Michael R. Minogue
Chairman, President and Chief Executive Officer at Abiomed
Thank you, Nicole, and good morning, everyone. In the fourth quarter, Abiomed delivered a company record of $270 million in revenue, up 12% year-over-year, with record revenue across the U.S., Europe and Japan. To note, this was a record quarter following a record Q4 last year with 17% growth and a record Q3 last quarter with 13% growth despite COVID and hospital labor shortages. In addition to reaching another record revenue month, in March, we supported more patients than ever before by executing our Abiomed 2.0 playbook. For the full fiscal year 2022, we delivered $1.032 billion in revenue, up 22% year-over-year and delivered yearly record results in a challenging environment. We achieved top-tier gross margins of 82%, revenue growth and operating margins of 22% to 25%, while investing $163 million in research and development, an increase of 34% from the prior year. As a result of our ongoing investment in innovation, our IP portfolio increased to 1,408 Impella patents with 1,416 patents pending. Our balance sheet also strengthened and we ended the year with $979 million in cash and maintain 0 debt, while funding multiple strategic investments. In fiscal year '22, Abiomed invested at record levels in innovation, advanced clinical evidence and further strengthened our premier commercial field team.
Operationally, we received regulatory approval for Impella technology in three countries. We're granted breakthrough device and Category B designation from the FDA for the Impella ECP and saw the guidelines for the treatment of cardiogenic shock patients with Impella upgraded to Class IIa by the European Society of Cardiology. We also generated 279 Impella publications, enrolled over 200 patients in RCTs and early feasibility study, and opened 646 sites globally with Impella Connect. Commercially, we hosted 20 live cases in the U.S. and Europe through our world-class interactive training platform, CAMP PCI, trained over 3,000 customers virtually and in person, launched our patient therapy awareness initiative and added 278 employees to our company. Abiomed has remained on course to become the global standard of care for circulatory support. I am proud of our customers and employees for their grit and dedication. They are the source of these impressive accomplishments during fiscal year '22. At Abiomed, we are helping to solve a health care crisis for the heart, lungs and kidneys, while helping to minimize the disruptions caused by COVID variants and hospital labor shortages. For today's call, I will highlight our leadership and innovation to create the field of heart recovery and our fiscal year '23 strategy and goals. So first, on innovation. The Abiomed product portfolio and pipeline has never been stronger. I will cover highlights on Impella 5.5, Impella ECP, Impella RP and our newest heart pump, Impella BTR. We are expanding a number of conditions and patients we can treat as we simultaneously increased the number of physicians utilizing our technology in the cath lab, surgery suite and ICU. First, the Impella 5.5 is a breakthrough product that grew 95% in the year and transformed our relationships with heart surgeons and heart failure cardiologists, who are embracing this technology around the world.
We recently announced the first Impella 5.5 with SmartAssist procedure in Japan, at Osaka Hospital, when an 82-year-old man suffered cardiogenic shock, but recovered, thanks to the Impella 5.5. In addition, we hit our 5,000th Impella 5.5 milestone when Dr. Tamer Attia at Emory University Hospital in Atlanta used Impella to treat 5.5 -- to treat a 41-year-old woman with cardiomyopathy and helped successfully bridge her to heart transplant. Impella 5.5 with SmartAssist and Impella Connect has changed how we are able to support cardiogenic shock and cardiomyopathy patients, who would otherwise have less of an option for heart recovery. We also received FDA approval for the Impella Bridge-to-Recovery, or Impella BTR early feasibility IDE study, and I'm happy to announce that the first patient enrolled is currently being supported with this breakthrough technology. The Impella BTR will provide patients a minimally invasive, forward flow, smart heart pump with the potential to allow home discharge and durability of over one year. Between the Impella 5.5 and BTR, Abiomed projects a USD four billion total addressable market based on an additional 100,000 U.S. patients. Impella ECP is another breakthrough technology. Its nine French size may enable more physicians to provide critical hemodynamic support to coronary artery disease patients enabling safer PCI procedures and more complete revascularization with an ultimate goal of improving their ejection fraction or heart function, now shown in PROTECT I, PROTECT II, PROTECT III and Restore EF, as well as other papers and studies in Italy, Germany and other parts of Europe.
As a reminder, our investor event on Impella ECP, including presentations from Dr. Amir Kaki and Dr. Chuck Simonton, are now available on our investor website. Turning to the right heart support. Earlier in the year, we launched Impella RP with SmartAssist in the U.S. This smart pump is the next generation of our FDA-approved right heart device with dual sensor technology and exclusive winning capability. Within the quarter, we also filed a PMA supplement for the Impella RP with insertion through the internal jugular vein, or IJ, in the neck. This insertion technique allows patients to get up and walk, while on support, also called ambulation, which improves outcomes and thus is preferred by heart surgeons. Like a flywheel, the excitement and energy from our innovation drives momentum and interest in our products and their clinical data. We have exciting clinical trials underway, including PROTECT IV and STEMI DTU. PROTECT IV will be the most extensive study ever done in the cath lab, not just on high-risk PCI, but on PCI overall, and will lay the foundation with success for a Class I guideline. Each year, there are over 100,000 patients in the cath lab that are staged for multiple PCIs or receive incomplete revascularization or suffer acute kidney injury or are readmitted to the hospital within 90 days. Additionally, there were over 300,000 patients in the U.S. each year that are turned down for CABG surgery and not referred to an interventional cardiologist or PCI. In a 2020 study published in circulation heart failure, authors reviewed testing for coronary artery disease in older patients with new onset heart failure and found that 61% of patients hospitalized with this condition did not receive testing for coronary artery disease, either during the index hospitalization or in the 90 days before or after admission. This data highlights an opportunity to improve care by identifying appropriate candidates for optimal CAD medical therapy and revascularization. As a reminder, our PROTECT II and PROTECT III patients, on average, are 70 years old, so relatively young and many years ahead that can benefit from the quality of life improvements with an improvement in ejection fraction.
We believe data generated from PROTECT IV in combination with educational efforts direct to patients and physicians opens up a $9 billion U.S. market opportunity for Impella-supported high-risk PCI. Finally, I would like to highlight some of our goals for fiscal '23. First, we will continue to innovate smaller, smarter and more connected devices to improve outcomes and ease of use. To be clear, the reason smaller devices are important is because they lower the risk of bleeding and vascular complications, which we believe will increase Impella utilization, especially with the late majority. Second, coming out of COVID, we plan to accelerate enrollment in key clinical studies, prioritizing Impella ECP Pivotal, STEMI DTU and PROTECT IV. And last, in leading the field with clinical publications, like PROTECT III and Restore EF that add to our extensive prospective database of real-world evidence. PROTECT III and Restore EF demonstrate that the new tools and techniques that physicians with expertise utilize allow for a proven improvement in their clinical outcomes with an improvement in their ejection fraction at 90 days. Lastly, we remain focused on commercial excellence, including engagement with the heart team, physician education and patient identification for multiple FDA-approved indications. Our patients-first culture remains the foundation of our success. So before concluding, I'd like to share a patient story. Bobby Goins, 31, a father, husband and sales representatives from Conway, Arkansas, lives an active lifestyle. When he is not working at his computer, Bobby can be found renovating his home, riding bikes with his three kids and playing on his men's softball league. Bobby tested positive for COVID-19 in early January '22, and within days, he experienced shortness of breast and chest pain. He called 911. He was transported by ambulance to the local hospital. Medical teams evaluated Bobby and determined his heart was severely weak. He was transported to St. Vincent in Little Rock, Arkansas, for escalated care.
Upon arrival, physicians identified that Bobby was in cardiogenic shock due to myocarditis with a severely low ejection fraction of below 10%, a life-threatening condition. Dr. Thurston Bauer implanted Impella 5.5 to support his heart and allow it to rest. Bobby's condition improved, and he was able to walk in the unit while on Impella support. After eight days, Impella was weaned and removed. Bobby returned home to his family and today has normal heart function. Bobby is back at work and enjoying time with his wife, Carly, and their children. Just months after this life-threatening condition, I got to meet Bobby as he visited Abiomed Headquarters in early April as a guest speaker to share the story of heart recovery to all our employees at our global annual company meeting. In conclusion, as we start fiscal year '23, Abiomed has flywheel momentum. Our innovation has never been better. Our clinical evidence is established, and we have the premier commercial organization. Our Abiomed 2.0 playbook allows us to adapt and execute and lead and manage and focus on improving patient outcomes as we pursue the ultimate goal of being the global standard of care. I am thankful for our employees and customers' courage, dedication and leadership during fiscal year '22. I will now turn the call over to our CFO, Todd Trapp.