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Hansa Biopharma Interim Report January–June 2019

18 Jul 2019, 08:00
Regulatory information
Imlifidase benefits highlighted in recent ATC presentations. Expansion outside transplantation with initiation of study in Guillain-Barré Syndrome (GBS) continues.

Highlights for the second quarter 2019

- At the 2019 American Transplant Congress (ATC), Dr. Edmund Huang of Cedars-Sinai Medical Center presented data demonstrating a significant reduction in time to transplant for highly sensitized patients treated with imlifidase over matched controls waiting under Kidney Allocations System (KAS). Dr. Huang’s session won ATC’s People’s Choice Award for the most impactful presentation.

- Hansa Biopharma continued to advance imlifidase toward potential marketing authorization for enabling kidney transplantation in highly sensitized patients in the EU and the U.S. MAA is currently under review by EMA while complementary analyses are conducted in the U.S. to further illustrate the value of imlifidase over matched controls. Subsequent meeting with the FDA expected to take place in the second half of 2019.

- CTA approvals received in Europe for a Phase 2 study with imlifidase in Guillain-Barré Syndrome (GBS). The initiation of the GBS study represents a continuation of the Company’s expansion outside the transplantation area into autoimmune diseases.

- Divested the equity holding in Genovis, which generated gross proceeds of SEK 89m (USD 9.6m).

- All resolutions passed at Hansa Biopharma’s 2019 Annual General Meeting. Two new board members, Eva Nilsagård and Mats Blom, appointed.

- Spending in R&D and SG&A increased in the second quarter to SEK 46m (Q2’18 SEK 44m) and SEK 39m (Q2’18 SEK 15m) respectively as the Company continues to ramp-up in R&D and prepare for a potential launch of imlifidase in kidney transplantation.

- Cash flow from operating activities for the second quarter ended at SEK -78m (SEK -49m); the Company’s cash position ended at SEK 763m end of June 2019. Cash flow was mainly driven by investments in activities related to the potential launch of imlifidase and the divestment of the Genovis equity holding.

Financial Summary

SEKm, unless otherwise statedQ2 2019Q2 2018H1 2019H1 2018
Net Revenue0.
SG&A expenses-38.5-14.8-67.9-30.0
R&D expenses-45.6-44.0-88.1-75.5
Other operating income/expenses-0.1-0.8-1.2-1.0
Operating profit/loss-83.7-58.8-156.4-105.4
Net profit/loss-82.4-58.8-154.9-105.3
Cash flow from operating activities-78.0 -49.0-179.6-93.1
Cash and short term investments June 30, 2019762.7 534.2762.7534.2
Shareholders’ equity, June 30, 2019755.4 543.0755.4543.0
EPS before and after dilution June 30, 2019 (SEK)-2.06 -1.55-3.87-2.77
Number of outstanding shares, June 30, 201940,026,107 38,083,12540,026,10738,083,125
Weighted average number of shares before and after dilution40,026,107 37,976,44040,014,05637,962,440
Number of employees, June 30, 201960 406040

Søren Tulstrup, President and CEO, comments

“Hansa Biopharma’s evolution into a commercial stage biopharmaceutical company continues according to plan. During the second quarter, our organization grew its footprint in both Europe and the U.S., and we continued to increase our engagement with the broader healthcare community within transplantation, autoimmune diseases and beyond.

I recently returned from the 2019 American Transplant Congress (ATC) in Boston where I noted a high level of excitement around Hansa Biopharma, our technology platform and our pipeline. Imlifidase was highlighted in three presentations during the conference including a plenary presentation by Dr. Edmund Huang from Cedars-Sinai Medical Center in Los Angeles. Dr. Huang presented data demonstrating that imlifidase significantly reduces the time to transplant for patients treated with imlifidase compared to matched controls on the kidney transplantation waitlist. This session won the ATC’s People’s Choice Award as the most impactful to the transplant community, further validating the transformative potential of imlifidase and our technology.

In the U.S., we are seeing signs from the current administration that increasing the kidney transplant rate and improving equity of access to this lifesaving therapy is high on the political agenda as part of a goal to significantly increase survival rate and quality of life for dialysis patients and at the same time reduce the > $100 billion spent annually by the U.S. government to treat chronic kidney disease and end-stage renal disease. If approved, imlifidase could be a key driver in helping thousands of highly sensitized patients get off of dialysis by enabling transplantation.

The regulatory review process for imlifidase in Europe is progressing following the acceptance of our Marketing Authorization Application (MAA) in February. The timeline for the process is 210 working days plus clock stops, as we have communicated earlier. Meanwhile, in the U.S. we are conducting complementary analyses with respect to transplantability for the highly sensitized patients participating in the Phase 2 studies with imlifidase compared to matched controls from the U.S. transplant registry in order to further illustrate the value of imlifidase in the U.S. healthcare system. Once completed, we will schedule a subsequent meeting with the U.S. Food and Drug Administration, which is expected to take place in the second half of 2019.

Overall, we continue to execute on our strategic agenda, with solid progress across our pipeline, including the recent initiation of two Phase 2 studies in Guillain-Barré Syndrome (GBS) and acute Antibody Mediated Rejection in kidney transplantation. In April, we decided to divest our equity holding in Genovis. The transaction provided a profitable exit from a non-core investment and generated funds that will help accelerate the development of our pipeline of clinical stage drug candidates as well as our next generation NiceR program for repeat dosing.

We envision a world where all patients with rare immunologic diseases can lead long and healthy lives. To help achieve this vision we are building a high-performance organization to exploit our unique immunomodulating technology platform to develop innovative lifesaving and life altering therapies, bring these to the patients with rare diseases who need them, and generate value to society at large.”

Søren Tulstrup
President and CEO of Hansa Biopharma

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on July 18, 2019.

For further information, please contact:

Klaus Sindahl, Head of Investor Relations
Hansa Biopharma 
Mobile: +46 (0) 709-298 269

Rolf Gulliksen, Head of Corporate Communications
Hansa Biopharma
Mobile: +46 (0) 733-328 634

About Hansa Biopharma

Hansa Biopharma AB (NASDAQ Stockholm: HNSA) is harnessing its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product, IDEFIRIX (imlifidase), is a unique antibody-degrading enzyme in late-stage clinical development to enable kidney transplantation in highly sensitized patients, with additional clinical studies in acute autoimmune indications. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden.