Oppdatert analyse fra DNM, her fra forsiden:
Update
Nordic Nanovector (Pharm. & Biotechnology, Norway)
Recommendation: Buy
Price target: NOK 30.00
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Waiting for protocol amendments to take effect
Q2 EBIT of NOK-113m was slightly better than our estimate. Patient recruitment for the PARADIGME trial remained fairly slow in Q2 (as of 26 August, 56 patients had been recruited, up from 51 on 26 May); however, the protocol amendments approved in late June have not yet really taken effect yet, which has a bearing here. We reiterate our BUY and NOK30 target price.
Slightly smaller operating loss than we expected . The cNOK113m operating loss in Q2 was better than our forecast of a loss of cNOK126m. Cost-containment efforts during the spring have had only a minor impact on operating costs to date, but we expect a more rapid decline in costs in H2 2020.
On-balance sheet cash should last into early 2021 . Quarter-end cash on the balance sheet was cNOK246m, in line with our estimate of cNOK248m; we believe this will last through to early 2021. However, this implies the company will need to raise additional cash in the not too distant future in order to be financed through to data read-out from the PARADIGME trial – which we expect in H2 2021.
No impact on recruitment from protocol amendments yet . On 30 June Nordic Nanovector announced that the FDA had approved the suggested protocol amendments to the PARADIGME trial aimed at increasing the speed of recruitment. However, it is likely to take 2–3 months before local authorities can implement the changes and therefore for the new amendments to take effect locally, which indicates we should see the more relaxed inclusion and exclusion criteria kick in this autumn.
Positive interim analysis for PARADIGME trial . The IRC recommended Nordic Nanovector discontinued the 100/20 dose arm and focused on the 40/15 arm. We believe this is positive, since we are fairly familiar with the level of clinical efficacy and safety to expect from the 40/15 arm. In addition, ultimately this arm should have c100–110 patients, which we believe would be enough for accelerated approval in 3L FL (assuming the 56 patients recruited so far are equally split between the two doses, and that the full trial still recruits c130 patients).
BUY and NOK30 target price reiterated . We have made only minor changes to our forecasts following the results, and reiterate our BUY and NOK30 target price. In our view, the company is right to focus its efforts on completing recruitment for the PARADIGME trial.
Fra rapportens innhold:
DNB Markets investment case and how we differ from consensus
In our base case, the company develops Betalutin all the way to the market and launches the product alone.
The first indication should reach the market in 2022. We have applied a 40% probability adjustment to FL sales, but development costs are unadjusted.
We estimate a global average price of USD150,000 per patient for Betalutin for all indications…
Upside risks to our investment case
The company could become a target for consolidation in the industry.
It might realise higher prices for Betalutin than we have factored in.
With strong clinical data, the approval process might be speedier than we have estimated, leading to a launch sooner than expected.
