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Basilea reports financial results for the first half-year 2011

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.
Head Public Relations &
Corporate Communications
+41 61 606 1102
media_relations@basilea.com

Barbara Zink, Ph.D., MBA
Head Corporate Development

+41 61 606 1233
investor_relations@basilea.com

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

Posted: August 2011

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