ABIOMED Announces Results for Fiscal Year Ended March 31, 2000; AbioCor Implantable Replacement Heart Progresses Toward Initial Clinical Trials.Business/Technology Editors and Health/Medical Writers DANVERS, Mass.--(BW HealthWire)--May 11, 2000 ABIOMED, Inc. (pronounced "AB-EE-O-MED"), (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 its fiscal year ended March 31, 2000 ("fiscal 2000"). Financial Results Operating revenues operating revenue Revenue from any regular source. Revenue from sales is adjusted for discounts and returns when calculating operating revenue. Compare other revenue. for the full fiscal 2000 were $22,517,000 compared to $22,090,000 in the previous fiscal year. These results reflect increases in 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) product revenues and contract revenues of 2% and 3%, respectively. While the portion of product revenues derived from sales of BVS disposable blood pumps and related accessories and services increased by 20% during the fiscal year, the portion derived from sales of BVS console equipment declined. John F. Thero, ABIOMED's Senior VP and CFO See Chief Financial Officer. , commented: "We believe this change reflects our decision early in the fiscal year to shift the focus of many of our sales representatives from new customer sales to increased support of existing customers, with the goal of increasing reorders of the higher margin consumable A material that is used up and needs continuous replenishment, such as paper and toner. "The low-tech end of the high-tech field!" BVS pumps. In part as a result of this decision, product margins increased to 68% from 63% in the previous fiscal year." ABIOMED also continued to invest in R&D during fiscal 2000 with R&D expenses totaling $15,633,000 compared to $13,450,000 in fiscal 1999. Development expenses for the AbioCor(TM) Implantable Replacement Heart represent 74% of this total. This increasing level of investment in the AbioCor program reflects the Company's intense efforts to prepare for initial human trials, scheduled to begin near the end of the current year, subject to regulatory approvals. The Company also increased its R&D investment in expanding the BVS product line. As a new BVS cannulae was released to the market during the fiscal year and a new BVS transport/backup drive console received 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. The Company reported a net loss of $10,454,000, or $1.19 per share, for fiscal 2000 compared to $6,712,000 or $0.78 per share in the previous year. This increase was primarily attributable to increased R&D expenditures, new selling and marketing programs for the BVS product line, and significant legal expenses associated with the successful defense of our rights to transcutaneous transcutaneous /trans·cu·ta·ne·ous/ (-ku-ta´ne-us) transdermal. trans·cu·ta·ne·ous adj. Transdermal. energy transmission technology used in the AbioCor. During the fourth fiscal quarter, the Company completed a public offering of 1,500,000 shares of common stock generating proceeds, net of expenses, of $95,400,000. AbioCor Program Update The AbioCor Implantable Replacement Heart is a medical device intended to replace a patient's diseased dis·eased adj. 1. Affected with disease. 2. Unsound or disordered. heart and take over completely its 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. function. It is now in an advanced stage of pre-clinical readiness testing. Key milestones achieved during fiscal 2000 include: 1. Final conversion of the AbioCor design from the configuration used for pre-clinical testing to the clinical configuration to be used in the initial human trials. 2. Ongoing production and manufacturing scale-up to produce quantities of clinically configured con·fig·ure tr.v. con·fig·ured, con·fig·ur·ing, con·fig·ures To design, arrange, set up, or shape with a view to specific applications or uses: systems for pre-clinical and clinical tests. 3. Readiness Training of the sites selected for initial clinical trial sites in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. : two of the five surgical teams have substantially demonstrated readiness. Agreement reached with the first international medical center, with pre-clinical tests now underway. 4. Extensive system and component level testing of the clinically-configured AbioCor continued to generate data on performance, durability and reliability to support the final application to be submitted to regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities for initiation of human trials. 5. Primary pre-clinical testing centers certified See certification. to be in compliance with regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. of Good Laboratory Practices. 6. Submissions to the regulatory authorities of key elements of the Company's proposed plan for initial human trials, including test protocols and protocols for biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. evaluation, with the goal of completing our 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 submission promptly upon completion of all pre-clinical tests. Dr. David M. Lederman, 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. , stated: "fiscal 2000 was a very important year in the growth of our Company. In particular, in fiscal 2000, we made significant progress in the development and preparation for initial clinical trials of the world's first fully implantable replacement heart. We are committed to making the AbioCor a clinical reality as soon as possible. We are not aware of any technical issues that should prevent us from entering clinical trials. We are very excited to be so close to the day when we can begin to offer a life-saving solution to so many patients who today have no medical alternative. The $95.4 million financing that we completed at the end of fiscal 2000, and the new and expanded 80,000 square foot facility that we began to move into during fiscal 2000, give us the resources and environment to aggressively move forward with this important product." Commenting on the BVS product line, Dr. Lederman added: "the BVS continues to be an excellent life-saving and profitable product line. These products, and the new developments associated with it, are of strategic importance to ABIOMED and to the eventual clinical introduction of the AbioCor. BVS revenues shifted in fiscal 2000 from a heavy dependence on sales to new customers to revenues derived primarily from reorders by existing customers. This product line has helped the Company establish important relationships with over 500 medical centers worldwide, including the medical centers that will use the AbioCor when approved. We plan to continue our investment in growing the BVS business through expanded sales and marketing programs as well as new product components and product line enhancements." 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. develops, manufactures and markets innovative cardiovascular products and is a leader in the research and development of advanced heart assist and replacement systems. The Company's BVS-5000(R) is the most widely used FDA-approved cardiac assist device for all patients with reversible reversible, adj capable of going through a series of changes in either direction, forward or backward (e.g., reversible chemical reaction). reversible hydrocolloid, n See hydrocolloid, reversible. heart failure. The Company's AbioCor Implantable Replacement Heart is in an advanced stage of development and intended to extend the lives of patients who would otherwise die from heart failure. 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 the anticipated timing of the Company's development and clinical trials of its AbioCor Implantable Replacement Heart, BVS revenue growth and the timing and ability to introduce new products and product line extensions Product line Extensions and Patient safety In a world of product line extensions, there are many different products with similar names. Examples of these include oxycodone versus oxycontin (oycodone CR), buproprion vs buprion SR vs bruproprion XL, codeine versus codeine contin . 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 detailed in the Company's filings with the Securities and Exchange Commission. 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.
ABIOMED, Inc.
FINANCIAL HIGHLIGHTS
CONSOLIDATED OPERATING RESULTS
(In thousands, except Three Months Ended Twelve Months Ended
per share data) (unaudited)
March 31, March 31, March 31, March 31,
2000 1999 2000 1999
Product Revenues $ 5,567 $ 5,716 $18,377 $18,079
Contract Revenues 487 476 4,140 4,011
Total Operating Revenues 6,054 6,192 22,517 22,090
Cost of Products Sold 1,799 2,071 5,882 6,772
R&D expenses 4,195 2,817 15,633 13,450
S,G&A expenses 3,628 2,932 12,562 9,772
Total Operating Expenses 9,622 7,820 34,077 29,994
Interest income and other 498 247 1,106 1,192
Net Loss $ (3,070) $ (1,381) $(10,454) $ (6,712)
Basic and Diluted $ (0.34) $ (0.16) $ (1.19) $ (0.78)
Net Loss per Share
Weighted Average Number of
Common Shares Outstanding 9,089 8,644 8,789 8,619
CONDENSED CONSOLIDATED BALANCE SHEET DATA
3/31/00 3/31/99 3/31/98
Cash and Marketable Securities $106,384 $ 18,181 $ 26,398
Current Assets $117,147 $ 27,850 $ 34,290
Total Assets $121,788 $ 32,982 $ 38,755
Current Liabilities $ 8,149 $ 5,705 $ 5,006
Long-term Liabilities $ 715 $ 205 $ 64
Stockholders' Equity $112,924 $ 27,072 $ 33,018
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