Earnings Release • Oct 23, 2012
Earnings Release
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Nantes, Lyon (France) –October 23, 2012: VIVALIS (NYSE Euronext Paris: VLS), a biopharmaceutical company, today released its recurring operating income (without change in inventory and production and services capitalized) for the third quarter of 2012 (IFRS) of 1.8 million euros and a consolidated cash position at September 30, 2012 of 15.7 million euros.
| (In euro thousands, IFRS, non audited) | rdQuarter 3 |
9 months | ||||
|---|---|---|---|---|---|---|
| 2011 | 2012 | Var. | 2011 | 2012 | Var. | |
| Revenue from services | 358 | 700 | +96% | 1,188 | 1,557 | +31% |
| Licensing revenue (upfront, milestones) | 2,395 | 338 | -86% | 6,253 | 979 | -84% |
| Total revenue | 2,753 | 1,038 | -62% | 7,441 | 2,536 | -66% |
| Of which EB66® andBioproduction |
2,307 | 567 | -75% | 5,893 | 1,096 | -81% |
| VIVA Screen™ | 446 | 471 | +6% | 1,549 | 1,439 | -7% |
| Income from public financing* | 581 | 753 | +30% | 1,671 | 2,291 | +37% |
| Total operating income(w/o production and services capitalized) |
3,334 | 1,791 | -46% | 9,112 | 4,827 | -47% |
*estimates
| (En milliers d'euros, normes IFRS-non audités) | 2011 | 2012 | ||||
|---|---|---|---|---|---|---|
| Q1 | Q2 | Q3 | Q1 | Q2 | Q3 | |
| Revenue from services | 477 | 353 | 358 | 524 | 332 | 700 |
| Licensing revenue (upfront, milestones) | 1,380 | 2,478 | 2,395 | 330 | 311 | 338 |
| Total revenue | 1,857 | 2,831 | 2,753 | 854 | 643 | 1,038 |
| Of which EB66® and Bioproduction VIVA Screen™ |
1,253 604 |
2,332 499 |
2,307 446 |
389 466 |
141 502 |
567 471 |
2012 third quarter revenue, including both revenue from services and licensing income, was 1.0 million euros compared with 2.8 million euros for the same period of 2011. Meanwhile, income from public financings (grants and research tax credit) increased 30%, thanks to the steep increase of the research tax credit between both periods. As a consequence, third quarter total operating income, excluding change in inventory and production and services capitalized, amounted to 1.8 million euros for 2012, vs. 3.3 million euros for 2011.
Revenue from services significantly increased by 96% between the two periods, as a result of the increase of services rendered for the discovery of new antibodies (the VIVA|ScreenTM technology) and above all, thanks to services rendered in the framework of biomanufacturing contracts.
At the same time, licensing revenue, including upfront and milestones payments, experienced a significant decrease as expected, following the end of the accounting revenue recognition period of some commercial licenses at the end of 2011.
Over the first nine months, total operating income, excluding change in inventory and production and services capitalized, amounted to 4.8 million euros in 2012vs. 9.1 million euros for the first nine months of 2011. The 37% increase in the income from public financings did not compensate the decrease in the EB66® licensing revenues recognized under IFRS.
Consolidated cash(including cash equivalent and current financial assets) amounted to 15.7 million euros at September 30, 2012, compared with30.6 million euros at December 31, 2011 and 18.0 million euros at June 30, 2012.
This level of cash includes 4.7millioneuros of investment realized during the first nine months of 2012, including the payments for the acquisitions of the Lyon based company Humalys and of the ISAAC technology acquired from the Japanese company SCWorld.
The Company would like to remind that, as a subsidiary majority owned by the Grimaud Group, it does not benefit from the payment of the research tax credit receivables the year following their booking any more. This payment has a 3-year lag and the next payment is expected in 2013. At September 30, 2012, the total research tax credit receivables exceed 6 million euros.
The Company maintained its scientific and commercial momentum since beginning of the year.
8new licenses, including, Biodiem (Australia), Merck Animal Health (USA), Farvet (Peru),Merial (France) and BioFactura (USA) have been signed since January 1,2012to use the EB66® cell line for the production of vaccines and monoclonal antibodies, of which 2 are commercial licenses. This is already the best performance achieved since the company's inception, and above its own objectives set at beginning of the year. These new licenses add to bring the total of active EB66® licenses to 31.
On another hand, with the initiation of Phase III clinical trials in Japan for a pandemic flu vaccine developed by Kaketsuken in collaboration with GSK vaccines and produced on the EB66® cell line, along with the marketing authorization granted to Kaketsuken for a veterinary vaccine against the EDS in Japan and produced on EB66® , the EB66® cell line has achieved new regulatory milestones over the last months.
For the VIVA|Screen™ technology (discovery of monoclonal antibodies), Sanofi Pasteur has started beginning of 2012 the third discovery program in the framework of the agreement signed in June 2010.This agreement has been expanded to add another target, increasing the potential of this strategic agreement to 140 M€ of milestone payments plus royalties. It confirms the strong interest that Sanofi has for the VIVA|Screen™ technology.
VIVALIS has built a solid asset base to continue its development:
Franck Grimaud, C.E.O. and Majid a major year for our EB66® technology that become of vaccines. The first marketing authorization received by a veterinary vaccine produced on EB66 any doubt a significant milestone of our development. It the marketing of veterinary vaccines de adding to our existing revenue sources royalties on sales. The veterinary vaccine market is significant with total sales over 5 billion dollars. In the human field, vaccine produced on our cell line is another milestone that bring of 8 new agreements and licenses strengthens our market presence with the attraction of new licensees as well as new indications with current licensees. its various application domains and we expect to sign new agreements in the coming months. progress, we believe that VIVALIS has very solid axes : the EB66® cell line, the antibody discovery platform monoclonal antibody products. » Mehtali, C.S.O., co-managers of VIVALIS, commented becomes every day the alternative to the eggs for the production f marks the beginning of a new cycle for VIVALIS with developed by our licensees and produced on our EB66 the initiation of a Phase III clinical trial for a first flu brings us closer to market. Finally, Our VIVA|Screen™ technology continue , solid grounds to continue its development around its 3 strategic platform VIVA|Screen™, and its commented: « 2012 is clearly ® is without veloped ® cell line, Finally, the execution ontinues to gain attraction in In view of this velopment portfolio of proprietary
Vivalis (NYSE-Euronext: VLS) is a biopharmaceutical company that provides innovati biotechnology and pharmaceutical industry for the manufacture of vaccines and recombinant proteins, and develops monoclonal antibodies for the prevention and treatment of intellectual property are leveraged in two main areas: Euronext: innovative cell harmaceutical diseases with unmet medical needs. Vivalis' expertise and ve cell-based solutions to the
Vivalis offers research and commercial licenses for its EB66 pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccin virosomes, VLPs and recombinant proteins, are currently on-going in the USA and Japan in Japan for use in animal health. Through these programs, Vivalis receives an upfront payment, clinical stage milestone payments along with royalties on licensees' net sales. ® cell line, derived from duck embryonic stem cells, to including monoclonal antibodies. Clinical trials of EB66 going and in 2012 a vaccine produced in EB66® cells received market approval vaccines, ® produced vaccines
Customized solutions for the discovery, developmen offered by Vivalis. Through these programs, Vivalis receives payments associated with the funding of discovery research, an upfront payment, clinical stage milestone payments along with royalt that are commercially developed from the use of the platform zed development and production of rare, fully human monoclonal antibodies are , royalties on net sales of licensed antibodies platform. t ies Group Grimaud (approx.
Based in Nantes and Lyon (France) and in Toyama (Japan), Vivalis was founded in 1999 by the Group 1,700 employees), one of the worldwide partnerships and licenses with world leaders in Biologicals, Transgene, Pfizer Animal Health, Kaketsuken, Kitasa and SAFC Biosciences. Vivalis is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio and a member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE leaders in animal genetic selection. Vivalis has established more than 30 biopharmaceutical industry, including Sanofi Pasteur, GlaxoSmithKline , Kitasato Daiichi Sankyo Vaccine, Merial, Merck Animal Health , to bio-clusters based in Toyama.
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 co guarantee can be given to any of the events anticipated by the forward which are subject to inherent risks, including risk factors described in the company's in economic conditions, the financial markets or the markets in which the company operates. looking company's objectives and strategies. No forward-looking statements contained in this document Document de R onomic mpany's looking document, Référence, changes
VIVALIS Franck Grimaud, CEO Email: [email protected] NewCap Financial communications agency
Axelle Vuillermet / Tel.: +33 (0) 1 44 71 94 91 Email: [email protected] Pierre Laurent
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