PARIS, Aug 28, 2008 (MARKET WIRE via COMTEX) -- BioAlliance Pharma publishes
its consolidated half- year accounts to June 30, 2008: increased revenue and
reinforced growth via new licensing agreements
Paris, August 28, 2008 - BioAlliance Pharma SA (Euronext Paris, ISIN code:
FR0010095596-BIO), the specialty pharmaceutical company focused on the treatment
of opportunistic infections in cancer and HIV, has published its consolidated
accounts to June 30, 2008. Notable features include:
Significantly increased revenues from two sources: (i) payments received under
the terms of Loramyc(R) licensing agreements in the United States, Europe and
Asia and (ii) revenue from direct Loramyc(R) sales. Over this accounting period,
upfront license fees (spread out over time in the accounts) amounted to EUR
5,190k. Sales of Loramyc(R) in France increased to EUR 330k and are growing
steadily, fully in line with BioAlliance Pharma's objectives.
Contained R&D expenditure at EUR 6,239k, mainly reflecting the company's
investment in late-stage clinical programs and preclinical work.
A healthy cash situation (EUR 43.9 million), combined with a significant
financial profit (EUR 1,067k).
Following a presentation to the French Association of Financial Analysts (SFAF)
at 9.00 am this morning (Paris time), BioAlliance Pharma will host a conference
call in English at 11.30am. Dial-in numbers and connection information are
available on the company's web site.
Summary of key progress in the first half of 2008. Over the first half of 2008,
BioAlliance Pharma pursued its business plan in niche markets focused on
oncology and infectious disease. Several significant advances were achieved, in
line with the strategic objectives that the company has set itself:
- Continuation of Loramyc(R)'s launch in France, with a significant progression
in the number of prescriptions and the number of patients treated (+65% between
the end of March 2008 and the end of June 2008). End of July, Loramyc(R) share
in its target OPC market reaches 5%.
- The company has been awarded marketing authorization for Loramyc(R) in 6
European countries, including the two largest markets after France (the United
Kingdom and Germany) where the product is being launched since July by the sales
& marketing teams at BioAlliance Pharma's SpeBio joint venture.
- The signature of two new licensing agreements for Loramyc(R) in Asia, with
Handok Pharmaceuticals (Korea, Malaysia, Singapore and Taiwan) and NovaMed
(China). These two agreements represent a potential total of $16.5 million and
feature significant royalties.
- Completion of Loramyc(R)'s pivotal Phase III trial in the United States with
encouraging interim results, which should enable filing of an NDA at the FDA by
the end of the year.
- Continuation of the company's R&D programs - notably its promising projects
liable to enter clinical phases in 2009 (on AMEP(TM), irinotecan Transdrug(R)
and new Lauriad(R) applications) and ongoing clinical trial on acyclovir
Lauriad(R).
- In early July, BioAlliance announced the suspension of its Phase II clinical
trial on doxorubicin Transdrug(R) on the recommendation of the Drug Safety
Monitoring Board and the Steering Committee due to severe adverse events and is
currently making investigations, which are due to be completed by the end of
December 2008.
- Signature of strategic alliances in Europe aimed at completing its product
portfolio, with in-licensing of the commercial rights for Europe to ondansetron
Oral Spray(R) (indicated in post-chemotherapy and post- radiotherapy nausea and
vomiting). This product reinforces BioAlliance Pharma's product range in
supportive care and is enabling the company to position itself as a key partner
for oncologists and infectious disease specialists. Earlier this month, the
company complemented its supportive care product portfolio with an additional
ondansetron delivery system - ondansetron RapidFilm(TM). European registration
files for both products are due to be submitted in 2009.
H1 2008 accounts
Available cash and cash equivalents
The company's cash reserves on 30 June 2008 amounted to EUR 43.9 million, versus
EUR 56.3 million on 31 December 31 2007. This drop of EUR 12.4 million is
essentially due to R&D investments (particularly the company's Phase III
clinical trials of its three lead products) and promotional efforts related to
Loramyc(R)'s launch on the French market. Over the period in question,
BioAlliance Pharma paid NovaDel Pharma Inc. EUR 1.9 million for acquisition of
the European commercial rights to ondansetron Oral Spray.
In 2009-2010, BioAlliance intends to reinforce its out-licensing activity in
order to generate revenue. The company will pursue its licensing policy for both
lead products (Loramyc(R) and acyclovir Lauriad(R)) and its early- stage
development projects (notably with candidates like orally administered
irinotecan Transdrug(R) in colon cancer and an anti-integrase program in the HIV
area).
Summary of operating activity
Revenues
Revenue for the period amounted to EUR 4,896k.
This mainly corresponds to fees received under the terms of the Loramyc(R)
licensing agreements (totaling EUR 5,190k), which can be broken down as follows:
- Royalties received from the company's SpeBio joint venture (EUR 2,325k). This
sum corresponds to a proportion of the EUR 3 million up-front license fee
(spread over 10 years) and a EUR 4.5 million milestone payment due for the first
half-year of 2007 following grant of marketing approval for Loramyc(R) in
Germany and the United Kingdom. Half of this total was accounted for over the
period in question, due to proportional consolidation of SpeBio's income.
- EUR 2,070k in royalties received from Par Pharmaceuticals, the license holder
for the United States. This sum corresponds to spreading of the up- front
license fee over a period of 30 months. The initial period of 24 month has been
extended to 30 months, which has been confirmed on the occasion of a meeting in
August with the FDA where the company was able to validate the registration
process of Loramyc(R) in the United States. This meeting was very positive and
allows to confirm the planned registration of the product in this territory by
the end of 2009.
- EUR 105k from the Korean company Handok Pharmaceuticals, corresponding to
spreading of the up-front license fee over a period of 27 months.
Over the period in question, Loramyc(R)'s sales in France rose to EUR 330k.
Payroll costs
Salary, remuneration and social security costs rose from EUR 3,673k for H2 2007
to EUR 4,378k for H1 2008, i.e. an increase of EUR 705k due to the growth in
staff numbers. The company has recruited in all business areas over 2007 and the
first half of 2008.
External costs
External costs amounted to EUR 9,278k as of June 30, 2008 versus EUR 6,749k as
of June 30, 2007, i.e. an increase of EUR 2,529k. This change reflects a
scheduled increase in R&D costs, which represented a total of EUR 6,239k for the
first half of 2008. These costs correspond to expenditure on the three Phase III
clinical trials (Loramyc(R) in the United States, acyclovir Lauriad(R) in labial
herpes and doxorubicin Transdrug(R) in primary liver cancer) and development
work on new in-house products. The company has also maintained its promotional
efforts related to the launch of Loramyc(R) in France.
Tax and related payments
This expenditure rose to EUR 315k for H1 2008, versus EUR 94k for H1 2007. It
mainly includes non-deductible VAT, land tax and salary tax, as well as tax
deducted at source relative to the license agreements signed by the company.
Depreciation expenses
Depreciation expenses rose from EUR 76k for H1 2007 to EUR 189k for H1 2008.
This variation results from the fitting out of office and lab space at
BioAlliance Pharma's European corporate headquarters in Paris.
Provisional expenses
Provisional expenses notably fell to EUR 178k as of June 30, 2008, versus net
expenses of EUR 205k for H1 2007. These amounts primarily correspond to amounts
set aside to cover disputes with former staff and suppliers.
Other operating revenues and expenses
Other operating revenues and expenses amounted to a net balance of EUR 240k as
of June 30, 2008, versus a net sum of EUR 1,463k as of June 30, 2007. These
items include a cost of EUR 1,926k corresponding to the license fee for
ondansetron Oral Spray. Furthermore, income of EUR 2,250k (representing the
difference between the value of the SpeBio shares held by BioAlliance Pharma and
the Group's portion of SpeBio's net operating profit) has been accounted for.
This difference results from the increase in SpeBio's share capital reserved for
SpePharm, for which the latter paid an additional EUR 4.5 million for the half
year and which is accounted for as a share premium.
Financial profit
The financial profit rose from EUR 270k for H1 2007 to EUR 1,067k for H1 2008.
These amounts mainly correspond to revenue from the sale of short- term
investment products used by the company to manage its cash reserves.
Net loss
As a result of the progression in business activity (reflected by the revenue
and expenditure items presented above), the net loss for the 6- month period
ending June 30, 2008 was EUR 7,924k, versus EUR 8,761k for H1 2007 (i.e. a
decrease of EUR 837k).
Schedule and perspectives:
Revenues:
The targets for Europe-wide sales of Loramyc(R) are EUR 25 million (a 23% market
share) in 2011 and EUR 33 million (a 30% market share) in 2012.
In France, 8,000 patients have already been treated with Loramyc(R). The goal
for the second half of 2008 is to double this figure and add 8,000 additional
patients.
Registration: the following dates are estimates and are subject to the status of
clinical and/or pharmaceutical results and any additional requests by regulatory
agencies.
BioAlliance Pharma is planning to file an NDA for Loramyc(R) in the United
States in late 2008.
In terms of ondansetron RapidFilmTM, an application for European marketing
approval is scheduled for the first half of 2009. An application for ondansetron
Oral Spray is due to be filed in the second half of 2009.
The company hopes to register acyclovir Lauriad(R) in Europe in 2009 and,
depending on an additional pharmacoclinical program, a marketing application in
the United States could potentially be filed in 2010.
Development
AMEP(TM), irinotecan Transdrug(R) and fentanyl Lauriad(R) (extension of
Lauriad(R) franchise) are all candidates for first-in-man use in 2009. The
feasibility of new therapeutic applications of the Lauriad(R) muco-adhesive
technology (in mucositis and inflammation) will be established at the end of
2008.
In compliance with the provisions of article 221-4 V of the Autorite des Marches
Financiers' (AMF, the French stock market regulator) General Regulations,
BioAlliance Pharma today announced the filing of its financial report for the
half year to June 30, 2008. The half-year financial report, including the
consolidated accounts to June 30, 2008, can be viewed in the "Informations
Actionnaires" section of the company's web site (www.bioalliancepharma.com).
The half-year accounts have been approved by the Executive Board, verified by
the statutory auditor and examined by the Supervisory Board on August 27, 2008.
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 drug resistance issues.
BioAlliance Pharma has launched its first portfolio product (Loramyc(R)) in
France and, more recently, in the UK, Germany and Denmark, and has already
received European Marketing Authorizations in Belgium and Luxemburg. The product
has also completed a pivotal Phase III clinical trial in the United States in
oropharyngeal candidiasis. The company is also performing a Phase III trial in
labial herpes with acyclovir Lauriad(R) (which is based on the same Lauriad(R)
muco-adhesive technology as Loramyc(R), enabling targeted release at the disease
site). BioAlliance Pharma also has a second technology (the Transdrug(R)
nanoparticle technology, designed specifically for intracellular targeting) and,
furthermore, is developing a new therapeutic entities program in oncology and
infectious disease. BioAlliance Pharma has established several strategic
alliances for commercializing Loramyc(R), with agreements in 2007 for Europe
(with the SpeBio joint venture) and the United States (with Par Pharmaceutical)
and in 2008 for Asia (Korea, Malaysia, Singapore and Taiwan with Handok
Pharmaceuticals and then China with Novamed). In May and August 2008, the
company expanded its product portfolio by acquiring the Europe commercial rights
to, respectively, ondansetron Oral Spray (OS) from NovaDel Pharma Inc. (Amex:
NVD) and ondansetron RapidFilmTM from APR/Labtec. 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 11 2008 under the number R. 08-021, which is
available on the AMF website (http://www.amf-france.org) or on BioAlliance
Pharma S.A.'s website (http://www.bioalliancepharma.com).
BioAlliance Pharma SA
Dominique Costantini, President and CEO
Tel.: +33 1 45 58 76 01
dominique.costantini@bioalliancepharma.com
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
nicolas.fellmann@bioalliancepharma.com
ALIZE RP
Caroline Carmagnol
Tel.: +33 6 64 18 99 59
caroline@alizerp.com
This information is provided by HUGIN
SOURCE: BioAlliance Pharma SA
