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Basilea Pharmaceutica AG (BPMUF.PK) Basel, Switzerland, July 25, 2008 - Basilea Pharmaceutica Ltd. (SWX:BSLN) announces its 2008 interim financial results - Basilea prepares to commercialize its two products currently under regulatory review.
Basilea Pharmaceutica Ltd. announced today its 2008 interim financial results reflecting the advancement of its three late-stage drugs and its activities in establishing an international commercial organization. Basilea focuses on preparing for the launches of its two drugs, alitretinoin and ceftobiprole currently under regulatory review and on bringing forward its broad-spectrum antifungal isavuconazole currently in late-stage phase III clinical trials.
Financial Summary Combined cash and short-term investments amounted to CHF 356.7 million as of June 30, 2008, compared to CHF 424.8 million at year-end 2007. Research and development expenses amounted to CHF 49.0 million in the first half of 2008 compared to CHF 60.6 million in the prior year period. Research and development expenses in the first-half of 2007 included expenses related to the manufacturing of commercial material in the amount of CHF 10.6 million resulting in a decrease in first-half 2008 spending as compared to first-half 2007. General and administrative expenses increased to CHF 29.4 million compared to CHF 10.8 million in the first half of 2007 due to investments related to the preparations for commercialization.
The increase in net cash used for operating activities as compared to the prior year period is mainly the result of a CHF 24.5 million milestone payment which the Company received in the first half of 2007.
Key figures
+-------------------------------------------------------------+ | (in CHF million), except per share data | H1 2008 | H1 2007 | |-----------------------------------------+---------+---------| | Revenues | 5.2 | 3.2 | |-----------------------------------------+---------+---------| | Expenses | | | |-----------------------------------------+---------+---------| | Research & Development | (49.0) | (60.6) | |-----------------------------------------+---------+---------| | General & Administrative | (29.4) | (10.8) | |-----------------------------------------+---------+---------| | Operating Loss | (73.1) | (68.1) | |-----------------------------------------+---------+---------| | Net Loss | (67.9) | (64.4) | |-----------------------------------------+---------+---------| | Cash Flow from Operating Activities | (66.5) | (28.0) | |-----------------------------------------+---------+---------| | Basic and Diluted Loss per Share in CHF | (7.11) | (7.40) | +-------------------------------------------------------------+
Notes: Unaudited consolidated figures in conformity with US GAAP
The unaudited condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd. for the first half of 2008 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 2008 reflect our investments in launch preparation and pre-marketing activities for both alitretinoin and ceftobiprole that are currently under regulatory review. We are very pleased that ceftobiprole has received its first regulatory approval in Canada under the trade name of ZEFTERA(TM). We also continued to invest in the phase III clinical trials of isavuconazole and in alitretinoin US phase III program preparations."
"Our financial results reflect our diligent and timely preparation for the anticipated launches of alitretinoin and ceftobiprole in 2008, subject to regulatory approval. Furthermore the results mirror our full commitment to bring isavuconazole through its last stage of clinical development", stated Dr. Anthony Man, CEO.
Product highlights for the six-month period include: Ceftobiprole - First-in-class anti-MRSA broad-spectrum cephalosporin antibiotic
* The U.S. Food and Drug Administration (FDA) issued an Approvable Letter for ceftobiprole for the treatment of complicated skin and skin structure infections including diabetic foot infections.
* Ceftobiprole (ZEFTERA(TM)) obtained regulatory approval from Health Canada authorizing the marketing of ceftobiprole for the treatment of complicated skin and soft tissue infections including diabetic foot infections.
Isavuconazole - Broad-spectrum azole-antifungal
* Basilea opened an additional supportive international multicenter safety and efficacy study including aspergillosis patients with impaired renal function and patients with rare mold infections.
Alitretinoin - Severe refractory Chronic Hand Eczema
* Ongoing preparations for US phase III clinical program and potential EU / Canada launch.
Conference Call Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Friday, July 25, 2008, 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 and 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 10657 followed by the # sign.
About Basilea Basilea Pharmaceutica Ltd. is 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 drugs under regulatory review (ceftobiprole and alitretinoin) and one phase-III investigational drug (isavuconazole). The company is currently building its sales and marketing organization to commercialize alitretinoin and to co-promote ceftobiprole in North America and major European countries, 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:
+-------------------------------------------------------------------+ | Media Relations | Investor Relations | |----------------------------------+--------------------------------| | Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D. | | Corporate Communication & Public | Head Corporate Development | | Relations | +41 61 606 1233 | | +41 61 606 1354 | investor_relations@basilea.com | | media_relations@basilea.com | | +-------------------------------------------------------------------+
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