ABIOMED, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the fourth quarter 2021 ABIOMED Earnings Conference Call. At this time, all participant lines are in listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you would need to press star then one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star then zero. I would now like to hand the conference over to Todd Trapp. Please go ahead.

Todd Trapp Thanks, Sarah. Good morning, and welcome to Abbeymed's fourth quarter 21 earnings conference call. This is Todd Trapp, Vice President and Chief Financial Officer, and I'm here with Mike Minogue, Abbeymed's Chairman, President, and Chief Executive Officer. The format for today's call will be as follows. First, Mike will discuss fourth quarter business and operational highlights. and then I will review our financial results, which were outlined in today's press release. After that, we will open the call to your questions. Before we begin, I would like to remind everyone that today's call includes forward-looking statements. The company cautions investors that any forward-looking statements involves risks and uncertainties and are not guaranteed in the future. Actual results may differ materially due to a variety of factors identified in our earnings press release and our most recent 10-K and 10-Q filed with the SEC. We do not undertake any obligations to update forward-looking statements. With that, let me turn the call over to Abumrad's Chairman, President, and Chief Executive Officer, Mike Minogue.

Thanks, Todd. And good morning, everyone. Throughout the COVID-19 pandemic, Abiy Ahmed has remained on course to advance our innovation and become the standard of care for circulatory support. We adapted and executed while successfully transitioning from our red, yellow, and green phases to Abiy Ahmed 2.0. The 2.0 marks our transformation into a smarter and more connected online medical device company with a COVID playbook. We conduct on-site and online training and education and provide patient support with smart algorithms to track real-world utilization in the cloud, identify best practices, and optimize patient care. For the quarter, AbbVieMed delivered a company record of $241 million in revenue, up 17% year-over-year. with double-digit growth and record revenue across the U.S., Europe, and Japan. Within the quarter, we saw monthly sequential improvement in both global revenue and patient utilization. Q4 investments continued while achieving a 26% gap operating margin. Applying our Aviamed 2.0 COVID playbook, we definitively transitioned to the green phase validated with record number of patients supported in a quarter, in a month, in a week, and in a day, all in Q4. Turning to the full fiscal year, Abiumed delivered $848 million in revenue, up 1% year-over-year, and 27% operating margin despite the COVID-19 pandemic. We took a disciplined approach to the fiscal year to help us navigate the uncertain environment and achieve our tactical plan. Over the past year, we endured the setbacks of COVID-19 and focused on keeping employees safe, making life-saving heart pumps and supporting our hospitals and patients. We controlled expenses and invested in innovation, new clinical studies and expanded distribution while remaining fiscally responsible. Our balance sheet strengthened to $848 million in cash while maintaining zero debt and acquiring an ECMO platform. In addition, our IP portfolio increased to 1,150 Impella patents and 940 patents pending. We achieved a significant number of regulatory approvals and established world-class online training and education with TAMP PCI. At Abiomed, our Patients First mindset gives us purpose and courage, and we always seek opportunities to lead, manage, adapt, and execute. For this fiscal year, I would like to thank our employees and customers for their courage, dedication to patients, and leadership throughout the pandemic. We exited the year slightly up in revenue, profitable, and stronger than ever before. For today's call, I will highlight our fiscal 21 innovation that will drive our success and momentum into our fiscal year 22 goals and beyond. In fiscal year 21, AvioMed launched revolutionary innovation across multiple patient populations, starting with the accelerated rollout of Impella Connect, our remote monitoring capability, allowing us to go live at nearly 1,000 hospitals in the U.S., Currently 70% of our patients are monitored in the cloud with Impella Connect. No other company in our space provides this level of 24 by seven onsite on-call and online support. This is particularly meaningful in the COVID environment. We have also expanded our global footprint with Impella Connect at 29 hospitals in Germany and 49 hospitals in Japan. Next, The Impella 5.5 with SmartAssist continues to deliver strong results. Within the quarter, our U.S. surgical revenue grew 46% year-over-year as we expanded this device to 53 more sites, totaling 211 sites. For the full fiscal year, U.S. surgical revenue grew 44% year-over-year, driven by strength in patient utilizations. The Impella 5-5 is a revolutionary product because it is minimally invasive, provides forward flow, and is a fully unloading heart pump designed for heart surgeons. It is inserted via the axillary artery or directly into the aorta and designed for longer duration support with patient ambulations. The Impella 5-5 has reported comparatively higher survival rates and native heart recovery for the acutely decompensating heart failure patient population, representing an additional 100,000 treatable U.S. patients. Heart surgeons are also enthusiastic about our BTR heart pump first in human experience, expected in the fourth quarter of this fiscal year. Turning to our Abimed Breathe OxyOne system, we have now treated 20 patients to date at several sites. In March, I visited our Breathe facility in Baltimore and met a Breathe ECMO patient on support at the nearby University of Maryland Medical Center. The feedback from physicians on this innovative, compact cardiopulmonary bypass system has been positive. Customers highlight the ease of use with the simple, intuitive interface and the light, portable design allowing for ambulation. We will continue to innovate and plan to optimize this technology with smart Expella software and connected cloud monitoring. Moving on to our regulatory progress, we advanced our U.S. FDA early feasibility study for the Impella ECP, a true nine French heart pump. As a reminder, in early Q4, we received FDA approval for the expansion of the early feasibility study to 20 patients and have enrolled 10 patients to date. The excitement for PROTECT4 is palpable in the heart failure community, and we recently announced our first patient enrolled at Ascension St. John Hospital in Detroit. It is important to note that PROTECT4 was designed by the leaders and best clinical trialists in the field of cardiovascular medicine. It is an on-label, prospective, multicenter, randomized controlled trial that is designed to provide the level of clinical evidence needed to achieve a global Class I guideline recommendation for Impella and high-risk PCI in the future. The intent of PROTECT IV RCT is to leverage and validate the best practices that we have learned over the past 10 years in the PROTECT series and CVAD studies that led to the exclusive FDA PMA approval of Impella for high-risk PCI. We believe the heart failure communities engagement will propel the PROTECT4 study to be a landmark trial for high-risk PCI overall as a new treatment alternative. In the past, we have defined our current addressable market for high-risk PCI as 121,000 U.S. patients. As a result of the PROTECT4 study, we are directly investing this year in outreach referral programs that we expect will better identify the undertreated population of an additional 319,000 high-risk PCI patients that are termed down for surgery and not referred for protected PCI treatment due to not being diagnosed or tested for coronary artery disease. Since the PROTECT4 study is on label, and spans the heart team, we now estimate our new U.S. addressable patient population for high-risk PCI to be 440,000 patients. For context, 15 million people in the U.S. have coronary artery disease and heart failure, and it causes approximately 1 million deaths per year. Coronary artery disease and heart failure remains the leading cause of death overall. and is the number one cause of death for people with type 2 diabetes. While we will not complete this study in fiscal year 22, we now have line of sight and a path forward to solidify the new standard of care for high-risk PCI with the goal of complete revascularization and improvement in patient quality of life and ejection fractions. Finally, I want to highlight some of our goals for Abimed 2.0 fiscal 22 and beyond with investments focused on extending our lead in innovation, advancing Impella clinical evidence, and establishing commercial excellence with a premier distribution team. First, we will continue to invest in R&D as we innovate best-in-class heart and lung support technologies that are smaller, smarter, and connected to improve ease of use and clinical outcomes. Second, we plan to execute multiple RCTs, including STEMI DTU, PROTECT IV, and ADVANCE the RECOVER IV cardiogenic shock design with the goal of achieving Class I guidelines overall. In addition, we expect to further validate the safety and efficacy of Impella and the importance of complete revaccination in high-risk PCI with the publications of Protect 3 and Restore EF. For cardiogenic shock, positive clinical results presented yesterday at the SCIE scientific sessions for the physician-initiated National Cardiogenic Shock Initiative will be published. Separately, the positive results presented by the MHLW-PVAD Japanese Heart Committee will also be published. Because these cardiogenic shock patients are difficult to randomize and consent, our best practice protocols are derived from over 10 years of real-world evidence and over 100,000 patients with physician-initiated and prospective FDA and PMDA studies in the U.S., Europe, and Japan. This new paradigm focuses on improved survival and native heart recovery. And finally, through a combination of our U.S. distribution expansion and leveraging Camp PCI, we plan to deliver best-in-class training and education on-site and online with the goal of identifying patients, improving outcomes, and driving Impella adoption. Before I conclude, I want to share a patient story. Chris Kirkman, a 48-year-old husband, father, and sales director from Zachary, Louisiana, has a family history of heart disease and has lived with hypertension for 20 years. In December 2020, after experiencing shortness of breath, fluid buildup around his abdomen, and difficulty sleeping, Chris visited a local emergency clinic. He was prescribed medication and sent home. Chris's symptoms gradually became more severe over the next few months. When he experienced trouble breathing, Chris's wife drove him to the local hospital where he was diagnosed with advanced coronary disease and congestive heart failure with poor ejection fraction at 20%. He was told he was too high risk for bypass surgery and discharged home with a wearable defibrillator. Chris was then referred to interventional cardiologist Dr. Abraham at Baton Rouge General Blue Bonnet. Dr. Abraham identified Chris as an appropriate candidate for protected PCI with Impella. When he returned for the scheduled procedure, Dr. Abraham successfully achieved complete revaccination with the help of Impella CP heart pump, and Chris was discharged home the next day. During his follow-up exam, Chris' ejection fraction improved to 45%. Today, Chris is thankful to be back at work and enjoying a healthier lifestyle with his wife and three children. In conclusion, I'm very proud of our employees and customers for their dedication and courage during the COVID pandemic. Despite the challenging circumstances on both professional and personal levels, Aviamed 2.0 delivered one of our most productive fiscal years in my 17-year tenure as CEO. I am confident that Aviamed will not just be a successful company, but will drive a new standard of care for multiple growing populations of high-risk heart failure patients around the world. We look to the new fiscal year with great excitement because we are a stronger company today and have a clear path for execution to fulfill our heart recovery mission. And last, we sincerely appreciate the continued support from our patients, customers, and shareholders. I will now turn the call over to Todd.