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Biotech / Medical : ABMD - Replacement Heart System
ABMD 183.86-1.5%2:15 PM EST

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From: tech10111/1/2019 4:29:51 PM
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Abiomed Announces Q2 FY 2020 Revenue of $205 Million and 29.4% Operating Margin



Business WireOctober 31, 2019

DANVERS, Mass.--(BUSINESS WIRE)--

Abiomed, Inc. ( ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported second quarter fiscal 2020 revenue of $205.0 million, an increase of 13% compared to revenue of $181.8 million for the same period of fiscal 2019. Operating income was $60.2 million, up 20%, compared to $50.3 million in the same period of fiscal 2019.

Financial and operating highlights for the second quarter fiscal 2020 include:

  • U.S. revenue totaled $172.0 million, an increase of 9% compared to revenue of $158.2 million during the same period of fiscal 2019 with U.S. patient usage of Impella heart pumps up 14%. In the second quarter, we opened 62 new sites, compared to 135 sites in the prior year, which impacted our U.S. growth rate by $3 million in revenue, or approximately two points of growth.
  • Outside the U.S., revenue totaled $33.0 million, an increase of 40% compared to revenue of $23.5 million during the same period of fiscal 2019. Specifically, Japan revenue was $9.6 million in the quarter, up 135% compared to the same period of fiscal 2019.
  • Gross margin was 83.0% compared to 83.6% during the same period of fiscal 2019.
  • Operating income was $60.2 million, or 29.4% operating margin compared to $50.3 million, or 27.7% operating margin in the same period of fiscal 2019.
  • GAAP net income was $13.1 million, or $0.28 per diluted share, which includes a $34.5 million, or $0.75 per share, unrealized loss from our investment in Shockwave. This compared to GAAP net income of $50.1 million or $1.09 per diluted share for the prior fiscal year, which benefited from $12.9 million, or $0.28 per share, of excess tax benefits.
  • The company generated operating cash flow of $74.3 million in the second quarter and $138.9 million year to date, an increase of 30% versus prior year. As of September 30, 2019, the company had $551.3 million of cash and marketable securities and maintains no debt.
  • On September 23, the company announced that the highest court in Germany, the Federal Court of Justice, ruled in favor of Abiomed in a patent challenge, specifically around the pigtail and design for insertion, filed by Thoratec in 2015, validating the strengths of Abiomed’s Impella-related patents. Abiomed has invested more than $500 million and 20 years of research and development for Impella and owns a robust world-wide portfolio of 715 patents and 622 patents pending, covering all aspects of its existing and future products.
  • On September 25, the company announced that the Impella 5.5 with SmartAssist received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is a minimally invasive, forward flow, fully unloading heart pump designed for heart surgeons, implanted via axillary artery or direct to the aorta.
  • On September 26, the company announced the results of PROTECT III, the ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. PROTECT III follows the PROTECT II Randomized Controlled Trial (RCT). The findings of this interim analysis on 898 patients demonstrates a reduction in the primary endpoint of death, stroke, myocardial infarction and repeat procedures at 90 days with Impella-supported Protected PCI, compared to PROTECT II.
  • On September 27, the company announced that data presented from the National Cardiogenic Shock Initiative Study (NCSI) on 250 consecutive AMI cardiogenic shock patients from 49 sites demonstrates 72% survival at discharge with 98% native heart recovery. The patients were treated with the NCSI protocol, which includes placing Abiomed’s Impella heart pump before revascularization via percutaneous coronary intervention (PCI). Investigators also now plan to institute new escalation protocols that will be applied in the cath lab immediately after Impella-supported PCI in order to further increase patient survival and native heart recovery.
  • On October 7, the company announced that the 1,000th patient has been treated with the Impella heart pump in Japan. Procedural outcomes data, available on the first 580 Japanese cases, demonstrates improvements in AMI cardiogenic shock and myocarditis survival rates during the procedure, compared to traditional therapies. The protocols used to introduce Impella in Japan were developed based on best practices learned from the experience treating patients in Europe and the United States, including the National Cardiogenic Shock Initiative, the Impella Quality (IQ) Database and the cVAD Study.
  • On October 25, the company announced that the FDA Post Approval Study demonstrates timely identification of right heart failure and early use of Impella RP leads to higher survival. When physicians followed the FDA’s approved protocol for Impella RP use they achieved 72% patient survival and 88% native heart recovery. These results, from the Impella RP’s post-approval study, match the survival rate in the Impella RP’s pre-approval study.
  • Today, the company announces the first U.S. patients treated with Impella 5.5 with SmartAssist. The first 10 patients were treated at the Cleveland Clinic, Hackensack Meridian Health and Cedars-Sinai Medical Center in Los Angeles. The Impella 5.5 with SmartAssist is being introduced in the U.S. through a controlled rollout at hospitals with established heart recovery protocols.
  • “We are pleased that this quarter demonstrated our ability to leverage best practices and support strategies to improve clinical outcomes overall for high risk PCI, cardiogenic shock and right heart failure,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed, Inc. “We have made progress on our key initiatives in the quarter, but we still have more work to do. Our innovation and ability to improve clinical outcomes remains the driver for Impella adoption through a function of training, data and time.”

    FISCAL YEAR 2020 OUTLOOK

    The company is maintaining its fiscal year 2020 guidance for total revenue to be in the range of $885 million to $925 million, an increase of 15% to 20% over the prior year. The company is also maintaining its fiscal year 2020 guidance for GAAP operating margin to be in the range of 28% to 30%.

    EARNINGS CONFERENCE CALL DETAILS

    The company will host a conference call to discuss the results at 8:00 a.m. EDT on Thursday, October 31, 2019. The conference call releasing full quarterly results will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

    To listen to the call live, please tune into the webcast via cts.businesswire.com or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11:00 a.m. EDT October 31, 2019 through 11:00 a.m. EST on November 7, 2019. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 7594662.

    ABOUT ABIOMED

    Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Impella Connect are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and SmartAssist are pending trademarks of Abiomed, Inc.
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