Hansa Medical AB

Interim Report April-June 2018 | Business UpdateJuly 19, 2018

Forward-looking statementsThis 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 HansaMedical’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 IdeS, technology changes and new products in HansaMedical’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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Presenters

Emanuel BjörneVP, B usiness Developm ent and IR

Eva Maria JoedVP, C hief F inancia l O fficer

Søren TulstrupPresident and C EO

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Corporate

› Strongly positioned to bring a lifesaving treatment to market and build a global biopharma franchise

› On track to expand organizational infrastructure to prepare for own launch of imlifidase (IdeS)

› Growing R&D team to complete ongoing studies and initiate further Phase II studies in new indications such as AMR and GBS

› Strenhtened board of directors expertise in biopharma commercialization and R&D through the appointments of Anders Gersel Pedersen and Andreas Eggert:

· Anders Gersel Pedersen, MD, Ph.D, currently serves as Executive Vice President, Research & Development at H. Lundbeck A/S and is a member of the boards of Genmab A/S and Bavarian Nordic A/S.

· Andreas Eggert, MBA has extensive experience in biopharma commercialization, in roles such as Senior Group Vice President, Global Product Strategy & Portfolio Development at H. Lundbeck A/S and Vice President & Global Business Manager at Wyeth/Pfizer in the US.

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Corporate

Imlifidase (IdeS) development

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Imlifidase development in transplantation is going according to plan

Study Subjects Status

Phase I (SWE) 29 healthy subjects • Completed 2014

Phase II (SWE) 8 sensitized patients • Completed 2015

Phase II (SWE) 10 sensitized patients • Completed 2016

Phase II (US) 17 highly sensitized patients • Fully enrolled. Finalization by end of Q3 2018

Highdes - Multicenter Phase II 18 highly sensitized patients • Fully enrolled. Finalization by end of

Q3 2018

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› US investigator initiated Phase II study at Cedars-Sinai Medical Center, Los Angeles

› Imlifidase enabled kidney transplantation for all enrolled patients (N=17) by turning positive cross-match test negative

› Enrollment finalized in January 2018

› Long term follow up data presented at the 2018 American Transplant Congress, in Seattle, June 6 by principal investigator Professor Stanley Jordan. The results demonstrate that:

· Patients show good renal function and minimal evidence of antibody mediated rejection at 19 months (mean) post kidney transplantation with graft and patient survival at 94 percent

· Imlifidase-treatment is not associated with increased risk infection

· No serious adverse events related to imlifidase were reported

· The treated patients exhibited extensive sensitization at cPRA 95 percent (median)

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US investigator initiated Phase II study in highly sensitized patients

› 18 highly sensitized patients have been treated with imlifidase and subsequently transplanted at:

· NYU Langone Medical Center, New York City, USA

· Johns Hopkins Medicine, Baltimore, USA

· Cedars-Sinai Medical Center, Los Angeles, USA

· Uppsala University Hospital, Uppsala, Sweden

· Hôpital Necker, Paris, France

› The primary objective of the study, to demonstrate that treatment with imlifidase enables kidney transplantation in highly sensitized patients, has been met for all 18 patients

› Enrollment completed in January 2018

› All patients to be followed for six months, primarily to collect data on safety, kidney function and frequency of rejection episodes

› Six month follow-up data expected for late Q3 2018

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Imlifidase in highly sensitized patients – The Highdes-study

› Finalization of the two Phase II studies in highly sensitized patients

· Highdes and the US investigator initiated Phase II study

· Six month follow up data at the end of Q3 2018

· In total 35 patients

· Data on safety, graft function and management of rejection episodes

› Meetings with FDA and EMA during H2 to discuss approval pathway for imlifidase

› Potential imlifidase BLA/MAA filing in transplantation in late 2018 or early 2019

Short term priorities

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Potential path to approval of IdeS in kidney transplantation

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2018 2019 2020

Recruitment of 35 patients finalized

6 month follow-up late Q3

Filing BLA/MAA Filing BLA/MAA

Potential approvalduring 2019

› Investigator initiated Phase II study with imlifidase in anti-GBM

› The primary objective of this study is to evaluate the safety and tolerability of imlifidase as well as efficacy assessed by evaluating renal function at six months after imlifidase treatment

› The aim is to enroll approximately 15 patients at up to 15 clinics in Europe by end of 2018

› As of end of June, 2018 seven patients had been included in the study

› Limited follow-up data is currently available from five of the seven patients who have all responded favorably. Imlifidase appears to be well tolerated in these patients.

› Press release July 9: US Orphan Drug Designation application approved by FDA:

· Development incentives

· Up to seven years of US marketing exclusivity from time of approval of BLA.

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Imlifidase in anti-GBM antibody disease

Additional Phase II studies planned

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Indication Description Nbr of patients Status

AMR Antibody mediated rejection post kidney transplantation Approx. 15-25 Anticipated start

H2 2018

Guillain-Barrésyndrome IgG attack on peripheral nerves Approx. 30 Anticipated start

H2 2018

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Financials and shareholder base

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Financials

* including short term investments

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› Build-up of the organization to prepare for commercial launch.

› Preparations for filing.

› Increased R&D team to support additional clinical studies and pre-clinical projects.

Q2 Q2 Q1 H1 H1 Year Year

2018 2017 2018 2018 2017 2017 2016

Net revenue 0.9 0.7 0.6 1.5 1.8 3.4 2.6

Sales, general and administration expenses -14.8 -10.7 -15.5 -30.3 -20.5 -43.7 -29.7

of which cost LTIP 2016 and 2018 -0.6 -1.5 -4.9 -5.5 -1.8 -4.5 -0.1

Research and development expenses -44.0 -33.8 -31.5 -75.5 -70.1 -137.1 -82.9

of which cost LTIP 2016 and 2018 0.4 -1.3 -0.4 - -2.3 -5.4 -0.4

Operating profit/loss -58.8 -44.9 -46.6 -105.4 -89.7 -176.1 -111.1

Cash flow from operating activities -49.0 -38.8 -44.1 -93.1 -82.5 -150.1 -94.6

Cash and cash equivalent* 534.2 170.0 575.0 534.2 170.0 616.1 253.6

FTE’s end of period 40 34 35 40 34 33 27

of which R&D 31 27 28 31 27 27 23

SEK m (unless otherwise stated)

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Nam e Num ber of shares Share (% )

Nexttobe AB 6,643,761 17.3Handelsbanken Funds 1,578,566 4.1Thomas Olausson (private and via company) 1,548,569 4.1Oppenheimer 1,416,700 3.7Avanza Pension 1,274,812 3.3Gladiator 1,025,000 2.7Norron Funds 1,010,743 2.6Polar Capital 826,135 2.2Fourth Swedish National Pension Fund 770,000 2.0Third Swedish National Pension Fund 765,073 2.0BWG Invest Sàrl 600,370 1.6Catella Funds 590,526 1.5AFA Insurance 546,404 1.4Sven Sandberg 507,000 1.3C WorldWide Asset Management 482,291 1.3Other 18,850,649 49.9In total 38,083,125 100.0

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

15 largest shareholders

June 30, 2018

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Category Nbr of shares Capital (%) Nbr of shareholders

Nexttobe AB 6,643,761 17.3 1Swedish private individuals 9,981,652 26.0 11,145Swedish institutions 8,115,049 21.1 45Foreign institutions 4,868,392 12.7 37Other Swedish 3,642,573 9.5 329Other foreign 1,046,468 2.7 850Anonymous foreign ownership 4,115,491 13.4In total 38,413,386 100.0 12,407

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

Shareholder categories June 30, 2018

Long term opportunities and priorities

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ADA toBiologics

ADA toGene Therapy

Anti-Drug Antibodies

MGrelapse

MSrelapse

AcuteITP Myasthenic

crisis

Dilatedcardiom.

Pemph.relapse

CIDP

Graves disease

NMOrelapse

NMDARE

LEMS

CAPS

ANCA (GPA)

SLEflares

Lupusnephritis

Anti-GBM

GBS

IgG-related autoimmune diseases

EnzE

BoneMarrow Oncology

ABOi

KidneyHLA

LiverHLA

LungHLA

HeartHLA

Transplantation

Pre-transplant treatm ent

KidneyAMR

LungAMR

HeartAMR

LiverAMR

Acute AM R

Planned studies Ongoing studies Number of patients

Imlifidase - Long term opportunities19

› Expand organization in preparation of US and EU launch

· Medical affairs

· Market access

· Patient advocacy

› Launch of imlifidase in first indication (kidney transplantation) in 2020 in the US 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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