Earnings Release • Jul 21, 2010
Earnings Release
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Press release
Nantes (France) – 21 July 2010 − VIVALIS (NYSE Euronext:VLS), a biopharmaceutical company, today announced its second quarter 2010 revenues (IFRS) of € 1.2 million, up 67% year-on-year, and a consolidated cash position of € 14.8 million as at 30 June 2010.
Following the acquisition of Humalys S.A.S. on 7 January 2010, VIVALIS will publish its financial data according to IFRS accounting standards. VIVALIS' financial statements were already published under French GAAP and IFRS rules in its 2009 Document de Référence registered with the AMF on 22 April 2010 under number R.10-026.
This change of rules has no impact on the cash and cash equivalent position. In contrast, the move to IFRS rules impacts the revenue recognition of licensing revenues. According to IAS18, "up-front payment" revenues and "milestone" revenues are recognized over the development period of these programs, whilst under French GAAP they are recognized in full upfront. The impact can be summarized as a "spreading out" of such revenues over the coming years.
(in thousands of euros, IFRS)
| Second quarter | First half | |||||
|---|---|---|---|---|---|---|
| 2009 | 2010 | Var. | 2009 | 2010 | Var. | |
| Revenues from services | 106 | 468 | +342% | 409 | 507 | +24% |
| Revenues from licensing | 596 | 703 | +18% | 977 | 1 263 | +29% |
| Total revenues | 702 | 1,171 | +67% | 1,386 | 1,770 | +28% |
Total revenues for the second quarter 2010, including revenues from services and licensing activities, increased 67% as compared to revenues for the same period in 2009, and are up 95% as compared to its first quarter 2010 revenues.
Revenues from services increased 342% from € 0.1 million for the second quarter of 2009 to € 0.5 million for the same period in 2010, witnessing new services of process development rendered to clients in 2010, while an important service agreement ended early 2009.
Meanwhile, revenues from licensing activities, comprising of revenues from up-front and milestone payments, increased by 18% as the result of the commercial and scientific progress achieved over the period. It should be noted that the € 3 million upfront from the Sanofi Pasteur contract announced on 8 June 2010 is, under IFRS, recognised over the duration of the contract.
Revenues from licensing activities represented 60% of revenues for the second quarter of 2010 versus 85% for the second quarter 2009.
For the first half of 2010, total revenues increased 28% to € 1.8 million. This progression of revenues is set to continue over the next quarters.
Consolidated cash and cash equivalents amounted to € 14.8 million as at 30 June 2010, compared to € 17.0 million at 31 March 2010.
It should be noted that this position does not include the € 3 million up-front payment triggered by the signing of the monoclonal antibody discovery agreement with Sanofi Pasteur, announced by the two companies on 8 June 2010, nor does it include R&D advance service fees included in this agreement. However, this level does include for this quarter the € 2.7 million investment in VIVALIS' Nantes facilities, including its new R&D laboratory. Nonetheless, thanks to the revenues generated by services and licensing activities, and strict cost control, the cash used over the quarter has been limited to € 2.2 million confirming VIVALIS' low cash burn business model.
VIVALIS has witnessed commercial and scientific progress in all its activities.
A new commercial license for the EB66® cell line has been signed in the animal health field. Regarding the Humalex® technology, validation of the relevance of the Humalys acquisition and its strong potential for value creation was achieved through a collaboration agreement and a commercial license with Sanofi Pasteur for the discovery and development of fully human monoclonal antibodies against several infectious diseases. This agreement is also the cornerstone of a shift in strategy and development model of VIVALIS, as it represents the largest financial agreement ever signed by the Company.
With 17 commercial licences and about 10 research licences signed to date on the EB66® cell line technology, the first major agreement signed on the Humalex® technology, ongoing scientific advances, and increased shareholders' equity position, VIVALIS is very confident of its development perspectives and the achievement of its financial and commercial objectives for 2010: 7 new licenses of the EB66® technology, one licensing and collaboration agreement on the Humalex® technology and a 2010 year-end consolidated cash position of more than €15 million (excluding current capital increase).
Franck Grimaud, C.E.O. and Majid Mehtali, C.S.O., co-managers of VIVALIS, said: "We are very pleased about the progress encountered during the last months. We have achieved significant milestones in the execution of our development plan. This first half has been marked by the acceleration of our growth with the Humalys acquisition that enables us to broaden our offering to the pharmaceutical and biotechnology industry in the monoclonal antibody field. If we had reported revenues under French Gaap, we would have had combined service and licence revenues totalling over € 4.6 million for the first half, as compared to € 4.7 million for VIVALIS for the entire 2009 year. Besides the major financial impact of the Sanofi Pasteur agreement, this collaboration validates, commercially and industrially, this platform. The assets we have generated and the strengthening of our capital that we are in the process to complete put us in a very strong position for a new phase of VIVALIS development, with the building of a portfolio of proprietary products that we will initiate in the coming months."
Next financial press release: 31 August 2010, after NYSE Euronext market closing: Results for first half 2010 VIVALIS (Euronext code: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of unmet medical needs. VIVALIS' expertise and intellectual property are exploited in three main areas:
VIVALIS offers research and commercial licenses for its EB66® cell line, derived from duck stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLPs and recombinant proteins, especially monoclonal antibodies with enhanced cytotoxic activity. VIVALIS receives upfront payment, clinical stage milestone payments and royalties on its licensees' net sales.
VIVALIS proposes customized solutions for the discovery, development and production of fully Human monoclonal antibodies. VIVALIS receives upfront payment, clinical stage milestone payments and royalties on its licensees' net sales.
VIVALIS performs discovery and early stage developments of small chemical molecules identified with VIVALIS proprietary screening platform, 3D-Screen, which identifies target protein conformational modulators. VIVALIS is building a portfolio of proprietary products for the treatment of Hepatitis C virus infection..
Based in Nantes (France), VIVALIS was founded in 1999 by the Grimaud group (ca. 1,500 employees), a worldwide leader in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Merck, CSL, Kaketsuken, Merial, Intervet, SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters.
VIVALIS Listed on Euronext Paris – Compartment C of NYSE Euronext Reuters: VLS.PA – Bloomberg: VLS FP Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes
This document contains forward-looking statements and comments on the company's objectives and strategies. No guarantee can be given as to any of the events anticipated by the forward-looking statements, which are subject to inherent risks, including the risk factors described in the company's document de référence, changes in economic conditions, the financial markets or the markets in which the company operates.
A French language prospectus including (i) the reference document (document de référence) of Vivalis filed with the Autorité des marchés financiers (AMF) on 22 April, 2010 under no. R. 10-026 as replaced by the reference document dated 1 July, 2010 and (ii) the securities note (note d'opération) (including a summary of the prospectus) approved by the AMF on 1 July 2010 under no 10-215, are available free of charge from Vivalis (6, rue Alain Bombard, 44 821 Saint-Herblain CEDEX), as well as on the websites of Vivalis (www.vivalis.com) and the AMF (www.amf-france.org).
Vivalis draws the attention of the public to the risk factors described in chapter 4 of the reference document and chapter 2 of the securities note.
This Press Release, together with the material set forth herein, does not constitute an offer of securities for sale nor a solicitation to purchase securities in any jurisdiction. Distribution of such Press Release in certain jurisdiction may constitute a breach of applicable laws and regulations.
With respect to the member states of the European Economic Area which have implemented the Directive 2003/71/EC of the European Parliament and the Council of November 4, 2003 (the "Prospectus Directive"), other than France, no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any relevant member state (other than France). As a result, the securities may not and will not be offered in any relevant member state (other than France) except in accordance with the exemptions set forth in Article 3(2) of the Prospectus Directive, if they have been implemented in that relevant member state, or under any other circumstances which do not require the publication by Vivalis of a prospectus pursuant to Article 3(2) of the Prospectus Directive and/or to applicable regulations of that relevant member state.
This Press Release does not constitute an offer to sell or the solicitation of an offer to buy any financial instruments in the United States. Securities mentioned in this document have not been and will not be registered under the Securities Act of 1993, as amended (the "Securities Act") and may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act. Any public offer of securities in the United States shall be made by means of a prospectus that may be obtained from the Company containing detailed information regarding the Company, its management and financial statements. The Company does not intend to register this offering in all or in part or to make public offer of securities in the United States.
This Press Release is not an invitation nor is it intended to be an inducement to engage in investment activity for the purpose of section 21 of the Financial Services and Markets Act 2000, as amended ("FSMA"). This document is directed only at (i) persons outside the United Kingdom; or (ii) persons in the United Kingdom that are "qualified investors" within the meaning of Article 2(1)(e) of Directive 2003/71/EC including any relevant implementing measure in each member state, that are also (a) persons authorized under FSMA or otherwise having professional experience in matters relating to investments and qualifying as investment professionals under article 19 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Financial Promotion Order"); or (b) institutions or corporations qualifying as high net worth persons under Article 49(2)(a) to (d) of the Financial Promotion Order; or (c) any other persons to whom this document for the purposes of Section 21 of FSMA can otherwise lawfully be made (all such persons together being referred to as "Relevant Persons"). Any person in the United Kingdom that is not a Relevant Person should not act or rely on this document.
No copy of this announcement has been or should be distributed or sent to the United States, Canada, Japan or Australia.
NewCap Financial communications agency Steve Grobet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email: [email protected]
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