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Basilea reports 2008 financial results

Basel, Switzerland, February 24, 2009 - Basilea Pharmaceutica Ltd.
(SIX:BSLN) announces 2008 financial results reflecting focused
investments to support launches of Toctino® and
ZEFTERA(TM)/Zevtera(TM). R&D investments were focused on phase III
clinical trials of Basilea's antifungal drug, isavuconazole, and the
start of the phase III program in the U.S. for alitretinoin
(Toctino®). Combined cash and short-term investments amount to
CHF 293.6 million as of December 31, 2008.

Basilea Pharmaceutica Ltd. began an important transition in 2008 from
an R&D organization to a fully integrated company with a strong
commercial focus in order to create further shareholder value through
launching Toctino® (alitretinoin) and ZEFTERA(TM)/Zevtera(TM)
(ceftobiprole) to generate revenues.

The Company announces its 2008 financial results reflecting focused
investments to support Toctino® marketed by Basilea's marketing
organization in UK, Germany and Denmark for the treatment of severe
chronic hand eczema and for the support of ZEFTERA(TM)/Zevtera(TM)
launch in Canada to treat complicated skin and soft tissue infections
including diabetic foot infections.

Key achievements in 2008 were the regulatory approvals of Toctino® in
UK, Germany, Denmark, France and Finland as well as its
recommendation for approval in six additional EU Member States.
Furthermore the approval of the novel antibiotic, ceftobiprole, by
the Canadian health authority as ZEFTERA(TM), by the Swiss authority
as Zevtera(TM) and the positive recommendation for approval from the
European Committee for Medicinal Products for Human Use confirming
that this novel antibiotic is considered to fulfill a high medical
need, is considered a major achievement.

Research and development investments were principally focused on
phase III clinical trials of the late-stage antifungal drug,
isavuconazole, and the start of a phase III program in the U.S. for
alitretinoin. In addition investments were made to advance programs
in late-stage research such as BAL30072, a novel antibiotic against
some of the most difficult to treat multi-resistant Gram-negative
bacteria, and BAL27862, an innovative cell death inducer, a cancer
compound active against a broad panel of tumor cell lines.

Financial Summary
Total revenues in 2008, excluding other income, amounted to CHF 11.8
million compared to CHF 7.9 million in 2007. Revenues included CHF
8.2 million (2007: CHF 6.6 million) related primarily to the release
of deferred revenue in connection with upfront and milestone payments
received for ZEFTERA(TM)/Zevtera(TM) and income from reimbursement of
costs related to co-promotion activities. In addition, revenues
included product sales in the amount of CHF 1.9 million in 2008 as a
result of the launches of Toctino® in Germany, the United Kingdom and
Denmark at the end of 2008.

Research and development expenses amounted to CHF 97.4 million in
2008 compared to CHF 115.7 million in 2007. The expenses in 2008
relate primarily to conducting the phase III clinical trials for
isavuconazole. In addition, R&D expenses include costs in connection
with the manufacturing of registration batches and process
development activities for isavuconazole. Furthermore, the Company
started the phase III clinical trials for alitretinoin in the U.S. in
2008.

Selling, general and administrative expenses amounted to CHF 66.8
million in 2008 and include expenses for the establishment and
maintenance of an international commercialization organization to
prepare and support the launch of Toctino® as well as the
co-promotion activities related to ZEFTERA(TM)/Zevtera(TM). Operating
loss totaled CHF 152.5 million in 2008 compared to CHF 136.5 million
in 2007 and net loss increased to CHF 143.5 million in 2008 (2007:
CHF 126.8 million), as a consequence of the increased investments in
the Company's commercial organization. Basic and diluted loss per
share amounted to CHF 15.02 for 2008 as compared to CHF 13.97 in
2007.

The cash out from operating activities increased to CHF 127.2 million
in 2008 compared to CHF 79.0 million. The increase resulting mainly
from the milestone payments received in 2007 in the amount of CHF
36.4 million related to the filings of the new drug applications for
ZEFTERA(TM)/Zevtera(TM) in the U.S. and Europe. Combined cash and
short-term investments amounted to CHF 293.6 million as of December
31, 2008, compared to CHF 424.8 million at year-end 2007.

Key Figures

+----------------------------------------------------------------+
| | 2008 | 2007 |
| (in CHF million) | | |
|--------------------------------------------+---------+---------|
| Revenues and other income | 12.0 | 8.2 |
|--------------------------------------------+---------+---------|
| Cost of sales | (0.3) | - |
|--------------------------------------------+---------+---------|
| Research & Development Expenses | (97.4) | (115.7) |
|--------------------------------------------+---------+---------|
| Selling, General & Administrative Expenses | (66.8) | (29.0) |
|--------------------------------------------+---------+---------|
| Operating Loss | (152.5) | (136.5) |
|--------------------------------------------+---------+---------|
| Net Loss | (143.5) | (126.8) |
|--------------------------------------------+---------+---------|
| Cash Flow from Operating Activities | (127.2) | (79.0) |
|--------------------------------------------+---------+---------|
| Basic and Diluted Loss per Share in CHF | (15.02) | (13.97) |
+----------------------------------------------------------------+

Notes: Consolidated figures in conformity with US GAAP

The consolidated financial statements of Basilea Pharmaceutica Ltd.
for 2008 can be found on the company's website at www.basilea.com.

Ron Scott, Chief Financial Officer, said: "Our expenses and results
in 2008 were in line with our expectations reflecting further
investments into our commercial organization to support the launches
of Toctino® and ZEFTERATM/ZevteraTM. We are pleased to see first
product sales for Toctino® in Germany, the United Kingdom and Denmark
and we look forward to launching Toctino® in additional countries in
2009. In addition to our focus on commercial activities, we invested
in the phase III clinical trials for isavuconazole and on the
initiation of Toctino phase III trials in the U.S."

"This last year was of major importance for Basilea with our first
market launches of two key products, Toctino® to treat severe chronic
hand eczema and ZEFTERATM/ZevteraTM to treat severe skin infections
including resistant bacterial infections such as
methicillin-resistant Staphylococcus aureus," stated Dr. Anthony Man,
CEO. "In 2009, we aim to create shareholder value by launching
Toctino in additional countries, working toward
ZEFTERA(TM)/Zevtera(TM) regulatory approvals and advancing our
highest priority R&D programs."

Key events for the twelve-month period in 2008 include:

Toctino® (alitretinoin) - Treatment of severe refractory chronic hand
eczema

* May: Canadian regulatory authority accepted New Drug Submission
for alitretinoin for review.
* July: Regulatory approval of Toctino® recommended by the
concerned EU Member States.
* September: Toctino® receives first national marketing
authorization in the United Kingdom.
* September: Toctino® receives marketing authorization in Denmark.
* October: Toctino® receives marketing authorization in Germany,
Finland and France.
* December: Start of U.S. phase III study on alitretinoin for the
treatment of severe chronic hand eczema.


ZEFTERA(TM)/Zevtera(TM) (ceftobiprole) - Anti-MRSA, broad-spectrum
antibiotic

* March: FDA issues Approvable Letter for ceftobiprole for the
treatment of complicated skin and skin structure infections
(cSSSI) including diabetic foot infections, indicating that the
ceftobiprole application is approvable.
* May: Presentation of detailed positive phase III results on
ceftobiprole in the treatment of community-acquired pneumonia
requiring hospitalization at the International Conference of the
American Thoracic Society.
* June: ZEFTERA(TM) receives its first marketing authorization by
Health Canada for the treatment of complicated skin and soft
tissue infections (cSSTI) including diabetic foot infections.
* September: FDA accepts for review the Complete Response to
ceftobiprole NDA Approvable Letter.
* October: Detailed positive phase III results on hospital-acquired
pneumonia including a sub-group analysis of patients with
ventilator-associated pneumonia presented at the joint meeting of
the Annual Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) and the Infectious Diseases Society of
America (IDSA).
* November: Zevtera(TM) receives approval by Swissmedic for the
treatment of cSSTI including diabetic foot infections.
* November: Zevtera(TM) receives a positive opinion from the EU
Committee for Medicinal Products for Human Use for the treatment
of cSSTI including diabetic foot infections.
* November: FDA issues Complete Response Letter for ceftobiprole
for the treatment of cSSSI including diabetic foot infections.


Isavuconazole - Broad-spectrum antifungal agent

* April: Start of an additional phase III study to evaluate the
efficacy and safety of isavuconazole in special patient
populations.
* April: New pre-clinical data presented at European Congress of
Clinical Microbiology and Infectious Diseases confirm that
isavuconazole's broad activity spectrum in vitro translates into
effective treatment in animal models.
* October: New clinical data displayed at ICAAC/IDSA showing that
isavuconazole was well tolerated and had predictable
pharmacokinetics at doses twice as high as investigated in phase
III clinical trials.


BAL30072 - Novel early-stage antibiotic against multi-resistant
Gram-negative bacteria

* September: New pre-clinical data on BAL30072's potent in vitro
activity against resistant Gram-negative "superbugs" such as
Acinetobacter and Pseudomonas aeruginosa were presented at
ICAAC/IDSA.



Conference Calls
Basilea Pharmaceutica Ltd. will hold two conference calls on February
24, 2009, one at 10 a.m. (CET) and one at 4 p.m. (CET) to discuss
today's press release.

The Company invites you to participate in the conference call
February 24, 2009, at 10 a.m. (CET)

Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+44 (0) 207 107 0611 (UK)
+1 (1) 866 291 4166 (USA)

A second conference call is scheduled on February 24, 2009, at 4 p.m.
(CET).

Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+44 (0) 207 107 0611 (UK)
+1 (1) 866 291 4166 (USA)

Note to Shareholders
The shareholders of Basilea Pharmaceutica Ltd. are kindly reminded
that the Ordinary General Meeting of Shareholders of Basilea
Pharmaceutica Ltd. will take place on Wednesday, April 29 at 2 pm at
the Hilton Hotel in Basel, Switzerland. The invitation will be
published in the Swiss Official Gazette of Commerce (Schweizerisches
Handelsamtsblatt). Shareholders who are recorded in the share
register with voting rights on April 16, 2009 will be entitled to
participate and exercise their voting rights.

About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated
research and development operations are currently focused on new
antibacterial, antifungal and oncology agents to fight drug
resistance and on the development of dermatology drugs. Basilea's
products are targeted to satisfy high medical and patient needs in
the hospital and specialty care setting. The company owns a
diversified portfolio including two commercialized drugs
(alitretinoin, ceftobiprole) and one investigational drug in phase
III (isavuconazole). Toctino® (alitretinoin) is marketed in the
United Kingdom, Denmark and Germany and is approved in Finland and
France. Alitretinoin has been recommended for approval in six
additional EU Member States and is under regulatory review in Canada
and Switzerland. Furthermore a phase III clinical trial on
alitretinoin for the treatment of severe chronic hand eczema is
ongoing in the U.S. Marketing applications for ceftobiprole
(ZEFTERA(TM)/Zevtera(TM)) were submitted in the U.S., the EU and
several other countries. The company has set up commercial
organizations in UK, Denmark, Germany and Canada, while it is
building sales and marketing organizations in other countries to
commercialize alitretinoin and to co-promote ceftobiprole, subject to
approval.

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 |
|----------------------------------+--------------------------------|
| Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D., MBA |
| Corporate Communication & Public | Head Corporate Development |
| Relations | +41 61 606 1233 |
| +41 61 606 1354 | investor_relations@basilea.com |
| media_relations@basilea.com | |
+-------------------------------------------------------------------+


This press release can be downloaded from www.basilea.com

The press release can also be downloaded from the following link:


This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.



 
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