TIDMPSK
RNS Number : 1059D
ProStrakan Group plc
17 March 2011
ProStrakan Group plc
Preliminary Results for the Year Ended 31 December 2010
Galashiels, UK, 17 March 2011: ProStrakan Group plc (LSE: PSK),
the international specialty pharmaceutical company, today announces
its Preliminary Results for the year ended 31 December 2010.
FINANCIAL HIGHLIGHTS
-- Total revenues of GBP100.2m (2009: GBP79.0m)
o Continued strong European performance
o Partnering income of GBP13.4m including GBP8.1m milestone
payment on US approval of Fortesta (2009: GBP5.2m)
-- EBITDA of GBP10.8m (2009: GBP5.1m loss)
-- Operating profit of GBP6.1m (2009: GBP9.6m loss)
-- Pre-tax loss reduced to GBP0.6m (2009: GBP15.0m)
-- Closing cash position of GBP19.4m (31 December 2009:
GBP19.0m)
OPERATING HIGHLIGHTS
-- Continued European growth
o European revenues up 21% to GBP80.0m
o Abstral a key driver of growth
o Adcal-D3 sales up 14% to GBP23.2m
-- US business experienced challenges and successes
o Sancuso sales of GBP6.8m despite manufacturing
interruption
o Fortesta approved by FDA
o Abstral approved by FDA in early January 2011
-- Worldwide partnering programme made a significant
contribution
o Partnering product sales revenues of GBP2.4m
o Fortesta FDA approval triggered GBP8.1m ($12.5m) milestone
payment (cash received January 2011)
o 13 approvals and 5 new product country launches through
partners
-- Refinancing of the Group's borrowing facility in January
2011
o New strategic relationship with Paladin Labs Inc.
announced
o Reduced rate of borrowing and capital repayments extended
until January 2014
o Exclusive out-license distribution agreement for Canada and
certain emerging territories
Commenting on the results, Peter Allen, Chairman & Acting
Chief Executive of ProStrakan, said:
"From a low point in the middle of 2010, when events had become
very challenging for ProStrakan, I am delighted to be in a position
to report that, as a result of a great deal of hard work on the
part of our many talented people, we were able to finish the year
very strongly.
"Since then, we have received, from Kyowa Hakko Kirin, an offer
to acquire ProStrakan which attaches full value to the business and
is being recommended for shareholder acceptance by the Board, as
well as having the support of the majority of our principal
shareholders. This process is ongoing and, assuming it is approved
by shareholders, ProStrakan's acquisition by KHK will mark a new
chapter in the ProStrakan story which, I believe, will be
beneficial to all concerned - shareholders and staff alike."
Further enquiries:
ProStrakan +44 (0)1896 664000
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Peter Allen, Chairman & Acting Chief Executive
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Allan Watson, Chief Financial Officer
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Callum Spreng, Corporate Communications
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Brunswick +44 (0)20 7404 5959
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Jon Coles / Justine McIlroy
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ProStrakan Group plc
Preliminary Results 2010
CHAIRMAN'S STATEMENT
2010 was a year of challenges and opportunities for ProStrakan
from which the business emerged strongly having reached the GBP100m
turnover milestone for the first time, assisted considerably by the
GBP8.1m US approval milestone for Fortesta. The Company recorded
its first ever profit at both EBITDA and EBIT levels and achieved
two US product approvals.
It was undoubtedly a year of two contrasting halves as the
business flourished in the first six months of the year, with
Abstral displaying continued strong growth in Europe and
contributing to an EBITDA positive first half. However the second
half of the year began less encouragingly with ongoing approval
delays to both Fortesta and Abstral in the US and an interruption
in manufacturing for Sancuso in the US. By the end of the year,
thanks to the persistence and diligence of the team at ProStrakan
and our partners, we responded successfully to these challenges,
achieving the US approval of Fortesta and the recommencement of
Sancuso's manufacture. The US approval of Abstral followed in the
early days of January 2011. Our US partner for Fortesta, Endo
Pharmaceuticals Inc. ("Endo"), launched Fortesta at the end of
February 2011 and we will shortly launch Abstral through our own US
sales force.
In addition, we announced in December a new strategic
relationship with Paladin Labs Inc. ("Paladin") of Canada which saw
Paladin adopt ProStrakan's existing GBP50.0m secured debt facility,
now denominated in Canadian dollars, with the addition of certain
conversion rights, and extending any capital repayments due on the
facility until 2014. As part of the agreement, approved by
shareholders in January 2011, Paladin have been granted the
exclusive option to distribute all of ProStrakan's products in
certain territories including Canada, Latin America, Sub-Saharan
Africa and Israel.
We also saw board changes at ProStrakan, with the Group's Chief
Executive, Dr Wilson Totten, resigning from ProStrakan in
September. I took on the additional role of Acting Chief Executive
upon Wilson Totten's resignation and, on behalf of the whole Board
I would like to take this opportunity to acknowledge the
significant role that he has played in the development of
ProStrakan during his time with the company. Since the end of 2010,
Jonathan Goodman, Chief Executive of Paladin, has joined the Board
of Directors of ProStrakan, as a consequence of our new strategic
relationship with Paladin, and I would also like to welcome
Jonathan to the Board.
Since the turn of the year, the Board has received an offer from
Japanese pharmaceutical company, Kyowa Hakko Kirin Co., Ltd.
("KHK"), to acquire ProStrakan and the Board of ProStrakan has
recommended that shareholders accept this offer. This process is
ongoing and, assuming it is approved by shareholders, ProStrakan's
acquisition by KHK will mark a new chapter in the ProStrakan story
which, I believe, will be beneficial to all concerned -
shareholders and staff alike.
This proposed transaction is being made through a Scheme of
Arrangement and the Scheme Document was posted to ProStrakan
shareholders on 8 March 2011. There will be a court meeting and
general meeting of shareholders on 31 March 2011 with the
transaction expected to complete on or around 21 April 2011,
subject to certain conditions outlined in the Scheme Document.
ProStrakan's progress thus far, and specifically in the face of
significant challenges during 2010 is a testament to the hard work,
energy and enthusiasm of its people, at head office, across Europe
and in the US, and I wish to record the Board's thanks and
admiration for the manner in which our people have risen to these
challenges. They have achieved a great deal, of which they can be
justifiably proud.
BUSINESS REVIEW
Overview
ProStrakan completed 2010 strongly as it pushed through the
GBP100m revenue mark and received two key product approvals in the
US.
This result demonstrates success in fulfilling the Group's
strategy of in-licensing and developing late-stage,
patient-friendly products for unmet medical needs; promoting these
products through our own sales forces in Europe and the US; and
out-licensing these products to high quality partners in non-core
areas.
The Group made significant progress in each of these three key
areas. It demonstrated success in developing Abstral in the US by
working closely with the US Food and Drug Administration ("FDA") in
meeting its requirements for a Risk Evaluation and Mitigation
Strategy ("REMS") programme, so enabling approval to be made in
early January 2011. The Group successfully promoted its existing
products in its EU and US markets, making particular progress in
Europe through the success of Abstral, which grew significantly in
its first full year of commercial availability. Finally it created
significant value by working closely with Endo, its partner in the
US for Fortesta, which was approved by the FDA late in the year and
triggered a significant registration milestone.
Total revenues for 2010 increased by 27% (29% at constant
currency) to GBP100.2m (2009: GBP79.0m). Included within this,
product sales grew by 20% (22% at constant currency) to GBP89.2m
(2009: GBP74.4m). Other income, from licensing and royalty
receipts, grew by 140% to GBP11.0m (2009: GBP4.6m) helped largely
by the GBP8.1m ($12.5m) milestone payment receivable from Endo upon
the approval of Fortesta. ProStrakan saw further growth from its
portfolio of European products, continued growth from Abstral in
Europe and another strong growth performance from Adcal-D3 in the
UK. The US business grew sales of Sancuso prior to the reduced
stock availability due to the interruption in its manufacturing in
October. Partnering income increased significantly due to both
increased product sales to business partners and increasing income
from license receipts including the milestone from Endo discussed
above.
The revenue growth helped improve profitability considerably and
after posting its first ever EBITDA positive performance in the six
months to 30 June 2010, the Group concluded the year positively by
being profitable at both EBITDA and EBIT levels for the full year.
Full year EBITDA was GBP10.8m for 2010 compared with a loss of
GBP5.1m in 2009 and operating profit was GBP6.1m compared to a loss
of GBP9.6m in 2009.
Segmental Revenue Analysis
The business is managed on a geographical basis and has three
key operating segments around which the Board and management run
the business. These operating segments are Europe, the US, and
Partnering Income, each of which is considered separately.
Europe
ProStrakan's European specialty pharmaceuticals business
continued to be the principal driver of revenues for the Group in
2010.
Total European revenues in 2010 grew by 21% to GBP80.0m (2009:
GBP66.5m). Approximately 45% of the Group's European revenues arise
in the UK, with the majority of the remainder being Euro
denominated incomes. Accordingly, foreign exchange movements can
impact reported growth rates. Compared to 2009, Sterling
strengthened slightly against the Euro in 2010, which reduced the
reported growth rates within Europe. Excluding the impact of
foreign currency fluctuations, revenue growth in Europe was
23%.
ProStrakan has a broad-based marketing and distribution
capability across Europe and the company's products are promoted
through its own sales forces in the UK, Germany, France, Spain and
Italy. The Company also has marketing and distribution operations
in Belgium, Holland, Luxembourg and Greece and a joint venture
covering the Nordic region. Each country promotes a range of
products, some of which are local to the specific country and
referred to as "local products", whilst others are considered
"Group products" as they are promoted in several different
countries. Each of these Group products are reviewed in detail
later in this report. Much of the revenue growth seen in Europe
during 2010 came from the success of these Group products,
benefiting from the increasing promotion and focus of the
countries.
ProStrakan's biggest European business is the UK. The UK
business experienced double digit growth due to good performance in
several of its key products. Key local products include Adcal-D3
which is the market leading branded calcium and vitamin D3 oral
supplement, used as an adjunct to specific therapy for the
treatment of osteoporosis. Adcal-D3 is still ProStrakan's
best-selling product and revenues grew by a further 14% in 2010 to
GBP23.2m (2009: GBP20.4m). In addition, the UK business also
markets Isotard XL, a once-daily prophylactic treatment for angina.
Good growth was seen in all other Group products sold in the UK,
with Abstral and Rectogesic making a significant contribution to
revenues.
Spain is the Group's second biggest European business. Spain
also achieved double digit growth, with the increased revenues
coming entirely from sales of Group products - primarily Abstral
and Rectogesic. Local products include Pencial, indicated for the
treatment of advanced prostate cancer and Tebetane, indicated for
the treatment of mild benign prostatic hyperplasia. The growth of
local products in Spain was impacted by government price reduction
measures introduced in the second half of 2010 which reduced
growth. During 2010 the company in-licensed three new
country-specific products for the Spanish market: Radiocare;
Dragul; and Devazol, products operating in oncology and urology
which complement the activities of the sales force.
The Group's French business grew strongly during 2010.The key
driver of growth was Abstral which performed very strongly and
greatly increased the sales of Group products in that market. Local
product sales reduced. The main local product is Insuplant,
indicated for diabetes and when the use of an implantable insulin
pump is indicated. Sales of this product are coming to an end as
the technology used to deliver the insulin is being phased out.
In Germany, revenue growth was modest, partly due to lost
revenues from two local products which were disposed of in 2009.
Group product sales were strong again heavily influenced by sales
of Abstral. The business completed a re-organisation during 2010
including a relocation of its office.
Other smaller European businesses also performed well. Italy saw
excellent growth as the business entered its first full year of
commercial operations, following its launch in 2009. The Italian
business launched CD2, a treatment for oral mucositis, in January
2011 in its local market. Operations in the Netherlands performed
well with increased sales from Tostran and local products. The
Group's joint venture in Scandinavia performed well as we commenced
rolling out Abstral across other Scandinavian countries during
2010, following its launch in Sweden in 2008.
United States
In the last two years ProStrakan has expanded into the US,
initially in the field of oncology support. 2010 US revenues were
GBP6.8m compared with GBP7.3m in 2009, down 8% (down 9% at constant
currency). All US revenues were generated by sales of Sancuso
transdermal patch, and this performance was heavily impacted by a
stock-out of Sancuso, now resolved, which greatly affected sales in
the second half of 2010.
Sancuso has received considerable focus since its launch at the
end of 2008 including the introduction of a number of initiatives
designed to invigorate growth. These have included the launch of a
specialty pharmacies distribution strategy; the introduction of a
new co-pay assistance card; and a sharpened focus on specialist
oncology hospitals and clinics with our primary target of achieving
formulary or clinical pathway status for Sancuso. Sancuso's
resultant performance in the first six months of 2010 also
demonstrated growth of 28% over the second half of 2009.
In October 2010, stocks of Sancuso were exhausted following the
decision by Aveva Drug Delivery Systems ("Aveva"), the manufacturer
of Sancuso, to temporarily cease all manufacturing at its Florida
facility in order to make changes to its own internal quality
assurance systems. Aveva recommenced manufacture of Sancuso in
December 2010 and ProStrakan recommenced distribution of this
product at the end of January 2011. This supply interruption had an
inevitable impact on revenues for Sancuso during 2010 and revenues
for Sancuso in the second half of 2010 were only GBP2.2m (H2 2009:
GBP3.6m).
Our strategy going forward includes an increased focus on
oncologists that specialise in head and neck cancer, where the
swallowing of tablets can be particularly difficult for patients.
These initiatives have been supported by the launch of a suite of
Sancuso promotional and instructional videos on YouTube, which are
proving of interest to medical specialists and patients alike.
ProStrakan's US operation is headquartered in Bedminster, New
Jersey. The US business focuses on sales & marketing, late
stage development and marketed product support and currently
accesses the US market via a sales force focused around major
metropolitan areas across the US. This sales force focuses on
oncologists and oncology support staff. In January 2011 the members
of the US sales force became employees of ProStrakan, having
previously been contracted through NovaQuest (Quintiles).
On 10 January 2011, ProStrakan announced the FDA approval of
Abstral (for the management of breakthrough pain in cancer patients
who are already receiving, and who are tolerant to, opioid therapy
for their underlying persistent cancer pain).
Abstral will be launched in the US shortly and will be the only
rapidly disintegrating sublingual tablet for breakthrough cancer
pain on the US market, where the overall annual market value for
immediate release fentanyl products is $550m (Source: Wolters
Kluwer, August 2010 MAT).
The combination of resumed manufacturing for Sancuso, and the
approval of Abstral means that both products will be promoted from
the second quarter of 2011 onwards.
Business Partnering
Alongside ProStrakan's European and US sales and marketing
operations, the third strand of ProStrakan's growth strategy is
focused on capitalising on its high value medicines in non-core
territories by entering into out-licensing arrangements with high
quality partners with strong distribution capabilities in those
markets. Partnering income increased in 2010 to GBP13.4m in
comparison with 2009 (GBP5.2m), boosted significantly by the
GBP8.1m US approval milestone for Fortesta.
Partnering income is made up of two types of revenue stream.
Licensing income, together with royalties, made up a major
component. Licensing income arises from third party distribution
agreements entered into with business partners which often involves
specific payments being made upon deal signature, receipt of
registration, and or subsequent milestone payments once certain
performance conditions are met. In addition to this, partnering
agreements then require ProStrakan to source and manufacture stock
which ProStrakan sells to business partners at an agreed price for
them to then sell to customers in the relevant country markets.
Total revenues from Licensing including milestones and royalties
were GBP11.0m (2009: GBP4.6m). The highlight in licensing
activities in 2010 was the receipt, in December 2010, of an
approval milestone of GBP8.1m ($12.5m) for Fortesta received from
our US partner, Endo. Endo launched Fortesta (branded as Tostran,
Tostrex, Itnogen and Fortigel in Europe, where it is marketed by
ProStrakan) in February 2011. ProStrakan will exclusively supply
Fortesta to Endo for the US and will receive an undisclosed royalty
rate on sales generated there.
Also during 2010, Partnering income included a further GBP2.4m
of product sales (2009: GBP0.6m), which included sales of Abstral,
Xomolix, Rectogesic, Tostran and Sancuso to business partners. The
largest single growth item within this was from Abstral sales which
included sales to Gedeon Richter in respect of Central and Eastern
Europe.
ProStrakan has a small but growing team dedicated to starting
and managing these alliances. Notable events for this team during
2010 included the following:
-- First product shipments of Sancuso to South Korea and
Singapore
-- Abstral launched in four of the seven CEE countries to which
it has been out-licensed
-- Five product launches through partners
-- 13 regulatory approvals through partners for ProStrakan
products
Bayer Schering Pharma has informed ProStrakan that it is handing
back the right to develop and commercialise Tostran in 65 countries
worldwide. The Group has also received notification that Solasia
Pharma KK is handing back the rights to market and sell Sancuso in
Japan, but that it will retain its rights in the other territories
for which it has an interest. Any monies received to date from
either partner are non refundable.
In December 2010 the Group announced that it proposed to enter
into a new strategic relationship with Paladin which provided them
with an exclusive option to distribute certain of ProStrakan's
products for Canada and certain emerging territories. This
agreement builds on the relationship which already exists between
the two companies under which Paladin has already in-licensed the
rights to distribute Abstral and Sancuso in Canada. The new
agreement, which was approved by shareholders in January 2011,
broadens this existing partnership, with Paladin being granted
exclusive option to distribute all of ProStrakan's products,
including Abstral, Sancuso, Rectogesic, Xomolix and Tostran, in
certain specific territories for which ProStrakan does not already
have distribution agreements. These territories include: Canada,
Latin America, Sub-Saharan Africa and Israel. Terms of the licence
agreements are not disclosed but equate to arm's length commercial
arrangements. In addition, Paladin will have the right for a
certain period to license any new products acquired or licensed by
ProStrakan for those same territories and on the same terms and
conditions. Since the year end, Paladin has received approval for
Abstral in Canada.
Group Products
ProStrakan has five core products which it markets and
distributes widely across the Group, whether in Europe, the US or
via business partners in the rest of the world. As detailed
earlier, these five core products are increasingly receiving the
majority of our focus in channeling the Group's sales and marketing
resources. Sales from these products grew by over 40% versus 2009
and generated the majority of the overall growth seen in
ProStrakan's product sales.
Abstral is a new, sub-lingual (under the tongue) formulation of
fentanyl, a long-established opioid used for the management of
episodes of breakthrough pain experienced by cancer patients who
are already receiving opioid analgesics for their chronic pain,
licensed from Orexo AB in Sweden.
Abstral was launched in Sweden in August 2008 and in the UK,
Germany, France and Spain during 2009. Abstral was launched in
Italy in August 2010. Abstral was also launched in Norway, through
our joint venture with Orexo AB. Abstral also generates significant
revenues from sales to business partners in CEE, Canada, Slovenia
and Ireland. In 2010, Abstral achieved sales across all areas of
GBP17.3m (2009: GBP5.8m).
Rectogesic is indicated for the relief of pain associated with
chronic anal fissure. This product is sold in Europe and by
business partners in Turkey, Ireland, Israel and Slovenia. The
product recorded further strong growth during 2010, with sales
increasing to GBP9.3m (2009: GBP8.1m).
Xomolix (also branded as Droperidol) is a branded, injectable
drug used primarily in hospitals for the prevention and treatment
of post-operative nausea and vomiting. It is sold in Europe and by
business partners. Total revenues grew to GBP7.8m during 2010
(2009: GBP7.5m).
Tostran (also branded as Tostrex, Itnogen, Fortigel and
Fortesta) is a transdermal testosterone gel that utilises a metered
dose delivery system for testosterone replacement therapy in male
hypogonadism. This product is sold in Europe and by business
partners, and was recently approved for sale in the US by our
business partner there. 2010 saw sales of this product increase to
GBP3.3m (2009: GBP2.1m) which included initial deliveries to Endo,
our US partner.
Sancuso is a transdermal patch that delivers granisetron, an
established 5-HT(3) receptor antagonist, steadily into the
bloodstream for up to seven days. It helps to prevent the
side-effects of nausea and vomiting in patients undergoing
chemotherapy (CINV) for up to five consecutive days, without the
need for daily injections or having to swallow pills. The majority
of revenues are generated from sales by ProStrakan in the US,
however revenues were also received from sales by business partners
in various Asian markets. Total revenues were GBP6.8m during 2010
(2009: GBP7.3m).
Product Development
The main driver of activity during 2010 was focused on the
approval of Abstral in the US which was successfully achieved in
early January 2011. This product was initially expected to receive
approval in June 2010 however the FDA announced in early June 2010
that it planned to extend the review period for Abstral.
This product is the first product to be approved in the US with
the FDA mandated class-wide REMS for transmucosal immediate release
fentanyl products. The Abstral REMS allows appropriate
prescriptions to be filled at retail pharmacies as well as
providing access to Abstral within hospitals.
The Group received a complete response from the FDA for
Rectogesic in the US on 1 April 2010. This response concerned the
statistical significance of pain relief demonstrated by the
clinical trial data. The business entered into detailed discussions
with the FDA over the most appropriate statistical analysis for a
product treating the pain associated with chronic anal fissure.
Following this, further work was done and on, 21 December 2010,
ProStrakan re-filed Rectogesic (0.4% nitroglycerin ointment) for
the treatment of pain associated with chronic anal fissure. The
PDUFA goal date for this review is at the end of June 2011.
Following discussions with the European regulatory bodies over
the registration of Sancuso in Europe, ProStrakan has re-filed
Sancuso in the EU and this re-filing has been validated and
approval is anticipated for this product in Q4 2011.
Manufacturing
ProStrakan outsources all of its manufacturing operations to
third party suppliers. It employs a core team at its corporate
headquarters in Galashiels which manages these relationships and
makes strategic decisions as to the most appropriate suppliers to
use for each product in each market.
The team works closely with existing suppliers to maintain
quality levels, ensure continuity of supply, influence pricing
levels and control stock. The business is currently managing
several transfers of existing products to new suppliers for varying
reasons including quality, continuity of supply and cost.
In October 2010 the business experienced a major product
interruption in the supply of its Sancuso transdermal patch
product. This interruption was caused by Aveva, the manufacturer of
Sancuso, ceasing all manufacturing at its Florida facility in order
to make changes to its own internal quality assurance systems. This
resulted in customers being without product for part of 2010. Aveva
recommenced manufacture of Sancuso in December 2010 and ProStrakan
restarted distribution of this product at the end of January 2011.
The business is working closely with Aveva in order to ensure
future continuity of supply.
Other Financial Items
Gross profit
Gross profit increased to GBP67.4m (2009: GBP52.6m), an increase
of 28% over the prior year. The increase in gross profit was a
result of the growth in product sales and the milestone receivable
as a result of the Fortesta approval. Gross margins were consistent
with the prior year at 67%. This stable margin comprised a number
of moving parts such as product cost savings delivered by the
manufacturing team, the impact of government price cuts in certain
EU markets, and product mix including the impact of higher levels
of milestone receipts.
Operating costs
Operating costs decreased by 4% to GBP56.6m (2009: GBP58.8m).
Within this, distribution costs saw a 6% increase as the Group
invested in its selling and marketing activities. Distribution
costs comprise the selling, marketing and distribution costs of the
Group's commercial teams and increases here reflect on-going
investment in the European Abstral brand, coupled with tight cost
control in the US commercial operations to reduce the impact on
profit of the Sancuso supply issue outlined above. Administration
costs increased by 12% to GBP8.5m (2009: GBP7.6m), this increase
being a result of one off project costs of GBP0.6m offset by a
credit in respect of share-based payments contained within the 2009
overheads. Development costs decreased by 44% to GBP6.7m (2009:
GBP12.0m) as a result of reduced clinical trial work on the Group's
portfolio. This reduction reflected that the Group had several new
drug application dossiers in preparation during 2009 and that
efforts were concentrated on certain post approval commitments for
Sancuso in the US. During 2010 the focus shifted to helping manage
those new drug applications through the regulatory process. Foreign
exchange movements had the impact of marginally reducing the
sterling equivalent cost of overseas operations compared to prior
year.
Other gains/losses
Other gains were GBPnil (2009: GBP1.1m) with gains in the prior
year arising from the sale of three non-core products in
Europe.
EBITDA and Operating Profit
As a result of the increased revenues and reduced overheads
discussed above ProStrakan is pleased to report a positive EBITDA
of GBP10.8m for the full year against an EBITDA loss of GBP5.1m for
2009. This is the first ever full year profit recorded at the
EBITDA level and follows the maiden positive EBITDA reported in the
unaudited results for the first half of the year.
Depreciation, amortisation and impairment costs increased by 4%
to GBP4.7m (2009: GBP4.5m). 2010 includes an impairment charge of
GBP0.7m (2009: GBP0.3m) in respect of writing down the book value
of certain acquired technology which the Group is no longer likely
to commercialise.
2010 reported operating profit GBP6.1m (2009: loss GBP9.6m) and
demonstrates progress in the previously stated objective of firmly
focusing on growing the business profitably.
Net Finance Costs and Taxation
Net finance costs including changes in fair value of warrants
increased to GBP6.7m (2009: GBP5.4m). This was due to a combination
of increased borrowing levels, a higher blended interest rate on
the borrowings and a GBP0.4m charge (2009: GBP0.2m charge) in
respect of changes to the fair value of warrants issued to the
lenders in March 2007.
Taxation charges for the year were GBP0.4m (2009: GBP0.6m),
including a GBP0.3m (2009: GBP0.5m) movement in the deferred tax
assets created in 2008 and local corporation taxes payable. The
Group has significant carried forward losses available to be to
offset against future operating profits.
Recognised loss for the financial year
The loss from continuing operations was GBP1.0m (2009:
GBP15.6m). As discussed previously the significant improvement was
as a result of increased revenues from Group products and reduced
overhead increases compared to previous years.
Loan Facility and refinancing
During 2010 the Group continued its borrowing relationship with
Fortress Investment Group, Morgan Stanley and Och-Ziff Capital
Management Group. In April 2010, a further GBP8.0m was drawn from
the facility bringing the total amount drawn to GBP46.6m. In line
with the facility agreement the Group made a GBP0.2m repayment to
the lenders during the year in relation to certain licensing
activities together with the first GBP1.0m capital repayment in
December 2010 making the total amount drawn GBP45.4m at 31 December
2010.
On 7 January 2011 at a general meeting of the company,
shareholders approved the assignment of the Company's debt facility
to Paladin and the assignment was completed on 12 January 2011.
This included the conversion of the facility into Canadian dollars.
In addition to the facility being assigned to Paladin, the facility
was amended so that Paladin has a right, from July 2011, to convert
all or part of the facility into ordinary share capital at GBP1.10
per share. Capital repayments are not due to commence until January
2014 at which point the value of the facility not converted is
re-payable. The rate of interest on the revised facility is 10.5%
compared with a blended rate of 11.9% on the original facility. The
Group took the opportunity to draw additional funds from the
facility as part of the assignment and, after fees, accrued
interest and an early termination payment to the original lenders
totalling GBP2.2m, the Group received a further GBP2.4m from the
facility.
In addition to the assignment Paladin and the Group entered into
an exclusive distribution and licence agreement in relation to the
commercialisation of certain of ProStrakan's products in various
territories (Canada / Latin America, Sub-Saharan Africa and
Israel.)
Cash Flow
Cash flow from continuing operations was an outflow of GBP0.7m
versus an outflow of GBP7.2m during 2009, reflecting the improved
trading position of the Group. The milestone from Endo, relating to
the US approval of Abstral, was received in January 2011 and is
therefore not reflected in the 2010 cash flows.
During the first half of 2010 the Group drew down GBP8.0m in
capital from its debt provider, in December the Group made its
first capital re-payment of GBP1.0m in line with the credit
facility and a further GBP0.2m of re-payments to the lenders in
relation to certain licensing activity during the year.
The items discussed above resulted in a GBP0.3m decrease in cash
and cash equivalents during the year (2009: GBP17.1m decrease)
which when combined with the impact of exchange losses, produced a
closing cash balance of GBP19.4m (2009: GBP19.0m).
Balance Sheet
The Group's non-current assets at 31 December 2010 were GBP35.5m
(2009: GBP40.2m). This total included intangible assets of GBP32.5m
(2009: GBP36.7m) which comprised acquired product rights GBP22.2m
(2009: GBP26.5m), goodwill GBP9.7m (2009: GBP10.0m) and other
intangibles GBP0.6m (2009: GBP0.2m). Net current assets have
decreased slightly due to an increase in trade and other
receivables being offset by near term capital re-payments of
GBP12.0m under the old loan facility which has since been delayed
to January 2014 as part of the refinancing discussed above. Total
borrowings increased to GBP44.4m (2009: GBP36.5m) and include funds
drawn-down from lenders, less the value of cumulative accretion of
loan warrants and the carrying value of facility set up costs. The
balance sheet as at 31 December 2010 reflects the lending
relationship that was in place at that time, with the arrangements
with Paladin having been put in place in early January 2011 and as
such having no impact in the closing balance sheet for 2010. The
total equity position as at 31 December 2010 was negative GBP6.2m
compared to a negative balance of GBP5.5m at 31 December 2009.
OUTLOOK
ProStrakan is now well-positioned to make the next step forward
in its development. Fortesta was launched by Endo at the end of
last month; Abstral will be introduced to the US oncology support
market through our own US sales force shortly and Sancuso is
already re-establishing itself in this market. We continue to
develop our European business, with continued focus on Abstral and
on capitalising on the market positions of our other European
products. Our business partnering team continue to seek out
opportunities to generate revenues.
Meanwhile the offer from KHK to acquire ProStrakan at a
significant premium will be considered by ProStrakan shareholders
at a court meeting and a general meeting on 31 March 2011. Subject
to shareholder and certain other approvals outlined in the Scheme
Document, ProStrakan will become the European and US divisions of a
significant pharmaceutical business that owns and develops a large
and attractive portfolio of pipeline products in various
therapeutic areas.
Peter Allen
Chairman & Acting Chief Executive
ProStrakan Group plc
17 March 2011
Consolidated income statement (audited)
for the year ended 31 December 2010
Year ended Year ended
31 December 31 December
2010 2009
GBPm GBPm
------------------------------------------------- --------------- ---------------
Revenue
Cost of goods sold 100.2 79.0
-------------------------------------------------
(32.8) (26.4)
---------------------------------------------- --------------- ---------------
Gross profit 67.4 52.6
Distribution costs (41.4) (39.2)
Administrative expenses (8.5) (7.6)
Development (6.7) (12.0)
Other gains - net - 1.1
------------------------------------------------- --------------- ---------------
Earnings before interest, taxation, depreciation
and amortisation 10.8 (5.1)
Depreciation, amortisation and impairment
charges (4.7) (4.5)
------------------------------------------------- --------------- ---------------
Operating profit/(loss) 6.1 (9.6)
Finance income 0.1 0.2
Finance costs (6.4) (5.4)
Movement in fair value of warrants (0.4) (0.2)
------------------------------------------------- --------------- ---------------
Loss before income tax (0.6) (15.0)
Taxation (0.4) (0.6)
------------------------------------------------- --------------- ---------------
Loss for the year from continuing operations (1.0) (15.6)
------------------------------------------------- --------------- ---------------
Discontinued operations - (0.2)
------------------------------------------------- --------------- ---------------
Loss for the year (1.0) (15.8)
------------------------------------------------- --------------- ---------------
Earnings per share for loss attributable to the equity
holders of the Company during the year
Basic and diluted earnings per share (expressed in pence
per share)
From continuing operations (0.5) (7.7)
From discontinued operations - (0.1)
------------------------------------------------- --------------- ---------------
(0.5) (7.8)
------------------------------------------------- --------------- ---------------
Consolidated statement of comprehensive income (audited)
for the year ended 31 December 2010
Year ended Year ended
31 December 31 December
2010 2009
GBPm GBPm
------------------------------------------- -------------- ---------------
Loss for the year (1.0) (15.8)
Currency translation differences - 2.5
------------------------------------------- -------------- ---------------
Total comprehensive income for the period,
net of tax (1.0) (13.3)
------------------------------------------- -------------- ---------------
Balance sheet (audited)
as at 31 December 2010
Group Group Company Company
31 31 31
December 31 December December December
2010 2009 2010 2009
GBPm GBPm GBPm GBPm
---------------------------------------------- --------- ------------ --------- ---------
Assets
Non-current assets
Investment in subsidiaries - - 150.1 146.0
Intangible assets 32.5 36.7 - -
Property, plant and equipment 1.1 1.2 - -
Deferred tax assets 1.9 2.3 - -
---------------------------------------------- ------------- -------- ---------- --------
35.5 40.2 150.1 146.0
--------------------------------------------- ------------- -------- ---------- --------
Current assets
Inventories 7.3 6.1 - -
Trade and other receivables 23.7 12.8 0.2 0.6
Research and development tax credits
receivable 0.1 - - -
Cash and cash equivalents 19.4 19.0 14.5 17.1
---------------------------------------------- ------------- -------- ---------- --------
50.5 37.9 14.7 17.7
--------------------------------------------- ------------- -------- ---------- --------
Liabilities
Current liabilities
Trade and other payables 26.0 23.7 77.3 71.7
Provision for other liabilities
and charges 0.8 0.4 - -
Borrowings 12.0 1.0 - -
Warrant liability 2.8 2.4 - -
---------------------------------------------- ------------- -------- ---------- --------
41.6 27.5 77.3 71.7
--------------------------------------------- ------------- -------- ---------- --------
Net current assets/(liabilities) 8.9 10.4 (62.6) (54.0)
---------------------------------------------- ------------- -------- ---------- --------
Non-current liabilities
Other non-current liabilities 18.2 20.6 - -
Borrowings 32.4 35.5 - -
---------------------------------------------- ------------- -------- ---------- --------
50.6 56.1 - -
--------------------------------------------- ------------- -------- ---------- --------
Net (liabilities)/assets (6.2) (5.5) 87.5 92.0
---------------------------------------------- ------------- -------- ---------- --------
EQUITY
Capital and reserves attributable
to the Company's equity holders
Share capital 172.6 172.3 172.1 171.6
Other reserves 71.5 71.5 63.3 63.2
Retained earnings (250.3) (249.3) (147.9) (142.8)
---------------------------------------------- ------------- -------- ---------- --------
Total equity (6.2) (5.5) 87.5 92.0
---------------------------------------------- ------------- -------- ---------- --------
Consolidated statement of changes in equity (audited)
for the year ended 31 December 2010
Share Other Retained Total
capital reserves earnings equity
GBPm GBPm GBPm GBPm
------------------------------------ -------- --------- --------- -------
Balance at 1 January 2009 172.2 69.9 (233.5) 8.6
------------------------------------ -------- --------- --------- -------
Other comprehensive income:
Loss for the year - - (15.8) (15.8)
Currency translation difference - 2.5 - 2.5
------------------------------------ -------- --------- --------- -------
Total comprehensive income for the
year - 2.5 (15.8) (13.3)
------------------------------------ -------- --------- --------- -------
Transactions with owners:
Employee share option scheme:
- value of services provided - 0.4 - 0.4
- leavers during year - (1.4) - (1.4)
- warrants issued - 0.1 - 0.1
- options exercised 0.1 - - 0.1
------------------------------------ -------- --------- --------- -------
0.1 (0.9) - (0.8)
------------------------------------ -------- --------- --------- -------
Balance at 31 December 2009 172.3 71.5 (249.3) (5.5)
------------------------------------ -------- --------- --------- -------
Balance at 1 January 2010 172.3 71.5 (249.3) (5.5)
------------------------------------ -------- --------- --------- -------
Other comprehensive income:
Loss for the year - - (1.0) (1.0)
Currency translation difference - - - -
------------------------------------ -------- --------- --------- -------
Total comprehensive income for the
year - - (1.0) (1.0)
------------------------------------ -------- --------- --------- -------
Transactions with owners:
Employee share option scheme:
- value of services provided - 0.6 - 0.6
- leavers during the year - (0.2) - (0.2)
Shares issued 0.4 (0.4) - -
Purchase of own shares by ESOP (0.1) - - (0.1)
------------------------------------ -------- --------- --------- -------
0.3 - - 0.3
------------------------------------ -------- --------- --------- -------
Balance at 31 December 2010 172.6 71.5 (250.3) (6.2)
------------------------------------ -------- --------- --------- -------
Statement of cash flows (audited)
for the year ended 31 December 2010
Group Group Company Company
Year ended Year ended Year ended Year ended
31 December 31 December 31 December 31 December
2010 2009 2010 2009
GBPm GBPm GBPm GBPm
---------------------- ------------ ------------ ------------ ------------
Cash (used)/generated
from operating
activities
Continuing operations (0.7) (7.2) (1.8) 14.3
Discontinued
operations - (7.8) - (7.8)
---------------------- ------------ ------------ ------------ ------------
Cash (used)/generated
in operating
activities (0.7) (15.0) (1.8) 6.5
Continuing
operations:
Taxation paid (0.1) - - -
Finance income 0.1 0.2 0.2 0.2
Finance cost (5.2) (4.2) (1.0) (1.7)
---------------------- ------------ ------------ ------------ ------------
(5.2) (4.0) (0.8) (1.5)
---------------------- ------------ ------------ ------------ ------------
Net cash
(used)/generated in
operating
activities (5.9) (19.0) (2.6) 5.0
---------------------- ------------ ------------ ------------ ------------
Cash flows from
investing activities
Purchase of
intangible assets (0.9) (1.0) - -
Purchases of
property, plant and
equipment (0.2) (0.1) - -
Proceeds from sale of
intangibles - 1.4 - -
---------------------- ------------ ------------ ------------ ------------
Cash flows
(used)/generated in
continuing
operations -
investing
activities (1.1) 0.3 - -
---------------------- ------------ ------------ ------------ ------------
Cash flows from
financing activities
Proceeds from
borrowings 7.9 5.0 - -
Borrowings repaid (1.2) (3.4) - -
---------------------- ------------ ------------ ------------ ------------
Net cash generated by
financing
activities 6.7 1.6 - -
---------------------- ------------ ------------ ------------ ------------
Net
(decrease)/increase
in cash and cash
equivalents (0.3) (17.1) (2.6) 5.0
Cash and cash
equivalents at the
beginning of the
year 19.0 34.7 17.1 12.1
Exchange gains on
cash and cash
equivalents 0.7 1.4 - -
---------------------- ------------ ------------ ------------ ------------
Cash and cash
equivalents at the
end of the year 19.4 19.0 14.5 17.1
---------------------- ------------ ------------ ------------ ------------
1. Notes
a. Basis of preparation
The financial statements have been prepared in accordance with
the Group's accounting policies which are based on International
Financial Reporting Standards ("IFRS") and IFRIC interpretations
endorsed by the European Union ("EU") and with those parts of the
Companies Act 2006 applicable to companies reporting under
IFRS.
The consolidated financial statements are presented in pounds
sterling and all values are rounded to the nearest million
(GBP'000'000), except when otherwise indicated.
The financial information for the years ended 31 December 2010
and 2009 set out above does not constitute statutory accounts
within the meaning of section 435 of the Companies Act 2006 ("the
Act"). Statutory accounts for the year ended 31 December 2009 have
been delivered to the Registrar of Companies, and the accounts for
the year ended 31 December 2010 will be delivered to the Registrar
of Companies following the Annual General Meeting. The auditors
have reported on those accounts; their reports were (i)
unqualified, (ii) did not include any reference to any matters to
which the auditors drew attention by way of emphasis without
qualifying their report and (iii) did not contain a statement under
section 498(2) or section 498(3) of the Companies Act 2006.
The Annual Report and Accounts for the year ended 31 December
2010 will be posted to shareholders in advance of the Annual
General Meeting which is due to be held on 26 May 2011. The results
for 2010 were approved by the Board of Directors on 17 March 2011
and are audited.
Interim and preliminary announcements notified to the London
Stock Exchange are available on the internet at
www.prostrakan.com.
b. Going concern
As part of the year end accounts exercise, the Directors are
required to satisfy themselves that it is reasonable for them to
conclude whether it is appropriate to prepare financial statements
on a going concern basis. The Directors of the Group have reviewed
various aspects of the business including budget plans covering the
periods for at least twelve months from the date of approval of the
accounts, taking account of reasonably possible changes in trading
performance, the current and forecast debt position, related
covenants, other sources of capital and various external factors.
Notwithstanding the Group's negative net asset positions position
as at 31 December 2010, the Directors are satisfied after making
these enquiries that the Group has adequate resources to continue
in business for the foreseeable future and, accordingly, consider
that it is appropriate to adopt the going concern basis in
preparing this full year financial information.
2. Segmental information
The chief operating decision-maker has been identified as the
Board of Directors. The Board reviews the Group's internal
reporting in order to assess performance and allocate resources.
Management has determined the operating segments based on these
reports.
The Board considers the business from a geographic perspective
and assesses the performance of UK, EU (excluding the UK), US and
Partnering income.
The Board assesses the performance of the operating segments
based on a measure of adjusted earnings before interest, tax,
depreciation and amortisation (EBITDA). This measurement basis
excludes the effects of non-recurring expenditure from the
operating segments. Finance income and expenditure are not included
in the result for each operating segment that is reviewed by the
Board. Other information provided to the Board is measured in a
manner consistent with that in the financial statements.
Total assets exclude cash and cash equivalents which are managed
on a central basis. These are part of the reconciliation to total
balance sheet assets.
2010 2009
GBPm GBPm
---------------------------------------------------------- ------ -------
Revenue
UK 35.9 31.7
EU (excluding the UK) 44.1 34.8
---------------------------------------------------------- ------ -------
Total European 80.0 66.5
US 6.8 7.3
Partnering income 13.4 5.2
---------------------------------------------------------- ------ -------
100.2 79.0
---------------------------------------------------------- ------ -------
Earnings before interest, taxation, depreciation and
amortisation
UK (1.3) (0.1)
EU (excluding the UK) 8.4 (0.5)
---------------------------------------------------------- ------ -------
Total European 7.1 (0.6)
US (4.8) (3.4)
Partnering income 8.5 (1.1)
---------------------------------------------------------- ------ -------
10.8 (5.1)
---------------------------------------------------------- ------ -------
A reconciliation of total EBITDA is provided as follows:
2010 2009
GBPm GBPm
---------------------------------------------------------- ------ -------
EBITDA 10.8 (5.1)
Depreciation, amortisation and impairment charges (4.7) (4.5)
Finance income 0.1 0.2
Finance cost (6.4) (5.4)
Revaluation of warrants (0.4) (0.2)
Discontinued operations - (0.2)
Taxation (0.4) (0.6)
---------------------------------------------------------- ------ -------
Loss for the year (1.0) (15.8)
---------------------------------------------------------- ------ -------
Total Assets:
2010 2009
GBPm GBPm
----------------------------------------------------- ------ -----
UK 6.2 6.0
EU (excluding UK) 23.0 23.4
----------------------------------------------------- ------ -----
Total EU 29.2 29.4
US 0.7 2.0
Partnering income 36.7 27.7
----------------------------------------------------- ------ -----
66.6 59.1
----------------------------------------------------- ------ -----
Reportable segments' assets are reconciled to total
assets as follows:
2010 2009
GBPm GBPm
----------------------------------------------------- ------ -----
Total segment assets 66.6 59.1
Cash and cash equivalents 19.4 19.0
----------------------------------------------------- ------ -----
Total assets per balance sheet 86.0 78.1
----------------------------------------------------- ------ -----
Capital expenditure:
2010 2009
GBPm GBPm
----------------------------------------------------- ------ -----
UK 0.2 0.2
EU (excluding the UK) 0.1 0.1
----------------------------------------------------- ------ -----
Total EU 0.3 0.3
US 0.1 -
Partnering income 0.7 0.8
----------------------------------------------------- ------ -----
1.1 1.1
----------------------------------------------------- ------ -----
Analysis of revenue by category:
2010 2009
GBPm GBPm
----------------------------------------------------- ------ -----
Product sales1 89.2 74.4
Licensing income 10.8 4.2
Royalty income 0.2 0.4
----------------------------------------------------- ------ -----
100.2 79.0
----------------------------------------------------- ------ -----
1 Product sales represents 89% of total revenues (2009: 94%)
3. Discontinued operations
On 2 July 2009 ProStrakan reported it had agreed to make a
payment in cash of GBP7.8m (EUR9.15m) in full and final settlement
with Aventis against a EUR13.4m tax liability, incurred by Aventis,
arising from the sale of ProSkelia SAS ("ProSkelia") by ProStrakan
in December 2006. This settlement resulted in an additional charge
of GBP0.2m against amounts already provided, which has been
included under discontinued operations.
2010 2009
GBPm GBPm
------------------------------------------------ ----- ------
Other losses - (0.2)
------------------------------------------------ ----- ------
Loss for the year from discontinued operations - (0.2)
------------------------------------------------ ----- ------
4. Other gains/(losses)
2010 2009
GBPm GBPm
----------------------------------------------------- ----- -----
Other financial assets at fair value through profit
or loss
- income from grants - 0.1
- profit on disposal of product rights(1) - 1.0
----------------------------------------------------- ----- -----
- 1.1
----------------------------------------------------- ----- -----
(1) The profit on disposal of product rights arose from the sale
of three non core products from the Groups German subsidiary.
5. Finance income and costs
2010 2009
GBPm GBPm
---------------------------------------- ------ ------
Finance income
Interest receivable on short-term
deposits 0.1 0.2
---------------------------------------- ------ ------
0.1 0.2
---------------------------------------- ------ ------
Interest payable on bank borrowings (5.2) (4.2)
Accretion of warrants on debt facility (0.7) (0.8)
Amortisation of set-up costs on debt
facility (0.5) (0.4)
---------------------------------------- ------ ------
Finance cost (6.4) (5.4)
6. Taxation
2010 2009
GBPm GBPm
-------------------------------- ----- -----
Current tax:
Income tax charge 0.1 0.1
-------------------------------- ----- -----
Deferred tax:
Deferred tax charge 0.3 0.5
-------------------------------- ----- -----
Tax charge in income statement 0.4 0.6
-------------------------------- ----- -----
The tax on the Group's losses before tax differs from the
theoretical amount that would arise using the standard rate of
corporation tax in the UK. The differences are explained below.
2010 2009
GBPm GBPm
Loss before tax - continuing activities (0.6) (15.0)
Loss before tax - discontinued activities - (0.2)
------------------------------------------------------------ ------ -------
Total (0.6) (15.2)
------------------------------------------------------------ ------ -------
Tax calculated at rate of corporation tax in the UK of 28%
(2009: 28%) (0.2) (4.3)
Expenses not deductible for tax purposes 1.0 0.9
Change in unrecognised deferred tax asset (1.6) 4.0
Recognised deferred tax rate change adjustment 1.2 -
------------------------------------------------------------ ------ -------
Tax charge in income statement 0.4 0.6
------------------------------------------------------------ ------ -------
7. Earnings per share
Basic
Basic earnings per share is calculated by dividing the loss
attributable to ordinary shareholders by the weighted average
number of ordinary shares in issue during the year, excluding those
held in the Executive Share Option Plan (ESOP), which are treated
as cancelled.
As at As at
31 December 31 December
2010 2009
Loss attributable to equity holders of the
Company (GBPm) (1.0) (15.8)
Basic earnings per share (pence per share) (0.5) (7.8)
-------------------------------------------------- ------------ ------------
Basic earnings per share from continuing
operations
Loss attributable to equity holders of the
Company (GBPm) (1.0) (15.6)
Basic earnings per share (pence per share) (0.5) (7.7)
-------------------------------------------------- ------------ ------------
Basic earnings per share from discontinued
operations
Loss attributable to equity holders of the
Company (GBPm) - (0.2)
Basic earnings per share (pence per share) - (0.1)
-------------------------------------------------- ------------ ------------
Weighted average number of ordinary shares 202.1 201.3
-------------------------------------------------- ------------ ------------
Diluted
IAS 33 requires presentation of diluted earnings per share when
a company could be called upon to issue shares that would decrease
net profit or increase net loss per share. For a loss making
company with outstanding dilutive potential ordinary shares, net
loss per share would only be decreased by the exercise of such
potential ordinary shares. Therefore diluted earnings per share is
not presented.
8. Intangible assets
Product
Goodwill rights Other(1) Total
Group GBPm GBPm GBPm GBPm
----------------------------- --------- -------- --------- -------
At 1 January 2010
Cost 10.0 51.1 1.0 62.1
Accumulated amortisation - (24.6) (0.8) (25.4)
----------------------------- --------- -------- --------- -------
Net book value 10.0 26.5 0.2 36.7
----------------------------- --------- -------- --------- -------
Year ended 31 December 2010
Opening net book amount 10.0 26.5 0.2 36.7
Additions - 0.3 0.6 0.9
Disposal - (0.1) - (0.1)
Amortisation charge - (3.6) (0.1) (3.7)
Impairment - (0.7) - (0.7)
Exchange differences (0.3) (0.2) (0.1) (0.6)
----------------------------- --------- -------- --------- -------
Closing net book value 9.7 22.2 0.6 32.5
----------------------------- --------- -------- --------- -------
At 31 December 2010
Cost 9.7 50.1 1.5 61.3
Accumulated amortisation - (27.9) (0.9) (28.8)
----------------------------- --------- -------- --------- -------
Net book value 9.7 22.2 0.6 32.5
----------------------------- --------- -------- --------- -------
At 1 January 2009
Cost 10.9 51.6 0.9 63.4
Accumulated amortisation - (21.0) (0.7) (21.7)
----------------------------- --------- -------- --------- -------
Net book value 10.9 30.6 0.2 41.7
----------------------------- --------- -------- --------- -------
Year ended 31 December 2009
Opening net book amount 10.9 30.6 0.2 41.7
Additions - 0.9 0.1 1.0
Disposals - (0.4) - (0.4)
Amortisation - (3.8) (0.1) (3.9)
Impairment - (0.3) - (0.3)
Exchange differences (0.9) (0.5) - (1.4)
----------------------------- --------- -------- --------- -------
Closing net book value 10.0 26.5 0.2 36.7
----------------------------- --------- -------- --------- -------
At 31 December 2009
Cost 10.0 51.1 1.0 62.1
Accumulated amortisation - (24.6) (0.8) (25.4)
----------------------------- --------- -------- --------- -------
Net book value 10.0 26.5 0.2 36.7
----------------------------- --------- -------- --------- -------
(1) Other intangibles include software and other costs.
Impairment tests for goodwill
Goodwill arising from previous acquisitions is tested annually
for impairment under IAS 36. No Goodwill impairment charges were
required during the year. Goodwill is allocated to the Group's
cash-generating units (CGUs) identified as follows:
(a) Development is treated as a separate CGU.
(b) Each commercial territory under the control and guidance of
a General Manager is a CGU.
The goodwill arising from the acquisitions of Elfar SA and
Arzneimittel Pharma GmbH was allocated to Spain and Germany
Commercial respectively. The rationale for this is that the CGUs
benefiting fundamentally from these acquisitions are these
identifiable Groups and these CGUs are not larger than the Group's
reported segments. The carrying amount of goodwill by division is
as follows:
Spain Germany
commercial commercial Total
GBPm GBPm GBPm
------------------------ ----------- ----------- ------
As at 1 January 2009 10.2 0.7 10.9
Exchange differences (0.8) (0.1) (0.9)
------------------------ ----------- ----------- ------
As at 31 December 2009 9.4 0.6 10.0
------------------------ ----------- ----------- ------
As at 1 January 2010 9.4 0.6 10.0
Exchange differences (0.4) 0.1 (0.3)
------------------------ ----------- ----------- ------
As at 31 December 2010 9.0 0.7 9.7
------------------------ ----------- ----------- ------
Measurement of recoverable amounts:
Spain and Germany Commercial
The value of the assets, being the ongoing trading of the
Spanish and German Commercial CGUs, are valued on a discounted cash
flow basis.
Key assumptions in the calculations are:
(i) sales, gross margin and expenses based on approved budgets
and forecasts for the next 10 years, being the average life of the
products currently marketed;
(ii) discount rates - 12%-14% pre tax, corresponding to the
internal rate of return used within the Group; and
(iii) growth rates - long term growth rates, in line with long
term planning and forecasts, are assessed on an individual basis
dependent on product portfolio maturity. Assumed rates are between
3% - 1% decreasing in outer years.
Management determined the budgeted gross margin based on past
performance and its expectations for the market development. The
weighted average growth rates used are consistent with the
forecasts included in industry reports. The discount rates used are
pre-tax and reflect specific risks relating to the relevant
segments.
9. Property, plant and equipment
Plant Furniture
& &
equipment fittings Total
Group GBPm GBPm GBPm
----------------------------- ---------- ---------- ------
At 1 January 2010
Cost or valuation 0.9 1.6 2.5
Accumulated depreciation (0.5) (0.8) (1.3)
----------------------------- ---------- ---------- ------
Net book value 0.4 0.8 1.2
----------------------------- ---------- ---------- ------
Year ended 31 December 2010
Opening net book amount 0.4 0.8 1.2
Additions 0.2 - 0.2
Depreciation charge (0.1) (0.2) (0.3)
----------------------------- ---------- ---------- ------
Closing net book value 0.5 0.6 1.1
----------------------------- ---------- ---------- ------
At 31 December 2010
Cost or valuation 1.1 1.6 2.7
Accumulated depreciation (0.6) (1.0) (1.6)
----------------------------- ---------- ---------- ------
Net book value 0.5 0.6 1.1
----------------------------- ---------- ---------- ------
At 1 January 2009
Cost or valuation 0.8 1.6 2.4
Accumulated depreciation (0.3) (0.7) (1.0)
----------------------------- ---------- ---------- ------
Net book value 0.5 0.9 1.4
----------------------------- ---------- ---------- ------
Year ended 31 December 2009
Opening net book amount 0.5 0.9 1.4
Additions 0.1 - 0.1
Depreciation charge (0.2) (0.1) (0.3)
----------------------------- ---------- ---------- ------
Closing net book value 0.4 0.8 1.2
----------------------------- ---------- ---------- ------
At 31 December 2009
Cost or valuation 0.9 1.6 2.5
Accumulated depreciation (0.5) (0.8) (1.3)
----------------------------- ---------- ---------- ------
Net book value 0.4 0.8 1.2
----------------------------- ---------- ---------- ------
10. Borrowings
On 27 March 2007 the Group entered into a GBP50 million debt
facility with the initial advance being provided by funds managed
by Fortress Investment Group, Morgan Stanley and funds managed by
Och-Ziff Capital Management Group ("Fortress"). The administrative
Agent is Morgan Stanley Bank International Limited. The debt
facility is secured over the intellectual property of the Group and
has strict requirements for drawing funds, compliance with
covenants and reporting requirements.
Draw-down under the facility is made with reference to the level
of sales from key products recorded by the Group in the previous
twelve month period (borrowing base capability). The level of
draw-down available at any one time is governed by financial
covenants which define the minimum sales levels required versus
year on year product growth targets and sales plans. Other
financial covenants require that the Group must maintain a minimum
cash level of GBP4.5m of which no more than GBP1.5m can be held by
certain subsidiaries at any time. The Group is also required to
provide regular monthly trading reports, as well as interim and
full year accounts in a timely manner.
The Group drew down an additional GBP8.0m from the facility in
April 2010 (GBP7.9m after fees) and repaid GBP0.1m in relation to
the disposal of Zindaclin making the total amount drawn at the
half-year of GBP46.5m. In the second half the Group re-paid a
further GBP0.1m relating to the disposal of Zindaclin and made the
first GBP1.0m capital repayment in December 2010 making the amount
drawn at 31 December GBP45.4m.
Under the terms of the facility, interest is repaid on a monthly
basis, with capital repayments due to commence in December 2010.
From that time the Group will repay GBP1.0m per month until the end
of February 2012, at which point the outstanding capital sum will
be repaid in full.
The maturity of the amount drawn down as at 31 December 2010 is
detailed below:
2010 2009
GBPm GBPm
----------- ----- -----
Current 12.0 1.0
1-5 years 33.4 37.6
----------- ----- -----
Total 45.4 38.6
----------- ----- -----
Interest on the amount drawn is charged at a rate of (i) the
greater of either one month LIBOR or 5% plus (ii) a margin of
between 5.0% and 5.5%, whilst the unused line fees on the un-drawn
amount, ranges between 0.25% and 0.5% depending on the un-drawn
amount.
The lenders have been issued with warrants over 5,018,414 shares
(representing 2.5% of current shares in issue). The warrants have a
ten year life and an exercise price of 98.052p per warrant.
On 12 January 2011 the Group completed the assignment of its
debt facility with Fortress to Paladin Labs Inc. details of which
are described in Note 12 Post balance sheet events. The warrants
issued on 27 March 2007 were unaffected by the refinancing.
(a) Debt instrument
The debt instrument and the warrant instrument have been
accounted for separately.
The fair value of the debt element for initial recognition was
measured at amortised cost. The fair value of the debt at initial
recognition, represented the value of the cash received less the
fair value of the warrants issued. No additional warrants were
issued in relation to the GBP17.0m drawn down during 2008, the
GBP5.0m drawn down during 2009 or the additional GBP8.0m drawn down
during 2010. As the debt is subsequently measured at amortised
cost, the initial GBP20.0m is accreted to the repayment amount of
GBP20.0m at maturity, using the effective interest rate method. The
effective interest rate was 11.35% (2009: 12.09%) for the year. The
amortised cost of the debt at 31 December was GBP44.4m (2009:
GBP36.5m).
2010 2009
GBPm GBPm
------------------------------------------- ------- ------
At 1 January 2010
Net funds drawn 38.6 37.0
Cumulative accretion of loan warrants (1.1) (1.9)
Carrying value of set up costs (1.0) (1.4)
------------------------------------------- ------- ------
36.5 33.7
Movements during the year
Funds drawn less funds repaid 6.8 1.6
Capitalisation of additional set up costs (0.1) -
Accretion of loan warrants 0.7 0.8
Amortisation of set up costs 0.5 0.4
------------------------------------------- ------- ------
7.9 2.8
At 31 December 2010
Net funds drawn 45.4 38.6
Cumulative accretion of loan warrants (0.4) (1.1)
Carrying value of set up costs (0.6) (1.0)
------------------------------------------- ------- ------
44.4 36.5
Less current portion (12.0) (1.0)
------------------------------------------- ------- ------
32.4 35.5
------------------------------------------- ------- ------
(b) Warrant liability
The warrant instrument is a derivative financial liability.
The warrants have been accounted for as a current liability as
the warrant agreement provides a choice to the lender over how and
when the contract is settled.
The fair value of the warrants issued to the lenders on 27 March
2007 of GBP3.0m, was determined by the use of the Binomial Tree
valuation model. The fair value of the warrants as at 31 December
2010 was GBP2.8m (2009: GBP2.4m) and resulted in an increase in
value of GBP0.4m (2009: GBP0.2m) being recognised in the Income
Statement. The significant inputs into the model were the share
price for the period leading up to the grant date being the closing
market price on those dates, the closing market value at 31
December 2010, exercise price of the grant, dividend yield of 0%,
expected life of the warrants, and an annual risk-free interest
rate based on UK Government bond yields-to-maturity as at valuation
date. The volatility measured at the standard deviation of expected
share price returns is based on the ProStrakan Group share value
over the expected life (for 2010) whereas in previous years this
was evaluated using a broad range of comparable companies.
2010 2009
GBPm GBPm
---------------------------------------------------- ----- -----
At 1 January 2010 2.4 2.2
Movement in fair value charged to income statement 0.4 0.2
---------------------------------------------------- ----- -----
At 31 December 2010 2.8 2.4
---------------------------------------------------- ----- -----
11. Cash generated from operations
Continuing operations
Group Company
2010 2009 2010 2009
GBPm GBPm GBPm GBPm
-------------------------------------------- ------- ------- ------ ------
Loss for the year (1.0) (15.6) (5.1) (3.8)
Adjustments for:
- tax 0.4 0.6 - -
- depreciation 0.3 0.3 - -
- amortisation (including write-down of
product rights) 4.4 4.2 - -
- profit on sale of products rights,
property, plant and equipment (see below) - (1.0) - -
- net movement in provisions for
liabilities and charges 0.4 (0.2) - -
- charges for share-based employee benefits 0.4 (0.9) 0.3 (1.0)
- finance income (0.1) (0.2) (0.2) (0.2)
- finance cost 6.4 5.4 1.0 1.7
- movement in fair value of warrants 0.4 0.2 - -
- changes in working capital (excluding the
effects
of acquisition and exchange difference on
consolidation):
- inventories (1.2) 0.9 - -
- trade and other receivables (10.9) (0.5) (5.6) (2.3)
- trade and other payables 1.3 (7.2) 7.8 19.9
- deferred income (1.5) 6.8 - -
-------------------------------------------- ------- ------- ------ ------
Cash (utilised)/generated from continuing
operations (0.7) (7.2) (1.8) 14.3
-------------------------------------------- ------- ------- ------ ------
In the cash flow statement, proceeds from
sale of property, plant and equipment
comprise:
Net book amount - 0.4 - -
Profit on sale of product rights, property,
plant and equipment - 1.0 - -
-------------------------------------------- ------- ------- ------ ------
Proceeds from sale of property, plant and
equipment - 1.4 - -
-------------------------------------------- ------- ------- ------ ------
Non-cash transactions
The principal non-cash transactions were the issue
of equity instruments to employees and Directors.
Discontinued operations
Group Company
2010 2009 2010 2009
GBPm GBPm GBPm GBPm
-------------------------------------------- ------- ------- ------ ------
Loss for the year - (0.2) - (0.2)
Adjustments for:
- net movement in provisions for
liabilities and charges - 0.2 - 0.2
- changes in working capital (excluding the
effects of
acquisition and exchange difference on
consolidation):
- trade and other receivables - - - -
- trade and other payables - (7.8) - (7.8)
-------------------------------------------- ------- ------- ------ ------
Cash utilised by discontinued operations - (7.8) - (7.8)
-------------------------------------------- ------- ------- ------ ------
12. Post balance sheet events
(a) Refinancing
On 16 December 2010 the Company announced that it had entered
into a strategic relationship with Paladin Labs Inc. ("Paladin"),
the Canadian based international specialty pharmaceutical company,
in which Paladin (through its wholly-owned subsidiary, Chimigen
Inc.) would acquire, by way of assignment, ProStrakan's existing
secured debt facility, with the addition of certain conversion
rights, and would be granted an exclusive licence to ProStrakan's
products for certain emerging territories. On the 7 January 2011 at
a General Meeting of the Company, shareholders approved the
assignment of the Company's existing debt facility with Fortress
Investment Group, Morgan Stanley and funds managed by Och-Ziff
Capital Management Group to Paladin. The assignment was completed
on the 12 January 2011.
The agreement builds on the relationship which already existed
between the two companies under which Paladin already had
in-licensed the rights to distribute Abstral and Sancuso in Canada.
The new relationship broadens this existing partnership, with
Paladin being granted exclusive licence to distribute all of
ProStrakan's products, including Abstral, Sancuso, Rectogesic,
Xomolix and Tostran, in certain specific territories for which
ProStrakan does not already have distribution agreements. These
territories include: Canada, Latin America, Sub-Saharan Africa and
Israel. In addition, during the term of the debt facility, Paladin
have the right to license any new products acquired or licensed by
ProStrakan for those same territories and on the same terms and
conditions.
The GBP50.0m secured facility is provided by Paladin in Canadian
Dollars at a rate of interest of 10.5% compared with a blended rate
of 11.9% on the original facility. Paladin have the option to
convert all or part of the outstanding principal debt into new
ProStrakan shares at a price of GBP1.10 per ordinary share, but
cannot convert during the initial six months of the life of the
amended agreement. In the event of a change of control of
ProStrakan during the initial six months (and providing Paladin
requires repayment of the facility), Paladin are entitled to
receive a payment equivalent to the balance of interest for the
first year of the loan, together with an early repayment fee of
GBP2.0m (CAD$3.3m). Full details of the facility were set out in
the circular sent to shareholders on 21 December 2010.
After fees and an early repayment interest payment paid to the
original lenders, the Group received a further GBP2.4m in cash from
the facility. Following the assignment and subsequent additional
draw down, the amount outstanding to Paladin Labs Inc is CAD$77.2m
(GBP50.0m) with the assignment occurring at an exchange rate of
1.54465 CAD$ = GBP1. The carrying value of the debt instrument will
be re-valued at period ends and as such creates a foreign exchange
exposure risk for the Group. The Group has reviewed the various
options available to it in order to hedging part of all of the
borrowings and have determined that due to the cost of such
instruments not to put in place foreign exchange hedging
measures.
The facility can be repaid at any time with Paladin's consent.
It is also repayable on demand by Paladin on the occurrence of
certain events of default and upon the Company being subject to a
change of control. On 17 February 2011 the Company and KHK (as
defined below) received a consent letter from Paladin consenting to
the early repayment of the whole of the facility conditional upon
completion of the proposed takeover of the Company by KHK as
further described in section (b) below, which will result in the
payments described above being made. Following repayment, Paladin's
rights to license any new products acquired or licensed by
ProStrakan for those same territories expires.
Paladin will be entitled, for so long as either any sums remain
outstanding under the facility or Paladin holds at least 15% of the
issued share capital of the Company, to appoint one non-executive
director to the Board of ProStrakan. On 12 January 2011, Jonathan
Goodman, Paladin's CEO, joined the Board of ProStrakan as a
Non-executive Director.
(b) Recommended cash acquisition of ProStrakan Group plc
On 21 February 2011, the boards of Kyowa Hakko Kirin Co., Ltd.
("KHK") and ProStrakan Group plc ("ProStrakan") announced that they
had reached agreement on the terms of the recommended cash
acquisition by KHK of the entire issued and to be issued share
capital of ProStrakan (the "Acquisition"). Under the terms of the
Acquisition, ProStrakan Shareholders will be entitled to receive
130 pence in cash for each ProStrakan Share, valuing the entire
issued and to be issued ordinary share capital of ProStrakan at
approximately GBP292 million (Yen39,420 million).The price of 130
pence per ProStrakan Share represents a premium of approximately 41
per cent to the closing price of 92.5 pence per ProStrakan Share on
12 November 2010, being the last business day immediately prior to
the start of ProStrakan's current offer period; and 100 per cent to
64.9 pence, being the volume weighted average closing price per
ProStrakan Share over the 6 months prior to 12 November 2010, being
the last business day immediately prior to the start of
ProStrakan's current offer period.
The Acquisition would represent a new opportunity for
ProStrakan's continued development and could, through the
complementary nature of ProStrakan and KHK, in terms of products,
geography and infrastructure, allow ProStrakan to grow at a faster
pace and to offer to patients and clinicians across Europe and the
US, in time, a broader range of medicines.
In consideration for KHK making the Acquisition, ProStrakan has
agreed to pay to KHK an inducement fee equal to one percent of the
value of the Acquisition if, prior to the date upon which the
Acquisition lapses or is withdrawn various events occur. In
addition, ProStrakan has made various non-solicitation undertakings
and has offered KHK the right, under certain circumstances to match
a superior proposal if one should be received. Details of the
Implementation Agreement agreed between the parties can be found in
the Scheme Document sent to shareholders on 8 March 2011.
It is proposed that the Acquisition be implemented by means of a
Scheme of Arrangement under Part 26 of the Companies Act 2006. Full
details of the Acquisition are set out in the Scheme Document sent
to shareholders on 8 March 2011.
13. Principal Risks and Uncertainties
The Group is exposed to a number of risks in the operation of
its business, the most important of which are discussed below.
Marketed products
In the year ended 31 December 2010, the Group's product sales
accounted for 89% (GBP89.2m) of total revenue versus 2009 at 94%
and (GBP74.4m) respectively. Of the currently marketed products,
the largest in-market sales were generated by Adcal-D3, Sancuso,
Isotard XL, Tebetane, Pencial, Rectogesic, Abstral and Droperidol
(Xomolix). There can be no assurance that this level of product
sales from marketed products can be either maintained or increased
in the future. Product sales may be affected by adverse market
developments, including the market for a particular product not
developing in the manner predicted by the Group, downward pressure
on pricing from governments and other third parties to limit
healthcare costs, increased competition and the withdrawal of a
product for regulatory reasons or otherwise.
Commercial success in the US
The Group has a strong track record of growth in Europe and
commenced its commercial operations in the US during late 2007
ahead of the launch of its first US product, Sancuso. The Group has
recently received approval to launch Abstral in the US. The
commercial success of these two products in the US will be a key
factor in the level of future success of the Group. There can be no
assurance that the Group will be successful in the US.
Manufacturing
ProStrakan outsources all of its manufacturing operations to
third party suppliers. The Group cannot guarantee its ability to
secure continuity of product supply from these third party
suppliers. During 2010, the business experienced a major product
interruption in the supply of one of its key products which led to
a material financial impact. The business is currently managing the
transfer of several existing products to new suppliers which by its
nature creates a risk to continuity of product supply.
Competition and intellectual property risk
The Group's business depends both on the continued successful
commercialisation of existing pharmaceutical products and the
in-licensing, product acquisition and/or development, obtaining and
maintaining marketing authorisations and subsequent successful
commercialisation of new pharmaceutical products. The risks faced
by the Group in relation to each of its products and product
candidates differ substantially depending on whether they are in
the market, seeking marketing authorisation(s) or in clinical
development. Due to the inherent risk in the development of
pharmaceutical products, it is probable that not all of the product
candidates in the Group's portfolio will successfully complete
development, obtain market authorisations, achieve satisfactory
price reimbursement and be launched. Further, the Group's products
may have to be removed from the market for regulatory reasons after
approval has been given.
Products seeking marketing authorisations
The Group is currently seeking a marketing authorisation for
Sancuso in Europe and for Rectogesic in the US during 2011. There
can be no assurance that any product for which a marketing
authorisation is sought will receive such authorisation and price
reimbursement (if applicable) in those territories for which market
authorisations are sought or if they do, that they will be
successfully commercialised in those territories.
Clinical and regulatory risk
Insufficient efficacy in the chosen indication or unacceptable
side-effect profiles may cause a product candidate to fail in
clinical development or limit its applicability should it reach a
commercial stage. Lack of performance by third party clinical
research organisations or an inability to recruit patients may
cause undue delays in clinical trials. Clinical and regulatory
issues may arise or changes to the regulatory environment may occur
that lead to delays, further costs, reduction in the commercial
potential of a product candidate or the cessation of programmes.
Ethical, regulatory or marketing approvals may be delayed or
withheld or, if awarded, may carry unacceptable conditions to
further development or commercial success. As both the product and
its manufacturer are subject to continual review there can be no
assurance that such marketing authorisation, once granted, will not
be withdrawn or restricted. If there are changes to the application
of legislation or regulatory policies, or problems are discovered
with the product or the manufacturer, or if the Group fails to
comply with regulatory requirements, the regulators could take
action which may negatively impact the Group's ability to sell the
products or the Group may incur substantial additional expense to
comply with the regulatory requirements. In addition, in certain
territories, even after obtaining a marketing authorisation, the
Group may decide to seek price reimbursement approval (if
applicable), which may delay the marketing of the Group's products,
limit their commercial potential or mean that the product cannot be
commercialised at all.
Commercialised product risk and development risk
The Group's ability to compete effectively with other companies
will depend in part on its ability to obtain and maintain patent
and/or trademark protection for certain of its products and product
candidates, preserve its trade secrets, defend and enforce its
rights against infringement and operate without infringing the
proprietary or intellectual property rights of third parties. The
validity and enforceability of patents and/or trademarks may
involve complex legal and factual issues resulting in a high degree
of uncertainty as to the extent of the protection provided.
Economic risk
The successful development and commercialisation of
pharmaceutical products carry a high level of risk and the returns
may be insufficient to cover the costs incurred. Restrictions on
health budgets worldwide or on the prices that may be charged for
new medicines through competitive or other pressures may limit a
medicine's sales potential. The Group may not be able to adequately
fund its own development or commercialisation activities to compete
with larger, more established competitors and it may fail to
attract partners on favourable terms or recruit the appropriate
calibre of staff to help develop or commercialise its products.
Furthermore, selected partners may fail to perform or commit the
resources necessary to develop or commercialise the Group's
products successfully.
Financial risk
The Group is currently loss making and sustainability is
dependent upon generating cash flows from successful development
and commercialisation of the Group's products. Until then, the
Group will be dependent upon additional funding through completion
of licensing deals or through injection of capital from debt or
equity sources. There can be no assurances that such funding will
be achieved on favourable terms, if at all. Failure to generate
additional funding may lead to postponement or cancellation of
programmes and/or a scale-back of operations.
Since the refinancing completed in January 2011 the Group has a
Canadian dollar debt facility for approximately GBP50.0m upon which
it currently pays interest at a rate of 10.5% on a quarterly basis
and which will require capital repayment in January 2014 unless the
lender elects to convert part or all of the outstanding capital sum
into equity of the Group. The facility contains a number of
covenants. If the Group is unable to meet these covenants at any
point then the capital sum will become fully repayable.
The Group is exposed to a number of foreign exchange risks. The
principal foreign exchange risk is associated with the debt
facility described above which is denominated in Canadian dollars.
Movements in the exchange rate between the Canadian dollar and
Sterling will have an impact on both the pounds sterling cost of
interest payments due and on the pounds sterling cost of repaying
the outstanding capital sum when it falls due. The Group has only
minor sources of income in Canadian dollars which it receives from
its distribution partners. The Group has not entered into any
hedging instruments for either the interest or capital elements of
the facility due to the high cost of these instruments and as a
result has a non-hedged foreign exchange exposure.
14. Responsibility Statement
The Annual Report for the year ended 31 December 2010 complies
with the Disclosure and Transparency Rules of the United Kingdom's
Financial Services Authority in respect of the requirement to
produce an Annual Financial Report. Andrew McLean, Company
Secretary, confirmed on behalf of the Board that, to the best of
each person's knowledge and belief:
-- the financial statements, prepared in accordance with IFRSs
as adopted by the EU, give a true and fair view of the assets,
liabilities, financial position and loss of the Group and Company;
and
-- the Directors' report contained in the Annual Report includes
a fair review of the development and performance of the business
and the position of the company and Group, together with a
description of the principal risks and uncertainties that they
face.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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