FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13s - 16 or 15d - 16 of
the Securities Exchange Act of 1934
For the month of November 2005
Acambis plc
(Translation of registrant's name into English)
Peterhouse Technology Park
100 Fulbourn Road
Cambridge CB1 9PT
England
(address of principal executive offices)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F
Forms 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information
contained in this Form also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934).
Yes No X
(if "Yes" is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g3-2(b): 82- ).
Enclosure:
3rd Quarter Results
Acambis announces third quarter results and hosts R&D Day
Cambridge, UK and Cambridge, Massachusetts - 15 November 2005 - Acambis plc ("
Acambis") (LSE: ACM, NASDAQ: ACAM) announces its results for the three and nine
months ended 30 September 2005, and hosts today a research and development (R&D)
day for analysts and investors.
Key points
R&D update
> ChimeriVax-JE
o Major milestone achieved as Phase III trials are initiated (see
separate announcement)
o Marketing and manufacturing agreement established with Bharat Biotech
to target key endemic market in India
> C. difficile: start of second Phase I trial imminent, first testing in
target population age group
> ChimeriVax-West Nile: preparations underway to enter Phase II trials before
year-end
> Pandemic influenza vaccine candidate undergoing pre-clinical development;
planning to enter Phase I testing within 18 months
> New research projects underway for vaccines against herpes simplex virus
and rhinovirus
Smallpox franchise:
> ACAM2000: pre-BLA meeting scheduled for 30 November
> MVA3000: submitted response to US Government Request for Proposals
o 500,000 doses shipped to Acambis from Baxter, transfer to the US
Government expected shortly
o Responses to Bavarian Nordic complaints submitted to Delaware District
Court and International Trade Commission
> C-VIG: Acambis instrumental in winning UK Government contract for Cangene
Key financials*
Three months ended 30 Nine months ended 30
September September
2005 2004 2005 2004
Revenue GBP4.6m GBP11.1m GBP17.0m GBP62.4m
(Loss)/profit before tax GBP(10.2)m GBP(4.3)m GBP(23.0)m GBP22.6m
(Loss)/earnings per share (10.3)p (2.8)p (18.8)p 14.1p
(Loss)/earnings per ADR $(0.36) $(0.10) $(0.67) $0.51
Cash GBP73.5m GBP115.0m GBP73.5m GBP115.0m
* Prepared under the Group's accounting policies based on International
Financial Reporting Standards
Gordon Cameron, Chief Executive Officer of Acambis, said:
"Our main focus throughout 2005 has been on investing to drive forward our
product pipeline, the principal asset for generating long-term value in Acambis.
By the end of this year, we will have made visible progress in all our
proprietary programmes, moving each into the next stage of development, as well
as initiating a number of very interesting new research projects into vaccines
against pandemic influenza, herpes simplex virus and rhinovirus. We are
particularly pleased to announce today a major milestone for our lead
proprietary product, our ChimeriVax-JE vaccine against Japanese encephalitis,
with the initiation of its pivotal Phase III trials."
Chairman's statement
OVERVIEW
Today, we are holding an R&D Day to update and inform investors and analysts
about our key programmes and our strategy for building our pipeline.
Our pipeline is our principal asset for generating long-term value in Acambis. I
am particularly pleased, therefore, to announce that we have initiated pivotal
Phase III trials of our lead proprietary product, ChimeriVax-JE, a vaccine
against Japanese encephalitis (JE). Investing to drive forward our pipeline has
been a key focus for 2005 and today's news represents a major milestone for the
project and the technology.
By the end of 2005 we will have made visible progress in all our proprietary
programmes, moving each into the next stage of development. In addition to
moving ChimeriVax-JE into Phase III, we are preparing to initiate the second
Phase I trial of our C. difficile vaccine, testing for safety and immunogenicity
in the target age population. Preparations are also ongoing to start Phase II
testing of ChimeriVax-West Nile before the end of the year and sanofi pasteur is
now conducting a further trial of ChimeriVax-Dengue. In addition, we have
initiated a number of very interesting new research projects into vaccines
against pandemic influenza, herpes simplex virus and rhinovirus, which gives us
a broad and balanced mix of early- and late-stage programmes in our pipeline.
We have also made progress in the revenue-generating areas of our business,
which we aim to maximise as sources of funding for investment in our pipeline.
Sales of the oral typhoid vaccine, Vivotif, performed beyond expectations in the
third quarter, as in the previous two quarters. We are also continuing to target
two key revenue-generating opportunities for 2006: US Government contracts for
MVA3000 and warm-base manufacturing of ACAM2000.
R&D DAY UPDATE
The focus of our R&D Day will be our three principal proprietary development
projects: ChimeriVax-JE, ChimeriVax-West Nile, and C. difficile. In addition,
our Chief Scientific Officer, Dr Thomas Monath, will and provide a summary of
our pre-clinical influenza programme and other new research projects.
ChimeriVax-JE
Since our last update in September, we have made significant progress with this
key project in terms of both clinical development and our commercialisation
strategy.
In a separate news release issued today, we have announced the start of Phase
lll testing of a single-dose regimen of ChimeriVax-JE in large-scale,
multi-centre trials in Australia and the US. Under the two trials, we will test
safety and efficacy in more than 2,800 subjects. The efficacy trial aims to
demonstrate non-inferiority to JE-VAX(R), a licensed JE vaccine, and the safety
trial will compare ChimeriVax-JE with placebo. ChimeriVax-JE is our most
advanced product developed using our proprietary ChimeriVax technology and the
start of advanced clinical testing of ChimeriVax-JE marks a major step forward
for both the project and the technology.
On the commercial front, on 8 November we announced that we have established a
marketing and manufacturing agreement with a leading Indian biopharmaceutical
company, Bharat Biotech International Limited (Bharat Biotech). We have
identified India, where this seasonal epidemic disease appears every year, as
one of the principal markets for a JE vaccine. At the present time, an epidemic
continues to affect areas of northern India and Nepal, where more than 1,000
people have died since July, most of them children. Under the terms of the
agreement, Bharat Biotech will undertake end-stage fill/finish processing of
ChimeriVax-JE at its facilities in India and, once the product is approved, will
market and distribute the vaccine in India and neighbouring countries. We are
also pursuing partnerships to target other endemic countries and the travellers'
market.
The JE virus causes disease in many parts of Asia, resulting in a reported
50,000 cases and 15,000 deaths each year1. Although first-generation vaccines
have been available for more than 60 years, both the World Health Organization's
Initiative for Vaccine Research and the Gates Foundation have identified a need
for development of a second-generation, affordable JE vaccine that has an
acceptable safety profile and requires fewer doses than currently available
vaccines. The introduction of a single-dose vaccine could potentially transform
the use of vaccines against JE by making it simpler, faster, easier and cheaper
for healthcare providers to administer, particularly in regions where achieving
compliance to multi-dose regimens can be difficult.
There are two segments to the JE market: travellers/military; and populations
living in the endemic region encompassing most of Asia, some Pacific Islands and
northern Australia. We are planning to conduct paediatric clinical trials in
India in parallel with the Phase III trials already initiated in Australia and
the US, building on a database of more than 500 ChimeriVax-JE-vaccinated adult
subjects collated from our previous Phase I and Phase II trials. We are
targeting licence applications for both the endemic and travel markets in the
first half of 2007.
In developing ChimeriVax-JE, we are aiming to address the unmet need for a safe
and effective single-dose JE vaccine. Whilst there are other JE products in
clinical development or being marketed, the data already collected give us great
confidence that ChimeriVax-JE will meet that preferred profile and be a highly
competitive product.
ChimeriVax-West Nile
The 2005 West Nile virus season is continuing in the US and current case counts
suggest that the level of disease this year is likely to be greater than in
2004. The primary target population for a West Nile vaccine is those aged 50
years and above, as they are more vulnerable to severe disease than other age
groups.
We are currently preparing to enter the next stage of our ChimeriVax-West Nile
development programme with the start of a Phase II clinical trial using vaccine
that has been manufactured by Acambis. During this stage, we aim to expand the
dose-ranging that was begun in the Phase I trial and, for the first time, to
explore the immunogenicity and tolerability of the vaccine in elderly subjects,
who are the primary target population for this vaccine. We continue to have the
most advanced programme to develop a vaccine against West Nile and are the only
company, to date, to have published data from a human clinical trial.
C. difficile
C. difficile is a major cause of hospital infections in many areas of the
developed world including the US, Canada, Europe and Australia. Before 2005, few
people outside of the medical profession had heard of Clostridium difficile (C.
difficile). The recent epidemic in Quebec, and then the numerous outbreaks
reported in the UK, caused public concern and intense media coverage.
Several companies are focusing their efforts on treating the disease using novel
antibiotics or various approaches to neutralise the toxins produced by C.
difficile, but we have long recognised the opportunity for a preventative
vaccine targeting "at risk" populations, including patients with relapsing
disease.
In July, we initiated a Phase I trial of our investigational C. difficile
vaccine in healthy adults. Following the FDA's review of preliminary safety data
from that trial, we shall shortly be initiating a second Phase I trial, which
will be conducted in healthy adults in the target population age range, i.e.,
those aged 65 years and above. Data from both trials will be available in 2006.
In the US, there are now more than 360,000 cases of C. difficile-associated
disease a year. In the UK in 2004, the number of cases reported by the Health
Protection Agency had increased by more than 25% over 2003 to 44,000, making C.
difficile a greater healthcare problem than the better-known MRSA, for which
15,000 cases were reported in the UK in 2004.
The increase in the UK reflects improved reporting but may also result from the
emergence of a more virulent strain of C. difficile. In its 24 September 2005
edition, The Lancet published a fast-track paper written by Acambis' C.
difficile Project Leader, Michel Warny PhD, and representatives of the US
Centers for Disease Control and Prevention (CDC), Quebec's University of
Sherbrooke, and the UK's Anaerobe Reference Laboratory. It highlighted that a C.
difficile strain (NAP1/027) capable of producing up to 23 times as many
disease-causing toxins as the normal strain is associated with recent outbreaks
in both North America and Europe. In addition, this new strain appears more
virulent since the largest outbreak investigated in this study was associated
with more severe disease and a higher fatality rate. This strain, which was
found in several outbreaks in the UK, challenges the medical community's ability
to control C. difficile infections.
ChimeriVax-Dengue
We are pleased to report that sanofi pasteur, to whom we have licensed worldwide
rights to the ChimeriVax-Dengue vaccine, is continuing development with the next
clinical trial of the vaccine. SP is now responsible for continued development
work, following completion of our Phase I tetravalent trial earlier in the year.
Influenza
The threat of an influenza pandemic has been the focus of much media coverage in
recent months and governments around the world are preparing their response. In
the US, President Bush announced in October that he had requested from Congress
$7.1bn of emergency funding for a pandemic programme, including $1.2bn for a
stockpile of bird flu virus vaccine, $1bn for anti-viral drugs and a further
$2.8bn for accelerated development of new influenza vaccine technology.
As part of our influenza programme, we are exploring development of a potential
pandemic vaccine using technology we acquired earlier in 2005. Our vaccine
candidate targets "A" strains of the influenza virus; all three pandemics of the
20th century were caused by "A" strains.
A major component of the new candidate is M2e, the extracellular domain of the
ion channel protein M2, which is specific to influenza A. Being highly
conserved, M2e is intended to elicit protective immune responses against all
strains of influenza A, which would suit governments' needs for stockpiling of
vaccine in advance of an outbreak. Our vaccine candidate is currently in
pre-clinical development and we plan to enter the clinic within 18 months.
Through a research collaboration with VIB, a Belgian research institute, we are
also developing a 'universal' vaccine candidate that would protect against both
A and B strains of influenza and, in contrast with current vaccines, would not
require annual changes to the formulation.
Research programmes
During the year, we have also initiated two research programmes to develop
vaccines against the Herpes Simplex Virus, cause of genital herpes, and
rhinovirus, which can cause asthma attacks and chronic lung disease, as well as
the common cold.
SMALLPOX VACCINE FRANCHISE UPDATE
MVA3000
On 3 October, we submitted to the US Department of Health and Human Services
(HHS) our response to its Request for Proposals (RFP) for the manufacture and
delivery of 20 million doses of Modified Vaccinia Ankara (MVA) attenuated
smallpox vaccine. This is the third in a series of MVA-related RFPs issued by
HHS and Acambis has been awarded contracts under both of the previous two RFPs.
We are co-developing our MVA vaccine candidate, MVA3000, with our partner,
Baxter Healthcare SA (Baxter).
Under this RFP, the US Government also requires advanced clinical testing, up to
and including obtaining a product licence, and has included options for the
purchase of up to 60 million additional doses and "warm-base" manufacturing over
the longer term. The RFP indicates that contract awards are expected to be made
in February 2006.
Work to deliver the 500,000 doses required under our second MVA contract with
the US Government is largely complete. We have completed release testing, the
doses have been shipped from our partner, Baxter, to Acambis and we expect to
transfer them to the US Government shortly. We also plan to initiate a clinical
trial in HIV infected subjects around the end of the year and in patients with
atopic dermatitis early in 2006.
In August, complaints were filed against Acambis by Bavarian Nordic with the
International Trade Commission (ITC) and the Delaware District Court. In
September, the ITC's process to consider the case was initiated when it
announced its decision to institute an investigation. In its statement, the ITC
commented: "By instituting this investigation, the ITC has not yet made any
decision on the merits of the case". We filed our response to the Delaware
complaint on 8 September and to the ITC complaint on 19 October. We currently
expect the ITC case to be heard by the end of 2006.
We maintain our view that we do not expect either case to impact HHS's timeline
for, nor the chances of Acambis participating in, the award of contracts in
February 2006 under the current RFP3. We continue to believe that Bavarian
Nordic's claims are without foundation and are defending our position
vigorously.
ACAM2000
We will shortly be meeting with the US Food and Drug Administration (FDA) to
discuss the dossier of ACAM2000 information we are compiling to submit under a
Biologics License Application (BLA). We aim to be in a position to start
submitting the first part of the "rolling" BLA, under the fast-track status
accorded to the programme, before the end of the year.
We continue to update the CDC on our progress towards this significant milestone
and to discuss provision of warm-base manufacturing to provide the US with
ongoing surge capacity in smallpox vaccine production.
Throughout 2005, we have continued to discuss with other governments their
requirements for stockpiling of emergency-use doses of smallpox vaccine and have
identified a number of ongoing opportunities. Based on current discussions,
however, and given the current international focus on the threat of pandemic
influenza, we do not expect to make significant sales in 2005. In several cases,
countries have indicated to us that they will await the outcome of the US
product licence application process before proceeding with their procurement
decisions. We believe that licensure of ACAM2000 would facilitate sales for
countries outside of the US who are considering stockpile options.
C-VIG
Cangene Corporation (Cangene) has been awarded a contract in September by the UK
Department of Health for doses of its Vaccinia Immune Globulin product (VIG),
C-VIG. The contract was worth C$17m, and as sales agent to Cangene, we receive a
royalty on the sales achieved under the contract.
This is the first major VIG contract awarded to Cangene outside North America.
C-VIG is used to treat some of the potential, serious adverse reactions that may
arise as a result of smallpox vaccination and is an important complementary
product to stockpiles of smallpox vaccine.
Vivotif(R)
Sales of Vivotif, the oral typhoid vaccine marketed and distributed in North
America by our subsidiary, Berna Products, continue to be ahead of the
equivalent period from the previous year. To date, 2005 sales of Vivotif have
consistently out-performed last year's, primarily as a result of Berna Products'
being able to capitalise on the competitor product being off the market for part
of the year. The competitor product has now begun to return to the market.
ARILVAX(TM)
We are continuing to seek to resolve with Chiron a suitable way forward for the
ARILVAX programme. With the recent announcement that Chiron is being acquired by
Novartis, we do not now expect resolution before the end of 2005 but will be
aggressively pursuing this in early 2006.
FINANCIAL REVIEW
The financial results, prepared under the Group's accounting policies based on
International Financial Reporting Standards, for the three months ended 30
September 2005 ("Q3") are presented below. The narrative reflects a comparison
of our activities in 2005 and 2004, and, unless otherwise stated, the
comparative figures in parentheses relate to the equivalent period in 2004.
Trading results
Revenue for Q3 was GBP4.6m (2004 - GBP11.1m). The main sources of revenue were
from our two contracts with the US National Institute of Allergy and Infectious
Disease for MVA3000, our fixed-price 155 million-dose smallpox contract with the
CDC, and product sales of Vivotif. Revenues from the CDC contract were lower in
2005 as the majority of work under this contract has already been completed; the
remaining activities are focused on work required for the BLA submission.
Cost of sales in Q3 amounted to GBP5.4m (2004 - GBP7.0m), the decrease being
attributable in the most part to the lower level of activity required on the 155
million-dose ACAM2000 contract with the CDC. This includes a provision of
GBP1.5m we made in Q3 with respect to some ACAM2000 inventory that had fallen
below specified potency levels. We continue to expense certain of the costs
relating to the manufacturing facility to R&D costs as a result of utilisation
of the facility for process development and manufacturing work for our R&D
programmes.
Expenditure on R&D in Q3 was GBP8.6m (2004 - GBP7.8m). Costs increased in Q3 as
we started incurring expenditure for the ChimeriVax-JE Phase III clinical trials
and are expected to be slightly higher in the fourth quarter, principally as a
result of the number of clinical trials we are planning to undertake in that
period and operational expenses relating to our Rockville fill/finish facility.
Sales and marketing costs in Q3 were GBP0.7m (2004 - GBP0.8m). Administrative
costs were GBP0.7m (2004 - GBP0.7m). Finance income in Q3 was GBP1.0m (2004 -
GBP1.2m). We currently assessing the cost of the MVA litigation referenced
above.
The pre-tax loss for Q3 was GBP10.2m (2004 - GBP4.3m). The change compared with
2004 principally resulted from a reduced gross margin and higher R&D
expenditure.
During Q3, the Group recorded a tax charge of GBP0.9m (2004 - credit of
GBP1.3m). Having reviewed our full-year tax planning, the effective tax rate for
the nine months to 30 September 2005 was 12.2% (nine months to 30 September
2004 - 34.1%), which resulted in a tax charge in the period.
Capital expenditure and financial investment
Capital expenditure for Q3 was GBP0.4m (2004 - GBP1.4m), principally relating to
the redevelopment of our US R&D facility.
Balance sheet highlights
i) Cash
Cash and liquid investments of the Group at 30 September 2005 amounted to
GBP73.5m (30 September 2004 - GBP115.0m, 31 December 2004 - GBP101.8m). The
decrease in cash in the first nine months of 2005 resulted primarily from the
ongoing operational expenditures of the Group and is in line with management's
expectations.
ii) Inventory
Inventory held at 30 September 2005 amounted to GBP3.7m (30 September 2004 -
GBP10.9m, 31 December 2004 - GBP6.0m). Inventory principally represents
work-in-progress and finished goods in relation to our ACAM2000 and Vivotif
vaccines.
iii) Current liabilities: amounts falling due within one year
Current liabilities reduced to GBP34.5m at 30 September 2005 (30 September
2004 - GBP64.1m, 31 December 2004 - GBP47.6m). A large proportion of this
balance continues to relate to accruals and deferred income arising under the
155 million-dose ACAM2000 contract with the CDC. At 30 September 2005, deferred
income relating to this contract was GBP10.7m (30 September 2004 - GBP25.9m, 31
December 2004 - GBP16.5m). This deferred revenue balance will continue to unwind
during 2005 and 2006 as BLA activities progress.
iv) Short-term borrowings and financial liabilities
The combined balance on our US dollar-denominated financing facilities reduced
in the period to 30 September 2005 to GBP13.4m (30 September 2004 - GBP14.9m, 31
December 2004 - GBP13.0m) as a result of the lease-financing facility continuing
to be repaid. The balance on this facility was GBP7.8m at 30 September 2005 (30
September 2004 - GBP11.0m, 31 December 2004 - GBP9.4m). The balance on the
overdraft facility at 30 September 2005 was GBP4.0m (30 September 2004 -
GBP3.9m, 31 December 2004 - GBP3.6m), the increase being attributable to
exchange rate movements in the period. The remaining balance of GBP1.6m at 30
September 2005 (30 September 2004 - GBPnil, 31 December 2004 - GBPnil) relates
to the discounted value of the future payments for the fill/finish facility
acquired earlier in 2005, payable between 2006 and 2017.
OUTLOOK
In September, at the time of our interim results announcement, we indicated that
our revenues for 2005 from predictable sources, such as our existing ACAM2000
and MVA3000 contracts, and sales of Vivotif(R), were expected to be around
GBP40m and that revenues from less predictable sources were not being included
in full-year guidance. We maintain that guidance. Revenues for the nine months
to 30 September 2005 were GBP17m. We expect to achieve a commensurately higher
level of revenue in the final quarter of the year, subject to achieving planned
milestones on our ACAM2000 and MVA3000 programmes.
References
1. World Health Organization, 2002
Enquiries:
A conference call for analysts will be held today (Tuesday, 15 November) at 9.30
am GMT. For details, contact Mo Noonan at Financial Dynamics on telephone number
+44 (0) 20 7269 7116. An instant replay of the call will be available until 15
December 2005 on telephone number UK: +44 (0) 20 7784 1024 and US: +1 718 354
1112. The pin code is 1030742#. A video webcast of the call will also be
available via Acambis' website at www.acambis.com. The webcast replay will be
available for 12 months until 15 November 2006.
Acambis plc
Gordon Cameron, Chief Executive Officer
David Lawrence, Chief Financial Officer
Lyndsay Wright, VP, Communications and Investor Relations
Tel: +44 (0) 1223 275 300
Financial Dynamics
David Yates/Davina Langdale
Tel: +44 (0) 20 7831 3113
About Acambis
Acambis is a leading developer of vaccines to prevent and treat infectious
diseases. Recognised internationally as the leading producer of smallpox
vaccines, Acambis is developing an investigational smallpox vaccine, ACAM2000,
and is manufacturing emergency-use stockpiles of this investigational vaccine
for the US Government and other governments around the world. It is also
developing an attenuated smallpox vaccine, MVA3000, under contracts with the US
National Institutes of Health. Acambis is establishing a travel vaccines
franchise through its US-based subsidiary Berna Products Corporation, which
markets Vivotif(R), the world's only licensed oral typhoid vaccine, in North
America. Acambis has other potential travel vaccines in development and is also
developing an investigational vaccine against the West Nile virus, which has
spread to 48 US States in the last six years.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US. Its primary
listing is on the London Stock Exchange (ACM) and its shares are listed in the
form of American Depositary Receipts on NASDAQ (ACAM). More information is
available at www.acambis.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995:
The statements in this news release that are not historical facts are
forward-looking statements that involve risks and uncertainties, including the
timing and results of clinical trials, product development, manufacturing and
commercialisation risks, the risks of satisfying the regulatory approval process
in a timely manner, the need for and the availability of additional capital. For
a discussion of these and other risks and uncertainties see "Risk management" in
the Company's 2004 Annual Report and "Risk factors" in its Form 20-F, in
addition to those detailed on the Company's website and in the Company's filings
made with the Securities and Exchange Commission from time to time. These
forward-looking statements are based on estimates and assumptions made by the
management of Acambis and are believed to be reasonable, though are inherently
uncertain and difficult to predict. Actual results or experience could differ
materially from the forward-looking statements.
Results for the three and nine months ended 30 September 2005
Group income statement
Three months Three months Nine months Nine months Year
ended ended ended ended ended
30 September 30 September 30 September 30 September 31 December
2005 2004 2005 2004 2004
(unaudited) (unaudited) (unaudited) (unaudited) (unaudited)
GBPm GBPm GBPm GBPm GBPm
Revenue 4.6 11.1 17.0 62.4 85.5
Cost of sales (5.4) (7.0) (14.3) (24.2) (35.0)
_____ _____ _____ _____ _____
Gross (loss)/ profit (0.8) 4.1 2.7 38.2 50.5
Research and development (8.6) (7.8) (23.1) (21.8) (29.4)
costs
Sales and marketing costs (0.7) (0.8) (2.0) (2.0) (2.8)
Administrative costs (0.7) (0.7) (2.7) (4.6) (5.6)
(including costs relating
to Canton plant impairment
and restructuring costs)
Other operating income: - - - 10.2 10.2
Settlement of Canton
agreement _____ _____ _____ _____ _____
Operating (loss)/profit (10.8) (5.2) (25.1) 20.0 22.9
Non-operating (expense)/ (0.1) (0.1) (0.4) (0.1) 0.2
income
Finance income 1.0 1.2 3.2 3.3 4.8
Finance costs (0.3) (0.2) (0.7) (0.6) (0.9)
_____ _____ _____ _____ _____
(Loss)/profit on ordinary (10.2) (4.3) (23.0) 22.6 27.0
activities before taxation
Taxation (0.9) 1.3 2.8 (7.7) (7.3)
_____ _____ _____ _____ _____
(Loss)/profit on ordinary (11.1) (3.0) (20.2) 14.9 19.7
activities after taxation
_____ _____ _____ _____ _____
Basic (loss)/earnings per (10.3)p (2.8)p (18.8)p 14.1p 18.5p
share (in pence)
Basic (loss)/earnings per $(0.36) $(0.10) $(0.67) $0.51 $0.71
ADR (in $) (note 2)
Diluted (loss)/earnings per (10.3)p (2.8)p (18.8)p 13.9p 18.1p
share (in pence)
Weighted average number of 107,247,263 105,846,740 107,179,027 105,549,428 106,300,080
ordinary shares in issue -
basic
Weighted average number of 107,247,263 105,846,740 107,179,027 106,936,965 108,649,389
ordinary shares in issue -
diluted
Group balance sheet as at 30 September 2005
As at As at As at
30 September 30 September 31 December
2005 2004 2004
(unaudited) (unaudited) (unaudited)
GBPm GBPm GBPm
Non-current assets
Goodwill 15.4 15.6 15.4
Other intangible assets 4.2 4.4 4.1
Property, plant and equipment 20.8 19.9 18.5
Deferred tax assets - 2.1 -
Other non-current assets - 2.7 2.5
_____ _____ _____
40.4 44.7 40.5
Current assets
Inventory 3.7 10.9 6.0
Trade and other receivables 14.3 9.1 15.6
Liquid investments 14.0 52.4 48.3
Cash and cash equivalents 59.5 62.6 53.5
_____ _____ _____
91.5 135.0 123.4
Current liabilities
Short-term borrowings (4.0) (3.9) (3.6)
Short-term financial liabilities (4.4) (4.3) (3.1)
Accruals and deferred income (19.8) (42.7) (27.9)
Trade and other payables (6.3) (13.2) (13.0)
_____ _____ _____
(34.5) (64.1) (47.6)
_____ _____ _____
Net current assets 57.0 70.9 75.8
_____ _____ _____
Total assets less current liabilities 97.4 115.6 116.3
Non-current liabilities
Investment in Joint Venture (0.3) (0.3) (0.3)
Long-term financial liabilities (5.0) (8.6) (6.3)
Accruals and deferred income - (0.4) -
Deferred and contingent consideration (0.5) (0.9) (0.5)
Deferred tax provision (1.6) (1.7) (1.7)
_____ _____ _____
(7.4) (11.9) (8.8)
_____ _____ _____
Net assets 90.0 103.7 107.5
_____ _____ _____
Shareholders' equity
Share capital 10.7 10.6 10.7
Share premium account 98.0 96.8 97.8
Other reserves (0.4) 0.2 (2.5)
Retained earnings (18.3) (3.9) 1.5
_____ _____ _____
Total shareholders' equity 90.0 103.7 107.5
_____ _____ _____
Group cash flow statement
Three months Three months Nine months Nine months Year
ended ended ended ended ended
30 September 30 September 30 September 30 September 31 December
2005 2004 2005 2004 2004
(unaudited) (unaudited) (unaudited) (unaudited) (unaudited)
GBPm GBPm GBPm GBPm GBPm
Operating activities
(Loss)/profit on ordinary (10.2) (4.3) (23.0) 22.6 27.0
activities before tax
Depreciation and 1.1 1.1 3.2 5.2 6.3
amortisation
Decrease/(increase) in 3.3 2.9 3.0 (34.4) (51.1)
working capital
Other non-cash movements (0.2) 1.1 (0.3) 1.7 2.6
Net finance costs (0.7) (1.0) (2.5) (2.7) (3.9)
Taxes paid (0.4) (0.2) (5.4) (1.3) (1.6)
______ ______ ______ ______ ______
Cash flows from operating (7.1) (0.4) (25.0) (8.9) (20.7)
activities
Investing activities
Purchase of business (1.2) (0.5) (1.4) (0.6) (0.8)
operations
Disposals of investments - - - 0.7 0.7
Purchases of intangibles (0.4) - (0.4) - -
Purchases of property, (0.4) (1.4) (3.0) (2.7) (3.4)
plant and equipment
______ ______ ______ ______ ______
Cash flows from investing (2.0) (1.9) (4.8) (2.6) (3.5)
activities
Financing activities
Interest element of (0.1) (0.3) (0.4) (0.5) (0.7)
finance lease payments
Interest paid (0.1) (0.1) (0.1) (0.1) (0.1)
Interest received 1.1 1.2 3.0 3.1 4.4
Proceeds from issue of 0.1 0.2 0.2 0.8 1.9
share capital
Capital element of finance (0.8) (0.8) (2.4) (1.6) (2.5)
lease payments
Purchase of liquid (14.0) (20.3) (26.0) (49.4) (52.9)
investments
Sale of liquid investments 35.0 13.0 60.3 20.5 28.1
______ ______ ______ ______ ______
Cash flows from financing 21.2 (7.1) 34.6 (27.2) (21.8)
activities
______ ______ ______ ______ ______
Increase/(decrease) in 12.1 (9.4) 4.8 (38.7) (46.0)
cash and cash equivalents
______ ______ ______ ______ ______
Reconciliation of movements in Group shareholders' equity
As at As at As at
30 September 30 September 31 December
2005 2004 2004
(unaudited) (unaudited) (unaudited)
GBPm GBPm GBPm
Retained (loss)/profit for the period (20.2) 14.9 19.7
Gain/(loss) on foreign currency exchange 2.0 0.2 (2.5)
Credit in respect of employee share schemes 0.7 0.4 0.7
Tax in respect of employee share schemes - 0.9 1.2
_____ _____ _____
(17.5) 16.4 19.1
New share capital subscribed 0.2 0.8 1.9
Purchase of Treasury shares (0.2) - -
_____ _____ _____
Net (decrease)/increase in shareholders' (17.5) 17.2 21.0
equity
Opening shareholders' equity 107.5 86.5 86.5
_____ _____ _____
Closing shareholders' equity 90.0 103.7 107.5
_____ _____ _____
Reconciliation of net funds
1 January Cash flow Non-cash Exchange 30 September
2005 GBPm movement movement 2005
GBPm (note 3) GBPm GBPm
GBPm
Liquid investments 48.3 (34.3) - - 14.0
Cash and cash equivalents 53.5 4.8 - 1.2 59.5
_____ _____ _____ _____ _____
101.8 (29.5) - 1.2 73.5
Short-term borrowings (3.6) - - (0.4) (4.0)
Financial liabilities (9.4 2.4 (1.6) (0.8) (9.4)
_____ _____ _____ _____ _____
88.8 (27.1) (1.6) - 60.1
_____ _____ _____ _____ _____
Notes
1. Basis of preparation
The financial information for the three and nine months ended 30 September 2005
is unaudited and has been prepared in accordance with the Group's accounting
policies, based on IFRS, that are expected to apply for 2005. The financial
information for the three and nine months ended 30 September 2004 is also
unaudited and has been restated under IFRS. These results have not been reviewed
by the Group's Auditors. Restated financial information for the three months
ended 31 March 2004 and year ended 31 December 2004 was published in May 2005.
There is a possibility that the directors may determine that some changes are
necessary when preparing the full annual financial statements for the first time
in accordance with accounting standards adopted for use in the European Union.
The IFRS standards and IFRIC (International Financial Reporting Interpretations
Committee) interpretations that will be applicable and adopted for use in the
European Union at 31 December 2005 are not known with certainty at the time of
preparing this interim financial information.
The financial information relating to the year ended 31 December 2004 does not
constitute statutory accounts within the meaning of Section 240 of the Companies
Act 1985. The data has been extracted from the full report for that year and has
been restated under IFRS. This information is currently unaudited. The report of
the Auditors on the 2004 accounts as prepared under UK GAAP was unqualified. The
statutory accounts presented under UK GAAP for the year ended 31 December 2004
were approved at the 2004 Annual General Meeting on 11 May 2005.
2. (Loss)/earnings per ADR (basic)
Each American Depository Receipt ("ADR") represents two ordinary shares. The
basic earnings per ADR is calculated by multiplying the earnings per ordinary
share by a factor of two and then multiplying by the prevailing US dollar
exchange rate at the end of the relevant period. The exchange rates used are
1.7691, 1.8094 and 1.9199 for the nine months to 30 September 2005, 30 September
2004 and year to 31 December 2004 respectively.
3. Non-cash movement
In December 2001, the Group entered into a lease-financing arrangement with
Baxter Healthcare Corporation in respect of the Group's manufacturing plant.
During the nine months to 30 September 2005 interest payable on the finance
lease was charged to the Group income statement, but was not fully paid in the
period. The unpaid element for the nine months ended 30 September 2005 of
GBP0.1m (2004 - GBP0.2m) is shown as a non-cash movement on the reconciliation
of net funds.
In May 2005 the Group paid GBP1.7m ($3.0m) to acquire BioReliance's fill/finish
assets and will pay a further c. GBP2.5m ($4.5m) in 12 installments between 2006
and 2017. This unpaid element has been discounted to GBP1.5m ($2.8m) to reflect
the time value of money and is shown as a non-cash movement on the
reconciliation of net funds.
4. Directors' responsibility
The Directors are responsible for the maintenance and integrity of the Group's
website. Uncertainty regarding legal requirements is compounded as information
published on the internet is accessible in many countries with different legal
requirements relating to the preparation and dissemination of financial
statements.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant Peptide Therapeutics Group has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
Date: 15 November, 2005 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.