1113481--3/1/2007--MEDICINES_CO_/DE

related topics
{product, liability, claim}
{product, candidate, development}
{property, intellectual, protect}
{acquisition, growth, future}
{personnel, key, retain}
{stock, price, share}
{stock, price, operating}
{control, financial, internal}
{provision, law, control}
{customer, product, revenue}
{regulation, government, change}
{financial, litigation, operation}
Risks Related to Our Financial Results We have a history of net losses and may not maintain profitability on an annual basis Our business is very dependent on the commercial success of Angiomax Our revenue has been substantially dependent on a limited number of domestic wholesalers and international distributors to which we sell Angiomax, and such revenue may fluctuate from quarter to quarter based on the buying patterns of these wholesalers and distribution partners and the levels of inventory they maintain Failure to achieve our revenue targets or raise additional funds in the future may require us to delay, reduce the scope of, or eliminate one or more of our planned activities Angiomax competes with all categories of anticoagulant drugs, which may limit the use of Angiomax Because the market for thrombin inhibitors is competitive, our product may not obtain widespread use We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do Near-term growth in our sales of Angiomax is dependent on acceptance by physicians, patients and other key decision-makers of Angiomax clinical data Our ability to generate future revenue from products will be affected by reimbursement and drug pricing We must comply with federal, state and foreign laws and regulations relating to the health care business, and, if we do not fully comply with such laws and regulations, we could face substantial penalties. We could be exposed to significant liability if we are unable to obtain insurance at acceptable costs and adequate levels or otherwise protect ourselves against potential product liability claims Risks Related to Regulatory Matters If we do not obtain regulatory approvals for our product candidates we will not be able to market our product candidates and our ability to generate additional revenue could be materially impaired We cannot expand the indications for which we are marketing Angiomax unless we receive FDA approval for each additional indication. Failure to expand these indications will limit the size of the commercial market for Angiomax Clinical trials of product candidates are expensive and time-consuming, and the results of these trials are uncertain If we or our contract manufacturers fail to comply with the extensive regulatory requirements to which we, our contract manufacturers and our products are subject, our products could be subject to restrictions or withdrawal from the market and we could be subject to penalties Risks Related to our Dependence on Third Parties for Manufacturing, Research and Development, and Distribution Activities We depend on single suppliers for the production of Angiomax, Cleviprex and cangrelor bulk drug substance and different single suppliers to carry out all fill-finish activities The development and commercialization of our products may be terminated or delayed, and the costs of development and commercialization may increase, if third parties on whom we rely to manufacture and support the development and commercialization of our products do not fulfill their obligations Use of third party manufacturers may increase the risk that we will not have appropriate supplies of our product candidates Risks Related to our Intellectual Property A breach of any of the agreements under which we license commercialization rights to products or technology from others could cause us to lose license rights that are important to our business or subject us to claims by our licensors If we are unable to obtain or maintain patent protection for the intellectual property relating to our products, the value of our products will be adversely affected We may be unable to utilize the Chemilog process if Lonza Braine breaches our agreement If we are not able to keep our trade secrets confidential, our technology and information may be used by others to compete against us If we infringe or are alleged to infringe intellectual property rights of third parties, it will adversely affect our business Risks Related to Growth and Employees If we fail to acquire and develop additional product candidates or approved products it will impair our ability to grow We may undertake strategic acquisitions in the future and any difficulties from integrating such acquisitions could damage our ability to attain or maintain profitability We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants Risks Related to Our Common Stock Fluctuations in our operating results could affect the price of our common stock Our stock price has been and may in the future be volatile. This volatility may make it difficult for you to sell common stock when you want or at attractive prices Our corporate governance structure, including provisions in our certificate of incorporation and by-laws and Delaware law, may prevent a change in control or management that security holders may consider desirable

Full 10-K form ▸

related documents
1113481--3/15/2006--MEDICINES_CO_/DE
1113481--2/29/2008--MEDICINES_CO_/DE
1113481--3/16/2010--MEDICINES_CO_/DE
1354217--3/17/2008--Volcano_CORP
1048477--2/28/2007--BIOMARIN_PHARMACEUTICAL_INC
1276591--2/28/2008--HANSEN_MEDICAL_INC
1048477--3/7/2006--BIOMARIN_PHARMACEUTICAL_INC
1180145--9/29/2009--Cardiovascular_Systems_Inc
907562--3/12/2010--DYAX_CORP
1048477--2/26/2010--BIOMARIN_PHARMACEUTICAL_INC
1008848--2/26/2010--ACORDA_THERAPEUTICS_INC
1276591--3/28/2007--HANSEN_MEDICAL_INC
1048477--2/28/2008--BIOMARIN_PHARMACEUTICAL_INC
1048477--2/27/2009--BIOMARIN_PHARMACEUTICAL_INC
1100962--3/1/2007--ENDO_PHARMACEUTICALS_HOLDINGS_INC
1047188--3/17/2008--PENWEST_PHARMACEUTICALS_CO
1047188--3/16/2010--PENWEST_PHARMACEUTICALS_CO
1411861--3/10/2010--MAKO_Surgical_Corp.
1351197--3/14/2008--ARTES_MEDICAL_INC
815838--3/12/2007--NOVEN_PHARMACEUTICALS_INC
711665--3/16/2006--PHOTOMEDEX_INC
711665--3/16/2007--PHOTOMEDEX_INC
1088856--3/31/2008--CORCEPT_THERAPEUTICS_INC
1351197--3/30/2007--ARTES_MEDICAL_INC
1411861--3/31/2008--MAKO_Surgical_Corp.
1088856--4/2/2007--CORCEPT_THERAPEUTICS_INC
946840--3/2/2009--VIROPHARMA_INC
887708--6/15/2009--CARACO_PHARMACEUTICAL_LABORATORIES_LTD
919015--3/26/2008--BIOSPHERE_MEDICAL_INC
919015--3/20/2009--BIOSPHERE_MEDICAL_INC