Company Highlights
January - March 2015
• Preparations to advance tozadenant into Phase 3 development in Parkinson’s disease as part of Biotie’s proprietary portfolio continued during the quarter. After the reporting period in April 2015, Biotie provided further information on the design and conduct of the Phase 3 program. As announced earlier, patient recruitment is expected to commence in the middle of 2015.
• After the reporting period in April 2015, Biotie also announced plans to strengthen its capital structure by up to approximately €95 million through a directed issue of convertible notes and warrants and a US Initial Public Offering to finance a Phase 3 trial of tozadenant in Parkinson’s disease. The plans are subject to shareholder approval at Biotie’s Annual General Meeting to be held on 26 May 2015 and to US regulatory review.
• Biotie’s partner H. Lundbeck A/S (Lundbeck) continued the rollout of Selincro in Europe and the product has to date been introduced in 29 European markets.
• The Phase 2 study for SYN120 in Parkinson’s disease dementia, funded by a grant from the Michael J Fox Foundation (MJFF), continued to recruit patients.
• Patient enrollment commenced in March 2015 into a Phase 2 clinical study investigating Biotie’s monoclonal anti-VAP-1 antibody BTT1023 in primary sclerosing cholangitis (PSC). Also in March 2015, the European Commission granted BTT1023 Orphan Drug Designation in the EU for the treatment of PSC.
• Biotie’s revenue for three months ended March 31, 2015 (three months ended March 31, 2014) was €0.9 million (€5.1 million) and the financial result was a net loss of €5.9 million (net loss of €1.7 million).
• Biotie ended the first quarter on March 31, 2015 with cash, cash equivalents and short term investments, which together are referred to as liquid assets, of €27.8 million (€32.4 million, December 31, 2014). Operating cash flow for the three months ended March 31, 2015 was €5.4 million outflow (€5.4 million outflow for the three months ended March 31, 2014).
Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the previous year (€ million)
for the period January - March 2015
• Revenues €0.9 million (€5.1 million).
• Research and development costs €4.8 million (€4.8 million)
• Financial result was a net loss of €5.9 million (net loss of €1.7 million)
• Cash flow from operating activities €5.4million outflow (€5.4 million outflow)
• Loss per share €0.01 (€0.00)
• Liquid assets at the end of period €27.8million (€32.4 million, December 31, 2014).
The interim report is unaudited. Liquid assets are comprised of cash, cash equivalents and investments held to maturity. Timo Veromaa, Biotie’s President and CEO commented, “Our focus in the last quarter has been on preparing our lead product tozadenant to advance into Phase 3 development. As announced earlier this month, we are delighted to have established a consortium, including certain U.S. based investors, to contribute to the financing of the program. These funds, together with a proposed US IPO, will allow us to commence a pivotal Phase 3 clinical trial that we believe could form the basis for approval of tozadenant by the FDA as an adjunctive treatment to levodopa in Parkinson’s disease.”
Outlook for 2015 and key upcoming milestones
Selincro® (nalmefene): Lundbeck will continue to increase its sales and marketing efforts in respect of Selincro in European markets during 2015 following the positive pricing and reimbursement decisions received in the second half of 2014. In addition to royalties, Biotie may also receive further milestone payments if the product reaches certain pre-determined sales.
Tozadenant (SYN115): A Phase 3 clinical study, which is expected to be the second pivotal study required for registration, is on track to commence patient recruitment in the middle of 2015, as originally planned. Top-line data from the double-blind part of the study is expected by the end of 2017. Additional studies required to ensure a strong regulatory filing package will continue to be performed at the same time as the clinical study.
SYN120: Patient enrollment into an 80-patient Phase 2 study with SYN120 in Parkinson’s disease dementia (the SYNAPSE study) started in December 2014. The study, funded by MJFF, is being conducted by the Parkinson Study Group at approximately 12 specialist sites in the United States. Top-line results of the study are expected in the second half of 2016.
BTT1023: Patient enrollment into an investigator-sponsored Phase 2 study in primary sclerosing cholangitis (the BUTEO study) started in March 2015. The 41-patient study is being conducted in the UK and is supported by grant funding from the UK’s National Institute for Health Research. It is expected that the requisite number of patients will have been treated by the end of 2016 to enable a pre-planned futility analysis in this two-stage study to be completed.
Financial: During the remainder of 2015, the Company expects to continue receiving Selincro royalties from Lundbeck and may receive a commercial sales milestone. Research and development expenses on all development products are expected to increase, predominantly due to the start of the tozadenant Phase 3 study, subject to the planned financing, including the US public offering, concluding as planned. The planned financing will increase the level of liquid resources in the Company.
Strategic: Pending shareholder approval in the Annual General Meeting of the planned funding arrangements for the tozadenant Phase 3 program, the Company will focus its efforts on efficiently commencing and executing the planned clinical program. SYN120 and BTT1023, funded largely by non-dilutive financing, are both expected to reach significant potential inflection points by the end of 2016.
Conference call
An analyst and media conference call will take place on 6 May 2015 at 8.00 a.m. Central European Time. The conference call will be held in English.
Lines are to be reserved ten minutes before the start of conference call. The event can also be viewed as a live webcast at www.biotie.com. An on demand version of the conference will be published on Biotie’s website later during the day Telephone conference numbers:
US callers: +1 646 254 3362
UK callers: +44(0)20 7136 2055
Finnish callers: +358(0)9 2310 1620
Access code: 7162757
In case you need additional information or assistance, please contact: Virve Nurmi, IR Manager, Tel: +358 2 2748 911 Key events after the reporting period
On April 23, 2015, the Company announced further detail on its Phase 3 clinical development plan for tozadenant. On April 23, 2015, the Company announced plans to strengthen its capital structure in aggregate by approximately €95 million, to finance a Phase 3 double-blinded clinical trial, including the open label extension, of its lead product candidate tozadenant, through a direct issuance of up to €42.5 million of convertible promissory notes and other equity-based instruments to certain US investors and certain existing shareholders, as well as a potential US public offering (“US IPO”) and potential other offerings in connection with the US IPO. The issue of the related shares is conditional on the granting of necessary authorizations and election of new Board members by the Annual General Meeting.
On April 23, 2015, the Company and certain US based investors entered into a subscription agreement for €27.5 million of convertible promissory notes (“Convertible Notes”) and other equity-based instruments (“Warrants”). The Convertible Notes can be converted into new shares in the Company by their holders at any time prior to the repayment of the Convertible Notes, which is scheduled to occur on or after May 1, 2035. Further, the Convertible Notes would automatically convert into new shares in the Company upon completion of a proposed US IPO. If the US IPO does not take place by May 1 2016, the Company can force the conversion of the Convertible Notes at any time thereafter until the repayment date. The Warrants will entitle to subscribe for shares in the Company until November 1, 2020.
About Biotie
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. Biotie’s development has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in 2013 and is currently being rolled out across Europe by partner Lundbeck. The current development products include tozadenant for Parkinson’s disease, which is transitioning into Phase 3 development, and two additional compounds which are in Phase 2 development for cognitive disorders including Parkinson’s disease dementia, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.
Turku, 6 May 2015
Biotie Therapies Corp.
Board of Directors
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900
e-mail: virve.nurmi@biotie.com
Distribution:
NASDAQ OMX Helsinki Ltd
Main media
www.biotie.com
