Final Results
Fulcrum Pharma PLC
09 November 2006
FULCRUM PHARMA PLC
('the Group' or 'the Company')
Preliminary Results for the Year Ended 31 August 2006
Fulcrum Pharma plc (AIM: FUL), the drug development and strategic outsourcing
services company, today announces its preliminary results for the year ended 31
August 2006.
Highlights
• Profit before tax of £154,000 (2005: loss of £76,000, £315,000 before
exceptional)
• Fee sales improved by 34% to £8.3m (2005: £6.2m)
• Successful acquisition and integration of Quadramed Ltd, a regulatory
services business
• Headcount increased by circa 50% and management team strengthened
• Strong sales performance in Europe
• Disappointing sales performance in US. New General Manager appointed
• Good contribution to sales by Japan
Commenting on the results, Chairman Prof. Sir Charles George said: 'We continue
to focus on building Fulcrum to a sufficient scale to deliver sustainable
profits. We remain committed to growing our services business, in particular in
pharmaceutical regulatory affairs, both organically and by acquisition. Finally,
I would like to thank the management and staff for all their efforts in bringing
the company back into profit this year.'
For further information, please contact:
Fulcrum Pharma PLC
Jon Court, Chief Executive Tel: 0870 710 7152
Fulcrum Pharma PLC
Preliminary Results for the Year Ended 31 August 2006
Chairman's Report
Business Review
I am pleased to report the Group returned to profitability in this year and has
maintained a strong balance sheet with net funds at 31 August 2006 of £1.9m
(2005 £1.5m). Fulcrum's results show a profit before tax for the full year of
£154,000 compared to last year's loss before tax of £76,000 (£315,000 loss
before exceptional credit).
Since last year's results the Group has successfully evolved to the next stage
of its development. Group fee sales have grown by 34%, the management team has
been strengthened and staff numbers have increased by nearly 50% through organic
growth and company acquisition. Pharmaceutical services remain a growth sector
in which changes in the regulatory environment have increased the demand for
regulatory services and know-how. Fulcrum has capitalised on this market
opportunity through the successful acquisition of Quadramed Limited
('Quadramed'), a regulatory services company based in the UK. The enhanced
performance of this company since acquisition has confirmed the strategic fit of
these services with Fulcrum's evolving business model.
Financial Results
The Group made a profit before tax of £154,000 (2005: loss of £76,000).
Amortisation relating to the acquisition of Quadramed was £51,000. The retained
profit for the year was £142,000 (2005: loss £89,000) and the basic earnings per
share was 0.12p (2005: loss per share 0.07p).
Fee sales increased by 34% to £8.3m (2005: £6.2m). Net operating costs,
excluding exceptional credits, were £3.9m compared to £3.0m last year. The
exceptional credit in the prior year of £239,000 represented income from the
surrender of the lease on the UK office less the cost associated with relocation
to new premises. The balance sheet remains strong with net funds at 31 August
2006 of £1.9m (2005: £1.5m).
Operating Review
Commercial, Sales and Business Development
Over the past year Fulcrum has grown in size and increased the range of services
it offers the pharmaceutical industry. Fee sales have increased in the full year
by 34% and in the second half sales were £4.6m compared to £3.7m in the first
half year. The Group has concentrated on strengthening the Fulcrum brand and has
sponsored and presented at major biotechnology and partnering conferences in the
US, Europe and Japan such as BIO 2006, BECIF, ASCO, DIA and Bio Business. Net
operating costs have increased, reflecting investment in the scale up of the
business, recruitment of staff and associated infrastructure. The Group is
increasing sales and marketing resource to capitalise on its expanded
operational capacity.
Establishing long term business relationships
Fulcrum has developed frameworks to manage long term strategic outsourcing
relationships with clients. This enables Fulcrum to grow client accounts,
improve productivity and mitigate risk. Fulcrum continues to provide expertise
and support to Medicines for Malaria Venture ('MMV'), including for the
development of the pyronaridine artesunate combination for treating acute
uncomplicated malaria. The latter project was nominated as MMV Project of the
Year 2005. In April 2006, long term business relationships were announced with
Celtic Pharma Development Services Bermuda Limited ('Celtic Pharma') and
NanoCarrier Co. Limited ('NanoCarrier'). Celtic Pharma is a leading global
private equity firm focused on pharmaceutical and biotechnology products.
NanoCarrier is a Japanese biotechnology company. Both relationships are expected
to deliver significant revenue over the next three years. Fulcrum also continues
to support the delivery of the Addex Pharmaceuticals SA ('Addex') portfolio of
products. Addex successfully achieved a further round of funding in August 2006.
Regional Performance
Pharmaceutical regulatory services are integral to all parts of Fulcrum's
business in Europe, US and Japan. Following the acquisition of Quadramed, the
Group has focused on growing regulatory services and products including late
stage electronic submissions. In tandem the management team has been
strengthened by new leadership appointments in Europe, US and Regulatory
Services.
Europe
Fee sales in Europe have strengthened throughout the year, and, excluding the
contribution from Quadramed, have increased by 38% over the previous year. To
enable the company to execute the additional work, there has been investment,
particularly in the second half of the year, in the recruitment of staff,
expansion into new office premises in Strasbourg and the opening of a new office
in Edinburgh. Under the leadership of the recently appointed General Manager for
Europe, Sarah Arbe-Barnes, it is planned that the sales team will be further
strengthened. The relocation of the UK office in Hemel Hempstead, which was
planned to take place in mid December 2005, had to be postponed following the
explosion at the Buncefield Oil Depot. The relocation is expected to take place
in December 2006 and the original foreseen savings can then be achieved.
US
Fee sales in the US fell by 11% where the sales performance in the second half
has been disappointing. Overall this position has been mitigated by the US
providing key resources to support European contracts. A new General Manager,
John Seman, was appointed in October 2006 to lead the US business. The Group
remains committed to the strategy of delivering services globally and the
objective of achieving a significant proportion of its income from the US.
Japan
Under the leadership of Teruyoshi Okuda and Kiyoshi Fujimaru, fee sales from
Fulcrum's two Japanese companies have increased by 17%. The business model of a
specialist oncology clinical research organisation and regulatory group has
begun to develop into a sustainable, profitable business. During the period,
several Government funded contracts with academia have been won. In addition,
the continued investment in business development has generated £1.4m of fee
sales from Japanese clients for Fulcrum in Europe and US and begun to create fee
income for Fulcrum Regulatory Services.
Fulcrum Regulatory Services ('FRS')
FRS is based around the nucleus of Quadramed, acquired in February 2006. Phil
Birch has been recruited to grow the existing regulatory services, as well as
building a complementary regulatory compliance offering. Quadramed itself has
had a successful initial seven months of trading within the group and its fee
sales show a 39% increase over the same period last year. This improvement in
sales demonstrates the strategic fit of these services with Fulcrum's evolving
business model and the potential for synergy with the rest of the Group.
The acquisition of Quadramed enables the Group to focus on growing regulatory
services across the business, and to offer electronic submission capability for
regulatory documents. As the regulatory agencies, such as FDA and EMEA, are
moving to a position where they will only accept electronic submissions, this
capability gives Fulcrum a strong position in this changing market.
Management Incentives
It is proposed to introduce a long term incentive plan to align senior
management with future goals for profitability and growth. Full details will be
provided to shareholders for approval.
Board Changes
As announced last year, it remains the intention of the Company to further
strengthen the Board with more expertise within the service sector. Dr Angus
Bell joined the board in March 2006 as a non-executive director and Dr David
Clough, who had been a non-executive director since the company was listed on
AIM in 2000, retired in May 2006.
Future Strategy and Outlook
Following the return to profitability, the Group has refined the strategy set
out last year:
1. Grow the service business within the four business units and further develop
the global service model.
2. Increase scale, particularly in pharmaceutical regulatory affairs, through
acquisition and organic growth.
3. Grow the business and its profitability with -
• Expanded sales effort and business development.
• Developing long term client relationships.
• Focusing on growing the most profitable, highest demand elements of
Fulcrum's services
The historic factors of capital efficiency and improved productivity continue to
drive drug developers towards outsourcing.
Conclusion
Fulcrum continues to focus on building the business to a sufficient scale to
deliver sustainable profits and remains committed to growing services,
particularly in pharmaceutical regulatory affairs, both organically and by
acquisition.
Consolidated Profit & Loss Account for the year ended 31 August 2006
Year Ended Year Ended Year Year
31 August 31 August Ended Ended
31 August 31 August 31 August 31 August
2006 2006 2006 2005
Unaudited Unaudited Unaudited Audited
--------------------- ----- --------- -------- --------- --------
Continuing Acquisitions Total
--------------------- ----- operations -------- --------- --------
---------
Note £'000 £'000 £'000 £'000
--------------------- ----- --------- -------- --------- --------
Turnover 2 14,360 1,091 15,451 12,626
Cost of sales (10,818) (620) (11,438) (10,014)
--------------------- ----- --------- -------- --------- --------
Gross profit 3,542 471 4,013 2,612
Selling expenses (540) (23) (563) (654)
--------------------- ----- --------- -------- --------- --------
Administrative (3,084) (294) (3,378) (2,320)
expenses
Exceptional
administrative credit 3 - - - 239
--------------------- ----- --------- -------- --------- --------
Total administrative
expenses (3,084) (294) (3,378) (2,081)
--------------------- ----- --------- -------- --------- --------
Other operating 65 - 65 -
income ----- --------- -------- --------- --------
---------------------
Operating profit/ (17) 154 137 (123)
(loss)
Interest receivable
and 59 56
similar income
Interest payable and
similar charges (42) (9)
--------------------- ----- --------- -------- --------- --------
Profit/(loss) on
ordinary
activities before 154 (76)
taxation
Tax on profit/(loss)
on 4 (12) (13)
ordinary activities ----- --------- -------- --------- --------
---------------------
Profit/(loss)for the
financial year 142 (89)
--------------------- ----- --------- -------- --------- --------
Earnings per share
(pence) 5
Basic 0.12p (0.07p)
Diluted 0.10p (0.07p)
Adjusted basic 0.12p (0.23p)
Statement of Total Group Recognised Gains and Losses for the year ended 31
August 2006
2006 2005
£'000 £'000
Unaudited Audited
-------- ---------
Profit/(loss) on ordinary activities after taxation 142 (89)
Exchange adjustments offset in reserves (27) (8)
------------------------------- -------- ---------
Total recognised gains and losses since last annual
report 115 (97)
------------------------------- -------- ---------
Consolidated Balance Sheet as at 31 August 2006
-------- -------
2006 2005
Unaudited Audited
£'000 £'000
-------- -------
Fixed assets
Intangible assets 1,216 -
Tangible assets 552 460
Investments 469 172
------------------------------ -------- -------
2,237 632
-------- -------
Current assets
Debtors 3,657 3,335
Short term investments 524 1,193
Cash at bank and in hand 1,571 678
------------------------------ -------- -------
5,752 5,206
Creditors: amounts falling due within one year (3,997) (2,481)
------------------------------ -------- -------
Net current assets 1,755 2,725
------------------------------ -------- -------
Total assets less current liabilities 3,992 3,357
Creditors: amounts falling due after more than
one (422) (31)
year -------- -------
------------------------------
Net assets 3,570 3,326
------------------------------ -------- -------
Capital and reserves
Called up share capital 6 1,285 1,219
Share premium account 6 4,547 4,370
Merger reserve 6 (454) (454)
Profit and loss account 6 (1,808) (1,809)
------------------------------ -------- -------- -------
Equity shareholders' funds 3,570 3,326
------------------------------ -------- -------- -------
Consolidated Cash Flow Statement for the year ended 31 August 2006
-------- -------- --------
Note 2006 2005
-------- -------- --------
£'000 £'000
Unaudited Audited
-------- -------- --------
Net cash inflow/(outflow) from operating 7 795 (493)
activities -------- -------- --------
------------------------------
Returns on investment and servicing of finance
Interest received 59 56
Interest paid (42) (9)
------------------------------ -------- -------- --------
Net cash inflow from returns on investments and
servicing of finance 17 47
------------------------------ -------- -------- --------
Taxation
Corporation tax paid (72) (3)
------------------------------ -------- -------- --------
Capital expenditure and financial investment
Purchase of own shares for employee share options
and (114) (29)
awards
Purchase of equity investments (297) (87)
Purchase of tangible fixed assets (310) (69)
------------------------------ -------- -------- --------
Net cash outflow from capital expenditure and
financial investment (721) (185)
------------------------------ -------- -------- --------
Acquisitions & disposals
Purchase of subsidiary undertakings (including (123) -
costs)
Cash acquired with subsidiary 445 -
------------------------------ -------- -------- --------
Net cash inflow from acquisitions and disposals 322
------------------------------ -------- -------- --------
Net cash inflow/(outflow) before management of
liquid 341 (634)
resources and financing -------- -------- --------
------------------------------
Management of liquid resources
Decrease in short term investments 669 230
------------------------------ -------- -------- --------
Financing
Increase in borrowings - 100
Capital element of finance lease payments (30) (37)
Bank loan repayments (87) (26)
------------------------------ -------- -------- --------
Net cash (outflow)/inflow from financing (117) 37
------------------------------ -------- -------- --------
Increase/(decrease) in cash 7 893 (367)
------------------------------ -------- -------- --------
Reconciliation of net cash flow to movement in net funds
-------- -------- --------
Note 2006 2005
£'000 £'000
Unaudited Audited
-------- -------- --------
Increase/(decrease) in cash 893 (367)
Decrease/(increase) in bank loans 87 (74)
Bank loan acquired with subsidiary (11) -
Decrease in short term investments (669) (230)
Decrease in finance leases 30 37
Other non-cash movements - (7)
------------------------------ -------- -------- --------
Change in net funds from cash flows 330 (641)
Net funds at 1 September 1,538 2,179
------------------------------ -------- -------- --------
Net funds at 31 August 7 1,868 1,538
------------------------------ -------- -------- --------
1 Financial Information
The results for the year ended 31 August 2006 are unaudited and do not
constitute statutory accounts within the meaning of section 240 of the Companies
Act 1985. They have been drawn up using accounting policies and principles
consistent with those applied in the preparation of the audited accounts for the
year ended 31 August 2005. The comparative information contained in the report
for the year ended 31 August 2005 does not constitute the statutory accounts for
the financial period. Those accounts have been reported on by the Company's
Auditors, PricewaterhouseCoopers LLP, and delivered to the Registrar of
Companies. The report of the Auditors was unqualified and did not contain a
statement under section 237(2) or (3) of the Companies Act.
2 Turnover
Turnover represents sales to third parties including fee income and pass through
costs.
Geographical analysis by origin
2006 2005
£'000 £'000
Unaudited Audited
-------- --------
Europe 5,162 3,082
USA 1,349 1,524
Japan 1,831 1,571
------------------------------------ -------- --------
Total fee sales 8,342 6,177
Pass through costs 7,109 6,449
------------------------------------ -------- --------
Turnover 15,451 12,626
------------------------------------ -------- --------
Geographical analysis by destination
2006 2005
£'000 £'000
Unaudited Audited
-------- --------
United Kingdom 2,184 3,245
Rest of Europe 4,669 3,290
North America 4,136 3,380
Japan 4,044 2,698
Rest of the World 418 13
------------------------------------ -------- --------
Turnover 15,451 12,626
------------------------------------ -------- --------
3 Exceptional item
The exceptional item in 2005 represents the income from the surrender of the
lease on the UK office less the costs associated with the relocation to new
premises.
2006 2005
£'000 £'000
-------- --------
Profit/(loss) on ordinary activities before taxation 154 (76)
Exceptional administrative credit - (239)
------------------------------------ -------- --------
Profit/(loss) on ordinary activities before taxation and
exceptional items 154 (315)
------------------------------------ -------- --------
4 Tax on profit/(loss) on ordinary activities
2006 2005
£'000 £'000
Unaudited Audited
-------- --------
UK taxation
UK corporation tax at 30% 10 -
------------------------------------ -------- --------
Overseas taxation 2 13
Corporation taxes
------------------------------------ -------- --------
Total current taxation 12 13
------------------------------------ -------- --------
Tax on profit/(loss) on ordinary activities 12 13
------------------------------------ -------- --------
5 Earnings/(loss) per share
2006 2005
Unaudited Audited
-------- --------
Basic earnings/(loss) per share 0.12p (0.07)p
Adjustment for exceptional credit - (0.16)p
------------------------------------ -------- --------
Adjusted earnings/(loss) per share 0.12p (0.23)p
Diluted earnings/(loss) per share 0.10p (0.07)p
------------------------------------ -------- --------
2006 2005
-------------------- -------------------
Profit Profit
before before
exceptional Exceptional exceptional Exceptional
items items Total items items Total
£'000 £'000 £'000 £'000 £'000 £'000
Unaudited Unaudited Unaudited Audited Audited Audited
----------- -------- -------- -------- -------- -------- -------
Profit/
(loss)
before 154 - 154 (315) 239 (76)
taxation
Tax on
profit/ (12) - (12) 35 (48) (13)
(loss) -------- -------- -------- -------- -------- -------
-----------
Profit/
(loss) 142 - 142 (280) 191 (89)
after -------- -------- -------- -------- -------- -------
taxation
-----------
5 Earnings/(loss) per share continued
2006 2005
Number Number
Unaudited Audited
--------- ---------
Weighted average number of shares 125,478,759 121,185,914
Weighted average number of shares held by the
Employee Share Ownership Trust (2,013,839) (676,406)
--------------------------------- --------- ---------
Weighted average number of shares for basic
earnings per share 123,464,920 120,509,508
Number of share options 23,110,875 -
--------------------------------- --------- ---------
Weighted average number of shares for diluted EPS 146,575,795 120,509,508
--------------------------------- --------- ---------
The basic earnings per ordinary share is based on the Group's profit for the
year of £142,000 (2005: loss of £89,000) divided by the weighted average number
of ordinary shares in issue, excluding those shares held by the Employee Share
Ownership Trust ('ESOT').
Exceptional costs or credits charged or credited against operating profit and
exceptional tax charges or credits do not relate to the profitability of the
Group on an ongoing basis. Therefore an adjusted basic earnings/(loss) per
ordinary share is also presented.
6 Reconciliation of movements on reserves and shareholders'funds
Called
up Share Profit
share premium Merger and loss
capital account reserve account Total
£'000 £'000 £'000 £'000 £'000
----------------- ------- -------- -------- -------- --------
At 1 September
2005 1,219 4,370 (454) (1,809) 3,326
Retained
profit for
year - - - 142 142
Issue of
ordinary share 66 177 - - 243
Purchase of
own shares for
ESOT - - - (114) (114)
Unrealised
exchange loss
on
consolidation - - - (27) (27)
----------------- ------- -------- -------- -------- --------
At 31 August
2006 1,285 4,547 (454) (1,808) 3,570
----------------- ------- -------- -------- -------- --------
7 Notes to the consolidated cash flow statement
Reconciliation of the operating profit/(loss) to net cash inflow/(outflow) from
operating activities:
2006 2005
£'000 £'000
Unaudited Audited
-------- --------
Operating profit/(loss) 137 (123)
Amortisation 51 -
Depreciation 197 197
Shares compensation charge - 21
Loss on disposal of fixed assets 15 -
Exchange loss (13) (8)
(Increase)/decrease in debtors (216) 17
Increase/(decrease) in creditors 624 (597)
------------------------------------ -------- --------
Net cash inflow/(outflow) from operating activities 795 (493)
------------------------------------ -------- --------
Analysis of net funds
As at As at
1 September 31 August
2005 Cash flow Acquisitions 2006
£'000 £'000 £'000 £'000
Audited Unaudited Unaudited Unaudited
--------- --------- -------- --------
Cash at bank and in hand 678 448 445 1,571
Bank loan (270) 87 (11) (194)
Short term investment 1,193 (669) - 524
Finance lease (63) 30 - (33)
--------------------- --------- --------- -------- --------
1,538 (104) 434 1,868
--------- --------- -------- --------
Major non -cash transactions
The only major non-cash transaction that occurred during the period was the
issue of 6,666,667 ordinary shares to satisfy part of the consideration on the
acquisition of Quadramed Limited. The details are set out in note 8.
8 Acquisition
On 8 February 2006, the Company acquired the entire issued share capital of
Quadramed Limited for an initial consideration of £1,090,000, of which £50,000
was paid in cash and £690,000 was paid by the issue of loan notes, £500,000 of
which are guaranteed, £250,000 was paid by the issue of 6,666,667 ordinary
shares of 1 pence each and £100,000 was paid in other consideration. Further
deferred consideration, based on the turnover of Quadramed Limited during the
first twelve months following completion of the acquisition, and estimated to be
£400,000, will be payable in convertible loan notes.
-----------------------------------------------
Book value and fair value of net assets
acquired in Quadramed Limited
£'000
-----------------------------------------------
Fixed assets 8
Debtors 165
Cash 445
Creditors - amounts falling due within one year (329)
------------------------------------ ---------
Net assets 289
------------------------------------ ---------
Consideration
------------------------------------ ---------
Cash consideration 50
Consideration in shares 250
Consideration in loan notes 690
Other consideration 100
Deferred consideration in convertible loan notes 400
Acquisition costs 66
------------------------------------ ---------
Total Consideration 1,556
------------------------------------ ---------
Capitalised goodwill 1,267
------------------------------------ ------- ---------
9 Copies of Annual Report
Copies of the Annual Report are being sent to the shareholders and will be
available to the public at the registered office of Fulcrum Pharma plc, 5th
Floor, Kodak House, Station Road, Hemel Hempstead, Hertfordshire, HP1 1JY.
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