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Oasmia Pharmaceutical: Clarity on pathway to US approval - Edison

Oasmia’s H1 FY21 results highlight recent developments made to realign the business. In December, global partner Elevar Therapeutics announced it had concluded discussions with the FDA on the pathway to US approval for Apealea (Cremophor-free paclitaxel) in ovarian cancer. The FDA has stated it requires two additional trials to form the basis of the NDA submission. We have delayed our forecast US launch by two years to 2025, which means our forecast timeframe to maiden profitability has now shifted to 2025. In Europe (ex-Nordics), Elevar is in final-round discussions for a distribution partner and has signed an agreement with Taiba Middle East FZ for the Middle East and North Africa (MENA) region. Our revised valuation of Oasmia is SEK2.42bn or SEK5.41/share.

Oasmia’s H1 FY21 results highlight recent developments made to realign the business. In December, global partner Elevar Therapeutics announced it had concluded discussions with the FDA on the pathway to US approval for Apealea (Cremophor-free paclitaxel) in ovarian cancer. The FDA has stated it requires two additional trials to form the basis of the NDA submission. We have delayed our forecast US launch by two years to 2025, which means our forecast timeframe to maiden profitability has now shifted to 2025. In Europe (ex-Nordics), Elevar is in final-round discussions for a distribution partner and has signed an agreement with Taiba Middle East FZ for the Middle East and North Africa (MENA) region. Our revised valuation of Oasmia is SEK2.42bn or SEK5.41/share.
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