CORRECTING and REPLACING ABIOMED Reports Third Fiscal Quarter Financial Results.Business Editors/Health/Medical Writers CORRECTION...by ABIOMED ABIOMED is a Danvers, Massachusetts-based company that builds the AbioCor Artificial Heart, the first fully implanted device of its kind. The AbioCor was approved for Humanitarian Use on September 5, 2006. , Inc. DANVERS Danvers, town (1990 pop. 24,174), Essex co., NE Mass.; settled in the 1630s, set off from Salem 1752, inc. as a town 1757. Danvers has light manufacturing, including electronic equipment, chemicals, machinery, and apparel. , Mass.--(BUSINESS WIRE)--Feb. 10, 2004 Second graph, fourth bullet of release should read: Cash consumed con·sume v. con·sumed, con·sum·ing, con·sumes v.tr. 1. To take in as food; eat or drink up. See Synonyms at eat. 2. a. by operating activities of $7.4 million in the nine months ended December December: see month. 31, 2003, a 42% decrease over cash consumed by operations in the comparable nine months of the prior year (sted Cash consumed by operating activities of $7.4 million, a 42% decrease over cash consumed by operations in the comparable quarter of the prior year). The corrected release reads ABIOMED Reports Third Fiscal Quarter Financial Results Product Revenues Increase 17%, Net Loss Reduced 56% From Prior Year 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 released financial results for the third quarter of fiscal year 2004 ended December 31, 2003, and commented on significant highlights of the quarter. Highlights of Financial Results of Operations for the quarter include: -- Continued progress toward our goal of profitability from existing business operations Business operations are those activities involved in the running of a business for the purpose of producing value for the stakeholders. Compare business processes. The outcome of business operations is the harvesting of value from assets : net loss for the quarter reduced to $0.09 per share compared to $0.13 per share in the previous consecutive quarter and $0.21 per share in the same quarter of the prior year -- Initial controlled commercial introduction of a new disposable disposable Nursing adjective Referring to that which is discarded or disposed of noun An item used in health care-related Pt contact which is discarded after use–eg masks, gloves, gowns, needles, paper products, syringes, wipes. See Biohazardous waste. blood pump for use with the AB5000(TM) 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 System -- Product revenues for the quarter of $6.5 million, a 17% increase from the corresponding quarter in the prior year -- Cash consumed by operating activities of $7.4 million in the nine months ended December 31, 2003, a 42% decrease over cash consumed by operations in the comparable nine months of the prior year "Our fiscal third quarter showed steady progress toward our goal of profitability from our existing commercial operations. Increased product revenues, combined with continued improvements to our operational efficiency have resulted in a third consecutive quarter of financial performance improvement," said chairman and chief executive officer Dr. David M. Lederman. "During the quarter, we also added staff resources in a number of areas that are intended to make us more efficient and more responsive to our customers and to our markets," Dr. Lederman added. "We have enhanced our capabilities in marketing, corporate communications Corporate communications is the process of facilitating information and knowledge exchanges with internal and key external groups and individuals that have a direct relationship with an enterprise. and engineering. We believe that these additions, and others to come, will make us a stronger company as we prepare for full commercial rollout of the AB5000 system." "We have identified important steps to further improve the performance of the AbioCor(R) and reduce the potential for adverse events such as stroke. In addition, we are extremely pleased to have added Boston's Beth Israel Deaconess Medical Center Both an international and regional referral center, Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts is a major teaching hospital of Harvard Medical School. It was formed out of the 1996 merger of Beth Israel Hospital (founded in 1916) and and its strong clinical team as an AbioCor clinical site, and look forward to their active participation in the trial," commented Dr. Lederman. Financial results for the third quarter of fiscal year 2004 ended December 31, 2003 are summarized in the attached table, and are detailed in ABIOMED's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. filed today with the Securities and Exchange Commission. The following are some of the topics discussed in the company's Form 10-Q filing: The AbioCor Clinical Trial: As the initial AbioCor clinical trial enters its final phase, the company continues to plan for the initial commercial introduction of the AbioCor replacement heart through a Humanitarian Device Exemption by the end of calendar 2004. While ABIOMED reported no new clinical trial implants during the quarter, the company disseminated disseminated /dis·sem·i·nat·ed/ (-sem´i-nat?ed) scattered; distributed over a considerable area. dis·sem·i·nat·ed adj. Spread over a large area of a body, a tissue, or an organ. its findings from a review of the AbioCor clinical experience to date to its clinical investigators A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under and advisors in preparation for upcoming implants. Product Revenues: Product revenues for the quarter were $6.5 million, a 17% increase over the comparable quarter of the prior year. While 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 blood pump reorders remain the single largest component of the revenue stream, enthusiastic customer response to the new model AB5000 blood pump contributed to the quarter's excellent result. ABIOMED has been conducting a carefully controlled clinical introduction of the AB5000 console and blood pump, and expects to begin a full commercial rollout of the AB5000 system during the first quarter of the next fiscal year. Progress toward profitability from existing commercial operations: The quarter ended December 31, 2003 showed continued strong progress toward profitable operations. Net loss was narrowed in the quarter to approximately $2.0 million, or $0.09 per share, 56% below the net loss of approximately $4.4 million, or $0.21 per share, in the same period of the previous year. ABIOMED will be hosting a conference call with analysts and investors to discuss fiscal 2004 third quarter results. This conference call is scheduled for today, February 10, at 11:00 a.m. Eastern Time and may be heard live via our website at www.abiomed.com. 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. (pronounced "AB'-EE-O-MED") is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED, which currently sells the BVS(R) 5000 Biventricular biventricular /bi·ven·tric·u·lar/ (bi?ven-trik´u-ler) pertaining to or affecting both ventricles of the heart. biventricular pertaining to or affecting both ventricles of the heart. Support System and the AB5000(TM) Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts. The company's AbioCor(R) Implantable Replacement Heart is the subject of an initial clinical trial being conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. This Release contains 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. , including statements regarding development of ABIOMED's existing and new products, the plans, timing and clinical results of the AbioCor trial, and the company's progress toward commercial growth and profitability. 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, 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 CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or that occur after the date of this Release or to reflect the occurrence of unanticipated events.
FINANCIAL HIGHLIGHTS
CONSOLIDATED OPERATING RESULTS (Unaudited)
(In thousands,
except per share
data) Three Months Ended Nine Months Ended
-----------------------------------------
Dec. 31 Dec. 31 Dec. 31 Dec. 31
2003 2002 2003 2002
-----------------------------------------
Product Revenues $6,526 $5,591 $16,825 $16,178
Funded Research & Development 157 29 299 324
-----------------------------------------
Total Operating Revenues 6,683 5,620 17,124 16,502
Cost of Product Revenues 2,125 2,088 4,758 5,359
R&D Expenses 3,115 4,990 10,831 16,288
S,G&A Expenses 3,680 3,272 10,098 11,028
-----------------------------------------
Total Operating Expenses 8,920 10,350 25,687 32,675
Loss from Operations (2,237) (4,730) (8,563) (16,173)
Interest and Other Income,
net 270 291 650 1,042
-----------------------------------------
Net Loss $(1,967) $(4,439) $(7,913) $(15,131)
=========================================
Net Loss per Share $(0.09) $(0.21) $(0.37) $(0.72)
Weighted Average Shares
Outstanding 21,173 21,016 21,102 20,984
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
Dec. March
31, 31,
2003 2003
------------------
Cash and Investments $47,447 $54,449
Working Capital $31,870 $57,336
Total Assets $58,831 $68,337
Current Liabilities $3,983 $6,247
Stockholders' Equity $54,848 $62,090
|
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion