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Basilea reports 2011 financials with better than expected operating results

Basilea Pharmaceutica AG /
Basilea reports 2011 financials with better than expected operating results
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The issuer is solely responsible for the content of this announcement.

* Solid cash position of CHF 197.1 million
* Toctino® sales of CHF 31 million representing a 24 percent year-on-year
volume growth
* Significant progress in its development pipeline potentially leading to a
European regulatory filing for ceftobiprole in pneumonia and an alitretinoin
filing in the U.S. in 2012

Basel, Switzerland, February 9, 2012 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
today presented solid financial results for the full-year 2011 with a year-end
cash position of CHF 197.1 million and a lower than expected operating loss of
CHF 57.3 million. In 2011, sales of Basilea's hand eczema drug Toctino®
(alitretinoin) increased to CHF 31.0 million in line with the company's
guidance, representing a year-on-year volume growth of 24 percent.

The U.S. alitretinoin HANDEL phase III treatment and six-month relapse
observation studies were completed in 2011. Topline data are expected to be
available in the first quarter 2012. The filing of a U.S. New Drug Application
(NDA) for alitretinoin is envisaged by the end of 2012 assuming positive data
and successful pre-NDA discussions with the FDA.

Basilea has audited the hospital acquired pneumonia and hospital-treated
community acquired pneumonia ceftobiprole phase III studies following the return
of global rights of ceftobiprole in early 2011. The pneumonia study data has not
yet been reviewed by health authorities. Based on the audit outcome and
interactions with health authorities, Basilea decided to file a ceftobiprole
application for marketing authorizations in Europe in the second half 2012 for
severe pneumonia treated in the hospital and is preparing for a later filing in
the U.S.

Isavuconazole is being tested in a global clinical program comprised of phase
III studies in invasive candidemia, invasive aspergillosis, and rare mold
infections plus renally impaired aspergillosis patients. Completion of
recruitment of the aspergillus and rare molds studies is anticipated in 2012 and
recruitment in the Candida study may continue into 2013. Reporting of topline
data for all studies continues to be targeted for 2013.

BAL30072 is a novel antibiotic developed for the treatment of life-threatening
multidrug-resistant Gram-negative infections. BAL30072 has demonstrated
synergistic effects in combination with antibiotics from the penem class,
expanding its spectrum of activity to almost all clinically important multidrug-
resistant Gram-negative pathogens. In 2011 two clinical phase I studies were
completed. Basilea is extending the phase I program in 2012 to evaluate
additional dosing regimens.

Basilea initiated a phase I program for its small-molecule microtubule-targeting
anti-cancer drug BAL101553 including patients with advanced solid tumors
refractory to current standard therapies. Preliminary safety and pharmacokinetic
results from this study are anticipated for the second half of 2012.

"Basilea remains resolutely focused on bringing its late-stage innovative
products of high medical need to patients," stated Dr. Anthony Man, Chief
Executive Officer. "We have aligned our R&D resources to support the two
anticipated regulatory filings this year with the highest priority. With our
decision to file ceftobiprole for the treatment of severe pneumonia, we started
the year with strong momentum. Bringing ceftobiprole back to patients with
severe infections is a priority as it has the unique potential for the early
treatment of seriously ill patients hospitalized with pneumonia due to Gram-
positive and Gram-negative bacteria."

Ronald Scott, Chief Operating Officer, said: "Toctino is the only approved drug
for the debilitating condition of severe chronic hand eczema. Sales volume
continued to grow at 24 percent despite significant pressure from European
health care budgets. New opportunities for expanding the growth of Toctino are
anticipated in 2012 both from increased revenue growth and data from our U.S.
phase III HANDEL study which could form the basis of a potential U.S. regulatory
filing." He added: "Our strong cash position allows us to focus on key portfolio
value drivers to achieve clinical milestones and partner our assets, bring our
drugs to the market and optimize the commercial value of Toctino."

Key Figures
+------------------------------------------------+---------+---------+
| (In CHF million, except per share data) | 2011 | 2010 |
+------------------------------------------------+---------+---------+
| Product sales | 31.0 | 29.2 |
+------------------------------------------------+---------+---------+
| Contract revenue | 35.2 | 86.4 |
+------------------------------------------------+---------+---------+
| Revenue from R&D services | 0.6 | 0.6 |
+------------------------------------------------+---------+---------+
| Other income | 0.2 | 127.0 |
+------------------------------------------------+---------+---------+
| Total operating income | 66.8 | 243.2 |
+------------------------------------------------+---------+---------+
|     Cost of sales | (2.4) | (2.2) |
+------------------------------------------------+---------+---------+
|     Research & development | (70.0) | (56.0) |
+------------------------------------------------+---------+---------+
|     Selling, general & administrative expenses | (51.7) | (77.2) |
+------------------------------------------------+---------+---------+
| Total operating expenses | (124.1) | (135.5) |
+------------------------------------------------+---------+---------+
| Operating loss/profit | (57.3) | 107.7 |
+------------------------------------------------+---------+---------+
| Net loss/income | (57.6) | 107.6 |
+------------------------------------------------+---------+---------+
| Cash flow from operating activities | (82.4) | 106.6 |
+------------------------------------------------+---------+---------+
| Cash and short-term investments | 197.1 | 283.0 |
+------------------------------------------------+---------+---------+
| Basic loss/earnings per share, in CHF | (6.01) | 11.22 |
+------------------------------------------------+---------+---------+
| Diluted loss/earnings per share, in CHF | (6.01) | 11.19 |
+------------------------------------------------+---------+---------+
Notes: Consolidated figures in conformity with US GAAP; rounding was
consistently applied

The consolidated financial statements of Basilea Pharmaceutica Ltd. for 2011 can
be found on the company's website at http://annualreport.basilea.com.

Financial summary
Product sales in 2011 amounted to CHF 31.0 million, which is in line with the
Company's guidance.

In 2011 contract revenue amounted to CHF 35.2 million, comprised of CHF 11.1
million deferred revenue recognition from previous ceftobiprole license-related
payments (2010: CHF 71.1 million). In addition, contract revenues in 2011
included CHF 21.3 million in connection with the licensing agreement with
Astellas on isavuconazole (2010: CHF 14.2 million). In 2011, other income
amounted to CHF 0.2 million, compared to CHF 127.0 million in 2010 of which
CHF 126.9 million were awarded to Basilea by an arbitration tribunal as
compensation for lost ceftobiprole payments. Total operating income decreased to
CHF 66.8 million, compared to CHF 243.2 million in 2010, mainly due to reduced
contract revenue and other income recognition related to regaining ceftobiprole
rights.

Research and development expenses amounted to CHF 70.0 million in 2011, compared
to CHF 56.0 million in 2010. This increase of CHF 14.0 million primarily
reflects the investments in pre-filing activities for ceftobiprole and
recruitment in the isavuconazole phase III clinical program.

Selling, general and administrative expenses decreased in 2011 to CHF 51.7
million (2010: CHF 77.2 million) mainly due to significantly reduced legal costs
after successfully completing arbitration proceedings against Johnson & Johnson
in 2010.

As a result of the aforementioned factors, operating loss totaled CHF 57.3
million in 2011, compared to an operating profit of CHF 107.7 million in 2010,
and net loss amounted to CHF 57.6 million (2010: net income of CHF 107.6
million). Basilea reported a better than expected average operating loss of CHF
4.8 million per month through continued prudent cost management.

2011 basic and diluted loss per share amounted to CHF 6.01, compared to basic
and diluted earnings per share of CHF 11.22 and CHF 11.19, respectively, in
2010.

In 2011, the net cash used by operating activities amounted to CHF 82.4 million,
whereas in 2010 the net cash provided by operating activities amounted to CHF
106.6 million. The positive operating cash-flow in 2010 was mainly the result of
the arbitration award and the significant upfront and milestone payments that
the company received related to the execution of a licensing agreement with
Astellas and a distribution agreement with Almirall. Combined cash and short-
term investments amounted to CHF 197.1 million as of December 31, 2011, compared
to CHF 283.0 million at year-end 2010.

Financial outlook
We expect continued growth in Toctino® sales during 2012 against a background of
European health care budget constraints. Toctino® sales for 2012 are estimated
to achieve low double-digit growth, assuming stable exchange rates, and
representing strong volume growth. Our total operating expenses are estimated at
around CHF 10 million per month primarily as a result of our continued
investment in development. Our average monthly operating loss is estimated at
CHF 6-7 million.

Portfolio
Toctino® (alitretinoin) - the only therapy approved for adults with severe
chronic hand eczema (CHE) unresponsive to potent topical corticosteroids

Toctino® was the first treatment to show effective clearing of severe CHE, with
clear or almost clear hands achieved in nearly 50 percent of patients treated
with 30 mg Toctino®. The once-daily oral therapy for adults is given for 12 to
24 weeks, depending on patient response. Post-treatment observations in patients
who responded to Toctino® indicate that treatment can provide long periods free
from relapse and improve patient satisfaction.

Toctino® is a known teratogen (a substance that can cause birth defects when
women are exposed during pregnancy). Strict pregnancy prevention one month
before, during, and one month after cessation of treatment as well as monthly
pregnancy testing are required for women of childbearing age.

Ceftobiprole - a novel broad-spectrum anti-MRSA (methicillin-resistant
Staphylococcus aureus) cephalosporin antibiotic against Gram-positive and Gram-
negative pathogens, including Pseudomonas and Acinetobacter species

Ceftobiprole is an investigational antibiotic for the potential first-line
empiric treatment of severe multi-drug resistant bacterial infections. Available
data demonstrate activity against a wide range of clinically-relevant Gram-
positive as well as Gram-negative bacteria, highlighting the potential of
ceftobiprole for the early treatment of severe infections such as pneumonia
treated in the hospital.

Isavuconazole - a novel broad-spectrum antifungal with the potential to become
the best-in-class azole for the treatment of severe invasive fungal infections

Isavuconazole has excellent in-vitro and in-vivo coverage of a broad range of
yeasts (such as Candida species) and molds (such as Aspergillus species) as well
as less common but clinically important molds such as Zygomycetes spp.
Isavuconazole is available in two dosage forms: an injectable and a highly
bioavailable oral form that very importantly provide for predictable dosing to
ensure adequate effective drug levels in the body. This allows for a seamless
intravenous-oral switch, which is a significant advantage for potentially
allowing patients to be treated outside of the intensive care unit or the
hospital setting.

BAL30072 - a novel sulfactam antibiotic specifically targeting multidrug-
resistant Gram-negative bacteria

BAL30072 is a novel antibiotic that in in-vitro and in-vivo models demonstrated
potent bactericidal activity against a broad range of multidrug-resistant Gram-
negative pathogens such as Pseudomonas or Acinetobacter species. It overcomes
bacterial resistance by several mechanisms and has enhanced stability against
bacterial beta-lactamase enzymes, such as extended-spectrum beta-lactamases
(ESBLs), carbapenemases and the recently characterized New Delhi metallo-beta-
lactamase 1 (NDM-1), which cause resistance against many currently marketed
antibiotics. The activity of BAL30072 is further enhanced when combined with
penem-class antibiotics.

BAL101553 - prodrug of BAL27862, a unique microtubule-targeting anticancer drug
to treat drug-resistant cancer

BAL101553 is a highly water-soluble prodrug of the synthetic small molecule
BAL27862. It allows intravenous and oral administration without solubilizing
excipients associated with adverse effects. BAL27862 arrests tumor cell
proliferation and induces tumor cell death through a characteristic
destabilizing effect on microtubules that is distinct from other anti-cancer
agents, which are also directed against the microtubule network. Anti-tumor
activity of BAL27862 has been demonstrated across a broad panel of solid tumor
models, including those resistant against conventional microtubule-targeting
drugs such as taxanes or Vinca alkaloids.

Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Thursday, February 9, 2012, 4 p.m. (CET), 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,
February 13, 2012, 6 p.m. (CET). 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 12749 followed by the # sign.

Note to shareholders
The shareholders of Basilea Pharmaceutica Ltd. are informed that the Ordinary
General Meeting of Shareholders of Basilea Pharmaceutica Ltd. will take place on
Tuesday, April 17, 2012 at 2 p.m. at the Hilton Hotel in Basel, Switzerland. The
invitation will be published in the Swiss Official Gazette of Commerce
(Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in the
share register with voting rights on April 5, 2012 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 Pharmaceutica International Ltd.'s
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 adults with 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@basilea.com | investor_relations@basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.


--- End of Message ---

Basilea Pharmaceutica AG
Grenzacherstrasse 487<br>P.O Box Basel Switzerland


Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;


Press Release (PDF):
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