Annual report 2017

Vision and Strategy

Our vision is to help improve the care of patients with severe immunological conditions by taking novel and innovative pharmaceuticals to market.

IdeS can potentially be used in several different transplant-related indications and acute autoimmune conditions in which IgG antibodies are proven, or suspected, to play a significant role for disease progression. In addition, IdeS has the potential to effectively inactivate anti-drug antibodies developed against biological drugs and gene therapies. Hansa Medical’s long-term vision is to make IdeS and Novel immunoglobulin cleaving enzymes for Repeat dosing (NiceR) available for as many of these IgG-mediated conditions as possible.

Our strategy

We are focused on the research, development and commercialization of novel immunomodulatory enzymes that eliminate harmful IgG antibodies from the body and have the potential to transform the lives of people in significant need of an organ transplant or patients with autoimmune conditions.

Our initial clinical focus is on IdeS, a single dose treatment of acute IgG-mediated conditions. In parallel, we are also developing novel IgG-inactivating drug candidates for repeat dosing under the project name NiceR, which may translate to wider usage as an IgG-removing agent.

Our short term strategic priorities are:

To quickly attain market approval for lead candidate IdeS as pre-treatment of sensitized patients prior to kidney transplantation, and start building a commercial infrastructure

To expand knowledge and awareness of the potential of lead candidate IdeS in additional transplant and autoimmune indications

To follow up with clinical studies in additional indications with significant unmet medical need where IdeS has apparent potential to effectively treat, or prevent, IgG-mediated pathophysiology

Hansa Medical’s lead drug candidate IdeS

IdeS – a novel therapeutic principle
Immunoglobulin G-degrading enzyme of Streptococcus pyogenes (IdeS, INN: imlifidase) is an enzyme that specifically cleaves immunoglobulin G (IgG). Our strategy takes advantage of the ability of IdeS to specifically and efficiently inactivate IgG, to prevent and treat patients who have developed pathogenic IgG. IdeS-mediated IgG elimination constitutes a novel therapeutic principle for the treatment of IgG-mediated human diseases. Our clinical studies are initially focused on desensitization of HLA-immunized patients prior to kidney transplantation, also referred to as sensitized patients. Our long-term vision is that IdeS will become the treatment of choice in several acute IgG-mediated conditions within autoimmunity and transplantation.

Introduction to Hansa Medical development programs

IdeS is an enzyme, currently in late stage clinical development, that specifically cleaves immunoglobulin G (IgG). Our strategy takes advantage of the ability of IdeS to specifically and efficiently inactivate IgG to prevent and treat patients who have developed pathogenic IgG. IdeS-mediated IgG elimination constitutes a novel therapeutic principle for the treatment of IgG-mediated acute human diseases.

NiceR (Novel immunoglobulin cleaving enzymes for Repeat dosing) is a preclinical research and development program under which IgG-cleaving enzymes with novel properties are developed. The aim of the development is to create novel IgG-inactivating drugs that can be used for repeated dosing in autoimmune conditions, oncology and transplantation where patients benefit from more than one dose of an IgG-modulating enzyme. The development program is currently in the lead optimization phase with the intention to select a lead candidate suitable for clinical development.

EnzE (Enzyme-based antibody Enhancement) is a preclinical research and development program under which the combination use of approved antibody based cancer treatments with IgG-modulating enzymes is examined. Recent findings demonstrate that pre-treatment with IgG-degrading or modulating enzymes has the potential to potentiate presently available antibody-based cancer therapies.

HBP-assay (serum quantification of Heparin-Binding Protein) is a novel diagnostic method developed by Hansa Medical to help predict severe sepsis in patients with infectious disease symptoms. Early prediction and treatment of risk patients is key to prevent death from severe sepsis. A first version of HBP-assay has been launched on the European market and has been evaluated in two finalized clinical studies in approximately 1,000 patients demonstrating superior performance in predicting severe sepsis. HBP-assay has been out-licensed to Axis-Shield Diagnostics who is now running additional clinical trials in Europe, the US and China, and the agreement includes rights to royalties from Axis-Shield to Hansa Medical.

Pipeline

Shareholder information

Share capital

Total shares outstanding as of 31 December 2017 amounted to 38,208,386 (37,807,386 A-shares and 401,000 C-shares). At year end the share capital amounted to SEK 38,208,386. At the general meeting, each share entitles the holder to one vote and each shareholder may vote the full number of shares held by him or her. All outstanding shares are fully paid up.

The company’s share capital is denominated in Swedish kronor (SEK) and divided amongst the company’s outstanding shares with a quotient value of SEK 1 per share.

HMED share price and trading volume January 1, 2013 to March 15, 2018

15 largest shareholders, December 31, 2017

Number of shares
Owners HMED HMED C Capital (%)%
Nexttobe AB 9,443,761 0 24.7
AFA Försäkring 1,825,959 0 4.8
Thomas Olausson (private and via company) 1,548,569 0 4.1
Avanza Pension 1,346,278 0 3.5
Handelsbanken Fonder 1,305,157 0 3.4
Gladiator 1,168,530 0 3.1
Oppenheimer 1,103,232 0 2.9
Polar Capital 609,589 0 1.6
BWG Invest Sàrl 600,370 0 1.6
Tredje AP-fonden 572,594 0 1.5
Sven Sandberg 539,700 0 1.4
Catella Fonder 488,280 0 1.3
C WorldWide Asset Management 440,541 0 1.2
Invesco 412,085 0 1.1
Hansa Medical AB 0 401,000 1.0
Others 16,402,741 0 42.8
Total 37,807,386 401,000 100.0

Turnover of the HMED share at Nasdaq Stockholm 2013 to 2017

MSEK

Financial summary for the group

1 January – 31 December 2017

KSEK, unless other stated 2017 2016
Profit/loss
Net revenue 3,442 2,579
Operating profit/loss -176,083 -111,135
Net profit/loss -176,660 -111,129
Per share data
Earnings/loss per share before and after dilution (SEK) -4.97 -3.37
Shareholders' equity per share (SEK) 16.68 8.09
Other information
Shareholders' equity 630,661 283,693
Equity ratio (%) 93 91
Cash flow from operating activities -150,105 -94,563
Cash and cash equivalents including short term investments 616,061 253,578
Number of employees end of the year 33 27

 

About Hansa Medical

Hansa Medical is a biopharmaceutical company focused on immunomodulatory enzymes for treatment and prevention of rare and severe autoimmune conditions and transplant rejection.

Hansa Medical AB
P.O. Box 785
SE-220 07 Lund, Sweden

info@hansamedical.com