29.02.2008 07:00:00
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BioAlliance Pharma Announces Its Full-Year Results for 2007
Regulatory News:
BioAlliance Pharma (Paris:BIO)
Revenues: +667% End-of year cash reserves: €56 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
in thousands of euros (IFRS compliant)
Fiscal year 2007
(ended Dec 31 2007)
Fiscal year 2006
(ended Dec 31 2006)
Revenues
3,529
460
Operating loss
(19,565)
(13,638)
Financial profit
1,317
473
Net consolidated loss
(18,249)
(13,165)
Net loss per share (in euros)
(1.46)
(1.52)
End-of-year cash and cash equivalents
56,256
17,573
2007 revenues rose strongly (+667%) year-on-year, testifying to the
successful signature of industrial agreements on Loramyc®
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® (launched in
France at the end of 2007). These licensing agreements generated €19
million in 2007, including €5 million in
equity and €14 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 of €19,565k reflects the
group's strong R&D investments. In fact, BioAlliance Pharma is
developing Phase III clinical trial programs (Loramyc®
in the United States, acyclovir Lauriad® and
doxorubicin Transdrug®) and a number of
innovative programs, prompting the group to invest a total of €11,865k
in R&D, versus €7,012k 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®'s
launch in France.
The costs linked to negotiation of the collaborative agreements signed
in 2007 (including the payment of €2
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financial exposure for this product, which was withdrawn in late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 adjustments, including a €1.8 million
charge linked to the accounting of warrants and options allotted since
2006 (in line with IFRS 2).
The financial profit is €1,317k, versus €473k
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 €40 million round of financing in
August 2007. These operations meant that the company had €56
million in available cash and cash equivalents as of Dec 31 2007, versus €17.6
million at the end of the previous fiscal year.
The net consolidated loss for the fiscal year 2007 was €18,249k,
versus a loss of €13,165 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 at BioAlliance Pharma. "With the launch of Loramyc®
in France, BioAlliance has delivered on the initial phases of its
commercial strategy and is preparing its international extension, with
Loramyc®'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, cancer and AIDS", added
Dominique Costantini, CEO.
2. Summary of key events in 2007
Loramyc®: 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 €80 million plus
significant royalties, €19 million of which
was paid in 2007. In early 2008, Loramyc®
received its first two PMAs in the rest of Europe (the United Kingdom
and Denmark), triggering a €2.5-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®: extension of its
international phase III trial in treatment of recurrent labial herpes
(currently underway in Australia and Europe) to the United States.
Doxorubicin Transdrug®: the company is
continuing to open additional centers in Europe for its Phase III
primary liver cancer trial.
Progress in research programs: BioAlliance Pharma has published
promising results for a novel therapeutic entity (AMEP™,
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 15th arrondissement
of Paris.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on
the treatment of opportunistic infections in cancer and HIV. The company
develops and commercializes innovative products which address resistance
issues. The company has launched its first portfolio product (Loramyc®)
in France and the compound is currently in Phase III clinical
development in oropharyngeal candidiasis in the USA. In addition, two
other innovative products are currently in Phase III clinical trials:
acyclovir Lauriad® in oral herpes (based on
the same Lauriad® muco-adhesive technology as
Loramyc®, which enables targeted release at
the disease site) and doxorubicin Transdrug®
in primary liver cancer (based on the Transdrug®
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 markets.
In 2007, the company has established strategic alliances for
commercializing Loramyc® 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") section of the reference document approved by the AMF 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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