RNS Number:5986J
Tissue Science Laboratories PLC
28 September 2006
28 September 2006
Interim Results for the six months ended 30 June 2006
Tissue Science Laboratories plc (LSE: TSL), the medical technology company
specialising in biologic tissue replacement and repair products, today announces
its Interim Results for the six months ended 30 June 2006.
Operational Highlights
* Successful expansion of direct sales team leading to strong growth in US
general surgery sales. Further sales team expansion underway
* Excellent progress made in vascular, ligament and bone development
projects
* Further value potential in core technology
* Partner channels delivered lower than forecast sales in urology and
orthopaedics
Financial Highlights
* Turnover up 8% to #5.4m (H1 2005: #5.0m)
* Improved margins at 68% (H1 2005: 51%) as a result of increased
manufacturing efficiency and improved sales mix
* Loss before tax #1.8m (H1 2005: Loss #0.8m) in line with management
expectations
* Solid cash position - #4.8m (31 Dec 2005: #6.8m) due to continued
careful cash management
Commenting on the results, Martin Hunt, CEO of TSL, said:
"Our performance in the first half of the year has been characterised by the
good progress made in our direct sales and marketing efforts and the positive
development of our clinical programme and technology pipeline. This gives us
much confidence for the future of the Company. We have invested in the
programmes set out in our fund raising in 2005 and are now beginning to see the
benefits of that strategy. These positives have, however, been offset by the
disappointing performance of our US distributors and marketing partners in the
first half of the year. Assuming partner sales do not recover materially in the
second half, our results for the year will be some way below current market
expectations. Despite this near term sales volatility, the Board remains
confident in both our technology and chosen markets and that there remains a
significant opportunity for future growth and value creation."
-Ends-
There will be a meeting for analysts this morning at 09.30am at Hogarth
Partnership's offices - 2nd Floor Upstream, No 1 London Bridge, London SE1 9BG.
For registration and/or enquiries, please contact Julie Cordice, Hogarth PR on
tel: 020 7357 9477 or jcordice@hogarthpr.co.uk.
Enquiries:
TSL plc Tel: 01252 369 603
Martin Hunt, Chief Executive
David Jennings, Finance Director
Hogarth Partnership Limited Tel: 020 7357 9477
James Longfield / Sarah Richardson
www.tissuescience.com.
Chief Executive's Statement
Strategy Overview
Our mission is to establish TSL as a leading player in the rapidly developing
field of biologic surgical repair materials. Our core Permacol(R) technology
platform already offers surgeons differentiated and innovative products derived
from porcine dermis across a broad range of surgical applications. We are also
making good progress in applying our technology across other tissues to develop
our new product pipeline.
In March 2005 we raised funds to develop our business in three principal areas.
Investment in building a direct sales and marketing infrastructure in the US,
supplementing our previous model of dependence on marketing and distribution
partners to one where we are increasingly able to control the sales marketing of
our products in selected market sectors. Investment in clinical studies to
support our marketing platform, and investment in new product development to
provide the next generation of products from our core technology from new
tissues such as porcine bone, ligaments and blood vessels.
Business Review H1 2006
We have been very encouraged by the progress made in each of these areas in the
first half.
Our US sales team has achieved significant success with Permacol in the first
half and this has led to the decision to further expand the sales team in the
second half of the year. It is important to note that the progress of our direct
US sales operation has been masked by lower than expected sales through our
partner channels in the first half of the year. This lack of visibility or
control of partner sales has been a driver in the Board's decision to evolve our
US business model.
In urology/gynaecology, CR Bard has faced an increasingly competitive market
environment leading to lower in-market sales in the pelvic-floor reconstruction
and incontinence procedures addressed by our range of products. In orthopaedics
Zimmer continues to support our product in Rotator Cuff repair in a very
positive way, however, the priority given to biologic materials and the rate of
adoption by the Zimmer sales organisation has been lower than we had
anticipated.
Investment in clinical trials which demonstrate the benefits of our core
Permacol(R) technology is vital for the future success of the business. We
recently announced positive results from pilot studies in the prophylactic
treatment of parastomal hernias and the treatment of anal fistulae. Recruitment
into our extended studies for therapeutic and prophylactic repair of parastomal
hernias is underway.
We have made very exciting progress in our new product development programmes.
We are developing products using porcine bone and ligaments to address
attractive orthopaedic applications and using porcine blood vessels to develop
grafts for use in vascular surgery. Process development and clinical work has
progressed well in the first half and we have completed pilot scale animal
studies to assess the further potential of all three products.
Financial Review
Turnover in the first half of the year was #5.4m (H1 2005: #5.0m) an increase of
8%. On a constant currency basis (translating H1 2006 revenues at the same $/#
exchange rate as that used in H1 2005) turnover increased by 4%. Although
turnover has shown only modest growth in total during the period, this has
masked strong growth in general surgery sales in both the US and Europe which
has been offset by a decline in sales in urology/gynaecology through CR Bard.
Sales in general surgery in the US increased by 63% in the first half to $4.4m
(H1 2005 $2.7m). Sales growth was driven principally by our direct US sales team
and we are planning further recruitment in the second half as we move from a
combined direct/distributor sales model to direct sales only model in certain
markets. Although the sales team is still new, we have achieved some notable
successes in the period and have built a strong base to support further growth
going forward. We are satisfied that investment in the direct sales model in the
US will yield significant returns in terms of future growth and profitability.
In Europe our UK direct team and our distributors also performed strongly with
50% growth to #0.9m (H1 2005: #0.6m).
Sales in urology/gynaecology through CR Bard declined in the period by 42% to
$2.9m (H1 2005: $5.0m) and this is obviously a significant disappointment. In
our core target market of vaginal repair and incontinence procedures the
competitive environment has moved rapidly and whilst our product continues to
perform well clinically, recent improvement in certain surgical techniques and
innovations in the product offerings of competitors has resulted in lower than
anticipated demand for our products. Consequently, Bard has had to re-position
its inventory levels to reflect these new market conditions and this has
resulted in lower stocking orders for the 'Pelvi' range of products so far this
year. We expect this inventory adjustment to persist into the second half of the
year and thereafter we expect forward sales to recover in line with in-market
demand.
In orthopaedic surgery sales to Zimmer were unchanged at #0.1m (H1 2005: #0.1m).
In the first half Zimmer has continued to develop its marketing platform and to
roll-out our product through its sales organisation. 'Ortho-biologics' remains a
new field for Zimmer and the adoption of our technology by the Zimmer sales
teams has been slower than anticipated. We are encouraged by Zimmer's continued
commitment to the application of our technology in rotator cuff repair and
continue to be confident for the future prospects for our product in this field.
Gross Margins improved strongly in the first half to 68% (H1 2005: 51%). This
was a result of increased manufacturing efficiency in the first half resulting
in lower unit manufacturing costs being achieved. In addition the increase in
direct sales in general surgery relative to partner sales in urology/gynaecology
and orthopaedics contributed to greater profitability at the gross margin level.
In line with our investment strategy, the first half saw an increase in costs.
Our direct sales team in the US increased the selling and distribution expenses
to #1.8m in the first half (H1 2005: #0.7m). Marketing expenses remained
unchanged at #0.9m (H1 2005: #0.9m). Expenditure on new product development and
clinical studies increased as planned to #1.4m (H1 2005: #0.6m). Administration
expenses increased to #1.4m (H1 2005: #1.2m), reflecting our additional US
infrastructure and administration resource versus the same period last year.
The US dollar weakened further during the period, trading at an average rate of
#1 = $1.79. The Company had in place hedging contracts which enabled a composite
rate of #1 = $1.74 to be used in translation of its US dollar denominated
transactions.
The increase in loss before tax to #1.8m (H1 2005 loss: #0.9m) was in line with
our expectations for the period and is a result of the planned investments in
selling and distribution and product development programme. As at 30 June 2006
the company had cash at bank and in hand of #4.8m and net funds of #3.0m,
slightly ahead of expectations.
The Company continues to manage its resources carefully and will continue to
direct resources into areas of our business where we see maximum growth
potential.
Sales & Marketing
General Surgery - US
We started the year with 20 general surgery sales representatives in the US and
their performance in the first half confirmed our belief in the evolution of our
US business model. We took the decision at the end of the first half to expand
this team further and by September we have recruited and deployed a further 19
reps. We are well on course to achieve our target of having 43 reps in place by
the year-end. This will give us direct sales coverage of the key US metropolitan
areas for the first time and we will enter 2007 in a very strong position from
which to achieve our growth objectives for next year. We will, as a consequence
of this initiative, terminate our existing non-partner regional distributor
arrangements by the end of 2006 and this process is already underway.
The decision to invest further in our direct sales team is underpinned by the
significant growth opportunity that already exists for biologic materials in
general and colorectal surgery. The attractiveness of this rapidly growing
market segment and the product features and benefits offered by porcine
materials has attracted new entrants into the market. Davol, a division of CR
Bard Inc, has recently introduced 'Collamend' a cross-linked porcine dermal
collagen into complex hernia repair. Lifecell Inc has also indicated that they
will be introducing a porcine derived collagen repair patch into the general
surgery market next year. We believe both of these developments are a validation
of our approach to the general surgery market and that TSL will retain
considerable 'first mover' advantage in terms of clinical data and product
characteristics to enable us to meet this competitive threat.
In addition we will seek to capitalise on our investment in a direct sales team
by bringing new products through our development pipeline into this field. We
have identified the therapeutic and prophylactic treatment of herniated stomas
as a major market opportunity going forward and are currently conducting
clinical studies to support future product launches. We have also made promising
progress in developing Permacol(R) for the treatment of anal fistulae where
there is a very large unmet surgical need. Clinical work to support a future
product launch in this area is ongoing.
Urology/Gynaecology
This area of our business has presented a considerable challenge in the first
half of the year. I have commented above on the competitive issues faced by our
marketing partner, CR Bard, and this remains an ongoing concern. We believe that
bio-materials offer surgeons demonstrable clinical advantages over synthetic
alternatives, and our challenge is to continue to develop innovative product
offerings to meet surgeons' evolving needs. We will work both with our marketing
partner and directly with the market to identify the next opportunities for our
materials in what is still new and developing surgical field.
Orthopaedics
The use of bio-materials in orthopaedic applications is a rapidly developing
area where the characteristics of such materials potentially offer surgeons
advantages versus traditional techniques. Our dermal sheet product is already
being marketed for rotator cuff repair in the shoulder by Zimmer Inc. and we
believe there is further scope to apply our sheet material in other orthopaedic
procedures such as knee and ankle ligament and tendon repair. Within our product
pipeline we have also made excellent progress during the period in the
development of both our bone and ligament tissues which offers us much potential
to offer a much broader orthopaedic product range in the attractive and growing
field of orthobiologics.
R&D
Excellent progress has been achieved in the development of porcine derived bone,
ligament and vascular grafts. Initial milestones of adapting the manufacture
process to produce the new tissues and assess initial graft biocompatibility
have been completed. The bone and ligament grafts have each completed initial
animal performance models with encouraging results, and the bone grafts have
further proceeded to a definitive preclinical animal performance model (started
June 2006, with results expected in March 2007). The ligament grafts are
expected to proceed to a definitive in-vivo performance study by Q1 2007.
We have also started (August 2006) our initial in-vivo functional study with
Permacol(R) processed vascular grafts. Pig coronary arteries were removed and
replaced with Permacol(R) processed vascular grafts and to date all grafts are
functioning satisfactorily. The initial study will be complete in Q4 2006, but
initial interim results are encouraging.
Clinical Studies
Prophylactic parastomal reinforcement study (PROPHECI)
Further data presented from the pilot study investigating the use of Permacol(R)
for the reinforcement of new stoma has confirmed that Permacol(R) may have
significant benefits in this indication. A follow-up multicentre, randomised,
controlled clinical study to demonstrate the effectiveness of Permacol(R) for
this indication is in the final stages of initiation. Full COREC (Central Office
for Research Ethics Committees) approval has been granted and individual study
sites are undergoing local approvals. Patient recruitment is expected to begin
imminently.
Parastomal hernia repair study
Study sites continue to be enrolled and approved to this multicentre,
randomised, controlled study. Patient recruitment is active and ongoing.
Urethral Bulking
Discussions with potential marketing partners are ongoing. We will not progress
with the US regulatory clinical study until we have secured a commercial
agreement for marketing the product. Recent analysis of European clinical study
results has indicated that Permacol Injection has greater longevity of action
than previously established - patients may benefit from treatment with this
product for up to three years which is significantly longer than other urethral
bulking agents.
Anal Fistulae
We have received encouraging results from in-vivo studies assessing the
performance of our injectable collagen formulations for the treatment of anal
fistula, and work is now progressing to develop this formulation for human
clinical study in 2007.
Cosmetic Injection
Clinical data demonstrates equivalence with market leading products (Perlane(R)
& Zyplast(R)) and the company is reviewing its options for the future
commercialisation of this product.
Product approvals/clearances
Clearance was received in the US and EU to extend the use of Zimmer CRP(R)
(Collagen repair Patch) to include all tendons of the rotator cuff. In addition
clearances were obtained for the CR Bard products Pelvisoft(R) and Pelvicol(R)
in Australia and Russia respectively.
Operations
Manufacturing operations performed strongly in the period achieving improved
product yields and efficiencies resulting in lower unit manufacturing costs.
Stock and work in progress increased in the period as a result of the planned
building of inventory to support our US sales operations and as a result of
lower than anticipated demand for some partner products. During the period our
manufacturing facility successfully completed routine regulatory audits from our
European notified body and distribution partners.
Summary and Outlook
Our performance in the first half of the year has been characterised by the good
progress made in our direct sales and marketing efforts and the positive
development of our clinical programme and technology pipeline. This gives us
much confidence for the future of the Company. We have invested in the
programmes set out in our fund raising in 2005 and are now beginning to see the
benefits of that strategy. These positives have, however, been offset by the
disappointing performance of our US distributors and marketing partners in the
first half of the year. Assuming partner sales do not recover materially in the
second half, our results for the year will be some way below current market
expectations. Despite this near term sales volatility, the Board remains
confident in both our technology and chosen markets and that there remains a
significant opportunity for future growth and value creation.
Martin Hunt
Chief Executive Officer
Tissue Science Laboratories plc
Consolidated Profit & Loss Account for the Six Months Ended 30 June 2006
Note Six months Six months Year
ended ended ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited)(Unaudited)* (Restated)*
#000s #000s #000s
TURNOVER: 2 5,367 5,001 10,171
Cost of Sales (1,711) (2,432) (5,071)
Gross Profit 3,656 2,569 5,100
Selling & Distribution costs (1,753) (737) (1,882)
Administrative Expenses
Research and development costs (1,379) (637) (1,297)
Other administrative costs (2,380) (2,103) (4,628)
--------- ---------- ----------
(3,759) (2,740) (5,925)
Operating Loss (1,856) (908) (2,707)
Interest Receivable 103 135 293
Interest Payable & similar charges
Bank & finance lease interest (75) (27) (94)
--------- ---------- ----------
LOSS ON ORDINARY ACTIVITIES BEFORE
TAXATION (1,828) (800) (2,508)
Taxation 0 (22) 140
--------- ---------- ----------
RETAINED LOSS ON ORDINARY
ACTIVITIES AFTER TAXATION (1,828) (822) (2,368)
========= ========== ==========
Basic loss per ordinary share 3 6.2p 3.0p 8.4p
========= ========== ==========
All amounts relate to continuing operations.
There is no difference between the retained loss on ordinary activities before
and after taxation for the period stated above and their historical cost
equivalents.
* The profit and loss accounts and cash flow statements for the periods ended 30
June 2005 and 31 December 2005, and the balance sheet at 30 June 2005 and 31
December 2005, have been restated for the adoption of FRS 20 "Share based
payment".
Tissue Science Laboratories plc
Consolidated Statement of total recognised gains and losses for the Six Months
Ended 30 June 2006
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited)* (Restated)*
#000s #000s #000s
Loss attributable to
shareholders of the company (1,828) (822) (2,368)
Foreign exchange translation
differences on foreign currency
subsidiary (87) 0 0
--------- ---------- ----------
Total recognised losses for the
period (1,915) (822) (2,368)
Prior period adjustment (72)
=========
Total losses recognised since
last annual report and financial
statements (1,987)
* The profit and loss accounts and cash flow statements for the periods ended 30
June 2005 and 31 December 2005, and the balance sheet at 30 June 2005 and 31
December 2005, have been restated for the adoption of FRS 20 "Share based
payment".
Tissue Science Laboratories plc
Consolidated Balance Sheet as at 30 June 2006
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited)* (Restated)*
#000s #000s #000s
Fixed Assets
Tangible assets 3,190 1,613 3,340
Current Assets
Stocks 3,319 2,387 2,301
Debtors 2,232 2,110 2,713
Cash at bank and in hand 4,839 9,163 6,842
--------- ---------- ----------
10,390 13,660 11,856
Creditors: amounts falling due
within one year (2,663) (2,600) (2,482)
--------- ---------- ----------
NET CURRENT ASSETS 7,727 11,060 9,374
Total assets less current
liabilities 10,917 12,673 12,714
Creditors: amounts falling due
after more than one year (1,578) (162) (1,554)
--------- ---------- ----------
NET ASSETS 9,339 12,511 11,160
========= ========== ==========
CAPITAL & RESERVES
Called up share capital 2,951 2,932 2,946
Share premium account 22,112 21,947 22,075
Shares to be issued 291 195 239
Merger reserve 545 545 545
Profit & loss account (16,560) (13,108) (14,645)
---------- ---------- ----------
EQUITY SHAREHOLDERS' FUNDS 9,339 12,511 11,160
========== ========== ==========
* The profit and loss accounts and cash flow statements for the periods ended 30
June 2005 and 31 December 2005, and the balance sheet at 30 June 2005 and 31
December 2005, have been restated for the adoption of FRS 20 "Share based
payment".
Tissue Science Laboratories plc
Consolidated Cash Flow for the Six Months Ended 30 June 2006
Note Six months Six months
ended ended Year ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited)* (Restated)*
#000s #000s #000s
Net cash outflow from
operating 4 (1,857) (1,504) (3,301)
activities
Returns on investment and
servicing of Finance 30 72 196
Taxation 172 (22) (32)
Capital expenditure &
financial (209) (226) (2,144)
investment
Cash outflow before use of
liquid resources & financing (1,864) (1,680) (5,281)
Financing
Net cash (outflow)/inflow from
financing (139) 7,391 8,651
-------- --------- ---------
(Decrease)/increase in cash in
the period (2,003) 5,711 3,370
======== ========= =========
RECONCILIATION OF NET CASHFLOW
TO MOVEMENT IN NET FUNDS
(Decrease)/increase in cash in
the period (2,003) 5,711 3,370
Cash outflow from movement in
debt & lease financing 182 161 343
Change in net funds resulting
from cash flows (1,821) 5,872 3,713
New finance leases (180) (95) (393)
Bank loan (1,300)
Currency translation
difference (2) (2) 18
-------- --------- ---------
Movement in net funds in the
period (2,003) 5,775 2,038
Net funds brought forward 4,966 582 2,928
-------- --------- ---------
Net funds carried forward 2,963 6,357 4,966
======== ========= =========
* The profit and loss accounts and cash flow statements for the periods ended 30
June 2005 and 31 December 2005, and the balance sheet at 30 June 2005 and 31
December 2005, have been restated for the adoption of FRS 20 "Share based
payment".
Tissue Science Laboratories plc
Notes
1. ACCOUNTING POLICIES AND BASIS OF PREPARATION
The financial information set out in this announcement does not constitute the
Company's statutory accounts for the six months ended 30 June 2006. Information
for the year ended 31 December 2005 has been derived from the statutory accounts
for that period which have been delivered to the Registrar of Companies.
The audit report for the year ended 31 December 2005 was unqualified.
The profit and loss accounts and cashflow statements for the periods ended 30
June 2005 and 31 December 2005, and the balance sheets at 30 June 2005 and 31
December 2005, have been restated for the adoption of FRS20 "share based
payment".
On the 1st January 2006 a wholly owned subsidiary, Tissue Science Laboratories
Inc., was incorporated in the USA. These interim results therefore consolidate
the results of Tissue Science Laboratories Inc. for the first time.
The accounting policies adopted are consistent with those adopted in the
previous period, except for the adoption of FRS20 in the period and the
consolidation of Tissue Science Laboratories Inc..
2. TURNOVER
A geographical analysis of turnover by destination is as follows:
Six months Six months Year
ended ended Ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited) (Audited)
#000s #000s #000s
United Kingdom 741 557 1,201
Europe 279 757 1,465
USA 4,250 3,615 7,413
Rest of World 97 72 92
----------- ----------- ----------
5,367 5,001 10,171
=========== =========== ==========
3. LOSS PER SHARE
Loss per ordinary share has been calculated based on the weighted-average of
ordinary Shares in issue during the period.
Six months Six months Year
ended ended Ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited) (Restated)
#000s #000s
Loss for the period (1,828) (822) (2,368)
Weighted average number of
ordinary shares 29,496,848 27,218,571 28,296,310
Loss per share 6.2p 3.0p 8.4p
=========== =========== ==========
4. RECONCILIATION OF OPERATING LOSS TO NET CASH OUTFLOW FROM OPERATING
ACTIVITIES
Six months Six months Year
ended ended Ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited) (Audited)
#000s #000s
Operating loss (1,856) (908) (2,707)
Depreciation of tangible
fixed assets 539 433 922
Decrease/(Increase) in debtors 305 (187) (633)
Increase in stocks (1,018) (837) (751)
Increase/(Decrease) in creditors 206 (19) (178)
Foreign exchange (gain)/loss (85) 2 (18)
Share based payments 52 12 64
----------- ----------- ----------
(1,857) (1,504) (3,301)
=========== =========== ==========
5. RESTATEMENT OF COMPARATIVES
The adoption of FRS 20 "Share based payment" from 1 January 2006 has required
the expense of share options to be fair valued. As a result of these changes in
accounting policy, the comparatives have been restated as follows:
(a) Profit and loss account Six months Year
ended Ended
30 June 31 December
2005 2005
(Unaudited) (Restated)
Retained loss for the period #000s #000s
As previously stated (810) (2,304)
Adoption of FRS 20 "Share based payment" (i) (12) (64)
----------- -----------
As restated (822) (2,368)
=========== ===========
(i) Under FRS 20 the fair values of share options issued have been recognised
and expensed.
(b) Balance sheet Shares to be Profit and
Issued Loss account
As at 30 June 2005 #000s #000s
As previously stated (175) (13,088)
Adoption of FRS 20 "Share based payment" (i) (20) (20)
----------- -----------
As restated (195) (13,108)
=========== ===========
Shares to be Profit and
Issued Loss account
As at 31 December 2005 #000s #000s
As previously stated (167) (14,573)
Adoption of FRS 20 "Share based payment" (i) (72) (72)
----------- -----------
As restated (239) (14,645)
=========== ===========
(i) Under FRS 20 the cumulative fair value of the shares to be issued has been
taken to the shares to be issued account and the expense taken to the profit and
loss reserve.
6. RECONCILIATION OF MOVEMENTS ON GROUP SHAREHOLDERS' FUNDS
Six months Six months Year
ended ended Ended
30 June 30 June 31 December
2006 2005 2005
(Unaudited) (Unaudited) (Restated)
#000s #000s
Loss for financial period
(as previously stated) (1,828) (810) (2,304)
Adoption of FRS 20 "Share
based payment) 0 (12) (64)
----------- ----------- ----------
Loss for the financial
period (as restated) (1,828) (822) (2,368)
Other recognised gains and
losses relating to the
period (87) 0 0
Share options based expense 52 11 64
Shares issued during the
period 5 469 483
Share premium on shares
issued during the period 37 7,083 7,211
----------- ----------- ----------
Net (reduction)/addition to
shareholders' funds (as
restated) (1,821) 6,741 5,390
Opening shareholders' funds
(as previously stated) 11,160 5,770 5,770
----------- ----------- ----------
Closing shareholders' funds
(as previously stated) 9,339 12,511 11,160
=========== =========== ==========
This information is provided by RNS
The company news service from the London Stock Exchange
END
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