Santhera Reports 2012 Financial Figures and Announces Restructuring
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Santhera Pharmaceuticals Holding AG /
Santhera Reports 2012 Financial Figures and Announces Restructuring
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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.
* * *
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(at)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.
News release FY2012:
http://hugin.info/137261/R/1693293/556557.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1693293]
Unternehmensinformation / Kurzprofil:
Datum: 16.04.2013 - 07:10 Uhr
Sprache: Deutsch
News-ID 249239
Anzahl Zeichen: 9784
contact information:
Town:
Liestal
Kategorie:
Business News
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