January – March 2015 in brief

• Net sales in the group amounted to KSEK 3,847, compared to KSEK 1,612 for the same period 2014
• Consolidated net result was KSEK -10,725 (-5,998)
• Operating result was KSEK -10,689 (5,896)
• Earnings per share before and after dilution was SEK -0.41 (-0.26)
• Phase II clinical study of IdeS successfully completed in highly sensitized dialysis patients awaiting kidney transplantation
• Göran Arvidson appointed CFO and thereafter acting CEO
• Cooperation initiated with leading US transplantation expert Dr Stanley Jordan at Cedars-Sinai Medical Center, Los Angeles
• Development of a new generation of IdeS molecules for repeat dosing initiated
• Preliminary application for listing on Nasdaq Stockholm submitted

Significant events after the reporting period

• Fully guaranteed MSEK 246 rights issue successfully concluded

CEO Comments
The first three months gave us a good start to the year, and we took important steps – both financially and in clinical develop­ment – to build a foundation for a strong Hansa Medical. The goal for Hansa Medical is to become a pharmaceutical company with important, life-saving products on the market. We are not there yet, and as everybody who follows the life science sector knows, you need patience to take clinical projects to the market as well as committed investors who believe in the company along the way.

Our shareholders showed us this trust when they backed our MSEK 246 rights issue that was announced in February, fully guar­anteed by subscription undertakings and underwriting. The pro­ceeds will be used to further strengthen our programme around the lead product IdeS, as well as evaluating opportunities for our other enzyme EndoS. This is an important undertaking that confirms that the shareholders also share our belief in our exciting R&D strategy.

In conjunction with the rights issue, we also announced that the estate of Bo Håkansson, Farstorps Gård AB, sold shares repre­senting about 15 percent of the total number of shares and votes outstanding in the company. The shares were acquired by a se­lected number of Swedish and international institutional investors, including Rhenman & Partners and Hjärt-Lungfonden.

Our primary focus is on the lead product and value driver IdeS, a bacterial enzyme that cleaves human IgG antibodies and is con­sidered to have great potential in kidney transplantation and rare autoimmune diseases. IdeS is currently in Phase II clinical devel­opment. In January, we announced preliminary data showing that IdeS has good efficacy in highly sensitized dialysis patients awaiting kidney transplantation. The study shows that IdeS has the capacity to make these patients eligible for transplantation by decreasing HLA antibodies to acceptable levels. Results from this study will be published in a well reputable journal.

Plans are in place to start the next Phase II study of IdeS in renal transplantation at Uppsala University Hospital, and Karolinska Uni­versity Hospital in Stockholm. We also believe that IdeS has other potential medical indications, including relatively rare and serious – even life-threatening – acute immune diseases, such as anti-GBM and Guillain-Barré syndrome.

At the same time, we are developing a new generation of molecules based on IdeS allowing repeat dosing and thereby broadening the therapeutic opportunities for chronic diseases. A number of prom­ising candidates will be optimized in 2015 in order to select a lead candidate and start preclinical development in 2016.

Our development partner Axis-Shield Diagnostics continues to further validate and market HBP-assay for prediction and diagnosis of severe sepsis world wide. In February, Axis-Shield entered a sub-license agreement for the Chinese market.

Taken all together, I believe that the first quarter clearly showed that we are in a good position – and have the means – to continue the journey to reach our goals.

Göran Arvidson
CFO and acting CEO