ThromboGenics Business Update H1 2015
(Thomson Reuters ONE) -
Regulated information
US organisation right-sized to meet current market needs
targeting break-even in US from 2016
ThromboGenics clinical and pre-clinical programs
progressing as planned - focus on diabetic eye disease
ThromboGenics confirms cash guidance for FY15
Cash position to support current business plans for at least 3 years
Highlights
Financial
* For the first half of 2015 ending June 30 2015, ThromboGenics reports total
revenues of ?6.0 million, including ?4.25 million of JETREA® sales in the US
and ?1.75 million in royalties from Alcon based on its ex-US sales of
JETREA®. This compares to ?5 million of JETREA® sales in the US and royalty
income of ?1.7 million reported for the same period in 2014. For the period
H2 2014, ThromboGenics reported ?3.8 million of JETREA® sales in the US and
a royalty income of ?1.7 million.
* Cash and investments were ?113.3 million as of the end of June 2015,
compared with ?127.1 million at the end of December 2014
* ThromboGenics' decision to reduce the size of its US organization so that
it is cash flow neutral in 2016 means that its current cash resources,
plus the anticipated royalties from Alcon, will be sufficient to support its
business plans for at least 3 years.
JETREA(® )in the US
* JETREA(®) achieved sales in US of ?4.2 million in the first half of 2015.
There has been no meaningful change in sales momentum despite additional
positive real world data that has been released in recent months
* ThromboGenics is adjusting its US organisation to current market needs
* ThromboGenics, Inc. will become a leaner customer-centric organisation. It
will supply JETREA(® )via its existing distribution network, and will
provide responsive medical and scientific data-driven support to the retina
community. The Company will continue to support physicians' efforts to
enhance patient awareness of the options available for treating symptomatic
VMA
* US retina physicians who wish to treat patients with JETREA(® )will continue
to have full access to the product and to receive scientific and medical
support
JETREA(® )outside the US
* ThromboGenics received ? 1.7 million in royalty income from its partner
Alcon in the first half of 2015 (? 1.7 million for H1 2014)
* Alcon continues to gain new marketing and reimbursement approvals and to
execute commercial launches of JETREA(® )across Europe and Rest of the World
(RoW)
* JETREA(® )is now approved in 53 countries globally and reimbursement is
secured in over 20 countries
Pre-clinical Research & Clinical Development
* ThromboGenics reported positive top-line results from the OASIS study in
March 2015. This randomized controlled study met its primary endpoint with
41.7% of patients treated with JETREA(®) achieving VMA resolution at day 28
post injection compared with only 6.2% of patients who received a sham
injection (p<0.001). The study also showed that the JETREA(®) safety profile
in this 24 month follow-up study was consistent with the drug's overall
safety profile as known from the approved label
* ThromboGenics remains on track to initiate its Phase IIa clinical study
assessing JETREA(® )for the treatment of diabetic retinopathy (DR) around
the end of 2015. A recent report from the American Academy of Ophthalmology
projects that by 2020 there will be 1.34 million people in the US with
vision-threatening DR.
* ThromboGenics is also evaluating the development of JETREA(® )for the
enzymatic treatment of Retinal Vein Occlusion (RVO). First in-vivo tests
have been completed, and the results are currently being processed for
publication in a peer-reviewed scientific publication
* New compounds under pre-clinical evaluation - focus is on diabetic eye
disease.
* Company plans to host an R&D Investor Event in late 2015/early 2016 at which
the Company will provide a review of its clinical and development pipeline
going forward.
Oncurious
* ThromboGenics spun out its oncology research activities into Oncurious NV, a
newly incorporated company in which ThromboGenics is the majority
shareholder. This company has been founded in conjunction with VIB (Flanders
Institute for Biotechnology). This new venture is initially focusing on
developing TB-403 for the treatment of medulloblastoma, the most common form
of brain cancer in children
* Oncurious is on track to commence a Phase I/IIa study before the end of 2015
Appointments
* Dominique Vanfleteren appointed ThromboGenics' Chief Financial Officer (CFO)
in January 2015
* Emmanuèle Attout appointed Independent Non-Executive Director of the Board
of ThromboGenics NV on May 5, 2015
* Baron Philippe Vlerick appointed Non-Executive Director of the Board of
ThromboGenics NV at an extraordinary shareholders' assembly that took place
on August 20, 2015
Leuven, Belgium - 26 August 2015 - ThromboGenics NV (Euronext Brussels: THR), an
integrated biopharmaceutical company focused on developing and commercializing
innovative medicines for treatment of vitreo-retinal disorders, today issues a
business and financial update for the six months ending 30 June, 2015.
ThromboGenics today has announced a re-sizing of its US organization to reflect
the current market demand for JETREA(®). A new leaner organization will be
responsible for providing distribution services, customer support and on-going
medical education for JETREA(®).
This change is designed to ensure that the Company's US operations are cash flow
neutral as of 2016. As a result of today's announcement, ThromboGenics expects
that the income from JETREA(®), including the royalty income from Alcon, should
become a source of cash to support the Company's R&D activities from 2016
onwards.
For treating physicians and their patients, nothing will change with regard to
the availability and support of the drug for use in symptomatic VMA/VMT.
ThromboGenics' strategy will continue to be focused on:
* Developing JETREA(® )in a significant new indication - Diabetic Retinopathy
* Progressing its pipeline of earlier stage projects which are focused on
developing treatments for diabetes-related vitreo-retinal diseases
* Cash generation from the commercialization of JETREA(®) (in its first
indication, sVMA/VMT), in the US and in the RoW via our partner Alcon
* Realizing value from Oncurious NV, a newly created oncology company in
which ThromboGenics is a major shareholder
Dr Patrik De Haes, ThromboGenics' CEO, said: "In recent months it has become
clear that we needed to evolve our strategy in order to generate significant
returns for our shareholders.
We remain convinced that in time JETREA(®) will be able to play a key role in
the changed standard of treatment for patients with sVMA. However this will not
result from incremental promotional efforts, but rather from new medical data
and clinical experience. This has resulted in today's announcement to make
changes to our US organization and our commercial strategy for JETREA(®).
Our smaller US team will continue to provide distribution, customer support and
medical education services for JETREA(®). US retina physicians and patients will
have continued access and support when seeking treatment with JETREA(®). These
changes are designed to make our US business cash flow neutral from 2016
onwards.
We will invest these newly freed-up resources in the further clinical
development of JETREA(®) in diabetic retinopathy, a very significant next
indication where there is a clear need for improved treatment options. Our Phase
II clinical trial in this indication remains on track to initiate around the end
of this year.
Our current cash resources of over ?100 million, along with anticipated royalty
income, should support the internal development of next-generation ophthalmology
products in diabetic eye disease for at least the next 3 years. This timeframe
will allow us to generate the clinical data needed to demonstrate the value of a
number of our pipeline projects.
Oncurious NV, a new oncology company we have set up with VIB, with ThromboGenics
NV as the majority shareholder, holds great potential to generate incremental
longer term value to our shareholders. The Phase I/IIa clinical trial planning
for TB-403 in medulloblastoma is progressing well and we expect to recruit the
first patient later this year.
Commercial Activities
JETREA(®) in the US
In the first half of 2015, ThromboGenics generated JETREA(® )sales of ?4.2
million. This was below the Company's expectations as the uplift in sales, which
was anticipated following the release of additional positive real-world data,
did not materialize.
This trend in sales has led the Company to change its commercial strategy in the
US. This change will lead to a smaller organization focused on providing
distribution, customer support and medical education services for JETREA(®). US
retina physicians will continue to have access to JETREA(® )to treat appropriate
patients with symptomatic vitreomacular adhesion (sVMA).
This adjustment to the commercial strategy should lead to ThromboGenics' US
operations being cash-flow neutral from 2016 onwards.
OASIS study - Positive Top-Line Results
In April, ThromboGenics announced positive top-line results from its OASIS study
"Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion including
Macular Hole" with JETREA(®) (ocriplasmin).
The OASIS study (n=220 patients) is a randomized, sham-controlled, double-masked
study that followed patients for 24 months post-injection. The study was
designed to provide long term and well-controlled efficacy and safety data for
JETREA(®) in patients being treated for symptomatic vitreomacular adhesion
(sVMA). The 24 month follow-up data is the longest period patients have been
studied post-treatment with this novel medicine.
The key findings of the OASIS study were as follows:
* 41.7% of patients treated with JETREA(®) achieved VMA resolution at Day 28
post injection compared with only 6.2% of patients who received a sham
injection (p<0.001); and
* The JETREA(®) safety profile in this 24 month follow up study was consistent
with the drug's overall safety profile as known from the approved label. No
new types of safety events were identified.
The OASIS data illustrate the importance of improved patient selection in order
to generate higher rates of VMA resolution with JETREA(®). It is known that an
epiretinal membrane (ERM) often adversely impacts the efficacy of JETREA(®).
Approximately 20% of the recruited patients in the OASIS study had an ERM
(despite it being one of the exclusion criteria, indicating the challenge of
accurately diagnosing this condition), suggesting that the 41.7% overall
resolution rate at day 28 post-injection could have been even higher. This
underscores the message that careful patient selection will lead to better
treatment outcomes.
Further analysis of all of the OASIS data, which will be interpreted with the
help of retina physicians, is ongoing. The results from these analyses are
planned to be shared with the retina community at the American Academy of
Ophthalmology conference of November 14 - 17, 2015.
ORBIT study
In March 2014, ThromboGenics launched the "Ocriplasmin Research to Better Inform
Treatment" (ORBIT) study.
This prospective, observational study is designed to assess clinical outcomes
and the safety of JETREA(® )administered in a real-world setting for the
treatment of symptomatic VMA by assessing both anatomical and functional
outcomes.
Six month data from the ORBIT study, were presented in a poster at the
Association for Research in Vision and Ophthalmology (ARVO) conference May 3-7
in Denver, Colorado.
The study showed that 58.1% of patients experienced sVMA/VMT resolution within
one month post-treatment. The study also showed that the safety of JETREA(®) was
consistent with the product's label and the data from the Phase III clinical
trials.
More JETREA(® )real-world data were the subject of several scientific poster
presentations that were delivered at the recent ARVO 2015 meeting.
JETREA(®) in Europe and RoW
ThromboGenics received ? 1.7 million in royalty income from its partner Alcon in
the first half of 2015 (? 1.7 million in H1 2014)
Alcon is continuing to commercialize JETREA(®) in its RoW territory. In
February, JETREA(®) was approved in Argentina, Israel and the Philippines.
In April, JETREA(®) was approved in New Zealand. This was the product's 52(nd)
approval outside the US.
Also in April the new ready-diluted formulation of JETREA(® )gained final EU
approval.
The planned launch of this new formulation of JETREA(®) will eliminate the
preparatory dilution steps prior to injection. At the point of administration
into the eye, the strength, potency, composition and pharmaceutical form of the
ready-diluted formulation remain identical to the currently available
formulation after dilution.
Research & Development Activities
Diabetic Retinopathy - A substantial potential new Indication for JETREA(®)
The Company is developing JETREA(® )for DR as part of its strategy to maximize
the value-creating opportunities for this novel drug and fill unmet medical
needs.
ThromboGenics' decision to develop JETREA(®) for the treatment of DR is based on
a scientific rationale that supports its utility in treating patients suffering
from this important sight-threatening condition before their disease progresses.
Research has shown that the presence of a posterior vitreous detachment (PVD),
where the vitreous is separated from the retina, may prevent the growth of new
blood vessels that are responsible for proliferative DR (PDR). This finding has
been reinforced by the fact that PDR is rare in patients who have a posterior
vitreous detachment.
JETREA(® )is able to generate a PVD by cleaving the protein linkages between the
vitreous and the retina and by liquefying the vitreous itself.
The Company and its clinical advisors believe that by using JETREA(®) to
generate a PVD, the development of the new blood vessels that cause PDR can be
prevented. This is because the new blood vessels will no longer be able to use
the vitreous as scaffolding and grow along the surface of the retina or into the
vitreous.
Given the growing number of diabetic patients in the US, it is clear that the
number of patients who are anticipated to suffer from diabetes-related eye
diseases, including diabetic retinopathy, is expected to increase substantially.
A recent report from the American Academy of Ophthalmology has projected that
the prevalence of individuals with any form of diabetic retinopathy in the
United States in the year 2020 will be 6 million people, of whom 1.34 million
persons will have vision-threatening DR.
ThromboGenics remains on track to initiate the planned Phase IIa DR trial with
JETREA(®) around the end of 2015.
Retinal Vein Occlusion - Lysing blood clots with JETREA(® )
In April, ThromboGenics announced that it would be evaluating JETREA(® )for the
treatment of retinal vein occlusion.
Retinal Vein Occlusion (RVO) is the second most common retinal vascular disease,
and thought to negatively impact the quality of life of 16 million patients
worldwide.
RVO is caused by the formation of clots in either the central retinal vein or in
branch retinal veins, which can profoundly affect visual acuity.
This new vitreo-retinal project with JETREA(® )aims to demonstrate the potential
of using locally delivered ocriplasmin for lysing the blood clots (in the
retinal veins) that are responsible for this condition.
ThromboGenics has secured a ?0.6 million grant from the Flemish Agency for
Innovation by Science and Technology (IWT) and will use this to collaborate with
the Ophthalmology Department of the University Hospital UZLeuven in Belgium to
further evaluate this potential indication. The IWT grant will also support a
partnership with the Mechanical Engineering Department of the KU Leuven to
develop a robotics-assisted system which has the ability to deliver the local
administration of ocriplasmin directly in the retinal veins.
The first RVO in vivo tests have been completed, and results are currently being
processed. The Company intends to work towards a scientific publication of these
findings.
Oncurious NV - A new oncology company
In April, ThromboGenics announced the formation of Oncurious NV, a new oncology
company that will develop TB-403 for the treatment of pediatric brain tumors.
Oncurious is a joint venture between ThromboGenics and VIB, the leading life
sciences institute in Flanders (Belgium). ThromboGenics is the majority
shareholder of Oncurious.
TB-403 is a humanized monoclonal antibody against placental growth factor
(PlGF). PlGF is expressed in several types of cancer, including medulloblastoma.
High expression of the PlGF receptor neuropilin 1 has been shown to correlate
with poor overall survival. Medulloblastoma is a rare, life-threatening brain
tumor that mainly affects children.
Treatment with TB-403 in relevant animal models for medulloblastoma has
demonstrated beneficial effects on tumour growth and survival.
The favourable safety profile of TB-403 has already been demonstrated in
clinical trials in patients with other diseases.
Oncurious will initiate a Phase I/IIa program with TB-403 in medulloblastoma
patients with the first patient expected to be enrolled by the end of 2015.
ThromboGenics plans to host an R&D Investor Event in late 2015/early 2016 at
which the Company will provide a detailed review of its clinical and development
pipeline.
Appointments
Emmanuèle Attout - Appointed Independent Non-Executive Director
In January, ThromboGenics nominated Emmanuèle Attout to be its new independent
non-executive director. Mrs. Attout was appointed during the ThromboGenics
Annual Shareholders Meeting of May 5, 2015. Due to her accounting and auditing
expertise, she is also a member of the Audit Committee of the Company.
Mrs. Attout was an audit partner at PricewaterhouseCoopers from 1994 till 2014.
She has been in charge of the audits for a wide range of clients, including in
recent years publicly-listed pharmaceutical companies and life sciences
businesses.
Baron Philippe Vlerick - Appointed Non-Executive Director
In May, Baron Philippe Vlerick was appointed as a non-executive member of the
Board of ThromboGenics NV. His appointment was confirmed at an extraordinary
shareholders' assembly that took place on August 20th.
Philippe Vlerick is the owner, Chairman and CEO of several businesses in Belgium
and abroad. He currently serves as the Chairman and Chief Executive Officer of
Vlerick Group (Belgium). He also serves as the Chairman and CEO of UCO Textiles
NV. In addition, he is the Vice-chairman of KBC Group, Corelio, smartphoto Group
and Durabilis. Baron Vlerick is also a member of the Board of Directors of
Exmar, Hamon & Cie, Besix Group and I.V.C. (Belgium).
Mr Vlerick holds a Degree in Philosophy and Law from the University of Leuven,
and an MBA General Management degree (PUB) (Ghent, Vlerick School of Management
- 1979). He also holds a Master's degree in Business Administration from Indiana
University, Bloomington (USA - 1980).
He was elected 2006 Manager of the Year by Trends, a leading business magazine
in Belgium. He was granted the title of Baron in 2008, and became Commander of
the Order of Leopold in 2013.
Dominique Vanfleteren - Appointed Chief Financial Officer
Dominique Vanfleteren was appointed as ThromboGenics' new Chief Financial
Officer (CFO) in January 2015.
Dominique Vanfleteren has over 25 years of experience in senior finance,
operational control and reporting roles with public international
biopharmaceutical companies. Before joining ThromboGenics, Mr. Vanfleteren
spent 12 years at UCB, where he held a number of senior international managerial
finance positions, the latest being the CFO of UCB's Asia Pacific Operations,
operating from Brussels and Shanghai. Prior to joining UCB, Dominique worked
for GlaxoSmithKline for 16 years.
Financial review
In the first half of 2015, ThromboGenics had total revenues of ?6.0 million,
including ?4.25 million of JETREA(®) sales in the US and ?1.75 million in
royalties from Alcon based on its ex-US sales of JETREA(®).
In the corresponding period in 2014, ThromboGenics reported ?5 million of
JETREA(®) US sales, and an ex-US royalty income of ?1.7 million.
In the second half of 2014, ThromboGenics reported ?3.8 million of JETREA(®)
sales in the US and an ex-US royalties of ?1.7 million.
In the first half of 2015, ThromboGenics' R&D expenses were ?10.3 million,
including a ?3.4 million amortization of the ocriplasmin Phase III program. This
compares with ?11.6 million of R&D expenses in the same period in 2014.
In the first half of 2015, selling and marketing expenses amounted to ?10.2
million compared with ?14.3 million in the first six months of 2014. The
reduction is largely related to the transition from a contract sales
organization to ThromboGenics' own sales team and lower marketing expenses.
For the first half of 2015, ThromboGenics reported a net loss of ?19.2 million,
or ?0.53 per share. In the corresponding period in 2014 the Company reported a
net loss of ?23.9 million or ?0.66 per share.
At the end of June 2015, ThromboGenics had ?113.3 million in cash and
investments, compared to ?127.1 at of the end of December 2014.
ThromboGenics believes that with this cash, and the anticipated royalty stream
from JETREA(®), it has the financial resources to support its activities for
at least the next 3 years.
On May 19, Baron Philippe Vlerick informed the Company that his ownership
interest in ThromboGenics' share capital had exceeded the 3% threshold.
On July 14, Biggar Ltd notified the Company that its shareholding in
ThromboGenics NV had dropped below transparency notification level.
A conference call for analysts, press and investors will be hosted by Dr Patrik
De Haes, CEO and Dominique Vanfleteren, CFO of ThromboGenics, on Wednesday 26
August, starting at 06:30 PM CEST, 12:30 PM EDT.
The dial-in numbers and participant passcode for the call are set out below:
Belgium 080040305 (Toll Free)
France 0805110270 (Toll Free)
Germany 08001016676 (Toll Free)
Ireland 1800931389 (Toll Free)
Netherlands 08009494524 (Toll Free)
United Kingdom 08002799501 (Toll Free)
United States (1) 8666765866 (Toll Free)
Click here for more international toll and toll free dial in numbers
Participant pin code: 31096974#
We request that participants dial in 5-10 minutes prior to the start time of
06:30 PM CEST, 12:30 PM EDT.
The presentation will be webcasted live, click here to register.
The presentation and transcript of the call will be made available on this page.
END
For further information please contact:
+---------------------------------------------+-------------------------------+
| | |
| ThromboGenics | Citigate Dewe Rogerson |
| | |
| Wouter Piepers, | David Dible/Malcolm Robertson |
| Global Head of Corporate Communications/ IR | |
| +32 16 75 13 10 / +32 478 33 56 32 | Tel: +44 20 7638 9571 |
| wouter.piepers(at)thrombogenics.com | David.Dible(at)citigatedr.co.uk |
| | |
+---------------------------------------------+-------------------------------+
About JETREA(® )(ocriplasmin)
JETREA(® )(ocriplasmin) is a truncated form of human plasmin. JETREA(®) acts as
a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen,
three major components of the vitreoretinal interface that play an important
role in vitreomacular adhesion.
In the US, JETREA(®) is indicated for the treatment of symptomatic vitreomacular
adhesion. In Europe, JETREA(®) is indicated for the treatment of vitreomacular
traction (VMT), including when associated with macular hole of diameter less
than or equal to 400 microns.
JETREA(® )was evaluated in two multi-center, randomized, double-masked Phase III
trials conducted in the U.S. and Europe involving 652 patients with
vitreomacular adhesion. Both studies met the primary endpoint of resolution of
VMA at day 28. This Phase III program found that 26.5% of patients treated with
ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving
placebo (p<0.01). The Phase III program also showed that JETREA was generally
well tolerated with most adverse events being transient and mild in severity.
In March 2015, ThromboGenics reported top line results from OASIS, a Phase IIIb
study. This randomized, sham controlled, double masked study followed-up
patients for 24 months post injection. In this study, retina physicians were
able to use SD-OCT to select patients with focal VMA and without Epiretinal
Membrane (ERM), two criteria which have been shown to lead to better treatment
outcomes with JETREA®. Despite this, OASIS data showed over 20% of the patients
recruited into study had ERM.
The trial showed that 41.7% of patients treated with JETREA® achieved VMA
resolution at Day 28 post injection compared with only 6.2% of patients who
received a sham injection (p<0.001); and that the drug's safety profile in the
24 month follow period was consistent with the drug's overall safety profile as
known from the approved label.
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative ophthalmic medicines. The Company's lead product,
JETREA(® )(ocriplasmin) was approved by the US FDA for the treatment of
symptomatic VMA and was launched by ThromboGenics in January 2013.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis,
for the commercialization of JETREA(®) outside the United States in 2012. To-
date JETREA(®) has been approved in over 50 countries globally.
JETREA(®) is currently being developed for diabetic retinopathy (DR), and
evaluated for retinal vein occlusion (RVO).
ThromboGenics is the major shareholder in Oncurious NV, a cancer-focused company
that was formed in April 2015 in collaboration with VIB, a leading life science
institute in Flanders (Belgium). Oncurious was created to develop TB-403
initially for medulloblastoma, the most frequent form of pediatric brain cancer.
ThromboGenics has retained the exclusive rights to use TB-403 for ophthalmic
indications.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ
(US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels
exchange under the symbol THR. More information is available at
www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking".
Such forward-looking statements are based on current expectations, and,
accordingly, entail and are influenced by various risks and uncertainties. The
Company therefore cannot provide any assurance that such forward-looking
statements will materialize and does not assume an obligation to update or
revise any forward-looking statement, whether as a result of new information,
future events or any other reason. Additional information concerning risks and
uncertainties affecting the business and other factors that could cause actual
results to differ materially from any forward-looking statement is contained in
the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or
purchase of securities or assets of ThromboGenics in any jurisdiction. No
securities of ThromboGenics may be offered or sold within the United States
without registration under the U.S. Securities Act of 1933, as amended, or in
compliance with an exemption therefrom, and in accordance with any applicable
U.S. state securities laws.
Consolidated key figures as of June 30, 2015
Unaudited Consolidated statement of financial position
+-------------------------------------------------------+
| In '000 euro 30 June 31 December |
| |
| 2015 2014 |
+-------------------------------------------------------+
| |
+-------------------------------------------------------+
| Property, plant and equipment 2,494 2,911 |
+-------------------------------------------------------+
| Intangible assets 58,978 62,388 |
+-------------------------------------------------------+
| Goodwill 2,586 2,586 |
+-------------------------------------------------------+
| Other non-current assets 203 1,600 |
+-------------------------------------------------------+
| Non-current tax receivable 2,133 2,061 |
+-------------------------------------------------------+
| Inventories 7,151 7,224 |
+-------------------------------------------------------+
| Trade and other receivables 8,102 12,604 |
+-------------------------------------------------------+
| Current tax receivable 1,331 2,264 |
+-------------------------------------------------------+
| Investments 891 3,853 |
+-------------------------------------------------------+
| Cash and cash equivalents 112,403 123,223 |
+-------------------------------------------------------+
| Total assets 196,272 220,714 |
+-------------------------------------------------------+
| Total equity 188,536 208,012 |
+-------------------------------------------------------+
| Current liabilities 7,736 12,702 |
+-------------------------------------------------------+
| Total equity and liabilities 196,272 220,714 |
+-------------------------------------------------------+
Unaudited Consolidated statement of comprehensive income
+-------------------------------------------------------+
| In '000 euro Half-year |
| |
| 2015 2014 |
+-------------------------------------------------------+
| |
+-------------------------------------------------------+
| Income 5,982 7,149 |
+-------------------------------------------------------+
| |
+-------------------------------------------------------+
| Operating result -19,789 -24,414 |
+-------------------------------------------------------+
| Finance income 1,044 821 |
+-------------------------------------------------------+
| Finance expenses -433 -210 |
+-------------------------------------------------------+
| Result before income tax -19,178 -23,803 |
+-------------------------------------------------------+
| Income tax expenses -1 -46 |
+-------------------------------------------------------+
| Net result for the period -19,179 -23,849 |
+-------------------------------------------------------+
| Result per share |
+-------------------------------------------------------+
| Basic earnings per share (euro) -0.53 -0.66 |
+-------------------------------------------------------+
| Diluted earnings per share (euro) -0.53 -0.66 |
+-------------------------------------------------------+
A full analysis of the interim financial statement, prepared in accordance to
IAS 34, as declared applicable by the European Union, is included under the
section "Condensed consolidated interim financial statements".
These statements were submitted to a limited review by the statutory auditor.
Condensed consolidated interim financial statements
Unaudited consolidated statement of comprehensive income
+---------------------------------------------------------+
| In '000 euro Half-year |
| |
| 2015 2014 |
+---------------------------------------------------------+
| Income 5,982 7,149 |
+---------------------------------------------------------+
| Sales 4,241 5,366 |
+---------------------------------------------------------+
| License income 0 33 |
+---------------------------------------------------------+
| Income from royalties 1,741 1,750 |
+---------------------------------------------------------+
| Cost of sales -1,172 -545 |
+---------------------------------------------------------+
| Gross profit 4,810 6,604 |
+---------------------------------------------------------+
| |
+---------------------------------------------------------+
| Research and development expenses -10,289 -11,618 |
+---------------------------------------------------------+
| General and administrative expenses -4,208 -5,096 |
+---------------------------------------------------------+
| Selling expenses -10,184 -14,344 |
+---------------------------------------------------------+
| Other operating income 82 42 |
+---------------------------------------------------------+
| Other operating expenses 0 -2 |
+---------------------------------------------------------+
| Operating result -19,789 -24,414 |
+---------------------------------------------------------+
| |
+---------------------------------------------------------+
| Finance income 1,044 821 |
+---------------------------------------------------------+
| Finance expenses -433 -210 |
+---------------------------------------------------------+
| Result before income tax -19,178 -23,803 |
+---------------------------------------------------------+
| |
+---------------------------------------------------------+
| Income tax expenses -1 -46 |
+---------------------------------------------------------+
| Net result for the period -19,179 -23,849 |
+---------------------------------------------------------+
| |
+---------------------------------------------------------+
| Attributable to: |
+---------------------------------------------------------+
| Equity holders of the company -19,179 -23,849 |
+---------------------------------------------------------+
| |
+---------------------------------------------------------+
| Result per share |
+---------------------------------------------------------+
| Basic earnings per share (euro) -0.53 -0.66 |
+---------------------------------------------------------+
| Diluted earnings per share (euro) -0.53 -0.66 |
+---------------------------------------------------------+
Unaudited consolidated statements of other comprehensive income
+------------------------------------------------------------------------------+
|In '000 euro Half-year |
| |
| 2015 2014|
+------------------------------------------------------------------------------+
|Result of the period -19,179 -23,849|
+------------------------------------------------------------------------------+
|Net change in fair value of available-for-sale financial 0 0|
|assets |
+------------------------------------------------------------------------------+
|Exchange differences on translation of foreign operations 60 -43|
+------------------------------------------------------------------------------+
|Actuarial losses on defined benefit plans 0 -229|
+------------------------------------------------------------------------------+
|Other comprehensive income, net of income tax 60 -272|
+------------------------------------------------------------------------------+
|Total comprehensive income for the period -19,119 -24,121|
+------------------------------------------------------------------------------+
|Attributable to: |
+------------------------------------------------------------------------------+
|Equity holders of the company -19,119 -24,121|
+------------------------------------------------------------------------------+
Unaudited consolidated statement of financial position
+-------------------------------------------------------------------------+
|In '000 euro 30 June 31 December|
| |
| 2015 2014|
+-------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------+
|ASSETS |
+-------------------------------------------------------------------------+
|Property, plant and equipment 2,494 2,911|
+-------------------------------------------------------------------------+
|Intangible assets 58,978 62,388|
+-------------------------------------------------------------------------+
|Goodwill 2,586 2,586|
+-------------------------------------------------------------------------+
|Other non-current assets 203 1,600|
+-------------------------------------------------------------------------+
|Employee benefits 0 0|
+-------------------------------------------------------------------------+
|Non-current tax receivable 2,133 2,061|
+-------------------------------------------------------------------------+
|Non-current assets 66,394 71,546|
+-------------------------------------------------------------------------+
|Inventories 7,151 7,224|
+-------------------------------------------------------------------------+
|Trade and other receivables 8,102 12,604|
+-------------------------------------------------------------------------+
|Current tax receivable 1,331 2,264|
+-------------------------------------------------------------------------+
|Investments 891 3,853|
+-------------------------------------------------------------------------+
|Cash and cash equivalents 112,403 123,223|
+-------------------------------------------------------------------------+
|Current assets 129,878 149,168|
+-------------------------------------------------------------------------+
|Total assets 196,272 220,714|
+-------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------+
|EQUITY AND LIABILITIES |
+-------------------------------------------------------------------------+
|Share capital 151,991 151,991|
+-------------------------------------------------------------------------+
|Share premium 157,661 157,661|
+-------------------------------------------------------------------------+
|Accumulated translation differences -216 -276|
+-------------------------------------------------------------------------+
|Other reserves -13,585 -13,228|
+-------------------------------------------------------------------------+
|Retained earnings -107,315 -88,136|
+-------------------------------------------------------------------------+
|Equity attributable to equity holders of the company 188,536 208,012|
+-------------------------------------------------------------------------+
|Minority interests 0 0|
+-------------------------------------------------------------------------+
|Total equity 188,536 208,012|
+-------------------------------------------------------------------------+
|Trade payables 4,592 7,369|
+-------------------------------------------------------------------------+
|Other short-term liabilities 3,144 5,333|
+-------------------------------------------------------------------------+
|Current liabilities 7,736 12,702|
+-------------------------------------------------------------------------+
|Total equity and liabilities 196,272 220,714|
+-------------------------------------------------------------------------+
Unaudited consolidated statement of cash flows
+------------------------------------------------------------------------------+
|In '000 euro Half-year |
| |
| 2015 2014|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Cash flows from operating activities |
+------------------------------------------------------------------------------+
|(Loss) profit for the period -19,179 -23,849|
+------------------------------------------------------------------------------+
|Finance expenses 433 210|
+------------------------------------------------------------------------------+
|Finance income -1,044 -821|
+------------------------------------------------------------------------------+
|Depreciation of property, plant and equipment 627 653|
+------------------------------------------------------------------------------+
|Amortization of intangible assets 3,410 3,415|
+------------------------------------------------------------------------------+
|Gain on sale of property, plant and equipment 0 16|
+------------------------------------------------------------------------------+
|Increase in accruals and employee benefits 0 110|
+------------------------------------------------------------------------------+
|Equity settled share-based payment transactions -357 277|
+------------------------------------------------------------------------------+
|Change in trade and other receivables including tax 5,436 -1,851|
|receivables and inventories |
+------------------------------------------------------------------------------+
|Change in short-term liabilities -4,967 -1,818|
+------------------------------------------------------------------------------+
|Net cash (used) from operating activities -15,641 -23,658|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Cash flows from investing activities |
+------------------------------------------------------------------------------+
|Disposal of property, plant and equipment 1 0|
+------------------------------------------------------------------------------+
|Change in investments 2,962 -9,003|
+------------------------------------------------------------------------------+
|Interest received and similar income 217 516|
+------------------------------------------------------------------------------+
|Acquisition of intangible assets 0 -13|
+------------------------------------------------------------------------------+
|Acquisition of property, plant and equipment -211 -471|
+------------------------------------------------------------------------------+
|Acquisition (divestments) of other non-current assets 1,397 -16|
+------------------------------------------------------------------------------+
|Net cash (used in) generated by investing activities 4,366 -8,987|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Cash flows from financing activities |
+------------------------------------------------------------------------------+
|Proceeds from issue of share capital 0 0|
+------------------------------------------------------------------------------+
|Paid interest -4 -5|
+------------------------------------------------------------------------------+
|Net cash (used in) generated by financing activities -4 -5|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Net change in cash and cash equivalents -11,279 -32,650|
+------------------------------------------------------------------------------+
|Cash and cash equivalents at the start of the period 123,223 164,570|
+------------------------------------------------------------------------------+
|Effect of exchange rate fluctuations 459 57|
+------------------------------------------------------------------------------+
|Cash and cash equivalents at the end of the period 112,403 131,977|
+------------------------------------------------------------------------------+
Unaudited consolidated statement of changes in equity
+------------------------------------------------------------------------------------------
| Cumulative Attributable
| Share Share translation Other Retained to equity Minority Total
| capital premium differences reserves earnings holders of interests
| the company
+-----------------------------------------------------------------------------------------+
|Balance as |
|at 1 January 151,991 157,661 -305 -13,783 -36,792 258,772 0 258,772|
|2014 |
+-----------------------------------------------------------------------------------------+
|Net result -23,849 -23,849 -23,849|
|2014 |
+-----------------------------------------------------------------------------------------+
|Change to |
|foreign |
|currency |
|translation -43 -43 -43|
|difference |
|and |
|revaluation |
|reserve |
+-----------------------------------------------------------------------------------------+
|Actuarial |
|losses on |
|defined -229 -229 -229|
|benefit |
|plans |
+-----------------------------------------------------------------------------------------+
|Net change |
|in fair 0 0|
|value of |
|investments |
+-----------------------------------------------------------------------------------------+
|Issue of |
|ordinary 0 0|
|shares |
+-----------------------------------------------------------------------------------------+
|Conversion |
|of warrants 0 0|
|by warrant |
|holders |
+-----------------------------------------------------------------------------------------+
|Share-based |
|payment 277 277 277|
|transactions |
+-----------------------------------------------------------------------------------------+
|Balance as |
|at 30 June 151,991 157,661 -348 -13,506 -60,870 234,928 0 234,928|
|2014 |
+-----------------------------------------------------------------------------------------+
+------------------------------------------------------------------------------+
|Balance as at 1 151,991 157,661 -276 -13,228 -88,136 208,012 0 208,012|
|January 2015 |
+------------------------------------------------------------------------------+
|Net result 2015 -19,179 -19,179 -19,179|
+------------------------------------------------------------------------------+
|Change to foreign |
|currency translation 60 60 60|
|difference and |
|revaluation reserve |
+------------------------------------------------------------------------------+
|Actuarial losses on 0 0|
|defined benefit plans |
+------------------------------------------------------------------------------+
|Net change in fair 0 0|
|value of investments |
+------------------------------------------------------------------------------+
|Issue of ordinary 0 0|
|shares |
+------------------------------------------------------------------------------+
|Conversion of warrants 0 0|
|by warrant holders |
+------------------------------------------------------------------------------+
|Share-based payment -357 -357 -357|
|transactions |
+------------------------------------------------------------------------------+
|Balance as at 30 June 151,991 157,661 -216 -13,585 -107,315 188,536 0 188,536|
|2015 |
+------------------------------------------------------------------------------+
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: ThromboGenics NV via GlobeNewswire
[HUG#1947730]
Unternehmensinformation / Kurzprofil:
Datum: 26.08.2015 - 17:40 Uhr
Sprache: Deutsch
News-ID 416101
Anzahl Zeichen: 62993
contact information:
Town:
Leuven
Kategorie:
Business News
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Die Pressemitteilung mit dem Titel:
"ThromboGenics Business Update H1 2015"
steht unter der journalistisch-redaktionellen Verantwortung von
ThromboGenics NV (Nachricht senden)
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