Basilea reports financial results for the first half-year 2011
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Basilea Pharmaceutica AG /
Basilea reports financial results for the first half-year 2011
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Basel, Switzerland, August 18, 2011 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announced today its financial results for the first half-year 2011, reporting
improved operating results, a solid cash position, 24% Toctino® sales growth in
local currencies and the broadening of its clinical pipeline.
Basilea Pharmaceutica Ltd. presented today its financial results for the first
half-year 2011 with improved operating results and a solid cash position of CHF
243.3 million. Basilea reported Toctino® sales of CHF 15.0 million for the first
half-year reflecting an 11% growth in Swiss Francs compared to the prior year
period while growth in local currencies was 24%.
The company is in the process of auditing clinical data generated in previous
ceftobiprole phase III studies for the treatment of pneumonia to determine data
quality for potential filings. Clinical audit analysis is expected to be
available in the fourth quarter to support discussions with health authorities.
Because of its broad antibiotic coverage, ceftobiprole has the potential to be
used as first-line empiric treatment especially for hospital-acquired pneumonia
where only limited monotherapy options with broad coverage of the clinically
relevant pathogens exist.
Regarding the Toctino® (alitretinoin) U.S. phase III HANDEL study, all patients
completed their treatment cycle by the end of June and Basilea expects to report
top line efficacy and safety data around year-end 2011.
In the first half of 2011, the phase III program for the antifungal
isavuconazole advanced under the Astellas collaboration and all three phase III
studies are recruiting patients. In addition, Basilea reported successful
completion of the first phase I study for its novel anti-Gram-negative
antibiotic BAL30072 and initiated the first-in-human study for its novel
anticancer drug BAL101553.
"We have significantly increased the strength and breadth of our clinical
pipeline during the first half of the year. We regained full rights to
ceftobiprole and are currently assessing data quality in the ceftobiprole
pneumonia studies. We are well underway with the audits and plan to enter
additional discussions with health authorities for potential regulatory filings.
We are also moving forward with preparations for analysis of top line data for
our phase III U.S. study of Toctino," stated Dr. Anthony Man, Chief Executive
Officer. "We have advanced our isavuconazole phase III program and are very
excited about the progress of our two new clinical programs, a novel antibiotic
against resistant Gram-negative bacterial infections and a new anticancer drug
destined to treat resistant cancers."
Ron Scott, Chief Financial Officer, said: "Through prudent cost management and
cost sharing structures with our development and distribution partners we
continue to improve our financial results. Despite challenging budgetary
constraints in European healthcare systems we see continued growth of Toctino
sales in markets where Toctino has been launched for more than a year and expect
increasing contributions from markets where the drug has recently been launched
by Basilea or our distributors. Furthermore, we are in discussions with
potential partners for ceftobiprole in order to optimize the value of this late-
stage asset."
Key figures
+-----------------------------------------------------+---------+----------+
| (In CHF million, except per share data) | H1 2011 | H1 2010 |
+-----------------------------------------------------+---------+----------+
| Product sales | 15.0 | 13.6 |
+-----------------------------------------------------+---------+----------+
| Contract revenue | 19.7 | 39.1 |
+-----------------------------------------------------+---------+----------+
| Total operating income | 34.9 | 53.1 |
+-----------------------------------------------------+---------+----------+
| Cost of sales | (1.1) | (1.1) |
+-----------------------------------------------------+---------+----------+
| Research & development expenses | (26.8) | (33.4) |
+-----------------------------------------------------+---------+----------+
| Selling, general & administrative expenses | (26.9) | (42.4) |
+-----------------------------------------------------+---------+----------+
| Total operating expenses | (54.7) | (76.8) |
+-----------------------------------------------------+---------+----------+
| Operating loss | (19.8) | (23.7) |
+-----------------------------------------------------+---------+----------+
| Net loss | (20.2) | (24.9) |
+-----------------------------------------------------+---------+----------+
| Cash flow used for/provided by operating activities | (37.8) | 16.2 |
+-----------------------------------------------------+---------+----------+
| Cash and short-term investments | 243.3 | 193.8[1] |
+-----------------------------------------------------+---------+----------+
| Basic and diluted loss per share, in CHF | (2.10) | (2.60) |
+-----------------------------------------------------+---------+----------+
[1] CHF 283.0 million as of December 31, 2010
Note: Consolidated figures in conformity with US GAAP; rounding was consistently
applied
The unaudited condensed consolidated interim financial statements of Basilea
Pharmaceutica Ltd. for the first half-year 2011 can be found on Basilea's
website at http://interimreport.basilea.com.
Financial summary
Product sales from Toctino® increased by 11% to CHF 15.0 million in the first
half of 2011 compared to CHF 13.6 million in the prior year period impacted by
the strong Swiss Franc. On a local currency basis product sales increased by
24% with continued volume growth in countries in which Basilea has its own
commercial organizations as well as increasing contributions from distributors.
Contract revenue decreased from CHF 39.1 million to CHF 19.7 million in the
first half of 2011. This was mainly due to accelerated recognition of
ceftobiprole upfront and milestone payments in 2010 as a result of Basilea
obtaining the rights to ceftobiprole. Total operating income, including other
income, thus decreased to CHF 34.9 million compared to CHF 53.1 million in the
first half of 2010.
Research and development expenses decreased to CHF 26.8 million in the first
half-year of 2011 compared to CHF 33.4 million in the prior year period. This
was mainly due to reduced isavuconazole development expenses as a result of cost
sharing under the license agreement with Astellas. In addition, development
expenses related to Toctino® decreased as the phase III HANDEL study in the U.S.
nears completion. Basilea invested in the clinical trial preparatory activities
for ceftobiprole. In addition, Basilea continued to invest in its novel
antibiotic BAL30072 to treat infections caused by resistant Gram-negative
bacteria that showed positive results from the first phase I clinical study
earlier this year, and in its novel anti-cancer compound BAL101553 that moved
into clinical phase I in the first half of 2011.
Selling, general and administrative expenses amounted to CHF 26.9 million in the
first half-year of 2011 compared to CHF 42.4 million in the prior year period.
The reduction in selling, general and administrative expenses was primarily due
to non-recurring legal expenses associated with Basilea's arbitration
proceedings against Johnson & Johnson in 2010 while Basilea continued to invest
in the commercialization of Toctino.
Net loss was reduced to CHF 20.2 million in the first half of this year compared
to CHF 24.9 million in the previous year period. This improvement was mainly due
to the decreased selling, general and administrative expenses as well as lower
development expenses resulting from Basilea's partnership on isavuconazole.
Basic and diluted loss per share was reduced to CHF 2.10 for the first half-year
of 2011 compared to CHF 2.60 for the first half-year of 2010.
Net cash used for operating activities amounted to CHF 37.8 million in the first
half of 2011. Combined cash and short-term investments amounted to
CHF 243.3 million as of June 30, 2011, compared to CHF 283.0 million at year-end
2010.
Financial outlook
Following a further strengthening of the Swiss Franc since last guidance, the
company expects Toctino® sales of CHF 29 - 32 million for the full year 2011,
assuming no further strengthening of the Swiss Franc, with main contributions
from Germany, UK and France. Basilea anticipates further improvement in
operating results due to currency impact on its non-Swiss Franc expenses and
anticipates an average monthly operating loss of approximately CHF 6 - 7 million
for 2011.
Portfolio update and outlook
Toctino® (alitretinoin) - the only therapy approved for adults with severe
chronic hand eczema (CHE) unresponsive to topical corticosteroids
Basilea currently markets Toctino® in Denmark, Finland, France, Germany, Norway,
Switzerland and the United Kingdom. It has appointed Almirall, S.A. as
distribution partner for additional selected European markets and Mexico, and
further distributors for Canada, Israel and the Republic of Korea. Basilea plans
to report top line efficacy and safety data of the U.S. phase III HANDEL study
around year-end 2011. Following the compilation of the data package, including
48-week bone mineral density data, Basilea intends to discuss with the FDA the
design of a risk evaluation and mitigation strategies (REMS) program and next
steps towards an NDA filing in the second half of 2012. In addition, the company
is working on new formulations to extend the product life cycle of Toctino®.
Ceftobiprole - a novel broad-spectrum anti-MRSA (methicillin-resistant
Staphylococcus aureus) cephalosporin antibiotic targeting Gram-positive and
Gram-negative pathogens, including Pseudomonas aeruginosa, for the potential
first-line treatment of severe infections treated in the hospital
Basilea regained full rights to ceftobiprole in February 2011. Following an FDA-
reviewed audit plan, the company is currently auditing the data of previously
conducted hospital-acquired pneumonia (HAP) and community-acquired pneumonia
(CAP) phase III studies for potential regulatory filings. Basilea has initiated
the partnering process for ceftobiprole.
Isavuconazole - a novel broad-spectrum antifungal with the potential to become
the best-in-class azole for the treatment of severe invasive fungal infections
Under the collaboration with Astellas the phase III program advanced during the
first half-year 2011. Recruitment into the phase III program including three
studies that target respectively, invasive yeast infections, invasive mold
infections, and rare molds and aspergillosis in renally impaired patients is
expected to be completed in 2012.
BAL30072 - a novel sulfactam antibiotic against multidrug-resistant Gram-
negative bacteria
Basilea reported positive results from the first phase I trial with BAL30072, a
single-ascending-dose study, in May 2011. BAL30072 was safe and well tolerated
at all dose levels. It displayed dose-proportional plasma levels as well as
linear pharmacokinetic properties. A multiple-ascending-dose phase I study is in
preparation with data anticipated for early 2012.
BAL101553 - a highly water-soluble prodrug of the synthetic small molecule
BAL27862, a unique microtubule destabilizing anticancer agent to treat drug-
resistant cancer
Basilea initiated a first-in-human phase I clinical study with BAL101553 in June
2011. The open-label, dose-escalation study investigates safety, tolerability
and pharmacokinetics of intravenous BAL101553 with the goal to establish dose
and administration schedule for phase II studies. The study includes adult
patients with advanced solid tumors who have failed standard therapy or for whom
no effective standard therapy is available. Preliminary safety and
pharmacokinetic data are anticipated for the second half of 2012.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Thursday, August 18, 2011, 4 p.m. (CEST), during which the company will discuss
today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 203 059 5862 (UK)
A playback will be available 1 hour after the conference call until Monday,
August 22, 2011, 6 p.m. (CEST). Participants requesting a digital playback may
dial:
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 19082 followed by the # sign.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development
operations are focused on antibiotics, antifungals and oncology drugs, as well
as on the development of dermatology drugs, targeting the medical challenge of
resistance and non-response to current treatment options in the hospital and
specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only approved
treatment for severe chronic hand eczema unresponsive to potent topical
corticosteroids, in Denmark, Finland, France, Germany, Norway, Switzerland and
the United Kingdom and has appointed distributors for Toctino® in other selected
European markets, Canada, Israel, Mexico and the Republic of Korea. A phase III
clinical program on alitretinoin for the treatment of severe chronic hand eczema
is ongoing in the U.S.
For its phase III compound isavuconazole, a potential best-in-class azole
antifungal for the treatment of life-threatening invasive fungal infections, the
company has entered into a license, co-development and co-promotion agreement
with Astellas Pharma Inc.
In addition, Basilea is developing ceftobiprole, a late-stage novel anti-MRSA
(methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin
antibiotic, for the first-line treatment of potentially life-threatening
resistant bacterial infections. Ceftobiprole has a broad coverage of both Gram-
positive bacteria, including MRSA, and many clinically important Gram-negative
bacteria such as Pseudomonas spp. Basilea's BAL30072, a novel antibiotic for the
treatment of resistant Gram-negative infections, and the oncology drug BAL101553
for the treatment of drug-resistant cancers are in phase I clinical testing.
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition, performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different from
any future results, performance or achievements expressed or implied by such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any forward-
looking statements contained herein as a result of new information, future
events or otherwise.
For further information, please contact:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, Ph.D. | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
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Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
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Unternehmensinformation / Kurzprofil:
Datum: 18.08.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 57344
Anzahl Zeichen: 19099
contact information:
Town:
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Kategorie:
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