Du är här

2014-04-08

Santhera Pharmaceuticals Holding AG: Santhera Reports Financial Figures for 2013 and Progress towards Turnaround

Santhera Pharmaceuticals Holding AG / Santhera Reports Financial Figures for
2013 and Progress towards Turnaround. Processed and transmitted by NASDAQ OMX
Corporate Solutions. The issuer is solely responsible for the content of this
announcement.
Liestal, Switzerland, April
8, 2014
- Santhera Pharmaceuticals (SIX: SANN) announced today financial results for
2013 and
marked reductions in cash burn and liabilities.
The cash position at year end 2013 amounted to CHF 5.0 million. The operating
result improved to CHF
-7.3 million and the net result to CHF
-5.8 million. The Company's financial situation has been strengthened by a
Standby Equity Distribution Agreement (SEDA) for up to CHF 10 million signed
with YA Global Master SPV Ltd. (YA Global) and a recent private placement of
CHF 1 million with new investor IGLU Group. At the end of the first quarter
2014, Santhera had cash reserves of CHF 5.3 million slightly above year-end
2013.

Key achievements for the past 15 months:

* Successful operational and financial restructuring resulting in reduced
cash burn and liabilities
* Supportive efficacy data for Raxone®in Leber's Hereditary Optic Neuropathy
(LHON)
* Preparation of Marketing Authorization Application (MAA) for Raxone®in LHON
to be filed shortly with the European Medicines Agency (EMA)
* Temporary authorization for use ( autorisation temporaire d'utilisation
dite de cohorte ) for Raxone®in LHON granted by the French National Agency
for the Safety of Medicines and Health Products (ANSM)
* Successful futility analysis of the Phase III DELOS trial with
Raxone®/Catena®in Duchenne Muscular Dystrophy (DMD)
* Agreement for exclusive patent license signed with US National Institutes
of Health (NIH) for Catena®/Raxone®in the treatment of primary progressive
Multiple Sclerosis (ppMS)
* US patent granted protecting the use of the oromucosal administration route
for fipamezole in the field of neurodegenerative diseases
* Financing of operations and going concern secured by a SEDA for a maximum
of CHF 10 million with YA Global and a private placement of CHF 1 million
with new investor IGLU Group

Key Financial Figures 2013

-------------------------------------------------------------------------
|(IFRS, consolidated, in CHF thousands) 2013 2012 |
| |
| restated due to IAS 19R |
|Cash and cash equivalents 5,044 12,283 |
|Net change in cash and cash equivalents -7,239 -11,123 |
|Net sales 1,319 3,538 |
|Operating expenses -8,744 -34,698 |
|Operating result -7,309 -31,152 |
|Net result -5,755 -31,445 |
-------------------------------------------------------------------------
"We are glad to report very positive progress, both financially and
operationally, towards a successful turnaround of Santhera," commented Thomas
Meier, Chief Executive Officer of Santhera. "After a difficult start at the
beginning of 2013 we have now obtained the necessary funding to allow the
continuation of our business operations well into 2015. In line with the
mandate given at the Annual Shareholders' Meeting in 2013, we preserved our
assets, advanced their development and increased their value." He continued:
"The temporary authorization in France for Raxone®for the treatment of LHON
is an important milestone in our efforts to make this treatment available to
patients whose disease could not be treated until now. We continue to work
towards a full market approval with the European regulatory authorities."

CHF 5.0 million cash at year-end 2013 and significant reduction in net cash
burn
As of December 31, 2013, Santhera had cash and cash equivalents of CHF 5.0
million (2012: CHF 12.3 million). Net change in cash was CHF -7.2 million
(2012: CHF -11.1 million) driven by a reduction in average monthly net cash
burn from CHF 0.7 million in the first quarter to CHF 0.3 million in the
fourth quarter of 2013 as a result of rigorous cost control and use of the
SEDA. Operational and financial restructuring measures reduced current and
non-current liabilities from CHF 6.9 million to CHF 2.6 million. Total equity
at year-end 2013 was CHF 7.1 million (2012: CHF 11.4 million).

Revenues from product sales
In 2013, Catena®generated net sales of CHF 1.3 million (2012: CHF 3.5 million)
primarily in Canada in the indication Friedreich's Ataxia. Sales from the
Named Patient Program increased to TCHF 467 (2012: TCHF 352). In line with
the sharp reduction in operating expenses (CHF 8.7 million in 2013 vs. CHF
34.7 million in 2012), the operating result improved to CHF -7.3 million
(2012: CHF -31.2 million including substantial impairments on intangibles and
the write-down of inventories). Expenses in Development were CHF 4.7 million
(2012: CHF 28.7 million). Marketing and sales expenses were halved to CHF 0.9
million (2012: CHF 1.8 million) while expenses for general and administrative
were reduced to CHF 3.1 million (2012: CHF 4.1 million). As a result,
Santhera reduced the net loss to CHF 5.8 million in 2013 (2012: CHF 31.4
million).

Outlook
In the coming weeks, the MAA for Raxone®for the treatment LHON will be filed
with the EMA whose decision is expected in the first half of 2015. Meanwhile
Raxone®is made available to LHON patients in France under the cohort ATU
granted by the ANSM in January 2014, allowing Santhera to generate product
sales. In the second quarter of 2014, pivotal data of the DELOS Phase III
study with Catena®/Raxone®in DMD will become available from the cohort of
patients not using steroids. The results will clarify the development and
regulatory path forward for this program. In ppMS, Santhera continues its
collaboration with the NIH in a randomized, placebo-controlled Phase II trial
(IPPoMS) with Catena®/Raxone®followed by a 12-months open-label extension
study.

Santhera closed the first quarter 2014 with cash of CHF 5.3 million, slightly
above year-end 2013 reflecting inflows of funds from the SEDA and a private
placement with IGLU Group in February 2014.

Despite the SEDA and the recent capital increase, Santhera's ability to
continue business operations into 2015 and beyond remains contingent on the
availability of additional financial resources. The Board of Directors and
Management of Santhera therefore continue their efforts to secure adequate
financing, including through further use of the SEDA, and to explore M&A
opportunities and/or sale or licensing of assets.

2013 Financial Information
The complete financial statements of Santhera and the report on corporate
governance are available on the Company's Web sitewww.santhera.com.

Condensed
Balance Sheets

-----------------------------------------------------------------------------------
|(IFRS, consolidated, in CHF thousands) December 31, 2013 December 31, 2012 |
| |
| |
| restated due to IAS 19R |
|Cash and cash equivalents 5,044 12,283 |
|Noncurrent assets 4,349 5,157 |
|Other current assets 343 845 |
|Total assets 9,736 18,285 |
| |
|Equity 7,106 11,365 |
|Noncurrent liabilities 997 3,992 |
|Current liabilities 1,633 2,928 |
|Total equity and liabilities 9,736 18,285 |
-----------------------------------------------------------------------------------
Condensed
Income Statements (based on going concern values)

---------------------------------------------------------------------------
|(IFRS, consolidated, in CHF thousands) 2013 2012 |
| |
| |
| |
| restated due to IAS19R) |
|Net sales 1,319 3,538 |
|Total revenue 1,319 3,538 |
|Gross profit 1,179 3,189 |
|Other operating income 256 357 |
|Development -4,709 -28,722 |
|Marketing and sales -926 -1,841 |
|General and administrative -3,109 -4,079 |
|Other operating expenses 0 -56 |
|Operating expenses -8,744 -34,698 |
|whereof non-cash-relevant items -837 -20'535 |
|Operating result -7,309 -31,152 |
|Net financial result 1,549 -136 |
|Result before taxes -5,760 -31,288 |
|Income taxes 5 -157 |
|Net result -5,755 -31,445 |
|Basic and diluted loss per share (in CHF) -1.55 -8.55 |
---------------------------------------------------------------------------
Condensed
Cash Flow Statements

--------------------------------------------------------------------------
|(IFRS, consolidated, in CHF thousands) 2013 2012 |
| |
| |
| restated due to IAS 19R |
|Operating cash flow -6,976 -11,039 |
|Cash and cash equivalents at January 1 12,283 23,406 |
|Cash and cash equivalents at December 31 5,044 12,283 |
|Net change in cash and cash equivalents -7,239 -11,123 |
--------------------------------------------------------------------------
Share Capital

--------------------------------------------------------------------
|(as of December 31) ...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.