Significant progress towards company growth
Paris, September 4, 2007 - BioAlliance Pharma SA (Euronext Paris - Code Isin : FR0010095596 -BIO), a specialty pharmaceutical company focused on the development of innovative therapeutics targeting cancer, HIV, opportunistic infections and drug resistance, today published its results for the first six months of 2007.
In the first half of 2007, BioAlliance Pharma successfully implemented its operational plan, in line with its strategic objectives:
- Loramyc® obtained manufacturer's pricing and a reimbursement rate for patients covered by social security, reflecting the value the new treatment brings to patients in France.
- The company set up its European sales operation - SpeBio - in the form of a joint venture focusing on oncology.
- The company finalized its US licensing agreement with Par Pharmaceutical, a partner providing an excellent fit, on July 2. As a result, BioAlliance Pharma closed commercial agreements worth EUR 80 million, plus significant royalty agreements linked to progress made by its first product.
These agreements, the company's three products in Phase III and its portfolio of cancer and HIV projects mean that BioAlliance Pharma has never been more confident in its capacity for growth.
Net sales for the period amounted to EUR 312,000, compared with EUR 198,000 in the first half of 2006. Operational expenses increased, reflecting a mature portfolio with three products in Phase III. Consequently, the company made a net loss in the first six months in 2007 of EUR 8.761 million, compared with a loss of EUR 5.023 million at June 30, 2006.
Net cash amounted to EUR 19.4 million at June 30, 2007, compared with EUR 17.6 million at December 31, 2006. The amount includes the first payments linked to Loramyc® in Europe.
"BioAlliance Pharma has brilliantly achieved its planned milestones," said Dominique Costantini, President and CEO of BioAlliance Pharma "We have obtained a manufacturer's price reflecting the innovation inherent in Loramyc®. We have set up a European structure that reinforces our financial position and we have strengthened our international position through the launch of Loramyc® in France, the SpeBio joint venture, and the license agreement with Par Pharmaceutical in the US (which took place in the second half of 2007)."
Loramyc® obtained manufacturer's pricing and a reimbursement rate for patients covered by social security, reflecting the value the new treatment brings to patients in France. ForLoramyc®, the first antifungal mucoadhesive buccal tablet indicated for oropharyngeal candidiasis in immunocompromised patients, the Company signed a convention in early June with France's Economic Committee for Health Products (CEPS - Comité Economique des Produits de Santé Français). This set a price of EUR 4 for a daily dose of Loramyc® on the French market, or a manufacturer's price of EUR 56 and a patient's price of EUR 70, for a box of 14 tablets. This price is at the upper end of analyst forecasts.
This summer, the product was added to the list of drugs that are reimbursed for patients covered by social security at 65 per cent and to the list of medicines approved for use by hospitals. As of September 2007, the sales team of scientific representatives from the Company's subsidiary, Laboratoires BioAlliance Pharma, has everything in place to launch the Group's first product in France.
The Company set up its European sales operation - SpeBio - under the form of a joint venture focusing on oncology. Sharing revenues and costs 50/50, this subsidiary based in Holland markets Loramyc® in Europe (outside France).The market authorizations for each country following the European mutual recognition procedure are scheduled for 2008. According to the terms of the joint venture agreement, BioAlliance Pharma will receive up to EUR 29.5 million from SpePharm, a company also specialized in hospital oncology. The Company has already received EUR 8 million.
BioAlliance Pharma successfully concluded its licensing agreement for the US with Par Pharmaceutical (agreement signed 2 July), an excellent match for BioAlliance Pharma, and a company that develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for oncology and HIV markets. In return for the license, BioAlliance Pharma received an initial USD 15 million payment from Par Pharmaceutical. PAR will also pay additional sums amounting to USD 50 million, in line with product development.
In addition to royalties, this means BioAlliance has closed a total of EUR 80 million from commercial agreements.
Three phase III clinical trials in progress show the maturity of BioAlliance Pharma's portfolio.
Ongoing clinical pivotal Phase III trial in the US for Loramyc®
The Company expects to finish recruiting patients at the end of 2007, which will allow it to complete this clinical trial in 2008 and file for product registration from the FDA (Food and Drug Administration) in the second half of 2008. FDA approval is anticipated for the first half of 2009.
Ongoing Phase II/III clinical trial for doxorubicin Transdrug® in Europe for primary liver cancer, which began in December 2006. Phase III study results are expected in the second half of 2009.
Initiation of phase III clinical trial for acyclovir Lauriad® in oral herpes in five countries: France, Australia Germany, the UK and the Czech Republic. The company expects to file for Marketing Authorization in Europe in the first half of 2009.
For each product, these forecasts depend on whether additional information is requested by agencies.
In parallel, BioAlliance Pharma is carrying out development work on its new entities, with the objective of selecting before year end a candidate that is capable of entering Phase I in 2008.
Financial data for the first half of 2007
|Thousands of Euros||Six months ending June 30 2007||Six months ending June 30 2006|
|Operational Income||- 9 030||- 5 249|
|Net income||- 8 761||- 5 023|
|Earnings per share (Euros)||- 0.94||-0.60|
|Cash at 30 June||19 381||24 163|
|Shareholders' equity||17 092||24 688|
Cash available at June 30 2007 amounts to EUR 19.4 million compared to EUR 17.6 million at December 31 2006. This positive difference comes from payments already made by SpePharm within the terms of the joint venture agreement, payments that have more than compensated for the net operating losses.
Sales for the period amounted to EUR 312,000. They derive mainly from services provided by BioAlliance to Eurofins-VIRalliance Inc (EVI) amounting to EUR 237,000, against EUR 198,000 for the first half 2006. Sales also include EUR 75,000 paid to BioAlliance upon signing the SpePharm agreement, as part of the EUR 3 million sum due to be paid over a ten year period. The amount accounted for in the six months to June 30, (EUR 75,000) is pro rata with the six months from January 1 and also consolidates the proportional integration of SpeBio at 50 per cent.
Operating costs are made up of the following items:
- Payroll costs increased from EUR 2.035 million in the first half of 2006 to EUR 3.673 million in the first half 2007, an increase of EUR 1.638 million. This increase is due to hiring of marketing and sales personnel in 2006 as part of the building up of the French sales team and in key functions including legal, regulatory and intellectual property.
- Purchases and external charges rose to EUR 6.749 million at June 30, 2007 against EUR 3.143 million at June 30 2006, an increase of EUR 3.606 million. This change reflects the planned growth in R&D activities, which alone accounted for EUR 5.405 million in the first half 2007. The costs correspond to moving three products to Phase III - Loramyc® (US), acyclovir Lauriad® and doxorubicin Transdrug® (Europe) as well as to working on new entities developed by the Company. The external charges also include the fees linked to the agreements concluded in March with SpePharm and in early July with Par Pharmaceutical.
The net cost of financial debt is a product which went from EUR 226,000 in 2006 to EUR 141,000 in 2007. These amounts correspond essentially to the products of the disposal of investments by the Company using its excess cash.
As a result of the change in activity reflected in expenditure and product above, the net loss for the six-month period ending June 30 2007 amounted to EUR 8.761 million against EUR 5.024 million in 2006, an increase of EUR 3.737 million.
About BioAlliance Pharma
BioAlliance Pharma SA (Euronext Paris: BIO) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics targeting drug resistance in cancer, HIV, and opportunistic infections.
The Company is conducting clinical development of three innovative products. Two products are based on the Lauriad(R) mucoadhesive technology, which allows an early and prolonged release of therapeutic agents at the site of the disease: one authorized product in France and two clinical international phase III trials ongoing (Loramyc(R) and acyclovir Lauriad(R)). One product is based on the Transdrug(R) nanoparticle technology designed specifically for intracellular targeting: one international phase III trial ongoing on primary liver cancer (doxorubicin Transdrug(R)). The company develops also a New Entities program focused on new targets in oncology and HIV. The company has concluded two strategic partnerships in 2007 to sell its Loramyc(R) product in Europe and in the US.
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 reference document approved by the AMF on 6 April 2007 under the number R. 07-031, which is available on the AMF website www.amf-france.org or BioAlliance Pharma S.A.'s website www.bioalliancepharma.com.
For press release and other company information, visit www.bioalliancepharma.com.
|BioAlliance Pharma SA|
President and CEO
Tel: +33 1 45 58 76 01
Chief Financial Officer
Tel: +33 1 45 58 71 00
Tel : +33 1 53 67 36 33
Andrew Lloyd & Associates
Tel: +33 1 56 54 07 00
| Juliette DOS SANTOS
Tel : +33 1 56 54 07 04
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|ONXEO||Euronext Paris||2.63 (c)||-0.38%||60 863|