Inari Medical, Inc.

Good day, and welcome to the Inari Medical third quarter of 2024 earnings call. All participants will be in a listen-only mode. And should you need any assistance on today's call, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. And to withdraw your question, please press star, then two. On today's call, we ask that you please limit yourself to one question and one follow-up during Q&A. Also, please be aware that today's call is being recorded. I would now like to turn the call over to Marissa Bytes, Vice President, Investor Relations. Please go ahead.

Thank you, Operator, and welcome to Inari's conference call to discuss our third quarter 2024 financial performance. Joining me on today's call are Drew Hikes, President and Chief Executive Officer, and Kevin Strange, 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 ANARI's estimated full-year 2024 revenue, operating loss or profitability expectations, and the expected operating performance and potential strategic benefits of LIM flow. These statements are based on ANARI'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 NARI'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. NRE 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 Q3 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 release. The press releases 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. And with that, I'll turn the call over to Drew Hikes, President and Chief Executive Officer.

Thank you all for joining our call today. In Q3, we continue to drive strong adoption of our therapies, resulting in record revenue of $153.4 million and 21% year-over-year growth. Based on our year-to-date progress, we are pleased to raise our full year revenue guidance and reaffirm our expectations to reach sustained operating profitability in the first half of 2025. Before proceeding, I'd like to formally welcome Kevin Strange, our new CFO, to today's call. With over 15 years of experience, including over four years here at Inari, Kevin brings tremendous expertise, judgment, and leadership to our C-suite. He has also shown a steadfast commitment to our mission and patience. Additionally, I'd like to thank Mitch Hill for his contributions. As a reminder, Mitch will remain with Inari through early January as we continue the transition. Turning back to our quarterly results, we drove strong performance across the entire Inari portfolio, including in our market-leading PE and DBT therapies and in our emerging therapies portfolio. We also delivered robust growth in our international business. As we advance into the fourth quarter, We are as excited as ever about our leading position in large and underserved vascular markets. This is especially true as we await the presentation of peerless data at the TCT symposium tomorrow. We believe this presentation marks the beginning of a golden era of randomized controlled data focused on thrombectomy for patients suffering from VTE. In Q3, our global VTE revenue was $145.3 million. up 19.7% versus the prior year, underpinned by our commercial expansion and market development efforts. During the quarter, we saw stable underlying market and share dynamics. The market for U.S. VTE procedures remained significantly underpenetrated, and as the market leader, we continue to expect to drive robust growth and adoption of mechanical thrombectomy for years to come. Our VTE-focused sales force, the largest in the industry, continues to mature as we hire reps and split territories at a measured pace. The team is making progress in helping their hospital customers build VT excellence programs to help ensure that each patient diagnosed with a DVT or PE is given consideration for interventional therapy. We are excited that a substantial opportunity remains ahead, and we look forward to continuing to drive higher adoption and penetration across our account base. Turning to our clinical work, We are proud to usher in the golden era of randomized controlled trial data in VTE through the presentation of our peerless data tomorrow. As a reminder, peerless is the first of our three major RCTs to complete enrollment. Peerless was designed to evaluate patient outcomes using FlowTriever as compared to catheter-directed thrombolysis. As a reminder of the patient population addressed by this study, we believe the annual incidence of intermediate high-risk PE is approximately 280,000 patients, all of whom are eligible for mechanical thrombectomy with flow trigger. Of these patients, today we believe only 15 to 20%, or about 50,000 patients annually, receive any type of catheter-based intervention. We estimate that of those 50,000, about one-third, or 15,000 patients, are still being treated with catheter-directed thrombolytics. Based on our ASPs, we therefore see roughly a $150 million opportunity to convert the remaining catheter-directed thrombolytic procedures to mechanical thrombectomy with FlowTriever. Of course, this is alongside the opportunity to continue to convert to 80% of patients still being treated by conservative medical management with anticoagulation alone. Should tomorrow's data be positive, over time, we would expect many more patients to receive mechanical thrombectomy treatment with our flow treatment device due to its unique large-bore aspiration technology and blood return capability. Data from the trial will be presented at TCT by Dr. Wisdom Jabber, professor of medicine at Emory University School of Medicine, during the late-breaking clinical trial session at 1144 a.m. Eastern Time tomorrow. I look forward to talking with many of you on-site and hope many of you will also join us for our peerless discussion happening at 2 p.m. Eastern Time tomorrow, following the late-breaking clinical trial session. Beyond peerless, we're making progress on enrollment in our two other currently active RCTs, both of which compare our products to conservative medical management. Peerless 2, comparing Flotriver to anticoagulation alone in PE, and Defiance, comparing Clotriver to anticoagulation alone in DBT. We believe our investment in these studies will further advance the field, change guidelines, extend our leadership position, and ultimately change the standard of care in VTE away from conservative medical management to frontline treatment with Flotrever and Clotrever. Turning to our global emerging therapies business, in Q3, we delivered over $8 million in emerging therapies revenue, up 64% versus the prior year. We expect emerging therapies to deliver a strong finish to the year, with several Q4 catalysts already in place and still others coming soon. Years of purposeful investment in this segment has led to the addition of four distinct patient populations outside of VTE, together comprising a $4 billion TAM in the U.S. alone. In our chronic venous disease portfolio, we continue to advance the adoption of Venacor, following our full market release earlier this year. As a reminder, physicians are using Venacor as both a tool to treat CBD and, in certain cases, to augment treatment in DBT. The addressable market in CBD includes an annual incidence of approximately 100,000 patients, representing a $1 billion U.S. TAM and a substantial prevalence pool of over 1 million patients. CLTI also remains an exciting opportunity for us, Limflow offers new hope for the 55,000 patients per year suffering from no-option CLTI, translating into a $1.5 billion U.S. TAM. I am pleased to report that our U.S. launch is progressing well. As we formally anniversary the addition of Limflow to Inari, we're making great progress. As of the end of Q3, we have received VAC approvals in over 50 of the approximately 200 high-volume limb salvage centers of excellence that comprise our early launch targets. We look forward to supporting initial procedures and growth over time across these and more centers. In addition, we've been hard at work to iterate on the first-generation lymph flow system, as is the Inari way. Earlier in the quarter, we received PMA approval from the FDA for our next-gen stent delivery system, and I'm happy to share that we are now in limited market release. We look forward to beginning the broad commercialization of this key component in 2025. Continuing with our work on lymph flow, I'm pleased to highlight that the NTAP proposed earlier this year for lymph flow procedures performed in the inpatient setting went into effect as planned at the beginning of October. Thanks to the NTAP, reimbursement for inpatient procedures has now increased by as much as $16,250. Regarding outpatient procedures, as noted on our last call, in Q3, CMS proposed to increase hospital outpatient reimbursement for the LIMPRO procedure from $27,500 to $35,000, a meaningful increase. This enhanced reimbursement is relevant to the roughly 20% of limb flow cases currently performed in a hospital outpatient setting. We expect to see the final ruling from CMS for outpatient reimbursement in the next two months. In acute limb ischemia, I'm pleased to share that we recently received 510K clearance for our next-gen ARDIX system and have commenced a limited market release. This product serves a $600 million U.S. TAM, characterized by tremendous unmet needs and a lack of purpose-built tools. ARDIX will not only address patients who would have been treated surgically, but we believe this second-generation device improves upon other repurposed endovascular platforms. We plan to commence a full market release later in Q4. Our final emerging therapies market addresses the treatment of AV fistula clots using our InThrill device. Based on physician feedback, we're working on a second-generation InThrill platform, and we look forward to bringing it to market next year. As evidenced by the great progress made year-to-date, we're confident our emerging therapies business can one day account for at least 20% of an RE revenue. Finally, I would like to discuss another record quarter in our international business, Revenue of $11.5 million was up 76.4% versus the prior year. Strength was primarily driven by adoption of our solutions in Europe. In LATAM, we recently received regulatory approval for FlowTriever in Brazil and are in the early stages of our launch in that market. We're also making continued progress on our expansion efforts into both China and Japan. In China, we've been hard at work for two years to gain regulatory clearance for ClotTriever and FlowTriever. Of late, in conjunction with the National Medical Products Administration, we ran a 25-patient study for clot fever in China. We're excited that we've recently completed that study and have submitted the data to the NMPA. We're now finalizing our go-to-market strategy, and we'll have more to share about that by year-end. Turning to Japan, we're pleased to announce we've obtained PMDA regulatory approval for our clot fever device, and are seeking reimbursement approval later in Q4. Looking ahead, our next step in Japan will be in the form of a post-market study of approximately 100 patients, supported by our recently established distribution agreement in Japan. In conclusion, we're excited about the progress we're making internationally and expect total international sales to one day account for at least 20% of Inari revenue. Before turning things over to Kevin, I'd like to highlight as we always do, a patient story that demonstrates the impact of our technology and highlights the kind of patient that makes the peerless study so relevant. A 58-year-old woman in Louisiana was admitted to her local hospital where she was determined to have an intermediate risk pulmonary embolism with large clot burden. Her physicians were familiar only with the ECOS thrombolytic procedure. Despite 11 hours of lytic infusion in the ICU, her improvement was only marginal. Given that she had completed the recommended treatment, she was discharged home with the hope that she would recover on oral anticoagulation. Unfortunately, that same evening, she was taken to a different hospital with persistent symptoms of trouble breathing and passing out. Her CT scan showed no change in her clot burden from before. This hospital, with the assistance of an art medical, had developed a comprehensive PE thrombectomy program and had several physicians well-versed in using the FlowTriever system. In a short 45-minute procedure, the patient had all of the acute and chronic thrombus removed from her lungs. The FlowSaver device was successfully used to safely return 600 cc's of the patient's own blood back to her. She was discharged home the following day and has since recovered completely. This case highlights the limitations of catheter-directed thrombolytic therapy, primarily incomplete thrombus resolution and ICU length of stay. The case also points to the need to educate more physicians about the benefits of FlowTriever, which include immediate symptom relief, rapid heart recovery, and short length of stay. These benefits are directly attributable to the FlowTriever system's unique mechanism of action, which offers both best-in-class thrombectomy and the safety of blood return. Our peerless study will directly address the thousands of patients like this one. With that, I will now turn the call over to Kevin.