Liestal, Switzerland, April16, 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 CHF11.1 million in 2012, the cash position at year-end amounted to CHF12.3 million. To secure operations, the Company has initiated further financial and operational restructuring measures. The Annual Shareholders` Meeting will be convened on May13, 2013 to decide on the future direction of Santhera.
Key financial figures 2012
CHF12.3 million cash reserves at year-end 2012 reflect significant reduction in cash burn As of December31, 2012, Santhera had cash and cash equivalents of CHF12.3 million (2011: CHF23.4 million). Net change in cash for 2012 versus 2011 was CHF11.1 million (2011: CHF-20.3 million). In 2012, the net cash burn was decreased to below the one-million-threshold per month (CHF0.9 million compared to CHF1.7 million in 2011). Total equity at year-end 2012 amounted to CHF11.7 million (2011: CHF43.0 million).
Revenues from product sales In 2012, Catena generated net sales of CHF3.5 million, a modest increase of 8.4% over 2011 (CHF3.3 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 CHF34.7 million (2011: CHF30.5 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 CHF22.2 million. These non-cash-relevant items were allocated to research and development (R&D). As a result, expenses in R&D increased to CHF28.7 million (2011: CHF18.1 million). Marketing and sales expenses further decreased to CHF1.8 million (2011: CHF2.1 million) while expenses for general and administrative were more than halved to CHF4.1 million (2011: CHF10.2 million which included restructuring costs). For 2012, Santhera reports a net loss of CHF31.4 million (2011: CHF27.8 million).
On February27, 2013, Santhera had announced its voluntary withdrawal of Catena from the Canadian market effective April30, 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.
See the article here:
Santhera Reports 2012 Financial Figures and Announces Restructuring