Hansa Biopharma kan nu for alvor kalde sig kommercielle. Første patient er nu behandlet og vi kan så småt begynde at regne på fremtidig indtægt som vi havde stor fornøjelse af i Veloxis, Genmab mfl. Første reimbursement i Q2/q3 men adgang for patienter inden hvis lokal funding kan skabes som vi har set det i q1. Det er en stor dag for menneskeheden, at patienter hvor det tidligere nærmest har været umuligt at blive behandlet nu kan få hjælp af Hansa Biopharma med IDEFIRIX.. Det siger lidt om potentialet at man blot ved godkendelse i første indikation/område (nyre i EU), potentialt kan få omsætning i mia klassen når der er yderligere 32 indikationer/områder godt på vej foruden at tale om alle de brikker i puslespillet som bliver lagt henadvejen (senest de 2 brikker: 2 indikationer i genterapi, Limb-Girdle og Duchenne) https://s24.q4cdn.com/980434894/files/doc_financials/2021/q1/20210421-Q1-2021-Road-Show-Presentation-FINAL.pdf
23/4 2021 08:12 Helge Larsen/PI-redaktør 1
93071 Læs også med her i hovedtråden for regnskabet:
https://www.proinvestor.com/boards/93036/Hansa-Biopharma-interim-report-Jan-Mar-2021
https://www.proinvestor.com/boards/93036/Hansa-Biopharma-interim-report-Jan-Mar-2021
23/4 2021 09:30 Aps invest 193076 Så er MSE igang med deres sædvanlige kurspres igen: Største sælgere
Største sælgere
Mægler Købt Solgt Netto Internt
MSE 18.847 64.001 -45.154
Største sælgere
Mægler Købt Solgt Netto Internt
MSE 18.847 64.001 -45.154
23/4 2021 09:57 joman18 093080 Jeg vil tro vi får en stigning herfra i eftermiddag - så jeg har købt lidt flere på dette niveau.
23/4 2021 15:49 Aps invest 293089 Ikke overraskende at amerikanerne bliver ved med deres kurspres....det har stået på i lang tid .... Morgan Stanley, JP Morgan og Goldmann Sachs fortsætter bare med at styre kursen...intet nyt i det....men møgirriterende
23/4 2021 16:23 B.Andersen 293091 Carnegie Hansa Biopharma (Hold): Launch expectations finally reasonable - up to HOLD
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
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
23/4 2021 16:34 B.Andersen 393092 SEB: "Case confirmed. Buy".
"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
"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
26/4 2021 07:35 Aps invest 493118 HANSA BIOPHARMA: DANSKE BANK INLEDER MED KÖP
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.
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.
26/4 2021 16:34 Aps invest 193131 God afslutning idag +5,8% under pæn omsætning, og kun JP Morgan der solgte lidt ud idag..... Største sælgere
Største sælgere
Mægler Købt Solgt Netto Internt
JPAG 9.777 53.215 -43.438 1.83
Største sælgere
Mægler Købt Solgt Netto Internt
JPAG 9.777 53.215 -43.438 1.83
26/4 2021 16:44 Aps invest 193132 Den blev trykket en del hen over dagen, men pæn stigning den sidste times tid...lover godt
