BioArctic (Buy, TP: SEK350.00) - Focus remains on Leqembi

The Q4 report was a non-event as Leqembi royalties had already been published. We believe investors will continue to focus on the Leqembi launch trajectory; however, we believe BioArctic’s pipeline will come into greater focus with the approaching start of the phase IIa trial for exidavnemab in Parkinson’s disease. We reiterate our BUY but have lowered our target price to SEK350 (365).

BioArctic AB: 1 director

A director at BioArctic AB sold 12,000 shares at 234.824SEK and the significance rating of the trade was 69/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly s...

BioArctic (Buy, TP: SEK365.00) - Launch progressing in the US

Q3 earnings were slightly below our estimate, as the milestone received from Eisai was less than we expected. We have adjusted our uptake trajectory for Leqembi to reflect the complex infrastructure needed to administer the drug (multiple MRIs and i.v. infusions) and have significantly reduced our short-term sales forecasts. Longer-term, we expect Leqembi to be a game-changer for Alzheimer’s patients. We reiterate our BUY, but have cut our target price to SEK365 (410).

BioArctic (Buy, TP: SEK410.00) - Approvals in focus; sales ramp-up adj...

The Q2 report was fairly undramatic, coming just after the most important event in the company’s history – full FDA approval of Leqembi. BioArctic is turning its sights to possible approval in Japan in September as well as a full launch in the US by its partner Eisai. The pipeline of new projects looks solid, although there was no more detail. We reiterate our BUY but have lowered our target price to SEK410 (430) on our view of a slower sales ramp-up.

Northern Lights

BioArctic (Buy, TP: SEK430.00) - Leqembi fully approved in the US

The FDA announced on 6 July that it had converted the accelerated approval for Leqembi to a full approval. As a result, we expect the CMS to grant the drug full reimbursement under the condition that patients take part in a data registry for the real-world outcomes of treatment with Leqembi. We note that the FDA recommends patients to be typed for ApoE4 status prior to initiation of treatment and that there is a Boxed Warning added to the label. We do not see this as something that should negati...

Swedish Small - caps - summer 2023

Swedish Small - caps - summer 2023

Northern Lights

BioArctic (Buy, TP: SEK430.00) - AdCom ‘yes’ vote on Leqembi

The FDA advisory committee (AdCom) voted unanimously that the Clarity AD trial data confirmed the clinical benefit of Leqembi for the treatment of Alzheimer’s disease. The discussions in the panel circled around safety and the use of Leqembi in ApoE4 homozygotes and use in combination with anti-coagulant treatment. We believe the FDA will give full approval for Leqembi on 6 July and thus the drug should receive full reimbursement from the CMS soon after full approval.

BioArctic (Buy, TP: SEK430.00) - Closing in on PDUFA date

The Q1 earnings beat was driven by EUR35m in milestones for initial US approval of Leqembi (substance name lecanemab) and filing in Europe and Japan. The next key event in our view is the PDUFA date (6 July), when we expect full FDA approval of Leqembi in the US. We reiterate our BUY and SEK430 target price.

Northern Lights

BioArctic (Buy, TP: SEK430.00) - Closing in on PDUFA date

The Q1 earnings beat was driven by EUR35m in milestones for initial US approval of Leqembi (substance name lecanemab) and filing in Europe and Japan. The next key event in our view is the PDUFA date (6 July), when we expect full FDA approval of Leqembi in the US. We reiterate our BUY and SEK430 target price.

Northern Lights

BioArctic (Buy, TP: SEK430.00) - Full focus on launch preparations

The Q4 report was largely a non-event, as the share price is being driven by the regulatory and clinical development of lecanemab. The next important event looks to be the file acceptance message from the FDA and PDUFA date for the full approval application. This should come around 6 March and we expect a priority review (suggesting a PDUFA date around 6 September for a 6-month review process). We reiterate our BUY and SEK430 target price.

Northern Lights

BioArctic (Buy, TP: SEK430.00) - Leqembi approved in the US

On Friday, the FDA granted accelerated approval for lecanemab (Leqembi) for the treatment of Alzheimer’s Disease. The indication is as expected and there are no unexpected safety warnings or monitoring requirements. The price (USD26.5k/patient/year) was a little lower than we expected. A launch is expected week commencing 23 January. BioArctic’s partner Eisai has already submitted an application for full US approval. We reiterate our BUY and have raised our target price to SEK430 (420).

Northern Lights

BioArctic (Buy, TP: SEK420.00) - ClarityAD data very convincing

BioArctic’s partner Eisai presented the full data set from the pivotal phase III trial ClarityAD at CTAD on 29 November. We were positively surprised by the transparency and detail of the presentation at CTAD. The data holds up well in our view and is consistently strong over all endpoints while the safety profile looks as expected. We expect BioArctic to see a positive share price reaction to the data release and that the safety discussions over the past few days will be put to rest.

Northern Lights

BioArctic (Buy, TP: SEK420.00) - Full top-line data likely next trigge...

Q3 revenues and earnings were solid at cSEK218m and cSEK133m, respectively, helped by a EUR15m milestone from Eisai. In our view, the next important share-price trigger will be more comprehensive data from the ClarityAD trial, due to be presented at CTAD on 29 November. We expect accelerated approval for lecanemab on or before the PDUFA date of 6 January 2023. We reiterate our BUY and SEK420 target price.