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Isconova (publ.) - Year-end Report January-December 2011


2/28/2012 9:33:36 AM

February 28, 2012 -- FOURTH QUARTER, OCTOBER 1 – DECEMBER 31, 2011

- Consolidated net sales totaled SEK 7.6 M (2.9)

- Operating result amounted to a loss of SEK 6.9 M (loss: 9.6)

- Net result amounted to a loss of SEK 6.8 M (loss: 9.6)

- Result per share before and after dilution amounted to a loss of SEK 1.64 (loss: 2.72)

- Cash flow from operating activities amounted to a deficit of SEK 4.5 M (deficit: 8.7)

JANUARY 1 – DECEMBER 31, 2011

- Consolidated net sales totaled SEK 20.2 M (17.8)

- Operating result amounted to a loss of SEK 36.6 M (loss: 28.6)

- Net result was a loss of SEK 35.8 M (loss: 30.5)

- Result per share before and after dilution amounted to a loss of SEK 8.75 (loss: 13.19)

- Cash flow from operating activities amounted to a deficit of SEK 28.4 M(deficit: 29.9)

SIGNIFICANT EVENTS DURING THE FOURTH QUARTER

- No significant events occurred during the quarter.

SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

- Rabies vaccines with Isconova’s Matrix-M™ launched in Russia

- Isconova appointed Sven Andréasson as new CEO

- Russell G. Greig appointed new chairman of the board

*) All figures pertain to the Group, unless otherwise stated. The figures in parentheses pertain to the corresponding period in the preceding year.

CEO’S COMMENTS

Isconova’s goal is to be the first choice for vaccine companies around the world who seek a partner for development of effective vaccines with the aid of adjuvants. Our objective is to take a larger stake in the final vaccine product, and in 2011 we have taken additional steps in both the human and veterinary vaccines’ markets to achieve this goal.

Human Vaccines

The positive results from the Phase I study of the Matrix M™ adjuvanted bird (H5N1) flu vaccine, which was conducted by the PANFLUVAC Consortium, demonstrated that the vaccine was well-tolerated and an effective enhancer of the antibody response to vaccination.

Importantly, Matrix M™ also showed dose sparing properties. Based on these encouraging data Isconova initiated its own Phase I trial for seasonal influenza in May, 2011.

Our existing licensing agreements with Crucell NV, part of the Johnson & Johnson group, was expanded to cover the use of Isconova adjuvant Matrix M™ in HIV and malaria vaccines, in addition to the existing indication for influenza vaccine.

We also expanded our partnership with Genocea Biosciences Inc, a Boston-based biotechnology company focused on discovering and developing novel T-cell antigens, where Genocea was granted the rights to use Isconova Matrix M ™ in the development of vaccines against two additional diseases - malaria and gonorrhoea. The most advanced program in our partnership with Genocea is a therapeutic vaccine adjuvanted with Matrix M against herpes simplex virus type-2, a sexually transmitted disease that is estimated to affect 500 million people worldwide. Genocea plan to begin clinical trials in 2012.

Consistent with our strategy to participate in the on-going market consolidation we acquired the assets of Nordic Vaccine A / S, a Danish research and development company specializing in adjuvants and drug delivery development. With the acquired patents, we further strengthened our position and patents within the Iscom and Matrix™ technologies.

Veterinary Vaccines

In the veterinary business, our partner in the Russian market, VetBioChem, in 2011 received regulatory approval for two Matrix M ™-based rabies vaccines (Rabix and Rabifel) for dogs and cats. Both products were launched in February 2012. The vaccines are the first marketed veterinary vaccines using Isconova’s adjuvant Matrix-M™Vet. Isconova will receive production revenues and royalties based on sales.

We also expanded our collaboration with the Norwegian company, PHARMAQ, following the successful application for an EU grant to discover and develop a new generation of fish vaccines.

In the 2H 2011 our partner, Intervacc, successfully completed a clinical study of Strangvac ®, an Isconova Matrix C adjuvanted vaccine being developed against the equine disease strangles. Strangles is a serious, and sometimes fatal, infection in horses with significant commercial potential as there is currently is no effective vaccine in the market.

Financials

Revenues increased significantly in 4Q 2011, primarily driven by a recovery in sales to MSD Animal Health. The total revenue increase on a year-to-year basis amounted to 13% including EC-sponsored development funding and 4% excluding this funding. Investments in Isconova- sponsored clinical trials have resulted in increased costs, along with management changes and supply chain upgrades.

Sven Andréasson new CEO

It is pleasing and exciting to hand over to our new CEO, Sven Andréasson, who will take office March 1. Sven has extensive experience from senior positions in the international pharmaceutical industry, including as President and CEO of Active Biotech. His business development skills and international experience will be of great value to Isconova as we move into the next phase of our growth.

Russell G. Greig

Acting CEO

ABOUT ISCONOVA

Isconova is a research and development company specializing in the development and commercialization of adjuvants and vaccines through the company’s unique expertise in vaccine technology. The company has a patented technology, a strong product platform, production and sales of adjuvant, and several partnerships with leading international vaccine and pharmaceutical companies.

Isconova has developed several adjuvants that are all based on Iscom, an immune-stimulating technological platform. Isconova has reported income for product deliveries in the veterinary field since 2005, and there are currently five veterinary vaccines in the market that use Isconova’s platform.

Isconova’s overall goal is to be the first choice for vaccine companies seeking a partner for effective development of adjuvanted vaccines and to successively secure a larger participating interest in vaccine products.

Isconova’s product portfolio

Isconova’s product portfolio consists of Matrix-C? (used in vaccines for horses), Matrix-M? (used in vaccines for humans, dogs and cats), as well as Matrix-Q? (used in animal vaccines in addition to horses, dogs and cat vaccines). In addition, the company sells the research reagents AbISCO®-100 and AbISCO®-300.

Isconova’s project portfolio

Isconova’s project portfolio consists of projects in human and veterinary vaccines and the company has signed partnership agreements pertaining to indications aimed for both markets. In addition to the signed partnership agreements, Isconova also conducts several proprietary projects.

In the human sector, Isconova has partnership agreements with several companies including the Dutch vaccine company Crucell, which is part of the Johnson & Johnson Group, and the US research and development company Genocea Biosciences. There is also cooperation with world leading institutes, for example, the Jenner Institute at Oxford University in the UK. In the veterinary field, Isconova has agreements with two major vaccine producers – Pfizer and MSD Animal Health – which market products that use Isconova’s product platform. Furthermore, Isconova has signed agreements with additional vaccine companies, where clinical studies are in progress. In addition to these projects, Isconova has signed more than ten Material Transfer Agreements (MTA), and is also involved in a number of EU projects.



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