BioAlliance Pharma Updates on Major Achievements of 2012 and Publishes Its 2012 Consolidated Financial Statements and Income for Q1 2013
PARIS--(BUSINESS WIRE)-- Regulatory News:
Successful key milestones reached on all orphan oncology clinical programs
First registration of Sitavig granted in European countries
Oravig licensing agreement signed for US
Income growth and operating costs under control.
BioAlliance Pharma SA (Paris:BIO), an innovative company dedicated to the development of orphan oncology products and to supportive care products today published its 2012 achievements and financial results.
BioAlliance Pharma growth strategy is supported by its 2 portfolio products, "orphan oncology drugs" and "specialty drugs", each of them dedicated to a specific strategic goal.
The 3 programs related to the orphan oncology pipeline represent breakthrough products developed for severe diseases with strong unmet medical need and potential sales blockbusters, true growth drivers for the company.
These programs are flagged as high priority in terms of research and development efforts and our teams have made tremendous advances, reaching the 2012 goals in due time.
Livatag: less than a year after the reinitiation of the development program, ReLive, clinical phase III trial in hepatocell carcinoma was implemented and active. About 20 centers are up and running in France and recruitment is on going
Validive; International Expansion of phase II clinical study, in the prevention of severe mucositis in patients treated with radio- chemotherapy for head and neck cancer. Following FDA authorization, BioAlliance is implementing the study in the US as well other European countries, which will optimize recruitment speed. The study planned by the company is due to end as soon as 2014, which will enhance value creation.
AMEP: Phase I/II trial in patients suffering from metastatic melanoma has been implemented as well as a collaboration with Copenhagen University to perform and fund a second phase I trial performed and funded by the University.
"Specialty products" are dedicated to licensing, which is a significant source of revenues to partly fund our development programs. The measures needed to add optimal value to these drugs have been implemented.
Loramyc/Oravig: execution of licensing agreement with Vestiq Pharmaceuticals for product promotion in the USA. Sales teams have just started promotional activities in January 2013.
Sitavig: Market Authorization granted in Europe in 8 countries, procedures are on-going in other European countries.
The consolidated financial statements for the financial year 2012, summarized in the table below, fully reflect this activity.
Consolidated income amounted to €4 million in 2012, an increase of 25% over the previous year, as a result of non-recurring payments from license partners, notably related to the Oravig agreement with Vestiq Pharmaceuticals in the United States.
Acceleration of development programs, central to the company's success and growth, has required an increased R&D investment (€9.3 million in 2012 versus €7.9 million in 2011) which has been offset by the successful management of general and administrative expenses. Accordingly, operating costs decreased by nearly 15%, contributing to the improvement in net income for the year.
In '000s of euros
Total operating expenses
The consolidated cash position as of December 31, 2012 amounted to €14.5 million.
Income for the first quarter of 2013
Consolidated income for the first quarter of 2013 stood at 407,000 euros. This quarter was highlighted by the recent marketing launch of Oravig in the USA.
Consolidated cash as of March 31, 2013 stands at 14 million euros, including the first $2 million payment from Vestiq received during the quarter as well as amounts derived from the first 2 drawdowns from the PACEO equity financing facility. Additional income is expected, notably reimbursement in 2013 of the 2012 research tax credit amounting to €2 million as well as unconditional payments from the Vestiq Pharmaceuticals partnership in 2013 and 2014.
"2012 has been a successful year for BioAlliance Pharma with major achievements for all of our active programs. 2013 should witness continuing and accelerating development with the planned trial extensions of Validive and Litavig in Europe and the USA," declared Judith Greciet, CEO of BioAlliance Pharma.
"Our success to date will encourage us to start a new year while remaining determined and enthusiastic to achieve the next steps and ensure real and constant company growth thanks to its key drugs and a high-quality team".
BioAlliance will comment on major current issues and its financial statements during its SFAF financial analysts meeting which will be held on April 16 (at 3:30 p.m., Salons Hoche - 9 avenue Hoche - 75009 Paris), and during the audio/web conference + tel: +33 1 707 709 34 /https://www.anywhereconference.com, login: 135281093, Pin code: 525116
About BioAlliance Pharma
A company dedicated to specialty and orphan products in the treatment of cancers and supportive care, with an approach focused on drug resistance. BioAlliance Pharma designs and develops innovative medicines mainly intended for hospital use and drugs in rare or orphan diseases. Created in 1997 and listed on the Euronext stock exchange in Paris in 2005, the company has ambitions to become a key player in these areas by linking innovation to patient needs. It possesses the key skills to identify, develop and register drugs in Europe and the United States.
For more information, visit the BioAlliance Pharma website at www.bioalliancepharma.com
BioAlliance Pharma has developed a portfolio of advanced products:
Loramyc®/Oravig® (Oropharyngeal candidiasis in immune compromised patients): Approved in 26 countries (Europe, USA, Korea), marketed in Europe and the United States.
Sitavig® (Herpes labialis): Registered in 8 European countries, undergoing approval in other European countries and the USA.
Fentanyl Lauriad® (chronic pain in cancer patients): Positive preliminary clinical Phase I results
Orphan Oncology products
Livatag® /doxorubicine Transdrug™ (Hepatocellular carcinoma): Phase III
Validive® / clonidine Lauriad® (Mucositis post-chemotherapy and radiotherapy in head and neck cancer): Phase II
Biotherapy AMEP® (Invasive metastatic melanoma): Phase I
This release contains certain implied or expressed forward-looking statements regarding BioAlliance Pharma SA and its activity. These statements depend on a number of known or unknown risks, on uncertainties and on other factors which could lead to the actual results, financial conditions, performance levels or output of BioAlliance Pharma SA differing significantly from the results, financial conditions, performance levels or output that is or are expressed or implied by such forward-looking statements. BioAlliance is providing this release on this date and does not undertake to update the forward-looking statements contained herein, whether as a result of new information, future events or for any other reason.
For a description of the risks and uncertainties likely to bring about a difference between the actual results, financial conditions, performance levels or output of BioAlliance Pharma SA, and those contained in the forward-looking statements, please refer to the "Risk Factors" section of the 2011 Reference Document filed with the Autorité des Marchés Financiers, the AMF, on April 24, 2012, which is available on the AMF website athttp://www.amf-france.organd on the company's site athttp://www.bioalliancepharma.com.
BioAlliance Pharma SA
Judith Greciet, CEO
Tel: +33 1 45 58 76 00
Nicolas Fellmann, CFO
Tel: +33 1 45 58 71 00
Tel: +33 6 64 18 99 59
Tel: +33 1 42 68 86 41
KEYWORDS: United States Europe North America France
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