Santhera Announces Interim Financial Results for the First Half Year of 2011 and Restructuring Plans to Concentrate on Catena® Franchise
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Santhera Pharmaceuticals Holding AG /
Santhera Announces Interim Financial Results for the First Half Year of 2011 and
Restructuring Plans to Concentrate on Catena® Franchise
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The issuer is solely responsible for the content of this announcement.
Liestal, Switzerland, August 29, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today the financial results for the first half of 2011 and plans for a
restructuring. In the first six months of 2011, Catena® reached net sales of
CHF 1.6 million, net cash burn was reduced to CHF 12.3 million and the net
result amounted to CHF -15.0 million. As of June 30, 2011, the Company had cash
reserves of CHF 31.4 million. Due to the pressure of the continuously volatile
markets, Santhera intends to concentrate its operations on its key asset Catena®
and its multiple opportunities in late-stage development to secure more
financial flexibility independent from fund raising or licensing income. As a
consequence the operational resources are planned to be reduced to secure cash
reach into 2013, well beyond the expected decision by the European Medicines
Agency (EMA) on the Marketing Authorization Application (MAA) in Leber's
Hereditary Optic Neuropathy (LHON).
Key financial figures (unaudited)
(IFRS, consolidated, for half year ended June 30, in CHF 2011 2010 Changes
thousands)
Cash and cash equivalents 31,399 43,6821 -28,1 %
Net change in cash and cash equivalents -12,283 -13,843 -11,3 %
Net sales 1,626 1,711 -5,0 %
Operating expenses -15,629 -15,703 -0.5 %
Operating result -13,925 -13,669 1.9 %
Net result -15,015 -14,163 6.0 %
1 as of December 31, 2010
2011 Interim Report: Cash reserves of CHF 31.4 million and debt-free balance
sheet
As of June 30, 2011, Santhera had cash and cash equivalents of CHF 31.4 million
(end of 2010: CHF 43.7 million) and no debts. Net change in cash in the first
half year of 2011 was reduced to CHF -12.3 million compared to CHF -13.8 million
in the same period in 2010, despite negative currency impacts. Total equity at
mid-year 2011 amounted to CHF 54.5 million (2010: CHF 67.1 million).
In the first six months of 2011, Catena® generated net sales of CHF 1.6 million
(first half of 2010: CHF 1.7 million). Operating expenses amounted to CHF 15.6
million (first half of 2010: CHF 15.7 million) in line with management
expectation. As a consequence, the operating result (CHF -13.9 million) was on
the same level as in the same period in the previous year (first half of 2010:
CHF
-13.7 million). The expenses for research and development were CHF 9.1 million,
while expenses for marketing and sales and general and administration amounted
to CHF 1.3 million and CHF 5.1 million, respectively . For the first half of
2011, Santhera reports a net result of CHF -15.0 million (first half of 2010:
CHF -14.2 million).
Santhera intends to align its organization to focus on the development and
commercialization of its Catena® franchise while continuing to evaluate
strategic alternatives. Under current financial planning assumptions and absent
further income from partnerships and/or funds from financing, the planned
restructuring and focus on Catena® allows Santhera to remain financed into 2013.
Strategic focus on Catena® offers multiple opportunities in orphan diseases
Catena® is marketed in Canada for the treatment of Friedreich's Ataxia and
available on named-patient basis in Europe and in other territories. In the
first half of 2011, Santhera generated revenues of CHF 1.6 million.
In Europe, the MAA for Catena®, potentially the first therapy for the treatment
of LHON, is currently under review. A decision from the EMA is anticipated in
late summer 2012.
Catena® is also being investigated in a Phase III trial in Duchenne Muscular
Dystrophy (the DELOS study). Following a review of the study assumptions, it has
been decided to increase the number of corticosteroid non-using patients beyond
40 as originally planned. As a consequence the planned interim analysis will be
delayed.
In addition, Catena® is being developed in MELAS syndrome (the MELTIMI study)
and Primary Progressive Multiple Sclerosis (the IPPOMS study), conducted as
investigator-initiated trials by the Columbia University of New York City and
the US National Institutes of Health, respectively. Enrollment of the last
patients into the MELTIMI study is expected in the second half of 2011.
Other pipeline programs
Following the analysis of additional data generated with fipamezole by Santhera
and its partners and the recent scientific debate on optimal clinical endpoints
for the measurement of dyskinesia in Parkinson's' disease as well as feedback
from the ongoing partnering process for North America, the Company decided to
seek advice from the US Food and Drug Administration (FDA) regarding further
clinical development of fipamezole, causing a delay in the partnering process
for North America.
Santhera foresees no further financial commitments for fipamezole or for
omigapil, its third clinical-stage compound, for which development will be
advanced only upon availability of external funds such as grant money.
Restructuring in Switzerland and in the U.S.
Santhera intends to concentrate its financial and human resources on Catena® and
to adjust the Company's organization to reduce costs and secure a cash runway
into 2013.
The operations in North America will be reduced to focus exclusively on the
commercialization of Catena® in Canada. In Switzerland, the Company intends to
concentrate on clinical development and regulatory affairs while nonclinical
research and administration are planned to be reduced. As a consequence,
Santhera intends to cut its workforce from currently 47 to 26. The legally
required consultation process with the Swiss employees has been initiated.
"Securing the financial flexibility in the ongoing volatile market environment
has become Santhera's highest priority. The Board of Directors unanimously
decided to restructure the Company and to strengthen the focus on Catena®. We
consider this the best option to maximize the value of the Catena® franchise for
the Company and its shareholders", said Michael Lytton, Chairman of the Board.
Management and Board changes
Thomas Meier, currently Chief Scientific Officer, will become Chief Executive
Officer, following Klaus Schollmeier who will become Chairman of the Board,
starting October 1, 2011. Helmut Kessmann, Chief Business Officer, and Barbara
Heller, Chief Financial Officer, have resigned and decided to leave the Company
within the next months to pursue other interests.
Considering the operational changes and the needs of the Company going forward,
the Board has decided to reduce the number of its members. As a consequence,
Michael Lytton, Chairman, Hans-Peter Hasler, Vice Chairman, and Bernd Seizinger
have tendered their resignation with effect from October 1, 2011, after which
the Board will consist of four members: Jürg Ambühl, Martin Gertsch, Timothy
Rink and Klaus Schollmeier. Mr Schollmeier will become Chairman of the Board and
Mr Gertsch will remain Chairman of the Audit Committee.
Klaus Schollmeier, designated Chairman of the Board, commented: "I sincerely
thank the leaving employees, executives and Board members for their long-term
and valuable contributions to Santhera. They all have been instrumental in
defining and implementing Santhera's strategy in orphan neuromuscular diseases."
Outlook
The EMA is currently reviewing the MAA for Catena® as first treatment of LHON
and a decision is expected in late summer 2012. Under current planning
assumptions, the measures announced today will secure cash reach beyond this
decision point and into 2013 giving Santhera enough financial flexibility to
develop the Catena® franchise and preserve other important assets in the
company's pipeline.
2011 Half-year Financial Information
The 2011 Interim Report of Santhera Pharmaceuticals including the unaudited
consolidated financial statements is available on the Company's Web site under
www.santhera.com/reports.
Condensed interim consolidated income statement (unaudited)
(IFRS, for half year ended June 30, in CHF thousands) 2011 2010
Net sales 1,626 1,711
Gross profit 1,446 1,482
Other operating income 258 552
Research and development -9,129 -7,947
Marketing and sales -1,329 -2,151
General and administrative -5,094 -5,553
Other operating expenses -77 -52
Operating expenses -15,629 -15,703
Operating result -13,925 -13,669
Financial result -833 -412
Income taxes -257 -82
Net result -15,015 -14,163
Basic and diluted loss per share (in CHF) -4.10 -3.87
Condensed interim consolidated balance sheet (unaudited)
(IFRS, in CHF thousands) June 30, 2011 December 31, 2010
Cash and cash equivalents 31,399 43,682
Noncurrent assets 29,843 31,157
Other current assets 4,118 3,927
Total assets 65,360 78,766
Equity 54,519 69,627
Noncurrent liabilities 3,842 3,882
Current liabilities 6,999 5,257
Total equity and liabilities 65,360 78,766
Condensed interim consolidated cash flow statement (unaudited)
(IFRS, for half year ended June 30, in CHF thousands) 2011 2010
Gross operating/investing cash flow -13,013 -15,762
Cash and cash equivalents at January 1 43,682 53,320
Cash and cash equivalents at June 30 31,399 39,477
Net change in cash and cash equivalents -12,283 -13,843
Share capital
June 30, 2011 December 31, 2010
Number of shares issued with par value of CHF 1 3,660,438 3,660,438
Conditional capital for stock options 644,296 644,296
Conditional capital for convertible rights 600,000 600,000
Authorized capital 1,800,000 1,800,000
* * *
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 severe neuromuscular diseases, an area of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is
marketed in Canada. Catena® is currently under review for marketing
authorization by the European Medicine Agency as the first therapy for patients
suffering from Leber's Hereditary Optic Neuropathy. For further information,
please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone +41 (0)61 906 89 52
klaus.schollmeier(at)santhera.com
Barbara Heller, Chief Financial Officer
Phone +41 (0)61 906 89 54
barbara.heller(at)santhera.com
Thomas Staffelbach, VP, Head of Public & Investor Relations
Phone +41 (0)61 906 89 47
thomas.staffelbach(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.
--- End of Message ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
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Datum: 29.08.2011 - 20:00 Uhr
Sprache: Deutsch
News-ID 60278
Anzahl Zeichen: 15944
contact information:
Town:
Liestal
Kategorie:
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