ABIOMED Announces Second Fiscal Quarter Results.Business Editors and Health/Medical Writers 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)--Oct. 25, 2001 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. (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 reported financial results for its second fiscal quarter ended September 30, 2001 ("Fiscal 2002") and commented on the progress of both its AbioCor(TM) Implantable Replacement Heart program and its 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) temporary artificial heart product line. Product revenues for the second fiscal quarter were $4.2 million, compared to $5.0 million in the same quarter of the prior year. Product revenues for the first half of Fiscal 2002 were $10.0 million compared to $10.5 million in the first six months of the previous fiscal year. All of these product revenues were derived from the BVS. Funded research and development revenues, reflecting the advance of the AbioCor into clinical trials and related timing of government funding for AbioCor pre-clinical research, declined to $0.1 million in the second fiscal quarter of Fiscal 2002 from $2.0 million in the same quarter of the prior year and to $0.4 million in the first half of Fiscal 2002 compared to $2.4 million in the same period of the prior year. The Company increased its spending on research and development in this fiscal quarter to $7.2 million from $5.6 million in the same quarter of the prior year. Research and development expenses increased to $14.3 million in the six months ended September 30, 2001 from $10.1 million in the six months ended September 30, 2000. The majority of this spending increase relates to preparing for and conducting initial clinical trials for the AbioCor and the manufacturing, testing and documentation activities associated with preparation for those trials. The Company reported a net loss of $7.1 million, or $0.34 per share, for its second fiscal quarter compared to a net loss of $1.5 million, or $0.07 per share, in the corresponding quarter last year and a net loss of $13.4 million, or $0.64 per share, for the first half of Fiscal 2002 compared to $ 3.5 million, or $0.17 per share, in the corresponding first six months of the previous fiscal year. Commenting on the fiscal quarter, Dr. David M. Lederman, Chief Executive Officer, said, "we entered into a new and exciting era for ABIOMED with the July 2, 2001 commencement of initial clinical trials for the AbioCor Implantable Replacement Heart. The initial results of those trials have been very encouraging. AbioCor hearts are today supporting the lives of four patients, who otherwise wouldn't have any hope." Dr. Lederman added, "we recognize that considerable work and clinical testing remain before the AbioCor is a proven therapy for end-stage heart failure End-stage heart failure Severe heart disease that does not respond adequately to medical or surgical treatment. Mentioned in: Heart Transplantation patients. However, we believe that we are on a path to success and have experienced no negative surprises. We remain confident that we can meet our schedule to complete five implants of the AbioCor this year and that we will, with 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. approval, proceed with an additional ten U.S. implants during the first half of the coming calendar year." Commenting on the Company's BVS product revenues, Mr. Gene Rabe, Senior Vice President Sales and Marketing, said, "the summer months in our industry have historically been slow with strong pick-ups typically in mid-to-late September. This year we were disappointed by relatively weak domestic end-of-quarter sales despite a modest overall increase in revenues from BVS pumps reordered by existing customers. The BVS remains the best product for its target patient populations and we are not aware of any significant competitive factors that dampen the prospects for further growth in this business." The Company has scheduled a conference call with analysts and investors to discuss its fiscal second quarter results. The conference call is scheduled for 11:00 a.m. (EST EST electroshock therapy. EST abbr. electroshock therapy ), Thursday, October 25, 2001, and can be heard via the Company's web site 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. The Company's first generation AbioCor Implantable Replacement Heart is being implanted im·plant v. im·plant·ed, im·plant·ing, im·plants v.tr. 1. To set in firmly, as into the ground: implant fence posts. 2. in selected patients as part of an initial clinical trial 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 (IDE (1) (Integrated Development Environment) A set of programs run from a single user interface. For example, programming languages often include a text editor, compiler and debugger, which are all activated and function from a common menu. ) 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. (FDA). The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS, a heart-assist device for the temporary support of all patients with failing but potentially recoverable hearts. This News 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 revenue growth and timing and results of clinical trials with the AbioCor. ABIOMED's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainty associated with development, testing and regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, unproven unproven Dubious, nonscientific, not proven, quack, questionable, unscientific adjective Relating to that which has not been validated by reproducible experiments or other scientific methods for determining effect or efficacy markets for products under development, competition, technological change, government regulation, dependence on limited sources of supply, future capital needs and uncertainty of additional funding, dependence on third-party reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. and other risks detailed in the Company's filings with the Securities and Exchange Commission. Investors are cautioned that all such statements involve risks and uncertainties. Readers are cautioned not to place undue reliance on these 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 after the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" or to reflect the occurrence of unanticipated events.
FINANCIAL HIGHLIGHTS
(unaudited)
CONSOLIDATED OPERATING RESULTS
(In thousands,
except per share
data) Three Months Ended Six Months Ended
Sept. 30 Sept. 30 Sept. 30 Sept. 30
2001 2000 2001 2000
Product Revenues $ 4,237 $ 4,953 $ 9,984 $ 10,457
Funded Research &
Development 107 2,032 352 2,387
Total Revenues 4,344 6,985 10,336 12,844
Cost of Product Revenues 1,183 1,485 3,174 3,420
R&D Expenses 7,171 5,605 14,315 10,096
S,G&A Expenses 3,900 2,959 8,044 5,936
Total Costs and Expenses 12,254 10,049 25,533 19,452
Interest and other 809 1,584 1,795 3,143
Net Loss $ (7,101) $ (1,480) $(13,402) $ (3,465)
Net Loss per Share $ (0.34) $ (0.07) $ (0.64) $ (0.17)
Weighted Average
Shares Outstanding 20,858 20,518 20,826 20,493
CONDENSED CONSOLIDATED BALANCE SHEETS
Sept. 30, March 31,
2001 2001
Cash and Marketable Securities $ 83,750 $ 92,498
Current Assets $ 94,865 $106,966
Total Assets $104,805 $118,013
Current Liabilities $ 8,712 $ 8,967
Long-term Debt $ 56 $ 368
Stockholders' Equity $ 96,037 $108,678
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