Santhera Delivered Solid Performance in 2016 and Advances All Programs
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Santhera Pharmaceuticals Holding AG /
Santhera Delivered Solid Performance in 2016 and Advances All Programs
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Liestal, Switzerland, March 7, 2017 - Santhera Pharmaceuticals (SIX: SANN)
reports the Group's audited financial results for 2016. The Company generated
net revenues of CHF 19.0 million (+340% year-on-year) from sales of its lead
product Raxone(®) for the treatment of Leber's hereditary optic neuropathy
(LHON). The operating result amounted to CHF -33.1 million (2015 comparable:
CHF -23.9 million) and the net result was CHF -35.4 million. Santhera submitted
a Marketing Authorization Application (MAA) for Raxone for the treatment of
Duchenne muscular dystrophy (DMD) in the EU and Switzerland, started the SIDEROS
phase III trial in DMD and made significant progress in all other product
development programs. Cash and cash equivalents by the end of February 2017
amounted to CHF 100.8 million.
"In the past year Santhera made excellent progress in all programs and 2016
marked our first full year as a commercial company," commented Thomas Meier,
PhD, Chief Executive Officer of Santhera. "We are equally excited about
Santhera's future. With our expanded geographic reach in Europe and the US,
additional clinical trials and regulatory filings, we paved the way for further
growth and value generation. Our strong financial position allows us to
aggressively pursue our business strategy, to advance our products and establish
Santhera as a leader in mitochondrial medicine."
Robust top-line growth driven by increasing Raxone sales
Net sales grew to CHF 19.0 million (2015: CHF 4.3 million) driven by strong
sales of the lead product Raxone(®) for the treatment of Leber's hereditary
optic neuropathy (LHON) in the EU.
Operating and net result reflects higher late stage development and market entry
costs
Higher development expenses of CHF 17.7 million (2015: CHF 10.5 million) were
attributable to costs associated with regulatory filings and the preparation and
initiation of additional clinical trials. The ongoing commercial roll-out of
Raxone across Europe, preparations for market entry in the second indication DMD
and the build-up of US operations resulted in higher expenses for marketing and
sales of CHF 21.1 million (2015: CHF 8.4 million) and general and administrative
of CHF 9.8 million (2015: CHF 8.2 million). In summary, total operating expenses
were CHF -48.6 million (2015 comparable: CHF -27.1 million) and the operating
result amounted to CHF -33.1 million (2015 comparable: CHF -23.9 million).
Comparable figures are provided to account for the extraordinary reversal of a
previous impairment charge of CHF 27.1 million (included in operating expenses)
following the approval of Raxone for LHON. Group net result in 2016 amounted to
CHF -35.4 million (2015: CHF 5.9 million).
Strong cash position allows for implementation of strategy as planned
Cash-flow from operating activities amounted to CHF -27.1 million (2015: CHF -
22.4 million). As of December 31, 2016, Santhera had cash and cash equivalents
of CHF 49.8 million (2015: CHF 76.9 million). In February 2017, after the
balance sheet date, Santhera successfully placed CHF 60 million senior unsecured
convertible bonds due 2022, resulting in a cash position by end of February
2017 of CHF 100.8 million. These cash reserves provide the financial flexibility
to support the Company's, development, regulatory and commercial projects as
planned.
Santhera established international operations
2016 was marked by a strong internationalization of Santhera's business
activities. In parallel to the commercial roll-out of Raxone, Santhera expanded
its operations across Europe and, by the end of 2016, sold Raxone into 15
countries. In February 2017, Santhera established presence in the United States
with its US-subsidiary Santhera Pharmaceuticals (USA), Inc. in the Boston
metropolitan area, one of the main centers for pharmaceutical companies in North
America. The US team currently intensifies relations to patient advocacy groups,
prepares market access and provides regulatory and medical affairs expertise.
Strong progress in all development programs
In 2016, Santhera submitted Marketing Authorization Applications (MAA) for
Raxone for the treatment of Duchenne muscular dystrophy (DMD) in the EU and
Switzerland and significantly advanced all product development programs.
Santhera also started the randomized, double-blind, placebo-controlled phase III
trial (SIDEROS) to assess the efficacy of Raxone in delaying the loss of
respiratory function in DMD patients receiving concomitant glucocorticoid
therapy. Details on progress made with Raxone and the development programs in
2016 were previously announced (press release of January 26, 2017) and are
described in the Annual Report 2016.
Outlook and Guidance
For the Company's Annual Shareholders' Meeting on April 4, 2017, the Board
proposes Philipp Gutzwiller, Elmar Schnee, Patrick Vink, MD, and Thomas Meier,
PhD, CEO of Santhera, for election as new members of the Board of Directors.
Subject to his election, Thomas Meier will also be appointed Delegate of the
Board. With these nominees, the Board will gain additional experienced senior
executives to strengthen the strategic expertise in global pharmaceutical
business growth. Jürg Ambühl, Board Member of Santhera since 2009, has decided
not to stand for re-election. The Board and management thank Mr. Ambühl for his
many valuable contributions and his strong commitment to the Company during
these decisive years.
Santhera will continue to grow its international business. The Company expects
2017 net sales of Raxone in the currently approved indication alone to reach CHF
21 to 23 million. Besides focusing on commercialization and reimbursement of
Raxone in LHON in Europe, additional priorities in 2017 will entail preparations
for market entry and launch for Raxone in the second indication DMD, and
advancement of all currently ongoing clinical trials.
2016 Full-Year Financial Information
Santhera 2016 Annual Report see www.santhera.com/investors-and-media/investor-
toolbox/financial-reports.
Condensed Consolidated Income Statement 2016 2015
(IFRS, in CHF thousands)
-------------------------------------------------------------
Net sales 19,033 4,321
Cost of goods sold -3,883 -1,371
Other operating income 361 188
Development -17,675 16,651
Marketing and sales -21,051 -8,356
General and administrative -9,805 -8,244
Other operating expenses -107 -16
Operating expenses -48,638 35
-------------------------------------------------------------
Operating result -33,127 3,173
-------------------------------------------------------------
Financial result -67 -239
Income taxes -2,221 3,015
Net result -35,415 5,949
-------------------------------------------------------------
Basic earnings/loss per share (in CHF) -5.65 1.11
Diluted earnings/loss per share (in CHF) -5.65 1.08
-------------------------------------------------------------
Condensed Consolidated Balance Sheet 2016 2015
(IFRS, in CHF thousands, as of December 31)
-----------------------------------------------------------------
Cash and cash equivalents 49,815 76,859
Noncurrent assets 28,442 33,208
Other current assets 12,535 7,085
Total assets 90,792 117,152
-----------------------------------------------------------------
Equity 74,351 106,247
Noncurrent liabilities 6,183 3,957
Current liabilities 10,258 6,948
Total equity and liabilities 90,792 117,152
-----------------------------------------------------------------
Condensed Consolidated Cash Flow Statement 2016 2015
(IFRS, in CHF thousands)
----------------------------------------------------------------
Cash flow from operating activities -27,137 -22,390
Cash and cash equivalents at January 1 76,859 17,435
Cash and cash equivalents at December 31 49,815 76,859
Net change in cash and cash equivalents -27,044 59,424
----------------------------------------------------------------
Share Capital 2016 2015
(number of shares with par value of CHF 1, as of December
31)
--------------------------------------------------------------------------------
Shares issued 6,279,857 6,262,798
Conditional capital for stock options 532,941 401,694
Conditional capital for convertible rights 650,000 650,000
Authorized capital 1,500,000 910,000
--------------------------------------------------------------------------------
.
Annual Report
The Santhera Annual Report 2016 is available for download on the Company's
website at www.santhera.com/investors-and-media/investor-toolbox/financial-
reports.
Upcoming Events
The Annual Shareholders' Meeting of Santhera will be held on April 4, 2017, in
Basel, Switzerland (shareholders will receive a separate invitation).
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, Norway,
Iceland and Liechtenstein for the treatment of Leber's hereditary optic
neuropathy (LHON). For Duchenne muscular dystrophy (DMD), the second indication
for Raxone, Santhera has filed a Marketing Authorization Application (MAA) in
the European Union and Switzerland. In collaboration with the US National
Institute of Neurological Disorders and Stroke (NINDS) Santhera is developing
Raxone in a third indication, 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 website
www.santhera.com.
Raxone(®) is a trademark 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(at)santhera.com
christoph.rentsch(at)santhera.com
US investor contact US Public Relations
contact
Hans Vitzthum, LifeSci Advisors, LLC John Gillespie, Medical
Dynamics
Phone +1 212 915 2568 Phone
+1 646 599 8626
hans(at)lifesciadvisors.com
jgillespie(at)rxmedyn.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 Annual Results 2016:
http://hugin.info/137261/R/2085378/786389.pdf
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Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 07.03.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 528500
Anzahl Zeichen: 14523
contact information:
Town:
Liestal
Kategorie:
Business News
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