Bildkälla: Stockfoto

Intervacc: Taking the final steps before Strangvac launch - ABG

Launch expected in Q1
Interactive US regulatory process initiated
Q4 EBIT SEK -9m, 116m in cash

EU KOL discussions ongoing and US regulatory submission
Intervacc expects Strangvac sales to start in Q1 and production of doses is now ongoing. Together with EU distribution partner Dechra, it is currently in discussions with many KOLs that provide feedback on how Strangvac can be applied and help promote it to vets. The schedule for continuing protection is two initial doses and a semi-annual booster thereafter. In February, it submitted the application to the Center for Veterinary Biologics (part of USDA), which initiates the process to unlock the ~10 million-strong US horse market (vs. EU ~6m). The US process is more interactive, and the regulator will respond with which additional data it requires. We believe this will be either: 1) no additional data, 2) further safety data or 3) further safety and efficacy data. We expect some additional data to be needed and see US approval in 2023 at the earliest.

Positive data-points towards the long-term uptake
In January, a study was published in the British Equine Veterinary Journal showing that Strangvac is effective against various Streptococcus equi strains collected from 19 different countries (all in the study). We consider this a positive de-risking factor that supports our expectations for a broad uptake of Strangvac. Intervacc also announced that it has applied for a supplementary protection certificate (SPC), which will add protection until 2036 in key markets (now 2031).

Meeting unmet need in strangles
Strangvac addresses a high unmet need to reduce the spread and infection of strangles. With limited competition and good blueprint in equine influenza vaccinations, we see strong arguments for high penetration down the line. We update launch assumptions in our model, assuming Swedish launch in Q1, and throughout Europe during the year. We now forecast ‘22e Strangvac sales of SEK 46m (prev. 110m).
... Läs mer på Introduce
Börsvärldens nyhetsbrev
ANNONSER