BioTie Therapies Corp. Interim Report 1 January - 30 September 2014
Biotie interim report 1 January - 30 September 2014
This is a summary of the interim report 1 January - 30 September 2014 published today. The complete report is attached to this release.
Company Highlights
July - September 2014
• Preparations to advance tozadenant into Phase 3 development in Parkinson's disease as part of Biotie's proprietary portfolio continued during the quarter and it is expected that the Phase 3 program will be able to start recruiting patients during H1 2015, as planned.
• The formal transfer process of global rights to tozadenant from UCB Pharma S.A. (UCB) to Biotie was concluded in August. The transfer agreement confirms that UCB will meet all its contractual and scientific commitments regarding the ongoing development program for tozadenant, which are expected to be fully completed by the end of 2014.
• Biotie was awarded a USD 2.0 million (approximately EUR 1.6 million) grant from The Michael J. Fox Foundation (MJFF) to investigate SYN120 in a Phase 2 study in Parkinson's disease dementia, further strengthening Biotie's presence in the Parkinson's disease space. The study is currently expected to begin recruitment around the end of 2014.
• A Phase 2 clinical study with Biotie's BTT1023 in primary sclerosing cholangitis (PSC) was awarded external grant funding of up to approximately EUR 1.0 million from the Efficacy and Mechanism Evaluation (EME) Programme funded and managed by the National Institute for Health Research (NIHR) in the UK. The study will be conducted in partnership with the University of Birmingham and is expected to start recruiting patients by the end of 2014.
• Biotie's partner H. Lundbeck A/S (Lundbeck) continued the rollout of Selincro in European markets, and it has now been introduced in well over 20 European markets, including the five key markets for which Biotie received a launch milestone. During the quarter, Selincro was launched in Spain, Germany and France, for which Biotie received a EUR 2.0 million milestone in each market. The National Institute for Health and Care Excellence (NICE), the United Kingdom's health technology assessment authority, issued draft guidance recommending the use of Selincro (nalmefene) within the conditions of its marketing authorization in the National Health Service (NHS) in England and Wales. The final guidance is expected in November 2014.
• Biotie decided not to exercise its exclusive option to acquire Neurelis, Inc. (Neurelis), a private specialty pharmaceutical company. In consideration of the timely transfer of the program to Neurelis, Biotie and Neurelis have agreed that Biotie may recover the cost of its investment to date in Neurelis' lead product NRL-1 through a share of future revenue generated by Neurelis.
• Biotie's revenue in Q3 2014 was EUR 7.2 million (EUR 4.5 million) and the financial result was a net profit of EUR 2.5 million (net loss of EUR 1.8 million).
• Biotie ended the third quarter on 30 September 2014 with liquid assets of EUR 35.9 million (EUR 34.0 million, 30 June 2014). Operating cash flow for the quarter was a net inflow of EUR 0.3 million (net inflow of EUR 2.7 million). Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million)
for the period July - September 2014
• Revenues EUR 7.2 million (4.5)
• Research and development costs EUR 3.4 million (4.4)
• Net profit (loss) EUR 2.5 million (-1.8)
• Cash flow from operating activities EUR 0.3 million (2.7)
• Earnings per share EUR 0.01 (-0.00) for the period January - September 2014
• Revenues EUR 13.1 million (21.9)
• Research and development costs EUR 10.9 million (10.7)
• Net profit (loss) EUR -2.7 million (4.1)
• Cash flow from operating activities EUR -9.3 million (13.4)
• Earnings per share EUR -0.01 (0.01)
• Liquid assets at the end of period EUR 35.9 million (46.9)
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, "Lundbeck continued to make Selincro available in additional European markets, including France, Germany and Spain, and we entered into several external collaborations to support the Phase 2 trials for SYN120 in Parkinson's dementia and for BTT1023 in primary sclerosing cholangitis, which are due to start by year-end. Meanwhile, Biotie's clinical team remained focused on the development of our lead compound tozadenant, a novel therapy to address a large unmet need in Parkinson's disease patients experiencing "end of dose wearing off" on current therapies. Looking ahead, we anticipate data from the NIDA funded Phase 2 trial of nepicastat in cocaine-dependence around the end of the year and expect to start the Phase 3 development for tozadenant in the first half of next year."
Outlook for 2014 and key upcoming milestones:
Selincro® (nalmefene): Lundbeck will continue the rollout of Selincro in additional European markets during 2014. Biotie has received all milestone payments associated with launches in EU markets but remains eligible to receive further potential milestone payments on launches in certain ex-EU markets and if the product reaches certain pre-determined sales, as well as further royalties on sales in all markets. The first clinical Phase 3 study under the joint Lundbeck/Otsuka development program in Japan is expected to be initiated in 2014, but will not impact Biotie's financial results.
Final guidance is expected in November 2014 from NICE, the United Kingdom's health technology assessment authority, regarding the use of Selincro in the NHS in England and Wales; positive draft guidance from NICE was issued in July 2014 and confirmed in final draft guidance issued in October 2014.
Tozadenant (SYN115): Phase 3 clinical studies are on track to commence patient recruitment in H1 2015, as originally planned.
SYN120: Phase 2 study in Parkinson's disease dementia is expected to begin recruitment around the end of 2014.
Based on the company's decision to focus on tozadenant, the previously planned Phase 2 study in Alzheimer's disease will not begin recruitment by the end of 2014 and will be assessed based on the development status of the other products within the portfolio.
Nepicastat (SYN117): The Phase 2 trial in cocaine dependence, funded by NIDA, completed patient enrolment in May, ahead of schedule. The top-line results from the study are expected around the end of 2014.
BTT1023: Patient recruitment for a Phase 2 study in primary sclerosing cholangitis is expected to start by the end of 2014. Strategic: The Company is currently in a solid financial position and all preparations are ongoing for the Phase 3 program with tozadenant to start patient recruitment H1 2015 and separate Phase 2 studies with SYN120 and BTT1023, funded largely with non-dilutive financing, to start patient recruitment around the end of 2014. The Company has concluded that it can best maximize the value of tozadenant by continuing its development within the current portfolio and is considering various options to finance this development, which may include a capital raise.
Financial: For the remainder of 2014, the Company expects further revenue from Selincro royalties from Lundbeck and an additional contribution towards certain tozadenant development costs from UCB. Additional research and development expenses will be incurred in respect of tozadenant, SYN120 and BTT1023.
Conference call
An analyst and media conference call will take place on 31 October 2014 at 10 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: +1646 254 3362
UK callers: +44(0)20 3427 1909
Finnish callers: +358(0)9 6937 9543
Access code: 8575215
In case you need additional information or assistance, please contact: Virve Nurmi, IR Manager, Tel: +358 2 2748 911
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 three additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, cocaine dependence, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.
Turku, 31 October 2014
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
Help employers find you! Check out all the jobs and post your resume.
This is a summary of the interim report 1 January - 30 September 2014 published today. The complete report is attached to this release.
Company Highlights
July - September 2014
• Preparations to advance tozadenant into Phase 3 development in Parkinson's disease as part of Biotie's proprietary portfolio continued during the quarter and it is expected that the Phase 3 program will be able to start recruiting patients during H1 2015, as planned.
• The formal transfer process of global rights to tozadenant from UCB Pharma S.A. (UCB) to Biotie was concluded in August. The transfer agreement confirms that UCB will meet all its contractual and scientific commitments regarding the ongoing development program for tozadenant, which are expected to be fully completed by the end of 2014.
• Biotie was awarded a USD 2.0 million (approximately EUR 1.6 million) grant from The Michael J. Fox Foundation (MJFF) to investigate SYN120 in a Phase 2 study in Parkinson's disease dementia, further strengthening Biotie's presence in the Parkinson's disease space. The study is currently expected to begin recruitment around the end of 2014.
• A Phase 2 clinical study with Biotie's BTT1023 in primary sclerosing cholangitis (PSC) was awarded external grant funding of up to approximately EUR 1.0 million from the Efficacy and Mechanism Evaluation (EME) Programme funded and managed by the National Institute for Health Research (NIHR) in the UK. The study will be conducted in partnership with the University of Birmingham and is expected to start recruiting patients by the end of 2014.
• Biotie's partner H. Lundbeck A/S (Lundbeck) continued the rollout of Selincro in European markets, and it has now been introduced in well over 20 European markets, including the five key markets for which Biotie received a launch milestone. During the quarter, Selincro was launched in Spain, Germany and France, for which Biotie received a EUR 2.0 million milestone in each market. The National Institute for Health and Care Excellence (NICE), the United Kingdom's health technology assessment authority, issued draft guidance recommending the use of Selincro (nalmefene) within the conditions of its marketing authorization in the National Health Service (NHS) in England and Wales. The final guidance is expected in November 2014.
• Biotie decided not to exercise its exclusive option to acquire Neurelis, Inc. (Neurelis), a private specialty pharmaceutical company. In consideration of the timely transfer of the program to Neurelis, Biotie and Neurelis have agreed that Biotie may recover the cost of its investment to date in Neurelis' lead product NRL-1 through a share of future revenue generated by Neurelis.
• Biotie's revenue in Q3 2014 was EUR 7.2 million (EUR 4.5 million) and the financial result was a net profit of EUR 2.5 million (net loss of EUR 1.8 million).
• Biotie ended the third quarter on 30 September 2014 with liquid assets of EUR 35.9 million (EUR 34.0 million, 30 June 2014). Operating cash flow for the quarter was a net inflow of EUR 0.3 million (net inflow of EUR 2.7 million). Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million)
for the period July - September 2014
• Revenues EUR 7.2 million (4.5)
• Research and development costs EUR 3.4 million (4.4)
• Net profit (loss) EUR 2.5 million (-1.8)
• Cash flow from operating activities EUR 0.3 million (2.7)
• Earnings per share EUR 0.01 (-0.00) for the period January - September 2014
• Revenues EUR 13.1 million (21.9)
• Research and development costs EUR 10.9 million (10.7)
• Net profit (loss) EUR -2.7 million (4.1)
• Cash flow from operating activities EUR -9.3 million (13.4)
• Earnings per share EUR -0.01 (0.01)
• Liquid assets at the end of period EUR 35.9 million (46.9)
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, "Lundbeck continued to make Selincro available in additional European markets, including France, Germany and Spain, and we entered into several external collaborations to support the Phase 2 trials for SYN120 in Parkinson's dementia and for BTT1023 in primary sclerosing cholangitis, which are due to start by year-end. Meanwhile, Biotie's clinical team remained focused on the development of our lead compound tozadenant, a novel therapy to address a large unmet need in Parkinson's disease patients experiencing "end of dose wearing off" on current therapies. Looking ahead, we anticipate data from the NIDA funded Phase 2 trial of nepicastat in cocaine-dependence around the end of the year and expect to start the Phase 3 development for tozadenant in the first half of next year."
Outlook for 2014 and key upcoming milestones:
Selincro® (nalmefene): Lundbeck will continue the rollout of Selincro in additional European markets during 2014. Biotie has received all milestone payments associated with launches in EU markets but remains eligible to receive further potential milestone payments on launches in certain ex-EU markets and if the product reaches certain pre-determined sales, as well as further royalties on sales in all markets. The first clinical Phase 3 study under the joint Lundbeck/Otsuka development program in Japan is expected to be initiated in 2014, but will not impact Biotie's financial results.
Final guidance is expected in November 2014 from NICE, the United Kingdom's health technology assessment authority, regarding the use of Selincro in the NHS in England and Wales; positive draft guidance from NICE was issued in July 2014 and confirmed in final draft guidance issued in October 2014.
Tozadenant (SYN115): Phase 3 clinical studies are on track to commence patient recruitment in H1 2015, as originally planned.
SYN120: Phase 2 study in Parkinson's disease dementia is expected to begin recruitment around the end of 2014.
Based on the company's decision to focus on tozadenant, the previously planned Phase 2 study in Alzheimer's disease will not begin recruitment by the end of 2014 and will be assessed based on the development status of the other products within the portfolio.
Nepicastat (SYN117): The Phase 2 trial in cocaine dependence, funded by NIDA, completed patient enrolment in May, ahead of schedule. The top-line results from the study are expected around the end of 2014.
BTT1023: Patient recruitment for a Phase 2 study in primary sclerosing cholangitis is expected to start by the end of 2014. Strategic: The Company is currently in a solid financial position and all preparations are ongoing for the Phase 3 program with tozadenant to start patient recruitment H1 2015 and separate Phase 2 studies with SYN120 and BTT1023, funded largely with non-dilutive financing, to start patient recruitment around the end of 2014. The Company has concluded that it can best maximize the value of tozadenant by continuing its development within the current portfolio and is considering various options to finance this development, which may include a capital raise.
Financial: For the remainder of 2014, the Company expects further revenue from Selincro royalties from Lundbeck and an additional contribution towards certain tozadenant development costs from UCB. Additional research and development expenses will be incurred in respect of tozadenant, SYN120 and BTT1023.
Conference call
An analyst and media conference call will take place on 31 October 2014 at 10 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: +1646 254 3362
UK callers: +44(0)20 3427 1909
Finnish callers: +358(0)9 6937 9543
Access code: 8575215
In case you need additional information or assistance, please contact: Virve Nurmi, IR Manager, Tel: +358 2 2748 911
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 three additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, cocaine dependence, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.
Turku, 31 October 2014
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
Help employers find you! Check out all the jobs and post your resume.