RNS Number:7425P
PPL Therapeutics PLC
15 September 2003
Date: Embargoed until 07.00 am, Monday 15 September 2003
Contact: Geoff Cook, Chief Executive Officer
PPL Therapeutics plc
Telephone: 020 7796 4133 15 September
(and thereafter 0131 440 4777)
Alistair Mackinnon-Musson
Philip Dennis
Hudson Sandler
Telephone: 020 7796 4133
Email: ppl@hspr.co.uk
PPL Therapeutics plc
Interim Report and Accounts 2003
PPL Therapeutics plc ("PPL") is pleased to report on the six month period ended
30 June 2003.
UPDATE ON REVIEW OF OPTIONS/STRATEGY
On 18 June this year PPL and Bayer Biological Products ("Bayer") announced a
decision to put their recombinant Alpha-1-Antitrypsin (recAAT) development
programme on hold.
In light of this decision, PPL announced a major restructuring of its business.
This has been an on-going process reducing headcount from 161 prior to the Bayer
announcement to the current level of 55 which is consistent with preserving the
value of PPL's key assets. As a result cash burn will be reduced from #0.6m
per month to approximately #0.25m per month. Both figures are stated after
taking account of the benefit of the Group's R&D tax credit.
In parallel with the restructuring, the Board has had consultations with major
shareholders to explore the options available to the Company, namely: to
restructure as a business based around its Fibrin I technology and to bring in
complementary intellectual property to broaden the product portfolio; the
outright sale of the Company; or its winding up.
The Board believes that there is the potential for significant long-term value
to be created from the Fibrin I product as part of a broader sealants business.
Although the majority of PPL's major institutional shareholders were supportive
of the sealants plan, the required level of support to go forward was
insufficient. Hence, the Board is recommending an orderly sale of the business
in order to maximise the short-term value of its assets for the benefit of all
shareholders.
Board changes
Consequently, the restructuring of the business will continue together with the
downsizing of the Board. Chief Executive Geoff Cook, together with Product
Development Director Martyn Breeze, Manufacturing Director Gordon Wright and
Non-Executive directors Dr Arthur 'Hamish' Hale and Dr Roger Brimblecombe will
step down from the Board with immediate effect and the Executive directors will
be leaving the Company in due course.
The sales process will be handled by a Board comprising two Non-Executive
directors, Chris Greig (Chairman) and Hugh Thompson, together with two Executive
directors, Lindsay Dunsmuir, Chief Financial Officer and Adam Christie, Business
Development Director.
The Board has appointed KPMG Corporate Finance to assist it in this process.
REVIEW OF PRODUCTS
Fibrin I
PPL's Fibrin I has the potential to be a leading product amongst surgical
sealants and haemostats. These products are used to stop bleeding during surgery
or seal tissue such as lung in order to prevent fluid or air leaks. The current
generation of fibrin sealants has multiple active ingredients which have to be
mixed for up to twenty minutes before use. This is clearly not convenient for
surgeons, who ideally want a sealant that is ready to use whenever they need to
seal tissue or stop blood loss.
PPL's Fibrin I is based on a fibrin monomer which is applied directly to tissue
along with a neutralising buffer where it immediately polymerises to form a clot
and seal the tissue. PPL has developed a ready to use liquid formulation which
stability studies suggest will enable surgeons to store and use Fibrin I
directly from the refrigerator.
While this will be seen as the product's major advantage by end users,
preclinical data suggest that the healing process associated with the use of
Fibrin I may be more rapid and natural with less inflammatory response than is
seen with conventional fibrin sealants. These benefits may account for the
reduction in post surgical adhesions seen in the preclinical programme, which
could turn out to be a valuable property of Fibrin I if these observations are
validated in clinical studies.
On 19 June PPL announced that it had signed non-binding Heads of Agreement with
Instituto Grifols SA (a subsidiary of Probitas Pharma) to manufacture Fibrin I
using Grifols plasma derived fibrinogen. Grifols is one of the leading plasma
fractionators in the world, and a supplier of FDA approved products in the US,
with a fully GMP compliant manufacturing facility.
recAAT
recAAT was in development in collaboration with Bayer's Biological Products
Division to address the supply constraints that restrict the availability of
plasma derived AAT therapy to patients that could benefit from it. The product
was being developed for hereditary emphysema and cystic fibrosis.
Following the announcement on 18 June, Bayer and PPL are currently finalising
the detailed terms of the agreement necessary to put the project on hold while
preserving Bayer's right to restart the project at a later date.
PPL will have no development, manufacturing or financial commitments in the
programme. Both parties will retain their existing IP rights.
recBSSL
recBSSL is a unique product with the potential to treat a diverse range of
patients who have in common the fact that they cannot produce normal levels of
lipase, which leads to impaired digestion and absorption of fat. In the case of
cystic fibrosis patients or those with acute pancreatitis, the pancreas is
damaged and does not produce sufficient lipase. Inadequate fat digestion in
these patients leads to steathorrea (fatty stools), lack of absorption of
fat-soluble vitamins and weight loss.
Existing products can require patients to take large numbers of tablets (up to
50 per day) and may be associated with side effects, especially at high doses.
These side effects occur because the products are based upon extracts of porcine
pancreas which contain both lipases and proteases. The availability of a pure
recombinant source of human BSSL could mean a much-reduced dose and fewer side
effects, increasing patient acceptability and compliance.
Pre-term infants represent a further group of patients who could be helped by
recBSSL. Babies do not produce their own lipase for the first six months or so
of life and normally rely on maternal milk as their source. Pre-term babies
often do not receive maternal milk (or if they do it has been pasteurised which
destroys BSSL activity), so they suffer from fat malabsorption. In this patient
group the consequences may be more serious as fats are not only required to
support appropriate growth rates but also for normal neurological and other
development.
FINANCIAL REVIEW
Following the announcement in June 2003 of the decision to put the recAAT
project on hold, the Board announced a major restructuring of the Group,
implementation of which commenced at that time and is currently ongoing. The
profit and loss account for the period includes a Fundamental Restructuring cost
of #8.1m reflecting the write down of assets to realisable values and a
provision for redundancy costs and other liabilities resulting from the decision
to put the recAAT project on hold.
The decision taken in 2002 to spin out the Group's Regenerative Medicine
business (classified as Discontinued Operations) was concluded in April 2003
when PPL Therapeutics Inc was sold realising a gain on disposal of #0.2m.
Revenues for the half-year were #0.4m with operating expenses at #6.1m. After
taking into account the restructuring costs and disposal of PPL Therapeutics Inc
described above, the net loss for the period was #12.8m after net interest
received of #0.1m and provision for R&D tax credit of #0.7m. Administrative
expenses were #1.5m, a decrease of #0.3m over the comparable period last year.
The decrease in loss over the comparable period in 2002 (excluding the
restructuring costs and gain on disposal of PPL Therapeutics Inc) was #0.6m.
This decrease was largely due to the reduction in administrative expenses
referred to above, the Regenerative Medicine costs that were taken out of the
business by the closure of the UK stem cell business at the end of 2002 and by
the disposal of PPL Therapeutics Inc in April 2003 offset by a decrease in net
interest receivable of #0.2m and a reduction in the R & D tax credit receivable
of #0.2m.
Capital expenditure in the period was #0.1m, (2002: #0.2m).
Net cash outflow, before the use of liquid resources and financing, for the
period was #3.1m. This included #1.5m received in June 2003 in relation to
PPL's R&D tax credit for the year ended 31 December 2002. Cash and cash
equivalent balances as at 30 June 2003 were #11.4m.
The underlying trading cash outflows of the Group excluding the Regenerative
Medicine business disposed of and adjusting for the timing of R&D tax credit
cash receipts for the six months ended 30 June 2003 were #3.6m.
Net assets were #12.1m following the restructuring write-downs and provisions.
Current Trading Position
The cash and cash equivalents balance at 31 August 2003, the latest date to
which unaudited management accounts are available, was #9.3m. It is estimated
that following the completion of the restructuring, the monthly cash burn of the
Group will be reduced to slightly over #0.25m per month (after the impact of the
R&D tax credit).
PPL Therapeutics plc
Consolidated Profit & Loss Account
Six months ended Six months ended Year ended
30 June 2003 30 June 2002 31 December 2002
Contin- Dis- Contin- Dis- Contin- Dis-
uing continued uing continued uing continued
Operations Operations Total Operations Operations Total Operations Operations Total
#000 #000 #000 #000 #000 #000 #000 #000 #000
Turnover 22 - 22 134 - 134 182 46 228
Research and
development
costs (4,248) (342) (4,590) (4,660) (898) (5,558) (9,111) (1,591) (10,702)
Administrative
expenses (1,351) (129) (1,480) (1,551) (279) (1,830) (3,115) (528) (3,643)
Trading loss
before
exceptional
item (5,577) (471) (6,048) (6,077) (1,177) (7,254) (12,044) (2,073) (14,117)
Exceptional
item - - - - - - (7,531) - (7,531)
Trading loss
after
exceptional
item (5,577) (471) (6,048) (6,077) (1,177) (7,254) (19,575) (2,073) (21,648)
Other
operating
income 149 225 374 - 539 539 - 983 983
Operating loss (5,428) (246) (5,674) (6,077) (638) (6,715) (19,575) (1,090) (20,665)
Gain on sale
of subsidiary - 229 229 - - - - - -
Fundamental
restructuring (8,131) - (8,131) - - - - - -
Loss before
interest (13,599) (17) (13,576) (6,077) (638) (6,715) (19,575) (1,090) (20,665)
Interest receivable &
similar income 207 442 774
Interest payable &
similar charges (112) (116) (220)
Loss on ordinary
activities before tax (13,481) (6,389) (20,111)
Tax on loss on ordinary 671 870 1,520
activities
Retained for the period (12,810) (5,519) (18,591)
Loss per share
Basic & diluted (11)p (5)p (16)p
Statement of Total Recognised Gains and Losses
Six months ended Six months ended Year ended
30 June 2003 30 June 2002 31 December 2002
Total Total Total
#000 #000 #000
Retained loss for the (12,810) (5,519) (18,591)
period
Exchange differences
arising on consolidation 130 96 106
Total losses recognised
during the period (12,680) (5,423) (18,485)
PPL Therapeutics plc
Consolidated Balance Sheet
As at As at As at
30 June 2003 30 June 2002 31 December 2002
#000 #000 #000
Fixed assets
Tangible assets 4,740 13,314 11,924
Investments 625 - -
5,365 13,314 11,924
Current assets
Stock - 118 96
Debtors 1,196 9,267 2,700
Short term investments 10,334 19,698 13,932
Cash at bank and in hand 1,072 1,652 587
12,602 30,735 17,315
Creditors: amounts falling due within
one year (2,315) (3,603) (1,808)
Net current assets 10,287 27,132 15,507
Total assets less current liabilities 15,652 40,446 27,431
Creditors: amounts falling due after
more than one year (2,533) (2,680) (2,663)
13,119 37,766 24,768
Provision for liabilities and charges (1,031) - -
Net assets 12,088 37,766 24,768
Capital & reserves
Called up share capital 59,291 59,227 59,291
Share premium account 55,035 55,035 55,035
Capital reserve 7,028 7,028 7,028
Profit & loss account (109,266) (83,524) (96,586)
Shareholders' funds 12,088 37,766 24,768
PPL Therapeutics plc
Consolidated Cash Flow Statement
Six months ended Six months ended Year ended
30 June 2003 30 June 2002 31 December 2002
Contin- Dis- Contin- Dis- Contin- Dis-
uing continued uing continued uing continued
Operations Operations Total Operations Operations Total Operations Operations Total
#000 #000 #000 #000 #000 #000 #000 #000 #000
Reconciliation of operating loss to
net cash outflow from operating
activities
Loss before
interest (13,559) (17) (13,576) (6,077) (638) (6,715) (19,575) (1,090) (20,665)
Depreciation
charges 6,955 22 6,977 820 70 890 2,270 126 2,396
Gain on sale of
tangible assets (14) - (14) (12) - (12) (26) 1 (25)
Gain on sale of
subsidiary - (229) (229) - - - - - -
Decrease/
(increase) in
stock 91 5 96 (2) (2) (4) 15 3 18
Decrease/
(increase) in
debtors 413 92 505 (1,211) 11 (1,200) 6,068 (31) 6,037
Increase/
(decrease) in
creditors 759 (12) 747 1,716 63 1,779 (87) 142 55
Increase in
provisions 1,031 - 1,031 - - - - - -
Non cash
consideration
for sale of IP (312) - (312) - - - - - -
Net cash outflow
from operating
activities (4,636) (139) (4,775) (4,766) (496) (5,262) (11,335) (849) (12,184)
Cash flow statement
Net cash outflow from
operating activities (4,775) (5,262) (12,184)
Returns on investments and
servicing of finance 135 365 528
Taxation received 1,471 1,520 1,520
Capital expenditure (62) (175) (255)
Net cash from disposal of
subsidiary undertaking 150 - -
Cash outflow before use of
liquid resources and
financing (3,081) (3,552) (10,391)
Management of liquid
resources
Decrease in short term
deposits 3,598 4,323 10,089
Financing
Issue of ordinary shares - - 64
Repayment of loans (2) (3) (7)
Capital element of finance
lease and hire purchase
rentals (34) (61) (108)
Net cash outflow from
financing (36) (64) (51)
Increase/(decrease) in cash 481 707 (353)
Consolidated Cash Flow Statement - continued
Reconciliation of net
cash flow to movement
in net funds
Increase/(decrease) in
cash 481 707 (353)
Cash flow from movement
in debt and lease
financing 36 64 115
Cash flow from decrease
in liquid resources (3,958) (4,323) (10,089)
Change in net funds (3,081) (3,552) (10,327)
Loans and finance
leases disposed of with
subsidiary 157 - -
New finance leases and
hire purchase
agreements - (25) (66)
Translation differences (37) (35) (40)
Movement in net funds (2,961) (3,612) (10,433)
Net funds at beginning
of period 11,772 22,205 22,205
Net funds at end of
period 8,811 18,593 11,772
Basis of Preparation
The interim report was approved by the Board of Directors on 15 September 2003.
The interim report has been prepared on a basis consistent with the statutory
financial statements for the year to 31 December 2002.
The financial information contained in this report does not constitute statutory
accounts within the meaning of section 240 of the Companies Act 1985. It is
unaudited. Figures for the year ended 31 December 2002 are abridged and derived
from the full statutory accounts which carry an unqualified auditor's report and
which have been filed with the Registrar of Companies.
The Directors have considered the current cash flow projections and have a
reasonable expectation that the Company and the Group as a whole have adequate
resources to continue in operation for the foreseeable future. The interim
accounts have therefore been prepared on the going concern basis.
Segmental data in this statement is analysed as follows:
Continuing Operations comprise the sealants business (incorporating Fibrin 1)
which is based in the UK and the transgenics business (in the UK and New
Zealand).
Discontinued activities comprise the Company's US subsidiary, PPL Therapeutics
Inc, which was concerned with Regenerative Medicine and was disposed of in April
2003.
The Group is entitled to claim tax credits for certain research and development
expenditure. The amount shown of #671,000 (2002 - #870,000) is an estimate of
the tax credit receivable for the six months ended 30 June 2003 plus the
underprovision of the tax credit received for the year ended 31 December 2002.
The basic loss per ordinary share for the six months ended 30 June 2003 is based
on the loss after taxation of #12,810,000 (2002 - #5,519,000) and on the
weighted average number of ordinary shares in issue and ranking for dividend
during the period of 118,582,994 (2002 - 118,454,485).
Analysis of Changes in Net Funds
At beginning Cash flows Disposal of Exchange At end
of period #000 subsidiary movements of period
#000 #000 #000 #000
Cash at bank and in hand 587 481 - 4 1,072
Debt due within one year (7) 2 5 - -
Debt due after one year (2,578) - 143 (41) (2,476)
Finance lease and hire purchase
agreements (162) 34 9 - (119)
(2,747) 36 157 (41) (2,595)
Current asset investments 13,932 (3,598) - - 10,334
11,772 (3,081) 157 (37) 8,811
- Ends -
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