Last close As at 05/08/2026
CHF50.70
▲ 0.20 (0.40%)
Market capitalisation
CHF681m
Research: Healthcare
Basilea has announced that it has filed its new drug application (NDA) for Zevtera (ceftobiprole) with the FDA. As part of this submission, the company is seeking approval for three indications: Staphylococcus aureus bacteraemia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). We note that the NDA is eligible for priority review and, hence, Basilea expects a regulatory decision on the approval of Zevtera in the US by Q224, potentially representing a significant catalyst for the company.
Written by
Basilea Pharmaceutica |
Zevtera back on track: NDA submitted to the FDA |
Milestone update |
Pharma and biotech |
7 August 2023 |
Share price performance
Business description
Analysts
Basilea Pharmaceutica is a research client of Edison Investment Research Limited |
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Basilea has announced that it has filed its new drug application (NDA) for Zevtera (ceftobiprole) with the FDA. As part of this submission, the company is seeking approval for three indications: Staphylococcus aureus bacteraemia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). We note that the NDA is eligible for priority review and, hence, Basilea expects a regulatory decision on the approval of Zevtera in the US by Q224, potentially representing a significant catalyst for the company.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
148.1 |
(6.6) |
(56.9) |
0.0 |
N/A |
N/A |
12/22 |
147.8 |
12.3 |
104.1 |
0.0 |
41.6 |
N/A |
12/23e |
156.7 |
40.9 |
312.6 |
0.0 |
13.9 |
N/A |
12/24e |
180.7 |
62.0 |
473.4 |
0.0 |
9.1 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Zevtera is an intravenous antibiotic medication that has demonstrated rapid bactericidal activity against various Gram-positive bacteria such as Staphylococcus aureus (including methicillin-resistant strains (MRSA)) and Gram-negative bacteria. Approval of Zevtera in the US remains a key strategic priority for the company, with a potentially lucrative commercial opportunity as the MRSA-treatment market is predicted to be worth c $5.5bn by 2030, with the US accounting for the majority of global anti-MRSA antibiotics by revenue.
Basilea has now announced that it has submitted the NDA application for Zevtera to the FDA, seeking approval for SAB, ABSSSI and CABP. The submission is based on the positive results observed in the Phase III ERADICATE study (for SAB), the Phase III TARGET study (for ABSSSI) and a Phase III study in CABP. We note that the FDA previously granted qualified infectious disease product (QIDP) designation to Zevtera, meaning the NDA is eligible for priority review (ie, within eight months of submission). Accordingly, Basilea expects a decision from the FDA in Q224, meaning a launch date for Zevtera in H224 is feasible. This could represent a major catalyst for investor attention, in our view, provided the company is successful with regulatory approval. Furthermore, if Zevtera is approved by the FDA, the QIDP designation allows up to 10 years of market exclusivity in the US. We also note that Basilea plans to commercialise Zevtera in the US with a licensing partner, which management hopes to have signed before the regulatory decision.
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Research: Industrials
External factors, US drought and excessive input prices, in the Speciality Agriculture business continue to weigh on volumes. As these reverse, strong market positions should help to drive activity back towards historical levels. With the Engineering division performing well the medium-term outlook is far more encouraging than the short-term market issues may suggest.