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2015-04-14

Santhera Pharmaceuticals Holding AG: Santhera Reports 2014 Financial Results and Significant Progress in All Programs

Santhera Pharmaceuticals Holding AG / Santhera Reports 2014 Financial Results
and Significant Progress 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
14, 2014 - Santhera Pharmaceuticals (SIX: SANN) announces the financial
results for the full year 2014 and reports significant progress in all
programs. The Company increased the income from sales of Raxone
®, submitted an application for marketing authorization (MAA) in Leber's
Hereditary Optic Neuropathy (LHON), reported the successful outcome of its
Phase III trial in Duchenne Muscular Dystrophy (DMD), and secured adequate
funds to advance all strategic projects and prepare for market entry.

Commenting on the results,Thomas Meier
, PhD, CEO of Santhera, said: "We report excellent progress in all strategic
programs for Raxone and have reached a number of important milestones. Among
the many highlights in 2014, the outstanding events were the re-filing of the
Marketing Authorization Application for Raxone to treat LHON and the positive
results from our Phase III study in DMD. From a financial point of view, the
increased income from sales of Raxone and two private placements in February
and August 2014 substantially strengthened Santhera's cash position. The
available cash ensures that adequate funds are available in support of
ongoing preparations for a potential launch of Raxone for the treatment of
LHON in Europe, and to advance other development and regulatory projects."

Financial Highlights:

* Financing and income from Raxone sales increased cash position

As of December 31, 2014, Santhera had cash and cash equivalents of CHF 17.4
million (2013: CHF 5.0 million) which corresponds to a net year-on-year
increase of CHF 12.4 million (2013: CHF -7.2 million). The Company realized
an aggregate gross amount of CHF 15.7 million through private share
placements, sale of treasury shares and sale of shares under the Standby
Equity Distribution Agreement, which together with increasing income from
product sales contributed to the strong cash position.

* Top-line growth driven by increasing sales of Raxone

Mainly due to increasing top-line growth in the second half year, net sales
2014 climbed to CHF 2.6 million (2013: CHF 1.3 million). Increasing sales
were generated with Raxone for LHON under the French temporary authorization
for use (cATU) and with the international Named Patient Programs for patients
with DMD and LHON.

* Operating and net result at previous year's level

Development expenses increased to CHF 5.7 million (2013: CHF 4.7 million).
Preparations for market entry contributed to higher general and
administrative expenses of CHF 4.2 million (2013: CHF 3.1 million). Overall,
the operating result of CHF -7.5 million was comparable to 2013 (CHF -7.3
million).

For the full-year 2014, Santhera reports a net result of CHF -7.5 million
(2013: CHF -5.8 million including extraordinary financial income of CHF 1.5
million from the settlement of finance lease liabilities).

Product and Pipeline Highlights:

* Received temporary approval in France for Raxone as first treatment for
LHON

In January 2014, the French National Agency for Medicines and Health Products
Safety granted a temporary approval (cATU) for Raxone to treat patients with
LHON. This cATU was renewed for 2015 and allows patients in France to receive
reimbursed treatment with Raxone before a marketing authorization is granted
in the European Union.

* Re-filed European MAA for Raxone in LHON - Regulatory review in progress

In May 2014, Santhera re-filed an MAA with efficacy data from the pivotal
RHODOS study and additional clinical efficacy data from an Expanded Access
Program. An opinion from the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency is expected in H1 this year. Subject
to approval, Santhera plans to launch Raxone as the first product authorized
in Europe for the treatment of LHON.

* Reported positive results of the DELOS Phase III trial with Raxone/Catena
in DMD

In May 2014, Santhera announced the positive outcome of the placebo-controlled
Phase III trial with Raxone in DMD. The study met its primary endpoint and
demonstrated that Raxone can delay the loss of respiratory function in
patients not using glucocorticoid steroids. The preservation of respiratory
function is considered of major clinical importance for Duchenne patients.

* Initiated collaboration with Parent Project Muscular Dystrophy (PPMD)

In November 2014, Santhera announced a collaboration agreement with the US
patient advocacy organization PPMD for a survey-based benefit/risk evaluation
in DMD. The survey will focus specifically on patient and caregiver
preferences regarding pulmonary therapies and will be used in support of the
Company's NDA filing in the USA.

* Continued collaborative Phase II trial with the US National Institutes of
Health (NIH) on Raxone/Catena in primary progressive Multiple Sclerosis
(ppMS)

Santhera continues its collaboration with the NIH in a double-blind,
placebo-controlled Phase II clinical trial investigating the efficacy of
Raxone/Catena in patients with ppMS, the compound's third indication. The
trial, which combines a 1-year observational run-in phase followed by a
2-year randomized, placebo-controlled treatment period is now fully enrolled.

* Initiated a clinical development program with omigapil in Congenital
Muscular Dystrophies (CMD) with support from private-public partnership

In July 2014, Santhera announced a public-private partnership with the NIH,
EndoStem, an EU 7th Framework Program, and two patient organizations, Cure
CMD and the Swiss Foundation for Research on Muscle Diseases (FSRMM), to
evaluate the pharmacokinetic profile, safety and tolerability of orally
administered omigapil. The clinical Phase I study in pediatric CMD patients
will also identify clinical parameters suitable for future efficacy studies.

* Started development of novel formulation for Raxone (idebenone)

Santhera is developing a transmucosal formulation for idebenone as part of its
future life cycle management efforts. This novel formulation, for which
patent applications have been filed, is aimed at offering improved
bioavailability and better convenience for certain patient populations.

Outlook

Santhera's main priorities in the near term are the marketing authorizations
of Raxone/Catena for the indications LHON and DMD. In Europe, the regulatory
review of the MAA for LHON is ongoing and an opinion from the CHMP is
expected in H1 2015. Subject to a positive decision, Raxone will become the
first product authorized for the treatment of LHON. Santhera currently
prepares to file for regulatory approvals for Raxone/Catena in DMD in the US
and EU. Recently, the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation for Raxone/Catena for the treatment of DMD.

Santhera expanded its Executive Management and started building a commercial
team to prepare the anticipated launch of Raxone in Europe. Marketing efforts
will focus on major European markets to be supplemented by national and/or
regional distribution agreements. The Company is also evaluating
opportunities to commercialize its products in North America.

Santhera believes that, with cash of CHF 14.0 million (March 31, 2015) and the
potential to use conditional and authorized capital, it has sufficient
financial flexibility to support the development and commercialization of the
current pipeline.

Upcoming Events

The Company's Annual Shareholder Meeting will be held on May 11, 2015 in
Basel, Switzerland (shareholders will receive a separate invitation).

2014 Full-Year Financial Information
Seewww.santhera.com/reportsfor the Santhera 2014 Annual Report.

------------------------------------------------------------
| Condensed consolidated income statement 2014 2013 |
| |
|(IFRS, in CHF thousands) |
| Net sales 2,591 1,319 |
| Gross profit 2,392 1,179 |
| Other operating income 533 256 |
| |
| Development -5,695 -4,709 |
| Marketing and sales -574 -926 |
| General and administrative -4,164 -3,109 |
| Other operating expenses -9 0 |
| Operating expenses -10,442 -8,744 |
| Operating result -7,517 -7,309 |
| Financial result -15 1,549 |
| Income taxes -2 5 |
| Net result -7,534 -5,755 |
| Basic and diluted loss per share (in CHF) -1.60 -1.55 |
------------------------------------------------------------

-------------------------------------------------------------
| Condensed consolidated balance sheet 2014 2013 |
| |
|(IFRS, in CHF thousands, as of December 31) |
| Cash and cash equivalents 17,435 5,044 |
| Noncurrent assets 4,414 4,349 |
| Other current assets 1,096 343 |
| Total assets 22,945 9,736 |
| Equity 17,238 7,106 |
| Noncurrent liabilities 2,680 997 |
| Current liabilities 3,027 1,633 |
| Total equity and liabilities 22,945 9,736 |
-------------------------------------------------------------

--------------------------------------------------------------
| Condensed consolidated cash flow statement 2014 2013 |
| |
|(IFRS, in CHF thousands) |
| Operating cash flow -6,063 -6,976 |
| Cash and cash equivalents at January 1 5,044 12,283 |
| Cash and cash equivalents at December 31 17,435 5,044 |
| Net change in cash and cash equivalents 12,391 - |
| 7,239 |
--------------------------------------------------------------

--------------------------------------------------------------------------------------
| Share capital 2014 2013 |
| |
|(number of shares with par va...

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