Inari Medical, Inc.

And welcome to Inari Medical's fourth quarter and full year 2023 conference call. At this time, all participants are in a listen-only mode. At the end of the company's prepared remarks, we will conduct a question and answer session. As a reminder, this call is being recorded and will be available on the company's website for replay shortly. And now I will turn the call over to John Hsu, Vice President of Investor Relations. Please go ahead.

Thank you, Operator. Welcome to Inari's conference call to discuss our fourth quarter and full year 2023 financial performance. Joining me on today's call are Drew Hikes, President and Chief Executive Officer, and Mitch Hill, Chief Financial Officer. This call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements related to INARI's estimated full-year 2024 revenue, operating loss or profitability expectations, and the expected operating performance and potential strategic benefits of LIMPFLOW, are based on INARI's current expectations, forecasts, and assumptions, which are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Actual outcomes and results could differ materially from any results performance, or achievements expressed or implied by the forward-looking statements due to several factors. Please review INARI's most recent filings with the SEC, particularly the risk factors described in our latest Form 10-K for additional information. Any forward-looking statements provided during this call, including projections for future performance, are based on management's expectations as of today. INARI undertakes no obligation to update these statements except as required by applicable law. On today's call, we will refer to both GAAP and non-GAAP financial measures in announcing our Q4 and full year 2023 results. Please refer to today's press release for reconciliation of the non-GAAP measures discussed on this call and referred to in the press release. The press release and the slides accompanying this call are available on our website at inarimedical.com. A recording of today's call will be available on our website by 5 p.m. Pacific time today. With that, I'll turn our call over to Drew.

Thank you, John, and thank you for joining our call today. We are thrilled with our Q4 and full year 2023 performance. In the fourth quarter, we achieved record revenue of more than $132 million, driven by strength in our core VT business, strong growth from our emerging therapies portfolio, and continued traction from international expansion. For the full year, we generated revenue of over $493 million, reflecting 29% growth for the year. We also made meaningful progress on our path to profitability, positioning Inari for sustained operating profitability in the first half of 2025, despite the incremental operating deficit support associated with our LIM flow acquisition. I would like to thank the Inari team for their hard work to make this year a success by every measure. We are succeeding in our goal to drive strong adoption of our market-leading PE and DBT therapies, while also executing on our plans to expand internationally and diversify commercially into sizable new patient populations that are underserved by today's standard of care. This expansion to new patient populations included the acquisition of Lymflo, which we announced and closed in Q4. Lymflo's purpose-built system allows for the transcatheter arterialization of the deep veins and is indicated to treat patients with chronic limb-threatening ischemia, or CLTI. This technology addresses a spectacular unmet need for these patients. providing new hope and an important new treatment option. I'll have more to share about our progress with Limflow later in the call. Going forward, we will begin providing a new revenue breakout that we believe better aligns with the three growth pillars of our business. Specifically, we'll report revenue from our global VTE portfolio and from our global emerging therapies portfolio, while also continuing to break out U.S. and international revenue. Mitch will have more to share about this new framework in his remarks. Before turning to these growth pillars, I wanted to share, as we always do, a story about the incredible impact our technology has on patients. Recently, a 30-year-old woman just two weeks postpartum presented to an ER in Louisiana with severe trouble breathing and leg swelling. As a complication from her recent pregnancy, this young mom was diagnosed with both a pulmonary embolism and a clot in her inferior vena cava, or IVC, a life-threatening situation. After consulting with her physicians, she decided to undergo a thrombectomy. First, her physicians used the new clot-triever XL catheter to effectively remove all the clot in her IVC, as it was purpose-built to do. The protrude sheath was also used adjunctively to protect against the risk of clot embolization. Next, her pulmonary embolism was successfully and efficiently treated using the T24 catheter. After a short hospital stay, the patient was able to return home to her newborn baby and family. Her successful outcome was made possible by the skill of her treating physicians and the breadth and depth of Inari's purpose-built toolkits across both DVT and PE. During 2023, we surpassed 130,000 cumulative patients treated globally, including this young mom. This was a humbling milestone for our organization. But despite all our success to date, much more work remains. And we believe we're in the earliest phases of the impact we can have on patients globally across multiple disease states. I will now provide an update on each of our three growth pillars, starting with VTE, which we believe represents a $6 billion TAM in the US alone. Our growth strategy in VTE continues to focus on commercial expansion, market development, high-quality clinical evidence, and continuous innovation. Commercially, we remain committed to our high-touch approach. We continue to split territories, adding reps selectively at a measured pace in areas with the greatest need. Given our high level of national account penetration, as the pace of new territory ads continues to moderate, we've started to see some nice corresponding productivity gains. Looking ahead, we remain confident in the ability of our world-class commercial team, the largest VTE-focused sales force in the industry, to drive significant growth. Turning to market development, we're increasing penetration within existing accounts via VTE Excellence, our comprehensive market development program. VTE Excellence is a series of playbooks and activities that we systematically execute to help support hospitals in the development of VTE programs. The goal is analogous to the programs that have been created in stroke, STEMI, and TAVR. As we execute VT Excellence, our penetration into the TAM at the account level increases and we are encouraged by the progress we are making. Today, in many of our most advanced accounts, we are now seeing TAM penetration rates above 50%. Most importantly, we believe VT Excellence is scalable and repeatable. On the clinical evidence front, we remain steadfast in our commitment to produce the highest quality clinical data to drive awareness, and ultimately change the standard of care in VTE. This commitment is reflected in the significant progress we continue to make across all three of our randomized controlled trials. In fact, we just completed patient enrollment for Peerless, our trial randomizing FlowTriever to catheter-directed thrombolysis. We were able to fully enroll this study in just over two years, a considerably faster pace than other currently enrolling RCTs. We look forward to the data readout in the second half of 2024. Enrollment for Defiance and Peerless 2 are also tracking in line with our expectations. Currently across the industry, there are no fewer than seven actively enrolling RCTs, each studying different aspects of VTE. This represents an exciting new era of investment and shared commitment to change the standard of care for this huge underserved group of patients. But make no mistake, Inari continues to be the clear leader in this effort. Taken together, we will study over 2,000 patients in our three RCTs, more than those conducted by all other sponsors combined. We believe this high-quality clinical evidence will ultimately enable us to treat a significant portion of the 700,000 U.S. patients suffering from VTE each year. Finally, we continue to innovate across our best-in-class toolkits. to protect and extend our leadership position. Over the past 12 months, we commercialized multiple new products to augment our VTE franchise, including T16 Curve, Klattriever XL, and Klattriever Bold Gen 2. The Flowtriever and Klattriever systems are fourth and third generation platforms, respectively, benefiting from six years of continuous iteration and improvement. However, we remain committed to further innovation within VTE. Next, I'll provide some updates across our portfolio of emerging therapies, our second growth pillar. This segment consists of four distinct patient populations outside of VTE, where we have identified an unmet need we believe we can address by leveraging our core competencies. Taken together, we believe these markets represent a $4 billion TAM in the US alone, and we are just getting started in each. Beginning with chronic venous disease, we continue to be encouraged by the initial commercial traction of Revcor, the first mechanical thrombectomy device to treat venous stent thrombosis. Between incidence and prevalence pools, we believe the addressable market for Revcor totals nearly 50,000 patients, representing a $500 million U.S. TAM. Looking ahead, in 2024, we plan to launch the second purpose-built tool within the CBD toolkit, further augmenting our portfolio and unlocking another portion of this significant TAM. Turning to dialysis access management, InThrill continues to build commercial traction over the past several quarters. InThrill is a thrombectomy system designed for small vessels, including AV fistulas and veins in the upper extremities and below the knee. The combined total addressable market is 250,000 procedures per year in the U.S., representing an incremental $1 billion market opportunity. Turning to CLTI, since closing the lymph flow acquisition in mid-November, we've made important progress in beginning to integrate the business into Inari while also executing the early US launch. We have successfully established the initial Limflow organization through a combination of Limflow and Inari personnel and a small number of external hires. We've undertaken important work to stabilize and build capacity across the supply chain while also beginning to integrate corporate support services. Commercially, the U.S. launch is proceeding in line with our expectations. We are successfully navigating VAC approvals and have completed an initial series of commercial cases. We held our first training summit in late January and had great engagement and feedback from the event. We anticipate building momentum throughout the year, highlighted by incremental reimbursement via an NTAP, which would go into effect in October. Taken together, we continue to view 2024 as a foundational year focused on physician training VAC approvals, thoughtful patient selection, and deliberate wound care follow-up. Limflow offers new hope and new options to the 55,000 no-option CLTI patients. We are encouraged by the progress we've made to date in accessing this $1.5 billion US TAM. Our last emerging therapies category is acute limb ischemia, a $600 million US TAM characterized by tremendous unmet needs and a lack of purpose-built tools. In fact, roughly 50% of ALI patients today must undergo an open surgical procedure to successfully remove their clot. We remain committed to better outcomes for these patients and continue working to bring our second generation Arctic system to market later in 2024. Finally, I would like to discuss our third pillar, international. In Q4, we continue to see strong growth led first and foremost by our European franchise. Alongside Europe, we continue to gain incremental product approvals and are now commercial in over 30 countries globally. Overall, international revenue was nearly $8 million in Q4, up more than 130% versus the prior year. Looking forward, we recently received favorable incremental reimbursement in France. Also, we remain on track to treat patients in both China and Japan this year on a commercial basis. While international sales are just 5% of our total revenue today, Given the spectacular unmet need and the investment we've made in establishing an international commercial footprint, we expect international sales to account for at least 20% of revenue over time. In closing, we're pleased with how the business performed in Q4 in 2023. For the year, we generated record revenue and strong growth of nearly 30%, driven by crisp execution across our growth pillars. Our field team continued to drive patients toward frontline treatment with our therapies while working to support the development of VTE programs. We announced our third RCT and built meaningful momentum across new product launches, and we saw another record quarter and strong growth from our international business. In addition, we laid the foundation for strong, sustained revenue growth via expansion of our purpose toolkits into new disease states with significant unmet needs. We also announced, closed, and began to integrate Limflow, our first acquisition. Finally, We delivered meaningful operating leverage while continuing to invest in burgeoning parts of the business. Going forward, I've never been more confident in the health of our business and our ability to generate meaningful revenue growth across our three growth pillars in 2024 and for many years to come. With that, I'll now turn the call over to Mitch.