19-8-2013 — /EuropaWire/ — Company Highlights April – June 2013
- Biotie obtained an exclusive option to acquire Neurelis, Inc., a private specialty pharmaceutical company based in San Diego, CA, focused on developing products for epilepsy and other disorders of the central nervous system.
- Biotie’s partner H. Lundbeck A/S (Lundbeck) launched Selincro(R), a new treatment for alcohol dependent patients, in the first European markets. By the end of June, Selincro was available in more than 10 EEA countries. The quarter’s revenues include a milestone payment of EUR 2 million following the UK launch in May and royalties of EUR 0.07 million in relation to sales made by Lundbeck during the quarter.
- Biotie announced the start of a Phase 2 clinical study evaluating nepicastat (SYN117) in cocaine dependence. The National Institute on Drug Abuse (NIDA) at the US National Institutes of Health is funding the conduct of the study.
- Biotie’s financial result in Q2 2013 was a net loss of EUR 4.0 million; the financial result for 6 months ended 30 June 2013 was a net income of EUR 6.0 million.
- Biotie ended the second quarter on 30 June 2013 with cash, cash equivalents and short term investments of EUR 44.7 million (EUR 44.7 million, 31 March 2013).
Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million)
for the period April – June 2013
- Revenues EUR 2.1 million (0.3).
- Research and development costs EUR 3.3 million (6.7 )
- Financial result EUR -4.0 million (-7.0)
- Cash flow from operating activities EUR 0.5 million (-6.7)
- Earnings per share EUR -0.01 (-0.02)
for the period January – June 2013
- Revenues EUR 17.4 million (0.4). Revenues consisted of the one-time milestone payment from UCB; and the UK launch milestone and royalties for Selincro from Lundbeck.
- Research and development costs EUR 6.3 million (12.5)
- Financial result EUR 6.0 million (-14.5)
- Cash flow from operating activities EUR 10.7 million (-15,9)
- Earnings per share EUR 0.01 (-0.04)
- Liquid assets at the end of period EUR 44.7 million (18.5)
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, “This has been an important quarter for Biotie as we witnessed the initial rollout of our first commercial product Selincro, for alcohol dependence, by our partner Lundbeck. We also purchased an option to acquire Neurelis Inc., a private CNS focused company, which brings with it NRL-1, a niche intranasal product for epileptic seizures that represents an exciting potential development opportunity for Biotie. We are currently in the process of further assessing NRL-1 and our proprietary programs as part of our ongoing portfolio review and we expect to provide an update on that during Q3 this year.”
Outlook for 2013 and key upcoming milestones
Selincro (nalmefene): Further to the launch of Selincro by Lundbeck in the first European markets in April 2013 and the subsequent launch in the UK in May 2013, for which Biotie received a milestone of EUR 2 million, Lundbeck will continue to launch Selincro in additional European markets through 2013 and into 2014. This is planned to include launches in Italy, Germany, Spain and France, for which Biotie would receive additional milestones of EUR 2 million in each market; some of these may occur in 2013. In addition, Biotie will continue to receive royalties on sales in all launched markets and make a contribution to Lundbeck towards any required post approval commitments studies, neither of which are expected to have a significant financial impact in 2013.
Tozadenant (SYN115): Biotie has granted UCB a license for exclusive, worldwide rights to tozadenant. Biotie and UCB will collaborate on the on-going clinical development of tozadenant and UCB will be responsible for the manufacture and commercialization of tozadenant. Biotie will conduct Phase 3 development in return for payments from UCB relating to defined development, regulatory and commercialization milestones. Patient enrollment in the Phase 3 program is currently planned to commence by the first half of 2015. The additional payments from UCB for conducting Phase 3 development of tozadenant, some of which may be received in 2013, are not likely to have a significant impact on the profitability of Biotie over the duration of the clinical development.
Neurelis (NRL-1): In June, 2013 Biotie obtained an exclusive option to acquire Neurelis, Inc., a private specialty pharmaceutical company, focused on developing products for epilepsy and other disorders of the central nervous system. Neurelis’ lead product, NRL-1, is a proprietary intranasal formulation of diazepam which is being developed to help patients with epilepsy who require intermittent use of diazepam to manage bouts of acute and repetitive seizures.
Under the terms of the option and merger agreement, Biotie has made a payment of US$1.0 million to Neurelis for the exclusive right, but not the obligation, to acquire all of the outstanding shares of Neurelis for a pre-defined amount of US$8.75 million, subject to certain adjustments, to be paid in new shares of Biotie to be issued on approval by the Board of Directors. Biotie may exercise the option right up until the start of the pivotal pharmacokinetic clinical studies that will form the basis of a 505 (b)(2) New Drug Application (but no later than December 3, 2014). This is expected in approximately 12-18 months’ time.
In the meantime, Biotie is responsible for the development of NRL-1, which primarily includes further manufacturing and pre-clinical work which Biotie is currently conducting.
SYN120: Biotie has generated an extensive clinical and preclinical data package for SYN120 and the compound is ready to enter Phase 2. Biotie is currently seeking a partnership for late stage clinical trials and has received interest from several parties.
Nepicastat (SYN117): Biotie, in partnership with the U.S. National Institute of Drug Abuse (NIDA), is jointly investigating the safety and efficacy of nepicastat in the treatment of cocaine dependence. A Phase 2 trial started in May 2013 and is expected to take approximately two years to complete.
BTT-1023 (VAP-1 antibody): Biotie is currently seeking a partner to best maximize the value of BTT-1023.
Financial: While the company has recorded a net income for the six month period ended 30June 2013, this was primarily due to the timing of a one-off milestone payment in relation to tozadenant in the first quarter. Given that the size and timing of such milestone payments cannot be predicted, this period’s performance should not be taken as indicative of future quarterly performance.
Portfolio review: Biotie is undertaking a portfolio review to ensure appropriate prioritization of projects that have the best development potential and provide the best opportunities of enhancing shareholder value. The review will comprise both Biotie’s internal development pipeline as well as certain potential new strategic opportunities. The company expects to report on the results of this review during Q3 2013.
Conference call
An analyst and media conference call will take place on Friday 2 August 2013 at 10:00 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 3367
UK callers: +44 (0)20 3427 1913
Finnish callers: +358 (0)9 6937 9590
Access code: 5758079
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 the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson’s disease, Alzheimer’s disease and other cognitive disorders, alcohol and drug dependence (addiction) and post-traumatic stress disorder), and inflammatory and fibrotic liver disease. The company has a strong and balanced development portfolio with several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie’s products address diseases with high unmet medical need and significant market potential.
Biotie’s most advanced product, SelincroR (nalmefene), licensed to Lundbeck A/S, has on 28 February 2013 received European marketing authorization for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. In addition, Biotie has a strategic collaboration with UCB Pharma S.A. covering tozadenant which is transitioning into Phase 3 development for Parkinson’s disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd.Turku, 2 August 2013
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
Attachment:
Biotie_interim report Q2 2013
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- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
- Editor's pick archive....