This exceptional performance was due to the sales and licensing agreements implemented for Loramyc® (Oravig® in the United States). In April 2010, Par/Strativa (in charge of Oravig® sales in the USA) paid BioAlliance Pharma a $20 million (€15 million) milestone payment (accounted for as turnover) following the approval of product marketing authorization. This marked the successful completion of a complex process now mastered by BioAlliance Pharma - one of the few innovative French healthcare SMEs to have registered a product in the USA. BioAlliance Pharma also obtained €4.5 million (fully recognized as revenue) upon signature of the licensing agreement with Therabel, its European partner (Therabel also made a share capital contribution of €3 million). Since 2007, BioAlliance Pharma has signed several international licensing agreements for Loramyc®/Oravig®, worth a total of €120 million (of which around €48 million have already been received by the company).
"With these exceptional milestone payments (non-recurring items by definition), our first product is clearly demonstrating its potential and its ability to generate a rapid return on investment", commented BioAlliance Pharma CEO Dominique Costantini. "With the September 2010 launch of Oravig® in the USA and Loramyc®'s ongoing revenue generation in Europe, we are already receiving royalties on our partners' sales and are keeping a close eye on sales growth. We are confident in the future because Loramyc®/Oravig® perfectly addresses the needs of both patients and prescribers in a serious pathology related to cancer treatments".
The turnover for 2010 also includes the sale of products to Therabel and Par/Strativa and royalties on partners’ sales (totaling €1.6 million) as well as direct sales invoiced by BioAlliance Pharma in France and in some European countries prior to the transfer of operations to Therabel (€0.5 million).
The company's consolidated cash and cash equivalents stood at €20.9 million as of December 31, 2010. In 2011, BioAlliance Pharma expects to earn a total of €4 million under the terms of its contract with Therabel and will also receive early reimbursement of its 2010 research tax credit.
On the basis of the model that has proved to be so successful for Loramyc®, BioAlliance Pharma is actively preparing the registration of its second product, Sitavir® (acyclovir LauriadTM), which is also based on the company's patented LauriadTM muco-adhesive technology). BioAlliance plans to file for marketing approval in the second half of 2011 in Europe and the USA.
About BioAlliance Pharma
Dedicated to cancer and supportive care – cancer related pathologies, chemotherapy and radiotherapy-induced complications and opportunistic infections in immunocompromised patients – BioAlliance conceives and develops innovative products, especially in the hospital setting and for orphan or rare diseases. Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA; the products’ commercialization rights are licensed to international commercial partners invested in the hospital setting. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health & quality of life.
BioAlliance Pharma has developed an advanced product portfolio:
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 26 European countries, in Korea and in the United States
Setofilm® (prevention and treatment of -chemotherapy, radiotherapy and post operative- induced nausea and vomiting in adults and children): Registered in 16 European countries
Sitavir™ (Acyclovir Lauriad TM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive preliminary Phase I results
AMEP® (invasive melanoma): Phase I
Clonidine LauriadTM (mucositis): Phase II
Doxorubicin Transdrug® (liver cancer): Phase II
For more information, visit the BioAlliance Pharma web site 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 2009 Reference Document filed with the AMF on June 29, 2010, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
BioAlliance Pharma SA Dominique Costantini, 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 Laurence Delval Tel.: + 33 1 42 68 86 42 laurence@alizerp.com
