Santhera Reports 2014 Financial Results and Significant Progress in All Programs
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Santhera Pharmaceuticals Holding AG /
Santhera Reports 2014 Financial Results and Significant Progress in All Programs
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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
See www.santhera.com/reports for 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 value of CHF 1, as of December
31)
-------------------------------------------------------------------------------
Shares issued 4,974,492 3,934,049
Conditional capital for stock options 659,269 684,414
Conditional capital for convertible rights 600,000 355,000
Authorized capital 1,500,000 1,800,000
-------------------------------------------------------------------------------
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 develops Raxone(®)/Catena(®) as treatment for patients with Leber
Hereditary Optic Neuropathy (LHON), Duchenne Muscular Dystrophy (DMD) and
primary progressive Multiple Sclerosis (ppMS), as well as omigapil for
Congenital Muscular Dystrophies (CMD), all areas of high unmet medical need for
which no therapies are currently available. 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, PhD, Chief Executive Officer
Phone +41 61 906 89 64
thomas.meier(at)santhera.com
US investor contact: US Public Relations contact:
Andrew McDonald, LifeSci Advisors, LLC Deanne Eagle, Planet Communications
Phone +1 646 597 6979 Phone +1 917 837 5866
andrew(at)lifesciadvisors.com deanne(at)planetcommunications.nyc
Disclaimer / Forward-looking statements
This press release 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 FY14:
http://hugin.info/137261/R/1910760/681538.pdf
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Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
[HUG#1910760]
Unternehmensinformation / Kurzprofil:
Datum: 14.04.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 385358
Anzahl Zeichen: 15187
contact information:
Town:
Liestal
Kategorie:
Business News
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