Santhera Successfully Concludes Restructuring in First Half Year of 2013

GlobeNewswire Europe

Liestal, Switzerland, August 30, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today the financial results for the first half of 2013 and reported the implementation of the strategy endorsed by the last Shareholders` Meeting. In the first six months of 2013 net cash burn was significantly reduced to CHF 4.7 million. Sales of Catena® amounted to CHF 1.1 million, resulting in a net loss of CHF 3.2 million. As of June 30, 2013, Santhera had cash reserves of CHF 7.6 million. The Company continues to explore strategic options and to secure additional financing.

Main achievements in 2013:

  • Shareholders` Resolution supports continuation of business and evaluation of strategic options including product licensing or sale and merger. 

  • Collaboration with the European Vision Institute Clinical Research Network (EVICR.net) to assess the natural course of Leber`s Hereditary Optic Neuropathy (LHON). Data to be included in a marketing authorization application (MAA) for Raxone® planned for early 2014. 

  • Exclusive license from the National Institutes of Health (NIH) to a US patent for the use of idebenone for the treatment of primary progressive Multiple Sclerosis (ppMS). The NIH is currently investigating Catena® in ppMS in a Phase II study. 

Key financial figures (unaudited)

(IFRS, consolidated, for half year ended June 30, in CHF thousands) 2013 2012
Cash and cash equivalents 7,572 12,2831
Net change in cash and cash equivalents -4,711 -7,179
Net sales 1,127 1,697
Operating expenses -5,957 -7,086
Operating result -4,802 -5,531
Net result -3,226 -5,466

1 As of December 31, 2012

Commenting on the first six months of 2013, Thomas Meier, Chief Executive Officer of Santhera, said, "In line with the strategy approved by our shareholders, we achieved substantial milestones in strengthening our assets and exploring strategic alternatives. We signed an important collaboration with EVICR.net to collect natural history data in LHON to be included in a revised MAA to be filed in the first quarter of 2014. We also signed an agreement with the NIH under which we secured global rights to Catena® in ppMS."

Cash burn down to a quarterly CHF 2.4 million due to significantly reduced expenses
As of June 30, 2013, Santhera had cash and cash equivalents of CHF 7.6 million (end of 2012: CHF 12.3 million). Net change in cash in the first half year of 2013 was again substantially reduced to CHF -4.7 million (2012: CHF -7.2 million) in line with management guidance. Total equity amounted to CHF 9.0 million by mid-year 2013 (end of 2012: CHF 11.4 million). The Company also resolved previous finance lease liabilities.

In the first six months of 2013, net sales of Catena® reached CHF 1.1 million (2012:CHF 1.7 million). The majority of sales (CHF 0.9 million) were generated in Canada by the end of April 2013, when the product was voluntarily withdrawn from the market. Sales under named patient and special access programs in Europe and the rest of the world increased to CHF 0.3 million (2012: CHF 0.2 million).

Operating expenses were reduced to CHF 6.0 million (2012: CHF 7.1 million) as a result of the refocused and reduced operations. Expenses for development accounted for CHF 3.2 million, while expenses for marketing and sales amounted to CHF 0.8 million. General and administrative expenses amounted to CHF 2.0 million. The lower expenses resulted in a reduced operating result of CHF -4.8 million (2012: CHF -5.5 million). For the first half of 2013, Santhera reports a net result of CHF -3.2 million (2012: CHF -5.5 million).

Outlook
The focus of Management`s attention remains on securing additional funds in order to reach critical future regulatory and development milestones. Santhera is continuing the discussions concerning financing, business combination or sale of certain assets to interested third parties. To date, no such agreement has been signed and there can be no guarantee that any transaction can be realized or that such transaction would generate sufficient funds to finance further operations.

Operationally, Santhera focuses on its three core development programs: i) the MAA for Raxone® in LHON with the European Medicine Agency, which the Company expects to file in the first quarter of 2014; ii) the DELOS Phase III study in DMD with top line data of the first cohort anticipated to be available in the second quarter of 2014; and iii) the collaboration with the NIH for the development of Catena® in ppMS.

2013 Half-Year Financial Information

The 2013 Interim Report of Santhera Pharmaceuticals including the unaudited consolidated financial statements is available on the Company`s Web site under www.santhera.com/reports. Some of the 2012 figures were restated due to the revised IFRS accounting standard IAS 19.

Condensed interim consolidated income statement (unaudited)

(IFRS, for half year ended June 30, in CHF thousands) 2013 2012
Net sales 1,127 1,697
Gross profit 1,000 1,532
Other operating income 155 23
Development -3,155 -3,517
Marketing and sales -754 -1,117
General and administrative -2,048 -2,432
Other operating expenses 0 -20
Operating expenses -5,957 -7,086
Operating result -4,802 -5,531
Financial result 1,569 -66
Income taxes 7 131
Net result -3,226 -5,466
Basic and diluted loss per share (in CHF) -0.88 -1.49

Condensed interim consolidated balance sheet (unaudited)

(IFRS, in CHF thousands) June 30, 2013 December 31, 2012
Cash and cash equivalents 7,572 12,283
Noncurrent assets 4,381 5,157
Other current assets 522 845
Total assets 12,475 18,285
Equity 8,983 11,365
Noncurrent liabilities 1,338 3,992
Current liabilities 2,154 2,928
Total equity and liabilities 12,475 18,285

Condensed interim consolidated cash flow statement (unaudited)

(IFRS, for half year ended June 30, in CHF thousands) 2013 2012
Cash and cash equivalents at January 1 12,283 23,406
Cash and cash equivalents at June 30 7,572 16,227
Net change in cash and cash equivalents -4,711 -7,179

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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 mitochondrial and neuromuscular diseases, areas of high unmet medical need with no current therapies. For further information, please visit www.santhera.com.

Raxone® and Catena® are trademarks of Santhera Pharmaceuticals.

 

For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
thomas.meier@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 1H13



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