Q3 Interim Report | Conference CallNovember 1, 2018

Forward-looking statements

This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Hansa Medical’s business, financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realized. Factors that could cause these differences include, but are not limited to, implementation of Hansa Medical’s strategy and its ability to further grow, risks associated with the development and/or approval of Hansa Medical’s products candidates, ongoing clinical trials and expected trial results, the ability to commercialize imlifidase, technology changes and new products in Hansa Medical’s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors.

No assurance can be given that such expectations will prove to have been correct. Hansa Medical disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Today’s presenters

Emanuel BjörneVP, Business Development and IR

Eva Maria JoedVP, Chief Financial Officer

Søren TulstrupPresident and CEO

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Corporate highlights

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Recent corporate progress

› Successful completion of two Phase 2 studies evaluating imlifidase for kidney transplantation in highly sensitized patients, with imlifidase enabling transplantation in all 35 patients· Met all primary and secondary endpoints in both studies, with graft survival of 91% at six-months post-transplantation· Treatment with imlifidase enabled highly sensitized patients to receive life-saving transplants

› Expect to submit BLA and MAA filings by Q1 2019, with their potential acceptance of submission within 60 days

› U.S. Food and Drug Administration (FDA) granted imlifidase Fast Track Designation for the investigation of imlifidase for transplantation

› Initiated long-term, observational, prospective study to provide regular follow-up data on graft survival · Study aims to encompass all patients from the four completed Phase 2 studies

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Continued corporate progress

› FDA granted Orphan Drug Designation to imlifidase for the treatment of anti-GBM antibody disease, a rare and acute kidney disease

› Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) issued a positive opinion on Orphan Drug Designation for imlifidase for the treatment of anti-GBM antibody disease

› Vincenza Nigro appointed Vice President, Global Medical Affairs · Brings more than two decades of international life

sciences industry experience in medical affairs, clinical development and commercial leadership roles

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Imlifidase: addressing a significant unmet need

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HLA-sensitization is a major barrier to kidney transplantation

› HLA-sensitization occurs in patients with anti-HLA antibodies to potential donors, resulting in lower likelihood of donor matching· HLA-sensitization can occur due to pregnancy, prior transplant or blood transfusion

› Approximately 30% of patients on transplant waitlists are moderately or highly sensitized (10-15% on waitlist are highly sensitized)1,2

› Effective methods to remove donor specific antibodies remains a significant challenge

› Approximately 100,000 patients on the U.S. kidney transplant waitlist and approximately 100,000 on the kidney transplant waitlist in Europe

Notes1) Jordan et al. British Medical Bulletin, 2015, 114:113–1252) Orandi et al. N Engl J Med 2016;374:940-50

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The importance of eliminating DSAs

Increased survival rate1

77%

44%

0%

20%

40%

60%

80%

100%

Dialysis Transplantation

8-year survival ratefor sensitized patients

Long-term dialysis results in cardiovascular complications like stroke and heart failure

Avoiding complications

› There are no approved therapies for elimination of DSAs› Desensitization approaches, including IVIg, PLEX and rituximab have very

limited effect on DSA are are not applicable in deceased donor transplantation

Notes1) Orandi et al. N Engl J Med 2016;374:940-502) www.usrds.org. 3) Shehata et al.3) Transfus Med Rev. 2010;24 Suppl 1: S7–S274) Vo et al. Transplantation. 2013 Mar 27;95(6):852-8

-

50 000,00

100 000,00

150 000,00

200 000,00

250 000,00

300 000,00

350 000,00

400 000,00

450 000,00

Transplant 5years

Dialysis 5 years

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Cost (USD) of transplantation vs dialysis4

Imlifidase: A unique, novel mechanism to rapidly degrade IgG› IgG-degrading enzyme of Streptococcus

pyogenes1

› Specifically cleaves IgG· Interacts with Fc-part of IgG with extremely high specificity· Cleaves at the hinge region, generating one F(ab’)2

fragment and one homo-dimeric Fc-fragment

› A novel approach to rapidly eliminate pathogenic IgG

› Rapid onset of action, with antibody-free window for approximately a week

Note: 1) Winstedt et al. (2015) PLoS ONE 10(7): e0132011

00.

5 h

1 h

2 h

4 h

6 h

8 h

1 d

2 d

3 d

7 d

14 d

21 d

28 d

64 d

0

2

4

6

8

10

[IgG

] (m

g/m

L)

IgG in human serum

n=10 patients

IgG Fc

F(ab’)2

imlifidase

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Positive Phase 2 study results demonstrate potential of imlifidase in kidney transplantation

Study overview – imlifidase in highly sensitized patients12

› Two single arm open label studies to assess the safety and efficacy of imlifidase with either a deceased or living donor kidney

› The studies enrolled a total of 35 highly sensitized patients who had either failed previous attempts of desensitization or were highly unlikely to receive a compatible kidney transplant

· Highdes study enrolled 18 patients at five sites in the U.S., France and Sweden;· U.S. investigator-initiated study enrolled 17 patients at the Kidney and Pancreas Transplant Center at

Cedars-Sinai Medical Center, Los Angeles

› Imlifidase achieved the primary objective of the study, enabling kidney transplantation in all 35 patients

› Patients followed for six months

Results demonstrate compelling efficacy at six month follow-up13

› Imlifidase enabled kidney transplantation for all 35 highly sensitized patients · This patient population is highly unlikely to receive a compatible kidney transplant · Patients had a median calculated Panel Reactive Antibody (cPRA) of >99.5%, with

over half having a cPRA of 100%

› The mean time on dialysis prior to imlifidase treatment and transplantation was >7 years · The majority of patients had experienced previous failed kidney transplants

› Following imlifidase treatment, patients had a rapid cross-match conversion and a clinically significant reduction in donor specific antibodies (DSAs), enabling transplant

› Graft survival at study completion, six months post-transplantation, was 91% · 32 patients were off dialysis with good kidney function with estimated glomerular filtration rate

(eGFR) within the expected range · Favorable safety profile after six-month follow-up

Supportive data from five clinical studies

Notes: 1) Winstedt et al. (2015) PLoS ONE 10(7): e0132011, 2) Lorant et al. Am J Transplant. 2018;1–11, 3) Jordan et al. N Engl J Med 2017;377:442-53

Study Subjects Status Publication

Phase 1 (Sweden) 29 healthy subjects • Completed 2014 PLOS ONE (2015)1

Phase 2 (Sweden) 8 sensitized patients • Completed 2015 American Journal of Transplantation (2018)2

Phase 2 (Sweden) 10 sensitized patients • Completed 2016 The New England Journal of Medicine (2017)3Phase 2 (U.S.) 17 highly sensitized patients • Completed 2018

Highdes Phase 2 (U.S., France, Sweden) 18 highly sensitized patients • Completed 2018

Observational follow-up study (U.S., France, Sweden)

Up to 46 previously treated and transplanted patients • Enrolling. Transplanted

patients to be followed up to five years

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Potential path to approval of imlifidase in kidney transplantation

2018 2019 2020

Potential approval in 2019

Potential launch 2020Filing BLA/MAA by Q1 2019

Completion of 3rd and 4th

Phase 2 study inSeptember 2018

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Highly targeted commercial approach at key centers of excellence

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Imlifidase in other indications

Additional imlifidase Phase 2 studies ongoing and planned18

Indication Description Number of patients Status

Anti-GBM disease

Ultra rare kidney disease Approx. 15

Ongoing. 7/15 patients treated as of September 30, 2018

AMRAntibody mediated rejection post transplantation

Approx. 30 Anticipated initiation in Q4 2018 (FPI Q1 2019)

Guillain-Barrésyndrome

IgG attack on peripheral nerves Approx. 30 Anticipated initiation in

Q4 2018 (FPI Q1 2019)

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Financials and shareholder base

Financials

* including short term investments

2020

Q3 Q3 Jan-Sep Jan-Sep Year Year

2018 2017 2018 2017 2017 2016

Net revenue 0.5 0.7 2.0 2.4 3.4 2.6

Sales, general and administration expenses -23.8 -9.6 -54.1 -30.1 -43.7 -29.7

of which cost LTIP 2016 and 2018 -4.8 -1.1 -10.3 -2.9 -4.5 -0.1

Research and development expenses -36.4 -31.2 -111.9 -101.3 -137.1 -82.9

of which cost LTIP 2016 and 2018 -4.4 -1.3 -4.4 -3.6 -5.4 -0.4

Operating profit/loss -60.5 -37.4 -165.9 -127.2 -176.1 -111.1

Cash flow from operating activities -54.0 -38.4 -147.1 -121.0 -150.1 -94.6

Cash and cash equivalent* 483.4 130.9 483.4 130.9 616.1 253.6

FTE’s end of period 49 34 49 34 33 27

of which R&D 38 27 38 27 27 23

SEK m (unless otherwise stated)

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NameNumber of

sharesShare

(%)

Nexttobe AB 6,643,761 17.4Oppenheimer 1,865,379 4.9Handelsbanken Funds 1,708,566 4.5Thomas Olausson (private and via company) 1,548,569 4.1Avanza Pension 1,276,397 3.4Gladiator 1,200,000 3.1Norron Funds 932,344 2.5AFA Insurance 920,534 2.4Polar Capital Funds PLC 888,057 2.3Fourth Swedish National Pension Fund 814,058 2.1Third Swedish National Pension Fund 762,505 2.0BWG Invest Sàrl 600,370 1.6Invesco 504,374 1.3Sven Sandberg 501,000 1.3C WorldWide Asset Management 482,291 1.3Other 17,484,920 45.9In total 38,083,125 100.0

Source: Monitor by Modular Finance AB. Compiled and processed data from various sources, including Euroclear, Morningstar and the Swedish Financial Supervisory Authority (Finansinspektionen).

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15 largest shareholders

September 30, 2018

Near term focus

› End-of Phase 2 meetings with FDA and EMA

› Imlifidase BLA/MAA filing in transplantation by Q1 2019 with potential launch in 2020

› Complete enrollment in Phase 2 study of imlifidase in anti-GBM

› Initiate enrollment in Phase 2 studies in Antibody Mediated Rejection (AMR) and Guillain-Barré syndrome (GBS)

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› Expand organization in preparation of U.S. and EU launch· Medical affairs· Market access· Patient advocacy

› Launch of imlifidase in first indication (kidney transplantation) in 2020 in the U.S. and EU

› Finalization of clinical studies in anti-GBM, AMR and GBS and potentially seek marketing authorization

› Clinical studies with the next generation of IgG eliminating enzymes for repeat dosing

› Clinical studies with IgG eliminating enzymes in oncology with market approved antibody based immuno-oncology drug

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Long term priorities

Q&A

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