PARIS -- 08/28/08 --
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® licensing agreements in the United States,
Europe and Asia and (ii) revenue from direct Loramyc® sales. Over this
accounting period, upfront license fees (spread out over time in the
accounts) amounted to EUR 5,190k. Sales of Loramyc® 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®'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® share in its target OPC market reaches 5%.
- The company has been awarded marketing authorization for Loramyc® 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® 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®'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® and new Lauriad® applications) and ongoing clinical trial on
acyclovir Lauriad®.
- In early July, BioAlliance announced the suspension of its Phase II
clinical trial on doxorubicin Transdrug® 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® (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®'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® and acyclovir Lauriad®) and its early-
stage development projects (notably with candidates like orally
administered irinotecan Transdrug® 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®
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® 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® 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®'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® in the United States, acyclovir
Lauriad® in labial herpes and doxorubicin Transdrug® 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® 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® 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®. 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® 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® 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® and fentanyl Lauriad® (extension of
Lauriad® franchise) are all candidates for first-in-man use in 2009. The
feasibility of new therapeutic applications of the Lauriad® 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 Autorité des
Marchés 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®) 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® (which is based on the same Lauriad® muco-adhesive
technology as Loramyc®, enabling targeted release at the disease site).
BioAlliance Pharma also has a second technology (the Transdrug®
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®, 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
