Liestal, Switzerland, August 31, 2012 - Santhera Pharmaceuticals (SIX: SANN) announced today the financial results for the first half of 2012. In the first six months of 2012, Catena® generated net sales of CHF 1.7 million. The net cash burn was significantly reduced to CHF 7.2 million resulting in a net loss of CHF 5.5 million. As of June 30, 2012, Santhera had cash reserves of CHF 16.2 million, which secure the funding of the current operations into 2013 and well beyond the expected decision by the European Medicines Agency (EMA) on the Marketing Authorization Application (MAA) in Leber's Hereditary Optic Neuropathy (LHON).
Main achievements in 2012:
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Stable Catena® sales in Canada and through named patient and special access programs in Europe and other territories
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Preparations for product commercialization in LHON in Europe following potential approval by the EMA
Key financial figures (unaudited)
| (IFRS, consolidated, for half year ended June 30, in CHF thousands) | 2012 | 2011 | Changes |
| Cash and cash equivalents | 16,227 | 23,4061 | -30.7 % |
| Net change in cash and cash equivalents | -7,179 | -12,283 | 41.6 % |
| Net sales | 1,697 | 1,626 | 4.4 % |
| Operating expenses | -7,126 | -15,629 | 54.4 % |
| Operating result | -5,571 | -13,925 | 60.0 % |
| Net result | -5,506 | -15,015 | 63.3 % |
1 as of December 31, 2011
Commenting on the operational and financial performance in the first six months of 2012, Thomas Meier, Chief Executive Officer of Santhera, said, "In the first six months of 2012, we have focused on the regulatory approval process and prepared for product commercialization in LHON. During this period we also achieved substantial cost reductions, which resulted in a markedly reduced cash burn in the first half of 2012 compared to the previous year. The cash position by mid-year secures the funding of Santhera's operations beyond the upcoming decision by the EMA, which is expected by the end of this year."
Cash reserves of CHF 16.2 million by mid-year 2012
As of June 30, 2012, Santhera had cash and cash equivalents of CHF 16.2 million (end of 2011: CHF 23.4 million) and no debts. Net change in cash in the first half year of 2012 was substantially reduced to CHF -7.2 million (2011: CHF -12.3 million). Total equity amounted to CHF 37.4 million by mid-year 2012 (2011: CHF 54.5 million).
Stable product revenues and substantially reduced expenses in first half of 2012
In the first six months of 2012, Catena® generated net sales of CHF 1.7 million, slightly higher than in the same period in 2011 (CHF 1.6 million). The majority of sales continue to originate from Canada (CHF 1.5 million) while the remainder are sales under named patient and special access programs in Europe and the rest of the world.
Operating expenses were markedly reduced to CHF 7.1 million (first half of 2011: CHF 15.6 million) as a result of the refocused operations and restructuring of the Company. The expenses for development accounted for CHF 3.5 million, while expenses for marketing and sales amounted to CHF 1.1 million including costs associated with the preparation of the launch in Europe in LHON. General and administrative expenses amounted to CHF 2.5 million. The lower expenses resulted in a substantially reduced operating result of CHF -5.6 million (first half of 2011: CHF -13.9 million). As a consequence, Santhera reports a net result of CHF -5.5 million (first half of 2011: CHF -15.0 million).
During the six-month period ending June 30, 2012, Santhera employed 23 full-time equivalents on average (first half of 2011: 46).
Outlook
A decision on the regulatory approval in LHON is expected by the end of 2012. As Santhera awaits the decision by EMA's Committee for Medicinal Products for Human Use, preparations for product commercialization following a positive opinion are continuing. Top line data from the exploratory Phase IIa study in MELAS syndrome are anticipated in the second half of 2012. This study with Catena® is conducted by the Columbia University of New York City.
Santhera continues to apply stringent cost controls and cash preservation measures. Based on the latest financial planning, the current programs are financed into 2013. The Company is in engaged discussions to extend and secure the financing of its operations.
2012 Half-Year Financial Information
The 2012 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) | 2012 | 2011 |
| Net sales | 1,697 | 1,626 |
| Gross profit | 1,532 | 1,446 |
| Other operating income | 23 | 258 |
| Research and development | -3,539 | -9,129 |
| Marketing and sales | -1,119 | -1,329 |
| General and administrative | -2,448 | -5,094 |
| Other operating expenses | -20 | -77 |
| Operating expenses | -7,126 | -15,629 |
| Operating result | -5,571 | -13,925 |
| Financial result | -66 | -833 |
| Income taxes | 131 | -257 |
| Net result | -5,506 | -15,015 |
| Basic and diluted loss per share (in CHF) | -1.50 | -4.10 |
Condensed interim consolidated balance sheet (unaudited)
| (IFRS, in CHF thousands) | June 30, 2012 | December 31, 2011 |
| Cash and cash equivalents | 16,227 | 23,406 |
| Noncurrent assets | 25,343 | 25,527 |
| Other current assets | 3,492 | 3,101 |
| Total assets | 45,062 | 52,034 |
| Equity | 37,392 | 42,984 |
| Noncurrent liabilities | 3,548 | 3,392 |
| Current liabilities | 4,122 | 5,658 |
| Total equity and liabilities | 45,062 | 52,034 |
Condensed interim consolidated cash flow statement (unaudited)
| (IFRS, for half year ended June 30, in CHF thousands) | 2012 | 2011 |
| Gross operating/investing cash flow | -8,709 | -13,013 |
| Cash and cash equivalents at January 1 | 23,406 | 43,682 |
| Cash and cash equivalents at June 30 | 16,227 | 31,399 |
| Net change in cash and cash equivalents | -7,179 | -12,283 |
| Share capital | ||
| June 30, 2012 | December 31, 2011 | |
| Number of shares issued with par value of CHF 1 | 3,677,438 | 3,673,463 |
| Conditional capital for stock options | 700,000 | 631,271 |
| Conditional capital for convertible rights | 600,000 | 600,000 |
| Authorized capital | 1,800,000 | 1,800,000 |
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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 under a NOC/c to treat Friedreich's Ataxia. The same compound is also under review for marketing authorization by the European Medicines 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 61 906 89 64
thomas.meier@santhera.com
Thomas Staffelbach, Vice President, Head of Public & Investor Relations
Phone +41 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.
