Santhera Reports 2010 Revenue of CHF 20.6 million and Prepares for MAA Filing in LHON
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Santhera Pharmaceuticals Holding AG /
Santhera Reports 2010 Revenue of CHF 20.6 million and Prepares for MAA Filing in
LHON
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Liestal, Switzerland, February 25, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today financial results for 2010 and provided an update on the
Company's commercial products and development pipeline. The specialty
pharmaceutical company recorded total revenue of CHF 20.6 million consisting of
CHF 3.5 million net sales with Catena(®) (a 113% increase over 2009), and
CHF 17.1 million revenue from its partner Ipsen for licensing the fipamezole
rights outside North America and Japan. The partnering agreement with Biovail
for the US and Canada was terminated for strategic reasons after Biovail's
merger with Valeant. Santhera continues to prepare for Phase III development of
fipamezole and intends to license the North American rights to a new partner.
The second half of 2010 was profitable and, as a result, full year change in
cash significantly fell 56% to CHF 9.6 million from the previous year. At year-
end, the cash position amounted to CHF 43.7 million.
Main achievements in 2010 include
· Commercial success with Catena(®): Net sales in Canada and through the
Named Patient Program have more than doubled in 2010.
· Strategic partnership for fipamezole: Ipsen acquired rights outside
North America and Japan for an upfront payment of EUR 13.0 million.
· Preparation for submission of Marketing Authorization Application
(MAA) in Leber's Hereditary Optic Neuropathy (LHON): The RHODOS study showed
efficacy of Catena(®) in protecting and improving vision of patients with LHON.
Key financial figures 2010
(IFRS, consolidated, in CHF thousands) 2010 2009 Changes
Cash and cash equivalents 43,682 53,320 -18%
Net change in cash and cash equivalents -9,638 -21,686 +56%
Revenue 20,609 22,339 -8%
whereof net sales 3,496 1,643 +113%
whereof revenue from licensing 17,113 20,696 -17%
Operating expenses -29,694 -48,544 -39%
Operating result -8,711 -25,895 +66%
Cash operating result -3,601 -22,238 +84%
Net result -11,256 -25,923 +57%
Commenting on the operational performance of 2010, Klaus Schollmeier, Chief
Executive Officer of Santhera, said: "The commercial success with Catena(®) in
Canada confirms the potential of specialty pharmaceutical products in
indications with a high medical need. Currently, we are preparing to submit a
European filing for marketing authorization in LHON within the next few months."
He continued: "Another important highlight was the partnering of the fipamezole
program outside North America and Japan with Ipsen. We recently regained the US
and Canadian rights after Valeant/Biovail terminated the agreement for strategic
reasons as a result of their merger. The program has succesfully advanced over
the last 18 months. We are moving ahead with the preparations for Phase III
development and intend to repartner the program for the North American markets."
Barbara Heller, Chief Financial Officer of Santhera, commented: "In 2010,
Santhera doubled the sales of Catena(®) in Canada and, together with licensing
income, generated over CHF 20 million revenue. The second half of 2010 was
profitable and, as in the previous year, operationally cash flow positive. We
considerably reduced our operating expenses primarily due to focused spending on
the key programs and the effects from the 2009 restructuring. As a result, the
net cash burn in 2010 ended below our earlier guidance. Based on our current
financial planning and assuming an approval in LHON, Santhera could be financed
well beyond 2013."
CHF 43.7 million cash at year-end 2010
As of December 31, 2010, Santhera had cash and cash equivalents of CHF 43.7
million (2009: CHF 53.3 million). Net change in cash for 2010 versus 2009 was
CHF -9.6 million compared to CHF -21.7 million. Total equity at year-end 2010
amounted to CHF 69.6 million (2009: CHF 83.5 million).
CHF 20.6 million revenue from sales and licensing, positive cash flow in second
half of 2010
In 2010, Santhera generated revenue of CHF 20.6 million (2009: CHF 22.3 million)
consisting of net sales of CHF 3.5 million (2009: CHF 1.6 million) of Catena(®)
as well as CHF 17.1 million (2009: CHF 20.7 million) income from partner Ipsen
representing the upfront payment of EUR 13.0 million for the development and
commercialization rights to fipamezole outside North America and Japan.
Operating expenses decreased to CHF 29.7 million from CHF 48.5 million in 2009.
As a consequence, the operating result significantly improved to CHF -8.7
million (2009: CHF -25.9 million). Considering non-cash-relevant one-time
effects (impairment of assets, IAS19-related pension liabilities, FX influence)
the cash operating result amounted to CHF -3.6 million (2009: CHF -22.2
million). Expenses in Research and Development (R&D) were substantially reduced
by 50% to CHF 15.7 million (2009: CHF 31.5 million) reflecting cost reductions
as a result of the restructuring of the early-stage drug discovery activities in
2009 and the phase-out of two large clinical studies. Marketing and Sales (M&S)
decreased by 8% to CHF 3.5 million (2009: CHF 3.8 million) while General and
Administrative expenses (G&A) were reduced by 21%, amounting to CHF 10.4 million
(2009: CHF 13.2 million).
Despite a net financial result of CHF -2.9 million (2009: CHF 0.04 million) that
was affected by FX translation differences on cash and cash equivalents in USD
and EUR, Santhera reported a considerably lower net loss of CHF 11.3 million for
2010 or an improvement of 57% compared to the previous year (2009: CHF 25.9
million).
In 2010, Santhera on average employed 47 full-time equivalents (2009: 74).
Outlook
In line with its strategy, Santhera continues to focus all financial and human
resources on its key value drivers, i.e. the submission of the MAA in LHON, the
preparation for the Phase III development and the repartnering of fipamezole as
well as the marketing efforts in Canada, require substantial resources.
Consequently, the Company allocates its personnel and funds primarily to these
activities and to a lesser extent to the other pipeline projects. Expecting
successful execution of all these projects allows the Company's operations to
remain well financed.
In the upcoming months, Santhera will submit the MAA in LHON. In addition, the
Company expects to report data from a proof-of-concept study in MELAS syndrome
(MELTIMI) in mid-2011. In the second half of 2011, Santhera plans to partner the
rights to fipamezole in North America. An interim analysis of the Phase III
study in Duchenne Muscular Dystrophy (DELOS) is expected in the same period.
Update on Products and Pipeline
Catena(®) in Friedreich's Ataxia - Sales and PROTI study
Catena(®) achieved net sales of CHF 3.5 million. In Canada, the drug has reached
a market penetration of more than 50% of eligible patients in its second full
year after launch in 2008. In Europe and elsewhere, sales under the Named
Patient Program (NPP) continue to grow. According to an agreement with Takeda
Pharmaceutical, revenue from NPP are split 25% (Santhera) and 75% (Takeda).
Santhera remains committed to the Friedreich's Ataxia community and exploring
the reasons why the ICARS rating scale used in the Company's two Phase III
studies (IONIA and MICONOS) failed to detect changes in the patient status over
the treatment period. Santhera has initiated a randomized withdrawal Phase IIIb
study with Friedreich's Ataxia patients currently participating in the MICONOS
extension trial. The primary objective of the two-month PROTI study is to
establish whether patients can correctly determine their treatment assignment as
assessed by patient-reported outcome measures. Approximately 80 patients will be
invited to suspend temporarily their participation in the MICONOS extension
study.
Catena(®) in Leber's Hereditary Optic Neuropathy (LHON) - RHODOS study and MAA
filing
Data from the RHODOS study support an MAA in LHON. Specifically, the results
show that the drug can protect patients who are at highest risk of vision loss
and enhance the recovery of visual acuity in severely affected patients. These
data are supported by secondary, clinically meaningful efficacy variables such
as clinical benefit, color contrast sensitivity and changes in retinal nerve
fiber layer thickness. In the study, Catena(®) showed consistent clinically
relevant superiority over placebo. Following discussions with the rapporteur and
corapporteur, Santhera will file an MAA with the European Medicines Agency (EMA)
in the first half of 2011. Given standard review timelines, the Company could
expect a potential marketing approval in the second half of 2012.
Catena(®)/Sovrima(®) in Duchenne Muscular Dystrophy - DELOS Phase III study
DELOS employs a group-sequential design and currently only patients not taking
glucocorticoids are being enrolled. Recruitment of this first group will be
completed within the next few weeks. The study protocol includes the possibility
for a first interim analysis testing for study assumptions and futility after
40 patients have been treated for six months.
Catena(®) in MELAS syndrome - MELTIMI Phase IIa study
The Columbia University of New York City and Santhera are collaborating in this
proof-of-concept study investigating the efficacy of two doses of Catena(®)
versus placebo over a treatment period of 28 days. The primary endpoint is the
change of a disease-relevant biomarker. Top-line results are expected in mid-
2011.
Catena(®) in Primary Progressive Multiple Sclerosis - IPPoMS Phase I/II study
This long-term Phase I/II investigator-initiated trial is being conducted by the
US National Institute of Neurological Disorders and Stroke (NINDS). Patients are
currently being recruited into the one-year observational period and the first
individuals were rolled over and randomized into the two-year, placebo-
controlled interventional part of the study.
Fipamezole in Dyskinesia in Parkinson's Disease
In September 2010, Ipsen acquired the rights to fipamezole outside North America
and Japan for an upfront payment of EUR 13.0 million. Santhera is entitled to
additional payments contingent to future development, regulatory and sales
milestones of up to EUR 128.0 million. In addition, Ipsen will pay royalties on
future net sales.
Santhera has regained the US and Canadian rights from Valeant/Biovail. Under
Biovail's stewardship over the last 18 months, the program has advanced
successfully. Work conducted includes numerous nonclinical and clinical studies
required prior to the start of Phase III development. These studies confirm the
good safety profile of fipamezole. Furthermore, the technical development was
completed. In parallel to the preparation of Phase III development, Santhera has
initiated a process to repartner the rights in North America.
Omigapil in Congenital Muscular Dystrophies
Santhera has completed the in vivo nonclinical development in support of a
clinical study. This work was funded by a research grant from the French patient
organization Association Française contre les Myopathies. Meanwhile, patent
protection was granted in Europe, Canada and in the United States until 2026 and
2027, respectively, complementing the orphan drug designation by the FDA.
Melanocortin-4 Receptor (MC-4R) antagonists in Cancer Cachexia
In October 2010, Santhera licensed the MC-4R program to BioLineRx of Tel Aviv,
Israel. BioLineRX acquired all rights to develop, sublicense and commercialize
the compound and will cover all future costs of the program. Santhera will
receive 22% to 25% of all sublicensing income or royalties on future sales.
2010 Financial Information
The complete financial statements of Santhera and the Company's report on
corporate governance are available on the Company's Web site www.santhera.com.
Condensed Income Statements
(IFRS, consolidated, in CHF thousands) 2010 2009
Net sales 3,496 1,643
Revenue from licensing 17,113 20,696
Total revenue 20,609 22,339
Gross profit 20,231 22,095
Other operating income 752 554
Research and development -15,690 -31,536
Marketing and sales -3,452 -3,752
General and administrative -10,442 -13,206
Other operating expenses -110 -50
Operating expenses -29,694 -48,544
whereof non-cash-relevant items -5,110 -3,657
Operating result -8,711 -25,895
Cash operating result -3,601 -22,238
Net financial result -2,872 39
Result before taxes -11,583 -25,856
Income taxes 327 -67
Net result -11,256 -25,923
Basic and diluted loss per share (in CHF) -3.08 -7.31
Condensed Balance Sheets
(IFRS, consolidated, in CHF thousands) December 31, 2010 December 31, 2009
Cash and cash equivalents 43,682 53,320
Noncurrent assets 31,157 36,824
Other current assets 3,927 4,557
Total assets 78,766 94,701
Equity 69,627 83,512
Noncurrent liabilities 3,882 2,654
Current liabilities 5,257 8,535
Total equity and liabilities 78,766 94,701
Condensed Cash Flow Statements
(IFRS, consolidated, in CHF thousands) 2010 2009
Operating cash flow -6,636 -20,753
Cash and cash equivalents at January 1 53,320 75,006
Cash and cash equivalents at December 31 43,682 53,320
Net change in cash and cash equivalents -9,638 -21,686
Share Capital
December 31, 2010 December 31, 2009
Number of shares issued (nominal value CHF 3,660,438 3,654,219
1)
Conditional capital for stock options 644,296 650,515
Conditional capital for convertible rights 600,000 490,182
Authorized capital 1,800,000 323,945
Corporate Calendar 2011
Monday, April 11 Annual Shareholders' Meeting, Basel
Friday, September 2 Interim Financial Report
* * *
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 severe neuromuscular diseases, an area of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena(®), to treat Friedreich's Ataxia is
marketed in Canada. For further information, please visit www.santhera.com.
Catena(®) is a trademark of Santhera Pharmaceuticals, Sovrima(®) is a trademark
of Takeda Pharmaceutical.
Webcast / Teleconference
At 9:45 CET / 8:45 UKT on February 25, 2011, Santhera will host an analyst
presentation in Zurich (SIX Swiss Exchange, ConventionPoint, Selnaustrasse 30,
Zurich). Anyone interested in participating may join either the webcast on
www.santhera.com/webcast or the teleconference using the conference ID 43915191
and one of the following dial-ins.
Switzerland 056 580 00 12
Germany 069 222 249 56
UK 0844 338 7409
International +44 (0) 1452 561 488
USA +1 877 328 49 99
The webcast will be available for playback one hour after the analyst
presentation ends.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone +41 (0)61 906 89 52
klaus.schollmeier(at)santhera.com
Barbara Heller, Chief Financial Officer
Phone +41 (0)61 906 89 54
barbara.heller(at)santhera.com
Thomas Staffelbach, VP, Head of Public & Investor Relations
Phone +41 (0)61 906 89 47
thomas.staffelbach(at)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.
--- End of Message ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
FY2010 results:
http://hugin.info/137261/R/1492258/427992.pdf
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Datum: 25.02.2011 - 07:00 Uhr
Sprache: Deutsch
News-ID 51896
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contact information:
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