ABIOMED Announces Results for Fourth Quarter and Year Ended March 31, 1999.DANVERS, Mass.--(BW HealthWire)--May 12, 1999-- Unveils Milestones on Path to Human Trials with AbioCor(TM) Implantable Heart Announces 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) Penetration of 90 Additional Medical Centers During the Year 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 fourth fiscal quarter and year ended March 31, 1999 ("Fiscal 1999"). 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 fourth quarter were $6,192,000 compared to $5,383,000, in the same quarter of the prior year. This increase includes a 20% increase in BVS product revenues offset by a 25% decrease in contract revenues. Operating revenues for the full fiscal 1999 were $22,090,000 compared to $22,445,000 in the previous fiscal year. These results reflect a 5% increase in BVS product revenues and a 23% decrease in contract revenues. The variability in contract revenues reflects the timing of government appropriations. The Company's backlog of government contracts and grants at March 31, 1999 was approximately $5.2 million. Commenting on the financial results, John F. Thero, ABIOMED's CFO See Chief Financial Officer. , reported that, "the Company increased its investment in R&D with expenses rising to $13,450,000 or 48% higher than R&D expenses of $9,090,000 in the prior fiscal year. Approximately $9,671,000 of the Company's 12-month R&D spending, or $1.12 per share, was for pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. and readiness testing of the 'AbioCor', the Company's battery-powered implantable replacement heart." He noted that, "due primarily to its higher level of R&D spending in fiscal 1999 compared to fiscal 1998, the Company incurred a loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the of $6,712,000, or $0.78 per share, compared to a loss of $995,000, or $0.12 per share, a year earlier." Commenting on the Company's new fiscal year, 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. , said that: " the activities in the year ahead represent what we have been looking forward to since the Company began operations." He outlined the Company's ongoing strategy in preparation for accelerated growth in the calendar year 2000 and beyond. He explained that, "the Company's most important assets, its human resources The fancy word for "people." The human resources department within an organization, years ago known as the "personnel department," manages the administrative aspects of the employees. , were approximately doubled in the past three years and are now approaching 200 full-time employees. This expansion, and its corresponding investment, reflects the Company's commitment to be ready for clinical trials and for the follow-on commercial introduction of the AbioCor." He highlighted the Company's plan at the start of the Company's current fiscal year with three primary goals: -0-
1) augmenting ABIOMED's sales, marketing and clinical support
capabilities, both domestically and internationally, to increase
revenues and profits with the existing product line;
2) achieving scheduled milestones to start human trials in the next
calendar year with the AbioCor implantable replacement heart in
selected initial patient indications; and
3) introducing other new products to market each year starting with
the current fiscal year.
-0- Regarding the BVS product line, Gene Rabe, ABIOMED's Vice President of Global Sales, explained: "we created the bridge to recovery segment of the cardiac assist market and have clearly established our position as the technology and market leader with a strong installed hospital base. The product has now been used in over 3,000 patients ranging in ages from 7 to 84 years. We are pleased that we now count 85% of all U.S. transplant centers as our customers, as well as over 80% of all centers that perform more than 500 heart surgeries annually. Moreover, 37 of our customers are among the top 42 U.S. cardiac centers The cardiac center is part of the medulla oblongata responsible for controlling the heart rate. External links
Referring to the Company's management resources, Dr. Lederman said that, "to further strengthen our leadership and to prepare for the clinical introduction and launch of new products, including the AbioCor, we have continued to attract senior and experienced professionals. In recent months we have added to our team Dr. Douglas McNair as Vice President of Clinical Affairs, Ms. Martha Bangs as Director of U.S. Clinical Affairs and Mr. John Hart
John Hart (about 1711 or 1713–May 11, 1779), was a signer of the United States Declaration of Independence as a representative of New Jersey. as Vice President of Marketing. Our plan for the coming years calls for continued additions of marketing, sales, and clinical personnel to what we believe is already the largest and most effective team specializing in advanced cardiac assist 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. . Similarly, we are actively seeking to expand our direct clinical presence in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community and our distributor is seeking regulatory approval for the BVS in Japan." Dr. Robert T.V. Kung, ABIOMED's Senior Vice President and Chief Scientific Officer cited a plan of defined program milestones leading to human trials which includes: "finalization Writing the table of contents (TOC) on a recordable CD or DVD disc. The finalization process ensures that the disc can be played back on most CD and DVD players. See disc-at-once. of human configuration; analysis of retrospective clinical data to assess the nature and rate of enrollment of initial patients; meeting reliability milestones for selected patient indications and durations of support under the reliability growth program started during 1998; building additional quantities of bovine bovine /bo·vine/ (bo´vin) pertaining to, characteristic of, or derived from cattle. bovine pertaining to, characteristic of, or derived from the ox or cattle, members of the family Bovidae. See also cattle. and human-configured pilot production systems for the formal reliability growth program; building systems for human trials; enrollment and readiness training of international clinical centers; readiness training of all selected U.S. clinical teams; formal pre-clinical validation trials under GLP See gateway location protocol. ; regulatory applications for clinical trials in the USA (IDE) and in the European Union (ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9000 and CE mark); and starting initial human trials." Dr. Lederman expanded: "the Company's development team working on the battery-operated AbioCor implantable replacement heart is executing on a plan for starting initial human trials in the year 2000." He added: "as we achieve technical and program milestones, we grow more optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op about our ability to deliver under this, the most ambitious undertaking in medical device history." He added that, "the AbioCor program now comprises more than 70 full-time engineers, scientists, and technical support personnel at ABIOMED alone, plus a large number of highly skilled specialists working as subcontractors to ABIOMED." Dr. Lederman continued: "research and development activities under this program, which have been ongoing for decades, incorporate such a wide combination of technologies that the program has the potential to generate an array of commercializable spin-off The situation that arises when a parent corporation organizes a subsidiary corporation, to which it transfers a portion of its assets in exchange for all of the subsidiary's capital stock, which is subsequently transferred to the parent corporation's shareholders. products. Examples include new implantable heart valves Heart valves Valves that regulate blood flow into and out of the heart chambers. Mentioned in: Heart Failure , implantable energy transmission systems, implantable monitoring systems for remote transmission and archival of physiological data, diagnostic software for virtual surgery, advanced implantable instrumentation and electronics, external monitoring systems, and many others. As the AbioCor moves into clinical trials, ABIOMED plans to increasingly look for opportunities to commercialize such technology directly or with third parties." Noting that ABIOMED's BVS product line has an installed base of over 425 medical centers in the United States and over 70 internationally, Dr. Lederman said: "ABIOMED has intensified activities to enhance the BVS product line, increase utilization and expand its clinical applicability, as well as to introduce new products. In the coming year, the Company has the opportunity to receive 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 for important product extensions and will begin what the Company expects will be an increased rate of new product introductions." The Company noted that this summer it plans to begin a phased expansion move to a new 80,000 sq. ft. facility, located within the same industrial park where it has current operations. The new facility will accommodate expanded development, production and reliability testing capabilities in anticipation of growth in its existing BVS product as well as capability for production ramp up Ramp Up To increase a company's operations in anticipation of increased demand. Notes: A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product. See also: Demand, Economies of Scale of AbioCor systems over the next several years. 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 product and is a leader in the research and development of advanced heart assist and replacement systems. The Company's BVS-5000 is the most widely used FDA-approved cardiac assist device and the only FDA-approved 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 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 the anticipated timing of the Company's development and clinical trials of its AbioCor implantable replacement heart, the continuing and increasing success of the Company's BVS product line, 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 ability to commercialize other technology, increase production and international expansion. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, both known and unknown. Facts that may adversely affect the timing of the Company's development, clinical trials, manufacturing and commercialization of the AbioCor and other new products include, without limitation, availability of sufficient financial resources, the risk of adverse results or technology roadblocks in the development and preclinical testing Noun 1. preclinical test - a laboratory test of a new drug or a new invasive medical device on animal subjects; conducted to gather evidence justifying a clinical trial preclinical phase, preclinical trial , risks associated with operating in a highly regulated environmen t including the possibility that the FDA or other 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 may require more preclinical testing than anticipated by the Company or delays in the approval for clinical trials once that testing is completed, ongoing development challenges including but not limited to those resulting from complex manufacturing and high quality requirements, dependence upon and intense competition in hiring and retaining key personnel, intellectual property risks, risks associated with technological change and competition and cost-overrun and funding risks Funding risk The risk associated with the impact on a project's cash flow from higher funding costs or lack of availability of funds. See: interest rate risk. . The Company cannot assure that the required milestones for clinical trials with the AbioCor will be met, or that they will be met on a timely basis, or that such clinical trials will be successful. Factors that may adversely affect the continued success of the BVS and international expansion include, without limitation, many of those listed above, as well as uncertainties associated with BVS market development; uncertainty of continuing BVS product development and improvements, dependence on limited sources of supply for certain key components of the BVS, risk of market withdrawal or produc t recall, third-party reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. policies and potential inadequacy of product liability insurance. These and other factors that may adversely affect the Company and its anticipated results, plans and objectives are set forth in further detail 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. -0-
ABIOMED, Inc.
FINANCIAL HIGHLIGHTS
CONSOLIDATED OPERATING RESULTS (Unaudited)
(In thousands, except per share data)
Three Months Ended Twelve Months Ended
March 31, March 31, March 31, March 31,
1999 1998 1999 1998
Product Revenues $ 5,716 $ 4,752 $ 18,079 $ 17,260
Contract Revenues 476 631 4,011 5,185
Total Operating Revenues 6,192 5,383 22,090 22,445
Cost of Products Sold 2,071 1,796 6,772 6,502
R&D Expenses 2,817 3,096 13,450 9,090
S, G & A Expenses 2,932 2,371 9,772 9,054
Total Operating Expenses 7,820 7,263 29,994 24,646
Interest and Other 247 385 1,192 1,206
Loss from Continuing
Operations (1,381) (1,495) (6,712) (995)
Loss from Discontinued
Operations -- (1,146) -- (1,513)
Net Loss $ (1,381) $ (2,641) $ (6,712) $ (2,508)
Loss from Continuing
Operations per Share $ (0.16) $ (0 .18) $ (0.78) $ (0.12)
Loss from Discontinued
Operations per Share -- $ (0.13) -- $ (0.19)
Net Loss per Share $ (0.16) $ (0.31) $ (0.78) $ (0.31)
Weighted Average Number
of Common and Common
Equivalent Shares Outstanding 8,644 8,561 8,619 8,074
CONDENSED CONSOLIDATED BALANCE SHEET DATA
March 31, March 31,
1999 1998
Cash and Marketable Securities $18,181 $26,398
Current Assets $27,850 $34,290
Total Assets $32,982 $38,755
Current Liabilities $ 5,705 $ 5,006
Long-term Liabilities $ 205 $ 64
Stockholders' Equity $27,072 $33,018
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