Currency in CHF
Last close As at 07/06/2023
CHF44.65
▲ −0.55 (−1.22%)
Market capitalisation
CHF585m
Research: Healthcare
Basilea has announced that there will be a minor delay in the timing of its new drug application (NDA) for Zevtera (ceftobiprole) to the FDA and it now anticipates submission in Q323 (previously H123). The decision comes because one of Basilea’s contract manufacturing organisations requires an additional three to six months to adapt its quality control systems before FDA inspection, a prerequisite for NDA review. Following the NDA submission, Basilea expects a regulatory decision on the approval of Zevtera in the United States by Q224. Management does not expect the recent news to affect its FY23 financial guidance and we believe a US launch date for Zevtera by late FY24 remains feasible.
Basilea Pharmaceutica |
Zevtera NDA submission pushed to Q323 |
Regulatory update |
Pharma and biotech |
19 April 2023 |
Share price performance Business description
Analysts
Basilea Pharmaceutica is a research client of Edison Investment Research Limited |
Basilea has announced that there will be a minor delay in the timing of its new drug application (NDA) for Zevtera (ceftobiprole) to the FDA and it now anticipates submission in Q323 (previously H123). The decision comes because one of Basilea’s contract manufacturing organisations requires an additional three to six months to adapt its quality control systems before FDA inspection, a prerequisite for NDA review. Following the NDA submission, Basilea expects a regulatory decision on the approval of Zevtera in the United States by Q224. Management does not expect the recent news to affect its FY23 financial guidance and we believe a US launch date for Zevtera by late FY24 remains feasible.
Year end |
Revenue (CHFm) |
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 |
47.6 |
N/A |
12/23e |
156.7 |
40.9 |
312.6 |
0.0 |
15.8 |
N/A |
12/24e |
180.7 |
62.0 |
473.4 |
0.0 |
10.4 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As a reminder, the approval of Zevtera, Basilea’s leading anti-MRSA antibiotic, in the US represents a key strategic priority for the company and a potentially lucrative commercial opportunity given that the country represents c 85% of global anti-MRSA antibiotics sales by revenue.
As part of its FDA submission, Basilea plans to submit the NDA for three indications: Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. The submission will be based on the positive results from the Phase III ERADICATE study, together with the positive Phase III TARGET study data reported in 2019.
The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Zevtera, which should allow for priority review following filing of the NDA. The company’s anticipated time of approval is now Q224 and Basilea’s management plans to sign a licensing partner prior to the regulatory decision. We note that if Zevtera is approved by the FDA, the QIDP designation would allow it up to 10 years of market exclusivity in the US.
|
|
Research: TMT
EML Payments has announced the appointment of a new interim CEO and a renewed focus to solve the immediate challenges facing the company. This includes strengthening support for the regulatory remediation process, optimising costs, targeting growth in core business areas and retaining talent. The board has also appointed Barrenjoey to conduct a strategic review of the business. We maintain our estimates.
Get access to the very latest content matched to your personal investment style.