• Crossing milestones in the progress of orphan products in clinical oncology.• Strengthening of the major cash to fund R & D programs, thanks to the successful capital increase in August.• Optimization of business partnerships international Loramyc ®.PARIS - (BUSINESS WIRE) - Regulatory News:
"The company will be able to continue its international growth with a renewed Board of Directors since July. ". BioAlliance Pharma SA (Paris: BIO) (Euronext Paris - BIO), a company dedicated to cancer treatment and supportive care, today announced its consolidated financial results for the six months ended 30 June 2011 and the main advances obtained recently.
• A first milestone was reached in the development of orphan product leader Livatag ®:◦ presentation of positive Phase II showing a doubling of median survival compared to standard therapy in primary liver cancer,◦ acceptance in early September of the clinical trial phase III by Afssaps, to confirm the clinical relevance of Livatag ®. The announced schedule is confirmed with a start of this pivotal study in 2012.• The AMEP Biotherapy ® showed a good tolerance and a clear signal of efficacy in humans through a first phase I trial by local metastatic melanoma. These preliminary results will accelerate as a result of its clinical development systemically (innovative program funded by OSEO).• The Company has optimized its partnerships with Loramyc ® including:◦ signed a marketing license agreement in Japan with Sosei Co. Ltd.. for a total of $ 18.5m in stages and royalties on future sales significant, with an initial payment of $ 3 million already received.◦ resume marketing rights in the United States to the Company by Strativa, because of its recent shift to generics, this without significant financial impact. The company immediately began an active search for a new trading partner in the U.S. with assets, Oravig ®, registered with the FDA in 2010.• Finally, the company is finalizing the application files for registration of Sitavir in recurrent herpes labialis, seen in a future filing with the U.S. and European agencies."These significant advances in the first half are the result of our commitment to value assets at the stage of BioAlliance commercial partnerships with the most appropriate and with developing products that meet an unmet need. EIles demonstrate the quality of work teams BioAlliance who can find the acceleration plan appropriate to the record, "said Judith Greciet, CEO of the Company. "The company will be able to continue its international growth with a renewed Board of Directors since July. ".
Analysis of the results of the first half of 2011
Consolidated financial statements (IFRS)in thousands of euros
30/06/2011 30/06/2010Recurring revenue / License AgreementsNon-recurring revenue / License Agreements
Other Revenue *
1019151
10
55520,181
621
Operating expenses
Including investment in R & D
Including non-recurring extraordinary charges
(9.936)(4.017)
(1.376)
(10.977)(3.608)
(1.161)
Operating income (8 757) 10 380Net income (8 750) 10 583
* Mainly derived from the direct use in France in 2010
The company is growing its recurring revenue: product purchases by trading partners as well as royalties on their sales donated to BioAlliance exceeded the one million euros in the first half, doubling compared to 2010. Variability of revenue is also linked to the presence of non-recurring items related to international licensing agreements.
During the first half of 2011, BioAlliance has limited its overall expenses while maintaining continued investment in its programs of R & D mainly phase II trial of clonidine Lauriad ® in severe mucositis, Phase I trial of AMEP ® in invasive melanoma, and the industrial development of Sitavir.
Net income ended 30 June 2011 was - 8750 euros. In the first half 2010, net income was directly related to obtaining registration of Oravig ® in the United States, which gave rise to an exceptional product license (milestone).
Cash at 30 June 2011 amounted to 14.2 million euros against 20.9 million euros at December 31, 2010. Most of the cash burn in the first half came from R & D as well as general and administrative expenses.
The capital increase launched on July 1, oversubscribed, was conducted for a net amount of 15.9 million euros, it will accelerate the development program Livatag ® and strengthen its portfolio of orphan drugs.
"Our level of cash now estimated at around € 30 million, gives us the financial strength to ensure our strategic growth plan, particularly our R & D programs in the short and medium term." Said Nicolas Fellmann, CFO.
Introductory meeting and conference call (in English) to financial analysts
BioAlliance will meet Thursday, September 22 at 9 am at its head office from 49 boulevard Martial Valin, Paris 15 ° (France). A conference call in English will be held at 11:30 (Paris time - GMT +1). The numbers and codes to call are listed below, and the number of replay.
From France and abroad: +33 (0) 1 70 77 09 37For replay of the call, dial +33 (0) 1 72 00 15 00 274 171 # then
The Company announced today that it made available to the public and filed with the AMF's Interim Financial Report 30 June 2011. The interim financial report includes the consolidated financial statements at 30 June 2011 and is available on the website of the Company at http://www.bioalliancepharma.com, under the heading "Regulatory Information".
The interim financial statements were reviewed by the auditors and approved by the Board of Directors September 21, 2011.
About BioAlliance
Company dedicated to specialty products and orphan products in the treatment of cancer and supportive care, with an approach based on drug resistance, BioAlliance designs and develops innovative drugs mainly target hospital and drugs in rare diseases or orphaned. Founded in 1997 and introduced on the market of Euronext Paris in 2005, the company aims to become a leading player in these areas, making the link between innovation and patient needs. She holds the key skills to identify, develop and register drugs in Europe and the United States, she says their marketing to a network of international trading partners located in the hospital.
Its targeted approaches in areas where medical needs are insufficiently met contribute to the fight against drug resistance and improve the health and quality of life for patients.
For more information, visit the website at www.bioalliancepharma.com BioAlliance
BioAlliance has developed an advanced product portfolio:Specialty ProductsLoramyc ® / ® Oravig (oropharyngeal candidiasis in immunocompromised patients): Recorded in 28 countries (Europe, US, Korea)Sitavir ® (herpes labialis): positive Phase III (final results), while recordingFentanyl LauriadTM (Chronic pain in cancer patients): positive preliminary clinical results of Phase IOrphan products in oncologyLivatag ® (hepatocellular carcinoma): Agreement Afssaps for entry into phase IIIClonidine LauriadTM (mucositis post-chemotherapy and radiotherapy in head and neck cancer): Phase IIBiotherapy AMEP ® (invasive metastatic melanoma): Phase I
Warning
This press release contains expressly or implicitly certain forward-looking statements concerning BioAlliance Pharma SA and its business. These statements involve certain known and unknown risks, uncertainties and other factors that could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ materially from results, financial conditions , performance or achievements expressed or implied by such forward-looking statements. BioAlliance providing this communication as of this date and does not undertake to update forward-looking statements contained herein, whether as a result of new information, future events or otherwise.
"The company will be able to continue its international growth with a renewed Board of Directors since July. ". BioAlliance Pharma SA (Paris: BIO) (Euronext Paris - BIO), a company dedicated to cancer treatment and supportive care, today announced its consolidated financial results for the six months ended 30 June 2011 and the main advances obtained recently.
• A first milestone was reached in the development of orphan product leader Livatag ®:◦ presentation of positive Phase II showing a doubling of median survival compared to standard therapy in primary liver cancer,◦ acceptance in early September of the clinical trial phase III by Afssaps, to confirm the clinical relevance of Livatag ®. The announced schedule is confirmed with a start of this pivotal study in 2012.• The AMEP Biotherapy ® showed a good tolerance and a clear signal of efficacy in humans through a first phase I trial by local metastatic melanoma. These preliminary results will accelerate as a result of its clinical development systemically (innovative program funded by OSEO).• The Company has optimized its partnerships with Loramyc ® including:◦ signed a marketing license agreement in Japan with Sosei Co. Ltd.. for a total of $ 18.5m in stages and royalties on future sales significant, with an initial payment of $ 3 million already received.◦ resume marketing rights in the United States to the Company by Strativa, because of its recent shift to generics, this without significant financial impact. The company immediately began an active search for a new trading partner in the U.S. with assets, Oravig ®, registered with the FDA in 2010.• Finally, the company is finalizing the application files for registration of Sitavir in recurrent herpes labialis, seen in a future filing with the U.S. and European agencies."These significant advances in the first half are the result of our commitment to value assets at the stage of BioAlliance commercial partnerships with the most appropriate and with developing products that meet an unmet need. EIles demonstrate the quality of work teams BioAlliance who can find the acceleration plan appropriate to the record, "said Judith Greciet, CEO of the Company. "The company will be able to continue its international growth with a renewed Board of Directors since July. ".
Analysis of the results of the first half of 2011
Consolidated financial statements (IFRS)in thousands of euros
30/06/2011 30/06/2010Recurring revenue / License AgreementsNon-recurring revenue / License Agreements
Other Revenue *
1019151
10
55520,181
621
Operating expenses
Including investment in R & D
Including non-recurring extraordinary charges
(9.936)(4.017)
(1.376)
(10.977)(3.608)
(1.161)
Operating income (8 757) 10 380Net income (8 750) 10 583
* Mainly derived from the direct use in France in 2010
The company is growing its recurring revenue: product purchases by trading partners as well as royalties on their sales donated to BioAlliance exceeded the one million euros in the first half, doubling compared to 2010. Variability of revenue is also linked to the presence of non-recurring items related to international licensing agreements.
During the first half of 2011, BioAlliance has limited its overall expenses while maintaining continued investment in its programs of R & D mainly phase II trial of clonidine Lauriad ® in severe mucositis, Phase I trial of AMEP ® in invasive melanoma, and the industrial development of Sitavir.
Net income ended 30 June 2011 was - 8750 euros. In the first half 2010, net income was directly related to obtaining registration of Oravig ® in the United States, which gave rise to an exceptional product license (milestone).
Cash at 30 June 2011 amounted to 14.2 million euros against 20.9 million euros at December 31, 2010. Most of the cash burn in the first half came from R & D as well as general and administrative expenses.
The capital increase launched on July 1, oversubscribed, was conducted for a net amount of 15.9 million euros, it will accelerate the development program Livatag ® and strengthen its portfolio of orphan drugs.
"Our level of cash now estimated at around € 30 million, gives us the financial strength to ensure our strategic growth plan, particularly our R & D programs in the short and medium term." Said Nicolas Fellmann, CFO.
Introductory meeting and conference call (in English) to financial analysts
BioAlliance will meet Thursday, September 22 at 9 am at its head office from 49 boulevard Martial Valin, Paris 15 ° (France). A conference call in English will be held at 11:30 (Paris time - GMT +1). The numbers and codes to call are listed below, and the number of replay.
From France and abroad: +33 (0) 1 70 77 09 37For replay of the call, dial +33 (0) 1 72 00 15 00 274 171 # then
The Company announced today that it made available to the public and filed with the AMF's Interim Financial Report 30 June 2011. The interim financial report includes the consolidated financial statements at 30 June 2011 and is available on the website of the Company at http://www.bioalliancepharma.com, under the heading "Regulatory Information".
The interim financial statements were reviewed by the auditors and approved by the Board of Directors September 21, 2011.
About BioAlliance
Company dedicated to specialty products and orphan products in the treatment of cancer and supportive care, with an approach based on drug resistance, BioAlliance designs and develops innovative drugs mainly target hospital and drugs in rare diseases or orphaned. Founded in 1997 and introduced on the market of Euronext Paris in 2005, the company aims to become a leading player in these areas, making the link between innovation and patient needs. She holds the key skills to identify, develop and register drugs in Europe and the United States, she says their marketing to a network of international trading partners located in the hospital.
Its targeted approaches in areas where medical needs are insufficiently met contribute to the fight against drug resistance and improve the health and quality of life for patients.
For more information, visit the website at www.bioalliancepharma.com BioAlliance
BioAlliance has developed an advanced product portfolio:Specialty ProductsLoramyc ® / ® Oravig (oropharyngeal candidiasis in immunocompromised patients): Recorded in 28 countries (Europe, US, Korea)Sitavir ® (herpes labialis): positive Phase III (final results), while recordingFentanyl LauriadTM (Chronic pain in cancer patients): positive preliminary clinical results of Phase IOrphan products in oncologyLivatag ® (hepatocellular carcinoma): Agreement Afssaps for entry into phase IIIClonidine LauriadTM (mucositis post-chemotherapy and radiotherapy in head and neck cancer): Phase IIBiotherapy AMEP ® (invasive metastatic melanoma): Phase I
Warning
This press release contains expressly or implicitly certain forward-looking statements concerning BioAlliance Pharma SA and its business. These statements involve certain known and unknown risks, uncertainties and other factors that could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ materially from results, financial conditions , performance or achievements expressed or implied by such forward-looking statements. BioAlliance providing this communication as of this date and does not undertake to update forward-looking statements contained herein, whether as a result of new information, future events or otherwise.
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