BASEL, Switzerland, Feb. 28, 2006 (PRIMEZONE) -- Basilea (SWX:BSLN) announced 2005 financial results reflecting positive operating cash flow. Payments from Basilea's license partner, Johnson & Johnson exceed CHF 100 million. Combined cash and short-term investments increase to CHF 229.6 million as of December 31, 2005.
Basilea Pharmaceutica Ltd. announced today its 2005 financial results reflecting strong operational performance. In 2005, Basilea continued to achieve major milestones on its late-stage clinical development portfolio focused on innovative drugs for the hospital market. Product highlights for the twelve-month period include:
Ceftobiprole (BAL5788) -- Broad-Spectrum Anti-MRSA Antibiotic
-- Entering a significant collaboration with Johnson & Johnson
for the development and commercialization of ceftobiprole
-- Initiation of ceftobiprole phase III pneumonia trials
-- Completion of accrual on ceftobiprole's first phase III skin
infection study
-- Initiating a second ceftobiprole phase III skin study to broaden
labeling including Gram-negative infections such as foot ulcer
infections suffered by diabetic patients
BAL8557 -- Antifungal Azole
-- Successful completion of BAL8557 phase II development with
positive phase II results
-- Retention of global commercialization rights on BAL8557
Alitretinoin (BAL4079) -- Chronic Hand Dermatitis Compound
-- Recruitment of more than 75% of total planned patients in
alitretinoin phase III trial in Europe and Canada
-- Completion of drug substance and drug product registration
campaigns
Anthony Man, M.D., Chief Executive Officer commented, "2005 had been another year of significant accomplishments for Basilea. Our collaboration with Johnson & Johnson was an important step in realizing the full potential of ceftobiprole. This effective partnership is evidenced by the initiation of two planned phase III trials in hospital-acquired pneumonia and the start of an additional phase III study including Gram-negative skin infections, which occur in diabetic foot ulcer patients. In addition, we announced positive phase II trial results on our novel broad-spectrum antifungal drug BAL8557 and our international phase III alitretinoin registration trial progressed well with more than seventy-five percent of patients recruited. Basilea is one of the few remaining small companies specializing in anti-infectives possessing both a late-stage clinical portfolio and a very substantial research base. Our 2005 financial results show a sound cash position reflecting both significant milestone payments related to our ceftobiprole collaboration and effective management of R&D expenses."
Financial Summary
Combined cash and short-term investments increased to CHF 229.6 million as of December 31, 2005, compared to CHF 203.2 million at year-end 2004 resulting from payments received from Johnson & Johnson's affiliate, Cilag GmbH International, totaling CHF 102.9 million including CHF 78.0 million in upfront and milestone payments. These payments resulted in positive cash flow from operating activities of CHF 34.4 million in 2005. The upfront and milestone payments were recorded as deferred revenue and are recognized as revenue over the term of the licensing agreement. Total revenues in 2005 amounted to CHF 30.5 million, including CHF 29.0 million related to the licensing agreement for ceftobiprole.
Research and development expenses increased to CHF 72.4 million in 2005 compared to CHF 68.9 million in 2004. These expenses primarily relate to investments in alitretinoin phase III registration trials program, successful completion of phase II clinical trials and preparation of the phase III program for Basilea's antifungal, BAL8557. Operating loss decreased to CHF 50.8 million in 2005 from CHF 75.7 million in 2004 and net loss decreased to CHF 49.6 million in 2005 (2004: CHF 75.5 million). Basic and diluted loss per share decreased to CHF 6.71 for 2005 as compared to CHF 10.93 in 2004.
Key Figures
2005 2004
(in CHF million)
Cash Flow from Operating
Activities 34.4 (64.2)
Revenues 30.5 0.3
Expenses
Research and
Development (72.4) (68.9)
General and
Administrative (8.9) (7.1)
Operating Loss (50.8) (75.7)
Net Loss (49.6) (75.5)
Basic and Diluted Loss
per Share in CHF (6.71) (10.93)
Notes: Consolidated figures in conformity with U.S. GAAP
The consolidated financial statements of Basilea Pharmaceutica Ltd. for 2005 can be found on the company's website at http://www.basilea.com
Ron Scott, Chief Financial Officer commented, "Basilea achieved a significant milestone in 2005 through our collaboration with Johnson & Johnson for the development and commercialization of ceftobiprole, Basilea's antibiotic effective against drug resistant bacteria. The terms of the collaboration confirm the potential value of ceftobiprole and provide access to leading commercialization resources in order to optimize the value of the product. Upfront and milestone payments received in 2005 under the agreement provide Basilea with a strong financial basis to bring our development compounds to the market. Our expenses in 2005 were in line with our expectations reflecting our investment in alitretinoin phase III clinical trials and advancing our antifungal compound, BAL8557, after successful completion of phase II trials. We received over CHF 100 million from our partner Johnson & Johnson in 2005 under our collaboration with the result that Basilea's operating cash-flow was positive for the year."
About Ceftobiprole (BAL5788)
Ceftobiprole is a first-in-class broad-spectrum hospital antibiotic that targets important drug-resistant bacteria with potent bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftobiprole has a broad-spectrum and has also shown a low potential to induce bacterial resistance in vitro.
Global collaboration with Johnson & Johnson's affiliate Cilag GmbH International -- February 2005
Basilea entered into an exclusive worldwide agreement with Cilag GmbH International, a Johnson & Johnson company, to develop, manufacture and market ceftobiprole. Ortho McNeil's research affiliate, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. assumed responsibility for all ceftobiprole development costs. Total payments under the collaboration in 2005 were CHF 102.9 million including CHF 78.0 million in upfront and milestone payments. Total upfront and milestone payments related to the collaboration could be worth up to CHF 370 million. Royalty payments are due to Basilea upon commercialization. Development is guided through a Joint Steering Committee that combines the expertise of both companies to bring ceftobiprole to the market as quickly as possible. Basilea has retained an option to co-promote ceftobiprole in all major markets.
Successful advancement of ceftobiprole phase III clinical program -- October 2005
Basilea announced completion of accrual on ceftobiprole's first phase III skin infection study (STRAUSS trial; Study of Resistant Staphylococcus Aureus Skin and Skin Structure Infections), focusing on Gram-positive infections. Basilea and its development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. commenced a second ceftobiprole phase III skin study (STRAUSS 2) to broaden the labeling including Gram-negative infections such as foot ulcer infections suffered by diabetic patients. In April 2005, ceftobiprole moved into international phase III clinical trials in nosocomial pneumonia (CHOPIN trials; Ceftobiprole in Hospital-acquired Pulmonary Infections).
About BAL8557
BAL8557 is Basilea's novel broad-spectrum antifungal agent destined for patients with severe invasive fungal infections. Unlike the other azoles, BAL8557 is a prodrug suitable for simple intravenous administration and its excellent oral absorption allows a convenient once daily or even once weekly dosing, supporting patient-tailored treatment schemes.
Positive results from the phase II clinical trial -- September 2005
Basilea successfully completed its key 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. An end-of-phase II package was prepared for regulatory authority discussions and the phase III drug supply chain was initiated. Basilea retained global commercialization rights to BAL8557 providing further strategic flexibility to optimize the value of this antifungal as it advances into phase III.
About Alitretinoin (BAL4079)
Alitretinoin is a novel vitamin A analog that is developed for patients with chronic hand eczema that is refractory to conventional topical treatments. Chronic hand dermatitis is a disabling condition for which there is currently no approved prescription treatment available.
Successful continuation of the alitretinoin phase III registration program
More than 75% of the total number of planned patients were entered into the pivotal phase III trial in Europe and Canada. Drug substance and drug product registration campaigns for alitretinoin were completed.
About Basilea
Basilea Pharmaceutica Ltd. (BSLN) founded in October 2000 is an independent biopharmaceutical company headquartered in Basel, Switzerland, that is actively engaged in the discovery and development of innovative medicines for the treatment of unmet medical needs. The company's fully integrated research and development operations are currently focused on new anti-bacterial and antifungal agents in the hospital setting to fight drug resistance and on dermatology drugs. Basilea is listed on the SWX (Swiss Exchange).
NOTE
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Tuesday, February 28, 2006, 4 p.m. (CET), during which the company will discuss its 2005 financial results. Dial-in numbers are:
+41 91 610 5600 (Europe and ROW) +1 866 291 4166 (USA) +44 20 7107 0611 (U.K.)
The playback will be available 1 hour after the conference call for 48 hrs. Participants requesting a digital playback may dial:
+41 91 612 4330 (Europe) +1 866 416 2558 (USA) +44 20 7108 6233 (U.K.)
and will be asked to enter the ID 396 followed by the pound 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 Tuesday, March 28, 2006 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 March 15, 2006 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.
Basilea Pharmaceutica Ltd. Corporate Information P.O. Box CH-4005 Basel Switzerland
The press release can be downloaded from www.basilea.com
The press release can also be downloaded from the following link: http://hugin.info/134390/R/1036875/167861.pdf