in the development of the leader orphan oncology product Livatag®:
The presentation of positive phase II results showing a doubled median survival when compared with the standard of care for the treatment of primary liver cancer;
The approval of Livatag® phase III clinical trial by the French regulatory Agency early September, aiming to confirm the clinical interest of the product. The timelines for Livatag® development are confirmed with the pivotal trial initiation planned in 2012.
• First phase I preliminary results of the local administration of the AMEP® biotherapy has shown a satisfactory safety and a strong signal of efficacy in patients with metastatic melanoma. These results will enable to accelerate its clinical development via systemic administration (innovative program co-financed by OSEO).
• The Company has optimized its Loramyc® partnerships with:
The signature of a licensing agreement with Sosei Co. Ltd. for commercialization rights in Japan. BioAlliance has already received a $3 million up-front payment out of a total of $18.5 million milestone payments and significant royalties on future sales will be received;
Full US commercialization rights regained from PAR Strativa due to its recent focus on generic products, with no significant financial impact. The Company is already leading an active research to identify the commercial partner for the USA for a asset, Oravig®, approved in 2010 by the US FDA (Food and Drug Administration).
• At last, the Company is finalizing the registration dossier for Sitavir®, dedicated to the treatment of recurrent herpes labialis, in view of the next regulatory filing to the US and European agencies.
“These significant breakthroughs of the first semester result from our willing to value BioAlliance’ assets both commercially with the most appropriate partners, and in development with products addressing unmet needs. It demonstrates the quality of BioAlliance’s teams who commit to the most efficient plan to bring products to registration”, declares Judith Greciet, CEO of BioAlliance Pharma. “The Company will pursue its international growth supported by a Board of Directors renewed last July”.
Analysis of the H1 2011 accounts
*Mostly direct sales in France in 2010
Recurrent revenues of the Company have increased over the first semester: supply of product to its commercial partners as well as royalties received amounted to over €1 million, a figure doubled compared to 2010. The variability of revenues is otherwise due to non recurring items, linked to international license agreements.
BioAlliance has decreased overall operating expenses, however the Company has maintained sustained investments in R&D programs: mainly phase II clinical trial with clonidine Lauriad® for the treatment of severe mucositis, phase I clinical trial with AMEP® for the treatment of metastatic melanoma, as well as industrial development of Sitavir®.
Net income totaled -8.750 thousands Euros as of June 30, 2011. In the first half of 2010, the net profit was directly linked to the US approval of Oravig® that generated an exceptional license revenue (milestone payment).
Cash reserves at the end of June 30, 2011 amounted to €14.2 million, compared with a €20.9 million as of December 31, 2010. The cash burn over the semester is mostly due to R&D investments and general and administrative expenses.
The capital increase launched on July 1st, 2011, over-subscribed, has succeeding in raising a net €15.9 million. This financing will allow to accelerate the development of Livatag® and to reinforce the Company’s “orphan oncology products” portfolio.
” Our cash position, as of today evaluated around €30 million, puts us in a solid position to fund our growth strategic plan, in particular R&D programs on the short and middle term”, declares Nicolas Fellmann, CFO of BioAlliance Pharma.”
Analyst meeting and conference call (in English)
BioAlliance Pharma will hold a meeting at 9 am on Thursday September 22, 2011, at its corporate headquarters (49 boulevard Martial Valin, Paris, France). A conference call in English will be organized at 11:30 am Paris time (GMT+1). Access numbers and codes are given below.
Dialing from France or abroad: +33 (0)1 70 77 09 37
For conference call replay, dial +33 (0)1 72 00 15 00 then 274171#
BioAlliance Pharma today announced the filing of its financial report for the half-year ended June 30, 2011. The half-year financial report, including the consolidated accounts as of June 30, 2011, can be viewed in the “Investor” section of the Company’s website (http://www.onxeo.com).
The half-year accounts have been verified by the statutory auditors and approved by the Board of Directors on September 21, 2011.