Result centre

Q2 2016 Interim report

Highlights

Company Highlights
April – June 2016

  • On January 19, 2016 Biotie announced that it entered into a combination agreement with Acorda Therapeutics, Inc. (Acorda) whereby Acorda, either directly or through a wholly-owned subsidiary, would make a public tender offer in Finland and in the United States to purchase all of the issued and outstanding shares, American Depositary Shares (ADSs), stock options, share units and warrants in Biotie that are not owned by Biotie or any of its subsidiaries (the Tender Offer). On April 13, 2016 Acorda announced the final results of the Tender Offer. As all the conditions to complete the Tender Offer had been satisfied it was confirmed that Acorda would complete the Tender Offer in accordance with its terms and conditions. The offer consideration was paid to the holders of equity interests who validly accepted the Tender Offer by April 8, 2016 in accordance with the terms and conditions of the Tender Offer, on or about April 18, 2016. Acorda also commenced a subsequent offer period in accordance with the terms and conditions of the Tender Offer (the Subsequent Offer Period). The Subsequent Offer Period commenced on April 14, 2016 and ended on April 28, 2016. The offer consideration was paid to holders of equity interests who had validly accepted the Tender Offer before the Subsequent Offer Period ended in accordance with its terms and conditions, on or about May 4, 2016. 694,904,307 shares, 3,178,662 ADSs, 435,000 2011 option rights, 4,280,125 2014 option rights, 12,401,120 2016 option rights, 1,949,116 swiss option rights, 25,000 2011 share rights, 3,972,188 2014 share rights and 220,400,001 warrants were tendered in the Tender Offer and Subsequent Offer Period, representing approximately 96.77 % of all the shares and votes in Biotie on a fully-diluted basis as defined in the terms and conditions of the Tender Offer.
  • On April 20, 2016 Acorda announced the redemption right and obligation under the Finnish Companies Act in respect of the Biotie shares held by the minority shareholders has arisen and that Acorda will initiate arbitral proceedings as provided in the Finnish Companies Act to effectuate the redemption of the Biotie shares held by minority shareholders. Biotie announced on 10 June, 2016 that based on an application filed by Acorda for the aforementioned arbitration proceedings, the Redemption Committee of the Finland Chamber of Commerce has petitioned the District Court of Finland Proper for the appointment of a trustee, in accordance with Chapter 18, Section 5 of the Finnish Companies Act, to look after the interests of Biotie's minority shareholders in the arbitration proceedings. In its decision, the District Court of Finland Proper appointed Attorney, MSc (Econ.) Jussi Perho to act as the trustee.
  • On June 13, 2016 Biotie announced that the voluntary delisting of its ADSs from the NASDAQ Global Select Market (Nasdaq US) had become effective. Following this, the ADSs are no longer tradable on any regulated security exchange. Biotie’s shares remain listed on Nasdaq Helsinki Ltd. (Nasdaq Helsinki), although the Company intends to delist the shares from Nasdaq Helsinki as soon as permitted and practicable under applicable laws.
  • Tozadenant, Biotie’s lead pipeline program, is in Phase 3 development in Parkinson’s disease. Patient recruitment continued during the second quarter into the TOZ-PD study, a 450-patient double-blind, placebo-controlled Phase 3 study with an open-label extension that is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA).
  • Phase 2 studies with SYN120 in Parkinson’s disease dementia and BTT1023 in primary sclerosing cholangitis, which are being conducted by third parties, continued to recruit patients.
  • Biotie’s revenue for three months ended June 30, 2016 (three months ended June 30, 2015) was €0.9 million (€1.3 million) and the financial result was a net loss of €19.5 million (net loss of €9.0 million).
  • At June 30, 2016 Biotie had cash and cash equivalents and short term investments (reported as financial assets held at fair value through profit and loss), which together are referred to as liquid assets, of €51.6 million (€79.0 million, December 31, 2015; €94.2 million, June 30, 2015). Operating cash outflow for the six months ended June 30, 2016 was €25.7 million outflow (€12.8 million outflow for the six months ended June 30, 2015).
  • On June 29, 2016 Biotie announced that Timo Veromaa, President and CEO, David Cook, CFO and Stephen Bandak, CMO are leaving the Company by June 30, 2016. According to the announcement, the Board of Directors of Biotie has appointed Antero Kallio, M.D., as the new CEO and Kristian Rantala as CFO for the Company, effective July 1, 2016. The responsibilities of the Chief Medical Officer will be divided among the Company's research and development team staff members as well as with Acorda’s Chief Medical Officer Burkhard Blank, M.D.
Outlook

Outlook for 2016 and key upcoming milestones

Selincro(®) (nalmefene): Biotie anticipates that Lundbeck will continue to make sales of Selincro in European markets during 2016, albeit that following the announcement made by Lundbeck in August 2015 it may devote fewer resources to Selincro going forward. In addition to royalties, Biotie may also receive further milestone payments if the product reaches certain pre-determined sales.

Tozadenant (SYN115): The Phase 3 clinical study, which is expected to be the second pivotal study required for registration, will continue to recruit patients during 2016, with top-line data from the double-blind part of the study expected by the end of 2017. This will be followed by the open-label portion of the study and a separate open-label study. Additional studies required for a regulatory filing package will continue to be completed prior to regulatory submissions.

SYN120: The 80-patient Phase 2 study with SYN120 in Parkinson's disease dementia (the SYNAPSE study), funded by MJFF, is being conducted by the Parkinson Study Group at approximately 12 specialist sites in the United States. Patient enrollment will continue and top-line results of the study are expected in the second half of 2017.

BTT1023: The 41-patient investigator-sponsored Phase 2 study in primary sclerosing cholangitis (the BUTEO study) is being conducted in the UK and is supported by grant funding from the UK’s National Institute for Health Research. Patient recruitment will continue, and it is expected that the requisite number of patients will have been treated to enable a pre-planned interim analysis in this two-stage study in the first half of 2017.

Financial: The Company expects to continue its investment in its development products in 2016 and will incur significant research and development expenses as the current studies progress. The Company has a strong level of liquid resources after the financing obtained in 2015 and this, together with further Selincro royalties, is expected to be sufficient for all the Company’s currently ongoing development activities; these liquid resources will decrease over time, as they are invested in the Company’s product development programs.

Strategic: The Company’s primary focus is to ensure that the Phase 3 clinical study for tozadenant is efficiently and effectively executed, with the top-line data expected by the end of 2017. SYN120 and BTT1023, significantly funded by non-dilutive financing, are expected to reach significant potential inflection points in the second and first halves of 2017, respectively. The completion of the Tender Offer by Acorda is not expected to have a significant impact on these objectives.

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Updated 12 May, 2016