Santhera Pharmaceuticals Holding AG : Santhera Reports 2012 Financial Figures
and Announces Restructuring
Santhera Pharmaceuticals Holding AG / Santhera Reports 2012 Financial Figures
and Announces Restructuring . Processed and transmitted by Thomson Reuters
ONE. The issuer is solely responsible for the content of this announcement.
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
(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
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.
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 May13, 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 May8, 2013 are invited to the Shareholders'
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.
* * *
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
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.
News release FY2012
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
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Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
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