BIOTIE THERAPIES CORP. Financial Statement Release 28 February, 2014 at
9.00 a.m.
Biotie Financial Statement Release 2013
This is a summary of the financial statement report 2013 published today. The
complete report is attached to this release.
Company Highlights
October - December 2013
* H. Lundbeck A/S (Lundbeck) continued the launch of Selincro (nalmefene) in
further European markets, with launches in 17 countries by the end of 2013.
Lundbeck expanded its existing alliance with Otsuka Pharmaceutical Co. Ltd.
(Otsuka) to include development and commercialization of nalmefene in Japan.
Biotie received royalties on sales of Selincro across all markets of EUR
49,000 during the fourth quarter.
* Continued activities to advance tozadenant (SYN115) into Phase 3 development
in Parkinson's disease in collaboration with partner UCB Pharma S.A. (UCB).
* Continued to actively develop NRL-1, a proprietary intranasal diazepam that
became part of Biotie's development portfolio in June 2013 through an option
agreement with Neurelis, Inc. (Neurelis).
* Biotie's loan obligations to Tekes (The Finnish Funding Agency for
Technology and Innovation) were reduced by EUR 2.8 million, with Tekes
forgiving certain capital loans relating to Biotie's carbohydrate and cancer
glycosylation projects that were discontinued in 2005 and an R&D loan
relating to Biotie's Integrin project that was discontinued in 2010.
* Biotie has continued discussions for a partnership for further development
and commercialization of SYN120. However, the Company has now concluded that
Biotie will be better served by progressing SYN120 internally to the next
stage of development.
* Biotie's financial result for Q4 2013 was a net income of EUR 2.1 million;
the financial result for 12 months ended 31 December 2013 was a net income
of EUR 6.3 million.
* Biotie ended 2013 with cash, cash equivalents and short term investments of
EUR 43.7 million (EUR 46.9 million, 30 September 2013). Operating cash flow
was EUR 10.9 million positive in 2013.
Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (EUR million)
for the period October - December 2013
* Revenues EUR 5.8 million (0.6).
* Research and development costs EUR 6.7 million (7.2*)
* Financial result, continuing operations EUR 2.1 million (-8.8*)
* Cash flow from operating activities EUR -2.5 million (-7.7)
* Earnings per share EUR 0.00 (-0.02)
for the period January - December 2013
* Revenues EUR 27.7 million (4.8).
* Research and development costs EUR 17.4 million (24.2*)
* Financial result, continuing operations EUR 6.3 million (-25.6*)
* Cash flow from operating activities EUR 10.9 million (-27.1)
* Earnings per share EUR 0.01 (-0.06)
* Liquid assets at the end of period EUR 43.7 million (33.8).
*Financial result for 2012 was impacted by a non-cash impairment charge of EUR
3.4 million for ronomilast
The financial statement release is unaudited. Liquid assets are comprised of
cash, cash equivalents and investments held to maturity.
Timo Veromaa, Biotie's President and CEO commented, "2013 was a highly
successful year for Biotie. Selincro was approved in Europe to treat alcohol
dependence, and our partner, Lundbeck, is now launching the product across
Europe. We secured a license agreement for our novel A2a antagonist, tozadenant,
with UCB Pharma and received a $20 million milestone payment in 2013. With UCB
funding we are now preparing to conduct Phase 3 tozadenant trials, which we
expect to start in the first half of 2015. Also, a Phase 2 trial commenced for
nepicastat in treatment seeking cocaine addicted patients, which is being funded
by the U.S. National Institute on Drug Abuse (NIDA). We remain focused on
delivering greater returns for our shareholders and as part of our evolving
strategy we plan to use our financial strength to create a clinical platform
with products that we can develop and commercialize ourselves."
Outlook for 2014 and key upcoming milestones:
Selincro: Lundbeck will continue the rollout of Selincro in additional European
markets into 2014. Biotie is eligible for launch milestones in France, Germany
and Spain of EUR 2 million in each market, and further royalties on sales in all
markets. Due to the early phase of the launch of Selincro no guidance can be
given on expected royalty revenue in 2014. The first clinical phase 3 study
under the joint Lundbeck/Otsuka development program in Japan is expected to be
initiated in 2014, but this will not impact Biotie's financial results.
Tozadenant (SYN115): Phase 3 development plans will continue in collaboration
with UCB and a key event this year will be the end-of-Phase 2 meeting with FDA,
planned for H1 2014. Biotie is expected to receive additional payments from UCB
in the low triple digit millions in total over the next six years, based on the
successful completion of defined development, regulatory and commercialization
milestones, which are intended to be used to cover the costs of the development
program. The Phase 3 program in Parkinson's disease is expected to commence by
H1 2015.
NRL-1: Biotie has concluded that its timely access to market is not guaranteed
and that Biotie will not exercise the option to acquire Neurelis in H1 2014 as
initially expected. Biotie will not make any further significant investment into
this opportunity until further notice.
Nepicastat (SYN117): A Phase 2 trial in cocaine dependence, funded by NIDA, is
continuing to recruit, and top-line data from the study is currently expected in
H1 2015.
BTT-1023: Preparations for a clinical Phase 2 study in primary sclerosing
cholangitis are ongoing. The Company is in advanced discussions for non-dilutive
co-funding for the study.
SYN120: Preparations for a Phase 2 study in Alzheimer's disease have started,
with the study expected to begin recruitment by the end of 2014.
Strategic: The Company will use its financial strength to seek additional
pipeline opportunities, including those that it could potentially develop itself
through to regulatory approval and beyond.
Financial: The company expects that both its revenue and research and
development expenses will increase during 2014, as a result of milestones that
will be received on both tozadenant and Selincro, and the development work that
will be performed on tozadenant and SYN120.
The Board of Directors proposal for handling of the loss of the parent company
The Board of Directors proposes that no dividend for the financial year 2013
will be paid and that the loss of the parent company for the financial year of
EUR 0.1 million (FAS) will be carried forward to shareholders' equity.
Conference call
An analyst and media conference call will take place on 28 February 2014 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: +1212 444 0481
UK callers: +44(0)20 3427 1918
Finnish callers: +358(0)9 6937 9590
Access code: 6369512
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
After the reporting period on 3 January 2014 Biotie announced that pursuant to
the authorization of the Annual General Meeting of Shareholders held on 4 April
2013, the Board of Directors resolved to issue 3,321,660 shares to the company
itself without consideration in accordance with Chapter 9 Section 20 of the
Finnish Companies Act (624/2006, as amended). The shares were issued for the
purposes of being conveyed to employees entitled to them pursuant to the terms
and conditions of the 2011 equity plans. The shares are of the same class as the
existing shares in the company. The new shares issued were registered with the
Trade Register on 8 January 2014 and entered into the book-entry system
maintained by Euroclear Finland Ltd.; they could be traded together with the
company's current series of shares on the stock exchange list of NASDAQ OMX
Helsinki Ltd from 9 January 2014.
After the reporting period on 3 January 2014, Biotie announced that the Board of
Directors had approved two new share-based incentive plans for the group
employees for awards to be made in the period 2014 to 2016 to follow-on from the
current incentive plans under which awards have been made in the period 2011 to
2013; the Stock Option Plan 2014 for its European employees and the Equity
Incentive Plan 2014 for its US employees (together the 2014 Plans). The 2014
Plans are intended to form part of the remuneration, incentive and commitment
program for the employees and to support the hiring of new employees as the
group increases the number of its employees to ensure that the currently planned
clinical trials are conducted effectively and efficiently. The incentives
support the attainment of the targets established by the group and the
implementation of the group's strategy, as well as the group's long-term
productivity. The 2014 Plans also reflect the competitive environment in which
the group operates, particularly in the US, and are an important tool in
enabling the group to attract and retain the right quality employees.
After the reporting period on 28 January 2014 and 28 February 2014, Biotie
announced that the Company has conveyed Biotie shares held as treasury shares
and that were issued on 2 January 2014 pursuant to the Stock Option Plan 2011
(232,500 shares conveyed) and the Equity Incentive Plan 2011 (106,250 shares
conveyed).
As a result of the conveyances, the total number of votes attached to Biotie's
shares increased to 338,750 votes and the total number of the Company's shares
held by the Company or its fully owned subsidiary is 9,479,700 shares. The
conveyance does not affect the number of registered shares (total of
456,032,398 shares).
After the reporting period on 28 February 2014, Biotie announced that it will
progress SYN120 internally to the next stage of development. Preparations for a
Phase 2 study in Alzheimer's disease have started, with the study expected to
begin recruitment by the end of 2014. Also, the Company announced that it has
concluded that its timely access to market for NRL-1 is not guaranteed and that
Biotie will not exercise the option to acquire Neurelis in H1 2014 as initially
expected. Biotie will not make any further significant investment into this
opportunity until further notice.
About Biotie
Biotie is a specialized drug development company focused primarily on products
for neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner. This
has delivered Selincro (nalmefene) for alcohol dependency, which received
European marketing authorization in February 2013 and is currently being rolled
out across Europe by partner Lundbeck, and tozadenant, a novel A2a antagonist
which is transitioning into Phase 3 development for Parkinson's disease in
collaboration with UCB. Biotie also has exclusive rights through an option to
acquire Neurelis, which includes NRL-1, an intranasal formulation of diazepam
for epileptic seizure management. Biotie plans to seek further opportunities of
this kind to generate a strong portfolio of products. Biotie's shares are listed
on NASDAQ OMX Helsinki.
Turku, 28 February 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
Attachment:
Biotie_Financial statement report 2013
[HUG#1765355]
