SBA Member, 30.07.2018
Cosmo reported H1 2018 results, which were in line with guidance. In July, Cosmo had a Type A meeting with the FDA to discuss the Complete Response Letter (non-approval) and requirement for a second phase III trial to gain US approval. The outcome will be announced soon. We conservatively push back US approval by ~3 years. EU filing of MethyleneBlue is set for Q4 2018. MethyleneBlue, with unchanged global peak sales of USD 700+ mn, should be transformational for Cosmo. Rifamycin SV/Rifafalk is expected to be approved in the US and EU in Q4 2018 and is likely Cosmo’s most underestimated pipeline product with EUR 600+ mn peak sales in all indications.
Key catalysts include:
- Rifamycin SV/Rifafalk US & EU approval travelers’ diarrhea (Q4 2018)
- MethyleneBlue EU filing colonoscopy (Q4 2018)
- Remimazolam US filing procedural sedation (Q1 2019)