REG-Sinclair Pharma Plc: Preliminary results for the year ended 30 June 2009
Sinclair Pharma plc
Preliminary results for the year ended 30 June 2009
Sustained EBITDA profit for second successive year as business restructured to
focus on commercialisation
12 October 2009, Godalming, UK: Sinclair Pharma plc (the "Company" or
"Sinclair": SPH:L), the international specialty pharma company, today announces
its preliminary results for the year ended 30th June 2009. Sinclair also
announced today the acquisition of two major revenue-generating dermatology
products, Flammazine and Flammacerium, from Solvay Pharmaceuticals for a total
consideration of €17.5 million. The acquisition will be financed by a
fundraising of up to £25 million (see separate press release).
FINANCIAL HIGHLIGHTS
* EBITDA profit before exceptional items of £2.3m (2008: £1.3m)
* Total revenue of £30.4m (2008: £30.3m)
* Gross profit of £20.7m (2008: £19.4m)
* Operating loss before exceptional items of £0.3m (2008: £0.8m)
* Operating loss after exceptional items of £2.7m (2008: profit of £2.2m)
* Loss per share after exceptional items of 3.9p (2008: earnings per share of
3.8p)
OPERATING HIGHLIGHTS
Restructured business to increase commercial focus and financial control:
* Goal to deliver sustainable profitability from recurring revenue
* Established a lean structure and reduced costs from non-core business
functions
* Appointed Christophe Foucher as Chief Operating Officer, responsible for
all commercial, supply-chain and manufacturing operations
* Acquired remaining minority interest in Laboratorios Novo Pharma in Spain
and renamed Sinclair Pharmaceutical España
Consolidated own sales and marketing activities in the Country Operations in
France, Italy and Spain:
* Appointed new Country Operations Directors
* Launched key products including:
*
+ Sebclair - a non-steroidal treatment for seborrheic dermatitis; cream
launched in Spain, and shampoo and scalp fluid line extension launched
in Italy
+ Papulex moussant - a topical anti-acne treatment launched in Spain
Continued expansion through marketing partner network
* Signed 65 new distribution agreements covering 27 products in 47 markets
* 44 launches of seven products in 22 countries
* Focussed on expansion in key territories including emerging markets
Maximising existing technologies through R&D and strategic licensing in/out
activities
* £3.3m non-cash deal with BMG to develop Sinclair's existing gynaecological
technology
* £2.1m agreement with Graceway for US distribution rights to Atopiclair
* £0.9m non-cash licensing agreement with JB2 SA for Sinclair's onychomycosis
kit
* £0.2m deal with major animal health company to evaluate the use of
Delmopinol to treat or prevent periodontal disease in companion animals
* £0.2m milestone received from Orapharma following the validation of the
Italian manufacturing site for Decapinol, which remains on track for launch
during FY2010.
Grahame Cook, Chairman of Sinclair Pharma, commented:
"We are pleased to announce Sinclair's second successive year of EBITDA profit
since IPO. This achievement is a direct result of the continued hard work of
Sinclair's employees and management team in the face of economic uncertainty
and the challenges it has presented to our business.
"By adapting our group via a restructuring programme we are now left with a
much leaner business and one that is poised to put into action a new, focussed
sales and marketing strategy and, in doing so, fully realise the value of our
product portfolio. With a new structure and commercial strategy in place, the
Board and Sinclair management look forward to delivering long-term
profitability and achieving our ambition of becoming a leading international
specialty pharma company that delivers shareholder value."
- Ends -
For further information please contact:
Sinclair Pharma plc Tel: +44 (0) 1483 410 600
Grahame Cook, Chairman
Dr Michael Flynn, CEO
Jerry Randall, CFO
Mariyam Rawat, Director of Communications & Investor relations
Email: investorrelations@sinclairpharma.com
Capital MS&L
Mary Clark, Anna Mitchell Tel +44 (0)20 7307 5337
Sinclair's management team will discuss the company's results at a presentation
and conference call for analysts today at 10.30am which will be held at Singer
Capital Markets Ltd, One Hanover Street, London, W1S 1YZ. Please contact Joanna
Whineray at Capital MS&L for further information on
+44 (0)20 7307 5337 or Joanna.whineray@capitalmsl.com
Notes to Editors:
About Sinclair Pharma Plc www.sinclairpharma.com
Sinclair Pharma plc is an international specialty pharmaceutical company
providing solutions to treat dermatological, oral care and gynaecological
diseases through advanced surface technology and innovative delivery systems.
It has a growing sales and marketing operation that is already present in
France, Italy, Spain and Portugal, and a complementary marketing partner
network that spans more than 90 countries.
"Safe Harbour" Statement under the US Private Securities Litigation Reform Act
of 1995: Some or all of the statements in this document that relate to future
plans, expectations, events, performances and the like are forward-looking
statements, as defined in the US Private Securities Litigation Reform Act of
1995. Actual results of events could differ materially from those described in
the forward-looking statements due to a variety of factors.
CHAIRMAN'S STATEMENT
Second year of EBITDA profit
The past 12 months have presented the global economy with some of the toughest
challenges of recent times. The effects have been far reaching with no sector
or geography left untouched. The life sciences, and especially pharmaceutical,
industries have also felt the effects of the downturn with many wholesalers
reducing the extent of their stocking to minimise their overall risk.
Against this backdrop Sinclair has delivered its second year of EBITDA profit.
While the past year has not been without its challenges, we have responded to
these by adapting our business to meet them head on.
The global outlook remains unclear but we share with you today solid results
that underline Sinclair's potential. These results are testament to the
continued hard work of Sinclair's employees and management team and their
dedication in helping Sinclair work towards achieving its goals.
A new commercialisation strategy
Sinclair has always prided itself on its ability to develop high quality
products for the treatment of a range of dermatological and oral treatments.
Having established an extensive portfolio of products, our focus now is on
fully realising the value of these products.
During the past year we have embarked upon an aggressive commercialisation
strategy and have restructured our business to maximise the potential in our
portfolio. At the same time we have created a new role - Chief Operating
Officer - and promoted Christophe Foucher to this position, following his
success in developing the Sinclair business in France. Under Christophe we have
united the business development team and operating companies to form a single
division with a common objective.
Following the acquisition of the remaining minority interest in Spain, Sinclair
now has 100% owned operations in France, Italy and Spain. The depth of
management expertise in these territories has been reinforced by the
appointment of new Country Operations Directors.
Sinclair's own operations are complemented by an extensive network of marketing
and distribution partners around the world. Sinclair continues to grow its
global footprint by building on existing strong relationships and by increasing
the level of marketing support it gives to its partners, allowing for greater
efficiency within the supply chain.
In combination these proactive and decisive steps make me confident that our
new approach equips us with the tools to progress our growth strategy.
Employees
Without the continued commitment and hard work of Sinclair's employees the
results we disclose today would not have been possible. Led by a strong
management team, Sinclair's employees are one of the greatest assets of the
business. On behalf of the Board and shareholders I would like to thank them,
and Sinclair's management, for their hard work.
Outlook
The implementation of a clearly focussed commercialisation strategy,
underpinned by an agile and efficient business structure, means we are well
positioned to drive up product revenues without sacrificing margins. We believe
our business presents several significant opportunities for ongoing growth and
our short-term goal remains to achieve sustainable profitability based on
recurring product revenues. The Board continues to believe that the commercial
success of Decapinol in the US will be one of the key drivers for the Group and
remains confident in Sinclair's ability to deliver long-term profitability.
We look to the year ahead with optimism as we continue our journey to becoming
a world class specialty pharma company, with innovative products that meet the
needs of the patient.
Grahame Cook ACA
Chairman
CHIEF EXECUTIVE'S REVIEW
Overview
Despite the challenging economic environment, we are pleased to report our
second successive year of profitability at the EBITDA level. Revenues for the
year ended 30 June 2009 were £30.4 million, impacted by wholesaler de-stocking,
particularly in the second half. However, a combination of greater revenues
from licensing fees and strong cost control resulted in an EBITDA of £2.3m
before exceptional items.
Sinclair has a strong and growing portfolio of products, both on the market and
in development, and an extensive network of sales and marketing partners; the
Group is now focused on the commercialisation of our products.
We have restructured and streamlined the business. Christophe Foucher has been
appointed as Chief Operating Officer with responsibility for all commercial and
supply chain activities in the Group. With 14 years of experience, he is
implementing the commercial strategy designed to enable Sinclair to optimise
the core business and achieve its long term goals. This restructuring includes
the integration of the business development and operating companies to form a
single division Sinclair Global Operations with a common objective.
Sinclair has purchased the outstanding 49.95% of Laboratorios Novo Pharma S.L.,
to create Sinclair Pharmaceutical España. Sinclair now has 100% owned
operations in France, Italy and Spain and the depth of management expertise in
these territories has been reinforced by the appointment of new Country
Operations Directors. Sinclair has also streamlined its operations in the UK
and, as a result of the regulatory changes in the market, has closed its UK
sales operation, now distributing its UK products solely through marketing
partners. Financial control has been increased by the appointment of a
financial controller dedicated to the commercial and manufacturing operations.
OPERATIONAL REVIEW
Sales & Marketing
Sinclair Global Operations
The newly formed Sinclair Global Operations,headed up by COO Christophe
Foucher,is divided into:
* Country Operations (formerly operating companies)
* International Operations (formerly business development)
The principal focus of the restructured organisation is on improving execution,
leverage, responsibility and accountability across the company. In addition,
the appointment of Jean-Louis Lamandé as Financial Controller for Sinclair
Global Operations increases the level of financial input into the
decision-making process.
Country Operations
During the full year 2009, Country Operations contributed £12.4m to group
revenues.
France
The French operation continues to spearhead the changes within the organisation
and has established the working model for Country Operations. During the period
we appointed Celine Genty as Country Operations Director and we reinforced the
marketing team with a Pharmacy Team, increasing the level of expertise in the
business.
We continue to leverage the strength of the existing French brands dedicated to
dermatology and the sales team now has full coverage of 3,200 dermatologists in
both hospitals and private clinics. Following the successful introduction of a
sell-out team, we have introduced and piloted a sell-in support team and
support advisors in France. The success of this process is clearly demonstrated
by the launch and sales of our Jonctum stretch marks cream, where areas with
sell-out support ordered more frequently. This model will be replicated in
Italy in the new financial year and Spain in the coming years.
There has also been an enhanced focus on direct sales to pharmacies with OTC
promotions of Oxyplastine and Ephydrol. As a result, we have seen direct sales
increase by 8% year on year.
Looking forward, we have recently started a high profile Key Opinion Leader
programme called Controverse that will help to cement Sinclair's position as a
specialist in the dermatology sector.
Sinclair Pharma France contributed £9.8m to group revenues during the year.
Italy
At the end of the last financial year the business was restructured to focus on
the therapeutic areas of acne, dry and sensitive skin and seborrhoeic
dermatitis. In addition, the sales force has been reorganised to use agents
rather than sales representatives providing greater flexibility and enabling
improved coverage and targeting.
During the year, Italy saw the successful launch of Sebclair Shampoo, Sebclair
Scalp Fluid, Papulex moussant, and new formula Dermachronic.
In Italy, we appointed Paolo Prioglio as Country Operations Director,
reinforcing the marketing team and increasing the level of expertise in the
business.
Sinclair Srl contributed £2.0m to group revenues.
Spain
Sinclair reinforced its presence in Spain through the acquisition of the
remaining shares in Laboratorios Novo Pharma S.L. This move was strengthened
with the appointment of Santiago Calavia Torres as Country Operations Director
of Dermatology and renaming the entity Sinclair Pharmaceutical España. Spain
has seen the successful launch of Sebclair and Papulex.
Sinclair Pharmaceutical España contributed £0.2m to group revenues during the
period.
UK
During the first half of the year the UK business was restructured to focus on
specialty dermatology sales. In December 2008 Sinclair increased its sales
presence through a co-promotion collaboration with York Pharma. However as a
result of the regulatory changes in the market, and as part of the
organisational restructure, Sinclair closed its UK sales operation in June
2009, but continues to sell products through marketing partners.
Sinclair Pharma UK contributed £0.4m to group revenues during the period.
International Operations
International Operations incorporates Sinclair's extensive network of marketing
and distribution partners. This currently extends to 94 countries and product
sales in 58 countries. The network leverages the experience and local knowledge
of our partners to extend the commercial reach of our product portfolio.
Sinclair continues to increase its global footprint and 2009 saw the continued
geographical expansion of Sinclair's product distribution with product sales of
£9.6m. This was a result of 45 launches in 22 markets covering seven product
ranges by the marketing partner network. Sinclair is also increasing the level
of marketing support it gives to its partners, implementing a new objective of
increasing product sell out, and ultimately generating more predictable income
in relation to orders and re-orders.
As part of the reorganisation, International Operations is focusing on
geographical expansion in key markets such as India, Poland, Greece, Turkey and
Israel.
Licensing Revenues
During the year Sinclair recognised licence fees and milestones of £7.4m (2008:
£4.8m).
The major components of this are:
* the agreement with Graceway for the sales of US distribution rights to
Atopiclair cream and lotion for £2.1m
* the non-cash licensing agreement with BMG Pharma for the licence of
Sinclair's gynaecological portfolio which contributed £3.3m
* the non-cash licensing agreement with JB2 SA for a licence of Sinclair's
onychomycosis kit, which contributed £0.9m.
Sinclair also received several smaller licence fees including: £0.2m from a
major animal health company to enable the company to evaluate the use of
Delmopinol to treat or prevent periodontal disease in companion animals and £
0.2m from Orapharma following validation of the Italian manufacturing site.
During the period we also signed 65 new distribution agreements covering 27
products in 47 markets. By extending the commercial presence of our product
portfolio on an increasingly global basis, we continue to make available to
patients effective solutions for specific dermatological and oral health needs.
RESEARCH AND DEVELOPMENT
The organisational restructuring has led to the establishment of the R&D
steering committee which has representatives from the technical team and the
commercial team. The committee evaluates opportunities arising from internal R&
D activities as well as potential in-licensing and co-development prospects.
R&D is focused on the development of new products and supporting existing
products - particularly through creating line extensions. Innovative delivery
systems and the use of advanced surface technology are our areas of focus
within the dermatology area.
Pipeline Development
We have continued to advance our pipeline and expand its future potential
through the signing of two product development and commercialisation deals with
BMG Pharma, a privately-owned US-based company. BMG will be developing and
registering a number of gynaecology products from Sinclair's pipeline. Sinclair
has in-licensed a range of skin anti-infection products based on patented
silver nanotechnology from BMG. These innovative deals present Sinclair with
significant pipeline development opportunities and new product assets. We also
acquired proprietary organic zinc technology which may be combined with other
technologies or used alone and a hydrogen peroxide delivery system which can be
used as an antibacterial in acne treatments.
There are 56 products and line extensions in the current R&D pipeline covering
dermatology and gynaecology, many of which we believe have the potential to
deliver substantial revenues.
Regulatory Affairs
During FY 2009 we achieved two new product registrations in the EU. These
registrations were the EU approval of Decapinol Perio vials for the management
of gum pockets in periodontal disease and DermaChronic foam for the treatment
of sensitive skin or chronic skin conditions such as atopic dermatitis,
xerosis, psoriasis and eczema.
Clinical Data
Supporting clinical and experimental data are of critical importance in
demonstrating the efficacy and mechanisms of actions of our products and can
also be a source of competitive advantage providing us with distinct product
claims.
During the year, results of 18 proof of concept studies were accepted for
publication, while four were published in peer reviewed journals, including:
* Atopiclair Cream: Treatment of pruritus in mild to moderate atopic
dermatitis with a topical non steroidal agent. Veraldi S, Lunardon L,
Schianchi R; The Journal of Drugs in Dermatology and two studies evaluating
the emollient DermaChronic Cream and Cleanser and our acne product Papulex
Cream Oil Free.
In addition ten clinical abstracts were presented at the 17th Congress of the
European Academy of Dermatology and Venereology(EADV) during September 2008 in
Paris.
Intellectual Property
Sinclair's approach to product pipeline development combines the sourcing and
developing of novel technologies externally with newly-acquired and existing
technologies to create new product concepts. In order to maximise the
commercial benefits arising from the innovative advantages inherent in our
products, Sinclair invests in the development of strong intellectual property
for all of its new products. Currently 35 Sinclair products enjoy patent
protection.
Manufacturing & Logistics
The Sinclair Group manufacturing and logistics function is managed and
coordinated by the team in Milan. The team's role is to enable Sinclair's
products to be validated and commercialised successfully either in-house or in
contract manufacturing facilities. The team is responsible for global supply
chain operations as our products are distributed worldwide. Sinclair
manufactures around two-thirds of its products through contract manufacturers
and a third of its products in-house through its Clery facility in France. In
FY 2009 approximately 11 million product units were manufactured. In a drive to
reduce cost of goods and maximise synergies, all in-house production will be
handled at Clery. An increasingly automated process is being implemented in
Clery in order to optimise manufacturing which will ultimately help make
Sinclair a leaner business.
Directors and Advisors
Board and Management changes
In November 2008, Steve Harris stepped down as Non-Executive Chairman. Grahame
Cook, previously the Senior Independent Director, was appointed as
Non-Executive Chairman. Penny Freer will now take on the role of Senior
Independent Director.
During the year we further bolstered Sinclair's team with the appointment of Dr
Ross Macdonald as Vice President of Business Development for North America &
South Pacific. In addition, following the appointment of Christophe Foucher as
COO and his subsequent success in restructuring the business, I am pleased to
announce today that he will be joining the Board.
Finally, following nine years as CEO of Sinclair Pharma, I will be retiring at
the next AGM, at which point Chris Spooner will take on the role of CEO. It has
been a pleasure working with the talented and dedicated team at Sinclair during
a transformational period in the company's history and I feel confident that
the new management team will take Sinclair forward through the next stage of
its growth.
Dr Michael Flynn
Chief Executive Officer
FINANCIAL REVIEW
Highlights
Sinclair recorded its second profitable full year at the EBITDA level. EBITDA
before exceptional items was £2.3m (2008: £1.3m) with basic loss per share
after exceptional items of 3.9p (2008: earnings per share of 3.8p).
Revenues, which were affected by wholesaler de-stocking, increased by 0.4% to £
30.4m (2008: £30.3m), gross profit increased by 6% to £20.7m (2008: £19.4m) and
the operating loss for the year, before exceptional items, reduced to £0.3m
(2008: £0.8m).
The 80% increase in EBITDA prior to exceptional items was achieved through a
strong contribution from licensing fees, combined with tight cost control.
Revenue
Total revenue for the year increased marginally by 0.4% to £30.4m (2008: £
30.3m), reflecting the challenges presented by the economic climate which led
to wholesalers reducing their stockholdings as a result of cash constraints.
This resulted in a one off reduction in sales during the year and going forward
smaller, more frequent orders for Sinclair. Revenues generated from licensing
fees, including non-cash licensing agreements, more than off-set the effects of
de-stocking, leading to the small increase in overall revenue.
Product revenue for the year was £22.0m (2008: £24.8m). A further £1.0m was
contributed by royalty payments (2008: £0.7m). Revenue of £7.4m was also
generated by licence fees and milestone payments (2008: £4.8m).
Direct sales through countryoperations
Sinclair's own sales and marketing operations in the UK, France, Italy, and
Spain generated revenue of £12.4m, a decrease of 10% year on year (2008: £
13.7m), £1.1m of this decrease being a result of ceasing promotion activities
to dispensing doctors in the UK in July 2008.
A breakdown of the contribution from Sinclair's own sales and marketing
operations for the period are
FY 2009 FY 2008
£m £m
France 9.8 9.0
Italy 2.0 2.6
UK 0.4 1.5
Spain 0.2 0.6*
Total 12.4 13.7
* FY08 figure includes revenue of £0.3m from CS Portugal, Sinclair's joint
venture partner in Portugal. CS Portugal has been deconsolidated from the Group
results in FY09 as the Group no longer has effective management control of this
associate from 1 July 2008.
Revenue through international operations
Revenue generated for the year from our marketing partners was £18.0m, an
increase of 8% year on year (2008: £16.5m). A breakdown is summarised below:
FY 2009 FY 2008
£m £m
Product sales 9.6 11.0
Royalties 1.0 0.7
License fees and milestones 7.4 4.8
Total 18.0 16.5
During the year Sinclair recognised license fees and milestones of £7.4m (2008:
£4.8m). The major components of this are the agreement with Graceway for the
sales of US distribution rights to Atopiclair Cream and Lotion for £2.1m, the
non-cash licensing agreements with BMG Pharma for the license of Sinclair's
gynaecological portfolio (£3.3m) and the licensing agreement with JB2 SA for
Sinclair's onychomycosis kit (£0.9m). Additional smaller components include £
0.2m from a major animal health company to enable it to evaluate the use of
Decapinol to treat or prevent periodontal disease in companion animals and £
0.2m from Orapharma following validation of the Italian manufacturing site.
Non-cash licensing agreements contributed £4.2m to both revenue and profit in
the year (2008: £1.2m).
Revenue Analysis
Following the challenges of the current economic environment we have seen the
impact on our business of wholesalers reducing their stockholdings as a result
of cash constraints. This resulted in a one off reduction in sales during the
year and followed by smaller, more frequent orders for Sinclair.
Despite overall product revenue increasing by only 0.4%, the Top 10 products
(revenue and royalties excluding licence fees) have seen an increase of 21%
year on year, with eight out of ten products in the Top 10 experiencing growth.
The relative position of the key products remained the same and we continue to
have eight products that contributed more than £1m in annual product revenue.
This has been led by continued growth of Aloclair and Fazol, the gathering
momentum of Sebclair and export of the French products such as Papulex and
Oxyplastine.
However the B.lift and B.derm dermocosmetic products and Claro are no longer in
this year's Top 10 products, which have significantly impacted revenue this
year. This was a direct consequence of substantial sales made into the market
in June 2008 that were not repeated in 2009 due to a slow sell out.
Exceptional Items
During the year there were some exceptional items recorded which were outside
the normal trading activities:
* Foreign exchange gains of £1.7m were recorded in the year on the
translation of an intra-group loan balance as a result of the Sterling's
weakening against the Euro during the year.
* Restructuring costs of £1.4m include severance costs and costs relating to
the restructuring of the sales forces in Italy, France, and the closure of
the UK sales operations during the year.
* Exceptional acquisition related costs were incurred in relation to a
strategic acquisition opportunity during the summer of 2008. These
discussions were put on hold as a result of the market volatility in the
autumn of 2008. Costs of £0.6m were incurred to that point.
* An impairment provision of £0.9m has been made against the value of the
product rights for Spiromix, as a result of manufacturing delays which
resulted in the product not being available for sale in Italy during the
year.
* A provision of £1.2m has been made during the year for a debt due from a
distributor. Movements on other doubtful debt provisions are included
within administrative expenses.
Total Operating Expenses
Total operating expenses for the Group excluding exceptional items were £21.0m,
a 4% increase on the prior year (2008: £20.2m). This increase was driven by
Sterling's weakness which added £1.6m to expenses compared to the prior year.
On a constant exchange rate basis, total operating expenses fell by £0.2m in
the year, reflecting the initial impact of the restructuring activities
undertaken in the year.
A renewed focus on sales and marketing increased these costs by 1.5%, in
addition to the impact of Sterling's weakness on costs. Other administrative
expenses decreased by £0.3m after the impact of currency movements as a result
of the restructuring efforts. This was in spite of an increase in amortisation
of £0.3m (at constant exchange rates), demonstrating our resolute commitment to
growing the business while keeping costs under tight control.
Operating Loss
Sinclair recorded an operating loss for the year of £0.3m (2008: £0.8m) before
exceptional items.
Taxation
There is no corporation tax charge on the profit for the year as a result of
the tax losses carried forward from prior years.
Financing Costs
Financing costs of £1.4m including exceptional items, were incurred as result
of the Group's increased level of net debt (2008: £1.1m). This includes £0.6m
interest on debt and £0.3m foreign exchange loss resulting from the translation
of Euro debt.
An exceptional cost of £0.3m was also incurred in relation to professional fees
associated with the negotiation of a financing agreement which failed to come
to fruition due to unfavourable terms.
Liquidity & Capital Resource
Sinclair had cash balances of £0.1m (2008: £1.1m) at 30 June 2009. Net cash
outflow during the year was £1.3m (2008: £3.3m), which included cash used in
operating activities of £0.5m (2008: £3.7m) and cash used in investing
activities of £2.8m (2008: £4.2m). Cash inflow from financing was £2.0m (2008:
£4.6m) which includes £1.0m, net of expenses, from an institutional placing of
new shares in December 2008.
In May 2009, Sinclair entered into a £10m equity line of credit with a three
year duration with GEM Global Yield Fund Limited. Sinclair will control the
timing and maximum amount of any draw down under this credit line and is not
obliged to draw on the funds on offer. To date none of this facility has been
utilised.
Following the period, in September 2009, Sinclair issued convertible unsecured
loan notes worth approximately £2.3 million to a leading institutional
investor. A first series of £1 million of the notes were issued immediately
with the final £1.3 million drawn down in early October.
Loss/earnings per share
Sinclair recorded a basic loss per share of 3.9p (2008: earnings per share of
3.8p).
Additions to intangible assets
Additions to intangible assets were £6.7m resulting from the addition of the
silver nanotechnology arm to the skincare portfolio (£3.9m), the in-licensing
of zinc technology (£1.4m) and the hydrogen peroxide technology (£1.0m), all of
which are non-cash transactions procured through strategic product swaps, as
well as some other smaller additions. These additions resulted in an increased
amortisation charge of £2.1m (2008: £1.5m).
Jerry Randall ACA
Chief Financial Officer
Unaudited Consolidated Income Statement
For the year ended 30 June 2009
Unaudited Audited
2009 2008
Notes Pre-exceptional Exceptional Total Pre-exceptional Exceptional Total
items items items items
(note 3) (note 3)
£'000 £'000 £'000 £'000 £'000 £'000
Revenue 2 30,408 - 30,408 30,278 - 30,278
Cost of sales (9,704) - (9,704) (10,830) - (10,830)
Gross profit 20,704 - 20,704 19,448 - 19,448
Selling, marketing (9,535) - (9,535) (8,444) - (8,444)
and distribution
costs
Administrative 3 (11,477) (2,428) (13,905) (11,803) 2,997 (8,806)
expenses
Operating (loss)/ (308) (2,428) (2,736) (799) 2,997 2,198
profit
Finance income 4 131 - 131 67 380 447
Finance costs 4 (1,173) (260) (1,433) (741) (330) (1,071)
(Loss)/profit before (1,350) (2,688) (4,038) (1,473) 3,047 1,574
taxation
Taxation 5 417 - 417 410 1,354 1,764
(Loss)/profit for (933) (2,688) (3,621) (1,063) 4,401 3,338
the year
Attributable to:
Minority interest - - - 1 - 1
Equity holders of (933) (2,688) (3,621) (1,064) 4,401 3,337
the Company
(933) (2,688) (3,621) (1,063) 4,401 3,338
(Loss)/earnings per 6 (1.0p) (2.9p) (3.9p) (1.2)p 5.0p 3.8p
share (basic)
(Loss)/earnings per 6 (1.0p) (2.9p) (3.9p) (1.2)p 4.8p 3.6p
share (diluted)
Unaudited Consolidated Balance Sheet
At 30 June 2009
Unaudited Audited
2009 2008
Note £'000 £'000
Non-current assets
Goodwill 7 51,062 48,110
Intangible assets 8 19,708 14,811
Investments 165 -
Property, plant and equipment 1,643 1,827
Deferred tax assets 1,304 708
Other non-current assets 89 317
73,971 65,773
Current assets
Inventories 3,807 3,380
Trade and other receivables 9 9,764 14,469
Current tax receivable 48 1,580
Cash and cash equivalents 88 1,052
13,707 20,481
Total assets 87,678 86,254
Current liabilities
Financial liabilities - borrowings 11 (3,733) (3,108)
Trade and other payables 10 (9,865) (11,666)
Deferred income (713) (566)
Current tax liabilities (163) (86)
Provisions (382) -
(14,856) (15,426)
Non-current liabilities
Financial liabilities - borrowings 11 (4,602) (4,140)
Deferred income (280) (357)
Other non-current liabilities (239) -
Provisions (343) -
(5,464) (4,497)
Total liabilities (20,320) (19,923)
Net assets 67,358 66,331
Equity
Share capital 1,033 935
Share premium account 23,131 21,472
Merger reserve 50,474 50,474
Other reserves 6,528 4,198
Retained deficit (13,808) (10,760)
Total shareholders' equity 67,358 66,319
Minority equity interests - 12
Total equity 67,358 66,331
Unaudited Consolidated Statement of Changes in Shareholders' Equity
For the year ended 30 June 2009
Share Share Merger Other Retained Attributable Minority Total
capital premium reserves deficit to equity interest
reserve holders of equity
the parent
£'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000
Balance at 1 July200 935 21,472 50,474 271 (14,775) 58,377 11 58,388
7(audited)
Exchange differences - - - 3,927 - 3,927 - 3,927
arising on
translation of
overseas
subsidiaries
Net expense - - - 3,927 - 3,927 - 3,927
recognised directly
in equity
Profit for the year - - - - 3,337 3,337 1 3,338
Total recognised - - - 3,927 3,337 7,264 1 7,265
incomefor the period
Share based payments - - - - 678 678 - 678
- value of employee
services
Balance at 30 June 935 21,472 50,474 4,198 (10,760) 66,319 12 66,331
2008 (audited)
Exchange differences - - - 2,330 - 2,330 - 2,330
arising on
translation of
overseas
subsidiaries
Net income - - - 2,330 - 2,330 - 2,330
recognised directly
in equity
(Loss) for the year - - - - (3,621) (3,621) - (3,621)
Total recognised - - - 2,330 (3,621) (1,291) - (1,291)
income for the
period
Share based payments - - - - 573 573 - 573
Options and warrants 1 - - - - 1 - 1
exercised
Share capital issued 97 1,722 - - - 1,819 - 1,819
Share issue expenses - (63) - - - (63) - (63)
Purchase of minority - - - - - - (12) (12)
interests
Balance at 30 June 1,033 23,131 50,474 6,528 (13,808) 67,358 - 67,358
2009 (Unaudited)
Unaudited Consolidated Cash Flow Statement
For the year ended 30 June 2009
Note Unaudited Audited
2009 2008
£'000 £'000
Cash flows from operating activities
Net cash outflow from operations 12 (1,225) (3,250)
Interest paid (803) (281)
Interest paid on finance leases (45) (41)
Taxation received/(paid) 1,603 (124)
Net cash used in operating activities (470) (3,696)
Investing activities
Interest received 456 67
Purchases of property, plant and equipment (482) (166)
Proceeds from sale of property, plant and equipment 27 47
Purchase of intangible assets (2,005) (3,907)
Payment of contingent consideration re CS Dermatologie (237) (223)
Deconsolidation of Portugal subsidiary (129) -
Acquisition of subsidiary undertaking, net of cash acquired (400) (14)
Net cash used in investing activities (2,770) (4,196)
Financing activities
Repayments of obligations under finance leases (219) (156)
Proceeds from borrowings 3,866 5,370
Repayments of borrowings (3,203) (653)
Proceeds from issue of share capital 1,598 -
Share issue costs (63) -
Net cashgeneratedfrom financing activities 1,979 4,561
Net decreasein cash,cash equivalentsand bank overdrafts (1,261) (3,331)
Cash, cash equivalents and bank overdrafts at 1 July (354) 2,604
Exchange gains on cash and bank overdrafts 18 373
Cash, cash equivalentsand bank overdraftsat end of year (1,597) (354)
Cash, cash equivalents and bank overdrafts includes:
Cash and cash equivalents 88 1,052
Bank overdrafts (1,685) (1,406)
Cash,cash equivalents and bank overdrafts (1,597) (354)
1. Basis of preparation
The financial information has been prepared in accordance with International
Financial Reporting Standards (`IFRS') as adopted for use in the European
Union. In preparing this financial information management has used the
principal accounting policies as set out in the Group's annual financial
statements for the year ended 30 June 2008 and which will be used in preparing
the financial statements for the year ended 30 June 2009. There have been no
changes to the accounting policies during the year.
The preliminary financial information has not been audited and does not
constitute statutory accounts within the meaning of section 434 of the
Companies Act 2006. The financial information for the year ended 30 June 2008
has been extracted from the Group's financial statements for the year ended 30
June 2008. The auditors' report on the financial statements for the year ended
30 June 2008 was unqualified and did not contain statements under either
section 498 (2) or section 498 (3) of the Companies Act 2006. The financial
statements for the year ended 30 June 2008 have been delivered to the Registrar
of Companies.
The preliminary financial information has been prepared on the going concern
basis which assumes that the Group has adequate resources to continue in
business for the foreseeable future. The company has today announced the
acquisition of two revenue-generating products from Solvay Phamaceuticals for €
17.5m, and an associated fundraising of up to £25m (see separate announcement),
and on the basis of which the Directors consider the going concern basis to be
appropriate.
CS Portugal has been deconsolidated from the Group results in FY09 as the Group
no longer has effective management control of this associate from 1 July 2008.
This announcement was approved by the Board of Sinclair Pharma plc on 12
October 2009.
2. Segmental information
The information below is not the full segmental disclosure as required by IAS
14 but selected segmental information only.
The Group's primary segment reporting is by business sector with geographical
location of assets being the secondary format. The Group is organised into two
operating segments: development, registration and commercialisation of products
through marketing partners (international operations), and direct sales and
marketing of pharmaceutical products to doctors and pharmacies (country
operations).
Primary reporting format - business sector
Unaudited Audited
2009 2008
International Country Total International Country Total
operations operations operations operations
£'000 £'000 £'000 £'000 £'000 £'000
Revenue 18,032 12,376 30,408 16,540 13,738 30,278
Segmental operating 1,905 (2,213) (308) 836 (1,635) (799)
(loss)/profit before
exceptional items
Exceptional items (2,428) 2,997
Operating (loss)/ (2,736) 2,198
profit
Finance income 131 447
Finance cost (1,433) (1,071)
(Loss)profit before (4,038) 1,574
tax
Taxation 417 1,764
(Loss)/profit for (3,621) 3,338
the financial year
Revenue Analysis
By destination, the Group's revenue derives from the UK, rest of Europe, the US
and rest of World.
Unaudited Audited
2009 2008
£'000 £'000
United Kingdom 1,129 2,450
Rest of Europe 18,319 18,517
United States of America 7,280 2,804
Rest of World 3,680 6,507
30,408 30,278
An analysis of revenue by category is set out in the
table below:
Unaudited Audited
2009 2008
£'000 £'000
Product revenue 21,999 24,808
Royalties 985 660
Licence fees and milestones 7,424 4,810
30,408 30,278
Non-cash transactions of £4.2m are included in Licence fees and milestones and
net profit (2008: £1.2m).
3. Exceptional operating items
Exceptional items represent significant items of income and expense which due
to their nature or the expected infrequency of the events giving rise to them,
are presented separately on the face of the income statement to give a better
understanding to shareholders of the elements of financial performance in the
year, so as to facilitate comparison with prior periods and to better assess
trends in financial performance.
Unaudited Audited
2009 2008
£'000 £'000
Foreign exchange gains 1,671 3,699
Restructuring costs (1,442) -
Aborted acquisition costs (555) (334)
Goodwill impairment - (368)
Impairment provision on product rights (898) -
Provision for doubtful debts (1,204) -
(2,428) 2,997
Foreign exchange gains of £1,671,000 represent the gain on the translation of
an intra-group loan balance (2008: gain of £3,699,000). This is a non-cash
item.
Restructuring costs of £1,442,000 include severance costs and costs relating to
the restructuring of the sales forces in Italy and France, and the closure of
the UK sales operation and Northampton site during the year.
Exceptional acquisition related costs were incurred in relation to a strategic
acquisition opportunity during the summer of 2008. These discussions were put
on hold as a result of the market volatility in the autumn of 2008. Costs of £
555,000 were incurred to that point.
Exceptional acquisition related costs in the prior year were incurred in
preparing for a major acquisition in July 2007. Sinclair was substantially
outbid in this transaction which resulted in a charge of £334,000 for
professional fees.
An impairment provision of £898,000 has been made against the value of the
product rights for Spiromix, as a result of manufacturing delays which resulted
in the product not being available for sale in Italy during the year.
An impairment charge of £368,000 was recorded in 2008 against the goodwill
arising on the acquisition of Sinclair Pharma UK Limited (formerly Ashbourne
Pharmaceuticals Limited) following the decision to restructure this operation
and exit the dispensing doctors' market in the UK.
A provision of £1,204,000 has been made during the year for a doubtful debt due
from a distributor. Movements on other doubtful debt provisions are included
within administrative expenses.
4. Finance income and costs
5.
Unaudited Audited
2009 2008
£'000 £'000
Finance costs
Interest on bank loans and overdrafts (591) (326)
Interest due on finance leases (45) (41)
Net foreign exchange losses on financing activities (319) (338)
Unwinding of discount on contingent consideration for - (18)
Groupe CS Dermatologie
Share based payments charge - warrants issued (86) -
Other finance charges (132) (18)
Exceptional finance costs (260) (330)
Finance costs (1,433) (1,071)
Finance income
Bank interest receivable 2 22
Interest received on tax refund re Groupe CS - 380
Dermatologie - exceptional item
Interest receivable on trade receivables 50 45
Unwinding of discount on non-current asset 77 -
Other interest income 2 -
Finance income 131 447
Net finance expense (1,302) (624)
Exceptional finance costs relate to professional fees incurred arranging
finance facilities that the Directors decided not to enter into as the terms
were unfavourable.
The Company has issued warrants to GEM Global Yield Fund Limited ("GEM
warrants") to subscribe for ordinary 1p shares in the Company, under the
agreement for GEM providing a three year £10m equity line of credit.
5. Taxation
6.
Unaudited Audited
2009 2008
£'000 £'000
Research and development tax credits - (140)
receivable
Overseas tax 96 81
Deferred overseas tax (523) (351)
Release of overseas tax provision - - (1,354)
exceptional item
Withholding tax 10 -
Tax credit on operating (loss)/profit (417) (1,764)
6. (Loss)/earnings per share
The basic (loss)/earnings per share has been calculated by dividing the (loss)/
profit for the year, by the weighted average number of shares in existence for
the year. Shares held by the Employees' Share Trust, including shares over
which options have been granted to Directors and staff, have been excluded from
the weighted average number of shares for the purposes of calculation of the
basic (loss)/earnings per share.
The loss and weighted average number of shares for the purpose of calculating
the diluted loss per share are identical to those used for the basic loss per
share at 30 June 2009, as the exercise of share options and warrants would have
the effect of reducing the loss per share and therefore is not dilutive.
For the year ended 30 June 2008 diluted earnings per share is calculated by
adjusting the weighted average number of ordinary shares outstanding to assume
conversion of all dilutive potential ordinary shares. Potential ordinary shares
of the Company are share options, warrants and awards. A calculation has been
undertaken to determine the number of shares that could have been acquired at
fair value (determined as the average annual market price of the Company's
shares) based on the monetary value of the subscription rights attached to
outstanding options, warrants and awards.
Unaudited Audited
2009 2008
(Loss)/profit attributable to equity shareholders (£ (3,621) 3,337
'000)
Weighted average number of shares 92,904,290 87,241,256
Adjustment for share options, warrants and awards - 4,523,701
Diluted weighted average number of shares 92,904,290 91,764,957
Basic (loss)/earnings per share (pence) (3.9p) 3.8p
Diluted (loss)/earnings per share (pence) (3.9p) 3.6p
7. Goodwill
Unaudited Audited
2009 2008
£'000 £'000
Cost
At 1 July 50,989 45,929
Additions 355 67
Exchange adjustments 2,597 4,993
At 30 June 53,941 50,989
Accumulated amortisation and impairment
At 1 July 2,879 2,511
Impairment charge (note 3) - 368
At 30 June 2,879 2,879
Net book value at yearend 51,062 48,110
Additions in the year ended 30 June 2009 relate to the purchase of the minority
interest in Laboratorios Novo Pharma SL (now Sinclair Pharmaceutical España)
for €330,000 plus expenses.
Exchange adjustments arise as a result of the impact of the difference in the
Sterling : Euro exchange rate at the beginning and end of the year on balances
recorded in Euros.8. Intangible Assets
Unaudited Audited
2009 2008
£'000 £'000
Cost
At 1 July 17,779 11,511
Additions 6,743 4,586
Disposals (108) (491)
Exchange adjustments 1,379 2,173
At 30 June 25,793 17,779
Amortisation and impairment
At 1 July 2,968 1,469
Charge for the year 2,084 1,483
Disposals (6) (51)
Impairment charge (note 3) 898 13
Exchange adjustments 141 54
At 30 June 6,085 2,968
Net book value at year end 19,708 14,811
Additions in the current period principally relate to the acquisition of rights
to the silver nanotechnology, the zinc technology and the purchase of
additional rights under an existing agreement for H202. Additions of £5,363,000
were from non-cash transactions.
Exchange adjustments arise as a result of the impact of the difference in the
Sterling : Euro exchange rate at the beginning and end of the year on balances
recorded in Euros.
9. Trade and other receivables
Unaudited Audited
2009 2008
£'000 £'000
Trade receivables 8,911 12,154
Less provision for impairment of trade receivables (1,389) (113)
Trade receivables net of provision 7,522 12,041
Other receivables 1,243 1,144
Prepayments and accrued income 999 1,284
9,764 14,469
10. Trade and other payables
Unaudited Audited
2009 2008
£'000 £'000
Trade payables 5,471 6,418
Other taxes and social security costs 788 426
Other payables 1,029 2,060
Accruals 2,577 2,762
9,865 11,666
11. Borrowings
Unaudited Audited
2009 2008
£'000 £'000
Bank loans 4,050 4,022
Other borrowings 492 -
Obligations under finance leases 60 118
Non-current borrowings 4,602 4,140
Obligations under finance leases 66 218
Bank loans 1,629 1,350
Bank overdrafts 1,685 1,540
Other borrowings 353 -
Current borrowings 3,733 3,108
Total borrowings 8,335 7,248
Borrowings included above are repayable as follows:
On demand or within one year 3,733 3,108
Over one and under two years 2,291 1,299
Over two and under five years 2,311 2,841
Total borrowings 8,335 7,248
The minimum lease payments under finance leases fall due
as follows:
2009 2008
£'000 £'000
Not later than one year 70 229
Later than one year but not more than five 65 128
135 357
Future finance charges on finance leases (9) (21)
Present value of finance lease liabilities 126 336
12. Cash flow from operations
Unaudited Audited
2009 2008
£'000 £'000
(Loss)/profit before tax (4,038) 1,574
Adjustments for:
Finance income (131) (447)
Finance costs 1,433 741
Share based payment - value of employee services 487 678
Depreciation 493 572
Amortisation of intangible assets 2,084 1,483
Non-cash licence agreements (5,363) -
Impairment charges 915 381
Loss/(profit) on disposal of property, plant & 56 (15)
equipment
Loss/(profit) on sale or disposal of product 102 (35)
rights
Increase/(decrease) in provision for doubtful 1,268 (696)
debts
Increase/(decrease) in provisions - net of 465 -
finance costs provision
Exchange gains (2,304) (4,424)
(4,533) (188)
Changes in working capital (excluding effects of
acquisitions)
Increase in inventories (192) (888)
Decrease/(increase) in receivables 4,419 (4,528)
(Decrease)/increase in payables (989) 2,676
Increase/(decrease) in deferred income 70 (322)
Net cash outflow from operations (1,225) (3,250)
Appendix:
Product Review
Dermatology
Sinclair provides specific solutions to dermatologists and pharmacists for
patients suffering from skin damage and skin injuries through its own
operations in France, Italy and Spain and through its international network of
marketing partners. It aims to do this by delivering higher value products with
special attributes based on its surface treatment technologies and innovative
delivery systems (foams, kits and sprays), treating major skin conditions such
as acne, eczema, fungal conditions and addressing family dermatology and
personal care needs. Core products in our Dermatology portfolio include
Papulex, Sebclair, Bio-Taches, Atopiclair, Oxyplastine and DermaChronic.
Papulex
Papulex is a dermo-cosmetic range of five products indicated for acne prone
skin. Its duo of actives makes it a superior treatment of mild to moderate acne
and the ideal accompaniment to acne Rx treatments. The whole range contains
nicotinamide 4%, an active chosen for its efficacy and tolerability.
Nicotinamide at such concentration prevents and treats inflammation, reducing
papule numbers by 75%1. The anti bacterial adhesion active, covered by a patent
of Sinclair, inhibits P. acnes adhesion by 82%2 and thus stops it proliferating
and limits inflammation.
Papulex is currently available in 10 countries including France, Russia,
Tunisia and Morocco. During the year Papulex generated revenues of £1.2m, and
was launched in Algeria and Spain.
Sebclair
Sebclair is a non-steroidal range of three products, available as a cream,
shampoo and scalp fluid, indicated for the management of seborrhoeic
dermatitis, including relief and management of the most common signs and
symptoms such as scaling/flaking, reddening, burning and pain3. Seborrhoeic
dermatitis is characterised by inflammation and desquamation in areas with a
rich supply of sebaceous glands, namely the scalp, face and upper trunk.
Following the initiation of commercial rollout, Sebclair has generated revenues
of £1.0m this financial year and is available in France, Portugal, Spain,
Italy, Poland and Turkey and was launched in the USA following the end of the
financial year.
Bio-Taches
Bio-Taches is part of the Derma Omnium range Sinclair acquired in FY 2008. The
range also includes Gen Ongles which treats nail deficiencies and Affina Lift
which helps to prevent and correct the effect of skin ageing. Bio-Taches
prevents and treats hyperpigmentations. The superior combination of actives
resulting in azeloglycine reduces the activity of hyperproductive melanocytes,
inhibits melanine production and reduces free radicals liberation that causes
inflammation. The range offers an emulsion, a peel-off mask and two sun care
products. Bio-Taches is available in 13 countries including Russia and Saudi
Arabia.
The Derma Omnium range contributed £0.8m revenues during the year.
Atopiclair
Atopiclair is a non-steroidal range containing two products, indicated for the
symptomatic treatment of atopic dermatitis, including the relief and management
of the most common signs and symptoms such as itching, burning and pain6.
Atopiclair helps to relieve dry skin by enhancing barrier function, maintaining
a moist skin environment, due to hyaluronic acid which is beneficial to the
healing process. Atopiclair also acts as an anti-oxidant. The product is
supplied as a cream and as a lotion.
In December 2008, Sinclair signed an agreement to sell the US distribution
rights and license the patent for use in atopic dermatitis, pertaining to
Atopiclair cream and lotion, to its US marketing partner Graceway for £2.1m
($3.1million). The payment is equivalent to the royalties Sinclair would have
anticipated to receive from Graceway over the next five years. Atopiclair sales
in the US have been affected by the economic environment, in common with other
atopic dermatitis treatment sales in the US.
Atopiclair delivered revenues of £2.1m this year and is available in 14
countries, and was launched in Korea, Poland and Israel.
Oxyplastine
Oxyplastine is an ointment formulated to prevent and protect skin against
irritation, in particular in cases of nappy rash. Oxyplastine forms a barrier
on the skin protecting it from external irritating agents. Its astringent
properties are due to a high concentration of zinc oxide (46%) reinforcing its
efficacy.
In France, Oxyplastine is a household brand but is sold in 18 countries in
total, including Germany, Switzerland and Algeria. During the year Oxyplastine
generated revenues of £1.5m.
DermaChronic
The DermaChronic range consists of a cleanser, a cream and a shampoo. The range
is indicated for people with sensitive skin or people with skin conditions such
as xerosis, atopic dermatitis, psoriasis and eczema. Cream stability is
achieved by a new self-preservation system that exploits the physical, not the
chemical, properties of the products.
Dermachronic is available in France and Italy. During the year, it generated
revenues of £0.3m.
B.lift and B.derm
B.lift is a range of corrective dermatology products which are applied as
creams and gels and which have special matrices that facilitate the penetration
of the active ingredient, Hexapeptide B, to help reverse skin wrinkles.B.derm
is a range of patented products containing hyaluronic acid for sensitive and
hyper reactive skin. Seven new distribution deals have been signed for these
products during the period.
Oral Health
Sinclair provides oral care solutions for mouth and gum diseases to specialists
and pharmacists, marketed through its international network of partners. The
oral care portfolio consists of two main product ranges, Decapinol and
Aloclair.
Decapinol
Decapinol® is an innovative range of treatments that helps treat gingivitis and
prevent periodontitis. Delmopinol, a surface-active agent is the key ingredient
in Decapinol. It is able to form a cationic barrier that reduces surface
tension on the teeth and gums, preventing microbial adhesion and colonisation
on their surface, thus hampering the adherence of bacteria and significantly
slowing the formation of new plaque without adversely altering the oral
bacterial flora. Decapinol is proven to reduce gingivitis and bleeding gums by
36% more than placebo and oral hygiene and in clinical trials had fewer side
effects and was better tolerated than the gold standard - chlorhexidine 7.
Decapinol gel can reduce gingivitis and mild to moderate periodontitis acting
on plaque adhesion and consequently on gingival inflammation and it is safe and
well-tolerated8.
In the US we are closely working with Orapharma to support their launch
preparations of Decapinol in the financial year 2010 and received a fee of £
0.2m following successful validation of the Italian manufacturing site. We also
continue to exploit other potential biofilm applications of Delmopinol and
received payment from a major animal health company to enable it to evaluate
the use of Decapinol to treat or prevent periodontal disease in companion
animals.
Decapinol is now available in seven countries: Greece, Italy, Slovakia,
Finland, Cyprus, Israel and Norway. During the year, it was launched in three
markets: Italy, Slovakia and Israel and generated revenues of £0.8m.
Aloclair & Aloclair plus
Aloclair is indicated to relieve the pain caused by aphthous mouth ulcers and
other minor oral lesions and also provides fast pain relief from chafing and
irritation caused by braces and ill fitting dentures. Its action is local and
mechanical, not pharmacological, and it can be administered several times a
day. Aloclair is available in three delivery formats, Aloclair Rinse, Aloclair
Gel and Aloclair Spray.
Aloclair Rinse clearly displays analgesic properties, which relieve the pain
associated with aphthous mouth ulcers9.
During the year the global roll-out of Aloclair continued with launches in 15
markets including Mexico, Korea and Greece. Aloclair generated revenues of £
2.6m this year.
Gynaecology
Sinclair is developing gynaecological solutions for gynaecologists and
pharmacists to be marketed through its international network of marketing
partners, outside the Americas. In order to achieve this we have out-licensed a
range of early stage gynaecology technologies to BMG Pharma, to develop and
register Sinclair's products, targeting a range of indications such as
interstitial cystitis, genital warts, vaginitis, vulvitis and anal and nipple
fissures. Moving forwards gynaecology will be one of Sinclair's major focus
areas.
References:
1: Multi-centre double-blind study, 1 045 patients suffering from mild to
moderate acne (nicotinamide versus excipient)
2: In vitro study, Biopredic 2000
After 6 weeks of treatment, 85% of specialists and 79% of patients assessed the
effectiveness of Papulex oil-free cream
3: Alisa L. & al., NPT 1 (Suppl. 1)/2009, Evaluation study on the activity and
tolerability of Papulex oil-free cream
4: Cimaz R., Safety & Effcicay of MAS066D in the treatment of signs and
symptoms associated with SD, 2008
5: Veraldi S., Menter A., Innocenti M., Treatment of mild to moderate
seborrhoeic dermatitis with MAS064D (Sebclair cream), a novel topical medical
device: results of a pilot, randomized, double-blind, controlled trial, JEADV
2007 ISSN 1468-3083
6: Abramovits W. & al., A multicenter, randomized, vehicle-controlled clinical
study to examine the efficacy and safety of MAS063DP (Atopiclair) in the
management of mild to moderate atopic dermatitis in adults, Journal of Drugs in
Dermatology 2006;5 (3): 236-244
7: Lang NP et al. Plaque formation and gingivitis after supervised mouth
rinsing with 0,2 delmopinol hydrochloride, 0,2%, chlorexidine digluconate and
placebo for 6 months. Oral diseases 1998; 4: 105-113
8: A double-blind, vehicle-controlled pilot clinical study to examine the
efficacy and tolerability of MAS033 (Decapinol Gel) in the management of
chronic gingivitis and mild to moderate periodontitis, Luca Francetti MD, DDS,
Giordano Bordini DDS, Matteo Basso DDS, PhD, Marco Rosso DH, Monica Loia DH,
Section of Periodontology, Department of Health technologies, Galeazzi
Institute, University of Milano, Mila, Italy
9: Lesclous, P (2002) Faculty of Dental Surgery (Paris, France) "Summary
assessment of the antalgesic efficacy of Aloclair RINSE against common aphthae"
10: Evaluation designed to ascertain the degree, onset & duration of pain
relief provided by Aloclair Rinse, (2002) Dental Surgery (Dorset, UK)
END
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