Luk
STOCKHOLM (Nyhetsbyrån Direkt) Danske Bank inleder bevakning av bioteknikbolaget Hansa Biopharma med köp och riktkursen 305 kronor.
Det rapporterar nyhetstjänsten PLX.

Aktien stängde på 161:20 kronor i fredags.

"Celebrating first commercial sales of Idefirix

Years in the making, the first sales of Hansa's Idefirix were booked in Q1, a milestone achievement. However, it is not the first sales that owners and watchers have been waiting for, but the longer term. National level reimbursement is the next key step on the journey, and management stated it expects the first of these to come before Q4 2020. In the meantime, potential further deals with gene therapy players add some optionality. Buy reiterated.

Q1 review

Q1 revenue of SEK 9m included SEK 6m of Idefirix sales. Interestingly, most sales came from Germany, which management had indicated was unlikely to be first to book commercial sales, but management suggested that we should not to see it as an upside to the near-term outlook. EBIT of SEK -104 was 10% less than our estimate, helped by lower than expected opex, which management confirmed should ramp gradually over the year. Importantly, Hansa still has SEK 1,255m cash remaining, which management stated is sufficient to last until 2023, in line with our estimates.

Clinical programme progressing, albeit in fits and starts

The clinical programme is progressing, with the GBS and AMR trials gathering pace and still on schedule, although the US kidney transplantation trial start was shifted back half a year, delaying the time to a potential BLA filing to early 2024.

Catalysts remain over the coming three quarters

With commercial progress demonstrated, reimbursement likely to come in the next few months (probably from Sweden first), and potential deals in gene therapy to be struck during the year, we see ample reason for investors to remain long on Hansa. Case confirmed. Buy".

Christopher W. Uhde, PhD
Pharma & Biotech Equity Analyst
christopher.uhde@seb.se

Q1 report in line with our expectations
First Idefirix commercial sales of SEK6m were recorded in Q1, which corresponds to two
treated patients. We expect reimbursement decisions by authorities in initial launch
countries from mid-2021. We expect Sweden to be first, based on the positive assessment
of TLV, which supports use in a highly select and narrow patient population. We forecast 39
commercial patients to be treated in 2021, which would translate into SEK93m of product
sales. The confirmatory EU study is due to start in H2(21), which we believe is likely to have
a negative impact on the early commercial uptake.

US delay and slow progress with development programmes to expand use
The enrolment into the US Phase III study in kidney transplantation has been pushed from
H1(21) to H2(21) and the company now targets a BLA submission during H1(24), previously
2023. The time to finalise the study protocol has been longer than expected, with FDA
discussions now lasting nine months. The delay is due to changes in FDA staffing and Covid-
19 priorities at the agency. We still expect a similar scope of the study i.e. 50-60 patients,
12-months follow-up, and a controlled design versus the kidney allocation system. Enrolment
in the Phase II studies in AMR and GBS is progressing slowly. At the current pace, we believe
there is a risk that the studies will not meet the target of being fully enrolled by YE(21), per
the company's guidance. In GBS, 8/30 patients have been enrolled vs. 5/30 at the Q4 update.

Consensus expectations more sober; up to HOLD (Sell)
We have upgraded the stock to HOLD (Sell) as we note that consensus estimates for the
uptake of Idefirix have been significantly downgraded in the past six months. Our revenue
estimates are now above consensus for 2021-23. Phase II data for Idefirix in GBS and AMR
is expected in H2(22) at the earliest, with a risk of further delays to the timeline due to the
slow patient recruitment. We continue to see better risk/reward elsewhere in the Swedish
biotech sector, with our top picks being Calliditas, Camurus and Oncopeptides.

http://nordic.carnegie.se/research.carnegie?file=kIAsgRS%2FDRQVfgvJPkOwbXo7E6xNVfVn4SOnIzhqhxo%3D