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Full Year Report January – December 2017

Regulatory

Successful IPO and continued positive result for BioArctic 

October – December 2017

  • Net sales for the period amounted to SEK 51.0 million (94.4) 
  • Operating profit amounted to SEK 14.7 million (97.3) 
  • Profit for the period amounted to SEK 11.8 million (75.0) 
  • Earnings per share were SEK 0.16 (1.19) 
  • Cash flow from operating activities amounted to SEK -45.7 million (705.6) 

January – December 2017

  • Net sales for the period amounted to SEK 140.7 million (105.6) 
  • Operating profit amounted to SEK 19.3 million (74.6) 
  • Profit for the period amounted to SEK 15.2 million (57.6) 
  • Earnings per share were SEK 0.22 (0.91) 
  • Cash flow from operating activities amounted to SEK -135.3 million (675.1) 

Key events during the period October – December 2017

  • BioArctic listed on Nasdaq Stockholm Mid Cap and trade in the company’s B-shares began on October 12
  • BioArctic announced that the Phase 2b study on BAN2401 in patients in the early stages of Alzheimer’s disease is continuing on to final analysis after 18 months of treatment. The effect criteria at the 12-month interim analysis of ADCOMS (primary endpoint) were not met. The study will contimue blinded until the study is completed, in accordance with the study protocol
  • Patent granted in Europe for BioArctic’s drug candidate BAN0805 for Parkinson’s disease
  • The Board of Directors proposes that no dividend is paid for the financial year 2017

Key events after the period

  • BioArctic received US patent protection for a method with a medical device, which is one of the components in the product candidate SC0806, for treatment of patients with Complete Spinal Cord Injury

Financial summary

SEKm Oct-Dec
2017
Oct-Dec
2016
Jan-Dec
2017
Jan-Dec
2016
Net sales 51.0 94.4 140.7 105.6
Other operating income 10.4 32.6 19.0 39.1
Operating profit 14.7 97.3 19.3 74.6
Profit for the period 11.8 75.0 15.2 57.6
Earnings per share, SEK[1], [2] 0.16 1.19 0.22 0.91
Equity per share, SEK[1], [2] 7.22 0.96 7.22 0.96
Cash flow from operating activities -45.7 705.6 -135.3 675.1
Cash flow from operating activities per share, SEK[1], [2] -0.60 11.19 -1.99 10.71
Equity/assets ratio, % 55.8% 8.6% 55.8% 8.6%
Return on equity, % 3.4% 98.9% 4.3% 68.1%
Number of shares 88,059,985 4,203,999 88,059,985 4,203,999

[1] There are no potential shares, thus there is no dilutive effect.
[2] The comparative figures have been recalculated as a result of the 15:1 split executed on August 1, 2017

CEO’s comments

A strategic year paving the way ahead

BioArctic’s most important task is to improve the quality of life of patients with diseases affecting the central nervous system. As we prepared the company during last year for the IPO, we further developed the company’s strategy. This was done in order to be able take full advantage of the opportunities and manage the challenges that lie ahead. BioArctic is today well equipped to drive our projects forward towards further successful collaboration and continued growth.

The listing of the company on Nasdaq Stockholm Mid Cap on October 12 received a lot of positive attention in the media. Since then intensive work has continued with the aim of increasing knowledge of and interest in BioArctic externally. Together with colleagues I have met a number of investors and participated in Life Science events in Sweden, other European countries and the US. We are delighted and find it inspiring that great interest continues to be shown in BioArctic after the IPO process.

Of BioArctic’s five projects for the treatment of patients in the early stages of Alzheimer’s disease, it is BAN2401, in collaboration with Eisai, that is the most advanced. On December 21, BioArctic announced that the Phase 2b-study on BAN2401 (Study 201) in 856 patients in the early stages of Alzheimer’s disease is progressing towards final analysis after 18 months of treatment. The antibody BAN2401, which selectively binds amyloid-beta protofibrils, did not meet the efficacy criteria in ADCOMS (primary endpoint) at the 12-month interim analysis based on an innovative Bayesian design with high requirements for meeting the effect criteria. In accordance with a predetermined study protocol, the study will continue blinded until completion. 18 months is considered to be a more relevant treatment period for demonstrating a clinical effect in a disease-modifying drug for Alzheimer’s disease. We look forward to the full results once the study has been completed after 18 months of treatment. These results are expected to be available in the second half of 2018.

The research collaboration with AbbVie regarding Parkinson’s disease is very intense and has led to that BioArctic has hired more employees, increased resources and has the ability to run the BAN0805 project considerably faster towards future clinical studies. BioArctic has had a robust patent strategy since the company was formed in 2003. A patent was granted in Europe during the period for the company’s drug candidate BAN0805 for Parkinson’s disease.

The company’s treatment for Complete Spinal Cord Injury, SC0806, is undergoing clinical trials in Phases 1/2 at specialist clinics in Sweden and work is ongoing to include clinics in Finland, Estonia and Norway. There is no effective treatment for these patients today. We look forward to continuing the important activities in this treatment area.

When I look back at the past year, I am proud of the fact that so much has happened in such a short timeframe. In 2017 we took the important strategic step of carrying out a successful IPO – the largest within the biotech sector in Sweden since 2000. We continued to run the company’s projects in three treatment areas, all with great unmet medical needs, well in line with our objectives. Finally, I would like to thank all investors for their confidence in the company, collaboration partners and all the employees at BioArctic who have contributed to a successful 2017.

Gunilla Osswald
President and CEO, BioArctic AB

Contacts

For further information, please contact:
Gunilla Osswald, CEO, gunilla.osswald@bioarctic.se, telephone + 46 (0)8 695 69 30
Jan Mattsson, CFO, jan.mattsson@bioarctic.se, telephone + 46 (0)703 52 27 72

Presentation

BioArctic invites to an audiocast with teleconference (in English) for investors, analysts and media today, February 20, at 09:30 – 10:30 a.m. CET.

CEO Gunilla Osswald and CFO Jan Mattsson present BioArctic, comment on the Full Year Report and answer questions.

Webcast: https://tv.streamfabriken.com/bioarctic-q4-2017

Dial-in telephone number from:

  • Sweden: + 46 8 566 426 62
  • Belgium: + 32 240 406 35
  • Germany: + 49 692 222 290 46
  • The Netherlands: + 31 207 168 416
  • Norway: + 47 235 002 53
  • Switzerland: + 41 225 675 548
  • UK: + 44 203 008 9811
  • US: + 1 855 831 5946

About BioArctic

BioArctic AB (publ) is a research based biopharmaceutical company focusing on disease modifying treatments and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. The company also develops a treatment for complete spinal cord injury. The company focuses on new types of treatments in areas with great unmet medical needs.

The company has high scientific competence and experience in developing drugs from idea to market through employees and key consultants. Collaborations with universities are of great importance to the company together with the strategically important global partners in the Alzheimer and Parkinson projects. BioArctic conducts its own clinical development in the field of complete spinal cord injury. Through long-term collaboration agreements with global pharmaceutical companies, BioArctic has demonstrated high skills and good ability to deliver innovative pharmaceutical projects.

In Alzheimer’s disease, BioArctic has collaborated with Eisai since 2005. The company has entered into a total of three research collaboration agreements and two license agreements relating to the antibodies BAN2401 and BAN2401 Back-up. The total aggregated value of these agreements may amount to EUR 218 million in addition to royalties. So far, EUR 47 million has been received. In Parkinson’s disease, BioArctic has collaborated with AbbVie since 2016, when a research collaboration agreement was concluded including, among other things, the antibody BAN0805. AbbVie is entitled to acquire a license to develop and commercialize the antibodies. The total aggregated value of the agreement may amount to USD 755 million in addition to royalty payments, of which USD 80 million has so far been received.

The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. For information about the projects, see the section Project portfolio.

BioArctic’s B-share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B).

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of Christina Astrén, IR & Communications Director, at 08:00 a.m. CET on February 20, 2018.