TIDMCTN
RNS Number : 5382D
ClearStream Technologies Group PLC
24 March 2011
For Immediate Release 24 March 2011
ClearStream Technologies Group plc
Interim Results for the six months ended 31(st) January 2011
A Period of Rapid Progress and Growing Opportunity
ClearStream Technologies Group plc ("ClearStream") the
specialist global supplier of medical devices used in coronary and
peripheral interventional procedures, announces un-audited interim
results for the six months ended 31(st) January 2011.
Key Points
-- Revenues up 56% at EUR9.11M - (2009: EUR5.85M)
-- Net profit of EUR0.12M (2009: net loss of EUR0.7M)
-- Net margins at 28% (2009: 24%)
-- Cash balances at period end of EUR1.6M (2009: EUR1.6m) after
funding expansion from operating cash flow
-- Continued upward trend in demand across all three sales
channels (branded devices; co-labelling; OEM)
-- Strong accelerating demand for peripheral product from OEM
channel
-- Positive outlook for the second half
Commenting on the results, Andy Jones, Group CEO of ClearStream
said:
"ClearStream has made a strong start to the current financial
year and our results at the half year stage are comfortably in line
with current expectations for the full year. The significant
increase in production capacity engineered during the previous
financial year has bedded down well; yields and gross margins
continue to improve. Taken together with the recently acquired
factory facility adjacent to our existing site, we now have the
capacity to service production demand in excess of EUR30m per
annum. .
"It is also particularly pleasing to see the growth trends in
OEM sales within the peripheral sector. This is the sub sector
where innovation and new product designs are opening new channels
of opportunity for the Company and gives further ground for
optimism about the future prospects for the Company.
On current trading and prospects, Mr Jones added:
"Our results and the rapid growth that we are now experiencing
underscore the value of our strategic diversification into the
peripheral angioplasty market, which is now the dominant part of
our business. It is an exciting growth market where our innovative
products have established brand recognition and market leadership.
Whilst we have seen a softening of sales in our coronary business,
this trend is expected to reverse following the re-launch of our
drug eluting stent, the Intrepide, later this year. With a
traditionally stronger second half, the Board anticipates a solid
performance in the six months to 31 July 2011 and believes that the
outlook for ClearStream remains positive."
Enquiries:
Andy Jones, Group CEO
ClearStream Technologies Group plc Tel: +353 (0)53 923 7111
Stephen Norcross - Corporate Broking
Marc Young - Corporate Finance
Charlotte Stranner - Corporate Finance
FinnCap Tel: +44 (0)20 7600 1658
Paul Vann/Tom Cooper
Winningtons Financial Tel: +44 (0)117 985 8989 or +44 (0)7768
807631
Business
ClearStream is an innovative developer and manufacturer of
medical devices, particularly catheters, stents and stent delivery
systems that are used in interventional, angioplasty procedures.
Its products are used in minimally invasive surgical procedures to
clear clogged arteries in both the coronary and the peripheral
(lower limb) vascular systems.
Overview
Building on the trends that we reported on last year, trading
during the first half of the current financial year has been
buoyant.
ClearStream operates three channels to market: the sale of
ClearStream branded devices sold through a licensed distributor
network; the sale of product on a co-labelling basis through third
parties; and the sale of unbranded devices sold on a
business-to-business (OEM) basis to other medical device companies
for use as angioplasty catheters or as stent delivery systems.
We have seen growth in sales across the OEM and co-label
channels, with the sale of peripheral products the main engine for
growth. It is particularly pleasing to see the strong growth in
demand for OEM product. A reduction in own brand sales reflects the
decision made by the Company to suspend shipment of the Intrepide
DES pending re-launch of the product. The underlying trend,
however, remains positive.
Over the past two years a steady slowing of demand for coronary
devices from OEM customers has been eclipsed by a strong rise in
demand for peripheral devices from new OEM customers. This reflects
the patterns of innovation in the peripheral market sphere with
many newly innovated products being developed to support procedures
for addressing conditions such as diabetic foot, which previously
could not be treated by angioplasty techniques. This pressure for
innovation reflects the rapid rise in diabetes seen in the
developed world, a trend that is likely to further accelerate in
the next few years driven by population demographics. The Board
believes that ClearStream is well placed to take advantage of the
opportunities that it will create for the supply of its advanced
stent and drug delivery systems.
The complex re-organisation of manufacturing lines and
production procedures to enable the Company to cope with the
demands of the increased sales volumes that it is enjoying has
settled in. We are now operating five production lines and all five
will be running at double shift by the end of the current financial
year. This re-organisation together with the steady improvements we
are achieving in yield and through-put will allow the Company
comfortably to service an annualised turnover well in excess of
EUR30m.
In anticipation of further growth and in order to be able to
offer our OEM customers a range of manufacturing and regulatory
services, the Company has instigated a further expansion programme:
new factory premises are being developed to house finished goods
warehousing and shipment, our R&D activity, sales and marketing
and central administration. There is also the space for a new clean
room facility to expand the range of manufacturing services
afforded to our business customers. This expansion programme has
liberated space in our existing factory to expand our balloon
production and flexible manufacturing facilities, to potentially
install a sixth production line and also potentially set up a
production line dedicated to training and process improvement.
The expansion programme, which will also see an upgrade to
existing clean room facilities, has been supported by Enterprise
Ireland with the award of a grant of just over EUR1m. The funding,
which may be drawn down over the next 3 years and which will help
finance the investments, includes research & development
funding, an employment grant, management training and funding for a
new management position of Chief Technical Officer.
Registries
News flow during the period included the announcement in August
2010 that the Pharmaceuticals and Medical Devices Agency, Japan
(PMDA), had given approval for ClearStream to sell its advanced
percutaneous transluminal angioplasty (PTA) balloon catheters in
Japan. Under the brand names SLEEK(TM) and Savvy Long(TM) the
devices are to be marketed by Cordis in Japan, further extending
the range of territories in which the products are sold, to one of
the largest and most highly regulated markets outside of the
USA.
This news was followed by further announcements in September and
December that ClearStream had received approval from the United
States' Food & Drug Administration ("FDA") for its ReeFlex and
Sleek OTW (over the wire) catheters.
In gaining FDA approval for these devices, ClearStream has
opened up the potential to supply the products into the largest
market in the world for peripheral catheters; the approvals
represent a significant step towards realising the Company's plans
for FY2011.
The ReeFlex is ClearStream's latest addition to its
ground-breaking ReeKross family of catheters. The ReeFlex employs a
technology similar to the ReeKross, but is modified for greater
flexibility which opens up the potential for the ReeFlex to be used
both in a broader range of procedures and in more markets. The
Company is currently engaged in an evaluation period with a
potential partner for distribution of the ReeFlex and ReeKross
catheters in the USA.
The Sleek OTW is an upgrade to the range of ClearStream's
catheters that are distributed by Cordis Corporation, a worldwide
leader in the development and manufacture of interventional
vascular technology. Gaining FDA clearance for the Sleek OTW is
another key milestone for ClearStream in its drive to become one of
the leading suppliers of innovative devices for use in
interventional peripheral angioplasty procedures into the US
market. This product upgrade enhances the range of catheters
distributed throughout the world by Cordis under a long term
distribution agreement with ClearStream that has recently been
extended for a further 4 years
Distributors
During the period significant effort has been invested in
expanding the Company's global network of distributors. New
distributor managers have been appointed to head up ClearStream's
own brand sales drive into Europe and Asia Pacific. The impact of
the Company's aggressive market entry plans and the new dedicated
Distributor Management Team and structure is already in
evidence.
Post period end, ClearStream announced the signature of a number
of new Distribution Agreements. The new markets served include
Norway, Denmark and Sweden in Scandinavia, Egypt and Iran in the
Middle East and Indonesia and The Philippines in the Asia Pacific
region.
VingMed Group, based in Oslo, has been appointed to distribute
the full range of Peripheral products throughout Norway, Sweden and
Denmark which together account for over 15,000 lower limb
procedures each year. VingMed has a well established sales
infrastructure, supplying medical devices across each of these key
Scandinavian markets.
In the Middle East, EgyptCare, based in Cairo and AGP in Teheran
have been appointed for the distribution of both coronary and
peripheral product portfolios across the two largest markets in the
region, Egypt and Iran, whilst in Asia Pacific, Mulya Husada Jaya
of Surabaya, Indonesia will also distribute both ranges. In the
Philippines, ClearStream has appointed Biodevices Inc. of Manila,
which has an extensive sales and marketing infrastructure already
well established across the territory.
These appointments underpin the Company's strategy of targeting
to develop markets where diabetes is a widely diagnosed disease
state and where the opportunities to grow sales across its product
portfolios are significant.
Product Development
For a number of years now the Company has engaged in an internal
product development strategy of designing a number of different
platforms for peripheral angioplasty catheters. The strategy has
continued on one hand driving convergence of these platforms for
efficient manufacture and on the other engaging in incremental
product development to adapt these catheters for specialist
below-the-knee procedures related to diabetes and critical limb
ischemia. This strategy has been highly successful in bringing
ClearStream to a strong position in this field. Such product
development will continue. In addition, the Company now seeks to
leverage its position in this niche by developing or acquiring new
technologies for complementary devices.
The Company has been preparing for this through the appointment
of Professor Patrick Prendergast to the Board last year, to enhance
the Board's ability to review and approve strategic technology
options. The Clinical advisory panel has been expanded with leading
doctors in the peripheral vascular field to provide the clinical
view. In a further move, the Company is seeking to appoint a Chief
Technical Officer (CTO). The CTO will have a business development
brief to seek out and acquire suitable technologies and devices
consistent with our clinical direction. This new post is supported
by Enterprise Ireland under the grant awarded to ClearStream.
To further build the product development capacity and capability
a new Product Development Manager is being appointed. This person
will lead the internal product development team in continued
catheter development and in the integration and commercialisation
of any new technology or devices sourced by the CTO.
Product development will move to the new facility in a purpose
built unit during the second half.
Staff and Management
Once again the Board would like to thank all of the staff of
ClearStream for their continued support and efforts during a period
of rapid change. We are now operating with a total complement of
260 (2009: 180). Further growth in staff numbers is expected as
additional lines and shifts are brought on line.
Results
As expected, demand from co-label and in particular OEM
customers advanced substantially during the period. Overall revenue
for the period was EUR9.2M (2010: EUR5.9); comprising EUR2.2M
(2009: EUR2.3M) for own brand products, EUR2.4M (2010: EUR1.0M) for
OEM sales and EUR4.6M (2010: EUR2.5M) for co-labelling sales. The
open order book at the start of the period was EUR2.5m reflecting
in part the production challenges ClearStream had faced in the
previous financial year. Going into H2, although its increased
production capacity is enabling the Company to meet the higher
levels of demand, the open order book had grown to EUR2.79M
reflecting the continued strong growth patterns in the
business..
After sales expenses of EUR0.65M and general and administration
expenses of EUR0.65M, the Company recorded an operating profit of
EUR1.29 M (2010: profit EUR0.12M). After R&D and regulatory
costs of EUR1.13M, depreciation and net interest the profit before
tax was EUR0.12M, which is very much in line with budgets and plans
for the full year.
The net cash outflow from operating activities in the period was
EUR1.1M. Cash at the end of the period was EUR1.6M (2010: EUR1.6M)
after financing the expansion of production facilities. Overall the
balance sheet remains robust with debtors of EUR3.16M, trade
creditors of EUR1.22M, short term debt (term loan, lease finance)
of EUR0.26M and long term debt (mortgage and lease) of EUR1.42M.
Additionally the Company has (but not yet used) short term
overdraft and invoice discounting facilities of EUR0.8M.
Outlook
The positive momentum enjoyed by ClearStream in the first half
of the current financial year is continuing into the third quarter
and the Board has every expectation that they will continue through
the year.
The upward pressure on orders is likely to be sustained in the
second half by the various OEM contracts that the Company has under
negotiation, the introduction of the Sleek OTW product into the
North American market and by the stocking orders anticipated from
ClearStream's growing distributor base.
The re-launch of Intrepide is unlikely to have a significant
impact in the current financial year but nevertheless is expected
to have an impact at the start of the new financial year.
Consolidated unaudited income statement
for the half year ended 31 January 2011
Six months Six months Year ended
31 July
ended ended 2010
31 January 31 January Audited
Notes 2011 2010
EUR EUR EUR
Revenue 9,114,751 5,853,931 15,087,069
Cost of Sales (6,529,375) (4,473,590) (10,657,513)
------------ ------------ -------------
Gross Profit 2,585,376 1,380,341 4,429,556
Selling & distribution costs (652,693) (630,404) (1,135,389)
Administration expenses (647,528) (576,345) (991,763)
Research & development expenses (1,129,928) (827,829) (1,677,037)
------------ ------------ -------------
Operating Profit /(Loss) 155,227 (654,237) 625,367
Finance Income 12,097 6,170 11,184
Finance Costs (45,707) (52,526) (106,202)
Finance Costs net (33,610) (46,356) (95,018)
------------ ------------ -------------
Profit/(Loss) attributable to equity
holders of the Company before tax 121,617 (700,593) 530,349
Income tax - - -
(Loss)/Profit attributable
to equity holders of the
Company for the year 121,617 (700,593) 530,349
------------ ------------ -------------
Diluted earnings Profit/ 4 0.3c - 1.12c
(loss) per share (cent)
Basic earnings Profit/ 5 0.3c - 1.12c
(loss) per share (cent)
Consolidated unaudited balance sheet
as at 31 January 2011
Six months Six months Year ended
31 July
ended ended 2010
31 January 31 January Audited
Notes 2011 2010
ASSETS EUR EUR EUR
Non-current assets
Property, plant and
equipment 3,064,626 2,779,876 2,805,187
Intangible Assets 1,948,752 1,980,915 1,971,783
------------- ------------- -------------
5,013,378 4,760,791 4,776,970
------------- ------------- -------------
Current Assets
Inventories 2,107,458 1,735,986 1,619,193
Trade and other
receivables 3,443,678 2,075,224 2,900,755
Cash and cash
equivalents 5 1,567,426 1,579,082 2,631,977
------------- ------------- -------------
7,118,562 5,390,292 7,151,925
------------- ------------- -------------
Total Assets 12,131,940 10,151,083 11,928,895
------------------------- ------ ------------- ------------- -------------
EQUITY
Capital and reserves attributable to equity
holders of the Company
Ordinary Shares 5,788,501 5,760,671 5,788,502
Share premium 16,914,297 16,874,628 16,914,297
Other reserves 404,301 368,355 367,301
Retained losses (15,594,515) (16,947,075) (15,716,133)
------------- ------------- -------------
7,512,584 6,056,579 7,353,967
------------- ------------- -------------
Minority interest in
equity 120 120 120
Total equity 7,512,704 6,056,699 7,354,087
------------- ------------- -------------
LIABILITIES
Non-current liabilities
Borrowings 1,415,857 1,654,584 1,527,347
Government grants 229,279 202,087 229,279
------------- ------------- -------------
1,645,136 1,856,671 1,756,626
Current liabilities
Borrowings 256,206 230,156 237,848
Trade and other payables 2,431,832 1,487,124 2,032,323
Deferred income 286,062 520,433 548,011
------------- ------------- -------------
2,974,100 2,237,713 2,818,182
Total liabilities 4,619,236 4,094,384 4,574,808
------------- ------------- -------------
Total Equity and
liabilities 12,131,940 10,151,083 11,928,895
------------------------- ------ ------------- ------------- -------------
-
Consolidated Statement of Changes
in Equity
for half year ended
31 January 2011
Share Share Other Retained Minority
capital premium reserve losses Interest Total
Balance
at 1
August
2009 5,760,671 16,874,628 338,355 (16,246,482) 120 464,218
Loss attributable to
equity holders of
the
group for
the
period - - - (700,593) - (700,593)
Employee share
options: - value of
employee
services - - 30,000 - - 30,000
Balance
at 31
January
2010 5,760,671 16,874,628 368,355 (16,947,075) 120 6,056,699
---------- ---------- ----------- -------- ------------- --------- ----------
Profit attributable
to equity holders of
the
group for
the
period - - - 1,230,942 - 1,230,942
New share
capital
issued 27,831 39,669 - - - 67,500
Employee share
options: - value of
employee
services - - (1,054) - - (1,054)
Balance
at 31
July
2010 5,788,502 16,914,297 367,301 (15,716,133) 120 7,354,087
---------- ---------- ----------- -------- ------------- --------- ----------
Profit attributable
to equity holders of
the
group for
the
period - - - 121,617 - 121,617
Employee share
options: - value of -
employee
services - - 37,000 - - 37,000
Balance
at 31
January
2011 5,788,502 16,914,297 404,301 (15,594,516) 120 7,512,704
---------- ---------- ----------- -------- ------------- --------- ----------
Consolidated unaudited cash flow statement
for the half year ended 31 January 2011
Six months Six months Year ended
ended ended 31 July 2010
31 January 31 January Audited
Notes 2011 2010
Cash flows from operations EUR EUR EUR
Cash outflow from operations 5 (357,173) (827,358) 586,065
Finance income 12,097 6,170 11,184
Finance cost (45,707) (52,526) (106,202)
Cash flows from operations (390,783) (873,714) 491,047
-------------- ------------ -------------
Cash flows from investing
activities
Purchases of plant and
equipment (580,637) (121,048) (352,788)
Additions to intangible assets - - (215)
Cash outflows from investing
activities (580,637) (121,048) (353,003)
-------------- ------------ -------------
Cash flows from financing
activities
Proceeds from debt factoring 26,050 (181,341) (181,341)
Proceeds from capital grant - - 39,634
Repayments of borrowings (115,820) (132,933) (249,373)
Repayments of leasing
obligations (3,361) (5,320) (8,425)
Cash flows from financing
activities (93,131) (319,594) (399,505)
-------------- ------------ -------------
Net (decrease)/ increase in cash,
cash equivalents
and bank overdrafts (1,064,551) (1,314,356) (261,461)
Cash, cash equivalents and bank
overdrafts at beginning
of year 2,631,977 2,893,438 2,893,438
Cash, cash equivalents and bank
overdrafts
at end of year 5 1,567,426 1,579,082 2,631,977
-------------- ------------ -------------
Notes to the Consolidated Financial Information
1. General information
The Company is a public limited company incorporated and
domiciled in Ireland, and is listed on AIM in the United
Kingdom.
2. Basis of preparation
This financial information has been prepared on a going concern
basis. The directors have reviewed the forecast income statement
and cash flows of the Group for the remainder of the year. They are
satisfied that in view of the Group's cash resources together with
existing and additional banking facilities along with the expected
trading and cash flow performance driven by cost reduction measures
and the anticipated increase in turnover, the Group has the
necessary resources to continue trading for the foreseeable
future.
This consolidated financial information, which is presented in
Euro, has been prepared in accordance with the Group's accounting
policies under IFRS.
The preparation of financial information in conformity with IFRS
requires the use of certain critical accounting estimates and
assumptions that affect the reported amounts of assets and
liabilities at the date of the financial information and the
reported amounts of revenues and expenses during the reporting
period. Although these estimates are based on management's best
knowledge of the amount, events or actions, actual results
ultimately may differ from those estimates. The areas involving a
higher degree of judgement or complexity, or area where assumptions
and estimates are significant to the consolidated financial
information are disclosed in note 4.
3. Critical accounting estimates and judgements
Estimates and judgements are continually evaluated and are based
on historical experience and other factors, including expectations
of future events that are believed to be reasonable under the
circumstances.
The Group makes estimates and assumptions concerning the future.
The resulting accounting estimates will, by definition, rarely
equal the related actual results. The Group has not identified any
estimates and assumptions that have a significant risk of causing a
material adjustment to the carrying amounts of assets and
liabilities within the next financial year.
4. Profit per share
Basic profit/ (loss) per share is calculated by dividing the
profit/loss attributable to equity holders of the Company by the
weighted average number of ordinary shares in issue during the
period.
Six months Six months Year ended
31 July
ended ended 2010
31 January 31 January Audited
2011 2010
(Loss)/profit attributable to
the equity holders of the Company 121,617 (700,593) 530,349
Weighted average number of ordinary
shares in issue 46,308,011 46,085,363 46,184,088
Basic (loss)/profit per share 0.26cent (0.15cent) 1.12cent
(cent per share)
----------- ----------- -----------
The Company has one category of dilutive potential ordinary
shares and that is share options. At 31 January 2011 there were
1,306,111 options (31 January 2010: 1,118,912 and 31 July
2010:1,091,111) over ordinary shares issued which could potentially
dilute basic earnings per share in the future. For the 31 January
2009 period calculations of diluted earnings per share are not
included because they were anti-dilutative for the period.
5. Reconciliation of operating profit/ (loss) to net cash
outflow from operating activities
Six months Six months Year ended
31 July
ended ended 2010
31 January 31 January Audited
(a) Cash flows from operating
profit before tax 2010 2009
EUR EUR
Operating profit/ (loss) 121,617 (700,593) 530,349
Adjustments for:
Depreciation 177,209 236,778 431,301
Amortisation of intangible 167,019 - 21,253
Amortisation of grants - - (12,442)
Interest income (12,097) (6,170) (11,184)
Interest expense 45,707 52,526 118,201
Provision for stock options 37,000 30,000 28,946
Share issue to Clinical Advisory
Panel - - 67,500
Changes in working capital:
- Inventory (488,265) 160,355 277,148
- Trade and other receivables (542,923) (556,517) (1,382,048)
- Trade and other payables 137,560 (43,737) 529,040
Cash flows from operations (357,173) (827,358) 598,064
----------- ----------- ------------
Six months Six months Year ended
31 July
ended ended 2010
31 January 31 January Audited
(b) Analysis of net cash 2011 2010
EUR
Cash at bank and on hand 1,567,426 1,579,082 1,431,977
Short -term bank deposit - - 1,200,000
1,567,426 1,579,082 2,631,977
----------- ----------- ------------
The fair value of cash and cash equivalents approximate to the
values shown above.
All cash and short-term deposits are placed in reputable
financial institutions with whom the group has a long history of
trading or a long-standing relationship and therefore are deemed of
good credit quality.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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