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Santhera Reports 2012 Financial Figures and Announces Restructuring Dienstag, 16. April 2013 - 07:14

April 16, 2013: Santhera Reports 2012 Financial Figures and Announces Restructuring

Liestal, Switzerland, April 16, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today financial results for 2012. The operating result increased to CHF -31.2 million and the net result to CHF -31.4 million both due to non-cash-relevant impairments. With a significantly reduced cash burn of CHF 11.1 million in 2012, the cash position at year-end amounted to CHF 12.3 million. To secure operations, the Company has initiated further financial and operational restructuring measures. The Annual Shareholders' Meeting will be convened on May 13, 2013 to decide on the future direction of Santhera.

Key financial figures 2012

(IFRS, consolidated, in CHF thousands) 2012 2011
Cash and cash equivalents 12,283 23,406
Net change in cash and cash equivalents -11,123 -20,276
Net sales 3,538 3,265
Operating expenses -34,701 -30,517
Operating result -31,155 -27,213
Net result -31,448 -27,838

CHF 12.3 million cash reserves at year-end 2012 reflect significant reduction in cash burn As of December 31, 2012, Santhera had cash and cash equivalents of CHF 12.3 million (2011: CHF 23.4 million). Net change in cash for 2012 versus 2011 was CHF 11.1 million (2011: CHF -20.3 million). In 2012, the net cash burn was decreased to below the one-million-threshold per month (CHF 0.9 million compared to CHF 1.7 million in 2011). Total equity at year-end 2012 amounted to CHF 11.7 million (2011: CHF 43.0 million).

Revenues from product sales In 2012, Catena® generated net sales of CHF 3.5 million, a modest increase of 8.4% over 2011 (CHF 3.3 million). As in previous years, the majority of sales originated from Canada for the indication Friedreich's Ataxia and the remainder from sales under the Named Patient Program in Europe and other territories. Operating expenses accumulated to CHF 34.7 million (2011: CHF 30.5 million). The operating result increased to CHF -31.2 million (2011: CHF -27.2 million) mainly due to result of impairments on intangibles and the write-down of inventories of CHF 22.2 million. These non-cash-relevant items were allocated to research and development (R&D). As a result, expenses in R&D increased to CHF 28.7 million (2011: CHF 18.1 million). Marketing and sales expenses further decreased to CHF 1.8 million (2011: CHF 2.1 million) while expenses for general and administrative were more than halved to CHF 4.1 million (2011: CHF 10.2 million which included restructuring costs). For 2012, Santhera reports a net loss of CHF 31.4 million (2011: CHF 27.8 million).

On February 27, 2013, Santhera had announced its voluntary withdrawal of Catena® from the Canadian market effective April 30, 2013. This decision followed review of additional data from clinical trials in patients with Friedreich's Ataxia, and subsequent consultation with Health Canada.

Outlook Santhera's current funding is not sufficient to support the going concern assumption and the Company depends on further financing to ensure the continuation of its operations through the fourth quarter of 2013 and to execute its strategy as outlined below.

Having filed a Marketing Authorization Application (MAA) with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in Leber's Hereditary Optic Neuropathy (LHON) in 2011, Santhera received a negative opinion on its MAA in January 2013 and withdrew its application for strategic reasons in March 2013. Santhera plans to file a new application based on emerging clinical evidence further evaluating the efficacy of Raxone® in the treatment of LHON. Santhera expects to submit a new MAA towards the end of this year.

The ability to file a revised MAA and to continue business operations until the CHMP reaches a decision on this new filing is contingent on the availability of sufficient financial resources. As a consequence, Santhera has implemented restructuring measures to further reduce its workforce, operational costs and its financial liabilities in connection with the lease of its premises and other obligations.

In addition, Management has initiated measures to secure additional financing by exploring possibilities of a merger, sale or licensing of its assets. Santhera has received expression of interest (non-binding Letters of Intent) from third parties for financial support. Nevertheless, shareholders should note that whilst the Management and Board of Directors continue to apply best efforts to evaluate available options and take the steps described, there can be no guarantee that any transaction can be realized or that such transaction would generate sufficient funds to finance further operations.

The access to additional funds is decisive for Santhera and its ability to continue operations and the absence of such a transaction would make it impossible to continue as a going concern. Under such circumstances, Santhera would have to discontinue its business operations and could no longer apply the going concern assumption in preparing its financial statements for 2013.

The Board believes in the Company's chances in securing additional financing with the possibilities for a merger, sale or licensing of its assets before the end of the third quarter 2013 with the objective to be able to meet all of its obligations for a further 12 months. Hence, the consolidated financial statements for 2012 have been prepared on a going concern basis.

Annual Shareholders' Meeting The Annual Shareholders' Meeting will be convened on May 13, 2013 to decide on the future direction of Santhera. The Board proposes the continuation of the Company's operations. In case the shareholders do not approve this motion, the Board would propose to the shareholders to liquidate Santhera. In addition, the Board proposes to re-elect Martin Gertsch for a period of one year. Currently Vice-Chairman, it is anticipated that he will become Chairman. Klaus Schollmeier, currently Chairman, will not stand for re-election, and Timothy Rink has tendered his resignation effective as of the day of the Shareholders' Meeting. Subject to the shareholders' approval, the Board would therefore consist of two members, Martin Gertsch and Jürg Ambühl. Shareholders entered into the share register by May 8, 2013 are invited to the Shareholders' Meeting.

2012 Financial Information  The complete financial statements of Santhera and the report on corporate governance are available on the Company's Web site www.santhera.com.

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About Santhera Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan neuromuscular and mitochondrial diseases, areas of high unmet medical need with no current therapies. For further information, please visit www.santhera.com.

 

Catena® and Raxone® are trademarks of Santhera Pharmaceuticals.

For further information, contact  Thomas Meier, Chief Executive Officer Phone: +41 61 906 89 64 thomas.meier@santhera.com

Disclaimer / Forward-looking statements  This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.