ABIOMED, Inc.

Good day and thank you for standing by. Welcome to the Abiomed FY23Q1 earnings call. All lines have been placed on mute to prevent any background noise. Should you require any assistance, please press star zero on your telephone keypad and an operator will assist you. During today's call, there will be a question and answer session. If you would like to ask a question during this time, simply press star one on your telephone keypad. I will now turn the conference over to Nicole Nass, Head of Investor Relations. Please go ahead.

Good morning, and welcome to Abbey Med's first quarter fiscal 2023 earnings conference call. This is Nicole Nass, Head of Investor Relations, and I'm here with Mike Minogue, Abbey Med's Chairman, President, and Chief Executive Officer, and Todd Trapp, Vice President and Chief Financial Officer. The format for today's call will be as follows. First, Mike will discuss first quarter business and operational highlights and then Todd will review our financial results, which were outlined in this morning's press release. After that, we will open the call to your questions. During the call, we will discuss certain financial information on a non-GAAP basis. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered an isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Reconciliations between GAAP and non-GAAP results are presented in the tables accompanying our earnings release. Finally, I would like to remind everyone that today's call includes forward-looking statements. The company cautions investors that any forward-looking statements involve 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 thought with the SEC. We do not undertake any obligation to update forward-looking statements. With that, let me turn the call over to Abiumed's Chairman, President, and Chief Executive Officer, Mike Minogue.

Thanks, Nicole. And good morning, everyone. In the first quarter of fiscal year 2023, Abiumed delivered a company record of $277 million in revenue, up 10% on a reported basis, and up 12% in constant currency year over year, with quarterly records across the U.S., Europe, and Japan. Aviamed has achieved record revenue in five of the last six quarters, despite ongoing headwinds with COVID variants, hospital labor shortages, supply chain constraints, and most recently, contrast media shortages. Aviamed 2.0 has proven to be resilient because our technology and 24 by 7 hospital support addresses the growing epidemic of heart disease in multiple emergency patient populations in the cath lab and surgical suite. Within the quarter, we supported a record number of patients in the U.S. and had the second highest patient utilization in Europe and Japan. We remain focused on innovation and strengthening clinical evidence, investing $41 million in research and development while achieving 23.8% operating margins. Our IP portfolio continues to grow with 1,487 patents and 1,610 patents pending. We ended the quarter with just over $1 billion in cash and maintain zero debt. Additionally, this morning we announced a new $200 million share repurchase program, a component of our capital deployment strategy, upon completion of our anticipated closure of the prior $200 million plan. Our continuous strong financial and operational performance is a result of our disciplined execution of our Avimed 2.0 playbook, which enables us to innovate breakthrough technology, advance clinical research, and support record levels of patients in this dynamic environment. For today's call, I'd like to highlight the continuous strength of our surgical products driven by heart recovery with Impella 5.5, Second, we will review publications of clinical data that validate the benefits associated with Impella-supported PCI procedures. And finally, we will cover the progress we've made in our pursuit of Class 1 guidelines with multiple pivotal trials, starting with surgery. In the U.S., surgical revenue grew 49% year-over-year, driven by a 66% increase in Impella 5.5. This revolutionary surgical heart pump with Smart Assist provides unique advantages for the chronic heart failure patient population suffering from cardiogenic shock. As presented during our June investor call with Doctors Jane Wilcox and David D'Alessandro from Northwestern Memorial and Mass General Hospital respectively, this game-changing technology has improved patient outcomes with 75% survival rate across all indications and 60% of patients returning home with their native hearts. These outcomes are particularly meaningful because these patients previously faced irreversible heart failure, which ultimately would have required a durable and planable LVAD or heart transplant. I encourage all investors to watch this webcast on our investor website. In Japan, we continue to find success with our controlled rollout of the Impella 5.5 with overwhelmingly positive surgical feedback. We've witnessed survival rates and duration of support similar to that in the US in the early stages of our product launch. We anticipate the expansion of this innovation to new sites and surgeons in Japan, setting the stage for heart recovery in surgery and protocols for the future. Turning to recent clinical data, RESTORE-EF, a prospective multicenter study evaluating best practices in contemporary high-risk PCI practice, will be published later this month in JSCI. It was most recently presented as an abstract at a large cardiology meeting. At their 90-day follow-up, study participants had a 29% relative improvement in their baseline LV, left ventricular ejection fraction. an overall 76% reduction in New York Heart Association Class III and Class IV heart failure symptoms, and an overall 97% reduction in Canadian Cardiovascular Society Class III or Class IV angina symptoms. The RESTORE-EF study, combined with PROTECT-1, PROTECT-2, and PROTECT-3 FDA studies and multiple independent physician studies, demonstrate definitive proof that Impellus-supported high-risk PCI can lead to a more complete revascularization and considerable left ventricular ejection fraction improvement, which improves heart function and quality of life for the patients. AMI cardiogenic shock has one of the highest mortality rates in the field of medicine. These are patients sometimes showing up at the hospital, getting CPR, and rushed to the cath lab. The survival rate has remained approximately 50% without Impella and associated best practices for the last 20 years. Impella technology is designed to not only improve survival, but enable heart recovery. Impella best practices, such as placing Impella pre-PCI, so before the physician places stents, It's been developed by the recognized physician experts in the field of circulatory support and is published in multiple clinical studies over the last decade from the United States, Germany, Italy, Denmark, and now Japan. In May, the International Journal of Cardiology published a meta-analysis of Impella pre-PCI versus post-PCI implantation in AMI cardiogenic shock. This publication summarized 13 papers totaling 6,810 patients and demonstrated a statistically significant lower mortality with Impella implantation before the PCI or the physician-placing stents. Multiple Impella studies demonstrate greater than 70% survival with greater than 90% native heart recovery. Heart recovery after AMI-cardiogen shock improves patient quality of life and makes Impella one of the most cost-effective therapies in the CMS Medicare population as well as private insurance. Lastly, I'd like to highlight our progress towards advancing clinical evidence through multiple pivotal trials. We had a record quarter for patient enrollment for both PROTECT4 and STEMI-DTU. Starting with PROTECT4, in Q1, we enrolled 91 patients. PROTECT4 is one of the most comprehensive studies ever done in the cath lab. This landmark trial will compare the benefits of an impella-supported high-risk PCI versus high-risk PCI without impella support. Researchers will measure complete revascularization, improvement in patient quality of life, and ejection fractions. For this STEMI DTU pivotal trial, we enrolled 45 patients in Q1. If successful, this trial could expand our indications into heart attack patients without cardiogenic shock, which represents a 200,000 patient population in the U.S. and 4 million patients worldwide that we do not treat today. I'm also excited to announce that in July, we received FDA IDE approval for RECOVER4. This is an FDA randomized controlled trial comparing all-cause mortality at 30 days in patients with STEMI cardiogenic shock with an Impella-based treatment strategy initiated prior to PCI versus a non-Impella-based standard of care treatment strategy. Our teams have worked closely with the FDA to generate a protocol focused on exception from informed consent, or EPIC, which we believe will help enroll patients in what has historically been a difficult patient population to enroll due to ethical and logistical concerns. The study details are posted in our earnings slides. Our current RCTs are built off a decade of prior studies and best practices with the goal of achieving Class I guidelines, the highest level of medical guidelines for high-risk PCI, cardiogenic shock, and STEMI. If successful, we believe we'll be the only company in med tech with exclusive FDA approvals, a dedicated IP portfolio, and class one guidelines. Before concluding, I'd like to share a patient story. Ethan Bradshaw, 30 years old, is a state trooper from North Carolina. Motivated by a family history of heart disease, Ethan takes pride in living a healthy lifestyle. He exercises several times each week and is a Brazilian Jiu-Jitsu instructor. On February 24, 2022, after experiencing chest pain and numbness in his arm at the gym, Ethan drove himself to Kernsville Medical Center. Upon arrival in the emergency room, Ethan collapsed. Medical personnel shocked Ethan multiple times and performed CPR on before transferring him to Forsyth Medical Center in Winston-Salem, North Carolina. Ethan was in cardiogenic shock when he got to the catheterization lab with a reduced ejection fraction of 20%, so his heart was working about a third of its strength. Dr. Samuel Turner implanted Impella CP with Smart Assist before the PCI and placing stents. After two days of support, Ethan's heart function showed dramatic improvement, and the impellent was weaned and removed, utilizing Smart Assist. After three weeks in the hospital, Ethan returned home with his native heart. Ethan's heart function returned to normal, and in May, he returned to the line of duty. In July, five months after his heart event, Ethan and his wife Michaela welcomed a baby boy, Ryan. Today, Ethan and Michela are visiting our headquarters in Danvers, where they'll meet with employees and share their inspiring story of heart recovery as part of our annual patient summit. In conclusion, at Abiomed, we're developing a new field of heart recovery and relentlessly pursuing better clinical outcomes and class one guidelines. In Q1, we made progress toward our goals and remained focused on developing smaller, smarter, more connected devices accelerating enrollment in key clinical studies, and building commercial excellence as we continue through our fiscal year. I would like to thank our employees and customers for their commitment to advancing the standard of care and recognize our shareholders for their continued support. I will now turn the call over to Todd Trapp, our CFO.