Interim Report January – September 2017

BioArctic listed on Nasdaq Stockholm Mid Cap

July - September 2017

  •  Net sales for the period amounted to SEK 31.5 million (1.2)
  •  Operating profit amounted to SEK 0.6 million (-10.2)
  •  Loss for the period amounted to SEK -0.1 million (-7.8)
  •  Earnings per share SEK 0.00 (-0.12)
  •  Cash flow from operating activities amounted to SEK -23.6 million (-9.8)

January - September 2017

  •  Net sales for the period amounted to SEK 89.7 million (11.2)
  •  Operating profit amounted to SEK 4.6 million (-22.7)
  •  Profit/loss for the period amounted to SEK 3.3 million (-17.4)
  •  Earnings per share SEK 0.05 (-0.28)
  •  Cash flow from operating activities amounted to SEK -89.6 million (-30.5)

Key events during the period July – September 2017  

  •  Alzheimer's disease: The Independent Monitoring Committee has conducted an additional interim analysis and recommended continuing the clinical Phase 2b study with BAN2401 for patients with early Alzheimer's disease.
  •  Complete Spinal Cord Injury: Since August, the patients receiving SC0806 treatment in the ongoing Phase 1/2 clinical trial are given the option of a 12 month additional rehabilitation in an extension study.
  •  On August 1, a split 15:1 was performed where the number of shares increased from 4,203,999 to 63,059,985.
  •  On September 18, a reclassification of 33,599, 989 shares of series A to shares of series B was performed.
  •  BioArctic held an Extraordinary General Meeting on September 4. The meeting elected former board member Wenche Rolfsen new Chairman of the Board, former board member Ivar Verner was elected Deputy Chairman and Eugen Steiner was elected new board member. Lars Lannfelt, former Chairman of the Board, remains as board member.
  •  BioArctic announced on September 13 its intention to list on Nasdaq Stockholm and published the company’s prospectus on September 29. 

Key events after the period  

  •  First day of trading in BioArctic’s B-share on Stockholm Nasdaq commenced on October 12.  
  •  In connection with the listing, BioArctic offered a new share issue that rendered SEK 600 million in cash.
  •  The European Patent Office (EPO) granted BioArctic’s patent for the drug candidate BAN0805, an antibody, for Parkinson’s disease.

Financial summary  

SEKm Jul-Sep 2017 Jul-Sep 2016 Jan-Sep 2017 Jan-Sep 2016 Jan-Dec 2016
Net sales 31.5 1.2 89.7  11.2 105.6
Other operating income 2.8 1.1 8.7  6.5 39.1
Operating profit 0.6 -10.2 4.6  -22.7 74.6
Profit/loss for the period -0.1 -7.8 3.3  -17.4 57.6
Earnings per share, SEK ¹) ²)
0.00 -0.12 0.05  -0.28 0.91
Cash flow from operating activities -23.6 -9.8 -89.6  -30.5 675.1
Cash flow from operating activities per share, SEK ¹) ²)
-0.37 -0.16 -1.42  -0.48 10.71
Equity/assets ratio 10.5% 87.5% 10.5%  87.5% 8.6%
Return on equity, % -0.2% -8.2% 5.3%  -17.5% 68.1%
Equity per share, SEK ¹) ²)
1.02 1.44 1.02  1.44 0.96
Number of shares, before dilution 4,203,999 4,203,999 4,203,999  4,203,999 4,203,999
Share split 15:1 58,855,986 58,855,986 58,855,986 58,855,986 58,855,986
Number of shares ¹) ²)
63,059,985 63,059,985 63,059,985 63,059,985 63,059,985
Average number of shares ¹) ²)
63,059,985 63,059,985 63,059,985  63,059,985 63,059,985

   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 at August 1, 2017.

CEO’s comments
BioArctic is in a phase of strong development. So far, the year has been characterized by high expectations and enthusiasm in anticipation of the continued development of the company and the projects. During the period intensive work together with Carnegie and DNB has been in progress in parallel with the daily operations, as we have been preparing for BioArctic’s introduction on Nasdaq Stockholm.  

We are very proud of the great interest that has been shown for BioArctic during the IPO process. The many exciting external meetings with potential investors during this period have been inspiring.

October 12 was the first day of trading with BioArctic’s B-share, and this was of course a historic day for the company. It is with great joy that we welcome new as well as previous shareholders to take part in the continued development of BioArctic in a public environment.

Among BioArctic’s five projects for treatment of patients with early stage Alzheimer’s disease, BAN2401, which is run in collaboration with Eisai, is the most advanced. The results from the complete BAN2401 Phase 2 study are expected to be available during the first half of 2019 at the latest.

Together with research groups at Uppsala University BioArctic is developing a totally new type of tool that enables improved diagnosis of Alzheimer’s disease, monitoring of the progression of the disease and objective measuring of the effect of drug treatment. The company’s ambition is to create a tool that can be used in research and drug development as well as in commercial application.

As a result of the research collaboration with AbbVie in Parkinson’s disease, BioArctic has recruited more employees, gained increased resources and are able to drive the BAN0805 project considerably faster towards clinical studies. In September, BioArctic participated in round- table discussion and presented scientific data at the international conference “20 years of alpha-synuclein in Parkinson’s Disease and related synucleinopathies: from the bedside to the bench and back to the patient.” The meeting took place in Athens, Greece. In October, the European Patent Office approved BioArctic’s European patent for the drug candidate BAN0805 for treatment of neurodegenerative disorders, including Parkinson’s disease. The patent has previously been granted in major markets including US, Japan and China.

The company’s treatment for complete spinal cord injury, SC0806, is undergoing clinical trials in Phase 1/2 at specialist clinics in Sweden and preparations are ongoing to include clinics in Finland, Estonia and Norway. Since August, patients treated with SC0806 in the ongoing study are offered the opportunity of a further 12 months of treatment in an extension study.

The raised SEK 600 million in connection with the IPO will enable BioArctic to continue the development of new innovative treatments aimed at improving the quality of life of patients suffering from neurodegenerative disorders like Alzheimer’s disease and Parkinson’s disease or patients with complete spinal cord injury. We are looking forward to the important activities that lie ahead.

Gunilla Osswald
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 you to an audiocast with teleconference (in English) for investors, analysts and media today, November 8, at 09:30 – 10:30 a.m. CET.

CEO Gunilla Osswald and CFO Jan Mattsson present BioArctic, comment on the interim report and answer questions.

Webcast: https://tv.streamfabriken.com/bioarctic-q3-2017
Dial-in telephone number from:
Sweden: + 46 8 566 42662
Switzerland: + 41 225 675 548
UK: + 44 203 008 9801
US: + 1 855 753 2235

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 high 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 and 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, Head IR & Communications, at 08:00 a.m. CET on November 8, 2017.

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About Us

BioArctic AB is a Swedish research based biopharma company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. The company also develops a potential treatment for Complete Spinal Cord Injury. BioArctic focuses on innovative treatments in areas with high unmet medical needs. Collaborations with universities are of great importance to the company together with our strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. 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. www.bioarctic.se

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