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Santhera Reports 2010 Interim Financial Results with Significant Reduction in Net Loss and Strong Increase in Product Sales |
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Santhera Pharmaceuticals Holding AG / Santhera Reports 2010 Interim Financial Results with Significant Reduction in Net Loss and Strong Increase in Product Sales processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Liestal, Switzerland, September 3, 2010 - Santhera Pharmaceuticals (SIX: SANN)
announced today the results for the first half year ended June 30, 2010. During
the reporting period, Catena® achieved net sales of CHF 1.7 million (plus 270%;
first half year 2009: CHF 0.5 million). Net cash burn (CHF 13.8 million) and net
loss (CHF 14.2 million) were both significantly lower in the first six months of
2010 compared to the same period in 2009 (CHF 21.6 million and CHF 23.4 million
respectively) and in line with expectations. As of June 30, 2010, Santhera had
cash and cash equivalents of CHF 39.5 million. The Company expects to be
profitable in the second half year 2010 considering the upfront payment of
EUR 13.0 million (CHF 16.9 million) from Ipsen for the rights to fipamezole
announced earlier today. Based on its current financial planning, Santhera is
funded well into 2013.
Major events of 2010 to date include
· Revenues from sales of Catena® in Canada and through the Named Patient
Program (NPP) have already reached level of prior full year after six months in
2010
· Positive results from RHODOS study with Catena® in Leber's Hereditary
Optic Neuropathy (LHON) open regulatory path for potential filings in 2011 for
marketing approval
· Pivotal MICONOS study with Catena®/Sovrima® in Friedreich's Ataxia was
disappointing
· Fipamezole in Dyskinesia in Parkinson's Disease partnered to Ipsen for
development and commercialization outside North America and Japan
Key financial figures (unaudited)
(IFRS, consolidated, for half year ended June 30, in 2010 2009 Changes
CHF thousands)
Total equity 67,148 83,512(1) -20%
Cash and cash equivalents 39,477 53,320(1) -26%
Net change in cash and cash equivalents -13,843 -21,564 36%
Net sales 1,711 463 270%
Operating expenses -15,703 -24,893 37%
Operating result -13,669 -24,528 44%
Net loss -14,163 -23,407 40%
(1) As of December 31, 2009
Commenting on the operational results, Klaus Schollmeier, Chief Executive
Officer of Santhera, said: "The data generated with Catena® in LHON are very
encouraging. The instant and strong interest among LHON patients and their
physicians reflects the high unmet medical need for a treatment for this
devastating eye disease. We are now considering regulatory filings options
together with health authorities. The second regional partnering of fipamezole
outside North America and Japan is another highlight. Fipamezole is the most
advanced drug candidate for levodopa-induced Dyskinesia in Parkinson's Disease.
Together with Ipsen and Biovail, we are committed to bring this important
product to the market as expeditiously as possible."
Commenting on the financial results, Barbara Heller, Chief Financial Officer of
Santhera, said: "The financial results for the first half of 2010 are well
within our expectations. In the first six months, we saw an impressive growth in
product sales and significantly reduced the operating expenses primarily in
research and development. The revenues from Catena® sales and the upfront
payment from the licensing agreement with Ipsen as announced earlier today will
result in a highly profitable second half year 2010. Our current cash position
as well as future product sales and milestone payments ensure that Santhera is
financed well into 2013."
Solid cash position and financed well into 2013
As of June 30, 2010, Santhera had cash and cash equivalents of CHF 39.5. Net
change in and cash equivalents in the first half year of 2010 was CHF 13.8
million compared to CHF 21.6 million in the same reporting period 2009. The
significant reduction in cash burn reflects the Company's clear focus of
activities and strict cost controls. Total equity at mid-year amounted to
CHF 67.1 million compared to CHF 83.5 million as of December 31, 2009. Santhera
continues to allocate funds primarily to the development programs with
Catena®/Sovrima® as well as marketing and business development activities.
The value of Santhera's intangible assets fell by CHF 3.1 million to CHF 30.7
million compared to CHF 33.8 million at year-end 2009, primarily due to currency
exchange-related valuation losses of the Euro-denominated Catena®/Sovrima®
asset.
Santhera's share capital was increased by the exercise of 6,023 employee stock
options. As of June 30, 2010, the share capital of Santhera Pharmaceuticals
Holding AG consisted of 3,660,242 registered shares with a nominal value of
CHF 1 each. Santhera remains fully equity financed.
Significantly increased sales, focused spending and reduced operating expenses
In the first six months of 2010, Catena® generated net sales of CHF 1.7 million
compared to CHF 0.5 million in the corresponding period in 2009. The bulk of the
revenues (CHF 1.6 million) originate from product sales in Canada while the
remainder comes from NPP sales in Europe and elsewhere. Gross profit amounted to
CHF 1.5 million (first half of 2009: CHF 0.4 million).
Operating expenses in the first half of 2010 were reduced by 37% to CHF 15.7
million (first half of 2009: CHF 24.9 million). This substantial decrease
resulted primarily from cost reductions in Research and Development (R&D) in
connection with the restructuring of the early drug discovery activities
announced in July 2009 and the phase out of two large clinical studies. Total
R&D amounted to CHF 7.9 million, representing 51% (first half of 2009: CHF 16.9
million and 68%) of total operating expenses. Marketing and Sales (M&S) slightly
increased to CHF 2.2 million or 14% of total operating expenses (first half of
2009: CHF 2.0 million or 8%) in line with expanded activities for Catena® in
Canada and in Europe. General and administrative expenses (G&A) decreased to
CHF 5.6 million, representing 35% of total operating expenses (first half of
2009: CHF 6.0 million or 24%). G&A includes expenses for corporate finance,
business development activities as well as infrastructure and all management
expenses which are not reallocated in general. Other operating income/expenses
amounted to CHF 0.5 million (first half of 2009: CHF -0.03 million) mainly from
a research grant. For the first half of 2010, Santhera reports a net loss of
CHF 14.2 million, which is significantly lower than the net loss of CHF 23.4
million reported for the first half of 2009.
Focus continues on core activities, cash runway secured well beyond 2013
After the close of books for the 2010 Interim Report, Santhera signed a license
agreement with Ipsen for the development and commercialization of fipamezole
outside the US, Canada and Japan for an upfront payment of EUR 13.0 million. For
the second half of 2010, Santhera anticipates to be profitable. Net cash burn
for the full year is expected to be well below the 2009 level. According to its
current financial planning, Santhera is funded well into 2013.
Preparation for regulatory filings of Catena® in LHON will continue over the
next months and expects to file for marketing approvals in the first half of
2011. In parallel to the regulatory work, Santhera will present the positive
results from the RHODOS study at upcoming scientific and medical conferences.
Enrollment of the first group of 40 patients into the pivotal DELOS study in
Duchenne Muscular Dystrophy is expected to be completed in a few weeks' time.
The proof-of-concept Phase IIa MELTIMI study in MELAS syndrome is expected to be
completed with top-line data available before the end of the year.
Update on Products and Pipeline
Product sales - Catena®
Product sales of Catena® in Canada and under the NPP continued to grow with
revenues for the first half of 2010 equal to the annual sales in 2009. In
Canada, the drug has been prescribed to 153 Friedreich's Ataxia patients (of an
expected population of approximately 300 individuals); 99 of them have secured
reimbursement from their insurance carriers. Sales on named-patient basis
continued to meet considerable interest in Europe and elsewhere.
Catena® in Leber's Hereditary Optic Neuropathy (LHON) - RHODOS Phase II/III
study
The RHODOS data reported in June 2010 showed that in LHON vision could be
preserved or even improved in patients receiving Catena® compared to those
receiving placebo. For example, a higher proportion of patients receiving
Catena® who were almost completely blind recovered sufficiently to read at least
5 letters on a standard eye chart versus placebo. The data also indicated that
the drug has the potential to protect patients at highest risk for vision loss
from further deterioration in their visual acuity. The positive visual acuity
outcomes were supported by improvements in color contrast sensitivity with
Catena® treatment compared to placebo. In the absence of any available treatment
for this rare and devastating disease, Santhera is discussing strategies to make
Catena® available to LHON patients as soon as possible. Filings for marketing
approval are anticipated for the first half of 2011.
Catena®/Sovrima® in Duchenne Muscular Dystrophy - DELOS Phase III study
Six centers in Europe and one in the United States are open for recruitment of
patients into this 12-month placebo-controlled study. DELOS employs a
group-sequential design and currently only patients not comedicated with
glucocorticoid are being enrolled. It is anticipated that recruitment of this
first group of patients will be completed within the next few weeks. A first
interim analysis will be conducted when patients in this group have been treated
for six months and is expected in the first half of 2011. An interim analysis of
DELOS was encouraged by both the European Medicines Agency (EMA) and the US Food
and Drug Administration (FDA). Both regulatory authorities indicated that a
single pivotal study providing robust efficacy data could suffice for approval.
Recently, Santhera was granted patent protection in Europe until 2026.
Catena®/Sovrima® in Friedreich's Ataxia - MICONOS Phase III study
The MICONOS results announced in May 2010 represent a major setback for this
development program. Santhera is awaiting further data from two ongoing
extension studies which will provide long-term follow-up data on the use of the
drug in Friedreich's Ataxia patients. The Company believes that the results of
the completed studies conducted to date and the experience of treating
physicians and patients underscore the benefit individual patients receive from
Catena®/Sovrima®. Still under investigation are the reasons for the failure of
MICONOS to demonstrate conclusively the efficacy of the drug. It is already
clear that the unexpected variability in disease progression as measured by the
available neurological rating scales and the limited size and duration of the
trial played an important role. In Canada, Santhera and Health Canada are
exploring possibilities to allow patients continued access to Catena® under the
existing NOC/c.
Catena® in MELAS syndrome - MELTIMI Phase IIa study
Santhera is collaborating with the Columbia University of New York City in this
Phase II proof-of-concept study. The trial investigates the efficacy of two
doses of Catena® versus placebo in reducing the levels of a disease-relevant
biomarker over a treatment period of 28 days. Recruitment is almost completed
and Santhera expects to report top-line results in the second half of 2010.
Fipamezole in Dyskinesia in Parkinson's Disease - Phase III development
On September 2, 2010, Santhera and Ipsen signed a license agreement under which
Ipsen acquired the rights to develop and commercialize fipamezole outside North
America and Japan. Santhera receives an upfront payment of EUR 13.0 million and
is entitled to up to EUR 128.0 million in development and sales milestones plus
royalties on Ipsen's future product sales. Santhera retains full rights in
Japan.
Meanwhile, preparation for the Phase III development at Biovail, Santhera's
partner in the United States and Canada, is progressing. Initiation of the first
pivotal study with fipamezole is currently planned for 2011. Biovail has entered
a definitive merger agreement with Valeant and a pipeline review is intended to
be undertaken.
Omigapil in Congenital Muscular Dystrophy - Phase II/III development
With a grant from the patient organization Association française contre les
myopathies, Santhera completed the nonclinical development required for omigapil
in support of a clinical study. In collaboration with international experts, in
the forthcoming months Santhera will develop a clinical trial protocol which
will be discussed with the EMA and FDA during protocol assistance meetings early
next year.
Half-year 2010 Financial Information
The 2010 Interim Report of Santhera Pharmaceuticals including the unaudited
consolidated financial statements is available on the Company's Web site under
www.santhera.com/reports.
--------------------------------------------------------+---------+---------
Condensed consolidated income statement (unaudited) | |
--------------------------------------------------------+---------+---------
(IFRS, for half year ended June 30, in CHF thousands) | 2010 | 2009
--------------------------------------------------------+---------+---------
Net sales | 1,711 | 463
--------------------------------------------------------+---------+---------
Gross profit | 1,482 | 365
--------------------------------------------------------+---------+---------
| |
--------------------------------------------------------+---------+---------
Other operating income | 552 | 0
--------------------------------------------------------+---------+---------
| |
--------------------------------------------------------+---------+---------
Research and Development | -7,947 | -16,876
--------------------------------------------------------+---------+---------
Marketing and Sales | -2,151 | -1,971
--------------------------------------------------------+---------+---------
General and Administration | -5,553 | -6,016
--------------------------------------------------------+---------+---------
Other operating expenses | -52 | -30
--------------------------------------------------------+---------+---------
Operating expenses | -15,703 | -24,893
--------------------------------------------------------+---------+---------
Operating result | -13,669 | -24,528
--------------------------------------------------------+---------+---------
Financial result | -412 | 1,155
--------------------------------------------------------+---------+---------
Income taxes | -82 | -34
--------------------------------------------------------+---------+---------
Net loss | -14,163 | -23,407
--------------------------------------------------------+---------+---------
Basic and diluted loss per share (in CHF) | -3.87 | -6.65
--------------------------------------------------------+---------+---------
-----------------------------------------------+-------------+-----------------
| |
| |
| |
Condensed consolidated balance sheet | |
(unaudited) | |
-----------------------------------------------+-------------+-----------------
(IFRS, in CHF thousands) |June 30, 2010|December 31, 2009
-----------------------------------------------+-------------+-----------------
Cash and cash equivalents | 39,477| 53,320
-----------------------------------------------+-------------+-----------------
Noncurrent assets | 33,585| 36,824
-----------------------------------------------+-------------+-----------------
Other current assets | 4,351| 4,557
-----------------------------------------------+-------------+-----------------
Total assets | 77,413| 94,701
-----------------------------------------------+-------------+-----------------
| |
-----------------------------------------------+-------------+-----------------
Equity | 67,148| 83,512
-----------------------------------------------+-------------+-----------------
Noncurrent liabilities | 2,665| 2,654
-----------------------------------------------+-------------+-----------------
Current liabilities | 7,600| 8,535
-----------------------------------------------+-------------+-----------------
Total equity and liabilities | 77,413| 94,701
-----------------------------------------------+-------------+-----------------
---------------------------------------------------------+---------+---------
Condensed consolidated cash flow statement (unaudited) | |
---------------------------------------------------------+---------+---------
(IFRS, for half year ended June 30, in CHF thousands) | 2010 | 2009
---------------------------------------------------------+---------+---------
Gross operating/investing cash flow | -15,762 | -22,013
---------------------------------------------------------+---------+---------
| |
---------------------------------------------------------+---------+---------
Cash and cash equivalents at January 1 | 53,320 | 75,006
---------------------------------------------------------+---------+---------
Cash and cash equivalents at June 30 | 39,477 | 53,442
---------------------------------------------------------+---------+---------
Net change in cash and cash equivalents | -13,843 | -21,564
---------------------------------------------------------+---------+---------
Share capital
June 30, 2010 December 31, 2009
Number of shares issued with par value of CHF 1 3,660,242 3,654,219
Conditional capital for stock options 644,492 650,515
Conditional capital for convertible rights 600,000 490,182
Authorized capital 1,800,000 323,945
* * *
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.
Webcast/Teleconference
At 15:00 CET / 14:00 UKT / 09:00 EST on September 3, 2010, Santhera's management
will host a teleconference/webcast. You can either join the webcast on
www.santhera.com/webcast or the teleconference using the conference ID 96144870
and one of the following dial-ins:
Switzerland 056 580 00 12 (local call)
Germany 0692 222 4956 (local call)
UK 0844 338 74 (local call)
Europe +44 (0) 1452 561 488 (standard international)
USA 1877 328 4999
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@santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller@santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@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.
[HUG#1442473]
--- End of Message ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
News release 1H2010:
http://hugin.info/137261/R/1442473/386704.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
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