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Year-end report 2013

Regulatory information
The year in brief

· Successfully completed Phase I study with IdeS. The results from the study demonstrate that IdeS is efficacious and well tolerated with a favorable safety profile.
· Hansa Medical receives SEK 3.4 million grant from VINNOVA to carry out Phase II study with IdeS
· Hansa Medical and Axis-Shield report most promising results from pivotal clinical trial with HBP-analysis
· Net sales for the Group amounted to SEK 1.8 (2.6) M
· The Group’s results amounted to SEK  -17.6 (-16.5) M
· Operating income for the Group amounted to SEK -17.6 (-16.8) M
· Earnings per share amounted to SEK -0.79 (-0.78)

CEO’s comments
Kidney transplantation surgeons in São Paulo, Los Angeles, Malmö, Istanbul and Paris struggle daily with the challenge to make kidney transplantation possible for the thousands of kidney disease patients having so-called donator-specific antibodies. Today, transplantation surgeons have slow and inefficient methods at hand to assist in this process. Quickness and efficacy are critical aspects for a transplantation surgeon since kidneys from deceased donors quickly deteriorates.

IdeS is an enzyme with one single function, to inactivate IgG antibodies. And the enzyme acts fast. Very fast. Donor-specific antibodies are of IgG-type and our vision for patients with donor specific antibodies is one single intravenous injection of IdeS in direct connection with kidney transplantation. IdeS has the potential to remove the antibody barrier within a couple of minutes after dosing for these patients, and hence enable transplantation for these patients.

Currently, it is not unusual that these patients have to wait 10-20 years for a transplant, if ever being transplanted. The patients’ alternative treatment is dialysis. Dialysis is a treatment method that can be safely applied during short periods, but living with dialysis for many years is associated with significantly increased risk of death from stroke and/or heart disease. Approximately one third of all dialysis patients die while waiting for a kidney transplantation.

From March 2013 to January 2014, we have carried out a Phase I study with IdeS including 29 healthy subjects. The Phase I study shows that IdeS is safe, fast and effective. Within minutes from dosing, no intact IgG is detectable in blood samples from healthy subjects.

A Phase II study application is currently being prepared including kidney transplantation patients at Uppsala University Hospital. The goal is to show that this fast and effective IgG inactivation and clearance makes transplantation possible for patients with donator-specific antibodies. The start of the study is planned for spring 2014, with likely completion during spring 2015. For this part of the development program, we have received significant support, a SEK 3.4 million grant from VINNOVA’s programme, Forska&Väx, with the motivation that, “IdeS at kidney transplantation, is a project incorporating high-level competence with strong clinical support within a field of significant medical need”. VINNOVA’s grant comprises a significant portion of the cost for the clinical activities in the Phase II study. We will also need to secure further investment capital in order to carry out the Phase II study with IdeS.

In November 2013, the first results from the so-called IMPRESSED study with HBP-analysis for prediction of severe sepsis at emergency clinics, were published. IMPRESSED is an abbreviation for Improved PREdiction of Severe Sepsis in the Emergency Department, and the study was undertaken between 2011-2013 in Sweden and the US, with 793 patients under Axis-Shield Diagnostic’s management. HBP-analysis is a diagnostic method providing emergency care doctors with an early alert signal that an infected patient is in immediate danger of developing the life-threatening condition severe blood poisoning, also known as severe sepsis. Using HBP-analys for identification of risk patients, the emergency doctor can initiate treatment much earlier and, thereby, increase the chance of saving thousands of lives and, at the same time, decrease healthcare costs. The results of the study show that increased plasma levels of HBP predicted the development of severe sepsis in 80 percent of the patients who developed severe sepsis within 72 hours. In the study, the market-leading biomarker for serious infection, procalcitonin, identified 59 percent of the patients.

Emanuel Björne, CEO, Hansa Medical AB (publ)


Significant events during the year

Succesfully completed Phase I study with IdeS
The Phase I study with IdeS was performed March 2013 to January 2014 and included 29 healthy subjects. The study was a double blind, randomized study in healthy subjects administered intravenous single doses of IdeS or placebo. Study objectives were to study safety, tolerability, pharmacokinetics and IgG-cleaving effect of the drug candidate IdeS.

The results from the study demonstrate that IdeS is efficacious and well tolerated with a favorable safety profile. IdeS cleaves IgG antibodies efficiently and no intact IgG is detectable in the circulation of healthy subjects within minutes after dosing. The results from the Phase I study are very encouraging. Hansa Medical will file a kidney transplantation Phase II study application at the Swedish Medical Products Agency during the first quarter of 2014.

Hansa Medical receives SEK 3.4 million grant from VINNOVA to carry out Phase II study with IdeS
The grant has been provided within VINNOVA’s (Swedish Governmental Agency for Innovation Systems) Forska&Väx-programme (Research & Growth Programme). VINNOVA states: ”IdeS at kidney transplantation, is a project incorporating high-level competence with strong clinical support within a field of significant medical need”.

The SEK 3.4 million will cover the costs of significant parts of seeing IdeS through a Phase II-study. An Phase II application with the Swedish Medical Products Agency is being prepared and will be filed at the
Medical Products Agency during the first quarter 2014.

VINNOVA received 333 applications mounting to a net worth of SEK 410 million. The Forska&Väx-programme targets companies from all industries demonstrating significant potential as to growth and development. Applicants need to showcase a viable international demand for their submitted project, demonstrate its ability to generate growth of the company and its potential to prompt new or better products, services and processes.

Hansa Medical and Axis-Shield report most promising results from pivotal clinical trial with HBP-analysis
The clinical study was carried out at Emergency Departments both in Sweden and the US through 2011-2013. Results show that HBP-analysis predicts patients with forthcoming severe blood poisoning (severe sepsis) with significantly higher accuracy than any of the other methods tested. Data was presented at the 6th Annual Symposium of the International Sepsis Forum in Rio de Janeiro, Brazil, on November 5, 2013.

The pivotal clinical study involved 763 ED-patients. 143 of those were admitted to the ED without signs of severe sepsis. They did however develop organ and/or circulatory failure within 72 hours. The study focused on whether blood sample quantification of HBP in ED-patients had the potential to predict patients’ susceptibility to develop severe sepsis. The study shows that HBP-analysis predicts severe sepsis with significantly higher accuracy than any of the other methods tested in the study.

The HBP-analysis has been compared to those methods most commonly used on the market today: blood sample quantification of Procalcitonin, Lactate, White Blood Cells and C-Reactive Protein (CRP). Quantification of Procalcitonin is the most commonly used method for general risk assessment of infectious disease patients. The study showed elevated levels of Procalcitonin in 59% of those 143 ED-patients that later developed severe sepsis. The corresponding value for HBP was 80%.

Complete Year-end release 2013 (in Swedish) attached