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Currency in SEK
Last close As at 09/06/2023
SEK8.90
▲ 0.48 (5.70%)
Market capitalisation
SEK461m
Research: Healthcare
IRLAB Therapeutics announced that Ipsen, the out-licensing partner for its lead asset, mesdopetam, has commenced standard clinical studies for the drug. These preparatory studies are necessary to progress into Phase III and confirm the arrangement is progressing as planned. The three studies to be conducted on healthy volunteers include a pharmacokinetic, a drug-to-drug interaction and a mass balance study, and will be run in parallel with the ongoing Phase IIb study conducted by IRLAB. As top-line data from Phase IIb are expected around the end of CY22, the data from the Ipsen studies will support the late-stage development of the drug. We maintain our estimates and valuation of IRLAB at SEK6.40bn or SEK123.7 per share.
IRLAB Therapeutics |
Ipsen confirms commitment with clinical studies |
Clinical study update |
Pharma and biotech |
8 September 2022 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics announced that Ipsen, the out-licensing partner for its lead asset, mesdopetam, has commenced standard clinical studies for the drug. These preparatory studies are necessary to progress into Phase III and confirm the arrangement is progressing as planned. The three studies to be conducted on healthy volunteers include a pharmacokinetic, a drug-to-drug interaction and a mass balance study, and will be run in parallel with the ongoing Phase IIb study conducted by IRLAB. As top-line data from Phase IIb are expected around the end of CY22, the data from the Ipsen studies will support the late-stage development of the drug. We maintain our estimates and valuation of IRLAB at SEK6.40bn or SEK123.7 per share.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.4 |
(91.4) |
(1.92) |
0.0 |
N/A |
N/A |
12/21 |
207.9 |
91.1 |
1.76 |
0.0 |
18.5 |
N/A |
12/22e |
62.1 |
(112.9) |
(2.18) |
0.0 |
N/A |
N/A |
12/23e |
0.3 |
(122.7) |
(2.37) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As part of the mesdopetam drug development plan, Ipsen intends to initiate three standard pharmacology studies, including a pharmacokinetic, a drug-to-drug interaction and a mass balance study in healthy participants. These studies will run simultaneously with the in-progress Phase IIb clinical trial, which is managed by IRLAB, and top-line data are expected around the end of CY22. The standard data from these studies are usually required for late-stage drug development and confirm Ipsen’s commitment to further studies. The studies are likely to be completed during Q322 and Q123.
As a reminder, mesdopetam is a D3 receptor antagonist being investigated in an ongoing Phase IIb trial for Parkinson’s disease (PD-LIDs). In July 2021, IRLAB licensed mesdopetam’s global rights to Ipsen for an upfront payment of US$28m, up to US$335m in potential milestones and low double-digit royalties on sales. As part of the agreement, IRLAB will fund the development of mesdopetam until top-line results from the currently ongoing Phase IIb trial are reported.
We note that top-line Phase IIb results will be important in defining Ipsen’s Phase III development strategy. These pharmacokinetic studies are part of Ipsen’s Phase III preparatory activities for mesdopetam, as announced in the initial licensing agreement. If the data from the Phase IIb study are positive, Ipsen will assume full responsibility for any further development, registration and commercialisation. For IRLAB, the top-line data are the most important near-term event, followed by the top-line readout from the Phase IIb study of pirepemat in the treatment of PD-related falls, which we expect in H223.
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Research: Healthcare
Despite the challenging financial backdrop, Basilea Pharmaceutica has announced that it has secured a CHF75m senior secured loan from Athyrium Capital Management (a US-based asset management company). The combination of this non-dilutive financing and cash on hand will allow the company to repay its outstanding convertible bonds (ISIN CH0305398148 with a nominal value of CHF117m, due in December 2022), outlined as the first leg of management’s strategic plan. This short-term arrangement is anticipated to bridge the company until expected operational profitability in FY23. Our valuation of Basilea remains unchanged at CHF893.8m or CHF75.5/share.
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