ThromboGenics Full Year 2014 Business Update
(Thomson Reuters ONE) -
Financial
* Total revenues of ?13.8 million in 2014 (2013 - ?112.8 million, including
?90 million in milestone payments from Alcon)
* US sales of JETREA(®) (ocriplasmin) in 2014 reached ?8.8 million (2013 -
?20.2 million)
* Gross profit of ?9.2 million - (2013 - ?106.4 million)
* Net loss of ?51.1 million in 2014 - (2013 - profit of ?26.4 million)
* Cash and investments of ?127.1 million as of the end of December 2014,
compared with ?172.4 million at the end of December 2013
Strategy
* In June 2014, ThromboGenics announced that it would maintain an independent
business strategy to deliver stakeholder value. This Board decision followed
the evaluation of various strategic options
* The implementation of the standalone strategy led to organizational changes
to focus resources on commercializing JETREA(®) (ocriplasmin) in the US and
to develop new clinical indications for this novel medicine
JETREA(® )in the US
* In 2014, over 3200 US patients were treated with JETREA(®). This reduction
in the number of patients treated was the result of decreasing adoption
rates resulting from perceived safety concerns following a small number of
published case series, a community in need of more and new real world data,
and the uncertainty following our strategic review. The Company is
addressing all challenges mentioned, and is ready to re-build sales.
* ThromboGenics continues to gather real-world data on JETREA(®) to support
the optimal use of this novel medicine. At present the Company is conducting
3 US studies: Data is expected from all 3 studies during the course of 2015.
* ThromboGenics' marketing and sales efforts in the US have evolved so that it
is better placed to communicate to retina specialists the growing body of
real-world data which can assist them to achieve the best possible clinical
outcomes with JETREA(®).
* ThromboGenics is targeting US sales between 3,500 and 4,000 vials of
JETREA(®) in 2015.
JETREA(®)outside the US
* ThromboGenics' partner Alcon (Novartis), continues to introduce JETREA(®
)across Europe in an overall positive reimbursement environment.
* The last twelve months have seen the first approvals and launches of
JETREA(® )in Asia and South America.
* JETREA(® )gained its 50(th) country approval globally with the Philippines
in February 2015.
Research & Development
* ThromboGenics will start a Phase II trial with JETREA(®) in diabetic
retinopathy (DR). This study is designed to assess the utility of the
product in this significantly underserved patient population. The first
patient is expected to be recruited into this study in H2 2015.
* In February 2015 ThromboGenics was awarded a ?1.1 million research grant
from the Flemish Agency for Innovation by Science and Technology (IWT) to
help fund on-going research into the pharmacological effects ocriplasmin is
exerting in the back of the eye following intravitreal injection.
* ThromboGenics will spin-out its cancer R&D activities into a joint venture
with VIB (Flanders Institute for Biotechnology). This new venture will focus
on the clinical development of TB-403 for medulloblastoma, the most frequent
form of brain cancer in children.
Corporate
* Dominique Vanfleteren was appointed as ThromboGenics Chief Financial Officer
(CFO) in January 2015
* Paul G. Howes (Nanaimo Bioventures LLC) was appointed as Executive Chairman
of ThromboGenics, Inc. in August 2014
* Paul G. Howes appointed member of ThromboGenics NV's Board of Directors in
August 2014
* Emmanuèle Attout was nominated as a new Independent non-executive director
in January 2015.
* Joseph Markoff, Ph.D., M.D. appointed Company Scientific Advisor in March
2015.
Leuven, Belgium - 12, March 2015 - ThromboGenics NV (Euronext Brussels: THR), an
integrated biopharmaceutical company focused on developing and commercializing
innovative ophthalmic medicines, today issues its business and financial update
for the year ending 31 December 2014.
ThromboGenics' strategy is focused on:
* Driving sales growth of JETREA(® )in the US
* Supporting Alcon to build sales of JETREA(®) outside the US
* Creating further value by developing new indications, and
* Progressing its pipeline of earlier stage projects focused on diabetic
vitreo-retinal diseases
The commercial success of JETREA(®) in the USis at the heart of this strategy.
To achieve this goal, ThromboGenics is focusing on increasing the number of
strategic key accounts that use JETREA(®) consistently for the treatment of
patients with symptomatic VMA. This approach is designed to ensure effective
communication of the growing body of real world data on JETREA(®) to the members
of the retina community who are spearheading the adoption of this novel
medicine.
In 2014, the Company strengthened its US commercial capability with the
appointments of Ed Kessig as US Head of Commercial, and Paul G. Howes, who
joined as the Executive Chairman of our ThromboGenics US entity.
ThromboGenics is continuing to support its partner Alcon (Novartis), which is
commercializing JETREA(®) outside the US.
As part of its plans to build further value from JETREA(®), ThromboGenics is
beginning to investigate this novel medicine for the treatment of diabetic
retinopathy (DR).
Dr Patrik De Haes, ThromboGenics' CEO, said: "It is clear that 2014 has been a
challenging year for ThromboGenics. Our sales of JETREA(®) in the US have
declined due to perceived safety concerns and a community waiting for more data
before starting, or re-starting a treatment with JETREA(®). We have also seen
some uncertainty which occurred in the wake of our strategic review.
These changes have led to our strategic accounts approach, which has focused
our marketing and sales efforts on key retinal centers across the US, and which
has put us in a better position to further improve the awareness and acceptance
of JETREA(®), the only pharmaceutical treatment for symptomatic VMA.
This commercial strategy, along with the growing body of real-world data that we
are collecting to help inform patient selection and deliver improved treatment
outcomes, will create the platform we need to start re-building the US sales of
JETREA(®) during the course of 2015.
We remain committed to creating significant additional long-term value through
our R&D activities and we are about to initiate a Phase II study with
JETREA(®)for diabetic retinopathy in the US. This is an important step in our
plans to build a stronger position in the treatment of diabetes related vitreo-
retinal diseases.
To support the implementation of this strategy we have made a number of key
senior management appointments in the last several months with Paul Howes
becoming Executive Chairman of ThromboGenics in the US, Dominique Vanfleteren
joining as our new CFO, and the more recent appointment of Dr Joseph Markoff as
Scientific Advisor.
2014 has been a challenging year for ThromboGenics but I am confident that the
changes we have implemented and the JETREA(® )real-world data that we will
release in the coming months will put us in a strong position to create value
for our shareholders."
JETREA(®) in the US
ThromboGenics achieved JETREA(® )sales of ?8.8 million in 2014 in the US.
This sales outcome reflects the challenges the Company has faced in introducing
this novel pharmacological therapy and changing the standard of care in terms of
the way symptomatic VMA is treated.
In 2014, the sales of JETREA(®) were negatively impacted by safety concerns
caused by a small number of ad hoc publications and the changes that have
occurred in our US organization.
ThromboGenics has learnt a great deal in 2014 and our experience has clearly
shown that changing the way retina physicians treat this important sight
threatening condition will require more data demonstrating the attractive
clinical profile of JETREA(®) - both in terms of efficacy and safety.
The importance of data in driving the sales of JETREA(® )has led to
ThromboGenics focusing its commercial efforts in the US on strategic accounts
that have been early adopters and that have the most experience using the
product. This approach is designed to increase gradually the number of retina
physicians in the US who have detailed knowledge and extensive experience of
using JETREA(®).
ThromboGenics is working to deliver the data needed to expand the use of
JETREA(®) by:
* further analyses of the data from the JETREA(®) Phase III program,
* 3 real-world studies OASIS, ORBIT and OZONE which are due to report in 2015.
The other important factor which has been shaping our commercial activities in
the US is the observation that physicians generate better treatment outcomes as
they become more experienced in using JETREA(®). This is largely because they
are able to identify the patients most suitable for treatment with this novel
medicine.
Patient selection delivers improved patient outcomes
A post-hoc data analysis of the Phase III trials with ocriplasmin showed that:
* VMA diameter less than or equal to 1,500 µm
* absence of an epiretinal membrane
* age below 65 years
* presence of a full thickness macular hole (< 400µm)
are independently associated with successful VMA resolution. Therefore, in
clinical practice, many retinal specialists have been using these parameters to
guide their patient selection for JETREA(®) injection.
The positive impact of this improved patient selection has been highlighted in a
growing number of recent publications. One of these provided analysis of data
from patients treated at the Cole Eye Institute in Cleveland and other centers.
This analysis showed that improved patient selection achieves a treatment
success rate of around 50%. This compares with a 26% nonsurgical resolution of
VMA reported in patients treated with ocriplasmin in the drug's pivotal Phase
III studies, which included over 30% patients who had an epiretinal membrane.
A similar outcome was published in a recent paper from retina specialists at the
Wills Eye Hospital, Thomas Jefferson University, in Philadelphia. In this paper,
they reported a 50% success rate in achieving VMT release in 58 eyes treated
with intravitreal ocriplasmin. A 27% closure rate was seen in patients with full
thickness macular hole. In this study higher rates of success were seen in
younger patients with focal VMT and who did not have epiretinal membrane.
Focus on key strategic accounts
The importance of data in driving the sales of JETREA(® )has led to
ThromboGenics focusing its commercial efforts in the US on those strategic
accounts which have embraced this first-in-class technology and have gained
valuable experience in delivering optimal outcomes.
With additional data coming in 2015, our plan is to broaden this approach to
increase significantly in time the number of retina physicians in the US who
have detailed knowledge and extensive experience of using JETREA(®).
Since the US launch of JETREA(®), it has also been clear that as retina
physicians treat more patients they become more confident about the patient
experience post therapy and as a result feel more comfortable in integrating
this novel medicine into the way they manage symptomatic vitreomacular adhesion
(VMA).
To help more physicians gain confidence in using this new pharmacological
treatment approach, a key focus for the Company's medical education activities
during 2014 has been to demonstrate that the real world safety profile seen with
JETREA(® )is in line with the product's approved label in the US.
This message has been reinforced to the retina community via a range of
conference presentations and published papers including a recent paper from the
MIVI-TRUST group, which comprises the lead investigators from the JETREA(®
)Phase III clinical trial program.
This analysis of the safety profile of JETREA(®) has shown that, in many cases,
the short-term adverse effects that a patient experiences post-injection are a
reflection of the drug's mode of action. This is supported by the fact that many
of the short-term adverse effects are similar to the ones seen in patients who
have undergone a surgical vitrectomy.
Paul G. Howes, Executive Chairman of ThromboGenics US, commenting on progress
with JETREA(®) in the US, said: "We have realigned our US sales efforts to focus
on key accounts, allowing us to communicate in a more effective manner with this
group of retinal physicians who are important in driving the adoption of this
novel medicine. We spent much of 2014 sharing with the retinal community that
the real-world safety experience with JETREA(®) is no different from what is in
our label. With the release of further clinical results planned for 2015 we are
confident that these data will allow us to focus more on the positive balance of
safety and efficacy outcomes that this novel medicine can deliver."
Collecting additional real-world JETREA(®)data
ThromboGenics is continuing to generate more real-world data on treatment with
JETREA(®).
With this additional real world data, the use of JETREA(® )could be optimized
further. This is a key element of ThromboGenics' strategy to drive the adoption
of this novel pharmacological option for the earlier treatment of symptomatic
VMA.
OASIS study
ThromboGenics is currently conducting the "Ocriplasmin for Treatment for
Symptomatic Vitreomacular Adhesion including Macular Hole" (OASIS) study to
generate long term data following treatment with ocriplasmin. This sham-
controlled double-masked study, which has recruited a total of 220 patients, is
designed to assess anatomical and functional outcomes following a single
intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic VMA/
VMT including macular hole.
This is an important study in terms of generating real world data with JETREA(®)
as the patients in the study are being followed up for a 24-month period post
injection.
The primary endpoint of the study is the proportion of subjects with
pharmacological VMA resolution at Day 28. This is the same primary endpoint as
for the Phase III clinical trial program with ocriplasmin. The study will also
provide data on a range of important secondary endpoints at the end of the 24-
month follow-up period.
Topline results from this study are expected to be released in Q1 2015.
ThromboGenics plans to communicate the full data from this study later this year
via a number of presentations at major ophthalmology meetings.
ORBIT study
In March 2014, ThromboGenics launched the "Ocriplasmin Research to Better Inform
Treatment" (ORBIT) study. This study has met with significant interest from the
US retina community and 97 retina centers across the US have been activated to
recruit patients.
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.
The study is looking at a number of parameters including resolution of VMA, full
thickness macular hole (FTMH) closure, changes in visual acuity (VA) and
occurrence and time to vitrectomy. It will also monitor adverse drug reactions
(ADRs) and changes from baseline in ocular signs and symptoms, such as
metamorphopsia, over time. These data will further characterize the efficacy and
safety profile of the product and provide data complementary to those from
JETREA(®)'s Phase III clinical program and physician experience during its first
year on the market.
Patients will be followed for up to 12 months following a single treatment with
JETREA(®). The ORBIT study is due for completion in mid-2016. The Company
intends to report data on a regular basis.
An interim analysis was presented by the ORBIT Steering Committee, represented
by Dr Mathew MacCumber, during the Macula Society Meeting from February 25 -
28, 2015 in Scottsdale, Arizona.
Dr Mathew MacCumber stated, "The interim analysis in the ORBIT study has shown
that the safety and efficacy profiles are consistent with the product's label
and the data from the Phase III clinical trials. Further analysis is ongoing to
assess these rates compared with the Phase III results.
The findings of the interim analysis suggest that ThromboGenics' medical
education activities are beginning to deliver results. A growing number of
retina centres are gaining the understanding they need, to select the patients
most suited for this novel pharmacological treatment option for symptomatic VMA.
With the ORBIT study, and other phase 4 studies ThromboGenics is doing, we will
be able to better define the real world safety and efficacy profile of
JETREA(®)"
The next interim data from the ORBIT study will be discussed at the ARVO meeting
of early May in Denver, Colorado.
OZONE study
In July 2014, ThromboGenics started the "Ocriplasmin Ellipsoid Zone
Retrospective Data Collection Study" (OZONE).
This is a retrospective patient US study designed to capture more data to
characterize the anatomic and symptomatic changes that potentially occur in the
six months immediately after treatment with JETREA(®) for symptomatic VMA.
Initial data from this study are expected in the first half of 2015.
Enhancing Symptomatic VMA Detection
Patients who first notice the symptoms of VMA often have their first discussion
about their condition with their general ophthalmologist. ThromboGenics has
begun implementation of its ID-VMA educational program to train ophthalmologists
about sVMA so that they can better decide when it is appropriate to refer a
patient with sVMA to a specialist retina clinic which has JETREA(®) experience.
A number of seminars in this program have already taken place with a total of
more than 500 ophthalmologists receiving training from a team of retina
specialists.
With greater experience of using JETREA(® )in the specialist retina centers and
a growing number of referrals of patients suitable for treatment with this novel
pharmacological treatment option, we are confident that JETREA(®)'s adoption
will accelerate.
ThromboGenics' US organization - new leadership
ThromboGenics is undertaking a number of new initiatives to strengthen its US
business and support the commercialization of JETREA(®) in the US.
Paul G. Howes (representing Nanaimo Bioventures LLC) appointed Executive
Chairman of ThromboGenics US..
Paul G. Howes, was appointed to the newly created position of the Executive
Chairman of ThromboGenics in the US. He also joined ThromboGenics NV's Board of
Directors.
Mr Howes brings over 25 years of commercial strategy and sales and marketing
experience to ThromboGenics, a significant amount of which has been in the field
of ophthalmology. He was previously President & CEO of Inotek Pharmaceuticals
where he is still an independent Board director. Prior to that he was President
of the Americas Region for Bausch & Lomb, during which he led a major expansion
of the US pharmaceutical business and a highly successful turn-around of the US
cataract surgical business. Prior to joining Bausch & Lomb in 2003, Mr Howes
spent 16 years in various senior management roles at Merck & Co., Inc.
Mr Howes is a graduate of Harvard College and earned his MBA from York
University in Toronto, Canada. He also currently serves as the Chairman of the
Board of Prevent Blindness America.
Ed Kessig appointed US Head of Commercial
Mr Kessig has significant commercial leadership experience across a broad range
of therapeutic categories and markets. He has held senior commercial roles at
Elan Pharmaceuticals, INO Therapeutics and Auxilium Pharmaceuticals. Before
joining ThromboGenics, Ed was the Senior Vice President of Sales at Auxilium. Mr
Kessig is also a member of the ThromboGenics' Executive Committee.
Dr Joseph Markoff, MD appointed Scientific Advisor
Joseph Markoff PhD MD joined the ThromboGenics as its Scientific Advisor. Dr
Markoff received his undergraduate degree from Oberlin College where he
currently serves as an honorary trustee. He received his medical training at the
University of Minnesota and served an ophthalmology residency at Wills Eye
Hospital in Philadelphia where he is currently a clinical professor. He founded
Philadelphia Eye Associates in 1978 and has directed the visual physiology
service at Wills Eye Hospital for over thirty years. He became Global Director
of Ophthalmology at Merck & Co, Inc. in 2010, a post he held until 2014. He now
consults extensively in the field of ophthalmology. He has published in the
subspecialties of retina, glaucoma and cataract in addition to participating in
over 50 clinical trials.
Optimizing the US Commercial Organization
During 2014, a series of operational improvements have been undertaken at
ThromboGenics, Inc. These changes have been made both to reduce costs as well as
to focus our marketing and sales efforts on those key accounts that have
embraced our technology and gained the most experience in delivering optimal
patient outcomes.
With additional data coming in 2015, our plan is to broaden this approach to
increase significantly the number of retina physicians in the US who have
detailed knowledge and extensive experience in using JETREA(®).
All of the above is expected to have a positive impact on revenues in 2015.
JETREA(®) outside the US
ThromboGenics' partner Alcon (Novartis), is continuing to commercialize
JETREA(®) across the rest of the world. The product recently received its
50(th) approval globally with the Philippines. Alcon has also been successful,
with the support of ThromboGenics, in building a strong market access platform
for JETREA(®) around the world.
Europe
In Europe, the main developments in 2014 concerned the reimbursement of
JETREA(®), with the product now being actively reimbursed in a number of key
markets including the UK, Germany and Spain.
Alcon is also conducting studies to generate more real world data on the use of
JETREA(®).
The results of a 129 patient study across six European centers were presented by
Alcon at the DOG Congress of Ophthalmology in Leipzig, Germany in September
2014. The study, which analyzed patients with early stage symptomatic VMT,
showed total resolution rates of 45-85% depending on patient sub-groups. In
patients with VMA diameter less than of equal to 1,500µm or the absence of an
epiretinal membrane resolution rates of up to 85% were observed. These positive
outcomes are in line with the success rates that are being reported by retina
physicians in the US.
JETREA(®) approvals in the Rest of the World
In 2014, good progress has been made to bring JETREA(® )closer to the market in
the Rest of the World, with first approvals in Asia and South America.
Asia
In April, JETREA(®) was approved in Malaysia for the treatment of adults with
VMT, including when associated with macular hole of diameter less than or equal
to 400 microns. The approval, the first in Asia, was gained following a Priority
Review conducted in September 2013.
In July 2014, JETREA(® )was approved in Singapore for the same indication.
South America
In the beginning of July, JETREA(®) was approved in Uruguay, the first country
in South America, for the treatment of adults with VMT, including when
associated with macular hole of diameter less than or equal to 400 microns.
In October, JETREA(®) was approved in Chile for the same indication.
Australia
In October, Australia's Therapeutic Goods Administration (TGA) approved
JETREA(®) for the treatment of adults with VMT, including when associated with
macular hole of diameter less than or equal to 400 microns.
Recent approvals
In February 2015, JETREA(®) was granted approval in Argentina, Israel and the
Philippines.
Progress towards gaining approval in Japan
Alcon has now completed a bridging clinical study in Japan. The Japanese trial,
a randomized, double-masked, multi-center study with patients receiving either
ocriplasmin or a sham injection, recruited a total of 168 patients with
symptomatic VMA including those associated with macular hole. The results from
this study are expected to form part of the regulatory submission that will be
made to the Japanese Ministry of Health, Labour and Welfare in 2015 to request
approval to market ocriplasmin in Japan.
Research & Development Update
Diabetic Retinopathy (DR)
The Company remains committed to expanding the use of JETREA(® )beyond
symptomatic VMA/VMT as part of its strategy to maximize new value-creating
opportunities for the drug.
ThromboGenics has decided that treatment of diabetic retinopathy (DR) is the
next target indication for JETREA(®) in the US. A Clinical Research Organization
has been engaged to assist in the conduct of a Phase II trial with JETREA(® )in
diabetic retinopathy in the US. This study is designed to assess the utility of
the product in this significantly underserved patient population.
The Company will start the DR study in H1 2015, with the first patient expected
to be recruited in H2 2015.
ThromboGenics has decided to evaluate JETREA(®) in the treatment of DR based on
the strong scientific rationale that supports why it could prove effective in
treating patients with this sight threatening condition before their disease
progresses. Research has shown that the presence of a posterior vitreous
detachment, where the vitreous is separated from the retina, may prevent the
growth of the 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 undergone a posterior vitreous detachment.
JETREA(® )is able to generate a posterior vitreous detachment 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 this anatomical change, 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 scaffolding of the vitreous to 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 eye disease, including
diabetic retinopathy is expected to increase substantially. A recent report from
the American Academy of Ophthalmology has projected that prevalence of
individuals with any diabetic retinopathy in the United States by the year 2020
will be 6 million people of whom 1.34 million persons will have vision
threatening DR.
Diabetic retinopathy is increasing in prevalence in the US. "Almost a third of
the adult population in the US are suffering from diabetes and a substantial
proportion of these - hundreds of thousands - will develop proliferative
diabetic retinopathy. Their number is going up every year; all these people will
be confronted with vision loss if they are not treated adequately. Any
investigation into how we can ameliorate the complications of this disease is
most welcome," says Dr. Michael S. Ip, Director, Retina Service, William S.
Middleton Memorial Veterans Hospital, and tenured Associate Professor,
Department of Ophthalmology and Visual Sciences, University of Wisconsin School
of Medicine and Public Health, Madison, WI.
In addition to JETREA(®), ThromboGenics' research is evaluating a number of
other potential therapies for diabetic eye disease. The Company is working on
compounds emanating from agreements with Eleven Biotherapeutics and Bicycle
Therapeutics. These projects are both in the pre-clinical phase of development.
"In 2014, the company clarified its long-term strategy and reoriented to focus
exclusively on ophthalmology. We are working hard to further expand the
ThromboGenics' research portfolio with innovative new potential medicines for
the treatment of eye disease. We will continue our strategy of partnering with
academic groups and other companies. I am confident that this approach will lead
us to a very exciting future," says Jean Feyen, Head of Pre-Clinical Research at
ThromboGenics.
Oncology R&D Spin-Out
ThromboGenics, is about to spin out its oncology research activities into a
joint venture with VIB (Flanders Institute for Biotechnology). This company will
focus on the clinical development of TB-403 for the treatment of
medulloblastoma, the most frequent form of brain cancer in children.
In time, ThromboGenics will look to raise funds from third parties in order to
finance the further development of this exciting oncology business.
Ocriplasmin IWT Research Grant
ThromboGenics has been awarded a ?1.1 million research grant from the Flemish
Agency for Innovation by Science and Technology (IWT). The grant will be used to
fund on-going research to further elucidate the pharmacological effects
ocriplasmin is exerting in the back of the eye following intravitreal injection.
Corporate
Nanaimo Bioventures LLC, represented by Paul G. Howes, appointed executive
Chairman ThromboGenics, Inc. and Paul G. Howes as Member of ThromboGenics NV's
Board of Directors
Mr Howes was previously President & CEO of Inotek Pharmaceuticals where he is
still an independent Board director. Prior to that, he was President of the
Americas Region for Bausch & Lomb, during which he led a major expansion of the
US pharmaceutical business and a highly successful turn-around of the US
cataract surgical business. Prior to joining Bausch & Lomb in 2003, Mr Howes
spent 16 years in various senior management roles at Merck & Co., Inc.
Mr Howes is a graduate of Harvard College and earned his MBA from York
University in Toronto, Canada.
He currently is the Chairman of the Board of Prevent Blindness America.
Dominique Vanfleteren appointed CFO
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 within quoted international
biopharmaceutical companies.
Before joining ThromboGenics, Mr Vanfleteren spent 12 years at UCB, a global
biopharmaceutical company, where he held a number of 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 GSK during 16 years. He held a number
of senior finance positions in Brussels and London, his latest being Finance
Director of GSK's Diversified Healthcare Services Europe.
Chris Buyse, ThromboGenics' former Chief Financial Officer and Board Member,
left the Company at the end of June 2014 to pursue other interests. Luc Philips,
former CFO of KBC group and Board Member of ThromboGenics since its IPO in
2006, acted as an interim CFO until the appointment of Dominique Vanfleteren.
Emmanuèle Attout - New Board Member
In January, ThromboGenics nominated Emmanuèle Attout to be its new Independent
non-executive director. Mrs. Attout will join the Audit Committee of the
Company.
Mrs. Attout has been an audit partner at PricewaterhouseCoopers since 1994. She
has been in charge of audits of a range of clients including banks, insurance
companies, investment funds and asset managers. She has in recent years been in
charge of the audits of listed pharmaceutical companies and life sciences
businesses.
Financial review
In 2014, ThromboGenics had total revenues of ?13.8 million, including ?8.8
million of JETREA(®) sales in the US, ?1.4 million of products recharged to
Alcon, ?3.4 million in royalties from Alcon based on its ex-US sales of
JETREA(®)and ?0.2 million of other income.
In 2013, ThromboGenics reported revenues of ?112.8 million including ?90 million
in milestone payments from Alcon.
In 2014, ThromboGenics' R&D expenses were ?22.6 million, including a ?6.8
million amortization of the ocriplasmin Phase III program. This compares with
?31.7 million of R&D expenses in 2013. This lower level of spending is partly
the result of a real decrease in expenditure, but also the consequence of
certain development work which ThromboGenics was able to invoice to external
partners in 2014 and the increased use of grant money.
In 2014, selling and marketing expenses amounted to ?29.9 million compared with
?37.6 million in 2013. The decrease is the result of change in strategic
priorities and the changes made to the company's commercial organization. The
2013 expenses also included some incremental costs resulting from the JETREA(®)
launch campaign.
In 2014, ThromboGenics reported a net loss of ?51.1 million, or ?1.42 loss per
share.
In 2013, the Company reported a net profit of ?26.4 million or diluted earnings
per share of ?0.71, mainly as a result of the ?90 million in milestone payments
it received from Alcon.
At the end of December 2014, ThromboGenics had ?127.1 million in cash and
investments, compared to ?136.6 million as of the end of September 2014, and
?148.8 million at the end of June 2014.
ThromboGenics believes it has the financial resources needed to fully sustain
the US commercialization of JETREA(®), the research and development of selected
new indications and formulations of JETREA(®), in the US, expand its R&D
pipeline and further broaden its commitment to become a leading ophthalmology
company.
A conference call for analysts, press and investors will be hosted by Dr Patrik
De Haes, CEO of ThromboGenics, Dominique Vanfleteren, CFO of ThromboGenics, and
Paul G. Howes, Executive Chairman of ThromboGenics, Inc. today at 06:30 PM CET,
13:30 PM EST.
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 pincode: 55630502#
We request that participants dial in 5-10 minutes prior to the start time of
06:30 PM CET, 13:30 PM EST.
The presentation will be webcasted live, click here to register.
The presentation and transcript of the call will be made available shortly on
www.thrombogenics.com under the investor information tab.
END
For further information please contact:
+------------------------------------------+-----------------------------------+
| | |
| | |
|ThromboGenics |Citigate Dewe Rogerson |
| | |
| | |
| | |
|Wouter Piepers, |David Dible/ Malcolm Robertson |
| | |
|Global Head of Corporate Communications &| |
|IR | |
| |Tel: +44 20 7638 9571 |
|+32 16 75 13 10 / +32 478 33 56 32 | |
| |malcolm.robertson(at)citigatedr.co.uk |
|wouter.piepers(at)thrombogenics.com | |
| | |
| | |
+------------------------------------------+-----------------------------------+
About JETREA(® )(ocriplasmin)
JETREA(® )(ocriplasmin) is a truncated form of human plasmin. In the US,
JETREA(®) is indicated for the treatment of symptomatic VMA. 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(®) is 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.
JETREA(® )has been evaluated in two multi-center, randomized, double-masked
Phase III trials conducted in the US and Europe involving 652 patients with
vitreomacular adhesion. Both studies met the primary endpoint of resolution of
VMA at day 28.
JETREA(®)'s 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.
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative ophthalmic and oncology medicines. The Company's
lead product, JETREA(® )(ocriplasmin), has been approved by the US FDA for the
treatment of symptomatic VMA and was launched in January 2013.
In Europe, JETREA(® )is approved for the treatment of vitreomacular traction
(VMT), including when associated with macular hole of diameter less than or
equal to 400 microns.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis,
for the commercialization of JETREA(®) outside the United States. ThromboGenics
and Alcon intend to share the costs equally of developing JETREA(®) for a number
of new vitreoretinal indications.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
also referred to as TB-403, for the treatment of oncology indications.
ThromboGenics is headquartered in Leuven, Belgium, and has an office in Iselin,
NJ (US). 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 US Securities Act of 1933, as amended, or in
compliance with an exemption therefrom, and in accordance with any applicable US
state securities laws.
Financial information 2014
Consolidated statement of comprehensive income
+------------------------------------------------------------------------------+
|In '000 euro (for the year ended on 31 December) 2014 2013|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Income 13,776 112,781|
+------------------------------------------------------------------------------+
|Sales 10,346 21,724|
+------------------------------------------------------------------------------+
|License income 33 90,034|
+------------------------------------------------------------------------------+
|Income from royalties 3,397 1,023|
+------------------------------------------------------------------------------+
|Cost of sales -4,600 -6,384|
+------------------------------------------------------------------------------+
|Gross profit 9,176 106,397|
+------------------------------------------------------------------------------+
|Research and development expenses -22,554 -31,734|
+------------------------------------------------------------------------------+
|General and administrative expenses -9,520 -11,579|
+------------------------------------------------------------------------------+
|Selling expenses -29,874 -37,622|
+------------------------------------------------------------------------------+
|Other operating income 67 49|
+------------------------------------------------------------------------------+
|Other operating expense -9 0|
+------------------------------------------------------------------------------+
|Operating result -52,714 25,511|
+------------------------------------------------------------------------------+
|Finance income 1,885 1,567|
+------------------------------------------------------------------------------+
|Finance expense -146 -664|
+------------------------------------------------------------------------------+
|Result before income tax -50,975 26,414|
+------------------------------------------------------------------------------+
|Income tax expense -140 -13|
+------------------------------------------------------------------------------+
|Net result for the period -51,115 26,401|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Attributable to: |
+------------------------------------------------------------------------------+
|Equity holders of the Company -51,115 26,401|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Result per Share |
+------------------------------------------------------------------------------+
|Basic earnings per share (euro) -1.42 0.73|
+------------------------------------------------------------------------------+
|Diluted earnings per share (euro) -1.42 0.71|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|In '000 euro (for the year ended on 31 December) 2014 2013|
+------------------------------------------------------------------------------+
|Result of the period -51,115 26,401|
+------------------------------------------------------------------------------+
|Net change in fair value of available-for-sale financial -72 23|
|assets |
+------------------------------------------------------------------------------+
|Exchange differences on translation of foreign operations 29 -11|
+------------------------------------------------------------------------------+
|Actuarial losses on defined benefit plans -229 0|
+------------------------------------------------------------------------------+
|Other comprehensive income, net of income tax -272 12|
+------------------------------------------------------------------------------+
|Other comprehensive income that may be reclassified to profit 0 0|
|or loss |
+------------------------------------------------------------------------------+
|Other comprehensive income that will not be reclassified to -272 12|
|profit or loss |
+------------------------------------------------------------------------------+
|Total comprehensive income for the period -51,387 26,413|
+------------------------------------------------------------------------------+
|Attributable to: |
+------------------------------------------------------------------------------+
|Equity holders of the Company -51,387 26,413|
+------------------------------------------------------------------------------+
Consolidated statement of financial position
+--------------------------------------------------------------------------+
| In '000 euro (for the year ended on 31 December) 2014 2013 |
+--------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------+
| ASSETS |
+--------------------------------------------------------------------------+
| Property, plant and equipment 2,911 3,634 |
+--------------------------------------------------------------------------+
| Intangible assets 62,388 69,209 |
+--------------------------------------------------------------------------+
| Goodwill 2,586 2,586 |
+--------------------------------------------------------------------------+
| Other non-current assets 1,600 1,711 |
+--------------------------------------------------------------------------+
| Employee benefits 0 73 |
+--------------------------------------------------------------------------+
| Non-current tax receivable 2,061 2,307 |
+--------------------------------------------------------------------------+
| Non-current assets 71,546 79,520 |
+--------------------------------------------------------------------------+
| Inventories 7,224 6,111 |
+--------------------------------------------------------------------------+
| Trade and other receivables 12,604 11,145 |
+--------------------------------------------------------------------------+
| Current tax receivable 2,264 2,017 |
+--------------------------------------------------------------------------+
| Investments 3,853 7,791 |
+--------------------------------------------------------------------------+
| Cash and cash equivalents 123,223 164,570 |
+--------------------------------------------------------------------------+
| Current assets 149,168 191,634 |
+--------------------------------------------------------------------------+
| Total assets 220,714 271,154 |
+--------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------+
| EQUITY AND LIABILITIES |
+--------------------------------------------------------------------------+
| Share capital 151,991 151,991 |
+--------------------------------------------------------------------------+
| Share premium 157,661 157,661 |
+--------------------------------------------------------------------------+
| Accumulated translation differences -276 -305 |
+--------------------------------------------------------------------------+
| Other reserves -13,228 -13,783 |
+--------------------------------------------------------------------------+
| Retained earnings -88,136 -36,792 |
+--------------------------------------------------------------------------+
| Equity attributable to equity holders of the Company 208,012 258,772 |
+--------------------------------------------------------------------------+
| Minority interests |
+--------------------------------------------------------------------------+
| Total equity 208,012 258,772 |
+--------------------------------------------------------------------------+
| Trade payables 7,369 10,352 |
+--------------------------------------------------------------------------+
| Other short-term liabilities 5,333 2,030 |
+--------------------------------------------------------------------------+
| Current liabilities 12,702 12,382 |
+--------------------------------------------------------------------------+
| Total equity and liabilities 220,714 271,154 |
+--------------------------------------------------------------------------+
+------------------------------------------------------------------------------+
|In '000 euro (for the year ended on 31 December) 2014 2013|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Cash flows from operating activities |
+------------------------------------------------------------------------------+
|(Loss) profit for the period -51,115 26,401|
+------------------------------------------------------------------------------+
|Finance expense 146 664|
+------------------------------------------------------------------------------+
|Finance income -1,885 -1,567|
+------------------------------------------------------------------------------+
|Depreciation on property, plant and equipment 1,297 1,181|
+------------------------------------------------------------------------------+
|Amortization of intangible assets 6,833 6,483|
+------------------------------------------------------------------------------+
|Gain on sale of property, plant and equipment 0 0|
+------------------------------------------------------------------------------+
|Increase in accruals and employee benefits 110 0|
+------------------------------------------------------------------------------+
|Equity settled share-based payment transactions 554 1,433|
+------------------------------------------------------------------------------+
|Change in trade and other receivables including tax -2,573 -10,060|
|receivables and stock |
+------------------------------------------------------------------------------+
|Change in short-term liabilities 54 1,175|
+------------------------------------------------------------------------------+
|Net cash (used) from operating activities -46,579 25,710|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Cash flows from investing activities |
+------------------------------------------------------------------------------+
|Disposal of property, plant and equipment (following a sale) 27 24|
+------------------------------------------------------------------------------+
|Change in investments 3,938 1,031|
+------------------------------------------------------------------------------+
|Interest received and similar income 953 1,387|
+------------------------------------------------------------------------------+
|Acquisition of intangible assets -12 -3,354|
+------------------------------------------------------------------------------+
|Acquisition of property, plant and equipment -571 -2,155|
+------------------------------------------------------------------------------+
|Acquisition of other non-current assets 111 13|
+------------------------------------------------------------------------------+
|Net cash (used in) generated by investing activities 4,446 -3,054|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Cash flows from financing activities |
+------------------------------------------------------------------------------+
|Proceeds from issue of share capital 0 2,960|
+------------------------------------------------------------------------------+
|Paid interests -11 -10|
+------------------------------------------------------------------------------+
|Net cash (used in) generated by financing activities -11 2,950|
+------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------+
|Net change in cash and cash equivalents -42,144 25,606|
+------------------------------------------------------------------------------+
|Cash and cash equivalents at the start of the period 164,570 139,398|
+------------------------------------------------------------------------------+
|Effect of exchange rate fluctuations 797 -434|
+------------------------------------------------------------------------------+
|Cash and cash equivalents at the end of the period 123,223 164,570|
+------------------------------------------------------------------------------+
Consolidated statement of changes in equity
+-----------------------------------------------------------------------------------------+
| Attributable |
| Share Share Cumulative Other Retained Minority |
| capital premium translation reserves earnings to equity interests Total|
| differences holders of |
| the Company |
+-----------------------------------------------------------------------------------------+
|Balance as |
|at 1 January 150,938 155,754 -328 -15,205 -63,193 227,966 0 227,967|
|2013 |
+-----------------------------------------------------------------------------------------+
|Net result 26,401 26,401 26,401|
|2013 |
+-----------------------------------------------------------------------------------------+
|Change to |
|foreign
Unternehmensinformation / Kurzprofil:
Datum: 12.03.2015 - 17:40 Uhr
Sprache: Deutsch
News-ID 378200
Anzahl Zeichen: 65560
contact information:
Town:
Leuven
Kategorie:
Business News
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"ThromboGenics Full Year 2014 Business Update"
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