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SOURCE: Antisoma plc
Antisoma's preliminary results for the year ended 30 June 2009
LONDON, UK and CAMBRIDGE, MA--(Marketwire - September 14, 2009) - Antisoma plc (
Highlights of 2008/2009
ASA404 programme advances and expands
AS1413 development gains momentum
AS1411 programme advances
Value realised from oral fludarabine asset
Strong cash position
Commenting on the results, Glyn Edwards, CEO of Antisoma, said: "We
have made important progress this year, with gathering momentum on
our two phase III programmes, positive phase II data for a third
product and our first product approval from the FDA. With the
pipeline maturing, we now have a dual focus on driving products
towards regulatory approvals and on building a strong platform for
product commercialisation."
Eric Dodd, Antisoma's CFO, added: "The successful divestment of oral
fludarabine to sanofi-aventis has added significantly to our cash
resources, further strengthening our balance sheet. We can now fund
all our priority programmes until mid-2011, beyond the time we expect
key phase III data for ASA404 and AS1413."
A webcast and conference call will be held today at 9:30 am BST. The
webcast can be accessed via Antisoma's website at
http://www.antisoma.com/asm/media/webcast/ and the call by dialling
+44 (0) 207 806 1964 UK Toll (US Toll +1 718 354 1390) and using the
Confirmation Code: 9656482. A recording of the webcast will also be
available afterwards on the Antisoma website.
Except for the historical information presented, certain matters
discussed in this statement are forward looking statements that are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from results, performance or
achievements expressed or implied by such statements. These risks and
uncertainties may be associated with product discovery and
development, including statements regarding the Group's clinical
development programmes, the expected timing of clinical trials and
regulatory filings. Such statements are based on management's current
expectations, but actual results may differ materially.
Joint Chief Executive and Chairman's statement
Overview
We have seen excellent progress this year on both of our phase III
drugs, ASA404 and AS1413. Our partner Novartis has advanced and
expanded the ASA404 programme in lung cancer. Meanwhile, we have
enlarged the AS1413 phase III trial in secondary acute myeloid
leukaemia (secondary AML) and reported new data supporting this
trial. We have also presented positive phase II data for a third
product, AS1411, and were successful in gaining FDA approval for -
and then divesting - a non-core asset, oral fludarabine. With the
funds from this divestment, we have sufficient cash to fund all our
priority programmes until mid-2011, which is after the time we expect
key phase III data for both ASA404 and AS1413. We are therefore
confident in our ability to reach these two potentially
transformational sets of results within the current cash life of the
business.
ASA404 programme advances and expands
Our Tumour-Vascular Disrupting Agent, ASA404, is making good progress
in the capable hands of our partner, Novartis. Earlier this month, we
announced that the 1200-patient phase III trial (ATTRACT-1) testing
the drug as a first-line treatment for non-small cell lung cancer
(the main form of lung cancer) had completed patient enrolment.
ATTRACT-1 builds on phase II data showing a five-month improvement in
median survival when ASA404 was added to standard first-line
chemotherapy for lung cancer. We expect that final data from the
ATTRACT-1 study will be available in late 2010 or early 2011 and that
filings for marketing licences will follow during 2011 if these data
are positive.
In January Novartis started a second, 900-patient phase III trial
(ATTRACT-2), testing ASA404 in patients who have already received one
round of treatment for non-small cell lung cancer. This trial is
designed to support applications to market ASA404 as a second-line
treatment. We are very pleased that Novartis has decided to evaluate
ASA404 in both the first-line and second-line settings, as this will
ensure that a broad spectrum of lung cancer patients could be
eligible for treatment with the drug.
During the year, the results of the two phase II trials supporting
phase III development in lung cancer were published in the British
Journal of Cancer and Lung Cancer. We also announced further
encouraging findings from a phase II trial in prostate cancer.
In February, we announced that Novartis had decided on priorities for
the further development of ASA404. After lung cancer, the next
priority will be HER2-negative metastatic breast cancer. The decision
to expand the development programme to include breast as well as lung
cancer underlines the broad potential of ASA404.
In addition to the USD 100 million that we have already received from
Novartis, we can earn substantial further milestone payments based on
progress of ASA404 in development and achievement of sales targets.
We will also earn royalties on all sales of the drug worldwide, and
have a strategically important option to co-commercialise ASA404 in
the US.
AS1413 development gains momentum
AS1413 is a novel chemotherapy drug with promising potential as a
treatment for blood cancers. A key property of AS1413 is its ability
to evade multi-drug resistance mechanisms. These are molecular pumps
used by cancer cells to expel drugs, including some of the major
chemotherapies in use today. By evading these mechanisms, AS1413 has
the potential to work in settings where other treatments are
compromised.
We are developing AS1413 initially as a treatment for secondary acute
myeloid leukaemia (secondary AML), a form of AML that evolves from
prior bone marrow disease or develops following radiotherapy or
chemotherapy for other cancers. Patients with secondary AML often
have multi-drug resistant disease and there are no drugs approved
specifically for this condition.
We are enrolling patients into a pivotal, randomised phase III trial
of AS1413 in secondary AML. This trial, called ACCEDE, compares
AS1413 plus cytarabine with daunorubicin plus cytarabine, the most
common initial treatment for AML. It is being conducted under a
Special Protocol Assessment (SPA) agreed with the US Food and Drug
Administration (FDA). During the period, we gained agreement from the
FDA for an expansion of the trial to 450 patients. In tandem with
this expansion, we have increased the number of hospitals involved in
the study in the US and opened the trial to recruitment in a variety
of countries across Europe, Asia, Australia and Latin America.
The ACCEDE study builds on data from an 88-patient phase II trial of
AS1413 in secondary AML. This reported a 39% complete remission rate
in patients receiving AS1413 plus cytarabine, which compares
favourably with rates of around 25% seen in secondary AML patients
receiving daunorubicin plus cytarabine in two previous studies.
Long-term follow up data from the AS1413 phase II trial were
presented at the American Society of Hematology (ASH) meeting in
December. These included the highly encouraging finding that among
those patients who showed a complete response to treatment, some 40%
were still in remission 18 months after receiving AS1413.
Data from the ACCEDE trial are expected to be available in late
2010 or early 2011. Should results be positive, we plan to market the
drug ourselves in the US while seeking partners for marketing in
other countries. We believe that beyond the initial opportunity in
secondary AML, AS1413 could also have potential in a variety of other
blood cancer settings.
AS1411 development advances
Our aptamer drug AS1411 has been the subject of considerable interest
this year, with the reporting of the first phase II data on the drug
and further data expected in the near future.
At the most recent ASH and ASCO meetings, we reported data from a
phase II trial in AML - the first randomised trial to test an aptamer
drug as a treatment for cancer. Combination of AS1411 with high-dose
chemotherapy increased the response rate compared with chemotherapy
alone in patients with disease unresponsive to or relapsed after
other treatments. This was achieved without any significant increase
in side effects. Following these positive findings, we are planning
phase IIb studies with AS1411 in AML. These will be designed to
identify the best way for us to approach a pivotal study that would
support applications for marketing.
In parallel with the trial in AML, we have been running a single-arm
phase II trial in renal cancer. This completed patient enrolment in
May, and is expected to report initial data later this year and final
data in the first half of 2010.
Like AS1413, AS1411 is unpartnered. We plan to continue development
through late-stage trials and to commercialise the product ourselves
in the US while seeking partners for other territories.
Other pipeline developments
We have had a number of developments in our earlier stage pipeline.
We discontinued development of our antibody drug AS1402 when it
became clear that a phase II trial in breast cancer was very unlikely
to yield sufficiently positive efficacy data to support further
development. Our antibody-cytokine fusion protein AS1409 completed a
phase I trial in melanoma and renal cancer, providing encouraging
evidence of anti-cancer activity which was presented at the ASCO
meeting in June. We are now considering next steps for this product.
Our phase I radiolabelled peptide, P2045, was divested to Bryan
Oncor, a company with a focus on radiopharmaceuticals. Finally, we
continue to make progress with our pre-clinical programmes, including
AMPK activators licensed from Betagenon; PPM1D inhibitors being
developed through a collaboration with The Institute of Cancer
Research; and the Flt-3 programme in autoimmune diseases, acquired
last year with Xanthus Pharmaceuticals.
Value realised from oral fludarabine asset
Antisoma acquired oral fludarabine with the acquisition of Xanthus in
June 2008. In December, we were successful in gaining FDA approval
for the marketing of this drug in chronic lymphocytic leukaemia
(CLL). This enabled us to conclude, as planned, a lucrative
divestment deal. In May, we sold our rights to market the drug in the
US to sanofi-aventis in return for an initial payment of USD 60
million (GBP 39.4 million).
Strong cash position maintained
Antisoma expects its cash resources to last until mid-2011, beyond
the time when data are expected from the key phase III studies of
ASA404 and AS1413. Divesting of oral fludarabine has removed any
potential funding shortfall up to the phase III results. We finished
the period with cash and short-term deposits of GBP 67.0 million,
which is similar to last year (2008: GBP 66.9 million).
Total revenues for the year ended 30 June 2009 were GBP 25.2 million,
compared with GBP 39.5 million last year. This year's revenues
reflect recognition of the balance of the USD 100 million upfront and
lung cancer phase III initiation milestones from Novartis (GBP 5.4
million) and half of the USD 60 million upfront payment from
sanofi-aventis (GBP 19.7 million). The balance of the sanofi-aventis
upfront payment is expected to be recognised in the financial year
2009-2010.
Total operating expenses have increased from GBP 28.7 million last
year to GBP 40.8 million this year, mainly reflecting an increase in
research and development (R&D) costs from GBP 22.2 million to GBP
35.9 million. General and administrative costs were GBP 4.9 million
(2008: GBP 6.5 million).
We have recorded a full-year loss of GBP 16.4 million, compared with
a profit of GBP 12.3 million last year. At this stage in our
development, profits and losses reflect the balance between
recognition of deferred revenues and our ongoing operating expenses.
This year, operating expenses exceeded the revenues recognised from
the Novartis and sanofi-aventis deals.
Preparing for commercialization
In line with our plan to become a company that markets as well as
develops cancer drugs, we have made two appointments of individuals
with significant commercial experience. Eric Dodd joined in November
as Chief Financial Officer, following a career in technology
businesses, and Michael Lewis, a senior commercial executive at the
medical device company Gambro, has joined our Board as a
Non-Executive Director. The Board wishes to thank Raymond Spencer,
our former Chief Financial Officer who left Antisoma in December
2008, for his contribution to the development of the Company.
Outlook
We anticipate important pipeline developments in the near future,
notably the initiation by Novartis of trials to evaluate ASA404 in a
second major cancer indication, metastatic breast cancer. We will
also be reporting the first data from our phase II trial of AS1411 in
renal cancer before the end of the year, with final data to follow in
the first half of 2010.
More broadly, we are moving forward with our plan to transform
Antisoma from a drug development company into a business with
marketed oncology products. With two drugs now well into phase III
testing, our pipeline is advancing in a manner that clearly fits with
this objective. The recent announcement that the key phase III trial
of ASA404 in lung cancer is fully enrolled emphasises our proximity
to potential marketing applications and opportunities to begin
generating sustainable revenues from product sales. We look forward
to the next period of evolution, confident in the knowledge that we
have the financial and human resources to support the advancement of
our key assets towards commercialisation.
All amounts arise from continuing operations.
[1] Certain costs have been reclassified between research and
development expenditure and administrative expenses as disclosed in
Note 1.
[1]Cash and cash equivalents and short-term deposits have been
reclassified as disclosed in Note 1.
[1] Cash and cash equivalents and short-term deposits have been
reclassified as disclosed in Note 1
Notes to the financial information for the year ended 30 June 2009
1. Basis of preparation
The financial information in this preliminary announcement has not
been audited and does not constitute statutory accounts as defined in
Section 435 of the Companies Act 2006. The information has been
extracted from the consolidated financial statements for the year
ended 30 June 2009. The financial statements will be delivered to the
Registrar of Companies after the Annual General Meeting. The
consolidated financial statements for the year ended 30 June 2008
have been delivered to the Registrar of Companies and were given an
unqualified audit opinion by the Company's auditors.
The financial information in this statement has been prepared in
accordance with International Financial Reporting Standards ('IFRS')
as endorsed by the European Union, International Financial Reporting
Interpretation Committee ('IFRIC') interpretations and those parts of
the Companies Act 2006 applicable to companies reporting under IFRS.
There have been no new standards during the year that have
significantly impacted the results of the Group.
Reclassification
The Directors have reviewed the classification of certain items
within the Income Statement and Balance Sheet and believe, in order
to aid comparison, it is more appropriate to classify the following
differently than was reported in prior periods:
The Group's definition of cash and cash equivalents has been restated
to reflect more accurately the underlying substance of the deposits.
Historically cash was classified as a deposit when its duration was
over 90 days whereas it now includes all cash deposited for more than
three months. The impact of the change is to increase cash and cash
equivalents and reduce short-term deposits by GBP nil (2008: GBP
23,000,000). The relevant comparatives in the cash flow statement
have been amended to reflect this adjustment.
Certain costs were previously included within administrative expenses
and have been reclassified in Research & Development in order to be
consistent with industry sector accounting practices. The impact of
the change is to increase research and development costs and reduce
administrative expenses by GBP 8,177,000 (2008: GBP 3,817,000).
Reallocated costs include business development, facilities and a
proportion of other overheads directly attributable to research and
development activities. There is no impact on operating profit/loss
or earnings/loss per share.
2. Segmental information
Primary reporting segment - business segment
The Directors are of the opinion that under IAS 14 - 'Segmental
information' the Group has only one business segment, being drug
development.
Secondary reporting segment - geographical segment
The Group's geographical segments are determined by location of
operations.
All revenue has been derived from external customers located in the
US and Europe. The principal sources of revenue for the Group in the
two years ended 30 June 2009 were:
Total assets are allocated based on where the assets are located.
The following table shows the costs in the period to acquire
property, plant, equipment and intangibles by location of assets:
Capital expenditure is allocated based on where the assets are
located.
Group
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
* Strong partnership maintained with Novartis
* Phase III trial in first-line lung cancer completes enrollment
of 1200 patients (September 2009)
* Phase III trial in second-line lung cancer initiated
* Breast cancer selected as next indication for development
* Phase III trial in secondary AML expanded
* Phase II trial shows durable responses in secondary AML
* Positive data from phase II trial in AML
* Plans announced for phase IIb development in AML
* Phase II trial in renal cancer completes patient enrolment
* Drug approved by FDA
* Divested to sanofi-aventis in USD 65 million deal
* Oral fludarabine divestment extends cash runway to mid-2011
* Cash life now extends beyond expected timing of key phase III
data
* Cash and short-term deposits of GBP 67.0 million at 30 June
2009
* Full-year loss of GBP 16.4 million
Glyn Edwards
Chief Executive Officer
Barry Price
Chairman
Unaudited consolidated income statement
for the year ended 30 June 2009
2009 2008[1]
Notes GBP '000 GBP '000
Revenue 2 25,230 39,527
Cost of sales (9,085) -
Gross profit 16,145 39,527
Research and development expenditure (35,904) (22,249)
Administrative expenses (4,884) (6,480)
Total operating expenses (40,788) (28,729)
Operating (loss)/profit (24,643) 10,798
Finance income 5,055 2,578
(Loss)/profit before taxation (19,588) 13,376
Taxation 3,161 (1,047)
(Loss)/profit for the year (16,427) 12,329
(Loss)/earnings per ordinary share
Basic (2.7)p 2.7p
Diluted (2.7)p 2.6p
Unaudited consolidated statement of recognised income and expense
for the year ended 30 June 2009
2009 2008
GBP '000 GBP '000
(Loss)/profit for the year (16,427) 12,329
Exchange translation difference on consolidation 8,923 (235)
Total recognised (expense)/income for the year (7,504) 12,094
Unaudited consolidated balance sheet
as at 30 June 2009
2009 2008[1]
Notes GBP '000 GBP '000
ASSETS
Non-current assets
Goodwill 6,708 5,559
Intangible assets 51,257 47,149
Property, plant and equipment 1,967 2,358
59,932 55,066
Current assets
Trade and other receivables 1,701 2,113
Current tax receivable 3,484 -
Short-term deposits 27,824 10,000
Cash and cash equivalents 39,215 56,861
72,224 68,974
LIABILITIES
Current liabilities
Trade and other payables (7,417) (9,866)
Current income tax liabilities - (297)
Deferred income (19,690) (5,401)
Provisions (1,902) (629)
Net current assets 43,215 52,781
Total assets less current liabilities 103,147 107,847
Non-current liabilities
Deferred income tax liabilities (6,708) (5,559)
Provisions (224) (81)
(6,932) (5,640)
Net assets 96,215 102,207
Shareholders' equity
Share capital 10,480 10,467
Share premium 119,783 119,629
Shares to be issued 2,273 2,273
Other reserves 46,919 37,996
Profit and loss account (83,240) (68,158)
Total shareholders' equity 3 96,215 102,207
Unaudited consolidated cash flow statement
for the year ended 30 June 2009
2009 2008[1]
GBP '000 GBP '000
Cash flows from operating activities
(Loss)/profit for the year (16,427) 12,329
Adjustments for:
Foreign exchange gain (2,238) -
Finance income (5,055) (2,578)
Tax (credit)/charge (3,161) 1,047
Depreciation of property plant and equipment 650 213
Derecognition of an intangible asset 8,750 -
Share-based payments 1,345 1,051
Operating cash flows before movement in working
capital (16,136) 12,062
Decrease in trade and other receivables 385 961
Increase/(decrease) in trade and other
payables and deferred income 12,829 (28,506)
Cash used in operations (2,922) (15,483)
Interest received 1,951 2,753
Income taxes paid (620) -
Research and development tax credit received - 2,011
Net cash used in operating activities (1,591) (10,719)
Cash flows from investing activities
Purchase of property, plant and equipment (232) (1,969)
Sale of property, plant and equipment 8 -
Purchase of intangible assets (1,779) (1,605)
Purchase of short-term deposits (17,824) (5,000)
Net cash outflow in respect of acquisitions - (237)
Net cash used in investing activities (19,827) (8,811)
Cash flows from financing activities
Proceeds from issue of ordinary share capital 167 20,966
Expenses paid in connection with issue of ordinary
share capital - (980)
Net cash generated from financing activities 167 19,986
Net (decrease)/increase in cash and cash
equivalents (21,251) 456
Exchange gains/(losses) on cash and cash
equivalents 3,605 (9)
Cash and cash equivalents at beginning of year 56,861 56,414
Cash and cash equivalents at end of year 39,215 56,861
2009 2008
GBP '000 GBP '000
US
Recognition of income from the divestment of oral
fludarabine
sanofi-aventis 19,690 -
Europe
Recognition of upfront and milestone payments on a
time apportioned basis:
Novartis 5,401 38,806
Other - 265
R&D services and materials
recharged:
Novartis 139 456
Total revenues 25,230 39,527
The following table shows the carrying value of segment assets by
location of assets:
2009 2008
GBP '000 GBP '000
Total assets
UK 105,331 75,264
US 26,825 48,776
Total 132,156 124,040
2009 2008
GBP '000 GBP '000
Capital expenditure
UK 1,875 3,574
US 136 26,900
Total 2,011 30,474
3. Statement of changes in equity
Other Other
Shares reserve: reserve: Profit
Share Share to be and
capital premium issued retranslation merger loss Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 July
2007 8,795 100,451 - (1,024) 19,595 (81,538) 46,279
Profit for
the year - - - - - 12,329 12,329
New share
capital
issued 1,672 20,158 - - 19,660 - 41,490
Expenses on
share issue
taken to
share premium - (980) - - - - (980)
Share capital
to be issued - - 2,273 - - - 2,273
Share
options:
value of
employee
services - - - - - 1,051 1,051
Foreign
exchange
adjustments
on
consolidation - - - (235) - - (235)
At 30 June
2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207
At 1 July
2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207
Loss for the
year - - - - (16,427) (16,427)
New share
capital
issued 13 154 - - - - 167
Share
options:
value of
employee
services - - - - - 1,345 1,345
Foreign
exchange
adjustments
on
consolidation - - - 8,923 - - 8,923
At 30 June
2009 10,480 119,783 2,273 7,664 39,255 (83,240) 96,215
Copyright © Hugin AS 2009. All rights reserved.
Antisoma plc
+44 (0)7909 915 068
Glyn Edwards, Chief Executive Officer
Eric Dodd, Chief Financial Officer
Daniel Elger, VP, Marketing & Communications
Buchanan Communications
+44 (0)20 7466 5000
(All media enquiries)
Mark Court, Lisa Baderoon
The Trout Group
+1 617 583 1308
(US investor enquiries)
Seth Lewis