

Andrew J. Hykes: We are encouraged by the progress we're seeing across emerging therapies and see huge opportunities to continue to drive meaningful growth.

Andrew J. Hykes: As always our renovation strategy is to target unmet patient needs with purpose built tools and in conjunction with that to protect our leadership by leveraging our strong and comprehensive IP portfolio.

Andrew J. Hykes: We will continue to lead the way with high quality market impacting clinical data.

Andrew J. Hykes: To that end, we remain on track to showcase our Peerless date in the second half of the year.

Andrew J. Hykes: As a reminder, PeerList is the first of our three RCTs, and we recently completed enrollment of 550 patients. The study will evaluate patient outcomes using our FlowTribur device as compared to catheter-directed thrombolysis. Peerless will generate high-quality clinical evidence that will move the field forward and further establish FlowTreater as the optimal interventional therapy for intermediate-risk PE patients. Meanwhile, enrollment is progressing well in our two other RCTs. Peerless 2, comparing flow trevor to anticoagulation alone, and Defiance, comparing clot trevor to anticoagulation alone.

Andrew J. Hykes: As a reminder, peerless is the first of our three RC Ts and we recently completed the 550 patient enrollment.

Andrew J. Hykes: The study will evaluate patient outcomes, using our <unk> devices compared to catheter directed thrombolysis.

Andrew J. Hykes: Peerless will generate high quality clinical evidence that will move the field forward and further establish flow tremor as the optimal interventional therapy for intermediate risk <unk> patients.

Meanwhile, enrollment is progressing well and our two other rct's peerless to comparing flow tree versus trying to graduation alone and defiance, comparing clot fever, two anti coagulation alone.

Andrew J. Hykes: Our registry data also continues to move the field forward. Last month, Dr. David Dexter presented interim two-year follow-up data from the CLOUT Registry, the largest prospective multi-center data set generated since the ATTRACT trial. These results confirm the excellent safety, low re-thrombosis, and effectiveness of the clot-treater system for the treatment of DVT.

Andrew J. Hykes: Our registry data also continues to move the field forward last month, Dr. David Dexter presented interim two year follow up data from the cloud registry the largest prospective multicenter data set generated since the attract trial.

Andrew J. Hykes: In fact, in the long-term follow-up from Clout, patients treated with Clotrivor demonstrated a significant and sustained improvement in post-thrombotic syndrome at rates that were one-third to one-half those seen in historical DBT studies. We continue to believe high-quality clinical evidence is critical to maintaining and expanding our leadership position and growing the market. Indeed, the robust underlying market growth in VTE today is in large part due to the data Inari has already generated and the commitment we have made to developing this market. Our next strategic priority is to continue to leverage our powerful commercial engines. The size, quality, and expertise of our team are meaningful differentiators for our business.

Andrew J. Hykes: These results confirm the excellent safety low return on both this and effectiveness of the clot River system for the treatment of DVT and.

Andrew J. Hykes: In fact in the long term follow up from cloud patients treated with placebo demonstrated a significant and sustained improvement in poster embolic syndrome at rates that were one third to one half those seen in historical DVT studies.

Andrew J. Hykes: We continue to believe high quality clinical evidence is critical to maintaining and expanding our leadership position and growing the market.

Andrew J. Hykes: Indeed, the robust underlying market growth and V. T. E. Today is in large part due to the data and already has already generated and the commitment we have made to developing this market.

Andrew J. Hykes: Our next strategic priority is to continue to leverage our powerful commercial engine.

Andrew J. Hykes: The size quality and expertise of our team are meaningful differentiators for our business.

Andrew J. Hykes: We have the largest VT-focused sales force in the industry, and we'll continue to hire reps and split territories at a measured pace to support our growth. Today, this team is driving VT Excellence initiatives to increase the use of our solutions within existing accounts. We're also having growing success engaging hospital administrators at the IDN level to facilitate the adoption of VT Excellence across multiple hospitals within their network from a top-down perspective. Taken together, our efforts are yielding great results. As an example, in some of our most advanced accounts, we are now seeing TAM penetration rates above 50%.

Andrew J. Hykes: We had the largest V T focused sales force in the industry.

Andrew J. Hykes: We will continue to hire reps and split territories at a measured pace to support our growth.

Today. This team is driving V T excellence initiatives to increase the use of our solutions within existing accounts.

Andrew J. Hykes: We're also having growing success engaging hospital administrators at the IBM level to facilitate the adoption of V. T excellence across multiple hospitals within their network from a top down perspective.

Taken together our efforts are yielding great results.

Andrew J. Hykes: As an example, and some of our most advanced accounts, we are now seeing Tam penetration rates above 50%.

Andrew J. Hykes: This is a testament to the fact that our VT Excellence Program is working to catalyze positive adoption patterns, but much work and opportunity remains. Over time, we are confident this team of experienced professionals can continue to move the needle from our current high single-digit TAM penetration to strong double-digit penetration and beyond. With the benefit of high-quality data and updated guidelines, we believe mechanical thrombectomy for VTE will ultimately exceed the TAM penetration rate seen today in acute ischemic stroke and could one day approach the TAM penetration of PCI for the treatment of STEMI.

Andrew J. Hykes: This is a testament to the fact that our V. T Excellence program is working to catalyze positive adoption patterns.

Andrew J. Hykes: But much work and opportunity remain.

Andrew J. Hykes: Overtime, we are confident this team of experienced professionals can continue to move the needle from our current high single digit Tam penetration to strong double digit penetration and beyond.

Andrew J. Hykes: With the benefit of high quality data and updated guidelines, we believe mechanical thrombectomy for V. T. He will ultimately exceed the Tam penetration rates seen today in acute ischemic stroke and could one day approached the Tam penetration of PCI for the treatment of stemming.

Andrew J. Hykes: We aim to accomplish these strategic objectives while delivering a premium financial profile characterized by strong, durable growth, best-in-class gross margins, and increasing operating leverage. We know that the strength of our financial profile is founded, first and foremost, on the success of our three growth pillars, our VTE franchise, Emerging Therapies franchise, and our international business. We're market leaders in a $6 billion TAM for venous thromboembolism technologies in the U.S., and we're continuing to drive adoption within the substantial underpenetrated opportunities.

Andrew J. Hykes: We aim to accomplish the strategic objectives, while delivering a premium financial profile.

Andrew J. Hykes: Characterized by strong durable growth.

Andrew J. Hykes: Best in class gross margins and increasing operating leverage.

Andrew J. Hykes: We know that the strength of our financial profile is founded first and foremost on the success of our three growth pillars. Our V. T E franchise emerging therapies franchise and our international business.

Andrew J. Hykes: We are market leaders in a $6 billion Tam for venous thromboembolism technologies in the U S and we're continuing to drive adoption within the substantial underpenetrated opportunity.

Andrew J. Hykes: In Q1, our global VT revenue was $137 million, up 20% versus the prior year, supported by our ongoing commercial expansion, market development, and evidence generation efforts. We continue to see strong underlying growth in USVT procedures and expect that this market, defined as mechanical thrombectomy alone, can and will continue to grow in the neighborhood of 20%. From a market position standpoint, although we anticipate continued competitive activity in this large and high-growth market, we remain highly confident in maintaining our leadership position and continuing to deliver robust VTE growth. All of this is factored into our guidance, which you'll hear from Mitch later on.

Andrew J. Hykes: In Q1, our global VT revenue was 137 million up 20% versus the prior year supported by our ongoing commercial expansion market development and evidence generation efforts.

Andrew J. Hykes: We continue to see strong underlying growth in USB T procedures and expect that this market defined as mechanical thrombectomy alone can and will continue to grow in the neighborhood of 20%.

Andrew J. Hykes: From a market position standpoint, although we anticipate continued competitive activity in this large and high growth market, we remain highly confident in maintaining our leadership position and continuing to deliver robust BTG growth.

Andrew J. Hykes: All of this is factored into our guidance, which you'll hear from Mitch later on.

Andrew J. Hykes: Turning to our Global Emerging Therapies business. In Q1, Emerging Therapies revenue was $6 million, up 185% versus the prior year. This segment consists of four distinct patient populations outside of VTE, together comprising a $4 billion TAM in the U.S. alone. For chronic venous disease, RevCore continues to perform well as the first mechanical thrombectomy device to treat venous stem thrombosis.

Andrew J. Hykes: Turning to our global emerging therapies business.

Andrew J. Hykes: In Q1 emerging therapies revenue was $6 million up 185% versus the prior year.

This segment consists of four distinct patient populations outside the V. T E together, comprising a $4 billion Tam in the U S alone.

Andrew J. Hykes: And chronic venous disease reservoir continues to perform well the first mechanical thrombectomy device to treat venous stent thrombosis.

Andrew J. Hykes: We're also excited to be executing the limited market release of VenaCore, our second purpose-built tool within the CBD toolkit, which will unlock another portion of this significant TAM. We hope to bring this technology fully to market in the second half of the year, and we'll have more to share then. As a reminder, we believe the addressable market for CBD includes an annual incidence of approximately 100,000 patients, representing a $1 billion U.S. TAM alongside a substantial prevalence pool.

Andrew J. Hykes: Also excited to be executed in the limited market release of Vienna Corp. Our second purpose built tool within the CBD toolkit, which will unlock another portion of this significant Tam.

Andrew J. Hykes: We hope to bring this technology fully to market in the second half of the year, we'll have more to share them.

Andrew J. Hykes: As a reminder, we believe the addressable market for CBD includes an annual incidence of approximately 100000 patients representing a 1 billion dollar U S. Tam alongside a substantial prevalence pool.

Andrew J. Hykes: Turning to CLTI, we have made great progress integrating the Limflow business into Inari and driving the early U.S. launch. Lymphlo offers new hope and new options to the 55,000 patients per year suffering from no-option CLTI, translating into a $1.5 billion US TAM.

Andrew J. Hykes: Turning to see L. T. I, we've made great progress integrating the <unk> business into an Ari and driving the early U S launch lymph.

Andrew J. Hykes: <unk> offers new hope and new options to the 55000 patients per year suffering from no option C. L T I.

Andrew J. Hykes: Translating into a $1 5 billion dollar U S Tam.

Andrew J. Hykes: We're highly encouraged by the progress we've made to date in accessing this patient population. For LymFlow, we continue to view 2024 as a year of foundation building and remain focused on physician training, VAC approvals, thoughtful patient selection, and deliberate wound care follow-up. We are successfully navigating backlog approvals today, and we have completed an initial and growing series of commercial cases. We're seeing good traction and enthusiasm from physicians and have already completed our first two commercial training programs.

Andrew J. Hykes: We're highly encouraged by the progress we've made to date in accessing this patient population.

Andrew J. Hykes: Prelim flow, we continue to view 2024 is a year of foundation building and remain focused on physician training vac approvals thoughtful patient selection and deliberate wound care follow up.

Andrew J. Hykes: We are successfully navigating vac approvals today, and we have completed an initial and growing series of commercial cases, we're.

Andrew J. Hykes: We're seeing good traction and enthusiasm from physicians and have already completed our first two commercial training programs.

Andrew J. Hykes: In addition, we are pleased to highlight that earlier this month, CMS proposed a new technology add-on payment, or NTAP, for lymph flow, as we had anticipated. The proposed NTAP would add up to an incremental $16,000 to the hospital's existing DRG. We expect to see a final ruling from CMS later this year.

Andrew J. Hykes: In addition, we're pleased to highlight that earlier this month CMS proposed a new technology add on payment or untapped for limb flow as we had anticipated the proposed untap would add up to an incremental $16000 to the hospitals existing DRG.

Andrew J. Hykes: We expect to see a final ruling from CMS later this year.

Andrew J. Hykes: The third market addressable by our emerging therapies portfolio is acute lymphoschemia, a $600 million U.S. TAM characterized by tremendous unmet needs and a lack of purpose-built tools. We remain on track to initiate a limited market release and commercialize our second generation Arctic system later in 2024. And our fourth and final emerging therapy market, Enthril for the treatment of AV fistula clot, continues to effectively address unmet needs in this large and underserved patient population. We're working on a second generation intro platform and look forward to bringing it to market next year. Finally, I would like to discuss our international progress.

Andrew J. Hykes: The third market addressable by our emerging therapies portfolio as acute limb ischemia, a $600 million U S. Tam characterized by tremendous unmet needs and a lack of purpose built tools.

We remain on track to initiate a limited market release and commercialize our second generation Arctic system later in 2024.

Andrew J. Hykes: And our fourth and final emerging therapies market integral for the treatment of AAV fistula clock continues to effectively address unmet needs in this large and underserved patient population.

Andrew J. Hykes: We're working on a second generation <unk> platform and look forward to bring it to market next year.

Andrew J. Hykes: Finally, I would like to discuss our international progress.

Andrew J. Hykes: Q1 was a very strong quarter internationally, with revenue of $9.5 million, up 120% versus the prior year. Growth in Q1 also reflected the largest sequential dollar increase we've ever had in international revenue. Strength was primarily driven by adoption of our solutions in Europe, but we also saw strong performance across Latin America, Canada, and Asia Pacific. We are pleased to see the investments we have made over the past several years in establishing our international business begin to translate into meaningful commercial traction in these markets.

Andrew J. Hykes: Q1 was a very strong quarter internationally with revenue of $9 5 million up 120% versus the prior year.

Andrew J. Hykes: Growth in Q1 also reflected the largest sequential dollar increase we've ever had in international.

Andrew J. Hykes: <unk> was primarily driven by adoption of our solutions in Europe, but we also saw strong performance across Latin America, Canada and Asia Pacific.

Andrew J. Hykes: We're pleased to see the investments we've made over the past several years in establishing our international business begin to translate into meaningful commercial traction in these markets.

Andrew J. Hykes: Although international sales still represent a relatively small part of our overall patient impact, we continue to expect international sales will count for at least 20 percent of revenue over time. Before I turn the line to Mitch, I'd like to share, as always, a story about the incredible impact of our technology on patients. Last month, a 29-year-old postpartum woman was just one day post-op for an emergency C-section at a university hospital in

Although international still represents a relatively small part of our overall patient impact. We continue to expect international sales will account for at least 20% of revenue over time.

Speaker Change: Before I turn the line to Mitch I'd like to share is always a story about the incredible impact of our technology on patients.

Speaker Change: Last month, a 29 year old post part a woman with just one day post opt for an emergency C section at a University hospital in Germany.

Andrew J. Hykes: Due to severe hemodynamic instability, this young mother was put on ECMO, scanned, and diagnosed with a pulmonary embolism. Thankfully, the physicians at this hospital were well-trained to utilize FlowTriever and the entire Inari Supporting Toolkit. Ultimately, her physician team utilized four of our devices, Entry 24, T20 Curve, FT2, and Flow Stasis, to rapidly and effectively treat her condition. The immediate result was substantial clot removal and the return to a normal heart rate.

Due to severe hemodynamic instability. This young mother was put on Ecmo scan and diagnosed with pulmonary embolism.

Speaker Change: Thankfully the physicians at this hospital, we're well trained to utilize flow tremor and the entire supporting in our toolkit Ulf.

Speaker Change: Ultimately her physician team utilized four of our devices and through 'twenty, four 'twenty curve F T two and flow spaces to rapidly and effectively treat her condition.

Speaker Change: The immediate result, with substantial clot removal and the return to normal heart rate.

Andrew J. Hykes: After several days of further improvement, this patient was discharged to her family and newborn baby and made a full recovery. She is just one of the many thousands of European patients whom we have been able to serve with our technology in the three years since we introduced our toolkits to the region. We're honored to help such patients return to their families.

Speaker Change: After several days of further improvement this patient was discharged to a family a newborn baby and made a full recovery.

Speaker Change: She is just one of the many thousands of European patients, whom we have been able to serve with our technology and the three years since we introduced our tool kits to the region.

Speaker Change: We're honored to help such patients returned to their families.

Andrew J. Hykes: Such patient stories motivate us to continue our efforts to offer Inari products throughout the world. In closing, we're pleased with our Q1 performance and confident in our outlook into the remainder of 2024 and beyond. We often say that we are just getting started at Inari, and despite being several years into our commercial journey, this remains more true today than ever. With that, I will turn the call over to Mitch. Thanks, Drew.

Speaker Change: Such patient stories motivate us to continue our efforts to offer an RV products throughout the world.

Speaker Change: In closing, we're pleased with our Q1 performance and confident in our outlook into the remainder of 2024 and beyond.

Speaker Change: We often say that we're just getting started and ari and despite being several years into our commercial journey. This remains more true today than ever.

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

Mitchell C. Hill: Turning to our first quarter 2024 results, Inari's revenue for the first quarter of 2024 was $143.2 million, up 23.3% over the same period of the prior year. This represents sequential growth of over $11 million. Global VT revenue in the first quarter was $137.2 million, up 20.3% over the same period of the prior year. Our best-in-class gross margin was 86.8% for the first quarter of 2024, compared to 88.2% in the prior year period. The year-over-year change was due to increasing internationalization of the business, ramp-up costs associated with new products, and product mix.

Mitchell C. Hill: Thanks drew turning to our first quarter 2024 results <unk> revenue for the first quarter of 'twenty 'twenty four it was $143 2 million up 23, 3% over the same period of the prior year. This represents sequential growth of over $11 million Global VP revenue in the first quarter was 100 and.

Mitchell C. Hill: $37 2 million up 23% over the same period of the prior year global emerging therapies revenue in the first quarter was 6 million up 184, 5% over the same period of the prior year International revenue of $9 5 million was up 120% compared to the prior year.

Mitchell C. Hill: Our best in class gross margin was 86, 8% for the first quarter of 2024 compared to 88, 2% in the prior year period.

Mitchell C. Hill: The year over year change was due to increasing internationalization of the business ramp up costs associated with new products and product mix.

Mitchell C. Hill: Operating expenses were $141.5 million in the first quarter of 2024 compared with $107.8 million for the same period in the prior year. R&D expenses were $26.9 million in the first quarter of 2024, up 21.8% compared with $22.1 million for the same period in 2023. The increase in R&D expenses was primarily due to increases in materials and supplies-related expenses, clinical and regulatory expenses, and personnel-related expenses in support of our growth drivers to support new products and build the clinical evidence base.

Mitchell C. Hill: Operating expenses were $141 5 million in the first quarter of 2024, compared with $107 8 million for the same period in the prior year.

Mitchell C. Hill: R&D expense was $26 9 million in the first quarter of 2024 up 21, 8% compared with $22 1 million for the same period of 2023. The increase in R&D expenses was primarily due to increases in materials and supplies related expenses clinical and regulatory expenses and personnel.

Mitchell C. Hill: Related expenses in support of our growth drivers to support new products and build the clinical evidence base.

Mitchell C. Hill: SG&A expense was $103.1 million in the first quarter of 2024, up 20.3% compared with $85.7 million for the same period of the prior year. The increase in SG&A expenses was primarily due to increases in personnel-related expenses as a result of increased headcount, increased commissions due to higher revenue, professional fees, and travel costs.

Mitchell C. Hill: SG&A expense was $103 1 million in the first quarter of 2024 up 23% compared with $85 7 million for the same period in the prior year. The increase in SG&A expenses was primarily due to increases in personnel related expense as a result of increased head count increased commissions.

Mitchell C. Hill: Due to higher revenue professional fees and travel costs.

Mitchell C. Hill: In the first quarter of 2024, the change in fair value adjustment of our contingent consideration of liability was $6.3 million, acquisition-related expenses were $2.8 million, and amortization expense related to our acquired intangible asset was $2.5 million. There were no expenses related to these three items in the prior year quarter.

Mitchell C. Hill: In the first quarter 2024, the change of fair value adjustment of our contingent consideration liability was $6 3 million.

Mitchell C. Hill: Acquisition related expenses were $2 8 million and amortization expense related to our inquired intangible asset was $2 5 million. There were no expenses related to these three items in the prior year quarter.

Mitchell C. Hill: Inari recorded a GAAP operating loss of $17.2 million in the first quarter of 2024, compared with a GAAP operating loss of $5.3 million for the same period of the prior year. On a non-GAAP basis, which excludes acquisition-related expenses, acquired intangible asset amortization, and changes in the fair value of contingent consideration, the first quarter operating loss was $5.6 million. The non-GAAP adjustments had no impact on the first quarter of 2023.

Mitchell C. Hill: And I recorded a GAAP operating loss of $17 2 million in the first quarter of 2024, compared with a GAAP operating loss of $5 3 million for the same period of the prior year on a non-GAAP basis, which excludes acquisition related expenses acquired intangible asset amortization and changes in the fair value of.

Mitchell C. Hill: Consideration the first quarter operating loss was $5 6 million and non-GAAP adjustments had no impact on the first quarter of 2023.

Mitchell C. Hill: The net loss was $24.2 million for the first quarter of 2024 compared to a net loss of $2.2 million for the same period of the prior year. The basic and fully diluted net loss per share for the first quarter of 2024 was $0.42 on a weighted average basic and diluted share count of $57.9 million. This compares with a basic and fully diluted net loss per share of $0.04 on a weighted average basic and diluted share count of $54.8 million for the same period of the prior year.

Mitchell C. Hill: Net loss was $24 2 million for the first quarter of 2024 compared to a net loss of $2 2 million for the same period of the prior year.

The basic and fully diluted net loss per share for the first quarter of 2024 was 42.

Mitchell C. Hill: On a weighted average basic and diluted share count of $57 9 million. This compares with a basic and fully diluted net loss per share of <unk> on a weighted average basic and diluted share count of $54 8 million in the same period of the prior year as.

Mitchell C. Hill: As we execute against our goals of driving strong growth and leverage within the business, we are also maintaining a thoughtful approach to managing our balance sheet. For example, in the first quarter of 2024, our cash flows used in operating activities were $12.3 million compared to approximately $2 million in the same period of 2023, primarily due to investments in our product portfolio, including LIMFLOW. At the end of the first quarter, we had a healthy balance of cash and investments totaling $102 million. We remain confident in our ability to self-fund our business and strategic objectives with current cash and access to liquidity. We anticipate our cash balance will remain at approximately $100 million for the rest of the year.

Mitchell C. Hill: As we execute against our goals of driving strong growth and leverage within the business. We are also maintaining a thoughtful approach to managing our balance sheet.

Mitchell C. Hill: In the first quarter of 2024, our cash flows used in operating activities were $12 3 million compared to approximately $2 million in the same period of 2023, primarily due to investments in our product portfolio, including lymphoma.

Mitchell C. Hill: At the end of the first quarter, we had a healthy balance of cash and investments totaling $102 million, we remain confident in our ability to self fund our business and strategic objectives with current cash and access to liquidity.

Mitchell C. Hill: We anticipate our cash balance will remain at approximately $100 million for the rest of the year.

Mitchell C. Hill: Turning to 2024 Outlook, we are raising our full-year 2024 revenue guidance. From prior guidance of $580 to $595 million to $592.5 to $602.5 million, this updated guidance reflects growth of approximately 20 to 22 percent over 2023. Our guidance reflects contributions from all three of our growth pillars, VTE, emerging therapies, and international.

Mitchell C. Hill: Turning to 2024 outlook, we are raising our full year 2020 for revenue guidance from prior guidance of 580 to 595 million to 592.5 to $602 $5 million. This updated guidance reflects growth of approximately 20% to 22% over 2023.

Our guidance reflects contributions from all three of our growth pillars, DTE emerging therapies and international.

Mitchell C. Hill: For 2024, from a phasing perspective, we continue to expect strong performance in the back half of the year. By way of reference, in 2023, we saw modestly higher revenue in Q2 versus Q1. We expect to see this typical seasonality again in Q2 2024. As a result, we expect Q2 revenue to be flat to slightly up sequentially. Lastly, I would like to comment on Inari's progress towards profitability. We are continuing to invest in our strategic objectives to drive growth while positioning the business to achieve sustained operating profitability in the first half of 2025.

Mitchell C. Hill: For 2024 from a phasing perspective, we continue to expect strong performance in the back half of the year by way of reference in 2023, we saw modestly higher revenue in Q2 versus Q1, we expect to see this typical seasonality again in Q2 2024 as a result, we expect Q.

<unk> revenue to be flat to slightly up sequentially.

Mitchell C. Hill: Lastly, I would like to comment on the nice progress towards profitability, we are continuing to invest in our strategic objectives to drive growth, while positioning the business to achieve sustained operating profitability in the first half of 2025.

Mitchell C. Hill: On our last call, we mentioned that we expect to see greater operating losses in the first half of 2024 versus the second half. We continue to hold this expectation today. With that, I'll turn the call back to the moderator for questions. During the Q&A segment, we will be joined by Dr. Tom Tu, Inari's Chief Medical Officer.

Mitchell C. Hill: Last call, we mentioned that we expect to see greater operating losses in the first half of 2024 versus the second half we continue to hold this expectation today.

Speaker Change: With that I'll turn the call back to the moderator for questions for the Q&A segment, we will be joined by Dr. Tom Two <unk> Chief Medical Officer.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

Speaker Change: We will now begin the question and answer session.

Speaker Change: To ask a question you May Press Star then one on your Touchtone phone.

Speaker Change: If you are using a speakerphone please pick up your handset before pressing the keys.

Operator: We ask that you please limit yourself to one question and one follow-up. At this time, we will pause momentarily to assemble our roster. The first question today comes from Larry Biegelsen with Wells Fargo. Please go ahead.

Speaker Change: We ask that you please limit yourself to one question and one follow up.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Speaker Change: Yes.

Okay.

The first question today comes from Larry Nicholson with Wells Fargo. Please go ahead.

Leigh: Hi, it's Leigh calling in for Larry. Thanks for taking our question. Just a question regarding the growth in Q1. So we backed into U.S. core VTE sales of about 128 million, and that's up about 16% year-over-year. Can you just confirm if our basic math is correct? And if that is correct, how do you bridge that against the 20% market growth that you are alluding to? And I have a follow-up question. Thank you.

Speaker Change: Hi, its lei, calling in for Larry Thanks for taking our question.

Speaker Change: Just.

Lei: Regarding the growth in Q1, so we back into the U S core B T. He sounds about 128 million and that's up about 16% year over year can you just confirm if our basic math is correct and if that is correct. How do you bridge that against a 20% market growth that you were alluding to.

Speaker Change: And I have a follow up thank you.

Andrew J. Hykes: Yeah, thanks, Leigh. This is Drew.

Speaker Change: Yeah. Thanks, Larry This is drew I can get started on that Mitch may want to chime in as well so relative to DTE. We're pleased with how that part of the business performed in Q1, we saw a 20% growth across BTG globally, a little faster than that internationally, albeit off a small base a little slower than that here in the U.

Andrew J. Hykes: I can get started on that. Mitch may want to chime in as well. So relative to VTE, we're pleased with how that part of the business performed in Q1. We saw 20% growth across VTE globally, a little faster than that internationally, albeit off a small base, a little slower than that here in the U.S., obviously off a much larger base. In terms of underlying market growth, historically, you've heard us characterize the growth in this market, which we define as mechanical thrombectomy for VTE, as growing in the neighborhood of 20%. Call it, you know, 18 to 22%.

Speaker Change: Obviously off a much larger base.

In terms of the underlying market growth.

Speaker Change: Historically, you've heard us characterize the growth in this market, which we define as mechanical thrombectomy for Vijay as growing in the neighborhood of 20% call. It 18% to 22% I think when the dust settles on Q1.

Andrew J. Hykes: I think when the dust settles on Q1.. you're going to see the same kind of robust underlying market growth. We have every expectation that that robust market growth will continue as we look ahead. In terms of our position in that market, we remain the clear market leader. So, despite competitive dynamics, despite the potential for modest share fluctuations back and forth, we remain the clear market leader in this market. And we're confident of continuing to be the market leader as we move forward.

Speaker Change: Youre going to see the same kind of robust underlying market growth and we have every expectation that that robust market growth will continue as we look ahead.

Speaker Change: Our position in that market, we remain the clear market leader.

Speaker Change: So despite competitive dynamics, despite the potential for modest share fluctuations back and forth. We remain the clear market leader in this market and we're confident in continuing to be the market leader as we move forward and that confidence is built on our purpose built solutions high quality data are the strength of our commercial engine all of those things.

Andrew J. Hykes: And that confidence is built on our purpose-built solutions, high-quality data, the strength of our commercial engine, all those things taken together. And I think as a result, we continue to expect robust growth from VTE. And that's exactly what you saw as we moved through 2023. That's what you saw most recently here in Q1. And that anticipation of robust growth from VTE is also reflected in the updated guidance. Yeah, and maybe.

Speaker Change: Taken together and I think as a result, we continue to expect robust growth from DTE and that.

Speaker Change: It's exactly what you saw as we moved through 2023, that's what you saw most recently here in Q1 and that anticipation of robust growth from ETE is also reflected in the updated guidance.

Mitchell C. Hill: Yeah, and maybe Leigh, just to add to Drew's comments, as you know, we don't aggregate the data at the USVP level, so, you know, I think I can sort of follow your map because the OUS side is growing faster, so the US side will be growing a little bit slower. I think Drew did a nice job addressing the market growth, you know, versus how we feel about it. One of the things I look at that I'm very pleased with for the business is just the dollar growth of the business, sort of quarter over quarter, if you look back over the past year, and as I look at the growth of the business, for example, from Q2 to Q3, and then from Q3 to Q4, and Q4 to Q1, the Q4 to Q1 time period with 10.5 million of sequential growth is actually the highest that we've had, you know, look back over the course of the past year, so we're really pleased with the progress the business is making, and for the reasons that Drew mentioned during the prepared remarks, you know, we feel like we're still just getting started.

Speaker Change: Yeah, and maybe easily for just to add to <unk> comments.

Speaker Change: No we don't aggregate the data in the U S. D. T level. So you know I think I can sort of follow your math because the U S side is growing faster. So the U S side was growing a little bit slower.

Speaker Change: You can do to get a nice job addressing the market growth versus how we feel about it.

Speaker Change: The thing as I look at that I am very pleased with where the business is just the dollar growth of the business.

Speaker Change: Quarter over quarter, if you look back over the past year.

Speaker Change: And as I look at the growth of the business for example from Q2 to Q3 and from Q3 to Q4 in Q4 to Q1 the.

Speaker Change: Q4 to Q1 time period with $10 5 million a sequential growth is actually the highest that we've had look back over the course of the past year. So we're really pleased with the progress the business is making and for the reasons that drew mentioned during the prepared remarks, we feel like we're still just getting started.

Leigh: Great, that's helpful. And then just as far as the sub-segments within VTE, can you comment more specifically around DVT versus PE market share? Based on, you know, dot calls we've done, it sounds like you're, you know, holding on to the PE share, perhaps a little better than the DVT share. Any call you can provide around that. Thanks again for taking questions.

Speaker Change: Great. That's helpful and then just as far as.

Speaker Change: Segments with N V. T E can you comment more specifically around DVT persons P E market share.

Speaker Change: Based on the dark horse we've done it.

Speaker Change: Sounds like you're holding onto the P share, perhaps a little better than the DVT share just any color you can provide around that thanks again for taking the question.

Andrew J. Hykes: Yeah, you know, we saw robust growth in VTE across both PE and DVT, balanced growth across both of the two franchises. We see competitive dynamics, you know, at play across both of the franchises, but robust growth in both areas. And that was clearly evident in the Q1 results.

Speaker Change: Yes, we saw robust growth N V T E across both PE and DVT.

Balanced growth across both of the two franchises, we see competitive dynamics.

Speaker Change: Across both of the franchises, but robust growth in both areas and that was clearly evident in the Q1 results.

Mitchell C. Hill: Yeah, and then Clay, I mean, we continue to feel like we're the clear and dominant market leader in the PE side of the business, probably a 4 to 1 lead there. I think on the DVT side of the business, consistent with where we were maybe back in the second half of 2023, kind of a 1.5 to 2 to 1 lead there. I guess I'd just like to comment, though, that this concept of shared dynamics or share shifts is something that's very dynamic, and it's something that kind of changes, you know, depending on who the treating physicians are.

Speaker Change: And then Les I mean, we continue to feel like we're the clear dominant market leader in the P side of the business is probably a four to one.

Les: Lead there I think on the DVT side of the business consistent with where we were maybe back in the second half of 2023 kind of a one and a half to two to one.

Les: Lead there.

Les: I guess I'd, just like to comment, though that this kind of this concept of share dynamics of share shifts, it's something that's very dynamic and it's something that kind of changes you know depending on who the treating physicians are I mean, it's.

Mitchell C. Hill: It's not a one-way street, you know, by any means, and we're definitely in there competing for share. We're in there working with the treating physicians, you know, working with the non-interventional physicians as well, you know, in our program building and everything else to try to help make sure that the patients get the best possible care.

Les: Not a one way street, you know by any means and we're in there definitely competing for share where in there working with the treating physicians working with that non interventional physicians as well.

Les: And our program building and everything else to try to help to make sure that patients get the best possible care.

Les: Okay.

Operator: The next question comes from Stephanie Piazzolla with Bank of America. Please go ahead.

Les: The next question comes from Stephanie <unk> with Bank of America. Please go ahead.

Stephanie Piazzola: Hi, thanks for taking the question. I wanted to ask about the guidance raised. It looks like you raised the guidance at the midpoint by more than the beat in the quarter, so maybe if you could expand on where the guidance raise is coming from, how much of it is from U.S. Corps versus OUS and emerging therapies. Thanks.

Stephanie: Hi, Thanks for taking the question I wanted to ask about the guidance raised it looks like you raised the guidance at the midpoint by more than the beat in the quarter. So maybe if you can expand on where the guidance raise is coming from how much of it is from U S core versus O U S.

Stephanie: Gene therapy. Thanks.

Andrew J. Hykes: Yeah, thanks, Stephanie. I'll get started on that.

Speaker Change: Yes, Thanks, Stephanie I'll just start on that Mitch may want to follow on.

Mitchell C. Hill: Mitch may want to follow on. So it's about a $5 million beat and about a $10 million raise at the midpoint. And I think that reflects the strength of momentum that we saw across all three parts of the business as we exited a strong 2023 and made our way through Q1. We saw strength in VTE, we saw robust growth across emergent therapies, and we saw another strong quarter of crisp execution and growth from the international part of our business. And I think all of those considerations are factored into the increase in guidance by $10 million at the midpoint.

Speaker Change: So it's about a $5 million beat and about a $10 million raise at the midpoint and I think that reflects the strength and momentum that we saw across all three parts of the business as we exited.

Speaker Change: Strong 2023 and made our way through Q1, we.

Speaker Change: We saw strength in BT EE, we saw robust growth.

Speaker Change: Across emerging therapies, and we saw another strong quarter of crisp execution and growth from the international part of our business and I think all of those.

Speaker Change: Considerations are factored in to the the.

Speaker Change: And guidance.

Speaker Change: $10 million at the midpoint.

Stephanie Piazzola: Yeah, and just to add to that, Stephanie, as I said there at the end of the prepared remarks, from the point of view of sort of the trajectory of the beat, if you will, you know, we're seeing a greater acceleration in the business in the second half, so we would expect to see some increase there. The flat to slightly up comment is something that, you know, we're kind of thinking through as it relates to our Q2 number, and, you know, we saw some seasonality, as Drew mentioned, you know, in the past couple of years, actually, in the business, and so we would expect to see that, you know, again here in 2024, you know, first couple of weeks of April, we saw lots of spring break activity and things of that kind in the business, so, you know, no surprise and no different than, you know, other companies are experiencing, but we just wanted to be confident in terms of the number we put out there for Q2, and that's hopefully helpful to your question.

Speaker Change: Yeah, and just to add to that Stephanie as I said there at the end of the prepared remarks from the point of view sort of the trajectory of.

Speaker Change: The beat if you will.

Speaker Change: We're seeing a greater acceleration in the business in the second half.

Speaker Change: So we would expect to see some increase there.

Speaker Change: Flat to slightly up comment is something that you know, we're kind of thinking through as it relates to our Q2 number and you know we saw some seasonality as you mentioned you know in the past.

Speaker Change: A couple of years actually in the business and so we would expect to see that you know again here in 2024.

Speaker Change: First couple of weeks of April we saw lots of spring break activity and things of that kind in the business. So you know no surprise and no different than other companies are experiencing but we just wanted to be confident in terms of the number we put out there for Q2 and that's hopefully helpful to your question.

Andrew J. Hykes: Yeah, thank you. That's really helpful. And then maybe just as a follow-up, I wanted to ask about, you know, a competitor recently launched a next generation version of their product, and there are some other new entrants expected in the market here soon. I know you mentioned that this is reflected in the guidance, but maybe if you could elaborate on that a little bit more, if you're seeing any early disruption from that, and kind of what you expect for the rest Thank you.

Speaker Change: Yeah. Thank you that's really helpful. And then maybe just as a follow up.

I wanted to ask about.

Speaker Change: A competitor recently launched a next generation version of their product then there was some other new entrants expected in the market here soon.

Speaker Change: I know you mentioned that this is reflected in the guidance, but maybe if you could elaborate on that a little bit more if you're seeing any disruption from that and kind of what you expect them to be here. Thank you.

Andrew J. Hykes: Yes, I don't think we've changed, or we've seen any big changes in the competitive landscape. You know, we see continued competitive dynamics, and continued entrance into this market. Not surprising, because this is one of the most attractive end markets in medtech.

Speaker Change: Yes, I don't think we've changed we've seen any big changes in the competitive landscape. We see continued competitive dynamics continued entrants to this market not surprising. This is one of the most attractive end markets in med Tech.

Andrew J. Hykes: And despite those dynamics, again, we remain the clear market leader and are confident and will continue to be the market leader. You heard us describe what that confidence is based upon. You know, this is a market that we built, and we're not going to sit by and idly, passively allow folks with inferior technology and inferior data to have unfettered access to this market. So we're going to compete. We're going to compete aggressively. That's what you've seen us do in the past.

Speaker Change: And despite those dynamics again, we remain the clear market leader and our confident and continuing to be the market leader you heard us describe what that confidence is based upon.

This is a market that we built and we're not going to sit by and ideally.

Speaker Change: <unk>.

Speaker Change: <unk> folks with inferior technology, an inferior data have unfettered access to this market.

Speaker Change: So we're going to compete we're going to compete aggressively that's what you've seen us do in the past that's what we would expect going forward as well to the extent, we do have new entrants I think they can be constructive from a market development standpoint, and after all that's where the real value creation opportunity is a real opportunity to impact patients and change the standard of care so alongside.

Andrew J. Hykes: That's what we would expect going forward as well. And to the extent that we do have new entrants, I think they can be constructive from a market development standpoint. And after all, that's where the real value creation opportunity is, the real opportunity to impact patients and change the standard of care. So alongside competing head-to-head, we're also going to continue to focus on the investments we're making to help develop the market. High quality data, market development, program development, and continuing to expand our commercial engine are all of those investments designed over time to continue to develop this market.

Competing head to head. We're also going to continue to focus on the investments, we're making to help develop the market and high quality data market development program development on continuing to expand our commercial engine all of those investments designed over time to continue to develop this market.

Speaker Change: Okay.

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

Speaker Change: The next question comes from Marie Thibault with P. T. I G. Please go ahead.

Marie Yoko Thibault: Good afternoon, and congratulations on a very nice quarter start to the year. I wanted to shift gears here a little bit and talk about international business. International remains strong in addition to USETE. And I caught mention of international expansion. Are you in new countries? What does the coverage landscape look like today? And what can you tell us about China and Japan?

Marie Yoko Thibault: Good afternoon, and congrats on a very nice quarter start to the year wanted to shift gears here, a little bit and talk about international International remains strong. In addition to U S. T E and I caught mentioned of international expansion, our U N new countries, what does the coverage landscape look like today.

Marie Yoko Thibault: And what can you tell us about in China, and Japan, I think that still set for this year.

Andrew J. Hykes: I think that's still set for this year.

Andrew J. Hykes: Yeah, thanks for the question, Marie. So we had another strong quarter of growth internationally, nine and a half million, the largest sequential increase, and absolute sequential increase we've had internationally. That continues to be led, first and foremost, out of Western Europe, where we've got kind of the longest head start on our international effort. We've got a well-established commercial footprint at this point, and are seeing robust growth continue to be driven out of Western Europe.

Yeah. Thanks for the question Murray.

Speaker Change: We had another strong quarter of growth internationally $9 5 million.

Speaker Change: The largest sequential increase absolute sequential increase we've had international that continues to be led first and foremost a out of western Europe, where we've got kind of the longest headstart of our international effort. We've got a well established commercial footprint at this point and are seeing robust growth continue.

Speaker Change: To be driven out of western Europe alongside that we're also seeing some more meaningful contributions from 12, maybe 15 other markets.

Andrew J. Hykes: Alongside that, we're also seeing some more meaningful contributions from 12, maybe 15 other markets outside of Western Europe, countries in Latin America, Canada, Brazil, Argentina, also across Asia Pacific, Australia, New Zealand, and Singapore. Some of those markets are not as far along as we are in Europe, but nonetheless, they are now at the point where they're contributing more meaningfully alongside the growth being driven out of Western Europe. And finally, we remain on track to put ourselves in a position to help patients in both China and Japan later this year.

Speaker Change: Outside of Western Europe.

Speaker Change: Countries in Latin America, Canada, Brazil, Argentina also across Asia Pacific and Australia, and New Zealand and Singapore. Some of those markets were not as far along as we are in Europe, but nonetheless, they are now at the point, where theyre contributing more meaningfully alongside.

Speaker Change: The growth being driven out of Western Europe, and then finally, we remain on track for putting ourselves in a position.

Speaker Change: To help the patients in both China and Japan.

Andrew J. Hykes: And I think as we get closer to those milestones, we'll have more to share respectively on our go-to-market strategies in both China and Japan, but that work continues, and we continue to expect treating patients in both those markets by the end of the year.

Speaker Change: Later, this year and I think as we get closer to those models.

Speaker Change: Those milestones will have more to share.

Speaker Change: Respectively on our go to market strategies in both China, and Japan, but that work continues and we continue to expect.

Speaker Change: Treating patients in both those markets by the end of the year.

Marie Yoko Thibault: Okay, very good. And then I wanted to ask about the second half of the 24 peerless data readout. What impact are you seeing at this point right now on utilization from doctors maybe anticipating that data, and how impactful do you think it can be to guidelines? We've seen some what seemed to be some more positive shifts toward mechanical thrombectomy in the guidelines, but we'd like to hear maybe from Dr. Tu a little bit on his thoughts on guideline impact. Thanks, Marie. I appreciate the question.

Speaker Change: Okay very good and then I wanted to ask about the second half of 'twenty for Peerless data read out.

Speaker Change: What impact are you seeing at this point right now on utilization from doctors, maybe anticipating that data.

Speaker Change: And how impactful do you think it can be to guidelines we've seen some.

Speaker Change: What seemed to be some more positive shifts toward mechanical thrombectomy in the guidelines, but we'd like to hear maybe from from Doctor to a little bit on his thoughts on guideline impact.

Thomas M. Tu: Thanks, Marie. I appreciate the question. And we are, of course, very excited about PureList. It represents the first in a series of randomized controlled trials that we've invested in. We're leading the way in terms of data generation for VTE. As a reminder, PureList is an RCT randomizing flow treaver to catheter-directed thrombolysis for intermediate risk PE. And, of course, despite the obvious drawbacks to lytic-based therapy, including unwanted risk of bleeding and increased costs, we still see that therapy being used in a portion of patients treated for PE.

Doctor: Thanks, Barry I appreciate the question and we are of course very excited about peerless. It represents the first in a cadence of randomized controlled trials that we've invested in.

Doctor: We're leading the way in terms of data generation for ETE. As a reminder, peerless is an RCT randomized <unk> flowed fever, two catheter directed thrombolysis for intermediate risk <unk>.

Doctor: And of course, despite the obvious.

Doctor: Drawbacks to a lytic based therapy, including unwanted risk of bleeding and increased costs, we still see that therapy being used in a portion of patients treated for P. E and I think this status. That's certainly a positive is going to go a long way in terms of shifting.

Thomas M. Tu: And I think this data set, certainly positive, is going to go a long way in terms of shifting the kind of holdouts supporting that therapy towards what we believe is a superior form of treatment. Now, as far as impact on guidelines is concerned, of course, an RCT carries a higher level of weight than some of the data we've generated to date. But I don't want to discount the value of the largest prospective registry in PE, which is the flash data, as well as the flame data, which is the largest contemporary study of mechanical thrombectomy for high-risk PE.

Doctor: The kind of hold outs supporting that therapy towards what we believe is superior.

Doctor: Form of treatment now as far as impact of guidelines or concern.

Doctor: Of course, an RCT carries a higher level of weights than some of the data we've generated to date, but I don't want to discount the value of.

Doctor: The largest ever prospective registry in P/e, which is the flash data as well as the flame data, which is the largest contemporary study of mechanical thrombectomy for high risk P. I think taken together.

Thomas M. Tu: And I think taken together, these are going to start shifting the guidelines towards specific mention of mechanical thrombectomy and, indeed, flow treaver as the source of the generation of all of this important data. The next question comes from Kallum Titchmarsh with Morgan Stanley. Please go ahead.

Doctor: These are going to start shifting the guidelines towards specific mention of mechanical thrombectomy, and indeed flow tremor as the source of the generation of all of this important data.

Doctor: The next question comes from Callum Titchmarsh with Morgan Stanley. Please go ahead.

Kallum L Titchmarsh: Yeah, thanks a lot for taking the question. Just on the reshuffling of the sales leadership, I wanted to get a bit more.

Kallum L Titchmarsh: Yeah. Thanks, a lot for taking the question just.

Kallum L Titchmarsh: On the reshuffling of the sales leadership I wanted to get a bit more color on what's going to change on the Tim should we anticipate adjustments in the way incentives are structured or maybe some initiatives to drive better productivity just keen to hear why you think now is the right time for a new direction here, whether this impacts your rough numbers. Thanks.

Andrew J. Hykes: Yeah, thanks for the question, Kallum. So back in October of last year, at our national sales meeting down in San Diego, our former sales leader in the US, John Burrell, announced his retirement from the team. John actually joined Inari alongside myself about seven years ago and has been a fantastic leader for us, but he was ready to downshift and basically exit a full-time operating role. So we announced that back in October, and John joined here during Q1.

Tim: Yes, thanks for the question Kevin.

Speaker Change: So back in October of last year at our National sales meeting down in San Diego.

Tim: Our former sales leader in the U S John Borough.

Tim: Downstairs retirement to the team John actually joined an already alongside myself about seven years ago.

Tim: It has.

Tim: Been a fantastic leader for us, but was ready to downshift in and basically exited a fulltime operating role so we announced that back in October.

Tim: Two months, even before the CIB.

Tim: It was received.

Tim: We began our search for a new leader.

Tim: Ultimately landing on Tim Benner, who.

Tim: Who joined here during Q1.

Andrew J. Hykes: I think the short-term strategy is the status quo. The commercial model that we have followed has obviously been very, very effective for us, and I think Tim is certainly respectful of all the success we've had and respectful of that model. He is settling into his new role. I think, like any new leader, he'll have some proposals and some recommendations on changes to make, but I would not anticipate any radical change in our commercial strategy, tactics, or execution.

Tim: Thank the short term strat.

Tim: Strategy is status quo. The commercial model that we have followed has obviously been very very effective for us.

Tim: And I think Tim is certainly respectful of all the success, we've had and respectful of that model. He is settling into his new role I think like any new leader I'm sure he'll have some proposals and some recommendations on changes to make but I would not anticipate any radical change in our commercial strategy or.

Tim: Tactics or execution.

Andrew J. Hykes: He's six or eight weeks into his new role at this point. In terms of the last part of your question on new rep ads, we're going to continue to add additional sales professionals each quarter as we move through this year. That's been a part of our model from the get-go. Those new ads are tempering a bit, tapering a bit at this stage of the rollout, but we continue to see opportunities to split territories and expand the commercial footprint, and I think that will be the same strategy under Tim's leadership as what we've followed historically. Got it. Thanks a lot.

Tim: Is six or eight weeks into his new role at this point in terms of the last part of your question on New Rep adds.

Tim: We're going to continue to add additional sales professionals each quarter as we move through this year.

Tim: It's been a part of our model.

Tim: From the from the get go.

Tim: Those new adds are a tempering of bit tapering a bit at this stage of the rollout, but we continue to see opportunities to split territories and expand our commercial footprint and I think that will be the same strategy under Tim's leadership is what we've what we've followed historically.

Kallum L Titchmarsh: And then one more, if possible, just, I think I know you said it'll take a number of years to conclude, but just checking if there's been any progress on the DOJ inquiry since the Q4 call. Yeah, so no update other than we are continuing to cooperate, and we've not seen any impact commercially from the investigation from the CID, nor do we anticipate seeing any impact commercially. So we're continuing to cooperate, but I think to your point, if you look at the precedent examples here, this is likely a process that's going to be measured in quarters and quarters.

Speaker Change: Got it thanks, a lot and then one more if possible just I think I know you said it will take a number of years to conclude but just checking if there's any progress on the Doj inquiries since the Q4 call.

Speaker Change: Yes, so no.

Speaker Change: Update other than we are continuing to cooperate.

Speaker Change: And we've not seen any impact commercially.

Speaker Change: From the.

Speaker Change: The investigation from the CIB.

Speaker Change: Nor do we anticipate.

Speaker Change: Seeing any impact commercially so we're continuing to cooperate but I think to your point.

Speaker Change: If you look at the precedent examples here this is likely a process that's going to be measured in.

Speaker Change: Quarters and quarters, if not years.

Andrew J. Hykes: The next question comes from Bill Plovanic with Canaccord. Please go ahead. There you go.

Speaker Change: The next question comes from Bill <unk> with Canaccord. Please go ahead.

William John Plovanic: Yeah, great. Thanks, and thanks for taking my questions. I'd like to kind of shift the topic to LIMFLO. Just help us understand, you know, how do you think about commercialization? When do you go beyond trial centers? How does NTAP go into effect in October, if we're at the proposed rate, you know, how would that impact your commercial strategy and kind of how much of a contribution was it to the quarter?

Bill: Yeah, great. Thanks, and thanks for taking my questions I would like to kind of shift the topic to wind flow.

Bill: Just help us understand how do you think about commercialization when do you go beyond trial centers, how does and tap going into effect in October if the proposed rate.

Bill: How would that impact your commercial strategy and kind of how much of a contribution was to the quarter.

Andrew J. Hykes: Great, thanks for all those, Bill. I'll try and remember each of them.

Speaker Change: Great. Thanks for all those bill I'll try and remember each of them.

Speaker Change: I think in general so far so good with limb flow, we feel really good first and foremost on the work that we've completed on the integration.

Andrew J. Hykes: I think, in general, so far, so good with LIMFLOW. We feel really good, first and foremost, about the work that we've completed on the integration. We're well over half of the way completed with the integration.

Andrew J. Hykes: We've wrestled to the ground some of the most complicated parts of that process and feel really good about the progress we've made in integrating LIMFLOW into Inari. We have the team now defined and established, and we feel good about the remaining work ahead to complete the integration. On the commercial side, we're also seeing some really nice initial traction with LIMFLOW. But, as you've heard us describe in the past, this is a year focused on foundation building as opposed to significant revenue contributions.

Speaker Change: We're well over half of the way completed with the integration we've wrestled to the ground. Some of the most complicated parts of that process and feel really good about the progress we've made in integrating limb flow into an ari.

Speaker Change: We've got the team now defined and established and.

Speaker Change: And we feel good about the remaining work ahead to complete the integration on the commercial side. We're also seeing some really nice initial traction with limb flow.

Speaker Change: You've heard US described in the past. This is a year focused on foundation building as opposed to significant revenue contributions were focused on training and in servicing on navigating back approvals on strengthening and stabilizing the supply chain on getting the untapped established and we hit an important milestone recently.

Andrew J. Hykes: We're focused on training and in-service training, navigating backlogs, strengthening and stabilizing the supply chain, and getting the NTAP established. We hit an important milestone recently with CMS including the NTAP in their proposed rule. Every expectation we have is that that will come online as anticipated in October and will provide up to $16,000 in incremental reimbursement. That will certainly support a broader economic value proposition for LIMFLOW and will certainly be a key part of the foundation that we're going to build off of as we move into 2025.

Speaker Change: With CMS, including the and tap in their proposed rule.

Speaker Change: The expectation we have is that that will come online as anticipated in October and will provide up to $16000.

Speaker Change: Incremental reimbursement.

Speaker Change: That will certainly.

Speaker Change: Support a broader economic value proposition for them flow and will certainly be a key part of the foundation that we're going to build off of as we move into 2025 and I think that's the time frame for us really beginning to flex the commercial.

Andrew J. Hykes: I think that's the timeframe for us really beginning to ramp up the commercial effort on LIMFLOW and really begin to ramp up with a significant expansion in accounts and cases that go along with it. Last point I'd make is that this is going to be a more focused commercial effort than what we've had to undertake in VTE, focused on a smaller number of sites and, as a result, a much narrowerly scoped commercial infrastructure that we're going to need to build to service these patients compared to what we've had to undertake in VTE.

Speaker Change: Effort on limb flow and really begin to ramp.

Speaker Change: With the significant expansion in accounts and cases that go along with it.

Speaker Change: Last point I'd make keep in mind this is going to be a more.

Speaker Change: We're focused commercial effort than what we've had to undertake in <unk> focused on a smaller number of sites and as a result.

Speaker Change: More narrowly.

Speaker Change: Narrowly scoped commercial infrastructure that we're going to need to build to service. These patients compared to what we've had to undertake N V T E.

William John Plovanic: And then, if I could, I know the commentary on the guidance for, especially the direction in Q2 of flat to up. Looking back, you haven't been flat to up since COVID in 2020. I'm just, is there something specifically you're seeing that you're concerned about? Has there been any change in pricing? Has there been any change in any part of your business? Was there a lot of stocking internationally? I'm just kind of curious about the conservatism and given the strength of the quarter and the guide for the year, but, you know, the second quarter, that's not a historical pattern for you. And thanks for taking my questions.

Speaker Change: And then if I could.

Speaker Change: I know the commentary on the guidance for especially the direction on Q2 of flat to up.

Speaker Change: You know looking back you haven't been flat to up since Covid and 2020 I'm just is there something specifically youre seeing that youre concerned about.

Speaker Change: Is there anything changes in pricing is there any changes in any part of your business was there a lot of stocking internationally I'm just kind of curious of the the conservatism given the strength of the quarter and the guide for the year, but.

Speaker Change: The second quarter, that's not the historical pattern for you and thanks for taking my questions.

Andrew J. Hykes: Sure, Bill. I can get started on that.

Speaker Change: Sure I can get started on that Mitch may want to pile on as well as you heard Mitch described we have seen some seasonality in Q2.

Mitchell C. Hill: Mitch may want to pile on as well. You know, as you heard Mitch describe, we have seen some seasonality in Q2 the last couple years. We're not sure we fully understand all the dynamics at play, but there appears to be some underlying seasonality to the incidence of VTE in Q2. If you go back in time, we've certainly been transparent about talking about that in previous years. We wanted to be thoughtful about that dynamic as we signal the cadence of revenue growth for the remaining three quarters here in 2024.

Mitchell C. Hill: The last couple of years.

Speaker Change: Not sure we fully understand all the dynamics at play, but there appears to be some underlying seasonality to the incidence of <unk> in Q2. If you go back in time, we've certainly been transparent about talking about that in previous years, we wanted to be thoughtful about that dynamic as we signaled the cadence of revenue build.

Mitchell C. Hill: For the remaining three quarters here in 2024, there is nothing else.

Mitchell C. Hill: There's nothing else at play other than that consideration, and I think as you look into Q3 and Q4, you know, we do see some really nice catalysts shaping up across all three different parts of the business that we believe are going to lead to an acceleration as we exit the second half of the year. And Bill, just to

Mitchell C. Hill: At play other than that consideration.

Mitchell C. Hill: And I think as you look into Q3 and Q4.

Mitchell C. Hill: We do see some really nice catalysts shaping up across all three different parts of the business.

Mitchell C. Hill: That we believe are going to lead to an acceleration as we exit the second half of the year and Bill just to quickly add even a flat quarter in Q2 would be 2020 plus percent growth year over year.

William John Plovanic: And Bill, just to quickly add, even a flat quarter in Q2 would be 20 plus percent growth year over year. So, you know, we're pleased that that sort of continues to be consistent in reinforcing the guide for the year as a whole, which is, with our revised numbers, kind of 20 to 22 percent. The next question comes from Chris Pasquale with Nefron Research.

Mitchell C. Hill: So we're pleased that that sort of continues to be consistent and reinforcing of the guide for the year as a whole, which is with our revised numbers as kind of 20% to 22%.

Christopher Thomas Pasquale: The next question comes from Chris Pasquale with Nefron Research. Please go ahead. Thanks for taking the questions. I wanted to start with emerging therapies. I was hoping you could talk a little bit about the VenaCore product and what that adds to that business.

Thomas M. Tu: Thanks for the question, Chris. This is Tom here.

Mitchell C. Hill: The next question comes from Chris Pasquale with Nephron Research. Please go ahead.

Christopher Thomas Pasquale: Thanks for taking the questions I wanted to start with emerging therapies I was hoping you could talk a little bit about divina core product.

Christopher Thomas Pasquale: What that adds to that business and how it differs from the use case for <unk>.

Thomas M. Tu: So, we are very excited about VenaCore. It is the second element in our purpose-built toolkit for chronic venous disease. This is a very large population with unmet need whose standard of care right now is really just compression stockings and watchful waiting. We're really excited about the performance of this product in its early limited market release. And as always, we'll have a lot more to share about the product and the go-to-market strategy once we move into full market release, which will be in

Christopher Thomas Pasquale: Thanks for the question Chris This is Tom here, so very excited about being a core is the second.

Christopher Thomas Pasquale: Element in our purpose built tool kit for chronic venous disease. This is a very large population with unmet need whose standard of care right. Now is really just compression stockings and watchful waiting we're really excited about the performance of this product and its early limited market release and as always we'll have a lot.

Christopher Thomas Pasquale: More to share about the product and the go to market strategy. Once we move into full market release, which will be in Q3.

Christopher Thomas Pasquale: Okay, I guess the way food.

Christopher Thomas Pasquale: For details then.

Christopher Thomas Pasquale: And Mitch just a detail on the income statement. There was a large tax provision this quarter was that a cash charge. So is that part of the burn here in <unk> and what was the reason for that.

Mitchell C. Hill: Yeah, the cash burn issue, Chris, is more a function of working capital changes. If you look at the cash flow statement, you'll see some increase in our accounts receivable and some increase in inventories. So that was really more what was going on there. The tax.., expense item wasn't a current cash issue, but it is reflective of the fact that, you know, the U.S. business is something that is, I think as I've said before, you know, the U.S. business at this point is profitable and growing, and, you know, what comes along with that, unfortunately, is taxes, so we're dealing with it, and we're doing our best to sort of plan for those, but that wasn't a current cash issue for us in Q1.

Mitchell C. Hill: Yeah, the cash burn issue, Chris is more a function of working capital changes if you look at the cash flow statement.

Mitchell C. Hill: You'll see some increase in our accounts receivable as an increase in inventories. So that was really more what was going on there.

Mitchell C. Hill: Thanks.

Mitchell C. Hill: Expense item wasn't a current cash.

Mitchell C. Hill: Issue, but it is reflective of the fact that you know the U S business is something that is I think as I've said before that you know the U S business at this point is profitable and growing.

Mitchell C. Hill: What comes along with that unfortunately as taxes. So we're dealing with it and we're doing our best to sort of plan for those but that wasn't a current cash issue for us in Q1.

David Kenneth Rescott: The next question comes from David Rescott with Baird. Please go ahead.

Mitchell C. Hill: The next question comes from David Westcott with Baird. Please go ahead.

David Kenneth Rescott: Great. Thanks, guys, and congrats on the strong start to the year. Thanks for taking the questions. Mitch, I wanted to follow up on some of your comments about the second half of the strong performance in the back half of the year. I'm just trying to reconcile what you said about whether or not there is acceleration in the back half. And when we specifically look at this in the US VTE number, I'm kind of getting up to the mid-teens in Q1 or so, a little bit above the mid-teens. Does that number kind of hold steady into the back half, or is it more of a better guide or stronger growth in the back half more based on emerging therapies and the international segment?

David Kenneth Rescott: Oh, great. Thanks, guys and congrats to the strong start to the year. Thanks for taking the questions.

David Kenneth Rescott: Mitch I wanted to follow up on some of your comments about the second half of the strong performance in the back half of the year.

David Kenneth Rescott: Just trying to reconcile if you said whether or not there is acceleration in the back half and when we specifically look at this.

David Kenneth Rescott: In the U S <unk> number I'm kind of getting to up mid teens.

David Kenneth Rescott: Q1, or so a little bit about mid teens.

David Kenneth Rescott: Does that number kind of hold steady into the back half or is more of the better guide of a stronger growth in the back half more based on emerging therapies and the international segment.

Mitchell C. Hill: Yeah, I mean, Chris, sorry, David, again, we're not providing the guidance at that level of detail. We are seeing the global VTE number, you know, continuing to grow sort of along the lines of what we experienced here in Q1, if not a little bit better. We are excited about the growth prospects for the international business, and then our emerging therapies business is gonna continue to build out this year. Tom just talked about the Vinacore product, which is gonna add to the CVD portfolio, and then later in the year, we'll have the Artex product, so we have some nice catalysts there to help us continue to build out kind of the multi-product platform opportunity for the company.

Speaker Change: Yes, I mean, Chris I'm, sorry, David again, we're not providing the guidance at that level of detail. We are seeing that the global ETE number continuing to grow.

David Kenneth Rescott: Sort of along the lines of what we experienced here in Q1, if not a little bit better.

David Kenneth Rescott: We are excited about the growth prospects for the international business and then our emerging therapies Vince is going to continue to build out this year, Tom just talked about the DNA core product, which is going to add to the C. V portfolio and then later in the year, we will have the artist products. So we have some nice catalyst there to help us kind of continuing to build that kind of a multi.

David Kenneth Rescott: Product platform opportunity for the company.

Mitchell C. Hill: Overall, I would comment on the market growth issue versus our specific growth in global VTE, and just say that it's kind of not a straight line. There's gonna be some puts and takes each quarter. Overall, as Drew mentioned during the prepared remarks, we are super excited about the opportunity to expand the interventional penetration rate into the treatment of VTE diseases, and we think it could be two to three times the size it is currently, so that is just a really terrific opportunity for us, and we feel like we're just getting started with that, and it's gonna be a little bit of ebbs and flows quarter to quarter as we move forward, but if we picture where the business can be sort of in the three to five to seven year timeframe, including the readouts of multiple RCTs and guideline changes and things like that, we're super excited about the prospects.

David Kenneth Rescott: Overall, I would comment on the market growth issue versus our specific growth in.

David Kenneth Rescott: Global <unk> and just say that it's you know it's kind of not as straight line, there's going to be some puts and takes each quarter.

David Kenneth Rescott: Overall as drew mentioned during the prepared remarks, and we are super excited about the opportunity to expand the interventional penetration rate into the treatment of diseases and we think it.

David Kenneth Rescott: It could be two to three times the size. It is currently so that is just a really terrific opportunity for us and we feel like we're just getting started with that.

David Kenneth Rescott: We're going to be a little bit of ebbs and flows quarter to quarter as we move forward, but we picture where the business can be you know sort of in the three to five to seven year timeframe, including the readouts of multiple rct's guideline changes and things like that we're super excited about the prospects.

David Kenneth Rescott: Okay, great. Thanks. Maybe that's a good segue to my next question, just specifically on the two-year kind of cloud data, specifically on the lower PTS rate than we saw in some of the prior trials. I'm curious if the data that you've seen there is enough at this point or has been enough to drive maybe incremental conversions of some physicians who may have been more hesitant to switch over to a thrombectomy, specifically on the PTS kind of readout there, and whether or not longer term, if and once this goes into guidelines, whether or not you think these results would benefit the thrombectomy category as a whole, or whether or not this is more specific to what you're seeing from cloud fever alone.

Speaker Change: Okay, great. Thanks, and maybe that's a good segue to my next question just specifically on the two year kind of cloud data specifically on the the lower Etfs rate than we saw in some of the prior trials I'm curious if if.

Speaker Change: The data that you've seen there is enough at this point or has been enough to drive maybe incremental conversions of some some physicians who may have been more hesitant to switch over to thrombectomy, specifically on the Pts kind of readout.

Speaker Change: Read out there and whether or not longer term if and once this goes into guidelines whether youre not you think these results would benefit the Trump vacuuming category as a whole or whether or not this is more specific to what youre seeing from from pottery barn <unk>. Thank you.

David Kenneth Rescott: Thank you. Great. Thanks for the question, David.

Thomas M. Tu: Great, thanks for the question, David. I'll answer them in reverse order.

Speaker Change: Great. Thanks for the question David.

Speaker Change: I'll answer them in reverse order.

Thomas M. Tu: The ClotReaver system has a unique mechanism of action, and we believe that it's the only device that has led to the kind of fantastic clinical results that we presented most recently in the Clout two-year interim data. I think the top-line readout of that data set shows that mechanical thrombectomy with ClotReaver is the best at removing thrombus, and that translates into the best short-term safety results as well as long-term safety and efficacy in prevention of post-thrombotic syndrome.

Speaker Change: The <unk> system has a unique mechanism of action and we believe that.

Speaker Change: The only device that has led to the kind of fantastic clinical results that we presented most recently in the clouds to your interim data I think the top line readout of that data set shows that mechanical thrombectomy with coop fever is the best at removing thrombus and that translates into the best <unk>.

Speaker Change: Term safety results as well as long term safety and efficacy and prevention of post for <unk> syndrome, and we are very.

Thomas M. Tu: And we're very happy about that data set and pleased to report it. I think as far as the commercial impact of the data set, you're going to see this affect two different physician populations, right? Of course, those that are still kind of mired in conservative therapy or old-fashioned therapy for DVT certainly have more reason to believe in ClotReaver. And then folks who perhaps have chosen alternative means to treat DVT now recognize the superior safety profile and efficacy of this device with better data than anything else that's out there.

Speaker Change: Happy about that data set and pleased to reported I think as far as the commercial impact of the dataset you're going to see.

Speaker Change: This effect two different physician populations right of course, those that are still.

Speaker Change: Kind of mired in conservative therapy or old fashion therapy for DVT, certainly have more reason to believe in QUADRA River, and then folks who perhaps have chosen alternative means to treat DVT now recognize the superior safety profile and efficacy of this device with better data than any.

Speaker Change: Thing else Thats out there.

Michael Anthony Sarcone: The next question comes from Michael Sarcone with Jeffries. Please go ahead.

Speaker Change: The next question comes from Michael Sarcone with Jefferies. Please go ahead.

Michael Anthony Sarcone: Hey, good afternoon, and thanks for taking my questions. Tom, maybe we can keep you in the hot seat. Just, you know, a follow-up to the PeerList 2 commentary, and I believe you had mentioned that the data set, if positive, could help catalyze more uptake of mechanical thrombectomy. What would you characterize or what are you looking for to define success or a positive read on that trial?

Michael Anthony Sarcone: Hey, good afternoon, and thanks for taking my questions.

Michael Anthony Sarcone: Tom maybe we can keep you in the hot seat just a follow up on the Peerless to commentary I believe you had mentioned the data said if positive could help catalyze more uptake of mechanical thrombectomy.

Michael Anthony Sarcone: What would you characterize or what are you looking for to define success or a positive read on that trial.

Thomas M. Tu: Sure. So, Michael, just for clarification, I believe you might be referencing PURELESS-1, which is our RCT of flow trevor versus catheter-directed thrombolysis for PE patients. That's the one whose enrollment is complete and whose data set we will anticipate presenting at a major clinical meeting in the second half of this year. You know, I think what you're going to see there is a strategy kind of endpoint, not to go into too much detail, but it's a win-ratio analysis of flow Trevor versus catheter-directed thrombolysis with important clinical as well as resource utilization metrics, things such And I think all of those are known benefits for our therapies over CDT, and we anticipate that this data, if positive, is going to reiterate those benefits and drive more people towards our therapy.

Thomas M. Tu: Sure. So Michael just for clarification, I believe you might be referencing peerless, one which was our RCT.

Michael Anthony Sarcone: Got it. Thanks, Tom. And then maybe one for Mitch.

Michael Anthony Sarcone: <unk> versus catheter directed thrombolysis for patients that's the one.

Michael Anthony Sarcone: <unk> enrollment is complete and whose dataset, we will anticipate presenting in a major clinical meeting.

Speaker Change: In the second half of this year.

Speaker Change: I think what youre going to see there is a strategy kind of endpoints.

Speaker Change: Not to go into too much of the details, but it is a win ratio analysis of float fever versus catheter directed thrombolysis with important clinical as well as resource utilization metrics things such as mortality, leading clinical deterioration and bail out as well as hospital ICU.

Speaker Change: Utilization and I think all of those are known benefits for our therapies over CVC and we anticipate that.

Speaker Change: This data if positive is going to reiterate some of those benefits and drive more people towards our therapy.

Speaker Change: Got it thanks, Tom and then maybe one for Mitch.

Mitchell C. Hill: Can you just talk about how you're thinking about the cadence of gross margin through the balance of the year? Sure. I'd be happy to do that.

Speaker Change: Can you just talk about how youre thinking about the cadence of gross margin through the balance of the year.

Mitchell C. Hill: Sure, happy to do that. You know, I think the 86.8% margin in Q1, you know, as I mentioned, there were some fluctuations there due to product mix and due to some ramp-up for the new products and internationalization. As we think about that for the remainder of the year, it looks like it'll be fairly flat or fairly consistent with that number, so not a significant fluctuation in that as we move through the rest of the year.

Mitchell C. Hill: Sure happy to do that I think the 86, 8% margin in Q1.

Mitchell C. Hill: I mentioned there were some fluctuations there due to product mix and due to some ramp ups of the new products in the internationalization as we think about that for the remainder of the year.

Mitchell C. Hill: It looks like it will be fairly flat are fairly consistent with that number so not a significant fluctuation in that as we move through this year.

Michael Anthony Sarcone: Got it. Thank you, Mitch. Thank you. The next question comes from Mike Matson with Needham.

Speaker Change: Got it thank you mentioned.

Speaker Change: Thank you.

Michael Stephen Matson: The next question comes from Mike Matson with Needham. Please go ahead. Hey guys, this is Joseph on for Mike. Just another one on gross margins.

Speaker Change: The next question comes from Mike Matson with Needham. Please go ahead.

Speaker Change: Hey, guys. This is Joseph on for Mike.

Joseph: Another one on gross margin.

Joseph: Maybe the reason why it was down this quarter or I guess was pricing a factor this quarter.

Joseph: Whats the pricing been like because it generally been stable.

Mitchell C. Hill: Yeah, I'm happy to help you with that. And the pricing, we're happy to report, has been very stable or even increased for Inari. We've been successful, you know, working with our customers. As you know, historically, we had the VPE; PPP is something that's kind of come into the picture over the past year or two. Starting out a couple of years ago, it was just kind of the PE, Price Per Procedure. Now we've kind of been able to offer a package to many hospitals so that the treating physicians are able to avail themselves of really all of the tools.

Speaker Change: Yeah, I'm happy to help you with that and the <unk>.

Mitchell C. Hill: Pricing.

Speaker Change: Happy to report has been very stable to even up for Oh Laurie.

Mitchell C. Hill: Yes.

Mitchell C. Hill: <unk> been successful working with our customers here.

Mitchell C. Hill: Historically, we had the <unk>.

Mitchell C. Hill: T E. PPP is something that's kind of come into the picture over the past year or two.

Mitchell C. Hill: Starting out from a couple of years ago. It was just a kind of a P E.

Mitchell C. Hill: Price per procedure, and then the country with silicon and eschew basis now.

Mitchell C. Hill: Now, we've kind of been able to offer a package to many hospitals. So that the treating physicians are able to avail themselves of really all of the tools, it's particularly useful in the complex DVT cases, which are probably around 15% to 20% of those where they can use the sort of the Korean element of this.

Mitchell C. Hill: It's particularly useful in complex DVT cases, which are probably around 15 to 20 percent of those, where they can use the..., sort of the coring element of the clot treaver to remove clot that's well-adherent, and they can also use the aspiration of the flow treaver to remove clot that may be up around the IBC or the IBC filter parts of the clot.

Mitchell C. Hill: <unk> to remove clot this wallet here and they can also use the aspiration of the.

Mitchell C. Hill: Oh cheever to remove costs that may be up around the ITC as IDC filter parts of the.

Mitchell C. Hill: So the pricing has been very stable to up for us, and you know we are continuing to work with hospitals to expand the concept of that kind of that pricing package. Okay, yeah, that's helpful. Just to reiterate, did you say 15 to 20 percent of the complex cases, you know, those customers are opting for the package deal? I'm sorry, 15 to 20 percent of the VTE procedures are complex in nature, meaning that physicians would benefit from using both the ClockTreeper family of products as well as the aspiration tools that are a part of the FlowTreeper family. So this idea of bundling together all of the products in kind of a larger toolkit is something that they really love.

Mitchell C. Hill: The anatomy so.

Mitchell C. Hill: The pricing has been very stable to up for us and we are continuing to work with hospitals to extend the concept of that kind of that pricing package.

Mitchell C. Hill: Okay. Yeah, that's helpful and just to reiterate did you say, 15% to 20% of the complex cases.

Mitchell C. Hill: Customers are opting for the package deal.

Mitchell C. Hill: Sorry, 15% to 20% of the DTE procedures are complex in nature, meaning that their physicians would benefit from using both.

Mitchell C. Hill: In the country for family of products as well as the aspiration tools that are a part of the flow cheaper family.

Mitchell C. Hill: So this idea of bundling together all of the products and kind of a larger tool kit is something that they really love.

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

Mitchell C. Hill: The next question comes from Adam Maeder with Piper Sandler. Please go ahead.

Adam Carl Maeder: Hi, good afternoon. Thank you for taking the questions here.

Adam Carl Maeder: Hi, good afternoon, and thank you for taking my questions here.

Adam Carl Maeder: I wanted to start on <unk> I believe you were previously targeting a mid 2020 for relaunch.

Thomas M. Tu: I wanted to start on Ardix. I believe you were previously targeting a mid-2024 relaunch. Just wanted to see if that still holds or if it's kind of shaping up to be a little bit later in 2024, and what's needed, I guess, from a clinical regulatory standpoint to get that product launched again in the states. And then a follow-up. Thank you.

Adam Carl Maeder: Just wanted to see if that still holds or if thats kind of shaping up to be a little bit later in 'twenty four.

Adam Carl Maeder: And what's needed I guess from a clinical regulatory standpoint too.

Adam Carl Maeder: To get that product.

Adam Carl Maeder: <unk> launched again in the states and that a follow up thank you.

Thomas M. Tu: Adam, this is Tom. Thanks for the question. We're really excited about Ardix. As you know, we were in the market with a first-generation product. We're really happy to see a pristine safety profile and excellent efficacy, which really offers a better option for patients who, in this mature market, really have had suboptimal choices. With Ardix Generation 2, what we're bringing is increased ease of use, as well as even better thrombectomy efficacy. And we are still targeting a mid-year launch of that 2.0 product. So we're just getting the finishing touches, and we'll have more to say as we make further progress.

Adam Carl Maeder: Adam This is Tom Thanks for the question, we're really excited about Arctic.

Thomas M. Tu: You know we've been in the market with the first generation product.

Thomas M. Tu: Really happy to see a pristine safety profile excellent efficacy, which.

Thomas M. Tu: It really offers a better option for patients who are in this mature market really have had suboptimal choices with Rx generation to what we're bringing is increased ease of use as well as even better thrombectomy efficacy and we are still targeting a mid.

Thomas M. Tu: Mid year.

Thomas M. Tu: Launch of that 2.0 product. So we're just getting the finishing touches and we will have more to say as we've made further progress.

Adam Carl Maeder: Thanks for the color, Dr. Tu. And, you know, one other question, and it's a bigger picture question about innovation. You know, NARI clearly has been very innovative in recent years, and you've launched a lot of different products and have more coming down the pike. You know, one question that I sometimes get from investors is around Flowtriever and Clottriever, any plans for future iterations of those technologies, and any, I guess, specific ways that you think that those products could be further improved. Thank you for taking the question. Yeah, absolutely. So

Speaker Change: Thanks for the color Dr too and.

Speaker Change: One other question and it's a bigger picture question on innovation.

Speaker Change: <unk> clearly has been very innovative in recent years.

Speaker Change: We've launched a lot of different products and have more coming down the pike.

Speaker Change: One question that I, sometimes get from investors is around flow treebank clock tree or any plans for future iterations of those technologies in any I guess specific ways that you think that those products can be further improved thank you for taking the questions.

Thomas M. Tu: Yeah, absolutely. As our flagship products and as the core driver of our mission as well as our growth, we are very much interested in continuing to invest in what are currently fourth-generation flow treaver and clot treaver products. And we continue to solicit feedback from physicians to look for areas where we can improve safety and efficacy, and we'll see continued investment in developing and introducing those concepts into our products. I think as far as the safety and efficacy profile that we now see becoming documented in high-level clinical data, I anticipate that we are reaching diminishing returns in terms of improvements there but can always improve elegance, form factor, and

Speaker Change: Yeah, absolutely so.

Speaker Change: As our flagship products and as the core driver of our mission as well as our growth.

Speaker Change: Very much interested in continuing to invest in what is currently fourth generation flow Trevor and clock fever products and we continue to solicit.

Speaker Change: Feedback from physicians.

Speaker Change: To look for areas, where we can improve safety and efficacy and we will see continued investment in developing and introducing those concepts into our products I think as far as the safety and efficacy profile that we now see a becoming documented in high level clinical data.

Speaker Change: Dissipate that we are reaching diminishing returns in terms of improvements there, but can always improve.

Speaker Change: Elegance form factor and ease of use.

Richard Samuel Newitter: The last question today is from Richard Newitter with Truist Securities. Please go ahead.

Speaker Change: The last questioner today is Richard newer there with <unk> Securities. Please go ahead.

Richard Samuel Newitter: Hi, thanks for taking the questions. I have two.

Richard: Hi, Thanks for taking the questions.

Richard: To me the first one just on the profit comments in the first half of 'twenty. Five I think you guys said you you continue to expect profitability in the first half of 'twenty five I'm just curious if.

Mitchell C. Hill: The first one is just on the profit comments in the first half of 25. I think you guys said you continue to expect profitability in the first half of 25. I'm just curious if that's meant to be read as the first quarter is probably still in a loss situation and the second quarter is positive, and the net of those two is break even to slightly positive. Is that the right way to look at it, or are you turning the corner, you think, as early as the first quarter?

Richard: That's meant to be read as you know the first quarter is probably still.

Richard: A loss situation in the second quarter is positive in the net of those two.

Richard: Breakeven to slightly positive is that the right way to look at it or are you turning the corner you think in as early as the <unk> and I have a follow up.

Mitchell C. Hill: Yeah, Richard. It's Mitch.

Niche: Yeah, Richard it's niche happy to try to address that question in Q1 of each year, we have a reset that happens with the ERISA taxes and also some of that company match.

Mitchell C. Hill: I'm happy to try to address that question. In Q1 of each year, we have a reset that happens with the ERISA taxes and also some of the company match in the 401k, and it's a larger number than you might imagine. And so that particular... And actually, if you look at the Q4 to Q1 walk that we're currently reporting, you can see some of that appearing in the numbers. So that'll happen again as we move from Q4 of 24 to Q4 of 25.

Speaker Change: Match in the 401, K and it's a larger number than you might imagine and so that particular and at that actually if you look at the Q4 to Q1 work.

Speaker Change: Currently reporting you can see some of that are appearing in the numbers.

Speaker Change: So that will happen again as we move from Q4 of 24 to Q4 of 25, and we would expect currently to see a loss in Q1 of 2025, but then we would go into the operating profit profile in Q2 of 2000 22025 and thereafter, so that's kind of the commentary we have about the first half of.

Mitchell C. Hill: And we would expect, currently, to see a loss in Q1 of 2025, but then we would go into the operating profit sort of profile in Q2 of 2025 and thereafter. So that's kind of the commentary we have about the first half of the year. And that's just something that all companies deal with in terms of the calendar year tax issues.

Speaker Change: The year and that's just something that's kind of all companies deal with in terms of the calendar year tax issues.

Richard Samuel Newitter: Okay, thanks for that color. And then maybe just on the, you know, you guys have referred to competitive dynamics a couple of times as, you know, potentially explaining the delta between your US Venus growth rate and, you know, the underlying market rate. I guess, you know, a year ago, you had a competitor launch, you talked about some trialing, and you expected that to be transient. I guess, can you characterize the competitive dynamics as we're now kind of moving into a second year or anniversary of the launch of the main competitor, and some new ones are coming on? What exactly is the competitive dynamic that's occurring, and why or why shouldn't we expect that? to be transient going forward. Yeah, I can...

Speaker Change: Okay. Thanks for that color and then maybe just on me you guys have referred to competitive dynamics a couple of times as you know.

Speaker Change: Potentially explaining the delta between your U S Venus growth rate and you know the underlying market rate I guess.

Speaker Change: A year ago.

Speaker Change: Do you have a competitor launch you talked about some trialing and you expected that to be transient I guess can you characterize the competitive dynamics as we're now kind of moving into our second year. We're anniversarying. The launch of the main competitor and some new ones are coming on what what exactly is the competitive dynamic.

Speaker Change: That's occurring and why or why shouldn't we expect that.

Speaker Change: To be transient going forward.

Andrew J. Hykes: Yeah, I can try and answer that, Richard. So we are going to see a competitive entry into this market. It's a large, attractive market, a high-growth market in the earliest stages of penetration and inflection from conserved medical management to frontline therapy with mechanical thrombectomy. So all of that, I think, underscores our confidence in continuing to be the market leader in this market despite new entrants coming in. And again, to the extent they can help from a market development standpoint, I think there's real value and real constructive work they can do alongside Inari to develop the market over time.

Speaker Change: Yes, I can try and answer that Richard.

Speaker Change: So we are going to see competitive entrants in this market. It is a large attractive market high growth market in the earliest stages of.

Speaker Change: Penetration, an inflection from conserve medical management to frontline therapy with mechanical thrombectomy.

Speaker Change: That competitive dynamic is factored into our guidance.

Richard: That's not a new part of our business, we obviously face those same dynamics as we moved through 2023 and.

Richard: <unk> delivered 28% growth we saw those same competitive dynamics play out here most recently in Q1.

Richard: <unk> grew 23%, including 20% and Vijay So all of that I think underscores our confidence in continuing to be the market leader in this market, despite new entrants coming in and again to the extent they can help from a market development standpoint, I think there's real value.

Richard: Real constructive work they can do alongside in order to develop the market overtime.

Operator: This concludes our question and answer session and concludes the conference call. Thank you for attending today's presentation. You may now disconnect.

Speaker Change: This concludes our question and answer session and concludes the conference call.

Speaker Change: You for attending today's presentation you may now disconnect.

Speaker Change: Yeah.

Speaker Change: [music].