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

Santhera Pharmaceuticals Holding AG / Santhera Reports Financial Figures for
2013 and Progress towards Turnaround . Processed and transmitted by NASDAQ OMX
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announcement.

Liestal, Switzerland, April8, 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 CHF5.0
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 CHF10 million
signed with YA Global Master SPV Ltd. (YA Global) and a recent private
placement of CHF1 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:

  oSuccessful operational and financial restructuring resulting in reduced
    cash burn and liabilities
  oSupportive efficacy data for Raxone^® in Leber's Hereditary Optic
    Neuropathy (LHON)
  oPreparation of Marketing Authorization Application (MAA) for Raxone^® in
    LHON to be filed shortly with the European Medicines Agency (EMA)
  oTemporary authorization for use (autorisation temporaire d'utilisation
    dite de cohorte) forRaxone^® in LHON granted by the French National Agency
    for the Safety of Medicines and Health Products (ANSM)
  oSuccessful futility analysis of the PhaseIII DELOS trial with
    Raxone^®/Catena^® in Duchenne Muscular Dystrophy (DMD)
  oAgreement for exclusive patent license signed with US National Institutes
    of Health (NIH) for Catena^®/Raxone^® in the treatment of primary
    progressive Multiple Sclerosis (ppMS)
  oUS patent granted protecting the use of the oromucosal administration
    route for fipamezole in the field of neurodegenerative diseases
  oFinancing of operations and going concern secured by a SEDA for a maximum
    of CHF10 million with YA Global and a private placement of CHF1 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."

CHF5.0 million cash at year-end 2013 and significant reduction in net cash
burn
As of December31, 2013, Santhera had cash and cash equivalents of CHF5.0
million (2012: CHF12.3 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 CHF0.7 million in the first quarter to CHF0.3 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 CHF6.9 million to CHF2.6 million. Total equity
at year-end 2013 was CHF7.1 million (2012: CHF11.4 million).

Revenues from product sales
In 2013, Catena^® generated net sales of CHF1.3 million (2012: CHF3.5
million) primarily in Canada in the indication Friedreich's Ataxia. Sales from
the Named Patient Program increased to TCHF467 (2012: TCHF352). In line with
the sharp reduction in operating expenses (CHF8.7 million in 2013 vs.
CHF34.7 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 CHF4.7 million
(2012: CHF28.7 million). Marketing and sales expenses were halved to CHF0.9
million (2012: CHF1.8 million) while expenses for general and administrative
were reduced to CHF3.1 million (2012: CHF4.1 million). As a result, Santhera
reduced the net loss to CHF5.8 million in 2013 (2012: CHF31.4 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 PhaseIII
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 PhaseII trial
(IPPoMS) with Catena^®/Raxone^® followed by a 12-months open-label extension
study.

Santhera closed the first quarter 2014 with cash of CHF5.3 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 site www.santhera.com.

Condensed Balance Sheets

(IFRS, consolidated, in CHF          December31, 2013 December 31, 2012
thousands)                                             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 January1   12,283 23,406
Cash and cash equivalents at December31 5,044  12,283
Net change in cash and cash equivalents  -7,239 -11,123

Share Capital

(as of December31)                           2013      2012
Number of shares issued (nominal value CHF1) 3,934,049 3,677,538
Conditional capital for stock options         684,414   695,925
Conditional capital for convertible rights    355,000   600,000
Authorized capital                            1,800,000 1,800,000

Corporate Calendar 2014

Tuesday, May20 Annual Shareholders' Meeting, Liestal, Switzerland

                                    * * *

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, such as Leber's Hereditary Optic Neuropathy, Duchenne
Muscular Dystrophy and primary progressive Multiple Sclerosis, all of them
areas of high unmet medical need with no current therapies. For further
information, please visit the Company's website 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 2013

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Source: Santhera Pharmaceuticals Holding AG via Globenewswire
HUG#1775339

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Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland

ISIN: CH0027148649;
 
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