Biotie interim report 1 January - 30 September 2015
(Thomson Reuters ONE) -
BIOTIE THERAPIES CORP. INTERIM REPORT November
12 2015 at 9.00 a.m.
Biotie interim report 1 January - 30 September 2015
Biotie (Nasdaq Helsinki BTH1V; NASDAQ: BITI) announces its interim report for
the three and nine month periods ended September 30, 2015.
Company Highlights
July - September 2015
* Tozadenant, Biotie's lead pipeline program, advanced into Phase 3
development in Parkinson's disease, as patient recruitment commenced into
the TOZ-PD study. TOZ-PD is a 450-patient double-blind, placebo-controlled
Phase 3 study with an open-label extension and 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 September 30, 2015 (three months
ended September 30, 2014) was ?0.8 million (?7.2 million) and the financial
result was a net loss of ?7.9 million (net income of ?2.9 million).
* At September 30, 2015 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 ?84.0 million
(?94.2 million, June 30, 2015; ?32.4 million, December 31, 2014). Operating
cash flow for the nine months ended September 30, 2015 was ?23.0 million
outflow (?10.3 million outflow for the nine months ended September
30, 2014).
Key figures (unaudited)
(? in thousands) 3 months to 3 months to 9 months to 9 months to
September September September September
30,2015 30, 2014 30, 2015 30, 2014
-------------------------------------------------------------------------------
Revenues 786 7,192 2,987 13,051
Research and (7,252) (4,221) (19,611) (11,931)
development costs
Net (loss)/profit (7,920) 2,927 (22,818) (2,645)
(Loss)/earnings per (0.01) 0.01 (0.03) (0.01)
share (?)
Cash flow used in (23,049) (10,263)
operating activities
September 30, December 31,
(? in thousands) 2015 2014
--------------------------------------------
Liquid assets 84,020 32,393
Equity 109,667 52,623
Equity ratio (%) 74.9 61.0
Timo Veromaa, Biotie's President and CEO commented, "The third quarter was
marked by the start of the Phase 3 trial with tozadenant, our novel
investigational product for patients with Parkinson's disease. Tozadenant has a
new mechanism of action and is designed to improve control of Parkinson's
symptoms in patients experiencing levodopa end-of-dose "wearing off" episodes.
We have already shown a significant clinical benefit of tozadenant in our
published Phase 2b study which based on our discussions with the FDA we believe
will be accepted as the first pivotal study. The ongoing Phase 3 study has
identical design in terms of enrollment criteria and endpoints, but we have
increased patient numbers per dose arm to further improve statistical power and
have focused on doses that have demonstrated to have been optimal in the Phase
2b trial. While tozadenant is clearly the focus for Biotie, we continue to make
progress with our mid-stage pipeline - SYN120, a 5-HT6/5-HT2a antagonist for
Parkinson's disease dementia and other cognitive disorders, and BTT1023, which
addresses a novel target in fibrotic liver disease. Both of these products are
in Phase 2 trials and data expected by the end of next year."
Product Portfolio Review:
Selincro(®) (nalmefene) is a dual-acting opioid system modulator and the first
therapy approved in Europe for the reduction of alcohol consumption in alcohol
dependent individuals.
Biotie has licensed global rights to Selincro to Lundbeck. Under the terms of
the agreement with Lundbeck, Biotie is eligible for up to ?94 million in upfront
and milestone payments, of which ?22.5 million had been received at September
30, 2015, plus royalties on sales of Selincro. Biotie is eligible to receive
further potential milestone payments on launches in certain ex-EU markets and if
the product reaches certain pre-determined sales. Biotie will continue to
receive royalties on sales and will make a contribution to Lundbeck towards post
approval commitment studies.
Lundbeck received European marketing authorization for Selincro in February
2013 and the product has since been introduced in Europe. Favorable
reimbursement decisions were made in the second half of 2014 in a number of key
markets, including France, Spain and the United Kingdom.
Lundbeck and Otsuka Pharmaceutical Co. Ltd. are collaborating, as part of their
existing alliance, to develop and commercialize nalmefene in Japan, and a 660-
patient Phase 3 study in Japan was commenced in Q1 2015.
Tozadenant (SYN115) is an orally administered, potent and selective adenosine
A2a receptor antagonist being developed for the treatment of Parkinson's
disease.
In a 420-patient Phase 2b trial, tozadenant displayed clinically important and
statistically significant effects across pre-specified primary and multiple
secondary endpoints at a number of doses. In addition, tozadenant has been found
to be generally safe and well tolerated in the ten clinical trials that have
been conducted to date. Full data from the Phase 2b study were published in
Lancet Neurology in July 2014.
In July 2015, Biotie announced the start of the tozadenant Phase 3 study in
Parkinson's disease (study TOZ-PD). The Company has agreed on a Special Protocol
Assessment for TOZ-PD with the FDA. Based on discussions with the FDA at the End
of Phase 2 meeting, Biotie believes that the planned Phase 3 clinical program,
together with existing data, could form the basis for approval of tozadenant as
an adjunctive treatment to levodopa in Parkinson's patients experiencing end-of-
dose wearing off episodes. The TOZ-PD study will use the primary and secondary
endpoints and enrollment criteria used in the Phase 2b clinical trial. The study
is expected to enroll 450 patients experiencing levodopa related end-of-dose
wearing off, who will be randomized to receive twice daily doses of 60mg or
120mg of tozadenant or placebo in addition to their standard anti-Parkinson's
disease medications for 24 weeks. The primary endpoint will be the reduction in
the number of hours spent in the "off" state in patients taking tozadenant as
compared to placebo between baseline and week 24, as assessed by patient-
completed diaries and averaged over three consecutive days. The double-blind
placebo controlled period is expected to be followed by a 52 week open label
treatment period to collect additional clinical safety data. The study is
currently planned to be conducted in the United States, Canada and selected
European countries. Based on current estimates top-line data from the double-
blind portion is expected to be available by the end of 2017.
Providing the double-blind portion of TOZ-PD meets its primary efficacy
endpoint, another open label trial is expected to be initiated in a separate
population of 450 patients to establish the requisite number of unique exposures
required for approval.
Biotie has exclusive worldwide rights to develop and commercialize tozadenant
for all uses to treat or prevent human diseases and disorders under a license
agreement with F. Hoffmann-La Roche Ltd (Roche).
SYN120 is an oral, dual antagonist of the 5-HT6 and 5-HT2A receptors. These two
distinct properties could result in a unique therapeutic profile for SYN120
combining pro-cognitive and antipsychotic activities in neuro-degenerative
diseases, such as Parkinson's and Alzheimer's. SYN120 has completed single and
multiple ascending dose Phase 1 clinical studies and a Phase 1 positron emission
tomography imaging study to determine therapeutic dose for subsequent Phase 2
studies. In these trials, doses well above the anticipated therapeutic dose were
well tolerated.
In July 2014, Biotie was awarded a grant of up to $2.0 million from the Michael
J. Fox Foundation (MJFF) to investigate SYN120 in Parkinson's disease patients
with dementia, and patient enrollment into a Phase 2a study primarily funded
under the grant was commenced in December 2014. The SYNAPSE study is an 80
patient, Phase 2a, randomized, double-blind, multi-center, placebo-controlled
trial in patients with Parkinson's disease dementia. Patients are randomized
1:1 to placebo or SYN120 dosed once daily over a 16 week treatment period. In
addition to assessing safety and tolerability, the main focus of the study is to
establish efficacy of SYN120 on cognition using the Cognitive Drug Research
(CDR) Computerized Cognition Battery as the primary efficacy endpoint. The study
is being conducted by the Parkinson Study Group (PSG) at approximately 12
specialist sites in the United States. Biotie and the PSG share responsibility
for the design and execution of the study, and top-line results of the study are
expected by the end of 2016.
Biotie has exclusive worldwide rights to develop and commercialize SYN120 under
a license agreement with Roche and will be able to use data from the MJFF-funded
study for any future regulatory submission for SYN120, including Alzheimer's
disease, although further clinical development plans in such indications will
depend on the availability of funding.
BTT1023 is a fully human monoclonal antibody that specifically binds to vascular
adhesion protein 1 (VAP-1), an endothelial cell adhesion receptor expressed on
blood vessels. Recent investigation has shown that VAP-1, in addition to its
previously demonstrated role in inflammation, is also involved in the process of
fibrosis, which can occur in several organs and is poorly treated with current
drugs.
In July 2014, Biotie partnered with the University of Birmingham, UK, who were
awarded grant funding to conduct an investigator-sponsored, Phase 2, proof of
concept study with BTT1023 in primary sclerosing cholangitis (PSC), a chronic
and progressive orphan fibrotic disease for which there are currently no FDA-
approved treatments. The grant was awarded by the UK's National Institute for
Health Research (NIHR) Efficacy and Mechanism Evaluation Programme, funded and
managed by NIHR on behalf of the Medical Research Council - NIHR partnership.
The grant holder and Co-Investigator for the study is Professor David Adams,
Director of the NIHR Biomedical Research Unit in Liver Disease and Centre for
Liver Research at the University of Birmingham.
The BUTEO study being funded under the grant opened for patient recruitment in
March 2015. It is an open label, single arm, multi-center study that will
evaluate efficacy, safety and pharmacokinetic properties of BTT1023 in 41
patients with PSC. Patients will receive BTT1023 via intravenous infusion every
two weeks over an 11 week treatment period. The primary efficacy endpoint is a
reduction of elevated levels of alkaline phosphatase, a blood biomarker of bile
duct inflammation; secondary endpoints include various measures of liver injury
and fibrosis.
The two-stage study design includes a pre-planned interim analysis. Based on
current estimates, it is expected that the requisite number of patients will
have been treated by the end of 2016 to enable the interim analysis to be
completed.
The European Commission has granted BTT1023 Orphan Drug Designation in the EU
for the treatment of PSC, and Biotie also intends to pursue orphan drug
designation for BTT1023 in the United States. Biotie retains full rights to
BTT1023.
Management Discussion and Analysis of Financial Condition and Results of
Operations
The following discussion and analysis should be read in conjunction with the
condensed consolidated financial information contained herein, which has been
prepared in accordance with International Accounting Standard 34, Interim
Financial Reporting. The Company presents its consolidated financial information
in euros.
Overview
In the periods presented the Company has earned revenue from Lundbeck, in the
form of royalties and commercial milestones for Selincro, and from UCB in the
form of Phase 3 development milestones and Phase 3 development funding for
tozadenant. The accounting policies that the Company applies in recognizing
these revenues are set out in detail in note 2 to the consolidated financial
statements for the year ended December 31, 2014.
The Company's research and development activities are central to its business
model and expenditure on research and development is recognized as an expense in
the period in which it is incurred. The Company's current research and
development activities mainly relate to the following key programs: Phase 3
clinical trial of tozadenant in Parkinson's disease which started recruiting
patients in July 2015; Phase 2a clinical trial of SYN120 in Parkinson's disease
dementia which is currently recruiting patients; and Phase 2 clinical trial of
BTT1023 in primary sclerosing cholangitis, which is currently recruiting
patients.
General and administrative expenses consist of salary-related and external costs
related to the Company's executive, finance and other support functions,
including the costs associated of compliance with the on-going requirements of
being a listed company on Nasdaq in the United States and on the Nasdaq OMX
market in Helsinki, including insurance, general administration overhead,
investor relations, legal and professional fees and audit fees.
Other operating income consists primarily of grant income and rent received on a
sub-lease; prior to September 2014 it also included rent from an investment
property.
Our policy is to invest funds in low-risk investments, which primarily consists
of money market funds and interest-bearing saving and investment accounts.
Savings and deposit accounts generate a small amount of interest income.
Interest expenses consist primarily of non-cash interest in respect of the Tekes
loans and the convertible capital loan.
Other net financial income (expense) primarily relates to all non-interest
related items and comprises net foreign exchange gains (losses) that arise from
our intercompany borrowings, and unrealized and realized gains from money market
funds, that are reflected as financial assets held at fair value through profit
and loss.
The Company does not generally pay any corporate income taxes, as there are
currently cumulative operating losses in each subsidiary company.
Results of Operations: comparison of the nine months ended September 30, 2015
and September 30, 2014
Revenue
Revenue decreased 77% by ?10.1 million to ?3.0 million for the nine months ended
September 30, 2015 compared to ?13.1 million for the nine months ended September
30, 2014. The decrease was primarily due to the payment of the Phase 3
development milestones from UCB for tozadenant of ?5.0 million in the first
three months of 2014, which did not recur thereafter due to the termination of
the related agreement and ?6.0 million of commercial milestones from Lundbeck
for Selincro that were received in the third quarter of 2014. This was partially
offset by an increase in royalties from Lundbeck for Selincro of ?1.9 million as
a result of increased sales and the first commercial milestone for Selincro
received in 2015 of ?0.5 million in the three months ended June 30, 2015. The
Company also recognized revenue related to Phase 3 development funding from UCB
in the periods that ended June 30, 2014, September 30, 2014 and March 31, 2015,
but not in the three months ended June 30, 2015 and September 30, 2015.
Research and development expenses
Research and development expenses increased by ?7.7 million for the nine months
ended September 30, 2015 to ?19.6 million, compared to ?11.9 million for the
nine months ended September 30, 2014. The majority of the expenditure in each
period was in relation to tozadenant, with the increase mainly being due to the
stage of the development activities. During the three months ended September
30, 2015, the company paid a total ?1.3 million of regulatory milestones in
respect of tozadenant and BTT1023.
General and administrative expenses
General and administrative expenses increased by ?0.4 million to ?5.7 million
for the nine months ended September 30, 2015, as compared to ?5.3 million for
the nine months ended September 30, 2014.
Other operating income
Other operating income for the nine months ended September 30, 2015 amounted to
?0.2 million, comprising sub-lease rental income and grant income from MJFF.
This is ?0.6 million lower than the ?0.8 million for the nine months ended
September 30, 2014, comprising rental income from an investment property in
Germany that was sold in September 2014.
Interest income
Interest income was minimal for both of the nine months ended September
30, 2015 and 2014.
Interest expenses
Interest expenses consist of non-cash interest expenses accrued on the Tekes
loans and the convertible capital loans, which remained broadly stable. As a
result, interest expenses were ?0.5 million for both of the nine month periods
ended September 30, 2015 and 2014.
Other net financial income (expenses)
Other net financial income (expenses) mainly comprises net foreign exchange
differences and was a net loss of ?0.3 million for the nine months ended
September 30, 2015, compared to a ?1.2 million gain for the nine months ended
September 30, 2014
Other comprehensive income (loss)
Other comprehensive income (loss) comprises currency translation differences,
which mainly arise from the translation of in-process R&D assets and goodwill in
our foreign subsidiaries. It was a gain of ?5.1 million for the nine months
ended September 30, 2015, an increase of ?0.2 million as compared to the gain of
?4.9 million for the nine months ended September 30, 2014. The movement for the
nine month period ended September 30, 2015 is due to the significant devaluation
in the Euro against the United States Dollar and Swiss Franc mainly during the
three month period ended March 31, 2015.
Liquidity and Capital resources
Cash flows
Net cash outflow from operating activities for the nine months ended September
30, 2015 was ?23.0 million, an increase of ?12.7 million as compared to the net
cash outflow of ?10.3 million during the same period in 2014, due to a higher
net loss.
Net cash outflow from investing activities was ?1.2 million for the nine months
ended September 30, 2015, a decrease of ?6.8 million as compared to the net cash
inflow of ?5.6 million in the same period in 2014, due to investment in and
proceeds from sale of financial assets at fair value through profit or loss.
Net cash inflow from financing activities was ?74.3 million for the nine months
ended September 30, 2015, an increase of ?74.3 million compared to the inflow of
?0.0 million for the same period in 2014. The reason for the increase was the
net proceeds received from the issue of the convertible notes on May 28, 2015 of
?30.2 million and the issue of share capital associated with the US public
offering on June 16, 2015 of ?44.1 million. The remaining inflows relate solely
to the proceeds from share issues in respect of employee equity plans and are
minimal in both periods.
Liquid assets, comprising cash and cash equivalents and financial assets at fair
value through profit and loss, totaled ?84.0 million at September 30, 2015 as
compared to ?32.4 million at December 31, 2014. The increase of ?51.6 million
was mainly due to the net proceeds received from the issue of the convertible
notes and US public offering of ?74.1 million, which was partially offset by
utilization of cash flow for financing the operating activities, principally
research and development expenses.
Cash and funding sources
Our main sources of revenue during the periods presented were from UCB in
relation to tozadenant and milestones and royalties from Lundbeck in relation to
Selincro sales.
On May 29, 2015, the Company announced that it had completed the issuance of in
total 220,400,001 convertible notes and 220,400,001 warrants, which may be
exercised at an exercise price of ?0.17 within a period of five years starting
six months after their date of issue, to certain US investors and certain
existing shareholders pursuant to the authorization granted by the Annual
General Meeting of shareholders on May 26, 2015. The total principal amount
raised from the issuance of the convertible notes was ?33.1 million. The
warrants were issued free of charge to the subscribers of the convertible notes.
On June 16, 2015, the Company announced that it had closed its US public
offering. It was confirmed that the Company had offered 3,806,047 American
Depositary Shares (ADS) in its US public offering at a price to the public of
$14.888 per ADS for gross proceeds of $56.7 million (?50.2 million at the fixed
ECB exchange rate of $1.1279 per euro as at June 10, 2015, the date of pricing).
The share to ADS ratio is 80 to one, and the ADS represent 304,483,760 newly
issued shares in the Company with a subscription price of ?0.165 (rounded
figure) per new share (at the above mentioned fixed exchange rate). This
includes the full exercise of the underwriters' over-allotment option. The
issuance of new shares by the Company for the purpose of the completion of the
US public offering was based on the authorization granted by the Annual General
Meeting of shareholders on May 26, 2015. Following the completion of the US
public offering the automatic conversion of the convertible notes issued by the
Company to certain US investors and existing shareholders and the issue of
220,400,001 new shares to such noteholders at the pre-determined conversion
price of ?0.15 per new share has also been effected.
We have no ongoing material financial commitments, such as lines of credit or
guarantees, which are expected to affect our liquidity over the next five years,
other than research and development loans, some of which are due for repayment
as described in note 13 to the unaudited condensed consolidated financial
statements for the nine months ended September 30, 2015.
Personnel
During the reporting period January - September 2015 (2014), the average number
of employees amounted to 38 (35) and at the end of the reporting period, Biotie
employed 39 people (35 people).
Equity rights
Swiss Option Plan
The Swiss company Biotie Therapies AG has a stock option plan under which stock
options have been granted to employees, directors and consultants. In connection
with the completion of the acquisition of Synosia, the option plan was amended
so that instead of shares in Synosia an aggregate maximum of 14,912,155 shares
in Biotie may be subscribed for based on the plan.
The Swiss subsidiary holds and has held Biotie's shares and such shares have
been conveyed to satisfy the terms and conditions of the Swiss option plan. The
conveyed shares previously held by the Company's subsidiary have been treated as
treasury shares and such shares have not carried any voting rights. As of
September 30, 2015 a total of 9,794,865 shares have already been delivered on
the basis of the Swiss option plan. As a result of certain of the stock options
being cancelled, a total of 2,053,134 stock options remain outstanding and as a
result, the outstanding shares and votes of Biotie may be further increased.
As at September 30, 2015, Biotie Therapies AG holds 2,605,691 shares in the
Company as treasury shares to settle the remaining options.
2011 Plans
In December 2011, the Board of Directors of Biotie approved two share-based
incentive plans for the Group employees; a stock option plan for mainly its
European employees and an equity incentive plan for mainly its US employees
(together the 2011 plans).
On December 17, 2014, pursuant to the authorization of the Annual General
Meeting of Shareholders held on April 3, 2014, the Board of Directors resolved
to issue 2,447,375 new 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 conveying them to employees
entitled to the shares pursuant to the terms and conditions of the 2011 plans.
The treasury shares are of the same class as the existing shares in the Company.
The shares were registered in the Finnish Trade Register on December 23, 2014.
At September 30, 2015 none of these shares were still held by the Company.
Stock Option Plan 2011: The maximum total number of stock options issued is
7,401,000, and they entitle their owners to subscribe for a maximum total of
7,401,000 new shares in the company or existing shares held by the company.
After giving effect to shares already issued, forfeitures and some of the
instruments based on the plan having been left unallocated, a maximum of
1,957,500 shares on September 30, 2015 may still be issued pursuant to the plan.
A total of 1,793,000 shares were subscribed for during the period January -
September 2015 under the plan and 1,793,000 of the treasury shares issued on
December 17, 2014 were used for these share subscriptions.
Equity Incentive Plan 2011: The maximum number of share units to be granted and
the number of corresponding shares to be delivered on the basis of the plan will
be total of 4,599,000 shares. However, due to share issues already made pursuant
to the plan, forfeitures and some of the instruments based on the plan having
been left unallocated, a maximum of 660,000 shares on September 30, 2015 may
still be issued pursuant to the plan.
A total of 654,375 shares have been conveyed to employees without consideration
during the period January - September 2015 pursuant to the authorization of the
Annual General Meeting of the Shareholders held on April 3, 2014 under the plan
and 654,375 of the treasury shares issued on December 17, 2014 have been used
for these share conveyances.
2014 Plans
On January 2, 2014 the Board of Directors of Biotie approved three year
incentive plans for employees. A stock option plan mainly for its European
employees and an equity incentive plan mainly for its US employees.
Stock Option Plan 2014: The maximum total number of stock options to be awarded
is 10,337,500, of which 4,320,000 relate to the Senior Management team only.
Stock options entitle their owners to subscribe for a maximum total of
10,337,500 new shares in the company or existing shares held by the Company. The
Board of Directors shall decide on the distribution of the stock options.
Equity Incentive Plan 2014: The maximum number of share units to be granted and
the number of corresponding shares to be delivered under the plan will be a
total of 14,002,500 shares, of which 2,520,000 relate to the Senior Management
team only.
Available Facilities
Biotie has a standby equity distribution agreement (SEDA) in place with US fund
Yorkville. Yorkville is under certain pre-agreed terms and conditions obliged to
subscribe and pay for Biotie shares in multiple tranches up to a total value of
?20 million during the period until November 12, 2015 at Biotie's discretion.
The purpose of this arrangement is to have an option to secure the financing of
Biotie's working capital in the short and medium term. Biotie last made use of
this arrangement in 2010, raising a total amount of ?1.1 million, but since then
has not conveyed any shares under this agreement.
Share capital and shares
After the US public offering, which closed on June 16, 2015, Biotie has shares
quoted on NASDAQ OMX (Small Cap) in Helsinki (ticker: BTH1V) and American
Depositary Shares (ADS) quoted on NASDAQ (Global Select Market) in the United
States (ticker: BITI), where each ADS represents 80 of the Company's shares. The
Company's shares all have equal rights and each share entitles the holder to one
vote at the general meeting of shareholders.
On September 30, 2015 the registered number of shares in Biotie Therapies Corp.
was 980,851,935. Of these shares 2,605,691 were held by the Company or its group
companies. The registered share capital of Biotie was ?279,218,058.55 (FAS).
Market capitalization and trading
The key data for each of the shares listed in Helsinki and the ADS listed in the
United States during the nine month period ended September 30 2015 is shown
below.
Shares listed ADS listed
in Helsinki in the United States*
-------------------------------------------------------------------------------
Price at end of period ?0.16 $13.09
Highest price during period ?0.26 $25.39
Lowest price during period ?0.14 $12.77
Average price during period ?0.20 $18.17
Market capitalization at end of ?154 million $159.7 million
period
Trading volume during period 157,665,690 shares 6,085,578 ADS
Turnover during period ?31.3 thousand $114.0 thousand
* All trading information in relation to ADS listed on the NASDAQ market in the
United States relates to the period since June 11, 2015, which was the first day
of trading on that market.
Annual General Meeting
The Annual General Meeting of Biotie Therapies Corp. was held on May 26, 2015
and the resolutions of the meeting were published in a stock exchange release on
the same day.
Risks and uncertainties
A detailed analysis of the risks that Biotie faces are set out in the Company's
Registration Statement on Form F-1 as filed with the U.S. Securities and
Exchange Commission on June 10, 2015 and the following summary of the key risks
should be read in conjunction with that document.
* We have incurred net losses since our inception and anticipate that we will
continue to incur substantial operating losses for the foreseeable future.
As of September 30, 2015, our retained earnings were an accumulated deficit
of ?177.6 million. We may never achieve or sustain profitability.
* Impairment charges or write-downs on our assets could have a significant
impact on our results of operations and financial results.
* We depend significantly on the success of tozadenant and our other product
candidates. Tozadenant and our other product candidates are still in
clinical development. If our clinical trials are not successful, we do not
obtain regulatory approval or we are unable, or unable to find a partner, to
commercialize tozadenant or our other product candidates, or we experience
significant delays in doing so, our business, financial condition and
results of operations will be materially adversely affected.
* Clinical drug development involves a lengthy and expensive process with
uncertain timelines and uncertain outcomes.
* The results of previous clinical trials may not be predictive of future
results and clinical trials of product candidates may not be successful.
* Clinical development, regulatory review and approval by the FDA, the EMA and
comparable foreign regulatory authorities are lengthy, time consuming,
expensive and inherently unpredictable activities. If we are ultimately
unable to obtain regulatory approval for our product candidates, our
business will be substantially harmed.
* The FDA's agreement to our SPA for our Phase 3 trial of tozadenant does not
guarantee any particular outcome from regulatory review, including ultimate
approval and may not lead to a faster development or regulatory review or
approval process.
* Collaborations on products and product candidates are important to our
business, and future collaborations may also be important to us. If we are
unable to maintain any of these collaborations, if these collaborations are
not successful, or if we fail to enter into new strategic relationships, our
business could be adversely affected.
* We rely on third parties to conduct our nonclinical and clinical trials and
perform other tasks for us. If these third parties do not successfully carry
out their contractual duties, meet expected deadlines, or comply with
regulatory requirements, we may not be able to obtain regulatory approval
for, or commercialize, our product candidates and our business could be
substantially harmed.
* We currently rely on third-party suppliers and other third parties for
production of our product candidates and our dependence on these third
parties may impair the advancement of our research and development programs
and the development of our product candidates.
* If we are unable to obtain and maintain sufficient intellectual property
protection for our product or product candidates, or if the scope of our
intellectual property protection is not sufficiently broad, our ability to
commercialize our product and product candidates successfully and to compete
effectively may be adversely affected.
* Our relationships with healthcare professionals, institutional providers,
principal investigators, consultants, customers (actual and potential) and
third party payors are, and will continue to be, subject, directly and
indirectly, to health care fraud and abuse, false claims, marketing
expenditure tracking and disclosure, government report pricing, and health
information privacy and security laws. If we are unable to comply, or have
not fully complied, with such laws, we could face penalties, including,
without limitation, civil, criminal and administrative penalties, damages,
fines, exclusion from government-funded health care programs and the
curtailment or restructuring of our operations.
* We cannot assure of the adequacy of our capital resources to successfully
complete the development and commercialization of our product candidates,
and a failure to obtain additional capital, if needed, could force us to
delay, limit, reduce or terminate our product development or
commercialization efforts. The adequacy of our capital resources is
particularly dependent on cash generation from milestones and royalties in
connection with sales of Selincro and other sources of non-dilutive funding.
* As a foreign private issuer in the United States, we are permitted to adopt
certain Finnish practices in relation to corporate governance matters that
differ significantly from NASDAQ corporate governance listing standards.
These practices may afford less protection to shareholders than they would
enjoy if we complied fully with corporate governance listing standards in
the United States.
Biotie continues to face a number of potential risks and uncertainties which
could have a material effect on the Group's performance over the remaining three
months of the financial year and thereafter and could cause actual results to
differ from expected and historical results.
Outlook for 2015 and key upcoming milestones
Selincro(®) (nalmefene): Biotie anticipates that Lundbeck will continue to make
sales 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): The Phase 3 clinical study, which is expected to be the
second pivotal study required for registration, commenced patient recruitment in
July 2015. Top-line data from the double-blind part of the study is expected by
the end of 2017, 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: 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 by the end 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 interim analysis in this two-stage study.
Financial: During the remainder of 2015, the Company expects to continue
receiving Selincro royalties from Lundbeck. Research and development expenses
will continue on all development products, with the tozadenant Phase 3 study now
recruiting patients. Following the financing received from the convertible notes
and the US public offering in Q2 2015, the Company has a strong level of liquid
resources that are expected to be sufficient for all the Company's currently
planned 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, funded largely by non-
dilutive financing, are both expected to reach significant potential inflection
points by the end of 2016.
Key events after the reporting period
Biotie announced on October 7, 2015 that, pursuant to the authorization of the
Annual General Meeting of Shareholders held on May 26, 2015, the Board of
Directors of Biotie has resolved to issue 106,088,336 shares to the Company
itself without consideration in accordance with Chapter 9 Section 20 of the
Finnish Companies Act (624/2006, as amended). The Treasury Shares are issued to
facilitate the timely delivery by the Company of such Treasury Shares underlying
the warrants issued in May 2015 to certain US investors and certain existing
shareholders based on the authorization granted by the Annual General Meeting of
the Company on May 26, 2015, if and when such above-mentioned warrants are
exercised.
The Treasury Shares were registered with the Finnish Trade Register on October
8, 2015, and admitted trading on NASDAQ OMX Helsinki Ltd on October 9, 2015. The
Treasury Shares are of the same class as the existing shares in the Company.
As a result of this Biotie has 1,086,940,271 shares in total of which
978,246,244 will be outstanding shares.
Biotie announced on November 2, 2015 the change in the number of votes relating
to the Swiss subsidiary of the Company, Biotie Therapies AG (previously Synosia
Therapeutics Holding AG and Biotie Therapies Holding AG) conveyed Biotie shares
against consideration pursuant to the option programs in October in total 7,739.
After the conveyances the total amount of voting rights is 978,253,983 and the
number of the Company's share held by the Biotie Group is 108,686,288 (9.99 per
cent). The conveyance does not affect the number of registered shares (total
1,086,940,271).
Conference call
An analyst and media conference call will take place on 12 November 2015 3:00 pm
Finnish time (8:00 pm Eastern 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
US callers: +1212 444 0412
UK callers: +44(0)20 3427 1900
Finnish callers: +358(0)9 6937 9543
Access code: 1072486
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 in 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.
Biotie's shares are listed on NASDAQ Helsinki (BTH1V) and ADS on Nasdaq Stock
Market LLC (BITI).
Group structure: The parent company of the group is Biotie Therapies Corp. The
domicile of the company is Turku, Finland. The Company has two operative
subsidiaries, Biotie Therapies Inc, located in South San Francisco, United
States of America and Biotie Therapies AG, located in Zurich, Switzerland.
The Group also has two non-operational subsidiaries, Biotie Therapies GmbH
located in Radebeul, Germany and Biotie Therapies International Ltd located in
Finland.
Forward looking statements: This interim report may contain statements that
constitute "forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements are statements other than historical fact and may
include statements that address future operating, financial or business
performance or Biotie's strategies or expectations. In some cases, you can
identify these statements by forward-looking words such as "may," "might,"
"will," "should," "expects," "plans," "anticipates," "believes," "estimates,"
"predicts," "projects," "potential," "outlook" or "continue," and other
comparable terminology. Forward-looking statements are based on management's
current expectations and beliefs and involve significant risks and uncertainties
that could cause actual results, developments and business decisions to differ
materially from those contemplated by these statements. These risks and
uncertainties include, but are not limited to, the timing and conduct of
clinical trials of Biotie's product candidates, plans to pursue research and
development of product candidates, the clinical utility of Biotie's product
candidates, the timing or likelihood of regulatory filings and approvals,
Biotie's intellectual property position, expectations regarding payments under
Biotie's collaborations and Biotie's competitive position. These risks and
uncertainties also include those described under the captions "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" in Biotie's Registration Statement on Form F-1 and future filings
with the Securities and Exchange Commission. Forward-looking statements speak
only as of the date they are made, and Biotie does not undertake any obligation
to update them in light of new information, future developments or otherwise,
except as may be required under applicable law. All forward-looking statements
are qualified in their entirety by this cautionary statement.
Turku, 12 November 2015
Biotie Therapies Corp.
Board of Directors
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (UNAUDITED)
For the three month For the nine month period
period ended September ended September 30,
30,
(? in thousands, except Note 2015 2014 2015 2014
per share data)
Revenue 3 786 7,192 2,987 13,051
Research and (7,252) (4,221) (19,611) (11,931)
development expenses
General and (2,189) (1,587) (5,694) (5,257)
administrative expenses
Other operating income 169 507 235 776
-------------------------------------------------------------------------------
Operating (loss)/profit (8,486) 1,891 (22,083) (3,361)
Interest income 2 1 3 4
Interest expenses (171) (175) (478) (486)
Other net financial 735 1,210 (260) 1,198
income (expenses)
-------------------------------------------------------------------------------
(Loss)/profit before (7,920) 2,927 (22,818) (2,645)
taxes
Income tax 4 - - - -
-------------------------------------------------------------------------------
Net (loss)/profit (7,920) 2,927 (22,818) (2,645)
-------------------------------------------------------------------------------
Other comprehensive
income
Items that may be
subsequently
reclassified to profit
or loss:
Currency translation (1,978) 3,913 5,060 4,866
differences*
-------------------------------------------------------------------------------
Total other (1,978) 3,913 5,060 4,866
comprehensive (loss)/
income
-------------------------------------------------------------------------------
Total comprehensive (9,898) 6,840 (17,758) 2,220
(loss)/income
-------------------------------------------------------------------------------
Net (loss)/income (7,920) 2,927 (22,818) (2,645)
attributable to equity
holders of the parent
Total comprehensive (9,898) 6,840 (17,758) 2,221
(loss)/income
attributable to equity
holders of the parent
Loss/(earnings) per
share (EPS) basic & 5 (0.01) 0.01 (0.03) (0.01)
diluted, ?
*The translation differences mainly arise in relation to in-process R&D assets
and goodwill. The movement for the nine month period ended September 30, 2015 is
due to the significant devaluation in the Euro against the United States Dollar
and Swiss Franc mainly during the three month period ended March 31, 2015.
All activities relate to continuing operations.
The accompanying notes are an integral part of these condensed consolidated
interim financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
As at As at
September 30, December 31,
2015 2014
(? in thousands) Note (unaudited)
-------------------------------------------------------------------------------
ASSETS
Non-current assets
Intangible assets 6 51,555 47,356
Goodwill 6 6,328 5,799
Property, plant and equipment 7 609 653
Non-current pre-payments 8 3,590 -
Other financial assets 337 324
-------------------------------------------------------------------------------
Total non-current assets 62,419 54,132
-------------------------------------------------------------------------------
Current assets
Accounts receivable and other receivables 1,965 1,806
Financial assets at fair value through profit 9 26,471 24,941
or loss
Cash and cash equivalents 57,549 7,452
-------------------------------------------------------------------------------
Total current assets 85,985 34,199
-------------------------------------------------------------------------------
Total assets 148,404 88,331
-------------------------------------------------------------------------------
EQUITY AND LIABILITIES
Shareholders' equity
Share capital 11 267,418 193,285
Reserve for invested unrestricted equity 5,417 5,378
Other reserves 14,089 9,029
Retained earnings (177,257) (155,069)
-------------------------------------------------------------------------------
Total equity 109,667 52,623
-------------------------------------------------------------------------------
Non-current liabilities
Non-current financial liabilities 9 20,690 20,690
Pension benefit obligation 670 670
Other non-current liabilities 10,143 9,671
Non-current deferred revenues 2,000 2,000
-------------------------------------------------------------------------------
Total non-current liabilities 33,503 33,031
Current liabilities
Accounts payable and other current liabilities 5,234 2,677
-------------------------------------------------------------------------------
Total current liabilities 5,234 2,677
-------------------------------------------------------------------------------
Total liabilities 38,737 35,708
-------------------------------------------------------------------------------
Total shareholders' equity and liabilities 148,404 88,331
-------------------------------------------------------------------------------
The accompanying notes are an integral part of these condensed consolidated
interim financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (UNaudited)
Attributable to equity holders of the parent company
Reserve Share-
for invested holders'
Share unrestricted Other Retained equity
(? in thousands) Note capital equity reserves earnings total
-------------------------------------------------------------------------------
Balance at January 193,285 5,252 2,517 (120,688) 80,366
1, 2014
-------------------------------------------------------------------------------
Net loss for the - - - (2,645) (2,645)
period
Other comprehensive - - 4,866 - 4,866
income
-------------------------------------------------------------------------------
Total comprehensive - - 4,866 (2,645) 2,221
income (loss)
Share based 12 - - - 596 596
compensation
Options and RSU 12 - 86 - - 86
exercised
-------------------------------------------------------------------------------
- 86 4,866 (2,049) 2,903
-------------------------------------------------------------------------------
Balance at 193,285 5,338 7,383 (122,737) 83,269
September 30, 2014
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Balance at January 193,285 5,378 9,029 (155,069) 52,623
1, 2015
-------------------------------------------------------------------------------
Net loss for the - - - (22,818) (22,818)
period
Other comprehensive - - 5,060 - 5,060
income
-------------------------------------------------------------------------------
Total comprehensive - - 5,060 (22,818) (17,758)
income (loss)
Share based 12 - - - 630 630
compensation
Options and RSU 12 - 39 - - 39
exercised
Issue of 11 33,060 - - - 33,060
convertible notes
and warrants
Transaction costs (2,844) - - - (2,844)
related to
convertible note
issue
Issue of share 11 50,239 - - - 50,239
capital
Transaction costs (6,322) - - - (6,322)
related to share
issue
-------------------------------------------------------------------------------
74,133 39 5,060 (22,188) 57,044
-------------------------------------------------------------------------------
Balance at 267,418 5,417 14,089 (177,257) 109,667
September 30, 2015
-------------------------------------------------------------------------------
The accompanying notes are an integral part of these condensed consolidated
interim financial statements
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
For the nine month period ended
September 30,
(? in thousands) Note 2015 2014
-------------------------------------------------------------------------------
Cash flow from operating
activities
Net loss (22,818) (2,645)
Adjustments for:
Non-cash transactions 13 412 466
Interest income (3) (4)
Interest expenses 478 486
Other net financial income 260 (1,198)
(expenses)
Change in working capital:
Change in accounts receivables and (3,638) (3,601)
other receivables
Change in accounts payable and 2,287 (2,325)
other liabilities
Change in deferred revenue - (1,415)
Interest paid (27) (27)
-------------------------------------------------------------------------------
Net cash used in operating (23,049) (10,263)
activities
-------------------------------------------------------------------------------
Cash flow from investing
activities
Investments in financial assets at (30,588) -
fair value through profit and loss
Proceeds from sale of financial 29,488 4,440
assets at fair value through
profit and loss
Proceeds from sale of investment - 1,350
property
Change in other financial assets - (51)
Investments in property, plant and (87) (133)
equipment
Investments in intangible assets (14) (30)
-------------------------------------------------------------------------------
Net cash (used in)/from investing (1,201) 5,576
activities
-------------------------------------------------------------------------------
Cash flow from financing
activities
Proceeds from option exercise and 39 86
RSU delivery
Net proceeds from convertible note 30,216 -
and warrants issue
Net proceeds from share issue 44,085 -
-------------------------------------------------------------------------------
Net cash from financing activities 74,340 86
-------------------------------------------------------------------------------
Net increase in cash and cash 50,089 (4,601)
equivalents
Effect of changes in exchange 8 (27)
rates on cash and cash equivalents
Cash and cash equivalents at the 7,452 10,221
beginning of the period
-------------------------------------------------------------------------------
Cash and cash equivalents at the 57,549 5,593
end of the period
-------------------------------------------------------------------------------
The accompanying notes are an integral part of these condensed consolidated
interim financial statements
notes to the UNAUDITED condensed CONSOLIDATED finAncIAl statements
1. General Information
Biotie Therapies Oyj ("Biotie" or the "Company") is a specialized drug
development company incorporated and domiciled in Finland, with its headquarters
at Joukahaisenkatu 6, Turku, Finland, focused on products for neurodegenerative
and psychiatric disorders. Biotie operates primarily in Finland and in the
United States. 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 in
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, a rare fibrotic disease of the liver. Biotie's
shares are listed on NASDAQ Helsinki (BTH1V) and on Nasdaq Stock Market LLC
(BITI). As used in these condensed consolidated financial statements, unless the
context indicates otherwise, all references to "Biotie" or the "Comp
Unternehmensinformation / Kurzprofil:
Datum: 12.11.2015 - 08:00 Uhr
Sprache: Deutsch
News-ID 434004
Anzahl Zeichen: 65643
contact information:
Town:
Turku
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 190 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Biotie interim report 1 January - 30 September 2015"
steht unter der journalistisch-redaktionellen Verantwortung von
Biotie Therapies Oyj (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
