Basilea reports 2007 financial results

 

Basilea Pharmaceutica Ltd. announces its 2007 financial results reflecting significant progress achieved in its late-stage drug portfolio. The completion of pivotal phase III clinical trial programs in the reporting period enabled two out of three late-stage compounds to move forward into regulatory review in the USA, Europe, Canada and Switzerland. Basilea anticipates completion of the review process for ceftobiprole and alitretinoin in several major markets during 2008.

 

Key achievements were the regulatory filings of ceftobiprole in the U.S., in the EU, in Canada and in Switzerland for the treatment of complicated skin and skin structure infections (cSSSI) including diabetic foot infections. Furthermore, the marketing authorization application (MAA) for alitretinoin was accepted for review by various EU Member States under decentralized procedure and by Switzerland. Additionally a New Drug Submission (NDS) for alitretinoin was filed with the Canadian health authority. These submissions support the use of oral alitretinoin in severe refractory chronic hand eczema.

 

Basilea initiated build-up of its commercial organization in 2007 to efficiently support its potential product launches. In addition Basilea invested in commercial product supplies. Subject to timely completion of several regulatory reviews on both ceftobiprole and alitretinoin, the company anticipates marketing authorizations and potential product launches to begin in 2008.

 

 

 

Combined cash and short-term investments amounted to CHF 424.8 million as of December 31, 2007, compared to CHF 176.6 million at year-end 2006. The increase in available funds compared to the prior year results mainly from the proceeds in connection with the secondary offering that was completed in March 2007. In addition, the company received further milestone payments of CHF 36.4 million under its license agreement related to the regulatory filings of ceftobiprole in 2007. Total revenues in 2007 amounted to CHF 7.9 million compared to CHF 7.2 million in 2006.

 

Research and development expenses amounted to CHF 115.7 million in 2007 compared to CHF 82.8 million in 2006. The expenses in 2007 relate primarily to the preparations of the regulatory filings for alitretinoin as well as conducting the phase III clinical trials for alitretinoin and isavuconazole.

 

In addition, the research and development expenses include CHF 11.4 million related to manufacturing of alitretinoin for potential commercialization, subject to regulatory approval. The general and administrative expenses amounted to CHF 29.0 million in 2007 and include expenses for the establishment of an international commercialization organization. Operating loss totaled CHF 136.5 million in 2007 compared to CHF 87.9 million in 2006 and net loss increased to CHF 126.8 million in 2007 (2006: CHF 85.1 million), as a consequence of the increased investments in research and development as well as the commercial organization. Basic and diluted loss per share amounted to CHF 13.97 for 2007 as compared to CHF 11.11 in 2006.

 

(in CHF million)	2007	2006
Revenues	7.9	7.2
Expenses
Research & Development	(115.7)	(82.8)
General & Administrative	(29.0)	(12.5)
Operating Loss	(136.5)	(87.9)
Net Loss	(126.8)	(85.1)
Cash Flow from Operating Activities	(79.0)	(72.5)
Basic and Diluted Loss per Share in CHF	(13.97)	(11.11)

Notes: Consolidated figures in conformity with US GAAP

 

The consolidated financial statements of Basilea Pharmaceutica Ltd. for 2007 can be found on the company's website at www.basilea.com.

 

Ron Scott, Chief Financial Officer, commented, "Our expenses and results in 2007 were in line with our expectations reflecting our investment in preparing regulatory filings for alitretinoin and conducting isavuconazole phase III clinical trials. In addition, the Company started to build a commercialization organization in North America and key European countries. The Company also invested in the production of commercial material in preparation for the launch of alitretinoin. Operating loss consequently increased in 2007 compared to the prior year as expected. Subject to regulatory approval, we anticipate launching two products in 2008 with associated potential revenue and milestone payments."

 

"The year 2007 was remarkable for the number of high impact company milestones achieved that signal our transition from a pure research and development organization to a fully integrated biopharmaceutical company. Our successes in 2007 bring us much closer to making our innovative drugs available to patients and health care providers alike. Our focus lies now on building an efficient international commercial operation to maximize the value of our portfolio assets for our shareholders," stated Dr. Anthony Man, CEO.

 

 

These submissions support the proposed use of oral alitretinoin in severe refractory chronic hand eczema.

 

 

 

 

 

 

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, March 19, 2008 at 3 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 March 7, 2008 will be entitled to participate and exercise their voting rights.

 

Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial and antifungal 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 pre-registration drugs and one phase-III investigational drug. The company is currently building its sales and marketing organization to commercialize alitretinoin and to co-promote ceftobiprole with its partner Cilag GmbH International, a Johnson & Johnson company, in North America and major European countries.

 

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.

 

 

General Information	Investor Relations
information@basilea.com	Dr. Barbara Zink investor_relations@basilea.com

 

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