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SEC Filings

HEARTWARE INTERNATIONAL, INC. filed this Form 10-Q on 11/02/2015
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The continuing development of many of Valtech’s products depends upon Valtech maintaining strong relationships with health care professionals. Notably, consolidation has occurred recently in the structural heart space as strategic players have acquired new technologies. Most of these players have greater financial resources and larger employee pools than Holdco and Valtech.

The research, development, marketing and sales of many of Valtech’s proposed products is dependent upon Valtech maintaining working relationships with health care professionals. Valtech relies on these professionals to provide Valtech with knowledge and experience regarding the development, marketing and planned sale of Valtech’s products. Health care professionals assist Valtech as researchers, marketing and product consultants, inventors and public speakers. If Valtech is unable to maintain Valtech’s strong relationships with these professionals and continue to receive their advice and input, the development and marketing of Valtech’s planned products could suffer, which could have a material adverse effect on Valtech’s future earnings and financial condition.

Valtech’s products are the subject of clinical trials, the results of which may be unfavorable, or perceived as unfavorable, and could have a material adverse effect on Valtech’s future business, financial condition, and results of operations.

As a part of the regulatory process of obtaining marketing clearance or approval for new products and modifications to or new indications for existing products, Valtech conducts and participates in numerous clinical trials with a variety of study designs, patient populations and trial endpoints. Unfavorable or inconsistent clinical data from existing or future clinical trials, or the market’s or a regulatory body’s perception of this clinical data, may adversely impact Valtech’s ability to obtain product clearances or approvals in some or all geographies. Success in pre-clinical testing and early clinical trials does not always ensure that later clinical trials will be successful, and Valtech cannot be sure that later trials will replicate the results of prior trials and studies. Any delay or termination of Valtech’s clinical trials will delay the filing of product submissions and, ultimately, Valtech’s ability to commercialize new products or product modifications. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product’s profile, which could inhibit further marketing and development of such products.

Valtech’s success is related to management’s performance.

To a large extent, Valtech’s success is predicated on the ability of its management team to effectively manage Valtech and the individual businesses that it operates. The loss of the services of a senior manager or other key employee without an adequate replacement or the inability to attract and retain new and qualified resources could have a negative impact on Valtech’s business outlook, activities and operating and financial results.

Valtech’s business is dependent on its relationship with suppliers.

Valtech currently manufactures its products at its own facilities or through subcontractors located in various countries, purchasing the components and materials used to manufacture these products from various suppliers. However, specific components and raw materials are purchased from primary or main suppliers (or in some cases, a single supplier) for reasons related to quality assurance, cost-effectiveness and availability. While Valtech works closely with its suppliers to expand capacity and ensure supply continuity, it cannot guarantee that its efforts will always be successful. Moreover, due to the strict standards and regulations governing the manufacture and marketing of its products, Valtech may not be able to quickly locate new supply sources in response to a supply reduction or interruption, with negative effects on its ability to manufacture its products effectively and in a timely fashion.