BASEL, Switzerland,, Jan. 31, 2007 (PRIME NEWSWIRE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) announced 2006 financial results reflecting successful investments in its three phase III drug candidates. Combined cash and short-term investments amount to CHF 176.6 million as of December 31, 2006.
Basilea Pharmaceutica Ltd. announced today its 2006 financial results reflecting the significant progress achieved in its investigational drug portfolio. Basilea continued to achieve major development milestones in 2006 announcing positive phase III clinical trial results for ceftobiprole; the completion of recruitment in the alitretinoin pivotal phase III trial; and the initiation of phase III clinical program for the antifungal isavuconazole. In addition, Basilea started integrating commercialization into its organization for the hospital and specialty pharmaceutical markets by exercising its co-promotion option for ceftobiprole.
Financial Summary
Combined cash and short-term investments amounted to CHF 176.6 million as of December 31, 2006, compared to CHF 229.6 million at year-end 2005. The change in net cash used for operating activities compared to the prior year results mainly from non-recurring payments received in 2005 in the total amount of CHF 102.9 million related to the ceftobiprole licensing agreement. Total revenues in 2006 amounted to CHF 7.4 million compared to CHF 30.5 million in 2005, as the Company realized non-recurring revenues from Johnson & Johnson of CHF 24.9 million in 2005 related to the licensing agreement for ceftobiprole.
Research and development expenses amounted to CHF 82.8 million in 2006 compared to CHF 72.4 million in 2005. These expenses relate primarily to investments in alitretinoin phase III registration trials and the preparation and initiation of phase III trials for the antifungal isavuconazole. Operating loss totaled CHF 87.9 million in 2006 compared to CHF 50.8 million in 2005 and net loss increased to CHF 85.1 million in 2006 (2005: CHF 49.6 million), which in both cases is mainly related to the non-recurring revenues resulting from the company's collaboration with Johnson & Johnson in 2005. Basic and diluted loss per share amounted to CHF 11.11 for 2006 as compared to CHF 6.71 in 2005.
Key Figures
(in CHF million) 2006 2005
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Revenues 7.4 30.5
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Expenses
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Research & Development (82.8) (72.4)
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General & Administrative (12.5) (8.9)
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Operating Loss (87.9) (50.8)
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Net Loss (85.1) (49.6)
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Cash Flow from
Operating Activities (72.5) 34.4
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Basic and Diluted
Loss per Share in CHF (11.11) (6.71)
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Notes: Consolidated figures in conformity
with US GAAP
The consolidated financial statements of Basilea Pharmaceutica Ltd. for 2006 can be found on the company's website at http://www.basilea.com.
Ron Scott, Chief Financial Officer, commented, "Our expenses and results in 2006 were in line with our expectations reflecting our investment in alitretinoin phase III clinical trials and the preparation and initiation of isavuconazole phase III clinical trials. Operating loss increased in 2006 compared to the prior year as expected, resulting from non-recurring revenues that were recognized in 2005 related to our licensing agreement with Johnson & Johnson. Our cash position provides Basilea with a strong financial basis to bring our development compounds to the market. "
"We now have three compounds in late-stage clinical development. The year 2006 was filled with significant progress and tangible achievements accomplished through focusing on maximizing the value of our assets for our shareholders. We expect further key phase III clinical trial results from both the ceftobiprole and alitretinoin programs this year. Based on achieving our clinical and regulatory milestones, we look forward to participating in the commercialization of ceftobiprole and alitretinoin next year", stated Dr. Anthony Man, CEO.
Product highlights for the twelve-month period include:
Ceftobiprole (BAL5788) - Anti-MRSA, Broad-spectrum Antibiotic
* Publication of first pivotal study results for the treatment of complicated skin infections indicating high clinical cure rates, good safety and tolerability. * Opening of additional phase III study for hospitalized patients suffering from community-acquired pneumonia (CAP) to broaden the number of potential indications. * Presentation of the detailed pivotal data at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) supported ceftobiprole's potent anti-MRSA activity and reaffirmed the enhanced broad-spectrum activity including Gram-negative pathogens. * Exercise of co-promotion option on ceftobiprole in North America and major European countries with Johnson & Johnson's affiliate Cilag GmbH International to participate in the anticipated launch and promotion of ceftobiprole in these markets. * And in 2007, the announcement of second pivotal phase III study results for the treatment of complicated skin infections and infections in diabetic foot patients including Gram-negative pathogens showing high clinical cure rates, good safety and tolerability.
Isavuconazole (BAL8557) - Broad-spectrum Antifungal Agent
* Designation of fast track status by the U.S. Food and Drug Administration (FDA) because of the potential benefit of our extended-spectrum antifungal for the treatment of severe invasive infections including patients with renal impairment. * Presentations of clinical and pre-clinical data at the International Society for Human and Animal Mycology (ISHAM) congress highlighted the promising safety and drug-drug interaction profile and confirmed broad-spectrum activity. * Initiation of phase III program with two global primary-treatment phase III trials for the treatment of invasive yeast and mold infections.
Alitretinoin (BAL4079) - Chronic Hand Dermatitis Compound
* Completion of phase III trial recruitment with over 1,000 patients in the largest randomized placebo-controlled study ever performed in patients suffering from severe chronic hand dermatitis.
Products in Phase III Development Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin that has demonstrated positive Phase III trial results in complicated skin and skin structure infections. Ceftobiprole has shown a low potential to select for resistance in-vitro and exhibits in-vitro activity against a wide spectrum of bacteria - including resistant bacteria like methicillin-resistant Staphylococcus areus (MRSA) - that cause many hospital and community-acquired infections. Top-line results of a second phase III study in skin infections were announced in early 2007. The FDA has granted ceftobiprole fast track status and the first registration filing is planned mid 2007. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International, a Johnson & Johnson company. Ortho-McNeil, Inc., another Johnson & Johnson company, will market ceftobiprole in the U.S. and its affiliate company, Janssen-Cilag, will market the product in Europe, Japan and China.
Alitretinoin is being developed by Basilea as a novel treatment for severe refractory chronic hand dermatitis, often a debilitating condition affecting an estimated one million patients in developed countries. Severely affected patients often suffer for years from the disease with no effective treatment options currently available. This lack of approved treatments contributes to the high socio-economic and individual patient burden. Following positive phase II results, a phase III program was designed meeting international regulatory requirements. The European and Canadian Phase III studies for alitretinoin are expected to deliver top-line data during the first quarter of 2007, with planned filing later this year in these markets. A clinical program for the USA is planned subject to review of phase III results.
Isavuconazole has a potent, broad-spectrum activity against both yeasts and molds. This new triazole is developed as a water-soluble pro-drug to allow safe and simple intravenous administration without contraindication in renally impaired patients. In addition, taken as convenient once daily or once weekly capsules, the prodrug results in excellent bioavailability. Basilea successfully completed its phase II trial with both high clinical cures rates and a safety profile comparable to gold standard therapy but with potentially a more flexible dosing schedule. Clinical drug interaction studies illustrated attractive pharmacokinetic features and the potential for less drug-drug interactions than a number of broad-spectrum antifungal drugs in current use.
About Basilea
Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX: BSLN). Basilea's fully 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 three investigational drugs in phase III clinical development. Basilea is building a sustainable hospital and specialty pharmaceutical business. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole.
Conference Call Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Wednesday, January 31, 2007, 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 und ROW) +1 (1) 866 291 4166 (USA) +44 (0) 207 107 0611 (UK)
The playback will be available 1 hour after the conference call for 48 hrs. 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 680 followed by the # sign.
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, March 7, 2007 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 February 23, 2007 will be entitled to participate and exercise their voting rights.
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.