Santhera Reports Stable Product Sales in 2011 and Cash Reserves of CHF 23.4 Million Following Completion of Restructuring
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Santhera Pharmaceuticals Holding AG /
Santhera Reports Stable Product Sales in 2011 and Cash Reserves of CHF 23.4
Million Following Completion of Restructuring
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Liestal, Switzerland, February 24, 2012 - Santhera Pharmaceuticals (SIX: SANN)
announced today financial results for 2011 and provided an update on the
commercial and development portfolio. Net sales of Catena® amounted to CHF 3.3
million, an increase of 6% in local currencies over the previous year. The
operating result was CHF -27.2 million and the net result was CHF -27.8 million.
With a cash burn of CHF -20.3 million in 2011, the cash position at year-end
amounted to CHF 23.4 million. Last year the Company successfully completed a
restructuring and is now focusing on Catena® in several orphan indications.
Considering its cash reserves, Santhera's current operations are financed into
2013.
Main achievements in 2011 include
- Continued commercial success with Catena® in Canada and through the Named
Patient Program in Europe and other territories
- Marketing Authorization Application in Leber's Hereditary Optic Neuropathy
(LHON) accepted for review by the European Medicines Agency
- Completion of restructuring and strategic focus on Catena® franchise and its
several opportunities in orphan diseases
Key financial figures 2011
(IFRS, consolidated, in CHF thousands) 2011 2010
Cash and cash equivalents 23,406 43,682
Net change in cash and cash equivalents -20,276 -9,638
Net sales 3,265 3,496
Operating expenses -30,517 -29,694
Operating result -27,213 -8,711
Net result -27,838 -11,256
Commenting on the operational performance of 2011, Thomas Meier, Chief Executive
Officer of Santhera, said: "The increase of 6% in net sales in local currencies
underlines the medical relevance of Catena® and the the commercial success of
this product in neuromuscular and mitochondrial orphan diseases. The submission
of the Marketing Authorization Application in Europe for LHON represents a
highlight of the past year. The review is ongoing and a decision by the European
Medicines Agency can be expected in the second half of 2012." He continued:
"Santhera ended 2011 with a better-than-anticipated cash position reflecting the
strict cost control and focused spending on key programs. Following the
restructuring and the accompanying cash preservation measures, the Company's
current operations are financed into 2013."
CHF 23.4 million cash at year-end 2011
As of December 31, 2011, Santhera had cash and cash equivalents of CHF 23.4
million (2010: CHF 43.7 million). Net change in cash for 2011 versus 2010 was
CHF -20.3 million (2010: CHF -9.6 million) whereby in 2011 the net cash burn
decreased from a monthly CHF 2.0 million in first half-year to a monthly CHF 1.3
million for the second half. Total equity at year-end 2011 amounted to CHF 43.0
million (2010: CHF 69.6 million).
Stable revenue from product sales
In 2011, Catena® generated net sales of CHF 3.3 million, and despite negative
currency influences ended almost at the level of 2010 (CHF 3.5 million). In
local currencies, sales increased by 6%. The majority of sales originated from
Canada for the indication Friedreich's Ataxia. Sales under the Named Patient
Program in Europe and other territories continue to grow. In 2011, no income
from partnering was achieved (2010: EUR 13.0 million from Ipsen). Operating
expenses amounted to CHF 30.5 million (2010: CHF 29.7 million). The operating
result of CHF -27.2 million (2010: CHF -8.7 million) reflects the absence of
licensing income and includes restructuring costs of CHF 3.5 million, primarily
allocated to general and administrative (G&A) and research and development
(R&D). In 2011, expenses in R&D increased to CHF 18.1 million (2010: CHF 15.7
million). Marketing and sales expenses further decreased to CHF 2.1 million
(2010: CHF 3.5 million) while G&A expenses remained stable at CHF 10.2 million
(2010: CHF 10.4 million). For 2011, Santhera reports a net loss of CHF 27.8
million (2010: CHF 11.3 million).
During the last quarter of 2011 Santhera completed a restructuring as announced
in August 2011. As a result, at year end there were 28.5 full-time equivalents
employed (2010: 44.7).
Outlook
In line with its revised strategy, Santhera focuses financial and human
resources on the Catena® franchise and its several opportunities in orphan
neuromuscular and mitochondrial diseases. The Company's main priorities for
2012 are the regulatory approval process for LHON and, tightly tied to its
progress, preparations for a market entry, as well as the ongoing DELOS
Phase III study in Duchenne Muscular Dystrophy. Based on the latest financial
planning, Santhera's current programs are financed into 2013.
Santhera is adding clinical study sites for the DELOS trial in the US and in
Europe as the intended size of the first cohort of patients, i.e. patients not
on glucocorticoid co-medication, has been increased to 80 participants. Topline
results from the MELTIMI Phase IIa study in MELAS syndrome, currently conducted
by the Columbia University of New York City, are anticipated by mid-year 2012.
In the second half of 2012, clinical data in Friedreich's Ataxia is expected
from the MICONOS-E two-year open label extension and the PROTI randomized
withdrawal studies. The long-term
IPPoMS Phase I/II study in Primary Progressive Multiple Sclerosis is advancing
as planned at the US National Institute of Neurological Disorders and Stroke.
Finally, with support from third-party funding, omigapil is being prepared for a
Phase I study in patients with Congenital Muscular Dystrophies.
Webcast / Teleconference
At 11:00 CET / 10:00 UKT on February 24, 2012, Santhera management will present
and discuss the 2011 financial results. The webcast is accessible
onwww.santhera.com/webcast or via teleconference using the conference ID
46 552 354 and one of the following dial-ins:
Switzerland 056 580 00 07
Germany 0692 222 4918
UK 0844 493 3800
International +44 (0) 1452 555 566
USA 1 866 966 9439
The webcast will be available for playback one hour after the presentation ends.
2011 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.
Condensed Balance Sheets
(IFRS, consolidated, in CHF thousands) December 31, 2011 December 31, 2010
Cash and cash equivalents 23,406 43,682
Noncurrent assets 25,527 31,157
Other current assets 3,101 3,927
Total assets 52,034 78,766
Equity 42,984 69,627
Noncurrent liabilities 3,392 3,882
Current liabilities 5,658 5,257
Total equity and liabilities 52,034 78,766
Condensed Income Statements
(IFRS, consolidated, in CHF thousands) 2011 2010
Net sales 3,265 3,496
Revenue from licensing 0 17,113
Total revenue 3,265 20,609
Gross profit 2,927 20,231
Other operating income 377 752
Research and development -18,125 -15,690
Marketing and sales -2,076 -3,452
General and administrative -10,213 -10,442
Other operating expenses -103 -110
Operating expenses -30,517 -29,694
whereof non-cash-relevant items -5,912 -5,110
Operating result -27,213 -8,711
Cash operating result -21,301 -3,601
Net financial result -318 -2,872
Result before taxes -27,531 -11,583
Income taxes -307 327
Net result -27,838 -11,256
Basic and diluted loss per share (in CHF) -7.60 -3.08
Condensed Cash Flow Statements
(IFRS, consolidated, in CHF thousands) 2011 2010
Operating cash flow -19,894 -6,636
Cash and cash equivalents at January 1 43,682 53,320
Cash and cash equivalents at December 31 23,406 43,682
Net change in cash and cash equivalents -20,276 -9,638
Share Capital
(As of December 31) 2011 2010
Number of shares issued (nominal value CHF 1) 3,673,463 3,660,438
Conditional capital for stock options 631,271 644,296
Conditional capital for convertible rights 600,000 600,000
Authorized capital 1,800,000 1,800,000
Corporate Calendar 2012
Monday, April 23 Annual Shareholders' Meeting, Basel
Friday, August 31 2012 Interim Financial Report
* * *
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. Santhera's first
product Catena® is currently marketed in Canada to treat Friedreich's Ataxia.
Catena® is also 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
Thomas Meier, Chief Executive Officer
Phone: +41 (0)61 906 89 64
thomas.meier(at)santhera.com
Thomas Staffelbach, Vice President, 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.
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