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 March 2007
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: Final Results
Results for the year ended 31 December 2006 and business update
Cambridge, UK and Cambridge, Massachusetts - 15 March 2007 - Acambis plc
(Acambis) (LSE: ACM) announces its results for the three months and year ended
31 December 2006 and provides an update on its business going forward.
Key points:
- - Financial highlights
o Full-year revenues of GBP30.9m, in line with guidance
o Pre-tax profit in Q4 of GBP2.2m
o Year-end cash position of GBP34.4m strengthened by ARILVAX settlement and
Berna Products sale; excludes GBP16.1m received in January 2007 from
ACAM2000 delivery
- - Clearer strategy and new executive leadership team established
o Clear focus on building high-value biotech company supported by
biodefence revenues
o Ian Garland appointed CEO from June 2007
- Current CEO Gordon Cameron remains in position until then to ensure
smooth transition
o Dr Michael Watson appointed Executive Vice President, R&D
o Elizabeth Brown appointed acting CFO
- - Restructuring programme being implemented
o GBP7m of annualised cost savings expected
- - R&D pipeline
o ChimeriVax-JE
- Worldwide marketing partnership established with sanofi pasteur
- Phase 3 efficacy data surpass expectations
- Paediatric trial ongoing in India
o ChimeriVax-West Nile
- Positive data from Phase 2 trial in healthy adults
- Phase 2 trial in elderly subjects ongoing
- Partnership discussions underway
o C. difficile
- Positive data from two Phase 1 trials
- Vaccine being formulated and manufactured for trials in 2008
o Universal Influenza vaccine proof-of-concept clinical trial to start in
Q2
- Biodefence franchise
o ACAM2000 licence approval process moving forward
- Information provided to FDA on Complete Response Letter
o MVA3000 activities being wound down during 2007
Three months ended Year ended
31 December 31 December
2006 2005 2006 2005
Revenue GBP17.5m GBP23.9m GBP30.9m GBP40.9m
Profit/(loss) before tax GBP2.2m GBP(5.1)m GBP(15.9)m GBP(27.7)m
Basic earnings/(loss) per share 2.0p (6.7)p (15.4)p (25.2)p
* Prepared under the Group's accounting policies based on International
Financial Reporting Standards
Peter Fellner, Chairman of Acambis, commented:
"We have made a strong start in setting Acambis on a firmer footing going
forward, including establishing a major partnership with sanofi pasteur on our
most advanced programme, a single-dose Japanese encephalitis vaccine, and
reporting excellent results with this vaccine in a second large Phase 3 pivotal
study. We have also initiated a carefully targeted restructuring exercise to
reduce the cost base going forward. I am confident that our new management team,
under Ian Garland's leadership, will effectively manage the strategy to build
our non-biodefence-related business."
Chairman's statement
OVERVIEW
In 2006, we initiated the transformation of Acambis into a high-value
biotechnology company that is supported by, rather than reliant on, its
biodefence revenues. Although Acambis faced significant challenges during 2006,
we also made good progress with our R&D pipeline and continued this success into
2007.
The greatest challenge was the decision of the US Department of Health and Human
Services (DHHS) not to award Acambis a contract under the MVA smallpox vaccine
tender process. This decision was disappointing, particularly in view of our
record of successfully delivering substantial quantities of our ACAM2000
smallpox vaccine to the US Government.
This outcome overshadowed positive clinical data from several of our key R&D
pipeline programmes, including our C. difficile and West Nile vaccines. This
success has continued into 2007 with the publication of exceptional data for our
single-dose Japanese encephalitis (JE) vaccine in a large Phase 3 pivotal
efficacy study.
In addition, the financial position of the Company has been strengthened through
a settlement with Novartis AG (Novartis) relating to ARILVAX, the sale of the US
marketing operations and a further ACAM2000 order from the US Centers for
Disease Control and Prevention (CDC), which in total generated cash proceeds of
$65.9m (c. GBP35m). Since the year-end, we have also established a
commercialisation partnership with sanofi pasteur relating to ChimeriVax-JE for
which we will receive EUR7.5m (c. GBP5m) in payments in the first half of 2007
and which will generate royalties on sales, payments for supply of bulk
manufactured product and a further EUR22.5m (c. GBP15m) in milestone payments
following marketing authorisations.
STRATEGY
When we announced our third quarter results in November 2006, the Board
re-emphasised the Company's strategy, which is to expand our R&D portfolio
further, supported by cash derived from the biodefence contracts, in order to
reduce the Company's future reliance on biodefence. The negative MVA vaccine
decision, communicated a matter of weeks later, underlines the importance of
pursuing this strategy as the future for Acambis to deliver shareholder value.
MANAGEMENT CHANGES
In view of the increasing emphasis upon expanding our non-biodefence pipeline,
the Board reviewed the management, together with the Company's cost base and its
operational capabilities. This aimed to ensure that Acambis' resources,
including the management, operational and financial assets, are appropriate to
address the Company's changing strategic goals.
Following this review, the Board decided to seek new leadership for the Company
to take Acambis into the next stage of its growth. On 7 March 2007, we announced
that we appointed Ian Garland as CEO, with effect from 1 June 2007. Ian was
previously Chief Financial Officer of Arrow Therapeutics Ltd, which was acquired
by AstraZeneca plc for $150m in February 2007. Prior to that, he was President
and Chief Operating Officer of Celltech Pharmaceuticals, Inc., encompassing the
US operations of Celltech Group plc. During that time, he achieved significant
US sales and earnings growth, the approval of two US New Drug Applications and
the divestment of several non-core businesses. Ian has extensive US experience
that will be invaluable given that the majority of the Acambis' operations are
based there.
Until Ian's arrival in June, Gordon Cameron has agreed to remain in his current
position as CEO to ensure a smooth transition. Gordon joined Acambis in 1996,
serving initially as CFO and as CEO for the last three years. He has overseen
substantial advances in the Company's business and operations, including the
successful implementation of major US Government biodefence contracts,
underpinning the development of Acambis. I would like to thank Gordon for his
important contribution over the last few years and wish him every success in his
future career.
David Lawrence, CFO, left at the beginning of March and Elizabeth Brown,
previously Vice President, Financial Management and Company Secretary, has been
appointed as acting CFO. She has served with Acambis for more than ten years and
has been responsible for all financial management and control within the Company
and for long-term financial planning.
In January 2007, we announced the appointment of Dr Michael Watson as Executive
Vice President, R&D, and Executive Director of the Board. Dr Watson replaces Dr
Thomas Monath, who retired as Chief Scientific Officer during 2006, but takes on
a broader role that is intended to facilitate the effective management and
integration of our Research, Development, Clinical and Medical Affairs
activities.
We have also further strengthened the Board by appointing Dr William Jenkins and
John Lambert as Non-executive Directors, with effect from 1 December 2006. These
appointments provide a valuable addition to the industry experience on the
Board.
We are confident that these Board and management changes will provide the
necessary leadership to achieve this re-orientation of Acambis' business.
RESTRUCTURING OF OPERATIONS AND COST BASE
The restructuring announced on 7 March 2007 is intended to increase the focus of
resources upon key programmes and core operational capabilities, and
significantly lower Acambis' cost base.
We intend to reduce Acambis' cost base by around 20%, with the majority of the
cost saving initiatives being implemented in 2007. The headcount will be reduced
from 260 by approximately 15% during this year across the organisation.
To utilise our resources most effectively, our R&D operations will now focus
primarily on activities through to Phase 2 clinical studies, although we may
still complete Phase 3 clinical studies in some cases. We will also continue to
develop scalable manufacturing processes utilising our world-class facilities
and will, generally, seek partners to commercialise our products. We do not
expect the reorganisation to have any impact on our existing pipeline.
The cash costs of the restructuring, all of which will be incurred in 2007, are
expected to be around GBP3m, which will be offset by the savings achieved during
this year. Following the full implementation, it is expected that the cost base
will decrease by approximately GBP7m per annum, with the first full year of
savings being in 2008.
R&D UPDATE
- - ChimeriVax-JE: excellent efficacy data reported, partnership with a global
vaccine player secured; Indian paediatric trial underway
After the year-end, we announced the achievement of three important milestones
for our ChimeriVax-JE programme: (i) publication of pivotal Phase 3 efficacy
data; (ii) establishment of a worldwide commercialisation partnership with
sanofi pasteur; and (iii) commencement of the paediatric study in India.
In the Phase 3 efficacy trial, our single-dose ChimeriVax-JE vaccine was tested
for non-inferiority to the three-dose JE-VAX(R), a licensed JE vaccine, based on
development of neutralising antibodies against the relevant homologous JE virus.
With seroconversion rates of 99.1% in the ChimeriVax-JE group compared with
74.8% in the JE-VAX group, we were able to demonstrate not only non-inferiority
but also statistical superiority (p<0.001).
This followed the reporting of excellent results from our pivotal Phase 3 safety
trial in October 2006, which showed that vaccination with ChimeriVax-JE was
systemically and locally well tolerated. Almost all adverse events which were
recorded were mild or moderate, although there was one serious adverse event
considered to be vaccine-related, which resolved without complications. In
total, more than 2,400 subjects were recruited for these two trials and the data
will support filings for endemic and travel vaccine markets.
In February 2007, we established a major partnership agreement with sanofi
pasteur, the vaccines business of the sanofi-aventis Group, one of the world's
leading vaccine companies. Under the agreement, we have granted sanofi pasteur
marketing, distribution and certain manufacturing rights to ChimeriVax-JE
worldwide, excluding India and the Indian subcontinent, where we have an
existing agreement with Bharat Biotech International Limited, and also excluding
the US, for which sanofi pasteur has been granted an option.
We will receive royalties on sales and payment for the supply of bulk
manufactured ChimeriVax-JE product, which we will continue to produce at our
Canton, MA facility. In addition, we will receive an upfront payment and
milestone payments following marketing authorisation of ChimeriVax-JE in key
endemic countries and in the European Union. The upfront and milestone payments
are together worth up to EUR30m (c. GBP20m), of which EUR7.5m (c. GBP5m) will be
received in the first half of 2007. The US-related option, if exercised, will
generate additional upfront and milestone payments, and will also provide
revenues from royalty payments. As sanofi pasteur is responsible for
lyophilisation and fill/finish of the bulk ChimeriVax-JE in the designated
regions, we have initiated a technology transfer process.
We believe that our agreements with both sanofi pasteur and Bharat Biotech
combine the best JE vaccine candidate with the best partners.
To support licence applications in the endemic regions, we are conducting a
paediatric trial in India, which is the first trial of ChimeriVax-JE in infants
and children. The trial aims to evaluate the safety and immunogenicity of one
dose of ChimeriVax-JE compared with two doses of the currently licensed JE
vaccine, a locally produced inactivated mouse-brain vaccine.
- - ChimeriVax-West Nile: leading vaccine candidate status maintained as trial
underway in target population
Having completed the first part of a Phase 2 trial of ChimeriVax-West Nile in
2006, we are currently conducting the second part of the trial in one of the key
target populations for the vaccine: elderly subjects. The second part of the
Phase 2 trial includes approximately 100 subjects aged 41 years and above, which
includes those who are considered by the CDC to be most at risk from severe
disease resulting from West Nile virus infection. We are comparing the safety,
tolerability and immunogenicity of ChimeriVaxTM-West Nile against placebo.
During 2006, we published positive data from the first part of the Phase 2
trial, which tested safety and immunogenicity in healthy adults. The data showed
that ChimeriVax-West Nile elicits a high immune response after a single dose,
with over 97% of all subjects who received ChimeriVaxTM-West Nile seroconverting
28 days after a single vaccination.
We have initiated partnership discussions with a view to out-licensing the
programme after the conclusion of our Phase 2 trial.
- - C. difficile: positive clinical trial data published in 2006; preparation of
clinical trial material ongoing in 2007
In 2006, we reported positive results from two Phase 1 trials that evaluated the
safety, tolerability and immunogenicity of our vaccine against C.
difficile-associated disease. In the first trial, our vaccine was tested in
young healthy adults at different dose levels. The second trial focused on
healthy elderly subjects aged 65 years and above, who are the principal target
population for the vaccine. The two trials both produced positive results, with
antibody responses seen in all subjects who received our vaccine. There were no
vaccine-related serious adverse events and the most common vaccine-related side
effects were mild in nature.
Currently, we are in the process of improving the formulation of the vaccine to
improve its stability profile. We will then manufacture new vaccine lots for the
next stage of clinical development, which we anticipate will be in 2008.
- - Influenza: application submitted to US FDA for clinical trials
In the next few weeks, we expect to submit an Investigational New Drug (IND)
application to the US Food and Drug Administration (FDA) to initiate clinical
testing of our ACAM-FLU-A vaccine candidate. ACAM-FLU-A is the first vaccine
candidate being developed under our influenza programme and is designed to
function as a universal vaccine against all 'A' strains of influenza by
targeting a conserved peptide component present in 'A' strains of the virus. As
such, it could be a candidate pandemic influenza vaccine, as well as becoming
one of the components for a universal seasonal vaccine.
Our influenza programme is intended to be a highly innovative approach to one of
the major killer diseases in the world today.
BIODEFENCE FRANCHISE UPDATE
- - ACAM2000: additional US Government order completed and progressing toward
licence approval
In December 2006, we successfully completed delivery of an additional 10 million
doses of our ACAM2000 smallpox vaccine to the CDC. This generated revenue of
approximately GBP16m, for which we received payment in January 2007. This order
brought the number of doses produced to date for the US Government to 192.5
million and was intended to incentivise us to continue work to establish a
warm-base manufacturing capability for ACAM2000. Under a warm-base manufacturing
contract, we would maintain an ongoing production readiness capability through
annual production runs. Finalisation of a warm-base manufacturing contract with
the US Government is expected follow after US licensure of ACAM2000.
In January 2007, as part of the normal review process, we received a Complete
Response Letter (CRL) from the FDA in response to our ACAM2000 Biologics Licence
Application (BLA). In the CRL, the FDA requested additional information that it
required to complete its review of the BLA and, two weeks ago, we provided that
information. The next key step in the review process is for the FDA to hold a
Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for
ACAM2000. The next scheduled VRBPAC meeting is in May and we are hoping to have
ACAM2000 reviewed at that meeting.
- - MVA3000: winding down activities during 2007
On 14 November 2006, we were notified by the US Department of Health and Human
Services (DHHS) that our proposal for the supply of doses of MVA3000 attenuated
smallpox vaccine was no longer being considered for a contract award under
DHHS's tender process. DHHS has since debriefed us and explained its rationale
for this decision, which centred on issues relating to the technical
specification of our MVA3000 product.
We are completing certain activities under our existing MVA R&D contract with
the US National Institutes of Health (NIH) and, as a result of DHHS's decision,
have agreed to wind down the programme by the end of that contract in September
2007.
- - MVA litigation: ITC decision
In September 2006, a judge at the International Trade Commission (ITC) ruled in
our favour in the litigation with Bavarian Nordic A/S (Bavarian Nordic) relating
to MVA, following an evidentiary hearing held in May 2006. The judge invalidated
each of the patent claims asserted against Acambis and denied Bavarian Nordic's
request for an exclusionary order. In November 2006, the ITC decided to review
the decision and, in February 2007, announced that the case would be remanded
back to the same judge. The target date for completion of the investigation has
been set at 19 October 2007. Cases are also ongoing at the District Court of
Delaware, US and the Commercial Court in Vienna, Austria.
Given the US Government's decision in November 2006 not to award us a contract,
all three cases are now largely immaterial to our strategic goals.
- - Listing: de-listing from NASDAQ completed, de-registration from the SEC
ongoing
In 2006, we announced our intention to deregister voluntarily from the US
Securities Exchange Act of 1934 and to delist our stock from NASDAQ. In our
view, the listing was no longer in shareholders' best interests. On 18 December
2006, we completed our voluntary de-listing from NASDAQ and terminated our
American Depositary Receipt facility, which became effective at the close of
trading on 14 February 2007. The process to deregister from the Securities and
Exchange Commission (SEC) is ongoing. Our obligation to report to the SEC is
expected to be suspended in the second quarter of 2007. Our ongoing obligations
under our London Stock Exchange listing are unaffected by this process.
As a result of our delisting and deregistration, we expect to achieve annual
cost savings of around GBP0.4m per annum. This is in addition to the GBP7m cost
savings referred to previously.
FINANCIAL REVIEW
The financial results prepared under the Group's accounting policies based on
International Financial Reporting Standards, for the year ended 31 December
2006, are presented below. The narrative reflects a comparison of our activities
in 2006 and 2005, and, unless otherwise stated, the comparative figures in
parentheses relate to the equivalent period in 2005. A high-level summary of the
results for the three months ended 31 December 2006 is also shown.
Trading results
Revenue for the year was GBP30.9m (2005 - GBP40.9m), which is in line with the
revenue guidance of around GBP30m given in 2006. The main sources of revenue
during 2006 were from product sales of 10 million doses of ACAM2000 to the US
Government, our two contracts with the NIH for MVA3000 and product sales of
Vivotif, up to the time that the Berna Products Corporation (BPC) business was
sold to Crucell NV (Crucell) in September. The higher levels of revenue in 2005
reflected more intensive levels of activity on our government contracts.
Cost of sales in 2006 decreased to GBP14.6m (2005 - GBP27.6m) and represents
costs relating to each of the above revenue items and certain costs of operating
our manufacturing facilities.
Our gross profit margin for the year increased to 52.8% (2005 - 32.5%). This
represents the change in the mix of revenues recorded in the two years.
Expenditure on R&D increased in the year to GBP37.0m (2005 - GBP34.1m) and was
slightly below guidance provided during 2006. The costs are net of a GBP1.2m
credit (2005 - GBPnil) relating to the ARILVAX programme as a result of reaching
settlement with Novartis. The two Phase 3 trials for ChimeriVax-JE contributed a
significant proportion to these costs in 2006. During 2006, we continued to
expense process development and manufacturing costs for work on our R&D projects
against R&D costs.
Sales and marketing costs in the year were GBP2.6m (2005 - GBP2.6m).
Administrative costs were GBP8.6m (2005 - GBP7.7m). The main reasons for the
increase in costs in 2006 were costs associated with the MVA litigation,
aborted acquisition costs and foreign exchange movements.
During 2006, two items of other operating income were recorded in our third
quarter's results. The first, GBP10.1m (2005 - GBPnil), relates to the $19.0m
settlement received from Novartis for the ARILVAX programme. The second relates
to the sale of the BPC business to Crucell on which other operating income of
GBP4.6m was recorded. This represented GBP9.0m ($17m) of proceeds, which was
offset by the value of fixed assets, working capital, goodwill, other intangible
assets and related deferred tax liabilities on the balance sheet.
Finance income in the year was GBP2.0m (2005 - GBP4.0m). The reduction was as a
result of lower cash levels during 2006 compared with 2005. Finance costs were
GBP0.7m (2005 - GBP1.0m), which primarily comprised interest payable on the
lease-financing facility that was put in place for the reactivation of our
manufacturing plant in Canton, MA. This facility was paid down in full at the
end of 2006.
Pre-tax loss for 2006 was GBP15.9m (2005 - GBP27.7m). The difference seen over
2005 is in part due to other operating income relating to ARILVAX and the sale
of BPC.
In 2006, we recorded a tax charge of GBP0.6m (2005 - credit of GBP0.7m). The
charge in 2006 relates to adjustments to tax in respect of prior periods.
Balance sheet highlights
i) Cash/debtors
Cash, cash equivalents and liquid investments of the Group at 31 December 2006
amounted to GBP34.4m (31 December 2005 - GBP68.0m). The reduction in cash during
the year is a result of increased investment in the R&D pipeline, repayment of
our lease-financing facility and the net cash outflow from working capital
movements as described below.
During the year, trade and other receivables decreased to GBP17.5m (31 December
2005 - GBP20.6m). The balance at the end of 2006 included the amount owing by
the US Government for the 10 million-dose ACAM2000 shipment made in the fourth
quarter. This trade debtor has been settled since the year-end.
ii) Inventory
Inventory held at 31 December 2006 amounted to GBP1.5m (31 December 2005 -
GBP3.6m). The balance principally represents work-in-progress and finished goods
in relation to our ACAM2000 vaccine. The reduction seen in 2006 is predominantly
a result of the shipment of ACAM2000 inventory during the fourth quarter of
2006. In 2005, the balance also included stocks of Vivotif, which were
transferred to Crucell in September 2006 as part of the sale of the BPC business
and are, therefore, no longer represented in the inventory balance.
iii) Current liabilities: amounts falling due in one year
At 31 December 2006, current liabilities were GBP15.6m (31 December 2005 -
GBP46.8m). Trade and other payables were GBP3.2m at 31 December 2006
(31 December 2005 - GBP16.1m). The high level outstanding at the end of 2005 was
principally attributable to the trade creditor for the production of 500,000
doses of MVA3000 shipped in the last quarter of 2005. At 31 December 2006 the
balance of accruals and deferred income was GBP6.6m (31 December 2005 -
GBP14.1m). This reduction seen during 2006 principally relates to payment of
creditors for the completion of the Phase 3 clinical trials for JE. Current
liabilities at the end of 2006 represent more normalised levels.
iv) Short-term borrowings and financial liabilities
The combined balance of our US dollar-denominated financing facilities was
GBP5.0m at 31 December 2006 (31 December 2005 - GBP12.8m). At the end of 2006,
we made our final payment to settle our lease-financing facility, resulting in
a nil balance at 31 December 2006 (31 December 2005 - GBP7.1m). The balance on
the overdraft facility at 31 December 2006 was GBP3.6m (31 December 2005 -
GBP4.0m), the decrease being attributable to exchange rate movements in the
period. The remaining balance of GBP1.4m at 31 December 2006 (31 December 2005 -
GBP1.7m) relates to the discounted value of the future payments for the
Rockville fill/finish facility acquired in 2005, payable between 2006 and 2017.
Fourth quarter results
The following section summarises the financial highlights for the three months
ended 31 December 2006 (Q4). Unless stated otherwise, the comparative figures in
parentheses relate to the equivalent three-month period in 2005.
Revenues in Q4 were GBP17.5m (2005 - GBP23.9m) and principally represented
product sales of 10 million doses of ACAM2000 to the US Government and our two
contracts with the NIH for MVA3000. The equivalent period in 2005 included
revenue from the shipment of 500,000 doses of MVA3000. Cost of sales was GBP4.8m
in Q4 (2005 - GBP13.3m) representing the lower proportion of revenue in 2006 for
the lower gross margin MVA contracts, over 2005. R&D costs were
GBP9.0m (2005 - GBP10.7m). In Q4, we recorded GBP0.4m (2005 - GBP0.6m) of
sales and marketing costs. Administrative costs were lower at GBP1.5m in Q4
(2005 - GBP4.9m). Costs in 2005 included a provision for the defence of the MVA
litigation.
The pre-tax profit in Q4 was GBP2.2m (2005 - pre-tax loss of GBP5.1m). The
change in the periods reflects the change in mix of revenues and gross margins
over the two periods.
On cash, in Q4, the final payments were made to settle the lease-financing
facility, increasing the payments in the quarter to GBP3.9m (2005 - GBP0.9m).
OUTLOOK AND GUIDANCE
Through the Board and management changes, the restructuring of our business and
cost base, and the good progress made in the pipeline projects, we have made a
strong start towards setting Acambis on a firmer footing for its next stage of
growth. We are committed to transitioning Acambis away from biodefence-related
activities by building out its non-biodefence pipeline, where we have had some
notable successes recently.
During 2007, it remains important for us to secure the expected ACAM2000
warm-base manufacturing contract, which can provide useful long-term revenues to
support our pipeline investment. However, as we are winding down the MVA3000
programme and nearing the end of the ACAM2000 licensure process, internal R&D
resources will continue to transition onto non-biodefence activities,
particularly our C. difficile and influenza programmes.
During 2007, we expect to receive EUR7.5m (c. GBP5m) in upfront and milestone
payments from sanofi pasteur for ChimeriVax-JE and residual revenue from the US
Government for MVA3000 as we wind down our existing contracts. As highlighted,
we also expect to secure an ACAM2000 warm-base manufacturing contract with the
US Government and will provide guidance on revenues as and when that contract is
finalised.
We expect R&D expenditure will be significantly lower this year, at around
GBP25-30m, principally as a result of having completed the ChimeriVax-JE Phase 3
trials, This represents a more normalised level for the next few years.
-ends-
A meeting and conference call for analysts will be held today at 9.00 am GMT.
For details, contact Jon Coles / Justine McIlroy / Margherita Lupi at Brunswick
on telephone number +44 (0) 20 7404 5959. An instant replay of the call will be
available until 22 March 2007 on telephone number UK: +44 (0) 20 8196 1998 and
US: + 1 (866) 583 1035. The pin code is 949716. A 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 March 2008.
Enquiries:
Acambis plc
Peter Fellner, Chairman
Gordon Cameron, Chief Executive Officer
Lyndsay Wright, VP, Communications and IR
Today: tel +44 (0) 20 7404 5959
Thereafter: tel +44 (0) 1223 275 300
Brunswick
Jon Coles / Justine McIlroy / Margherita Lupi
Tel: +44 (0) 20 7404 5959
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology has also
been used to develop ChimeriVax-West Nile, which is undergoing Phase 2 clinical
testing, making it the most advanced investigational vaccine against the West
Nile virus. Acambis also has the only vaccine in development against Clostridium
difficile bacteria, a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). More information is available at
www.acambis.com.
The market opportunities for Acambis' pipeline programmes
Japanese encephalitis
According to the WHO, approximately 30,000 to 50,000 people suffer from JE
annually, mainly in Asia(1). During a recent epidemic in northern India and
Nepal, JE killed more than 1,000 people, most of them children(2). An estimated
three billion people live in JE-endemic regions, which include Thailand, China,
Japan, India and parts of Australia. The current market's value is believed to
be $100-150m. A single dose, safe and effective vaccine offers the potential to
expand the market by changing vaccine recommendations and encouraging more
countries to include a JE vaccine in paediatric vaccination schedules.
West Nile virus
While the epidemiological picture of West Nile virus infection in the US is not
yet well established, data from 2006 demonstrated that this continues to be a
problem suited to a vaccination approach. In 2006, the incidence of cases and
deaths increased significantly, by 41% and 35%, respectively, compared to 2005.
C. difficile
Hospital-acquired infections caused by C. difficile bacteria are an increasing
problem in many developed countries, including the US, Canada and the UK. It is
estimated that C. difficile causes at least 350,000 cases in the US alone (based
on an assumed infection of 1% of the hospital population each year) with annual
costs to the healthcare system exceeding $1 billion.(3)
Today, no vaccine exists to protect individuals against C. difficile-associated
disease (CDAD) and Acambis is the only company known to have undertaken clinical
trials of a vaccine against CDAD. Current treatment of CDAD includes the use of
an antibiotic, metronidazole or vancomycin, and even surgery in most severe
cases to eradicate the C. difficile bacterium.
Influenza
Today, influenza represents the single largest vaccine market in the world. It
is also still a major global killer, resulting in an estimated one billion cases
and 300,000 to 500,000 deaths every year. Yet, no lasting immunity against the
virus is acquired, after either natural infection or immunisation, because of
the virus' ability to mutate.
This ability also creates the potential for pandemics, which are caused by
mutation of the influenza virus into a particularly virulent strain. Three
pandemics occurred in the 20th century, all caused by "A" strains of the
influenza virus. Experts believe the next pandemic could cause disease in two
billion people. Based on best-case scenarios modelled on the mild pandemic of
1968, this could result in two to seven million deaths. However, if the death
toll associated with the 1918 influenza virus were applied to today's world
population, there could be 180 to 360 million deaths globally.(4)
References
(1) WHO, Water Related Disease, Japanese encephalitis
www.who.int/water_sanitation_health/diseases/encephalitis/en/
(2) WHO, Regional Office for South-East Asia, Immunization and Vaccine
Development, Japanese encephalitis
www.searo.who.int/en/section1226/section2073.asp
(3) Kyne et al., Clinical Infectious Diseases 2002; 34:346-353
(4) Kamps-Hoffmann-Preiser, Influenza Report 2006.
"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 2005 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 year ended 31 December 2006
Group income statement
Three months Three months Year Year
ended ended ended ended
31 December 31 December 31 December 31 December
2006 2005 2006 2005
(unaudited) (unaudited) (unaudited) (audited)
GBPm GBPm GBPm GBPm
Revenue 17.5 23.9 30.9 40.9
Cost of sales (4.8) (13.3) (14.6) (27.6)
--------- --------- --------- ---------
Gross profit 12.7 10.6 16.3 13.3
Research and
development costs (9.0) (10.7) (37.0) (34.1)
Sales and marketing
costs (0.4) (0.6) (2.6) (2.6)
Administrative costs (1.5) (4.9) (8.6) (7.7)
Other operating
income:
- Settlement of
ARILVAX agreement - - 10.1 -
- Profit on sale of
business operation 0.2 - 4.6 -
- Fair value of shares
received for grant of
licence - - - 0.4
--------- --------- --------- ---------
Operating
profit/(loss) 2.0 (5.6) (17.2) (30.7)
Finance income 0.5 0.8 2.0 4.0
Finance costs (0.3) (0.3) (0.7) (1.0)
--------- ---------
Profit/(loss) on
ordinary activities
before taxation 2.2 (5.1) (15.9) (27.7)
Taxation: UK - (1.5) (0.8) (1.7)
Taxation: Overseas (0.1) (0.6) 0.2 2.4
========= ========= ========= =========
Profit/(loss) on
ordinary activities
after taxation 2.1 (7.2) (16.5) (27.0)
========= ========= ========= =========
Basic earnings/(loss)
per share (in pence) 2.0p (6.7)p (15.4)p (25.2)p
Diluted earnings/(loss) per
share (in pence) 1.9p (6.7)p (15.4)p (25.2)p
Weighted average
number of
ordinary shares in
issue - basic 107,289,255 107,261,327 107,285,860 107,211,367
Weighted average
number of ordinary
shares in issue -
diluted 108,214,491 107,261,327 107,285,860 107,211,367
Group balance sheet as at 31 December 2006
As at As at
31 December 31 December
2006 2005
(unaudited) (audited)
GBPm GBPm
Non-current assets
Goodwill 12.4 14.9
Other intangible assets 0.7 4.2
Property, plant and equipment 14.6 19.8
Deferred tax asset - 0.3
Financial assets: available for sale investments 0.6 0.6
------------ ------------
28.3 39.8
Current assets
Inventory 1.5 3.6
Current tax assets 0.6 1.3
Trade and other receivables 17.5 20.6
Financial assets: derivative financial instruments - 0.1
Liquid investments 7.5 18.8
Cash and cash equivalents 26.9 49.2
------------ ------------
54.0 93.6
Current liabilities
Financial liabilities:
- short-term borrowings (3.6) (4.0)
- short-term financial liabilities (0.1) (7.2)
Trade and other payables (3.2) (16.1)
Accruals and deferred income (6.6) (14.1)
Income tax payable (2.1) (3.1)
Provisions - (2.3)
------------ ------------
(15.6) (46.8)
------------ ------------
Net current assets 38.4 46.8
Non-current liabilities
Investment in Joint Venture (0.3) (0.3)
Long-term financial liabilities (1.3) (1.6)
Other non-current liabilities - -
Deferred tax liabilities - (1.7)
------------ ------------
(1.6) (3.6)
------------ ------------
Net assets 65.1 83.0
============ ============
Shareholders' equity
Share capital 10.7 10.7
Share premium 98.0 98.0
Other reserves (2.8) (0.9)
Retained earnings (40.8) (24.8)
------------ ------------
Total shareholders' equity 65.1 83.0
============ ============
Group cash flow statement
Three months Three months Year Year
ended ended ended ended
31 December 31 December 31 December 31 December
2006 2005 2006 2005
(unaudited) (unaudited) (unaudited) (audited)
GBPm GBPm GBPm GBPm
Operating activities
Profit/(loss) on
ordinary activities
before tax 2.2 (5.1) (15.9) (27.7)
Depreciation and
amortisation 0.7 2.1 3.8 5.3
Increase in working
capital (10.2) (5.8) (21.7) (2.8)
Profit on sale of
business operations (0.2) - (4.6) -
Other non-cash
movements 0.7 (0.2) 2.4 (0.7)
Net finance costs (0.2) (0.5) (1.3) (3.0)
Taxes paid (0.2) 5.0 (1.1) (0.4)
--------- --------- --------- ---------
Cash flows from
operating activities (7.2) (4.5) (38.4) (29.3)
Investing activities
Purchase of business
operations - (0.3) - (1.7)
Proceeds from sale of
business operation 0.2 - 9.0 -
Purchase of intangibles - - (0.2) (0.4)
Purchase of property,
plant and equipment (0.3) (0.7) (0.9) (3.7)
Proceeds from sale of
property, plant and
equipment - - 0.5 -
--------- --------- --------- ---------
Cash flows used in
investing activities (0.1) (1.0) 8.4 (5.8)
Financing activities
Interest element of
finance lease payments (0.1) (0.2) (0.4) (0.6)
Interest paid (0.1) (0.1) (0.2) (0.2)
Interest received 0.5 0.8 2.2 3.8
Proceeds from issues
of shares - - - 0.2
Purchase of own shares - - - (0.2)
Capital element of
finance lease payments (3.9) (0.9) (6.6) (3.3)
Purchase of liquid
investments (7.5) (8.8) (13.6) (34.8)
Sale of liquid
investments 10.0 4.0 24.9 36.8
--------- --------- --------- ---------
Cash flows from
financing activities (1.1) (5.2) 6.3 1.7
--------- --------- --------- ---------
Decrease in cash and
cash equivalents (8.4) (10.7) (23.7) (33.4)
Net foreign exchange
difference (0.7) 0.4 (2.2) 1.6
Cash and cash
equivalents opening
balance 32.4 59.5 49.2 81.0
--------- --------- --------- ---------
Cash and cash
equivalents closing
balance (note 3) 23.3 49.2 23.3 49.2
========= ========= ========= =========
Reconciliation of movements in Group shareholders' equity
Year ended Year ended
31 December 31 December
2006 2005
(unaudited) (audited)
GBPm GBPm
Retained loss for the period (16.5) (27.0)
(Loss)/gain on foreign currency exchange (1.8) 1.6
Foreign currency exchange realised on sale of
business operation (0.1) -
Revaluation of available for sale investments - 0.1
Credit in respect of employee share schemes 0.5 0.8
------------ ------------
(17.9) (24.5)
New share capital subscribed - 0.2
Purchase of Treasury shares - (0.2)
------------ ------------
Net decrease in shareholders' equity (17.9) (24.5)
Opening shareholders' equity 83.0 107.5
------------ ------------
Closing shareholders' equity 65.1 83.0
============ ============
Notes
1. Basis of preparation
With the exception of the financial information for the year ended 31 December
2005 which is audited, the financial information for the three months to 31
December 2005 and for the three months and year ended 31 December 2006 is
unaudited. The financial information for both years has been prepared in
accordance with the Group's accounting policies which are based on IFRS as
adopted by the European Union and the Listing Rules of the Financial Services
Authority.
This summary of results does not constitute the full financial statements within
the meaning of s240 of the Companies Act 1985. The 2005 financial statements,
which were approved at the 2006 Annual General Meeting on 23 June 2006, have
been reported on by the Company's auditors and subsequently delivered to the
Registrar of Companies. The audit report was unqualified and did not contain a
statement under s237(2) or s237(3) of the Companies Act 1985.
2. Directors' responsibility
The Directors are responsible for the maintenance and integrity of the Group's
website. The Company notes that UK legislation governing the preparation and
dissemination of financial information may differ from that required in other
jurisdictions.
3. Cash and cash equivalents
Cash, cash equivalents and bank overdrafts include the following for the
purposes of the cash flow statement:
2006 2005
GBPm GBPm
Cash and cash equivalents 26.9 49.2
Bank overdrafts (3.6) -
-------- --------
23.3 49.2
======== ========
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 March 2007 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.