ABIOMED, Inc.

And good day and thank you for standing by. Welcome to the Q1 2022 Abbeel Med, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Todd Trapp, Chief Financial Officer. Please go ahead.

Good morning, and welcome to Abbeymed's first quarter fiscal year 2022 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 first quarter business and operational highlights, and then I will review our financial results, which were outlined in our 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 in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Reconciliation between GAAP and non-GAAP results are presented in the tables in our earnings release. Finally, I would like to remind everyone today, this 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 obligation to update forward-looking statements. With that, let me turn the call over to Abumed's Chairman, President, and Chief Executive Officer, Mike Minogue. Thanks, Todd.

Good morning, everyone. AbbVieMed reported a strong start to our fiscal year 22 with global record revenue and record patient utilization in the U.S., Europe, and Japan. In Q1, we delivered revenue of $253 million, up 53% versus prior year, and up 5% versus prior quarter. Within the quarter, we achieved a 26.2% non-GAAP operating margin while continuing to invest with a focus on extending our lead in innovation, advancing clinical evidence, and building a premier commercial team. Our balance sheet remains robust with $805 million in cash and zero debt while acquiring Precardia, a heart failure company. We grew our IP portfolio to 1,216 Impella patents and over 1,000 patents pending. We have maintained our disciplined execution on our strategic goals and Abiumed 2.0 continues to drive our success. I am proud of our employees for their continued hard work and dedication to our patients and mission of recovering hearts and saving lives. On today's call, I will highlight progress on our product innovation milestones for Impella 5.5 and RP, the regulatory status for Impella ECP, and briefly discuss our strategy to be the leading company for all cardiologists and heart surgeons at every heart hospital, which means they have a cath lab and a surgical suite. Beginning with innovation, the Impella 5.5 with Smart Assist continues to perform very well. In the quarter, our US surgical revenue grew 115% year over year and 17% versus prior quarter as we expanded this life-saving device to 46 more sites or 257 sites out of the 1,113 heart hospitals in total. Impella 5.5 is a revolutionary product. It does not require a sternotomy or coring of the left ventricle, and it is a forward flow, fully unloading, weanable heart pump designed for heart surgeons to implant in less than 60 minutes via the axillary artery in the shoulder. The minimally invasive implant also allows for early ambulation for the patient, which correlates to faster recovery and better outcomes. The longer usage time for the Impella 5.5 allows the SmartAssist software to track aortic pressure, left ventricular pressure, make predictive analysis on volume and right heart stability, and communicate in the cloud with Impella Connect. We look forward to continuing to roll this device out to the remaining 856 heart hospitals in the U.S. and many more outside the U.S. We also received FDA premarket approval for the Impella RP with SmartAssist as safe and effective to treat acute right heart failure. This smart pump is the next generation of right heart support and already has exclusive weaning capability and FDA approval for right heart failure with multiple FDA studies and a recent emergency use authorization for COVID patients with pulmonary embolism. It is the first single venous access percutaneous heart pump with a sensor for the right ventricle. The sensor technology provides real-time guidance and trends that help with pump management and weaning. Much of this groundbreaking information on the right ventricle will be published and will elucidate the field of right heart failure. The Impella CP, Impella 55, and Impella RP now all utilize smart assist software enhanced with Impella Connect to enable remote monitoring from any internet connected device through a secure HIPAA compliant website. The Impella Connect software is now live at more than 80% of our U.S. sites and approximately 80% of our U.S. patients on support are monitored in the cloud. No other company in this space offers this capability or 24 by 7 service to the hospital, which is ideal with COVID. We also continue to accelerate the rollout of Impella Connect in Germany and Japan. Next, we remain ahead of schedule on our Impella ECP early feasibility study, EFS. Impella ECP is the world's smallest heart pump and measures nine French in diameter, easing insertion and removal from the body. This allows for a smaller active site, optimal for protective PCI, which we believe will continue to drive better outcomes and overall utilization. To date, we have achieved our initial FDA study milestones, enrolled 25 patients, and submitted additional clinical data to the FDA for review. We plan to expand this breakthrough technology to new sites with product enhancements already implemented in the EFS process to up to 50 patients. In parallel, Based on our interaction with the FDA, we have started to prepare the details of the single-arm pivotal Impella ECP high-risk PCI study. Next quarter, we expect to confirm our IDE protocol and submit for approval with the goal to enroll our first pivotal patient for high-risk PCI by the end of our fiscal year. We want to compliment the FDA for this EFS program overall, which allows for faster innovation, real-time safety feedback, and accelerated access to new technology for U.S. patients. Finally, our strategy to become the leading player for the heart team, which includes interventional cardiologists, heart failure cardiologists, intensivists, and heart surgeons grows stronger. Our breakthrough platform now includes the Impella portfolio, ECMO with Breathe, ECPELLA, and recently acquired Precardia. Precardia was designated by the FDA as a breakthrough technology and will complement our existing product portfolio increase options for patients with acutely decompensated heart failure, called ADHF, and expand our relationship with heart failure specialists managing the ICU. Heart failure is the leading cause of hospitalization in patients older than 65 years of age, and we believe this device has the potential to be a revolutionary tool for the treatment of millions of patients in early stage ADHF. a new patient population for Abiumed. This strategic acquisition in combination with our continued Impella 5.5 success and our future Impella BTR pump marks our movement towards minimally invasive devices for the heart failure community, including our hub and spoke hospital network in every region of the country. To further enhance these clinical efforts, we continue to invest in commercial excellence with a focus on the broader heart failure community and the referral network. Specifically, we began our direct outreach referral programs that we expect will better identify the undertreated high-risk PCI patient population of 440,000 U.S. patients. We continue to deliver best-in-class training and education by leveraging Camp PCI and transition to both virtual and on-site settings. We have seen physician traction on our educational platform through events such as live cases and advisory boards and are excited to expand Camp PCI internationally as well as at Camp Heart Failure and Camp Heart Surgery this fiscal year. Before I conclude, I would like to share an inspiring patient story. John Fisher, 77, is a husband, grandfather, and retired law enforcement officer from Ashland, Ohio. John has been experiencing chest pain for more than a year, had been. When the chest pain became more severe following his recovery from COVID-19, he decided to seek treatment. After an evaluation... John was diagnosed with coronary artery disease and evaluated for coronary artery bypass surgery called CABG surgery. Due to a low ejection fraction of 15% and multiple comorbidities, including type 2 diabetes, John was turned down for surgery. Interventional cardiologist, Dr. Atush Mathur, determined John was a candidate for protective PCI with Impella. Dr. Mature inserted the Impella CP with Smart Assist while he performed a complete revascularization. John returned home six days later. Today, his heart function is normal with a current EF of 55%, and he enjoys walking his dogs, woodworking, and spending time with his grandson, who happens to work at Abiomed in headquarters. In closing, we will continue to create and deliver value by successfully advancing our innovation, clinical research, and commercial distribution. We remain steadfast to our mission of creating the field of heart recovery and driving a new standard of care for multiple growing patient populations around the world. Q1 was a solid start. and we believe we are well positioned for success in fiscal year 22. I would like to thank our employees and customers for their dedication to the mission of recovering hearts and saving lives, and we appreciate the ongoing support of our shareholders. I would like to now turn the call over to Todd Trapp, our CFO.