Basilea Pharmaceutica AG: Basilea reports 2009 interim results

Basilea Pharmaceutica Ltd. announced today its 2009 interim financial results reflecting the advancement of its two marketed products Toctino® and ZEFTERA™/Zevtera™.

Basilea focuses on preparing additional Toctino® launches in Europe and Canada, working towards ceftobiprole regulatory approval in key markets as well as on bringing forward its broad-spectrum antifungal isavuconazole currently in phase III clinical trials.

Financial summary

Combined cash and short-term investments amounted to CHF 224.9 million as of June 30, 2009, compared to CHF 293.6 million at year-end 2008. Revenue and other income increased to CHF 12.2 million compared to CHF 5.3 million in the prior year period, mainly as a result of the increased product sales due to successful first launches of Toctino® in Europe. Research and development expenses amounted to CHF 44.5 million in the first half of 2009 compared to CHF 49.0 million in the prior year period, mainly reflecting the continuous investment in the phase III clinical trials of isavuconazole and Toctino® in the U.S. General and administrative expenses increased to CHF 34.8 million compared to CHF 29.4 million in the first half of 2008 due to investments in commercialization of Toctino®.

Key figures

 +-------------------------------------------------------------------+ | (in CHF million), except per share data | H1 2009 | H1 2008 | |-----------------------------------------------+---------+---------| | Revenues and other income | 12.2 | 5.3 | |-----------------------------------------------+---------+---------| | Expenses | | | |-----------------------------------------------+---------+---------| | Cost of Sales | (0.7) | - | |-----------------------------------------------+---------+---------| | Research & Development | (44.5) | (49.0) | |-----------------------------------------------+---------+---------| | Selling, General & Administrative | (34.8) | (29.4) | |-----------------------------------------------+---------+---------| | Operating Loss | (67.8) | (73.1) | |-----------------------------------------------+---------+---------| | Net Loss | (66.5) | (67.9) | |-----------------------------------------------+---------+---------| | Cash Flow from Operating Activities | (68.2) | (66.5) | |-----------------------------------------------+---------+---------| | Basic and Diluted Loss per Share in CHF | (6.95) | (7.11) | +-------------------------------------------------------------------+

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 2009 can be found on the company's website at [ www.basilea.com ].

Ron Scott, Chief Financial Officer, commented, "Our financial results in the first half of 2009 reflect our successful launch of Toctino in the first wave of European countries. We are pleased with the acceptance of Toctino by patients and physicians and we look forward to maximizing the sales potential of Toctino as we roll out the product into additional countries. Our half-year financials reflect a solid cash basis, diligent cost control as well as investment in launches of Toctino and ZEFTERA/Zevtera. We continue to invest in the phase III clinical trials of isavuconazole and the ongoing U.S. phase III program of Toctino."

"We have reached a new milestone for Basilea as we report for the first time full six months' product sales," stated Dr. Anthony Man, CEO. "We aim to expand the availability of Toctino in second half 2009 and are working together with Johnson&Johnson PRD towards ceftobiprole regulatory approval in key markets. We remain focused on our key value drivers and on successfully advancing the priority clinical programs of our innovative pipeline."

Management reconfirms guidance for the year. Toctino® sales are estimated at around 15-20 million Swiss Francs. Net loss is estimated at between 12-13 million Swiss Francs per month.

Product and pipeline update

Toctino® (alitretinoin) - only approved therapy for severe chronic hand eczema unresponsive to topical corticosteroids

Following the submissions of pricing and reimbursement dossiers, decisions from authorities in France, Finland, Spain, Benelux, Austria and Italy are expected during the second half of 2009 and through 2010. Regulatory decisions on the Marketing Authorization Applications filed in Switzerland and Canada, and in 15 additional European countries are anticipated during the second half of 2009 and the first half of 2010, respectively. Regulatory filings in additional territories such as Latin America and the Middle East are planned this year. In the U.S., the first multi-centered, controlled clinical phase III study on alitretinoin for patients with severe refractory chronic hand eczema is ongoing. Following the positive Final Appraisal Determination issued in July and in the absence of any appeals a final guidance by the National Institute for Health and Clinical Excellence (NICE) is expected at the end of August this year.

ZEFTERA™/Zevtera™ (ceftobiprole) - the first approved anti-MRSA broad-spectrum cephalosporin antibiotic for the treatment of severe skin infections

The clinical site inspections in relation to the November 2008 Complete Response Letter issued to Johnson&Johnson Pharmaceutical Research and Development, L.L.C. (PRD) by the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) and the European Medicines Agency (EMEA)-led Good Clinical Practice inspections have been completed. Subject to acceptability of the resubmission a decision by the FDA on the complete response could occur in the first half of 2010. The EMEA Committee for Medicinal Products for Human Use (CHMP) could potentially issue a recommendation to the EU Commission by the end of 2009.

Isavuconazole - broad-spectrum azole-antifungal for the treatment of severe invasive fungal infections

Isavuconazole is currently in phase III development for the treatment of patients with severe invasive fungal infections. Patient recruitment to the trials was temporarily impacted by a clinical supply delay which has been addressed. Clinical drug supply is scheduled to be available by year-end. As a consequence recruitment time will be extended and phase III top-line results are anticipated to become available in 2011.

Early-stage programs

BAL30072, a novel antibiotic against the most difficult-to-treat multi-resistant Gram-negative bacteria, and BAL27862, a novel anti-cancer compound with activity against a broad range of tumor types, including those unresponsive to standard therapeutics such as Taxol, are currently undergoing pre-IND (Investigational New Drug) studies. Subject to successful completion of pre-IND studies, the initiation of phase I clinical trials is planned for the second half of 2010.

Key events for the period January to June 2009

Toctino® (alitretinoin) - the only therapy approved for severe chronic hand eczema unresponsive to topical corticosteroids

 * Preliminary NICE recommendations Preliminary positive recommendations with some limitations on the use of Toctino® within its licensed indication developed by Appraisal Committee of the National Institute for Health and Clinical Excellence (NICE). * Expansion of potential European commercial availability Marketing Authorization Application submitted for Toctino® in 13 additional European Union (EU) Member States as well as in Norway and Iceland. * Inclusion in new German dermatology treatment guidelines Toctino® incorporated in the new treatment guidelines for the management of hand eczema from the German Society of Dermatology. * Acceptance for use by the Scottish Medicines Consortium Toctino® accepted by Scottish Medicines Consortium (SMC) for use within National Health Service Scotland for the treatment of adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. The SMC considered Toctino's economic case demonstrated. * Series of European approvals Marketing authorizations received for Toctino® in Austria, Belgium, Luxemburg, the Netherlands and Spain for the treatment of adults with severe CHE unresponsive to potent topical corticosteroids.

ZEFTERA™/Zevtera™ (ceftobiprole) - the first approved anti-MRSA broad-spectrum cephalosporin antibiotic for the treatment of severe skin infections

 * Arbitration claims filed against Johnson&Johnson Arbitration claims filed against Johnson&Johnson over its handling of ceftobiprole clinical studies. * Review process in EU delayed European Medicines Agency (EMEA) halted the European Commission decision process on ceftobiprole for the treatment of complicated skin and soft tissue infections pending completion of Good Clinical Practice inspections.

BAL30072 - novel antibiotic against multi-resistant Gram-negative bacteria

 * New data presented at ECCMID New in-vitro efficacy data on BAL30072 were presented at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID).

Conference call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Friday, August 14, 2009, 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 17, 2009, 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 17790 followed by the # sign.

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 (Toctino®, ZEFTERA™/Zevtera™) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Austria, Belgium, Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin has been recommended for approval in Italy and is under regulatory review in Canada, Switzerland and 15 additional European countries. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Ceftobiprole is marketed in Canada under the brand name ZEFTERA™ and in Switzerland under Zevtera™. Marketing applications for ceftobiprole 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:

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Basilea Pharmaceutica AG: Basilea reports 2009 interim results