Isconova AB (publ.) – interim report January-June 2012*)
SECOND QUARTER, APRIL 1 – JUNE 30, 2012
- Consolidated net sales totaled SEK 5.3 M (4.2)
- Operating result amounted to a loss of SEK 8.2 M (loss: 10.7)
- Net result amounted to a loss of SEK 8.2 M (loss: 10.5)
- Result per share before and after dilution amounted to a loss of SEK 1.98 (loss: 2.52)
- Cash flow from operating activities amounted to a deficit of SEK 11.7 M (deficit: 3.0)
FIRST SIX MONTHS, JANUARY 1 – JUNE 30, 2012
- Consolidated net sales totaled SEK 10.3 M (8.2)
- Operating result amounted to a loss of SEK 19.2 M (loss: 20.5)
- Net result amounted to a loss of SEK 19.2 M (loss: 20.1)
- Result per share before and after dilution amounted to a loss of SEK 4.61 (loss: 4.83)
- Cash flow from operating activities amounted to a deficit of SEK 20.1 M (deficit: 13.1)
SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- The Annual General Meeting was held on May 10, 2012 in Uppsala. The Meeting resolved on the composition of the Board of Directors and the introduction of an employee stock option plan directed toward certain directors, the CEO and senior executives.
- First results reported from the successful Phase 1 trial of Isconova’s Matrix M™ adjuvant.
SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER
- Isconova’s adjuvant, Matrix-M™, approved by the FDA for Genocea’s IND Phase I/II clinical trial. The study started mid-August.
- Isconova initiated cooperation with Virbac – one of the world’s leading veterinary medicine companies.
- Isconova carries out a fully guaranteed rights issue of approximately SEK 50 million.
- An Extraordinary General Meeting (EGM) will be held October 1, 2012.
|Summary of results
| 12 months
|Net sales, SEK M
|Operating loss, SEK M
|Net loss, SEK M
|Loss per share, SEK
Cash flow from operating
activities, SEK M
*) All figures pertain to the Group, unless otherwise stated. The figures in parentheses pertain to the corresponding period in the preceding year.
In recent months, we have been able to report a number of important events for Isconova. Data from the Phase I study that was conducted and sponsored solely by Isconova on an influenza vaccine showed highly encouraging positive results and confirmed the clinical superiority of vaccines with our adjuvant Matrix-M™. It is the company's first own clinical study and as such represents a significant milestone for Isconova. It significantly strengthened the documentation for Isconova’s Matrix technology and provided further "proof of concept" for future development of human vaccines. These data also strengthen considerably the base for the partnership Isconova has with J&J/Crucell as we strive to create a vaccine franchise in the influenza market.
Furthermore, our partner Genocea Biosciences recently received approval from the U.S. Food and Drug Administration, FDA, for an IND (Investigational New Drug) application to initiate a Phase I/II clinical study for their vaccine under development against Herpes Simplex Type-2 (HSV-2). The vaccine has the potential to become the first therapeutic vaccine against HSV-2 infection. It is the first time FDA has evaluated and approved Matrix-M™ for a clinical study which is a breakthrough for Isconova and a validation of quality of our proprietary Matrix-M™ technology. Our partnership with Genocea also covers a number of other indications.
In July, we also signed an agreement with Virbac, a world leader in veterinary medicine. In a first step, Isconova’s adjuvant Matrix-M™ will be used for the development and improvement of vaccines for the global veterinary market. The first products to be developed are vaccines based on Matrix-M™ for dogs, against certain infectious diseases. Isconova will receive milestone payments and royalties based on Virbac’s future sales of these vaccines.
Revenues showed good progress in the first half 2012 with an increase of 25 percent compared with the same period last year. Expenses were as planned and overall loss was lower compared to the previous six months.
Since taking over as CEO in March, I have met the majority of our current business partners, both in the veterinary and human market, and reviewed all existing projects and existing contracts. The objective is to expand our current business relationships while also seeking additional partnership agreements for the development of new vaccines that require a powerful and safe adjuvant, and where Matrix-based products can lead to better and more effective vaccines. Recent events , where we report significant progress, encourage us that further expansion of our business partnerships is certainly realizable.
During October, we will conduct a rights issue of SEK 50 M. It will enable the company to implement the business plan that we have worked on during the spring. We will thus be able to run company sponsored clinical trials to further document Matrix-M™ for new indications in both the human and veterinary markets. Additionally, we will further develop our GMP (Good Manufacturing Practice) production.
The rights issue is fully guaranteed by a consortium of existing shareholders and potential new investors with insightful knowledge of the vaccine market.