BioAlliance Pharma Announces Its Full-Year Results for 2007.PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- Regulatory News: BioAlliance Pharma (Paris:BIO) * Revenues: +667% * End-of year cash reserves Cash reserves See: Cash investments cash reserves Investment funds that are held in short-term assets such as Treasury bills and certificates of deposit until more permanent investment opportunities are available. : EU56 million BioAlliance Pharma SA (Eurolist: BIO) today presented its consolidated financial results for the fiscal year ended December 31, 2007. * 2007 was a distinctive year for BioAlliance Pharma, which delivered on all its stated operational objectives. 1. Fiscal year 2007 [TABLE OMITTED] 2007 revenues rose strongly (+667%) year-on-year, testifying to the successful signature of industrial agreements on Loramyc[R] in Europe (incorporation of SpeBio, a joint venture with SpePharm) and in the United States (agreements with Par Pharmaceutical and the latter's proprietary products division, Strativa Pharmaceuticals) and the first sales of Loramyc[R] (launched in France at the end of 2007). These licensing agreements generated EU19 million in 2007, including EU5 million in equity and EU14 million in license fees. These revenues will be recognized over 2 to 10 fiscal years, depending on BioAlliance Pharma's commercial involvement. The operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. of EU19,565k reflects the group's strong R&D investments. In fact, BioAlliance Pharma is developing Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the programs (Loramyc[R] in the United States, acyclovir acyclovir /acy·clo·vir/ (a-si´klo-ver) a synthetic purine nucleoside with selective activity against herpes simplex virus; used as the base or the sodium salt in the treatment of genital and mucocutaneous herpesvirus infections. Lauriad[R] and doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased Transdrug[R]) and a number of innovative programs, prompting the group to invest a total of EU11,865k in R&D, versus EU7,012k in 2006. This significant effort is fuelling a mature, balanced product portfolio. The operating loss also includes the following items: * Promotional expenses associated with Loramyc[R]'s launch in France. * The costs linked to negotiation of the collaborative agreements signed in 2007 (including the payment of EU2 million to Immtech Pharmaceuticals for the European rights to a novel chemical entity in Phase III - this represents BioAlliance's maximum financial exposure for this product, which was withdrawn in late February 2008, due to poor tolerance). * Various G&A expenses, including intellectual property. * IFRS IFRS International Financial Reporting Standard(s) IFRS Inter Frame Relay Service IFRS Indiana Facilities Registry System adjustments, including a EU1.8 million charge linked to the accounting of warrants and options allotted since 2006 (in line with IFRS 2). The financial profit is EU1,317k, versus EU473k in 2006. This profit results from investment of the company's cash and cash equivalents. In addition to license payments received, the company completed a EU40 million round of financing in August 2007. These operations meant that the company had EU56 million in available cash and cash equivalents as of Dec 31 2007, versus EU17.6 million at the end of the previous fiscal year. The net consolidated loss for the fiscal year 2007 was EU18,249k, versus a loss of EU13,165 in 2006. The outlook for 2008: "2007 was a decisive year for our group. We underwent a major transformation on the financial level, with both our first sales revenues and a level of cash and cash equivalents that will enable accelerated growth in 2008, via intensified R&D investments and the targeted acquisition of complementary products", commented Nicolas Fellmann, CFO See Chief Financial Officer. at BioAlliance Pharma. "With the launch of Loramyc[R] in France, BioAlliance has delivered on the initial phases of its commercial strategy and is preparing its international extension, with Loramyc[R]'s market launch across the rest of Europe in 2008. In parallel, our other products are making independent progress. These innovative projects are preparing the ground for BioAlliance to become a European specialty pharma company with a portfolio focused on opportunistic infections Opportunistic infections Infections that cause a disease only when the host's immune system is impaired. The classic opportunistic infection never leads to disease in the normal host. , cancer and AIDS", added Dominique Costantini, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . 2. Summary of key events in 2007 * Loramyc[R]: a innovation award in France in June; launch on the French hospital prescription market in September; completion of patient inclusions in the pivotal US trial in November, completion of the European Mutual Recognition Procedure in December 07, two international sales agreements (in March in Europe and in July in the USA) for EU80 million plus significant royalties, EU19 million of which was paid in 2007. In early 2008, Loramyc[R] received its first two PMAs in the rest of Europe (the United Kingdom and Denmark), triggering a EU2.5-million milestone payment by the company's partner SpePharm under the terms of the joint agreement. * International development of the company's portfolio: Acyclovir Lauriad[R]: extension of its international phase III trial in treatment of recurrent labial labial /la·bi·al/ (la´be-al) 1. pertaining to a lip or labium. 2. in dental anatomy, pertaining to the tooth surface that faces the lip. la·bi·al adj. herpes (currently underway in Australia and Europe) to the United States. Doxorubicin Transdrug[R]: the company is continuing to open additional centers in Europe for its Phase III primary liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. trial. * Progress in research programs: BioAlliance Pharma has published promising results for a novel therapeutic entity (AMEP AMEP Adult Migrant English Program AMEP African Middle East Petroleum Co. AMEP Asymptotic Multi-User Error Probability AMEP Association for Medical Education in Pakistan AMEP Automated Missile Engagement Planner [TM], intended for the treatment of invasive melanoma), enabling the compound to enter the active regulatory study phase. The company's portfolio currently features 7 products, including 3 in Phase III. * Other information BioAlliance Pharma has announced that it is to move into new European corporate headquarters in the 15tharrondissement of Paris. About BioAlliance Pharma BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. . The company develops and commercializes innovative products which address resistance issues. The company has launched its first portfolio product (Loramyc[R]) in France and the compound is currently in Phase III clinical development in oropharyngeal oropharyngeal /oro·pha·ryn·ge·al/ (-fah-rin´je-al) 1. pertaining to the mouth and pharynx. 2. pertaining to the oropharynx. candidiasis candidiasis (kăn'dĭdī`əsĭs), infection of the mucous membranes caused by the fungus Candida albicans. Other terms for candidiasis are yeast infection, moniliasis (after a former name of the fungal genus), and thrush, the in the USA. In addition, two other innovative products are currently in Phase III clinical trials: acyclovir Lauriad[R] in oral herpes (based on the same Lauriad[R] muco-adhesive technology as Loramyc[R], which enables targeted release at the disease site) and doxorubicin Transdrug[R] in primary liver cancer (based on the Transdrug[R] nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. markets. In 2007, the company has established strategic alliances for commercializing Loramyc[R] in Europe (with JV SpeBio) and the USA (with Par Pharmaceutical). For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA 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 BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA 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 a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque ris·qué adj. Suggestive of or bordering on indelicacy or impropriety. [French, from past participle of risquer, to risk, from risque, risk; see risk.] Adj. ") section of the reference document approved by the AMF AMF ACE (Allied Command, Europe) Mobile Force AMF Autorité des Marchés Financiers (French) AMF Action Message Format AMF Arab Monetary Fund AMF Asian Monetary Fund AMF Autocrine Motility Factor on April 6 2007 under the number R. 07-031, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com). |
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