| ABIOMED INC ITEM 1A RISK FACTORS An investment in our common stock involves a high degree of risk |
| Current and prospective investors should carefully consider each of the risks and uncertainties described in this section and all of the other information in this Report |
| Our business, financial condition and results of operations could be severely harmed by any of the following risks |
| The trading price of our common stock could decline if any of these risks and uncertainties develop into actual events |
| We do not operate at a profit and cannot be assured of future profitability |
| We have had net losses in each of the past three fiscal years |
| We are committed to making large expenditures in fiscal 2007 and subsequent fiscal years for our new products under development, including those acquired in connection with our recent acquisition of Impella CardioSystems, AG, (now Impella CardioSystems GmbH, a Division of ABIOMED) which may result in losses in future periods |
| These expenditures include costs associated with performing clinical trials, continuing our research and development relating to our new products under development, seeking regulatory approvals and, if we receive these approvals, commencing commercial manufacturing and marketing |
| The amount of these expenditures is difficult to forecast accurately, and cost overruns may occur |
| We plan to fund a portion of these expenditures from our existing financial resources and revenues from AB5000, BVS and Impella product sales |
| We cannot be sure that we will have the necessary funds to develop and commercialize our new products, or that additional funds will be available on commercially acceptable terms, if at all |
| In the event that we are unable to obtain the necessary funding to develop and commercialize our products, our business may be adversely affected |
| Our operating results may fluctuate unpredictably |
| Our annual and quarterly operating results have fluctuated historically and we expect these fluctuations to continue |
| Among the factors that may cause our operating results to fluctuate are: • costs we incur developing and testing the AbioCor, AbioCor II and other new products or product enhancements; • the timing of regulatory actions, such as product approvals or recalls; • costs we incur in anticipation of future sales, such as inventory purchases, expansion of manufacturing facilities, or establishment of international sales offices; • the timing of customer orders and deliveries; • competitive changes, such as price changes or new product introductions that we or our competitors may make; and • economic conditions in the health care industry and the state of cost containment efforts, including reimbursement policies |
| We believe that period-to-period comparisons of our historical and future results will not necessarily be meaningful, and that investors should not rely on them as an indication of future performance |
| To the extent we experience the factors described above, our future operating results may not meet the expectations of securities analysts or investors from time to time, which may cause the market price of our common stock to decline |
| Our principal products and current primary source of revenues, the AB5000, BVS 5000 and Impella circulatory assist products, are vulnerable to competitive pressures, disruptions in sales, continuing review and extensive regulatory requirements |
| We believe that we will continue to rely heavily on these products for at least the next several years until we 10 ______________________________________________________________________ obtain regulatory approval for new products |
| In the event that a competitor were to introduce new treatments, products and technologies which compete with our products, add new features to their existing products or reduce their prices to make their products more financially attractive to customers, our revenue from our AB5000, BVS 5000 and Impella products could decline |
| For example, in the event of the expansion of technologies, which allow heart surgical procedures to be performed without stopping the heart, a reduction in the market for the AB5000 and BVS 5000 products could potentially result |
| Further, the AB5000 and BVS 5000 products are subject to stringent and continuing FDA and other regulatory requirements, including compliance with the QSR, adverse event reporting, prohibitions on promoting the products for unapproved uses, and continued inspection and market surveillance by the FDA If our products are recalled or otherwise withdrawn from the market, our revenues would likely decline, which would hurt our business |
| In addition, variations in the quantity and timing of sales of our new AB5000 consoles have a disproportionate effect on our revenues, because the price of the console is substantially greater than the price of our disposable blood pumps |
| If we cannot maintain and increase our disposable blood pump revenues from our AB5000 and BVS 5000 product line, our overall business and financial condition could be adversely affected |
| Our product revenues increased in fiscal 2006 by 14prca in comparison to fiscal 2005 and in fiscal 2005 our product revenues increased by 51prca in comparison to fiscal 2004 |
| To maintain or increase revenues from sales of our current products, we may be required to adopt new sales and marketing strategies, some of which may require expending additional capital resources, or execute on existing strategies |
| The new strategies we may adopt or execute on include: • regularly introducing enhancements and product line extensions; • product expansion within our markets through the acquisition of existing companies whose products may require additional development or clinical analysis for regulatory approval; • expanding sales of our AB5000, BVS 5000 and Impella products within international markets, some of which require separate regulatory approvals; and • seeking new categories of patients to support with our technology platform |
| In the event that we are unsuccessful in carrying out these new strategies, our revenues may decline |
| We may not be successful in expanding our sales activities into international markets |
| We are seeking to expand our international sales of the AB5000, BVS and Impella circulatory assist systems by recruiting direct sales and support teams for selected countries in Europe |
| Our international operations will be subject to a number of risks, which may vary from the risks we experience in the US, including: • our ability to continue to increase our global distribution; • the need to obtain regulatory approvals in foreign countries before our products may be sold or used; • longer sales cycles; • dependence on local distributors; • limited protection of intellectual property rights; • difficulty in collecting accounts receivable; • fluctuations in the values of foreign currencies; and • political and economic instability |
| If we are unable to effectively expand our sales activities in international markets, our results of operations could be negatively impacted |
| 11 ______________________________________________________________________ We depend on third party reimbursement to our customers for market acceptance of our products |
| If third party payers fail to provide appropriate levels of reimbursement for purchase and use of our products, our profitability would be adversely affected |
| Sales of medical products largely depend on the reimbursement of patients’ medical expenses by government health care programs and private health insurers |
| The cost of our AB5000 and BVS 5000 systems is substantial, and we anticipate that the cost of implanting the AbioCor in a patient will also be substantial |
| Without the financial support of the government reimbursement for CMS patient care or third party insurers’ payments for patient care, the market for our products will be limited |
| Medical products and devices incorporating new technologies are closely examined by governments and private insurers to determine whether the products and devices will be covered by reimbursement, and if so, the level of reimbursement which may apply |
| We cannot be sure that third party payors will reimburse sales of our products now under development, or enable us to sell them at profitable prices |
| We also cannot be sure that third party payors will continue the current level of reimbursement to physicians and medical centers for use of the AB5000 and BVS 5000 products |
| Any reduction in the amount of this reimbursement could harm our business |
| The federal government and private insurers have considered ways to change, and have changed, the manner in which health care services are provided and paid for in the US In the future, it is possible that the government may institute price controls and further limits on Medicare and Medicaid spending |
| These controls and limits could affect the payments we collect from sales of our products |
| Internationally, medical reimbursement systems vary significantly, with some medical centers having fixed budgets, regardless of levels of patient treatment, and other countries requiring application for, and approval of, government or third party reimbursement |
| Even if we succeed in bringing our new products to market, uncertainties regarding future health care policy, legislation and regulation, as well as private market practices, could affect our ability to sell our products in commercially acceptable quantities at profitable prices |
| Prior to approving coverage for new medical devices, most third party payors require evidence that the product has received FDA approval, is not experimental, and is medically necessary for the specific patient |
| Increasingly, third party payors require evidence that the devices being used are cost-effective |
| Our Impella, AbioCor and other products under development may not meet these or future criteria, which could hurt our ability to market and sell these products |
| If we fail to achieve and maintain the high manufacturing standards that our products require or if we are unable to develop additional manufacturing capacity, we will not be successful |
| Our products require precise, high quality manufacturing |
| Our failure to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, design defects or component failures, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business |
| We have from time to time voluntarily recalled certain products |
| Despite our very high manufacturing standards, we cannot completely eliminate the risk of errors, defects or failures |
| If we are not able to manufacture the AB5000, BVS 5000 and Impella Recover products in accordance with necessary quality standards, our business and results of operations may be negatively affected |
| The AbioCor involves even greater manufacturing complexities than our current commercial products |
| The AbioCor must be significantly more durable and meet different standards, which may be more difficult to achieve, than those that apply to our current product line |
| If we are unable to manufacture the AbioCor or other future products on a timely basis at acceptable quality and cost and in commercial quantities, or if we experience unanticipated technological problems or delays in production, our business will suffer |
| The manufacture of our products is and will continue to be complex and costly, requiring a number of separate processes and components |
| Achieving precision and quality control requires skill and diligence by our 12 ______________________________________________________________________ personnel |
| Further, to be successful, we believe we will need to increase our manufacturing capacity |
| We may experience difficulties in scaling up manufacturing of our new products, including problems related to product yields, quality control and assurance, component and service availability, adequacy of control policies and procedures, and lack of skilled personnel |
| If we cannot hire, train and retain enough experienced and capable scientific and technical workers, we may not be able to manufacture sufficient quantities of our current or future products at an acceptable cost and on time, which could limit market acceptance of our products or otherwise damage our business |
| If our suppliers cannot provide the components we require, our ability to manufacture our products could be harmed |
| We rely on third party suppliers to provide us with certain components used in our existing and other products under development |
| Relying on third party suppliers makes us vulnerable to component part failures and to interruptions in supply, either of which could impair our ability to conduct clinical tests or to ship our products to our customers on a timely basis |
| Using third party vendors makes it difficult and sometimes impossible for us to test fully certain components, such as components on circuit boards, maintain quality control, manage inventory and production schedules and control production costs |
| Vendor lead times to supply us with ordered components vary significantly and can exceed six months or more |
| Both now and as we expand our manufacturing capacity, we cannot be sure that our suppliers will furnish us with required components when we need them |
| These factors could make it more difficult for us to effectively and efficiently manufacture our products, and could adversely impact our results of operations |
| Some suppliers may be the only source for a particular component, which makes us vulnerable to cost increases and supply interruptions |
| Vendors may decide to limit or eliminate sales of certain products to the medical industry due to product liability or other concerns, and we might not be able to find a suitable replacement for those products |
| Manufacturers of our product components may be required to comply with the FDA or other regulatory manufacturing regulations and to satisfy regulatory inspections in connection with the manufacture of the components |
| If we cannot obtain a necessary component, we may need to find, test and obtain regulatory approval for a replacement component, produce the component ourselves or redesign the related product, which would cause significant delay and could increase our manufacturing costs |
| Any of these events could adversely impact our results of operations |
| We own patents, trademarks, trade secrets, copyrights and other intellectual property and know-how that we believe gives us a competitive advantage |
| If we cannot protect our intellectual property, competition could force us to lower our prices, which could hurt our profitability |
| Our intellectual property rights are and will continue to be a critical component of our success |
| A substantial portion of our intellectual property rights relating to the AB5000, BVS 5000, Impella products, AbioCor, AbioCor II and other products under development is in the form of trade secrets, rather than patents |
| In order to preserve certain proprietary information as trade secrets, we are required to restrict disclosure of information intended to constitute trade secrets to third parties |
| We protect our trade secrets and proprietary knowledge in part through confidentiality agreements with employees, consultants and other parties |
| Certain of our consultants and third parties with whom we have business relationships may also provide services to other parties in the medical device industry, including companies, universities and research organizations that are developing competing products |
| In addition, some of our former employees may seek employment with, and become employed by, our competitors |
| We cannot assure that confidentiality agreements with our employees, consultants and third parties will not be breached, that we will have adequate remedies for any such breach, or that our trade secrets will not become known to or be independently developed by our competitors |
| The loss of trade secret protection for technologies or know-how relating to the AB5000, BVS 5000, Impella products, AbioCor or AbioCor II could adversely affect our business prospects |
| Our business position will also depend in part on our ability to defend our existing and future patents and rights and conduct our business activities free of infringement claims by third parties |
| We intend to seek 13 ______________________________________________________________________ additional patents, but our pending and future patent applications may not be approved, may not give us a competitive advantage, and could be challenged by others |
| Patent proceedings in the US and in other countries may be expensive and time consuming |
| In addition, patents issued by foreign countries may afford less protection than is available under US patent law, and may not adequately protect our proprietary information |
| Our competitors may independently develop proprietary technologies and processes that are the same as or substantially equivalent to ours, or design around our patents |
| Companies in the medical device industry typically obtain patents and frequently engage in substantial intellectual property litigation |
| Our products and technologies could infringe on the rights of others |
| If a third party successfully asserts a claim for infringement against us, we may be liable for substantial damages, be unable to sell products using that technology, or have to seek a license or redesign the related product |
| These alternatives may be uneconomical or impossible |
| Patent litigation could be costly, result in product development delays and divert the efforts and attention of management from our business |
| If we cannot attract and retain the management, sales and other personnel we need, we will not be successful |
| We depend heavily on the contributions of the principal members of our business, financial, technical, sales and support, regulatory and clinical, operating and administrative management and staff, many of whom would be difficult to replace |
| Competition for skilled and experienced business management, scientific personnel and sales personnel in the medical devices industry is intense |
| If we lose the services of any of the principal members of our management and staff, or if we are unable to attract and retain qualified personnel in the future, especially scientific and sales personnel, our business could be adversely affected |
| We expect to grow rapidly if our products under development advance through the approval process |
| The expansion of personnel and facilities will strain our management and our financial and other resources |
| If we cannot manage this growth successfully, our business will likely suffer |
| Product liability claims could damage our reputation and hurt our financial results |
| The clinical use of medical products, even after regulatory approval, poses an inherent risk of product liability claims |
| We maintain limited product liability insurance coverage, subject to deductibles and exclusions |
| We cannot be sure that product liability insurance will be available in the future or will be available on acceptable terms or at reasonable costs, or that such insurance will provide us with adequate coverage against potential liabilities |
| Claims against us, regardless of their merit or potential outcome, may also hurt our ability to obtain physician endorsement of our products or expand our business |
| Many patients supported by our products do not survive |
| There are many factors beyond our control that could result in patient death, including the condition of the patient prior to use of the product, the skill and reliability of physicians and hospital personnel using and monitoring the product, and product maintenance by customers |
| However, the failure of the life support products we distribute for clinical test or sale could give rise to product liability claims and negative publicity |
| The risk of product liability claims will increase as we introduce new products that are intended to support a patient until the end of life |
| For example, the AbioCor will have a finite life and could cause unintended complications to other organs and may not be able to successfully support all patients |
| Its malfunction could give rise to product liability claims whether or not it has extended or improved the quality of the patient’s life |
| We cannot be sure that we can obtain liability insurance to cover the AB5000, BVS 5000, Impella products, AbioCor or other new products at a reasonable cost, if at all |
| If we have to pay product liability claims in excess of our insurance coverage, our financial condition will be adversely affected |
| 14 ______________________________________________________________________ Failure of our Impella acquisition to achieve its potential benefits could harm our business and operating results |
| The acquisition of our Impella division may not achieve its anticipated benefits for a variety of reasons, including: • our inability to obtain FDA approval and market acceptance for Impella’s products; • problems in successfully coordinating our research and development efforts; • difficulty in integrating sales, support and product marketing; • costs and delays in implementing common systems and procedures, including financial accounting systems; and • the inability to retain and integrate key management, research and development and customer support personnel |
| Further, we cannot assure you that we will realize any of the anticipated benefits and synergies of the acquisition |
| Any one or all of the factors identified above could cause increased operating costs, lower than anticipated financial performance, or the loss of customers, employees or business partners |
| The failure to integrate Impella successfully would have a material adverse effect on our business, financial condition and results of operations |
| The substantial costs of our Impella acquisition could harm our financial results |
| In connection with our acquisition of Impella, we incurred substantial costs |
| These include fees to legal counsel, independent accountants and consultants |
| We may also be required to make additional contingent payments under the terms of the acquisition, in an amount of up to approximately dlra28dtta2 million, based on our future stock price performance and milestones related to FDA approval and unit sales of Impella’s products |
| If the benefits of the acquisition do not exceed the associated costs, including any dilution to our stockholders resulting from the issuance of shares of our common stock in the transaction, our financial results, including earnings per share, could suffer, and the market price of our common stock could decline |
| If we acquire other companies or businesses, we will be subject to risks that could hurt our business |
| In the future, we may pursue new acquisitions to obtain complementary businesses, products or technologies |
| Any such acquisition may not produce the revenues, earnings or business synergies that we anticipated, and an acquired business, product or technology might not perform as we expected |
| If we pursue an additional acquisition, our management could spend a significant amount of time and effort in identifying and completing the acquisition |
| If we complete an additional acquisition, we may encounter significant difficulties and incur substantial expenses in integrating the operations and personnel of the acquired company into our operations while preserving the goodwill of the acquired company |
| In particular, we may lose the services of key employees of the acquired company and we may make changes in management that impair the acquired company’s relationships with employees and customers |
| Any of these outcomes could prevent us from realizing the anticipated benefits of our additional acquisitions |
| To pay for an acquisition, we might use stock or cash |
| Alternatively, we might borrow money from a bank or other lender |
| If we use our stock, our stockholders would experience dilution of their ownership interests |
| If we use cash or debt financing, our financial liquidity would be reduced |
| We may be required to capitalize a significant amount of intangibles, including goodwill, which may lead to significant amortization charges |
| In addition, we may incur significant, one-time write offs and amortization charges |
| These amortization charges and write offs could decrease our future earnings or increase our future losses |
| 15 ______________________________________________________________________ Our rights distribution, certificate of incorporation and Delaware law could make it more difficult for a third party to acquire us and may prevent our stockholders from realizing a premium on our stock |
| Our rights distribution and provisions of our certificate of incorporation and of the Delaware General Corporation Law may make it more difficult for a third party to acquire us, even if doing so would allow our stockholders to receive a premium over the prevailing market price of our stock |
| Our rights distribution and those provisions of our certificate of incorporation and Delaware law are intended to encourage potential acquirers to negotiate with us and allow our Board of Directors the opportunity to consider alternative proposals in the interest of maximizing stockholder value |
| However, such provisions may also discourage acquisition proposals or delay or prevent a change in control, which could negatively affect our stock price |
| The market value of our common stock could vary significantly, based on market perceptions of the status of our development efforts |
| The perception of securities analysts regarding our product development efforts could significantly affect our stock price |
| As a result, the market price of our common stock has and could in the future change substantially when we or our competitors make product announcements |
| Many factors affecting our stock price are industry related and beyond our control |
| Our future success is strongly dependent on development of new assist products and implantable replacement heart devices |
| Our development efforts may not be successful |
| We are currently devoting our major research and development and regulatory efforts, and significant financial resources, to the development of the AbioCor and AbioCor II, product extensions of existing commercial products and new products, such as the Impella Recover 2dtta5 and 5dtta0 micro blood pumps |
| The development of assist and replacement heart devices such as the AbioCor, AbioCor II, Impella blood pumps and other new products, presents enormous challenges in a variety of areas, many or all of which we may have difficulty in overcoming, including blood compatible surfaces, blood compatible flow, manufacturing techniques, pumping mechanisms, physiological control, energy transfer, anatomical fit and surgical techniques |
| Specifically, for many years, we and other parties have been attempting to develop a heart replacement device |
| We cannot be sure that we will be successful in our development efforts, and in the event that we are unable to commercialize the AbioCor and AbioCor II, our business and financial condition could be adversely affected |
| The markets for our products under development are unproven |
| Even if our products are successfully developed and approved by the FDA and corresponding foreign regulatory authorities, they may not enjoy commercial acceptance or success, which would adversely affect our business and results of operations |
| Several factors could limit our success, including: • our need to create a market for our new products: AB5000, AbioCor, AbioCor II, Impella products and possible limited market acceptance among physicians, medical centers, patients and third party payers; • the need for surgeons and cardiologists to develop or be trained in new surgical techniques or non-invasive procedures in order to use our products effectively; • limitations on the number of patients who may have access to physicians and medical centers with adequate training, equipment and personnel to make use of our products; • limitations inherent in first generation devices, and the potential failure to develop successive improvements, including increases in service life, which would reduce the addressable market for our products; • the lifestyle limitations that patients will have to accept; • the timing and amount of reimbursement for these products, if any, by third party payers; 16 ______________________________________________________________________ • the introduction by other companies of new treatments, products and technologies which compete with our products, and may reduce their market acceptance, or make them obsolete; • the reluctance, due to ethical considerations, of physicians, patients and society as a whole to accept significant medical devices that replace or assist the heart; and • the reluctance of physicians, patients and society as a whole to accept the finite life and risk of mechanical failure of devices that replace or assist the heart |
| The commercial success of the AB5000, AbioCor, AbioCor II, Impella Recover 2dtta5 and 5dtta0 micro blood pumps and other heart assist products will require acceptance by cardiovascular surgeons and interventional and heart failure cardiologists, a limited number of whom significantly influence medical device selection and purchasing decisions |
| We may achieve our business objectives only if our other products are accepted and recommended by leading physicians, which is likely to be based on a determination by these physicians that our products are safe, cost-effective and represent acceptable methods of treatment |
| Although we have developed relationships with leading cardiac surgeons and cardiologists, we cannot assure that these existing relationships and arrangements can be maintained or that new relationships will be established in support of our products |
| If cardiovascular surgeons and cardiologists do not consider our products to be adequate for the treatment of our target cardiac patient population or if a sufficient number of physicians recommend and use competing products, it would seriously harm our business |
| Testing of our new products will involve uncertainties and risks which could delay or prevent new product introductions, require us to incur substantial additional costs or result in our failure to bring our products to market |
| Development and testing of design changes to the AbioCor, AbioCor II, Impella 2dtta5 and 5dtta0 micro blood pumps and other products under development is often extensive, expensive and time consuming |
| Some of the tests for our products may require months or years to perform, and we could be required to begin these tests again if we modify one of our products to correct a problem identified in testing |
| Even modest changes to certain components of our products can take months or years to complete and test |
| If results of pre-clinical or clinical testing of our products under development indicate that design changes are required, such changes could cause serious delays that would adversely affect our results of operations |
| A number of companies in the medical industry have suffered delays, cost overruns and project terminations despite achieving promising results in pre-clinical testing or early clinical testing |
| In the event that we suffer setbacks in the pre-clinical or clinical testing of our heart assist and replacement products, these products may be delayed, require further funding, and possibly may not be brought to market |
| If we fail to obtain approval from the FDA and/or from foreign regulatory authorities, we cannot market and sell the affected products currently under development in the US and/or other countries |
| If we cannot demonstrate through clinical testing on humans or other means that the AbioCor or other new products under development and testing are safe and effective, we will not be able to obtain regulatory approvals in the US or other countries for the commercial sale of these products |
| We cannot assure that the FDA or any other regulatory authority will act quickly or favorably on our requests for this product approval, or that the FDA or any other regulatory authority will not require us to provide additional data that we do not currently anticipate in order to obtain product approvals |
| If we are successful in obtaining FDA approval for an HDE for the AbioCor, the initial approval is likely to include conditions or limitations to particular indications that would limit the available market for these products |
| If we are not able to obtain regulatory approvals for use of the AbioCor or our other products under development, or if the patient populations for which they are approved are not sufficiently broad, the commercial success of these products could be limited |
| We intend to market our new products in international markets, including the European Union and Japan |
| We must obtain separate regulatory approvals in order to market our products in other jurisdictions |
| The approval 17 ______________________________________________________________________ process may differ among those jurisdictions and approval in the US or in any other jurisdiction does not ensure approval in other jurisdictions |
| Obtaining foreign approvals could result in significant delays, difficulties and costs for us, and require additional trials and additional expense |
| If we obtain regulatory approval of our new products, the products will be subject to continuing review and extensive regulatory requirements, which could affect the manufacturing and marketing of our products |
| The FDA continues to review products even after they have received initial approval |
| If and when the FDA approves the Impella and AbioCor devices, or our other products under development, the manufacture and marketing of these products will be subject to continuing regulation, including compliance with QSR, adverse event reporting requirements and prohibitions on promoting a product for unapproved uses |
| We will also be required to obtain additional approvals in the event we significantly modify the design of an approved product or the product’s labeling or manufacturing process |
| Modifications of this type are common with new products, and we anticipate that the first generation of each of our products will undergo a number of changes, refinements and improvements over time |
| For example, the current configuration of the AbioCor’s thoracic unit, or “replacement heart,” is sized for patients with relatively large chest cavities, and we anticipate that we will need to obtain regulatory approval of thoracic units of other sizes |
| If we are not able to obtain regulatory approval of modifications to our current and future products, the commercial success of these products would be limited |
| We and our third-party suppliers of product components are also subject to inspection and market surveillance by the FDA for QSR and other requirements |
| Enforcement actions resulting from failure to comply with government requirements could result in fines, suspensions of approvals, recalls of products, operating restrictions and criminal prosecutions, and affect the manufacture and marketing of our products |
| The FDA could withdraw a previously approved product from the market upon receipt of newly discovered information, including a failure to comply with regulatory requirements, the occurrence of unanticipated problems with products following approval, or other reasons, which could adversely affect our operating results |
| The cost of developing and manufacturing the AbioCor, AbioCor II, Impella micro blood pumps and other planned new products is substantial for a company of our size and might exert a strain on our available resources |
| Spending on our AbioCor, AbioCor II, Impella micro blood pumps and other products under development will remain significant for some time |
| We expect that we will also need to make significant expenditures to begin to manufacture and market the AbioCor and our other planned new products in commercial quantities for sale in the US and other countries, if and when we obtain regulatory approval |
| We cannot be sure that our estimates of capital expenditures for the development of our new products will be accurate |
| We could have significant cost overruns, which could reduce our ability to commercialize our products |
| Any delay or inability to commercialize our products under development could adversely affect our business prospects and results of operations |