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2016-04-12

Santhera Pharmaceuticals Holding AG: Santhera Reports Increase in Product Sales, Positive Net Result for 2015 and Progress in All Programs

Santhera Pharmaceuticals Holding AG / Santhera Reports Increase in Product
Sales, Positive Net Result for 2015 andProgress in All Programs . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
Liestal, Switzerland, April
12, 2016 - Santhera Pharmaceuticals (SIX: SANN) announces increasing income
from product sales, a positive net result for 2015 and significant progress
in all development programs. Net revenues grew by 67% to CHF 4.3 million in
sales of the lead product Raxone®for the treatment of Leber's hereditary
optic neuropathy (LHON). For 2015, the Company reported a positive net result
of CHF 5.9 million influenced by a revaluation of intangible assets and
inventory. Cash and cash equivalents by year-end amounted to CHF 76.9
million. Commercial rollout for Raxone for the treatment of LHON in the EU
and filing preparations for Duchenne muscular dystrophy (DMD) in the EU and
the US are on track.

2015 Annual Results and a Company update will be presented today by Thomas
Meier, PhD, Chief Executive Officer of Santhera, during the "Investor &
Analyst Track" sessions (at 13.30 hrs) at the Swiss Biotech Day in Basel.

"We are very excited about Santhera's progress last year," commentedThomas
Meier
, PhD, Chief Executive Officer of Santhera. "Our first product approval and
launch in the EU marked a transforming milestone towards a fully-integrated
specialty pharmaceutical company. The pan-European roll-out of Raxone for the
treatment of LHON is ongoing and we are preparing for regulatory filings and
market entry for DMD, the product's second indication."

"The successful financing transactions in 2015 demonstrated the enthusiasm of
shareholders and investors about the progress and prospects of Santhera,"
addedChristoph Rentsch
, Chief Financial Officer of Santhera. "Our Company is well financed and we
have adequate resources to execute our current commercial and development
plans."

Corporate and Pipeline Highlights:

· Strong top-line growth

Net revenue from product sales in 2015 rose to CHF 4.3 million, a 67% increase
compared to the previous year (2014: CHF 2.6 million). Net revenues in Q4
2015, the first full quarter post approval, were CHF 1.9 million. In Q1 2016
sales reached CHF 3.3 million, corresponding to a 75% increase compared to Q4
2015.

· Successful commercialization of Raxone drives strong sales
development

On September 9, 2015, Santhera received marketing authorization for Raxone for
the treatment of LHON in all EU member states, Norway, Iceland and
Liechtenstein. By end of Q1 2016, sales were reported primarily for Germany
and France with additional sales also reported for several other countries.
Based on the number of packs sold, it is estimated that as of end of March
2016, there were approximately 220 patients receiving Raxone for the
treatment of LHON in Europe.

· Positive operating result for 2015

Development expenses increased to CHF 10.5 million (2014: CHF 5.9 million) due
to costs associated with regulatory filings and study preparation. The launch
preparations and market entry for LHON in Europe resulted in marketing and
sales expenses of CHF 8.4 million (2014: CHF 0.6 million) and general and
administrative expenses of CHF 8.2 million (2014: CHF 4.4 million). Approval
of Raxone for LHON allowed for the reversal of a previous impairment charge
of CHF 27.1 million (related to LHON development costs) and inventory and led
to an improvement of the operating result from CHF -23.9 to CHF 3.2 million
(2014: CHF -7.9 million).

· Positive net result of CHF 5.9 million

For the full-year 2015, Santhera reported a net result of CHF 5.9 million
(2014: CHF -8.0 million).

· Successful financing, CHF 82.4 million raised

The Company realized an aggregate gross amount of CHF 82.4 million (net: CHF
80.5 million) through the issuance of newly created shares and private share
placements which, together with increasing income from product sales,
substantially improved the financial flexibility and cash reach.

· Strong cash position secures development and commercialization plans

As of December 31, 2015, Santhera had cash and cash equivalents of CHF 76.9
million (2014: CHF 17.4 million), which corresponds to a net year-on-year
increase of CHF 59.4 million (2014: CHF 12.4 million). The cash position as
of March 31, 2016, was CHF 69.4 million.

· Strengthening the organization

By year-end 2015, Santhera had 59 employees. By end of March 2016, the number
of employees further increased to 65 (representing 59.4 full-time
equivalents), predominantly in marketing and sales as well as clinical
development functions.

Outlook

Santhera's priorities for Raxone are its continued commercial rollout for the
treatment of LHON across the EU and the regulatory approval and market entry
to treat DMD both in the EU and the USA. Complementing its own
commercialization efforts in key European countries, in January 2016 Santhera
entered into a distribution and supply agreement with Ewopharma to support
the launch of Raxone for the treatment of LHON in 11 countries in Eastern
Europe and the Baltics.

Following the successful outcome of the phase III DELOS clinical trial,
Santhera has already held pre-submission meetings with European regulators
and in the coming weeks plans to submit a Marketing Authorization Application
(MAA) for the treatment of DMD patients not using glucocorticoids as a type
II variation of the existing marketing authorization for LHON. In the USA,
Santhera will imminently submit a meeting request and comprehensive briefing
material in preparation for a pre-NDA meeting with the FDA to discuss an NDA
filing for DMD.

On the development side, given the clear medical need to address respiratory
function decline in all DMD patients, Santhera has initiated a new clinical
trial with Raxone in patients using glucocorticoids (SIDEROS). A successful
outcome of this trial will offer the potential for a future labeling
extension to add the treatment of DMD patients using glucocorticoids.
Clinical development programs with Raxone in primary progressive multiple
sclerosis (PPMS) and omigapil in congenital muscular dystrophies (CMD) are
also progressing.

Santhera believes that, with cash reserves of CHF 69.4 million (March 31,
2016) and the option to use conditional and authorized capital, it has
sufficient financial flexibility to support the commercialization of Raxone
in Europe and its ongoing development and regulatory projects.

Additional Information

For additional information, please visit the Company's website
atwww.santhera.comwhere the Annual Report 2015and theCompany
Presentation(from 15:00 hrs) given at the Swiss Biotech Day will be
available.

Upcoming Events

The Annual Shareholders' Meeting of Santhera will be held on May 11, 2016, in
Basel, Switzerland (shareholders will receive a separate invitation).

2015 Full-Year Financial Information
Seewww.santhera.com/reportsfor the Santhera 2015 Annual Report.

--------------------------------------------------------------
| Condensed Consolidated Income Statement 2015 2014 |
| |
|(IFRS, in CHF thousands) Restated1 |
| Net sales 4,321 2,591 |
| Cost of goods sold -1,371 -199 |
| Other operating income 188 533 |
| |
| Development 16,651 -5,876 |
| Marketing and sales -8,356 -580 |
| General and administrative -8,244 -4,395 |
| Other operating expenses -16 -9 |
| Operating expenses 35 -10,860 |
| Operating result 3,173 -7,935 |
| Financial result -239 -15 |
| Income taxes 3,015 -2 |
| Net result 5,949 -7,952 |
| Basic earnings/loss per share (in CHF) 1.11 -1.69 |
| Diluted earnings/loss per share (in CHF) 1.08 -1.69 |
--------------------------------------------------------------

-----------------------------------------------------------------
| Condensed Consolidated Balance Sheet 2015 2014 |
| |
|(IFRS, in CHF thousands, as of December 31) Restated1 |
| Cash and cash equivalents 76,859 17,435 |
| Noncurrent assets 33,208 4,491 |
| Other current assets 7,085 1,096 |
| Total assets 117,152 23,022 |
| Equity 106,247 17,315 |
| Noncurrent liabilities 3,957 2,680 |
| Current liabilities 6,948 3,027 |
| Total equity and liabilities 117,152 23,022 |
-----------------------------------------------------------------

----------------------------------------------------------------
| Condensed Consolidated Cash Flow Statement 2015 2014 |
| |
|(IFRS, in CHF thousands) Restated1 |
| Cash flow from operating activities -22,390 -6,063 |
| Cash and cash equivalents at January 1 17,435 5,044 |
| Cash and cash equivalents at December 31 76,859 17,435 |
| Net change in cash and cash equivalents 59,424 12,391 |
----------------------------------------------------------------

--------------------------------------------------------------------------------------
| Share Capital 2015 2014 |
| |
|(number of shares with par value of CHF 1, as of December 31) |
| Shares issued 6,262,798 4,974,492 |
| Conditional capital for stock options 401,694 604,029 |
| Conditional capital for convertible rights 650,000 600,000 |
| Authorized capital 910,000 1,500,000 |
--------------------------------------------------------------------------------------
1Some positions have been restated, see Annual Report 2015, note 2 "Correction
of errors".
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. Santhera's lead product Raxone® is authorized in the
European Union for the treatment of Leber's hereditary optic neuropathy
(LHON). Santhera develops Raxone®in two additional indications, Duchenne
muscular dystrophy (DMD) and primary progressive multiple sclerosis (PPMS),
and omigapil for congenital muscular dystrophy (CMD), all areas of high unmet
medical need. For further information, please visit the Company's
websitewww.santhera.com.

Raxone
®and Catena
®are trademarks of Santhera Pharmaceuticals.

For further information, contact:

Thomas Meier, PhD, Chief Executive Officer Christoph Rentsch, Chief
Financial Officer
Phone +41 61 906 89 64 Phone +41 61 906
89 65
thomas.meier@santhera.com
christoph.rentsch@santhera.com

US investor contact

US Public Relations contact

Hans Vitzthum, LifeSci Advisors, LLC Deanne Eagle, Planet
Communications
Phone +1 212 915 2568 Phone +1 917 837
5866
hans@lifesciadvisors.com ...

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