Highlights for the fourth quarter 2019 
-    The ongoing review of an MAA for imlifidase in Europe by EMA is on track. Responses to the Day 120 questions were submitted on December 20, 2019. An opinion from the CHMP is expected in the second quarter of 2020. 

-    Reached agreement with the FDA on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the U.S. Hansa will conduct a randomized, controlled clinical study in a well-defined population with the highest unmet medical need in context of the Kidney Allocation System.

-    Our pipeline advanced with completion of enrollment in the investigator initiated Anti-GBM study and two patients treated in each of the new Phase 2 programs in Guillain Barré Syndrome (GBS) and Antibody Mediated Rejection (AMR). 

-    The Company continued to build a medical and commercial organization to support a potential commercial launch of imlifidase in 2020. Accordingly, investments in R&D and SG&A increased in the fourth quarter to SEK 58m (Q4'18: SEK 43m) and SEK 53m (SEK 36m), respectively. 

-    Cash position was SEK 601m at the end of December 2019, positively impacted by the divestment of the equity holding in Genovis in April 2019 generating gross proceeds of SEK 89m.

-    Cash flow from operating activities for the fourth quarter ended at SEK -75m (SEK -57m) and at SEK - 335m (SEK -205m) for the financial year 2019.

Events after the end of the reporting period
-    CSO, Christian Kjellman, will assume an expanded responsibility as CSO and COO effective immediately as we prepare to implement a focused launch strategy through leading transplantation clinics and experts upon a conditional approval of imlifidase in the EU. 

Financial Summary

SEKm, unless otherwise stated Q4 2019 Q4 2018 FY 2019 FY 2018
- unaudited
Net Revenue 1.2 1.4 3.4 3.4
SG&A expenses -53.4 -36.3 -167.3 -90.4
R&D expenses -57.7 -42.6 -192.9 -154.6
Other operating -0.1 -2.3 -1.9 -4.0
income/expenses
Operating profit/loss -110.1 -80.6 -359.7 -246.5
Net profit/loss -110.9 -81.2 -360.0 -248.0
Cash flow from operating -75.0 -57.5 -334.8 -204.6
activities
Cash and short-term 601.1 858.2 601.1 858.2
investments Dec 31, 2019
Shareholders' equity, Dec 31, 562.8 859.9 562.8 859.9
2019
EPS before and after dilution -2.77 -2.07 -9.00 -6.47
(SEK)
Number of outstanding shares 40,026,107 39,959,890 40,026,107 38,959,890
Weighted average number of 40,026,107 39,153,175 40,020,429 38,326,098
shares before and after
dilution
Number of employees 74 52 74 52

Søren Tulstrup, President and CEO, comments
"2019 was an important and overall successful year for Hansa Biopharma - a year with significant progress across our pipeline and platform development activities and a year where we achieved the landmark milestone of getting our first Marketing Authorization Application accepted for review by a regulatory agency, namely the MAA for imlifidase in kidney transplantation in Europe, which was accepted for review by EMA on Feb 28, 2019. If approved, we would be able to launch the first in a series of drug candidates in our internal pipeline addressing conditions with high unmet medical need and through this transform Hansa into a commercial-stage biopharmaceutical company. The review is progressing according to plan, and we submitted the Day 120 responses to EMA in December.

In the US, following a meeting with the FDA on November 20, 2019 we now have a clear path forward towards a BLA submission for imlifidase in kidney transplantation that could support accelerated approval. Given the requirement by the FDA to conduct a randomized, controlled trial prior to submitting a BLA, I am pleased that we were able to agree with the FDA on a trial design that is limited in scope, includes patients with a high degree of unmet medical need, and is strongly powered to show a significant benefit for the imlifidase arm compared to the control arm.

Among our pipeline activities we have also seen significant progress in other areas during 2019. The completion of enrollment of patients in the investigator initiated anti-GBM antibody disease study marks an important milestone for Hansa Biopharma's expansion outside transplantation. We look forward to the next milestone in the third quarter this year when the first data read-out from the anti-GBM study is expected to be presented.   

In addition to the anti-GBM study, we have also initiated two new programs in Phase 2 during 2019, one in Antibody Mediated Rejection episodes (AMR) and one in the acute autoimmune disease Guillain Barré Syndrome (GBS). Both studies are now actively recruiting patients and we expect to complete enrollment in AMR towards the end of 2020 and in GBS during the first half of 2021.

Hansa Biopharma is continuously making progress in transitioning the organization into a fully integrated global biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generates value to society at large.

An exciting year lies ahead of us and I look forward to updating you on our journey and progress during 2020." 

Søren Tulstrup
President and CEO of Hansa Biopharma

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on February 6, 2020.