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 on www.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 |
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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@santhera.com
Thomas Staffelbach, Vice President, Head of Public & Investor Relations
Phone +41 (0)61 906 89 47
thomas.staffelbach@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.
