Last close As at 05/08/2026
CHF50.70
▲ 0.20 (0.40%)
Market capitalisation
CHF681m
Research: Healthcare
Basilea has announced that the US FDA has accepted its New Drug Application (NDA) for ceftobiprole. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 3 April 2024, meaning that Basilea will have a regulatory decision for its lead antibiotic asset in the US in early-Q224, consistent with prior guidance. Supported by three separate Phase III clinical trials, 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). With the bacterial infection market in the US representing a sizeable opportunity, we believe the decision from the FDA could represent a significant catalyst for Basilea.
Written by
Basilea Pharmaceutica |
FDA accepts New Drug Application for ceftobiprole |
Regulatory update |
Pharma and biotech |
3 October 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 the US FDA has accepted its New Drug Application (NDA) for ceftobiprole. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 3 April 2024, meaning that Basilea will have a regulatory decision for its lead antibiotic asset in the US in early-Q224, consistent with prior guidance. Supported by three separate Phase III clinical trials, 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). With the bacterial infection market in the US representing a sizeable opportunity, we believe the decision from the FDA could represent a significant catalyst for Basilea.
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 |
158.2 |
43.5 |
332.2 |
0.0 |
13.9 |
N/A |
12/24e |
180.7 |
63.2 |
482.3 |
0.0 |
9.1 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As a reminder, ceftobiprole is an intravenous antibiotic that has demonstrated rapid bactericidal activity against Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains (MRSA)), and Gram-negative bacteria. The medication is already approved in selected countries across Europe, Latin America, the Middle East, North Africa and Canada, marketed as either Zevtera or Mabelio. However, approval of ceftobiprole in the US is a strategic priority for Basilea. The global treatment market for MRSA was estimated at $3.9bn in 2022, and projected to reach $5.5bn by 2030, corresponding to a compound annual growth rate of 4.3%, attributed to growing incidence rates of MRSA infections. With the US accounting for the lion’s share of global anti-MRSA antibiotics by revenue (c 85%, according to IQVIA, March 2023), this could translate into a lucrative commercial opportunity, provided regulatory approval is achieved.
In early August 2023, Basilea announced that it had submitted an NDA application for ceftobiprole to the FDA. The company is seeking approval based on positive clinical efficacy and safety data from three separate studies: ERADICATE (for SAB), TARGET (for ABSSSI) and a Phase III trial (for CABP). We note that the ERADICATE trial, the results for which were recently published in the New England Journal of Medicine, was the largest double-blind, randomised registrational study conducted for a new SAB antibiotic treatment, which should help on the regulatory front, in our view. We also note that the FDA has already granted qualified infectious disease product designation to ceftobiprole, allowing up to 10 years of market exclusivity in the US, subject to approval.
Now, in early October 2023, Basilea has announced that the FDA has accepted its NDA for ceftobiprole, and set 3 April 2024 as the PDUFA goal date, meaning a potential launch in H224 is feasible. FDA acceptance of this NDA represents a key milestone for the clinical development of the antibiotic drug, and we believe that this regulatory decision in early-Q224 could be a major catalyst for investor attention.
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Research: Financials
PB Holding reported H123 results on 27 September. The company’s most important asset, car insurer Bovemij, in which it has a 5.3% stake, has already reported H123 results. Apart from regular operating costs of approximately €0.2m on an annual basis for the holding, PB Holding has no large expenses as it has a large tax loss asset and a net cash position of €0.5m following a share buyback after the period end.