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SEC Filings

10-Q
HEARTWARE INTERNATIONAL, INC. filed this Form 10-Q on 11/02/2015
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The shares of Holdco common stock to be received by HeartWare stockholders and Valtech shareholders in connection with the Transactions will have different rights from the HeartWare common stock and the Valtech shares.

Upon completion of the Transactions, HeartWare stockholders and Valtech shareholders will become Holdco stockholders and their rights as stockholders will be governed by Holdco’s Certificate of Incorporation and Bylaws and Delaware law. The rights associated with each of the HeartWare common stock and Valtech ordinary shares are different than the rights associated with shares of Holdco common stock. Material differences between the rights of stockholders of HeartWare and the rights of shareholders of Holdco include differences with respect to among other things, exclusive forum provisions, stockholder actions, stockholder proposals and nominations, and Australian exchange listing rules (which no longer applies). Material differences between the rights of Holdco shareholders following the Transactions and the rights of Valtech shareholders before the Transactions include, among other things, differences with respect to the board of directors and the special rights of preferred shareholders. See “Comparison of the Rights of Holders of HeartWare Common Stock and Holdco Common Stock” beginning on page 144 and “Comparison of the Rights of Holders of Valtech Shares and Holdco Common Stock” beginning on page 146.

Risks Relating to Valtech’s Business

If Valtech fails to successfully introduce its products to the market, Valtech’s growth prospects may suffer.

If Valtech is slow in bringing its products to market or otherwise fails to successfully develop, manufacture, design clinical trials for, obtain regulatory approvals of, introduce or commercialize its product pipeline on a timely basis, or if products are not well accepted by the market, Valtech’s growth prospects may suffer.

Valtech has never generated any revenue from product sales and may never be profitable.

To date, Valtech has no commercial sales and has never generated any revenue from commercial product sales. Valtech’s ability to generate revenue and achieve profitability depends on Valtech’s ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize, one or more of its product candidates. Neither Valtech nor the combined company can predict when it will begin generating revenue from product sales, as this depends heavily on Valtech’s success in many areas, including but not limited to:

 

    attracting, hiring and retaining qualified personnel;

 

    completing nonclinical and clinical development of Valtech’s product candidates;

 

    developing and testing of Valtech’s product designs;

 

    obtaining regulatory and marketing approvals for product candidates for which Valtech has completed clinical studies;

 

    developing a sustainable and scalable manufacturing process for any approved product candidates and establishing and maintaining supply and manufacturing relationships with third parties that can process and provide adequate (in amount and quality) products to support clinical development and the market demand for Valtech’s product candidates, if approved;

 

    launching and commercializing product candidates for which Valtech obtains regulatory and marketing approval, either directly or with collaboration partners or distributors;

 

    obtaining adequate third-party coverage and reimbursements for Valtech’s products;

 

    obtaining market acceptance of Valtech’s product candidates as viable treatment options;

 

    addressing any competing technological and market developments;

 

 

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