2021 Annual Report Abiomed Fy 2021 Annual Report Annual 2021 Fy
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FY 2021 ANNUAL REPORT ABIOMED FY 2021 ANNUAL REPORT I AM ABIOMED I AM HEART RECOVERY 81% $848 82% $651 83% $513 83% 18 19 20 21 $400 Gross Margin Gross DOLLARS IN MILLIONS IN DOLLARS Net Cash Balances* 17FY 84% $277 17 18 19 20 21 FY 16 $848 +1% $230 $841 +9% $249 $769 +30% $225 $594 +33% 18 19 20 21 $157 DOLLARS IN MILLIONS IN DOLLARS DOLLARS IN MILLIONS IN DOLLARS Total Revenue Total 17 18 19 20 21 $445 +35% 17FY $90 GAAP Operating Income Operating GAAP FY Fiscal Year Ends March 31st Ends March Fiscal Year FY 2021 - COVID YEAR - COVID FY 2021 FINANCIAL PERFORMANCE * Net cash balances are defined as total cash, short-term and long-term marketable securities. The Company currently has no debt. 1 996 940 1,150 789 720 850 568 541 653 18 19 20 21 470 311 317 18 19 20 21 411 241 274 PATENTS PENDING PATENTS Total Impella Publications Total FY 17 FY 17 Total Abiomed Patent Portfolio Abiomed Patent Total $122 1,509 21 $99 1,441 $94 1,362 DEVICE PROGRESS ® 18 19 20 21 $75 1,197 18 19 20 DOLLARS IN MILLIONS IN DOLLARS $66 1,138 Sites Impella U.S. Total FY 17 FY 17 Research & Development Spend & Development Research IMPELLA YEAR - COVID FY 2021 31st Ends March Fiscal Year FY21 HIGHLIGHTS Q1 Q2 4/29/2020 5/27/2020 7/16/2020 Abiomed Expands Abiomed Hosts Virtual FDA Approves Data Product Portfolio with Clinical Data and Streaming from the Acquisition of Cardio- Innovation Day Impella Console, pulmonary Support Setting the Stage for Technology (ECMO) Artificial Intelligence 6/01/2020 Algorithms FDA Issues 6/05/2020 5/19/2020 EMERGENCY USE FDA Approves PROTECT III Sub-study AUTHORIZATION Abiomed’s Shows Placing Impella for Impella RP® as First-in-Human Trial Prior to High-Risk PCI Therapy for COVID-19 of Impella ECP™, is Associated with Patients with Right Lower Mortality WORLD’S Heart Failure and Compared to SMALLEST Pulmonary Embolism Bailout PCI HEART PUMP 7/30/2020 90 DAY MACCE: Large Multi-Center PROTECT III 6/16/2020 Study in Japan Finds PROTECT II-LIKE Abiomed Launches 77% SURVIVAL p<0.0001 Online Virtual AND OVER 90% Physician Education p=0.03 NATIVE HEART Program, CAMP PCI 31.0% p=0.035 RECOVERY IN SURVIVORS FOR CARDIOGENIC 21.9% SHOCK 15.0% Impella 2.5/CP 8/4/2020 Impella 2.5 FDA Issues Emergency IABP Use Authorization for Impella® Heart Pumps N=210 N=215 N=373 to Provide Unloading PROTECT II PROTECT III Therapy to COVID-19 Protect II-like Patients on ECMO MACCE: Death, Stroke, MI, Repeat Revascularization *Dangas et al. Am J Cardiol. 2014;113:222-228 and Impella N=Number of patients with 90-day follow-up 2 Q3 Q4 10/28/2020 12/5/2020 1/7/2021 FIRST The Impella ECP™ Abiomed Continues PATIENTS Heart Pump to Strengthen its TREATED Completes the First Intellectual Property Stage in its FDA Early with More Than with the Feasibility Study 1,000 Patents 10/08/2020 World’s Smallest TCT Connect Heart Pump, the Presentations Highlight 9FR 12/5/2020 how Impella® Enables IMPELLA FDA Grants 510(k) Improved Outcomes ™ ECP Clearance to the for High-Risk PCI, XR™ Sheath for Cardiogenic Shock Impella 2.5® and Right Heart 11/5/2020 Failure Patients FIRST 1,000 12/21/2020 PATIENTS 10/26/2020 TREATED First Patients, with Impella 5.5® Including a FDA Grants 510(k) 1/29/2021 ® COVID-19 Patient, Clearance for with SmartAssist Treated with Abiomed’s Innovative Large Clinical Abiomed’s Innovative Cardiopulmonary Study Presented ECMO Technology Support Technology at STS 2021 Finds the Abiomed Breethe 79% SURVIVAL Oxy-1 System™ RATE WITH IMPELLA 5.5® WITH SMARTASSIST® for Cardiogenic Shock Heart Failure Patients 3 I am Abiomed. I am Heart Recovery. Together with my teammates, we put Patients First and are committed to recovering hearts and saving lives. We sustain our winning culture by acting with honor and integrity in all that we do. We are dedicated to ensuring that Abiomed’s growth as the standard of care is based on innovation, improving outcomes and appropriate use. We advocate for every patient to receive the care we desire for our own family and friends, and we recognize the potential benefits of other products and treatments. We inspire each other and have the courage and grit to explore new ideas and approaches that can change the world. We work together to achieve our goals and demand the best of ourselves. We are dedicated to continuous improvement and strive for perfection. And we always seek opportunities to lead, manage, adapt and execute. I am Abiomed. Patients First! 4 5 CHAVEZ ADAMS HOLLY SPRINGS, NC IMPELLA CP® WITH SMARTASSIST® 6 Chavez Adams, a 29-year-old husband and lawyer, tested positive for COVID-19 in August 2020. He experienced flu-like symptoms and made a full recovery. Six weeks later, Chavez developed a fever and decided to seek treatment at his local urgent care clinic. Recognizing Chavez’s heart rate was dangerously high, the urgent care nurse sent him to WakeMed Health in Raleigh, North Carolina, for escalated care. Chavez was admitted with a weak heart and ejection fraction of less than 20%. Once in the catheterization lab, Dr. Saroj Neupane quickly identified that Chavez had myocarditis due to COVID-19 and was in cardiogenic shock. He placed the Impella CP® with SmartAssist® heart pump to support Chavez’s heart. Chavez continued to improve and regained his strength. After three days on support, Impella CP with SmartAssist was weaned and explanted. Chavez returned home with his native heart, and today he has normal heart function with an ejection fraction of 60%. Chavez is back to working full-time, exercising 4-5 times a week and looks forward to traveling again with his wife, Ashlea. Due to Chavez’s cardiogenic shock, it was crucial to implant the Impella CP with SmartAssist to support his heart and allow it the opportunity to recover. It warms my heart to see Chavez survived COVID-19 and has returned to his active lifestyle. — DR. SAROJ NEUPANE 7 KERRI BRYLES ST. LOUIS, MO IMPELLA 5.0® 8 Kerri Bryles, 45, a mother, wife and pharmacist, always led a healthy lifestyle and loved participating in boot camp workouts. In November 2020, Kerri’s husband, Tim, tested positive for COVID-19. Shortly after, Kerri began feeling ill and noticed her oxygen levels were low. She decided to seek treatment at a local hospital where she tested positive for COVID-19. The hospital was at capacity due to the coronavirus pandemic and transferred Kerri to St. Luke’s Hospital in Chesterfield, Missouri. The medical team discovered Kerri was in cardiogenic shock due to heart-related issues driven by COVID-19. She also had torrential mitral regurgitation. Dr. Jeremy Leidenfrost determined Kerri’s heart needed support and placed the Impella 5.0® heart pump. Kerri’s condition improved, she regained strength, and Impella 5.0 was removed after five days on support. Physicians performed a mitral valve replacement and on December 18, 2020, Kerri returned home with normal heart function and was reunited with her children. Kerri is now back to her boot camp workouts and her busy routine as a mom. Kerri was COVID-19 positive when we identified she had torrential mitral regurgitation. With the help of Impella, our team was able to send her home to her family with her native heart. It is a true joy to see Kerri now thriving with her husband and three children. — DR. JEREMY LEIDENFROST 9 JAY RHONE LANDOVER, MD ABIOMED BREETHE OXY-1 SYSTEM™ 10 Jay Rhone, 47, is a devoted family man, retired Marine and ambulatory services nurse at the Pentagon in Arlington, Virginia. In January 2021, Jay was experiencing severe shortness of breath when his wife called 911. Jay was rushed to a local hospital and the medical team determined he had a pulmonary embolism. Jay was transferred to the University of Maryland Medical System for treatment and Dr. Bartley Griffith placed Jay on veno-arterial extracorporeal membrane oxygenation (VA ECMO) with the Abiomed Breethe OXY-1 System™. Jay’s condition began to improve and he was able to walk around the hospital daily while on support. With Jay stabilized while on Breethe, Dr. Griffith determined his lung clots had acute-on-chronic origins and required surgical removal. After surgery, Jay made a full recovery and was successfully weaned off support after six days. Today, Jay has returned to work and enjoys time with his wife and three children. The Abiomed Breethe OXY-1 System allowed us to treat Jay with a revolutionary technology that facilitated early mobilization and physical rehabilitation, which was critically important in his recovery and allowed him to return home to his family earlier. — DR. BARTLEY GRIFFITH 11 ROSIE COLEMAN LITTLE ROCK, AR IMPELLA 5.5® WITH SMARTASSIST® 12 Rosie Coleman, 64, a retired executive director of elementary education in Arkansas, lives an active lifestyle. In November 2020, Rosie began experiencing shortness of breath and was diagnosed with pneumonia. She decided to seek treatment at the University of Arkansas for Medical Sciences (UAMS) Medical Center in Little Rock, Arkansas. The medical team diagnosed Rosie with congestive heart failure with an ejection fraction of 20% and recommended her for coronary artery bypass grafting (CABG) surgery. On December 11, 2020, Dr. Jay K. Bhama, cardiac surgeon and chief of the division of cardiovascular surgery at UAMS, performed a high-risk quadruple bypass surgery and repaired her tricuspid and mitral valves.