8.00 AM CEST / 22-Apr-2021 / Hansa Biopharma AB (STO:HNSA)
Hansa Biopharma interim report Jan-Mar 2021
First commercial sales of Idefirix® recorded in Q1; New preclinical collaboration with argenx; Encouraging three-year follow-up data in kidney transplantation
Lund, Sweden April 22, 2021 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January - March, 2021.
Highlights for the first quarter 2021
First commercial sales of Idefirix® recorded in Q1 2021 following treatment of the first patients. Commercial launch activities in early launch countries continue to be carried out as planned. National level reimbursement application processes underway and decisions by authorities in the first markets expected from mid-year and onwards.
First Healthcare Technology Assessment report published in Sweden. The Swedish "TLV" assessment is favorable to the use of Idefirix® in highly sensitized patients incompatible with a deceased donor.
Hansa Biopharma enters into preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies for potential use in both the acute and chronic setting of autoimmune diseases and transplantation.
Encouraging three-year follow-up outcome and safety data in imlifidase treated transplant patents in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data expected to be presented later in the year in a peer-reviewed journal.
Magnus Korsgren, M.D., Ph.D. appointed new Head of R&D. Dr Korsgren will lead research and development activities based on Hansa's proprietary enzyme technology platform as the Company expands into new therapeutic areas.
Patient recruitment in the phase 2 studies in AMR and GBS ongoing under a risk-based, site-by-site approach due to the COVID-19 pandemic. In the AMR trial, 9 out of a target of 30 patients have been enrolled, and in the GBS trial 8 out of 30 have been enrolled.
US trial: Hansa continues to be in productive dialogue with the FDA and expects to reach an agreement near-term with the Agency on the protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is ongoing. Hansa expects to initiate the trial over summer and to recruit the first patient in the second half of 2021.
COVID-19 pandemic: The global COVID-19 pandemic may still adversely impact Hansa Biopharma's operational business and trial activities.
Events after the end of the reporting period
Hilary Malone, PhD. in Molecular Neuropharmacology (born 1965, U.S. and UK citizen) proposed as new member of the Board of Directors at the next AGM. Dr. Malone is currently COO and EVP at Valo Health, Inc. (U.S.) and has held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others. Birgit Stattin Norinder has decided not to stand for re-election to the Board of Directors at the next AGM.
Financial summary
Solid cash position of SEK 1,255m at the end of March 2021.
Investments in SG&A and R&D in the first quarter amounting to SEK 60m (Q1'20: SEK 39m) and SEK 47m (Q1'20: SEK 53m), respectively, in line with plans.
Cash flow from operating activities for the first quarter ended at SEK -121m (Q1'20: SEK -121m).
SEKm, unless otherwise stated - unaudited
Q1 2021
Q1 2020
FY 2020
Revenue
9.0
0.9
6.1
Gross profit
7.3
0.5
5.1
SG&A expenses
-60.1
-38.7
-203.0
R&D expenses
-47.4
-52.5
-227.2
Operating profit/loss
-103.7
-91.4
-422.8
Net profit/loss
-103.9
-93.4
-420.9
Cash flow from operating activities
-120.9
-121.2
-290.3
Cash and short-term investments
1,254.7
476.9
1,377.5
Shareholders' equity
1,149.8
473.9
1,242.1
EPS before and after dilution (SEK)
-2.34
-2.33
-9.98
Number of outstanding shares
44,473,452
40,026,107
44,473,452
Weighted avg. number of shares before and after dilution
44,473,452
40,026,107
42,176,872
Number of employees
101
78
87
Søren Tulstrup, President and CEO of Hansa Biopharma, comments:
"Hansa Biopharma's evolution into a fully integrated, commercial-stage biopharmaceutical company is now a reality following the Company's first commercial sales of Idefirix® and treatments of the first patients.
Our long-term objective is to build Hansa into a recognized global leader in rare diseases across multiple broad therapeutic areas through the development of new transformative medicines for patients suffering from rare immunologic diseases. In order to do so, we need to successfully execute on our strategic priorities. This early in 2021, we have already demonstrated clear progress across our business and organization and that we are on track to deliver on our targets for the year.
In Europe, our commercial launch activities continue to be rolled out and implemented in early launch countries as planned. As part of this effort, we continue to have close interactions with national reimbursement authorities and leading transplant clinics. Decisions by authorities in the first of the early launch countries can be expected from mid-year and onwards following publication of Healthcare Technology Assessments to evaluate the health-economic impact from using Idefirix®. A first such assessment was recently published in Sweden, which was favorable to the use of Idefirix® in scenarios representing both high and low mortality assumptions for dialysis patients.
On March 29, Hansa entered into a preclinical research collaboration agreement with argenx BV to explore the potential of combining imlifidase, Hansa's IgG antibody-cleaving enzyme, and efgartigimod, argenx's FcRn antagonist. We are pleased to collaborate with argenx, a leader in the field of FcRn-inhibition, as they share our commitment to bringing innovative new medicines to patients suffering from autoimmune diseases. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation and may potentially unlock additional therapeutic value.
In the US, Hansa is in productive dialogue with the FDA and we expect to finalize near-term an agreement with the Agency on a protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is already ongoing and we are encouraged by the strong interest shown by leading US transplant centers to participate in the trial. Subject to the expected agreement with FDA on the study protocol in the coming months, we expect study initiation over the summer and the first patient to be enrolled in the second half of 2021.
In our ongoing phase 2 programs, GBS and AMR, we see patient enrollment progressing again following a temporary halt in the recruitment process during large parts of 2020 due to the COVID-19 pandemic. In December 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach. As of April 21, 2021, 9 out of a target of 30 patients have now been enrolled in the AMR study, while 8 out of 30 have been enrolled in the GBS study. Depending on the impact of the COVID-19 pandemic, enrollment is expected to be completed towards the end of 2021, as previously guided.
Furthermore, I am pleased to announce that our long-term follow-up study in highly sensitized kidney patients continues to show encouraging outcomes after imlifidase treatment and transplantation. We now have three-year data available, demonstrating follow-up outcomes in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data is expected to be published later this year following submission of a manuscript to a peer-reviewed journal.
I am also happy to see that we continue to attract the talent and competences needed to build a high-performance organization. In March, we announced the recruitment of Magnus Korsgren, M.D., Ph.D as our new Head of R&D. Dr. Korsgren's extensive international experience in translational medicine and drug development will be very helpful for our continued efforts to build a highly valuable pipeline of drug candidates within transplantation, autoimmune diseases and beyond.
Speaking about attracting highly qualified, international competences, I am also very pleased to see Hilary Malone, Ph.D in Molecular Neuropharmacology, being proposed at the next AGM as a new member of the Board of Directors at Hansa Biopharma. Ms. Malone currently holds the position of Executive Vice President and Chief Operating Officer at Valo Health, Inc. in the US and has previously held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others.
Hansa is off to a good start in 2021 and I look forward to updating you on our progress as we deliver on our mission to bring lifesaving and life altering therapies to patients with rare diseases who need them while generating value to shareholders and society at large."
Upcoming milestones and news flow
H1 2021 NiceR: initiate IND-enabling tox studies
Q2/Q3 2021 First national reimbursement agreement
H2 2021 Kidney transplantation US: First patient dosed
H2 2021 AMR Phase 2 study: Complete enrollment
H2 2021 GBS Phase 2 study: Complete enrollment
H2 2022 Kidney transplantation US: Complete enrollment
H2 2022 AMR Phase 2 study: Data read out
H2 2022 GBS Phase 2 study: Data read out
H2 2023 Kidney transplantation US: 12 months follow-up completed
H1 2024 Kidney transplantation US: BLA submission
Conference call details
Hansa Biopharma will host a telephone conference today Thursday April 22 14:00 CET / 8:00am EST.
The presentation will be held in English and be hosted by Hansa Biopharma's CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentation" and will also be made available online after the call.
To participate in the telephone conference, please use the dial-in details provided below:
Sweden: +46 8 50 55 83 75
United Kingdom: +44 333 300 90 35
United States: +1 833 526 83 82
The webcast will be available on https://streams.eventcdn.net/hansa/2021q1/
The interim report and latest investor presentation can be downloaded from our web
Interim report January - March 2021
https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx
Investor road show presentation Q1, 2021
https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx
This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.
For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Katja Margell
Head of Corporate Communications
Hansa Biopharma
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
Hansa Biopharma interim report Jan-Mar 2021
First commercial sales of Idefirix® recorded in Q1; New preclinical collaboration with argenx; Encouraging three-year follow-up data in kidney transplantation
Lund, Sweden April 22, 2021 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January - March, 2021.
Highlights for the first quarter 2021
First commercial sales of Idefirix® recorded in Q1 2021 following treatment of the first patients. Commercial launch activities in early launch countries continue to be carried out as planned. National level reimbursement application processes underway and decisions by authorities in the first markets expected from mid-year and onwards.
First Healthcare Technology Assessment report published in Sweden. The Swedish "TLV" assessment is favorable to the use of Idefirix® in highly sensitized patients incompatible with a deceased donor.
Hansa Biopharma enters into preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies for potential use in both the acute and chronic setting of autoimmune diseases and transplantation.
Encouraging three-year follow-up outcome and safety data in imlifidase treated transplant patents in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data expected to be presented later in the year in a peer-reviewed journal.
Magnus Korsgren, M.D., Ph.D. appointed new Head of R&D. Dr Korsgren will lead research and development activities based on Hansa's proprietary enzyme technology platform as the Company expands into new therapeutic areas.
Patient recruitment in the phase 2 studies in AMR and GBS ongoing under a risk-based, site-by-site approach due to the COVID-19 pandemic. In the AMR trial, 9 out of a target of 30 patients have been enrolled, and in the GBS trial 8 out of 30 have been enrolled.
US trial: Hansa continues to be in productive dialogue with the FDA and expects to reach an agreement near-term with the Agency on the protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is ongoing. Hansa expects to initiate the trial over summer and to recruit the first patient in the second half of 2021.
COVID-19 pandemic: The global COVID-19 pandemic may still adversely impact Hansa Biopharma's operational business and trial activities.
Events after the end of the reporting period
Hilary Malone, PhD. in Molecular Neuropharmacology (born 1965, U.S. and UK citizen) proposed as new member of the Board of Directors at the next AGM. Dr. Malone is currently COO and EVP at Valo Health, Inc. (U.S.) and has held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others. Birgit Stattin Norinder has decided not to stand for re-election to the Board of Directors at the next AGM.
Financial summary
Solid cash position of SEK 1,255m at the end of March 2021.
Investments in SG&A and R&D in the first quarter amounting to SEK 60m (Q1'20: SEK 39m) and SEK 47m (Q1'20: SEK 53m), respectively, in line with plans.
Cash flow from operating activities for the first quarter ended at SEK -121m (Q1'20: SEK -121m).
SEKm, unless otherwise stated - unaudited
Q1 2021
Q1 2020
FY 2020
Revenue
9.0
0.9
6.1
Gross profit
7.3
0.5
5.1
SG&A expenses
-60.1
-38.7
-203.0
R&D expenses
-47.4
-52.5
-227.2
Operating profit/loss
-103.7
-91.4
-422.8
Net profit/loss
-103.9
-93.4
-420.9
Cash flow from operating activities
-120.9
-121.2
-290.3
Cash and short-term investments
1,254.7
476.9
1,377.5
Shareholders' equity
1,149.8
473.9
1,242.1
EPS before and after dilution (SEK)
-2.34
-2.33
-9.98
Number of outstanding shares
44,473,452
40,026,107
44,473,452
Weighted avg. number of shares before and after dilution
44,473,452
40,026,107
42,176,872
Number of employees
101
78
87
Søren Tulstrup, President and CEO of Hansa Biopharma, comments:
"Hansa Biopharma's evolution into a fully integrated, commercial-stage biopharmaceutical company is now a reality following the Company's first commercial sales of Idefirix® and treatments of the first patients.
Our long-term objective is to build Hansa into a recognized global leader in rare diseases across multiple broad therapeutic areas through the development of new transformative medicines for patients suffering from rare immunologic diseases. In order to do so, we need to successfully execute on our strategic priorities. This early in 2021, we have already demonstrated clear progress across our business and organization and that we are on track to deliver on our targets for the year.
In Europe, our commercial launch activities continue to be rolled out and implemented in early launch countries as planned. As part of this effort, we continue to have close interactions with national reimbursement authorities and leading transplant clinics. Decisions by authorities in the first of the early launch countries can be expected from mid-year and onwards following publication of Healthcare Technology Assessments to evaluate the health-economic impact from using Idefirix®. A first such assessment was recently published in Sweden, which was favorable to the use of Idefirix® in scenarios representing both high and low mortality assumptions for dialysis patients.
On March 29, Hansa entered into a preclinical research collaboration agreement with argenx BV to explore the potential of combining imlifidase, Hansa's IgG antibody-cleaving enzyme, and efgartigimod, argenx's FcRn antagonist. We are pleased to collaborate with argenx, a leader in the field of FcRn-inhibition, as they share our commitment to bringing innovative new medicines to patients suffering from autoimmune diseases. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation and may potentially unlock additional therapeutic value.
In the US, Hansa is in productive dialogue with the FDA and we expect to finalize near-term an agreement with the Agency on a protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is already ongoing and we are encouraged by the strong interest shown by leading US transplant centers to participate in the trial. Subject to the expected agreement with FDA on the study protocol in the coming months, we expect study initiation over the summer and the first patient to be enrolled in the second half of 2021.
In our ongoing phase 2 programs, GBS and AMR, we see patient enrollment progressing again following a temporary halt in the recruitment process during large parts of 2020 due to the COVID-19 pandemic. In December 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach. As of April 21, 2021, 9 out of a target of 30 patients have now been enrolled in the AMR study, while 8 out of 30 have been enrolled in the GBS study. Depending on the impact of the COVID-19 pandemic, enrollment is expected to be completed towards the end of 2021, as previously guided.
Furthermore, I am pleased to announce that our long-term follow-up study in highly sensitized kidney patients continues to show encouraging outcomes after imlifidase treatment and transplantation. We now have three-year data available, demonstrating follow-up outcomes in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data is expected to be published later this year following submission of a manuscript to a peer-reviewed journal.
I am also happy to see that we continue to attract the talent and competences needed to build a high-performance organization. In March, we announced the recruitment of Magnus Korsgren, M.D., Ph.D as our new Head of R&D. Dr. Korsgren's extensive international experience in translational medicine and drug development will be very helpful for our continued efforts to build a highly valuable pipeline of drug candidates within transplantation, autoimmune diseases and beyond.
Speaking about attracting highly qualified, international competences, I am also very pleased to see Hilary Malone, Ph.D in Molecular Neuropharmacology, being proposed at the next AGM as a new member of the Board of Directors at Hansa Biopharma. Ms. Malone currently holds the position of Executive Vice President and Chief Operating Officer at Valo Health, Inc. in the US and has previously held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others.
Hansa is off to a good start in 2021 and I look forward to updating you on our progress as we deliver on our mission to bring lifesaving and life altering therapies to patients with rare diseases who need them while generating value to shareholders and society at large."
Upcoming milestones and news flow
H1 2021 NiceR: initiate IND-enabling tox studies
Q2/Q3 2021 First national reimbursement agreement
H2 2021 Kidney transplantation US: First patient dosed
H2 2021 AMR Phase 2 study: Complete enrollment
H2 2021 GBS Phase 2 study: Complete enrollment
H2 2022 Kidney transplantation US: Complete enrollment
H2 2022 AMR Phase 2 study: Data read out
H2 2022 GBS Phase 2 study: Data read out
H2 2023 Kidney transplantation US: 12 months follow-up completed
H1 2024 Kidney transplantation US: BLA submission
Conference call details
Hansa Biopharma will host a telephone conference today Thursday April 22 14:00 CET / 8:00am EST.
The presentation will be held in English and be hosted by Hansa Biopharma's CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentation" and will also be made available online after the call.
To participate in the telephone conference, please use the dial-in details provided below:
Sweden: +46 8 50 55 83 75
United Kingdom: +44 333 300 90 35
United States: +1 833 526 83 82
The webcast will be available on https://streams.eventcdn.net/hansa/2021q1/
The interim report and latest investor presentation can be downloaded from our web
Interim report January - March 2021
https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx
Investor road show presentation Q1, 2021
https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx
This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.
For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Katja Margell
Head of Corporate Communications
Hansa Biopharma
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
22/4 2021 08:31 Aps invest 5
93040 Positivt at Hansa er igang med salget af Idefirix....Hansa Biopharma's evolution into a fully integrated, commercial-stage biopharmaceutical company is now a reality following the Company's first commercial sales of Idefirix® and treatments of the first patients.
22/4 2021 09:58 Aps invest 493045 Stiger 8% idag...Lad os håbe det er shorterne som har forpestet kursen i lang tid, som trækker sig og finder andre aktier de kan trykke ned.
22/4 2021 10:23 Aps invest 393048 Det er ihvertfald de mæglere som har trykket kursen ned i lang tid, som har travlt med at købe idag...måske shortcovering, og hvis det fortsætter tror jeg godt kursen snart kan komme over 200 igen. Største Købere idag:
MSE 40.251 20.623 +19.628 3.190
MLEX 26.822 9.726 +17.096 8
GSAG 12.475 2.660 +9.815
MSE 40.251 20.623 +19.628 3.190
MLEX 26.822 9.726 +17.096 8
GSAG 12.475 2.660 +9.815
22/4 2021 13:11 Kyed01 093052 Jeg er endelig kommet på brake even nu så det er herligt.
Håber/tror også på +200 snart
Håber/tror også på +200 snart
22/4 2021 14:07 Esset 093054 Den er vist ikke blanket meget.
https://www.fi.se/sv/vara-register/blankningsregistret/
https://www.fi.se/sv/vara-register/blankningsregistret/
Estimater fra analytikerne fremgår på slide 81 her
26 patienter i år
https://s24.q4cdn.com/980434894/files/doc_financials/2021/q1/20210421-Q1-2021-Road-Show-Presentation-FINAL.pdf
26 patienter i år
https://s24.q4cdn.com/980434894/files/doc_financials/2021/q1/20210421-Q1-2021-Road-Show-Presentation-FINAL.pdf
22/4 2021 15:20 Aps invest 193055 STOCKHOLM (Nyhetsbyrån Direkt) Läkemedelsbolaget Hansa Biopharma planerar för att ha det första nationella avtalet om ersättning för läkemedlet Idefirix, så kallad reimbursement, på plats från mitten av 2021.
Det sade Hansa Biopharmas vd Søren Tulstrup under sin presentation i samband med delårsrapporten för det första kvartalet 2021.
Prisnivåer har hittills förhandlats fram i sju länder, däribland Tyskland och Storbritannien samt länder i Norden och Benelux.
Det sade Hansa Biopharmas vd Søren Tulstrup under sin presentation i samband med delårsrapporten för det första kvartalet 2021.
Prisnivåer har hittills förhandlats fram i sju länder, däribland Tyskland och Storbritannien samt länder i Norden och Benelux.
