Bioalliance Pharma updates on major achievements of 2012 and publishes its 2012 consolidated financial statements and income for Q1 2013

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.

Paris, April 15, 2013 – BioAlliance Pharma SA (Euronext 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.
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”.