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Changed Risks for ACCELERON PHARMA INC (XLRN)

Our relationships with healthcare providers, physicians and third-party payers will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which, in the event of a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings

We currently have limited marketing, sales and distribution experience and capabilities and, for luspatercept and, outside of the PH field, sotatercept, we will be dependent upon Celgene for commercialization

inter partes

We may require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts

internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock

If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed

We have incurred net operating losses since our inception and anticipate that we may continue to incur substantial operating losses for the foreseeable future We may never achieve or sustain profitability

Comprehensive tax reform legislation could adversely affect our business and financial condition

We incur significant costs as a result of operating as a public company and complying with the Sarbanes-Oxley Act, and our management is required to devote substantial time to compliance initiatives If we fail to maintain an effective system of

We manufacture ACE-083, ACE-2494, our other unpartnered and preclinical therapeutic candidates, and, for our Acceleron-sponsored trials, luspatercept, at our manufacturing facility If our manufacturing facility is damaged or destroyed or production at this facility is otherwise interrupted, our business and prospects would be negatively affected

We are dependent on Celgene for the successful development and commercialization of sotatercept outside of the PH field and our most advanced therapeutic candidate, luspatercept If Celgene does not devote sufficient resources to the development of luspatercept, discontinues development of luspatercept, is unsuccessful in its efforts, or chooses to terminate the luspatercept agreement with us, our business will be materially harmed