BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the supportive care and treatment of cancer patients, today presented its consolidated half-year accounts to June 30, 2010.
The first half of 2010 was marked by two major events that testify to the quality of BioAlliance Pharma’s teams and products:
− European licensing agreement of Loramyc® and Setofilm®, both products registered in most of European countries, signed with Therabel;
− US approval of Oravig®, known as Loramyc® in Europe, enabling the commercial partner, Strativa Pharmaceutical (a division of Par Pharmaceutical) to launch the product in the US at the end of August 2010. BioAlliance Pharma is to date one of the first small medium-size innovative French companies with a product registered in this major territory.
«BioAlliance Pharma has demonstrated its ability to bring a product from concept to market with the patient in mind », declares Dominique Costantini, CEO of BioAlliance Pharma. «These successful events have already brought about €23 million from its commercial partners as non recurrent milestones during the first semester 2010. Our growth model, based on partnerships, is now proving its effectiveness; our ongoing and future launches will ensure recurrent revenues based upon royalties on net sales. These revenues will allow us to pursue developing our innovative product portfolio and may strengthen it with targeted acquisitions intended for rare cancers or severe pathologies».
Analysis of the H1 2010 accounts
Revenues for the first half of 2010 amounted to €21.4 million, a strong increase compared to the €4.1 million generated in the first half of 2009. They included the non recurrent payments of €20.6 million received from the out-licensing agreements of Loramyc® and Setofilm® and were mainly composed of following items:
A €15.6 million milestone payment from Par Pharmaceutical, our US licensee for Oravig®, corresponding to the approval of the product in April and to the staggering over 33 months of the upfront payment received in 2007;
A €4.5 million upfront payment received upon signature of the European licensing agreement of Loramyc® and Setofilm® from Therabel.
Loramyc® sales for the first half of 2010 amounted to €0.6 million, mainly corresponding to the direct sales of the product in France during Q1 2010, before implementation of the agreement with Therabel, providing the transfer of the commercial activities as of April 1st, 2010.
After taking into account operating expenses of €11 million, including notably R&D costs, commercial costs relating to Loramyc® in France (1st quarter) as well as general and administrative expenses, the operating profit reached €10.4 million. During this semester, BioAlliance Pharma has pursued the clinical development of four promising products: two in the area of supportive care (clonidine Lauriad® and fentanyl Lauriad®), one for the treatment of metastatic melanoma (AMEP® biotherapy) and one for the treatment of primary liver cancer – orphan status (doxorubicine Transdrug).
The accounts showed a financial profit of €0.2 million and the net profit for first half-year was consequently €10.6 million.
As of June 30, 2010, the Company’s cash and cash equivalent amounted to €28.9 million, reflecting a significant reinforcement of the Company’s financial resources compared with a €14.7 million cash balance as of December 31, 2009. This strong cash position is mostly due to the €22.5 million payment received on the first semester resulting from the licensing agreements with Par/Strativa and with Therabel.
Post-closing events and outlook
BioAlliance Pharma has received positive advice of the Health Authorities to submit mid-2011 its acyclovir Lauriad® European registration dossier, based on the positive phase III clinical trial.
«This advice of the European Health Authorities confirms the quality of the results obtained with the efficacy study of our product, acyclovir Lauriad®, developed for the treatment of oro-facial herpes», comments Dominique Costantini. «We have demonstrated treatment efficacy together with a new prevention effect and a very good tolerance, all competitive advantages on this large potential prescription market. We now are going to actively prepare the next steps».