Printer Friendly
The Free Library
19,585,950 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Abiomed Announces 16% Revenue Growth to $16.4 Million for First Quarter of Fiscal 2009.


* Impella Disposable Revenue Increased 323%

* 86 U.S. Hospitals to Date Have Purchased Impella 2.5

* 107 Patients Enrolled to Date in Impella 2.5 Protect II Study

DANVERS, Mass. -- Abiomed, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABMD ABMD areal bone mineral density
ABMD AEGIS Ballistic Missile Defense (US Navy)
ABMD Advanced Ballistic Missile Defense
) today announced first quarter of fiscal 2009 revenue of $16.4 million, up 16% compared to revenue of $14.1 million for the same period of fiscal 2008.

Recent financial and operating highlights include:

* On June 2, 2008, Abiomed announced that it had received U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 510(k) clearance of its Impella([R]) 2.5 Cardiac Assist Device. Through August 6, 2008, 56 of the approximately 1,700 U.S. hospitals with catheterization catheterization

Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages.
 labs have acquired Abiomed's Impella 2.5 device under the 510(k) clearance and 86 U.S. hospitals have purchased the Impella 2.5 device overall.

* Total Impella revenue was $5.9 million, up 228%, and Impella disposable revenue was $5.5 million, up 323%, for the first fiscal quarter of 2009 compared to the same period of fiscal 2008.

* Total legacy business revenue (BVS BVS Biblioteca Virtual em Saúde (Brazil)
BVS Bureau of Vital Statistics
BVS Brethren Volunteer Service (Church of the Brethren)
BVS Boston Vegetarian Society (Cambridge, MA) 
([R]) 5000, AB5000[R], iPulse(TM), intra-aortic balloon or IAB (1) See Internet Architecture Board.

(2) (Interactive Advertising Bureau, New York, www.iab.net) An industry association founded in 1996 to set standards and guidelines for interactive advertising and marketing.
, AbioCor([R]), service and other) was $10.5 million for the first fiscal quarter of 2009 and decreased approximately 15% compared to the same period of fiscal 2008. AB5000 patient utilization during the first quarter of fiscal 2009 was approximately flat with the fourth quarter of fiscal 2008.

* Total disposables, service and other revenue (non-console revenue) comprised approximately 90% of total revenue for first quarter of fiscal 2009. A total of 709 disposable units were shipped during the quarter (excluding IAB disposables).

* Abiomed is currently conducting an Impella 2.5 study for high-risk percutaneous coronary intervention Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a therapeutic procedure to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.  (PCI (1) (Payment Card Industry) See PCI DSS.

(2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus).
) at up to 150 U.S. hospitals (Protect II study). As of August 6, 2008, 187 U.S. hospitals are pursuing the study, with 55 hospitals ready for enrollment of patients, 36 with Investigational Review Board (IRB IRB

See: Industrial Revenue Bond
) approval but not yet enrolling, and 96 hospitals having submitted to the IRB or submission is pending. We have completed 107 patients from 28 hospitals or 16% of the 654 patients required.

* Abiomed's pivotal study with Impella 2.5 for acute myocardial infarction acute myocardial infarction (·kyōōtˑ mī·ō·karˑ·dē·  (AMI) was approved by the FDA for up to 150 hospitals (Recover II study). As of August 6, 2008, 53 U.S. hospitals are pursuing the study. No hospitals are enrolling patients yet, however, 4 hospitals have IRB approval, and 49 have submitted to the IRB or submission is pending.

* Based on the recent Centers for Medicare and Medicaid services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and  (CMS (1) See content management system and color management system.

(2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system.
) update on August 1, 2008, the BVS 5000 and AB5000 are the only ventricular assist devices ventricular assist device: see under heart, artificial.  (VADs) eligible for diagnostic related group 1 (DRG DRG,
n the abbreviation for diagnosis-related group.


DRG

see dorsal respiratory group.

DRG Diagnosis-related group Managed care A unit of classifying Pts by diagnosis, average length of hospital stay, and
 1) for heart recovery. Additionally, the AbioCor total replacement heart has been re-assigned to DRG 1.

* Gross margin for the first quarter of fiscal 2009 was 66%. The Company implemented certain Impella console placement programs during the quarter to generate future disposable revenue. For the U.S. pivotal studies, thirty-eight consoles were placed on consignment with the expectation that the respective hospitals will purchase a minimum amount of future disposables and participate in the pivotal studies. Eight consoles for Impella 2.5 commercial use were placed on consignment with the expectation that the respective hospitals will purchase a minimum amount of disposables within a given period of time. If these expectations for future disposable orders are not met within the given timeframe, the Company has the right to take back the Impella consoles. Eight AB5000 and twelve iPulse consoles transferred title based on completion of the deployment utilization agreements with the hospitals. Four AB5000 consoles were consigned with the expectations for future disposable revenue. The total effect of these console placement programs negatively impacted gross margin for the first quarter of fiscal 2009 by approximately eight gross margin points.

* The first quarter of fiscal 2009 GAAP GAAP

See: Generally Accepted Accounting Principles


GAAP

See generally accepted accounting principles (GAAP).
 net loss was approximately $9.1 million, or $.28 per share, which included stock option and other stock-based compensation expense of $1.7 million and intangibles amortization of $0.4 million. Excluding these charges the non-GAAP net loss for the first quarter of fiscal 2009 was approximately $7.0 million, or $.21 per share. The GAAP net loss for the first quarter of fiscal 2008 was $8.3 million, or $.26 per share and included stock option and other stock-based compensation expense of $1.7 million and $0.4 million of intangibles amortization.

"Our top Fiscal Year 2009 goal is launching our Impella 2.5 platform including successful clinical trial execution. During this first fiscal quarter of 2009, we were pleased with our revenue growth from Impella and the continued momentum in our two U.S. pivotal studies for the Impella 2.5," said Michael R. Minogue, Chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and President of Abiomed.

Abiomed today announced it is reaffirming its full-year fiscal 2009 revenue estimate of approximately $75 million to $80 million.

The Company will host a conference call today at 8:00 a.m. ET to discuss its first quarter of fiscal 2009 results. Michael R. Minogue, Chairman, Chief Executive Officer and President, and Daniel J. Sutherby, Chief Financial Officer will host the conference call.

To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial 866.362.4829; the international number is 617.597.5346. The access code is 21674892. A replay of this conference call will be available beginning at 10 a.m. ET on August 7, 2008 through 11:59 p.m. ET on August 21, 2008. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 25571704.

ABOUT ABIOMED

Based in Danvers, Massachusetts Danvers is a town in Essex County, Massachusetts, United States. Located on the Danvers River near the northeastern coast of Massachusetts, Danvers is most widely known for its association with the 1692 Salem witch trials. , Abiomed, Inc., is a leading provider of medical devices that provide circulatory circulatory /cir·cu·la·to·ry/ (ser´ku-lah-tor?e)
1. pertaining to circulation, particularly that of the blood.

2. containing blood.


cir·cu·la·to·ry
n.
1.
 support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.

USE OF NON-GAAP MEASURES

In addition to financial measures prepared in accordance with generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records.

Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting
 (GAAP), this earnings announcement also contains non-GAAP financial measures of net loss and net loss per share, in each case excluding, where appropriate, stock option expense, and intangibles amortization.

We believe that the inclusion of these non-GAAP financial measures in this earnings announcement helps investors to gain a meaningful understanding of our core operating results and future prospects, and can also help investors who wish to make comparisons between us and other companies on both a GAAP and a non-GAAP basis, particularly with respect to stock option expenses. The non-GAAP financial measures included in this earnings announcement are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. In addition, the non-GAAP financial measures included in this earnings announcement may be different from, and therefore may not be comparable to, similar measures used by other companies. Although certain non-GAAP financial measures used in this release exclude the accounting treatment of stock option expense and other items outlined in this release and above, these non-GAAP measures should not be relied upon independently, as they ignore the contribution to our operating results that is generated by the incentive and compensation effects of the underlying stock option programs.

FORWARD-LOOKING STATEMENTS forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 

This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.
[TABLE OMITTED]
[TABLE OMITTED]
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Aug 7, 2008
Words:1410
Previous Article:Dale Earnhardt Jr. Ready to Race No. 5 GoDaddy.com Chevrolet.
Next Article:Axesstel Announces Second Quarter 2008 Results.
Topics:



Related Articles
APPLIED BIOSYSTEMS REPORTS $29.9 MILLION NET INCOME 2ND QTR.
Cannon Express Inc. (Public Company Reports).
Lab Equipment/Distribution Sales Index up 8% in 2002. (Executive briefing: news, trends & market intelligence for instrument executives).
Abiomed Announces Fiscal 2007 Revenue up 16% to $51 Million.
ABIOMED REPORTS ON EUROPEAN GROWTH STRATEGY.
Abiomed Announces 26% Growth and Record Revenue of $17.5 Million for Fourth Quarter of Fiscal 2008.
CommVault Announces First Quarter Fiscal 2009 Financial Results.
Blue Coat Reports Revenue of $102.5 million in Q1 2009.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles