Basilea reports 2010 interim results
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG / Basilea reports 2010 interim results processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, August 19, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
significantly increases revenues and cash position in the first half of 2010.
Basilea Pharmaceutica Ltd. announced today its 2010 interim financial results
reflecting the positive impact of the partnering agreement with Astellas Pharma
Inc. for Basilea's phase III antifungal agent isavuconazole; the continued
commercial roll-out of Toctino® (alitretinoin) for the treatment of severe
chronic hand eczema including a distribution agreement with Almirall, S.A.; and
the positive one-time impact from the accelerated recognition of upfront and
milestone payments related to the antibiotic ceftobiprole.
Basilea increased its cash position to CHF 193.8 million in the reporting period
providing the company with greater operational flexibility for advancing its
broad and innovative product portfolio. Toctino® product sales almost doubled
year-on-year to CHF 13.6 million in the first half of 2010 based on the
continued market penetration in Germany, the United Kingdom and Denmark and
first contributions from recent launch countries France and Switzerland.
Operating expenses were lower compared to H1 2009 with continued investments
into the commercialization of Toctino® and the advancement of the phase III
clinical programs for Toctino® and isavuconazole.
In the first half of 2010, the average monthly net loss was significantly
reduced to around CHF 4.2 million primarily due to recognition of the
isavuconazole upfront payment and the positive one-time accounting impact
related to ceftobiprole. Excluding this one-time effect, the average monthly net
loss was approximately CHF 8.5 million.
Financial summary
Combined cash and short-term investments amounted to CHF 193.8 million as of
June 30, 2010, compared to CHF 178.4 million at year-end 2009. The improved cash
position and operating cash flow in the first half of 2010 is mainly a result of
the upfront payments which the Company received under the licensing agreement
with Astellas and the distribution agreement with Almirall. Revenue and other
income increased to CHF 53.1 million compared to CHF 12.2 million in the prior
year period. Contract revenue increased from CHF 4.2 million in the first half
of 2009 to CHF 39.1 million in the first six months of 2010 as a result of an
accelerated recognition of upfront and milestone payments due to the notice of
termination of the licensing agreement for ceftobiprole as well as from
recognized revenues related to the collaborations with Astellas and Almirall. In
addition, Toctino® product sales increased by 84% from CHF 7.4 million in the
first six months of 2009 to CHF 13.6 million in the first half of 2010. Research
and development expenses were significantly reduced to CHF 33.4 million in the
first half of 2010 compared to CHF 44.5 million in the prior year period, mainly
reflecting the cost sharing mechanism under the co-development arrangement with
Astellas. The Company continued to invest in the phase III clinical trials of
isavuconazole and the U.S. trial of Toctino®. General and administrative
expenses rose to CHF 42.4 million from CHF 34.8 million in the first half of
2009 impacted by legal expenses associated with the Company's arbitration
proceedings against Johnson & Johnson. In summary, net loss for the first six
months of 2010 was significantly reduced to CHF 24.9 million as compared to CHF
66.5 million in the respective period in 2009.
Key figures
+-----------------------------------------+---------+---------+
| (In CHF million, except per share data) | H1 2010 | H1 2009 |
+-----------------------------------------+---------+---------+
| Revenues and Other Income | 53.1 | 12.2 |
+-----------------------------------------+---------+---------+
| Expenses | | |
+-----------------------------------------+---------+---------+
| Cost of Sales | (1.1) | (0.7) |
+-----------------------------------------+---------+---------+
| Research & Development | (33.4) | (44.5) |
+-----------------------------------------+---------+---------+
| Selling, General & Administrative | (42.4) | (34.8) |
+-----------------------------------------+---------+---------+
| Operating Loss | (23.7) | (67.9) |
+-----------------------------------------+---------+---------+
| Net Loss | (24.9) | (66.5) |
+-----------------------------------------+---------+---------+
| Cash Flow from Operating Activities | 16.2 | (68.2) |
+-----------------------------------------+---------+---------+
| Basic and Diluted Loss per Share in CHF | (2.60) | (6.95) |
+-----------------------------------------+---------+---------+
Note: Unaudited consolidated figures in conformity with US GAAP
The unaudited condensed consolidated interim financial statements of Basilea
Pharmaceutica Ltd. for the first half of 2010 can be found on the company's
website at http://interimreport.basilea.com.
Ron Scott, Chief Financial Officer, commented, "The significant upfront payments
related to the partnering agreements concluded in the first half year have
further improved our cash position. Going forward we will be eligible to
additional payments on achievement of certain milestones and we also anticipate
an increasing positive impact on our bottom-line resulting from the partnering
of isavuconazole and the commercialization of Toctino."
"As a result of our product partnering strategy, we have even more financial
flexibility to ensure sustainable value creation from our rich portfolio," added
Dr. Anthony Man, CEO. "We aim to advance our phase III programs for Toctino and
isavuconazole and move our next two innovative research compounds into clinical
development within the next six months. Once the transition of ceftobiprole back
to Basilea has been completed, we will finalize our strategy for this novel
antibiotic."
Given the decline in the value of the Euro versus the Swiss Franc and
considering the negative impact on pricing as well as the delays in national
reimbursement decisions due to the scrutiny currently put on healthcare budgets
across Europe, Basilea now expects Toctino® product sales of around CHF 30
million in 2010. Considering the impact of collaborations entered into the first
half of 2010 and the positive accounting impact related to ceftobiprole upfront
and milestone recognition, Basilea reduces its net loss guidance in 2010 to be
estimated at between CHF 3?4 million per month as compared to its previous
guidance of approximately CHF 9 million per month. This equates to an estimated
net loss of approximately CHF 8 million per month for 2010, excluding the impact
from the accelerated recognition of upfront and milestone payments related to
ceftobiprole.
Product and pipeline update
Toctino® (alitretinoin) - the only therapy approved for severe chronic hand
eczema unresponsive to topical corticosteroids
Basilea currently markets Toctino® in Denmark, France, Germany, Switzerland and
the United Kingdom and has appointed Almirall, S.A. as its distributor for
Toctino® in other selected European markets and Mexico in June 2010.
In the U.S., patient enrollment into the phase III HANDEL study has reached
around 90% of the targeted patient number. Patient recruitment is anticipated to
be completed in Q4 2010 with the last patients completing treatment in H1 2011.
Top line results will now be expanded to include clinical relapse data at six
months after completing treatment and are anticipated to be available at the end
of 2011. Submission of the New Drug Application is anticipated in 2012.
Zevtera(TM) (ceftobiprole) - the first approved anti-MRSA (methicillin-resistant
Staphylococcus aureus) broad-spectrum cephalosporin antibiotic targeting
Gram-positive and Gram-negative pathogens, including Pseudomonas
Full rights to ceftobiprole are being transferred from Cilag GmbH International,
a Johnson & Johnson company, back to Basilea. The arbitration proceeding against
Johnson & Johnson relating to milestone payments and other damages suffered by
Basilea as consequence of the rejection of approval of ceftobiprole is ongoing.
An arbitration decision is anticipated before the end of 2010.
Isavuconazole - a novel broad-spectrum antifungal with the potential to become
the best-in-class azole for the treatment of severe invasive fungal infections
Basilea entered into a license, co-development and co-promotion agreement with
Astellas Pharma Inc. Following the temporary hold on new patient recruitment,
the process to re-open phase III clinical sites for the isavuconazole trials has
commenced. First approvals from local authorities have been obtained and
continuation of patient recruitment is anticipated in Q3 2010. Patient
recruitment is anticipated to be completed in 2012 and first trial results are
expected in 2013.
Early-stage programs
Basilea is preparing to move two novel innovative molecules into phase I
clinical testing.
BAL30072 is a novel sulfactam antibiotic against multi-resistant Gram-negative
bacteria. Phase I clinical testing is anticipated to start in Q4 2010.
BAL101553 is a highly soluble prodrug of BAL27862, a microtubule destabilizing
antitumor drug. Phase I clinical testing is anticipated to start in Q1 2011.
Key events for the period January to June 2010
Toctino® (alitretinoin)
* Basilea signed distribution agreement with Almirall, S.A.
Basilea appointed the Spanish pharmaceutical company Almirall, S.A. as its
exclusive distributor for Toctino® in selected European markets and Mexico.
Basilea is eligible for upfront and milestone payments totaling EUR 27
million.
* Inclusion in Italian treatment guidelines for chronic hand eczema
The Italian Society of Dermatology published its guidelines for the
management of chronic hand eczema recommending Toctino® as the treatment of
choice when systemic treatment of severe chronic hand eczema is indicated.
* Marketing authorization in Italy
Following the recommendation for regulatory approval under the European
decentralized procedure, Toctino® received national regulatory approval in
Italy and acceptance for reimbursement.
* Integration in expert consensus for management of chronic hand eczema in
France
A French expert panel recommended Toctino® as the treatment of choice when
clinical signs persist under topical corticosteroids in a position paper.
Zevtera(TM) (ceftobiprole)
* European CHMP concluded re-examination
The European Committee for Medicinal Products for Human Use (CHMP) confirmed
its previous negative opinion on the use of ceftobiprole for the treatment
of complicated skin and soft tissue infections (cSSTI) and recommended that
ceftobiprole should not be granted marketing authorization in the European
Union despite indications that ceftobiprole was beneficial to patients.
Janssen-Ortho discontinued sales in Canada
Janssen-Ortho Inc., a Johnson & Johnson company, and holder of the Market
Authorization in Canada discontinued the sale of ceftobiprole in Canada.
* Full global rights to be regained
Johnson & Johnson company Cilag GmbH International gave notice that it will
return global rights of ceftobiprole to Basilea.
Isavuconazole
* Basilea provided update on phase III program
Following the review of the phase III clinical program certain protocol
amendments were implemented and the process to re-open phase III clinical
sites for the isavuconazole trials commenced.Patient recruitment is
anticipated to be completed in 2012 with top line results expected in 2013.
* Basilea announced global partnership with Astellas Pharma Inc.
Basilea entered into a license, co-development and co-promotion agreement
with Astellas Pharma Inc. for isavuconazole on a worldwide basis, including
an option for Japan. Basilea received an upfront payment of CHF 75 million
and is eligible to up to CHF 478 million in additional development and sales
milestones.
* Successful phase III clinical study futility analysis
Based on a pre-planned futility analysis the Independent Data Safety
Monitoring Board recommended the continuation of the study exploring
isavuconazole for the treatment of invasive Aspergillus infections.
Early-stage programs
* BAL101553 (prodrug of BAL27862, a microtubule destabilizing antitumor drug)
New research data presented at the Annual Meeting of the American
Association of Cancer Research (AACR) in Washington, D.C. confirmed that the
compound shows activity in a wide range of cancer types, including those
resistant to current treatment options.
* BAL30072 (sulfactam antibiotic)
Data presented at the European Congress of Clinical Microbiology and
Infectious Disease (ECCMID) demonstrated potent in-vitro and in-vivo
activity of BAL30072 against clinically relevant Gram-negative bacteria.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Thursday, August 19, 2010, 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) 207 107 0611 (UK)
A playback will be available 1 hour after the conference call until Monday,
August 23, 2010, 6 p.m. (CEST). Participants requesting a digital playback may
dial:
+41 (0) 91 612 4330 (Europe)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 10637 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 currently 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, France, Germany, Switzerland and the United Kingdom
and has appointed Almirall, S.A. as its distributor for Toctino® in other
selected European markets and Mexico. Furthermore, a phase III clinical program
on alitretinoin for the treatment of severe chronic hand eczema is ongoing in
the U.S. The company has entered into a global partnership with Astellas Pharma
Inc. for its phase III compound isavuconazole, a potential best-in-class azole
antifungal, for the treatment of life-threatening invasive fungal infections.
Full rights to ceftobiprole, the first approved anti-MRSA broad-spectrum
cephalosporin antibiotic, for the treatment of potentially life-threatening
resistant bacterial infections, are being transferred from Cilag GmbH
International, a Johnson & Johnson company, back to Basilea.
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 |
+-----------------------------+--------------------------------+
| Adesh Kaul | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1460 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1438858]
--- 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,
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Datum: 19.08.2010 - 07:16 Uhr
Sprache: Deutsch
News-ID 39800
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