12th Oct 2009 07:00
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 announcesits preliminary results for the year ended 30th June 2009. Sinclair alsoannounced today the acquisition of two major revenue-generating dermatologyproducts, Flammazine and Flammacerium, from Solvay Pharmaceuticals for a totalconsideration of EUR17.5 million. The acquisition will be financed by afundraising 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 Espana
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 profitsince IPO. This achievement is a direct result of the continued hard work ofSinclair's employees and management team in the face of economic uncertaintyand the challenges it has presented to our business."By adapting our group via a restructuring programme we are now left with amuch leaner business and one that is poised to put into action a new, focussedsales and marketing strategy and, in doing so, fully realise the value of ourproduct portfolio. With a new structure and commercial strategy in place, theBoard and Sinclair management look forward to delivering long-termprofitability and achieving our ambition of becoming a leading internationalspecialty pharma company that delivers shareholder value." - Ends -
For further information please contact:
Sinclair Pharma plc Tel: +44 (0) 1483 410 600
Grahame Cook, ChairmanDr Michael Flynn, CEOJerry Randall, CFO
Mariyam Rawat, Director of Communications & Investor relations
Email: [email protected]
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 presentationand conference call for analysts today at 10.30am which will be held at SingerCapital Markets Ltd, One Hanover Street, London, W1S 1YZ. Please contact JoannaWhineray at Capital MS&L for further information on
+44 (0)20 7307 5337 or [email protected]
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 Actof 1995: Some or all of the statements in this document that relate to futureplans, expectations, events, performances and the like are forward-lookingstatements, as defined in the US Private Securities Litigation Reform Act of1995. Actual results of events could differ materially from those described inthe 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 toughestchallenges of recent times. The effects have been far reaching with no sectoror geography left untouched. The life sciences, and especially pharmaceutical,industries have also felt the effects of the downturn with many wholesalersreducing 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 tothese 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 commercialisationstrategy and have restructured our business to maximise the potential in ourportfolio. At the same time we have created a new role - Chief OperatingOfficer - and promoted Christophe Foucher to this position, following hissuccess in developing the Sinclair business in France. Under Christophe we haveunited the business development team and operating companies to form a singledivision 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 marketingand distribution partners around the world. Sinclair continues to grow itsglobal footprint by building on existing strong relationships and by increasingthe level of marketing support it gives to its partners, allowing for greaterefficiency 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 wellpositioned to drive up product revenues without sacrificing margins. We believeour business presents several significant opportunities for ongoing growth andour short-term goal remains to achieve sustainable profitability based onrecurring product revenues. The Board continues to believe that the commercialsuccess of Decapinol in the US will be one of the key drivers for the Group andremains confident in Sinclair's ability to deliver long-term profitability.We look to the year ahead with optimism as we continue our journey to becominga world class specialty pharma company, with innovative products that meet
theneeds of the patient.Grahame Cook ACAChairmanCHIEF EXECUTIVE'S REVIEWOverview
Despite the challenging economic environment, we are pleased to report oursecond successive year of profitability at the EBITDA level. Revenues for theyear ended 30 June 2009 were 30.4 million, impacted by wholesaler de-stocking,particularly in the second half. However, a combination of greater revenuesfrom licensing fees and strong cost control resulted in an EBITDA of 2.3mbefore exceptional items.Sinclair has a strong and growing portfolio of products, both on the market andin development, and an extensive network of sales and marketing partners; theGroup is now focused on the commercialisation of our products.We have restructured and streamlined the business. Christophe Foucher has beenappointed as Chief Operating Officer with responsibility for all commercial andsupply chain activities in the Group. With 14 years of experience, he isimplementing the commercial strategy designed to enable Sinclair to optimisethe core business and achieve its long term goals. This restructuring includesthe integration of the business development and operating companies to form asingle 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 Espana. Sinclair now has 100% ownedoperations in France, Italy and Spain and the depth of management expertise inthese territories has been reinforced by the appointment of new CountryOperations Directors. Sinclair has also streamlined its operations in the UKand, as a result of the regulatory changes in the market, has closed its UKsales operation, now distributing its UK products solely through marketingpartners. Financial control has been increased by the appointment of afinancial controller dedicated to the commercial and manufacturing operations.OPERATIONAL REVIEWSales & MarketingSinclair 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 Lamande as Financial Controller for SinclairGlobal Operations increases the level of financial input into thedecision-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 organisationand has established the working model for Country Operations. During the periodwe appointed Celine Genty as Country Operations Director and we reinforced themarketing team with a Pharmacy Team, increasing the level of expertise in thebusiness.We continue to leverage the strength of the existing French brands dedicated todermatology and the sales team now has full coverage of 3,200 dermatologists inboth hospitals and private clinics. Following the successful introduction of asell-out team, we have introduced and piloted a sell-in support team andsupport advisors in France. The success of this process is clearly demonstratedby the launch and sales of our Jonctum stretch marks cream, where areas withsell-out support ordered more frequently. This model will be replicated inItaly in the new financial year and Spain in the coming years.There has also been an enhanced focus on direct sales to pharmacies with OTCpromotions of Oxyplastine and Ephydrol. As a result, we have seen direct salesincrease 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 onthe therapeutic areas of acne, dry and sensitive skin and seborrhoeicdermatitis. In addition, the sales force has been reorganised to use agentsrather than sales representatives providing greater flexibility and enablingimproved 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 theremaining shares in Laboratorios Novo Pharma S.L. This move was strengthenedwith the appointment of Santiago Calavia Torres as Country Operations Directorof Dermatology and renaming the entity Sinclair Pharmaceutical Espana. Spainhas seen the successful launch of Sebclair and Papulex.
Sinclair Pharmaceutical Espana contributed 0.2m to group revenues during the period.
UKDuring the first half of the year the UK business was restructured to focus onspecialty dermatology sales. In December 2008 Sinclair increased its salespresence through a co-promotion collaboration with York Pharma. However as aresult of the regulatory changes in the market, and as part of theorganisational restructure, Sinclair closed its UK sales operation in June2009, 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 marketingand distribution partners. This currently extends to 94 countries and productsales in 58 countries. The network leverages the experience and local knowledgeof our partners to extend the commercial reach of our product portfolio.Sinclair continues to increase its global footprint and 2009 saw the continuedgeographical expansion of Sinclair's product distribution with product sales of 9.6m. This was a result of 45 launches in 22 markets covering seven productranges by the marketing partner network. Sinclair is also increasing the levelof marketing support it gives to its partners, implementing a new objective ofincreasing product sell out, and ultimately generating more predictable incomein 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 amajor animal health company to enable the company to evaluate the use ofDelmopinol 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&Dsteering committee which has representatives from the technical team and thecommercial 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 potentialthrough the signing of two product development and commercialisation deals withBMG Pharma, a privately-owned US-based company. BMG will be developing andregistering a number of gynaecology products from Sinclair's pipeline. Sinclairhas in-licensed a range of skin anti-infection products based on patentedsilver nanotechnology from BMG. These innovative deals present Sinclair withsignificant pipeline development opportunities and new product assets. We alsoacquired proprietary organic zinc technology which may be combined with othertechnologies or used alone and a hydrogen peroxide delivery system which can beused 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. Theseregistrations were the EU approval of Decapinol Perio vials for the managementof gum pockets in periodontal disease and DermaChronic foam for the treatmentof 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 indemonstrating the efficacy and mechanisms of actions of our products and canalso be a source of competitive advantage providing us with distinct productclaims.
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 theEuropean Academy of Dermatology and Venereology(EADV) during September 2008
inParis.Intellectual PropertySinclair's approach to product pipeline development combines the sourcing anddeveloping of novel technologies externally with newly-acquired and existingtechnologies to create new product concepts. In order to maximise thecommercial benefits arising from the innovative advantages inherent in ourproducts, Sinclair invests in the development of strong intellectual propertyfor all of its new products. Currently 35 Sinclair products enjoy patentprotection.
Manufacturing & Logistics
The Sinclair Group manufacturing and logistics function is managed andcoordinated by the team in Milan. The team's role is to enable Sinclair'sproducts to be validated and commercialised successfully either in-house or incontract manufacturing facilities. The team is responsible for global supplychain operations as our products are distributed worldwide. Sinclairmanufactures around two-thirds of its products through contract manufacturersand a third of its products in-house through its Clery facility in France. InFY 2009 approximately 11 million product units were manufactured. In a drive toreduce cost of goods and maximise synergies, all in-house production will behandled at Clery. An increasingly automated process is being implemented inClery in order to optimise manufacturing which will ultimately help makeSinclair a leaner business.Directors and AdvisorsBoard 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 DrRoss Macdonald as Vice President of Business Development for North America &South Pacific. In addition, following the appointment of Christophe Foucher asCOO and his subsequent success in restructuring the business, I am pleased toannounce today that he will be joining the Board.Finally, following nine years as CEO of Sinclair Pharma, I will be retiring atthe next AGM, at which point Chris Spooner will take on the role of CEO. It hasbeen a pleasure working with the talented and dedicated team at Sinclair duringa transformational period in the company's history and I feel confident thatthe new management team will take Sinclair forward through the next stage ofits growth.Dr Michael FlynnChief Executive OfficerFINANCIAL REVIEWHighlightsSinclair recorded its second profitable full year at the EBITDA level. EBITDAbefore exceptional items was 2.3m (2008: 1.3m) with basic loss per shareafter 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) andthe 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 ledto wholesalers reducing their stockholdings as a result of cash constraints.This resulted in a one off reduction in sales during the year and going forwardsmaller, more frequent orders for Sinclair. Revenues generated from licensingfees, including non-cash licensing agreements, more than off-set the effects ofde-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, andSpain 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 activitiesto 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 GBPm GBPm 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 jointventure partner in Portugal. CS Portugal has been deconsolidated from the Groupresults in FY09 as the Group no longer has effective management control of thisassociate from 1 July 2008.
Revenue through international operations
Revenue generated for the year from our marketing partners was 18.0m, anincrease of 8% year on year (2008: 16.5m). A breakdown is summarised below: FY 2009 FY 2008 GBPm GBPm 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 thesales of US distribution rights to Atopiclair Cream and Lotion for 2.1m, thenon-cash licensing agreements with BMG Pharma for the license of Sinclair'sgynaecological portfolio ( 3.3m) and the licensing agreement with JB2 SA forSinclair's onychomycosis kit ( 0.9m). Additional smaller components include 0.2m from a major animal health company to enable it to evaluate the use ofDecapinol 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 AnalysisFollowing the challenges of the current economic environment we have seen theimpact on our business of wholesalers reducing their stockholdings as a resultof cash constraints. This resulted in a one off reduction in sales during theyear 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 tohave eight products that contributed more than 1m in annual product revenue.This has been led by continued growth of Aloclair and Fazol, the gatheringmomentum of Sebclair and export of the French products such as Papulex andOxyplastine.However the B.lift and B.derm dermocosmetic products and Claro are no longer inthis year's Top 10 products, which have significantly impacted revenue thisyear. This was a direct consequence of substantial sales made into the marketin 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 bySterling'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 inthe year, reflecting the initial impact of the restructuring activitiesundertaken in the year.A renewed focus on sales and marketing increased these costs by 1.5%, inaddition to the impact of Sterling's weakness on costs. Other administrativeexpenses decreased by 0.3m after the impact of currency movements as a resultof the restructuring efforts. This was in spite of an increase in amortisationof 0.3m (at constant exchange rates), demonstrating our resolute commitment togrowing 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 resultof the Group's increased level of net debt (2008: 1.1m). This includes 0.6minterest on debt and 0.3m foreign exchange loss resulting from the translationof Euro debt.An exceptional cost of 0.3m was also incurred in relation to professional feesassociated with the negotiation of a financing agreement which failed to cometo fruition due to unfavourable terms.
Liquidity & Capital Resource
Sinclair had cash balances of 0.1m (2008: 1.1m) at 30 June 2009. Net cashoutflow during the year was 1.3m (2008: 3.3m), which included cash used inoperating activities of 0.5m (2008: 3.7m) and cash used in investingactivities 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 ofnew shares in December 2008.In May 2009, Sinclair entered into a 10m equity line of credit with a threeyear duration with GEM Global Yield Fund Limited. Sinclair will control thetiming and maximum amount of any draw down under this credit line and is notobliged to draw on the funds on offer. To date none of this facility has beenutilised.Following the period, in September 2009, Sinclair issued convertible unsecuredloan notes worth approximately 2.3 million to a leading institutionalinvestor. A first series of 1 million of the notes were issued immediatelywith 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 thesilver nanotechnology arm to the skincare portfolio ( 3.9m), the in-licensingof zinc technology ( 1.4m) and the hydrogen peroxide technology ( 1.0m), all ofwhich are non-cash transactions procured through strategic product swaps, aswell as some other smaller additions. These additions resulted in an increasedamortisation 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) GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'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 2,198profit 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 1,574taxation Taxation 5 417 - 417 410 1,354 1,764 (Loss)/profit for (933) (2,688) (3,621) (1,063) 4,401 3,338the year Attributable to: Minority interest - - - 1 - 1 Equity holders of (933) (2,688) (3,621) (1,064) 4,401 3,337the 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 3.8pshare (basic) (Loss)/earnings per 6 (1.0p) (2.9p) (3.9p) (1.2)p 4.8p 3.6pshare (diluted)
Unaudited Consolidated Balance Sheet
At 30 June 2009 Unaudited Audited 2009 2008 Note GBP'000 GBP'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 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 Balance at 1 July200 935 21,472 50,474 271 (14,775) 58,377 11 58,3887(audited) Exchange differences - - - 3,927 - 3,927 - 3,927arising on translation of overseas subsidiaries Net expense - - - 3,927 - 3,927 - 3,927recognised directly in equity Profit for the year - - - - 3,337 3,337 1 3,338 Total recognised - - - 3,927 3,337 7,264 1 7,265incomefor 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 66,3312008 (audited) Exchange differences - - - 2,330 - 2,330 - 2,330arising 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 - 1exercised
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 GBP'000 GBP'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 InternationalFinancial Reporting Standards (`IFRS') as adopted for use in the EuropeanUnion. In preparing this financial information management has used theprincipal accounting policies as set out in the Group's annual financialstatements for the year ended 30 June 2008 and which will be used in preparingthe financial statements for the year ended 30 June 2009. There have been nochanges to the accounting policies during the year.The preliminary financial information has not been audited and does notconstitute statutory accounts within the meaning of section 434 of theCompanies Act 2006. The financial information for the year ended 30 June 2008has been extracted from the Group's financial statements for the year ended 30June 2008. The auditors' report on the financial statements for the year ended30 June 2008 was unqualified and did not contain statements under eithersection 498 (2) or section 498 (3) of the Companies Act 2006. The financialstatements for the year ended 30 June 2008 have been delivered to the Registrarof Companies.The preliminary financial information has been prepared on the going concernbasis which assumes that the Group has adequate resources to continue inbusiness for the foreseeable future. The company has today announced theacquisition of two revenue-generating products from Solvay Phamaceuticals for EUR17.5m, 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 beappropriate.
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 geographicallocation of assets being the secondary format. The Group is organised into twooperating segments: development, registration and commercialisation of productsthrough marketing partners (international operations), and direct sales andmarketing of pharmaceutical products to doctors and pharmacies (countryoperations).
Primary reporting format - business sector
Unaudited Audited 2009 2008 International Country Total International Country Total operations operations operations operations GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'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) 2,198profit Finance income 131 447 Finance cost (1,433) (1,071) (Loss)profit before (4,038) 1,574tax Taxation 417 1,764 (Loss)/profit for (3,621) 3,338the financial year Revenue AnalysisBy destination, the Group's revenue derives from the UK, rest of Europe, the USand rest of World. Unaudited Audited 2009 2008 GBP'000 GBP'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 GBP'000 GBP'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 dueto 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 betterunderstanding to shareholders of the elements of financial performance in theyear, so as to facilitate comparison with prior periods and to better assesstrends in financial performance. Unaudited Audited 2009 2008 GBP'000 GBP'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 tothe restructuring of the sales forces in Italy and France, and the closure ofthe UK sales operation and Northampton site during the year.Exceptional acquisition related costs were incurred in relation to a strategicacquisition opportunity during the summer of 2008. These discussions were puton 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 goodwillarising on the acquisition of Sinclair Pharma UK Limited (formerly AshbournePharmaceuticals Limited) following the decision to restructure this operationand exit the dispensing doctors' market in the UK.A provision of 1,204,000 has been made during the year for a doubtful debt duefrom a distributor. Movements on other doubtful debt provisions are includedwithin administrative expenses. 4. Finance income and costs 5. Unaudited Audited 2009 2008 GBP'000 GBP'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 GBP'000 GBP'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 forthe year. Shares held by the Employees' Share Trust, including shares overwhich options have been granted to Directors and staff, have been excluded fromthe weighted average number of shares for the purposes of calculation of thebasic (loss)/earnings per share.The loss and weighted average number of shares for the purpose of calculatingthe diluted loss per share are identical to those used for the basic loss pershare at 30 June 2009, as the exercise of share options and warrants would havethe 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 byadjusting the weighted average number of ordinary shares outstanding to assumeconversion of all dilutive potential ordinary shares. Potential ordinary sharesof the Company are share options, warrants and awards. A calculation has beenundertaken to determine the number of shares that could have been acquired atfair value (determined as the average annual market price of the Company'sshares) based on the monetary value of the subscription rights attached tooutstanding 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)
3.6p7. Goodwill Unaudited Audited 2009 2008 GBP'000 GBP'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 minorityinterest in Laboratorios Novo Pharma SL (now Sinclair Pharmaceutical Espana)for EUR330,000 plus expenses.Exchange adjustments arise as a result of the impact of the difference in theSterling : Euro exchange rate at the beginning and end of the year on balancesrecorded in Euros.8. Intangible Assets Unaudited Audited 2009 2008 GBP'000 GBP'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 14,811Additions in the current period principally relate to the acquisition of rightsto the silver nanotechnology, the zinc technology and the purchase ofadditional rights under an existing agreement for H202. Additions of 5,363,000were from non-cash transactions.Exchange adjustments arise as a result of the impact of the difference in theSterling : Euro exchange rate at the beginning and end of the year on balancesrecorded in Euros.
9. Trade and other receivables
Unaudited Audited 2009 2008 GBP'000 GBP'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 GBP'000 GBP'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 11,66611. Borrowings Unaudited Audited 2009 2008 GBP'000 GBP'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 GBP'000 GBP'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 GBP'000 GBP'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 ReviewDermatology
Sinclair provides specific solutions to dermatologists and pharmacists forpatients suffering from skin damage and skin injuries through its ownoperations in France, Italy and Spain and through its international network ofmarketing partners. It aims to do this by delivering higher value products withspecial attributes based on its surface treatment technologies and innovativedelivery systems (foams, kits and sprays), treating major skin conditions suchas acne, eczema, fungal conditions and addressing family dermatology andpersonal care needs. Core products in our Dermatology portfolio includePapulex, Sebclair, Bio-Taches, Atopiclair, Oxyplastine and DermaChronic.
Papulex
Papulex is a dermo-cosmetic range of five products indicated for acne proneskin. Its duo of actives makes it a superior treatment of mild to moderate acneand the ideal accompaniment to acne Rx treatments. The whole range containsnicotinamide 4%, an active chosen for its efficacy and tolerability.Nicotinamide at such concentration prevents and treats inflammation, reducingpapule numbers by 75%1. The anti bacterial adhesion active, covered by a patentof Sinclair, inhibits P. acnes adhesion by 82%2 and thus stops it proliferatingand 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 revenuesof 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 thefinancial year.Bio-Taches
Bio-Taches is part of the Derma Omnium range Sinclair acquired in FY 2008. Therange also includes Gen Ongles which treats nail deficiencies and Affina Liftwhich helps to prevent and correct the effect of skin ageing. Bio-Tachesprevents and treats hyperpigmentations. The superior combination of activesresulting in azeloglycine reduces the activity of hyperproductive melanocytes,inhibits melanine production and reduces free radicals liberation that causesinflammation. The range offers an emulsion, a peel-off mask and two sun careproducts. Bio-Taches is available in 13 countries including Russia and SaudiArabia.
The Derma Omnium range contributed 0.8m revenues during the year.
Atopiclair
Atopiclair is a non-steroidal range containing two products, indicated for thesymptomatic treatment of atopic dermatitis, including the relief and managementof the most common signs and symptoms such as itching, burning and pain6.Atopiclair helps to relieve dry skin by enhancing barrier function, maintaininga moist skin environment, due to hyaluronic acid which is beneficial to thehealing process. Atopiclair also acts as an anti-oxidant. The product issupplied as a cream and as a lotion.In December 2008, Sinclair signed an agreement to sell the US distributionrights and license the patent for use in atopic dermatitis, pertaining toAtopiclair cream and lotion, to its US marketing partner Graceway for 2.1m($3.1million). The payment is equivalent to the royalties Sinclair would haveanticipated to receive from Graceway over the next five years. Atopiclair salesin the US have been affected by the economic environment, in common with otheratopic 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 againstirritation, in particular in cases of nappy rash. Oxyplastine forms a barrieron the skin protecting it from external irritating agents. Its astringentproperties are due to a high concentration of zinc oxide (46%) reinforcing itsefficacy.
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.
DermaChronicThe DermaChronic range consists of a cleanser, a cream and a shampoo. The rangeis indicated for people with sensitive skin or people with skin conditions suchas xerosis, atopic dermatitis, psoriasis and eczema. Cream stability isachieved by a new self-preservation system that exploits the physical, not thechemical, properties of the products.
Dermachronic is available in France and Italy. During the year, it generated revenues of 0.3m.
B.lift and B.dermB.lift is a range of corrective dermatology products which are applied ascreams and gels and which have special matrices that facilitate the penetrationof the active ingredient, Hexapeptide B, to help reverse skin wrinkles.B.dermis a range of patented products containing hyaluronic acid for sensitive andhyper reactive skin. Seven new distribution deals have been signed for theseproducts during the period.Oral HealthSinclair provides oral care solutions for mouth and gum diseases to specialistsand pharmacists, marketed through its international network of partners. Theoral care portfolio consists of two main product ranges, Decapinol andAloclair.
Decapinol
Decapinol(R) is an innovative range of treatments that helps treat gingivitis andprevent periodontitis. Delmopinol, a surface-active agent is the key ingredientin Decapinol. It is able to form a cationic barrier that reduces surfacetension on the teeth and gums, preventing microbial adhesion and colonisationon their surface, thus hampering the adherence of bacteria and significantlyslowing the formation of new plaque without adversely altering the oralbacterial flora. Decapinol is proven to reduce gingivitis and bleeding gums by36% more than placebo and oral hygiene and in clinical trials had fewer sideeffects and was better tolerated than the gold standard - chlorhexidine 7.Decapinol gel can reduce gingivitis and mild to moderate periodontitis actingon plaque adhesion and consequently on gingival inflammation and it is safe andwell-tolerated8.In the US we are closely working with Orapharma to support their launchpreparations of Decapinol in the financial year 2010 and received a fee of 0.2m following successful validation of the Italian manufacturing site. We alsocontinue to exploit other potential biofilm applications of Delmopinol andreceived payment from a major animal health company to enable it to evaluatethe use of Decapinol to treat or prevent periodontal disease in companionanimals.
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 andother minor oral lesions and also provides fast pain relief from chafing andirritation caused by braces and ill fitting dentures. Its action is local andmechanical, not pharmacological, and it can be administered several times aday. Aloclair is available in three delivery formats, Aloclair Rinse, AloclairGel 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 15markets including Mexico, Korea and Greece. Aloclair generated revenues of
2.6m this year.GynaecologySinclair is developing gynaecological solutions for gynaecologists andpharmacists to be marketed through its international network of marketingpartners, outside the Americas. In order to achieve this we have out-licensed arange of early stage gynaecology technologies to BMG Pharma, to develop andregister Sinclair's products, targeting a range of indications such asinterstitial cystitis, genital warts, vaginitis, vulvitis and anal and nipplefissures. Moving forwards gynaecology will be one of Sinclair's major focusareas.
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 moderateseborrhoeic dermatitis with MAS064D (Sebclair cream), a novel topical medicaldevice: results of a pilot, randomized, double-blind, controlled trial, JEADV2007 ISSN 1468-30836: Abramovits W. & al., A multicenter, randomized, vehicle-controlled clinicalstudy to examine the efficacy and safety of MAS063DP (Atopiclair) in themanagement of mild to moderate atopic dermatitis in adults, Journal of Drugs inDermatology 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 theefficacy and tolerability of MAS033 (Decapinol Gel) in the management ofchronic 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, GaleazziInstitute, 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)
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