RNS Number:4707O
Alizyme PLC
08 August 2003
Meetings today:
Alizyme will be holding meetings at 10.00 am and 11.30 am at the offices of
Buchanan Communications, 107 Cheapside, London EC2V. If you would like to attend
please call Charlie Forsyth or Lisa Baderoon on 020 7466 5000.
For Immediate Release 08 August 2003
Alizyme plc
Interim Report for the six months ended 30 June 2003
Cambridge UK, 08 August 2003: Alizyme plc (LSE:AZM) today announces its interim
results for the six months ended 30 June 2003.
Announced today
* Takeda granted rights to a licence and development agreement worth up to
US$42 million for Japanese rights to ATL-962 for the treatment of obesity and
all related diseases (see separate announcement)
HIGHLIGHTS FOR PERIOD
* Renzapride - Successful results from Phase IIb clinical trial
in constipation-predominant IBS (c-IBS) patients
* Renzapride - Completion of patient recruitment into Phase IIb
clinical trial in mixed symptom IBS (m-IBS)
* ATL-962 - Completion of recruitment into Phase IIb clinical
trial in obese patients
* Fundraising - Successfully raised #16.1m (#15.1m net of
expenses) in February 2003
* Cash and liquid resources - #15.4 million at 30 June 2003
(#11.3 million at 30 June 2002)
* Loss after tax - #7.1 million for the six months to 30 June
2003 (six months to 30 June 2002: #4.5 million)
For further information, please contact:
ALIZYME plc +44 (0) 1223 896000
Dr Richard Palmer, Chief Executive Officer
Tim McCarthy, Finance Director
BUCHANAN COMMUNICATIONS +44 (0) 20 7466 5000
Lisa Baderoon M: 07721 413 496
Rebecca Skye Dietrich
Further information on Alizyme can be found on the Company's website:
www.alizyme.com
Chairman's and Chief Executive's Statement
Overview
During the last six months, we have again made substantial progress as a Company
and in the development of our clinical programmes. We started the year with a
successful fundraising exercise, which completed in February, raising #16.1
million (#15.1 million after expenses). We were very encouraged by the level of
support from both existing and new shareholders, in what could only be described
as difficult market conditions. The fundraising secured Alizyme's financial
position, to enable us to continue to progress our four products through
clinical development whilst at the same time strengthening our bargaining
position in the commercialisation of these products through out-licensing.
Our product portfolio is now moving towards later stage development. With
COLAL-PREDTM in Phase III, renzapride having successfully completed its first
Phase IIb clinical trial and ATL-962 due to complete its first Phase IIb
clinical trial later in the year, Alizyme could be in a position, by the end of
2003, of having three products either approved for, or qualifying to enter into,
Phase III clinical development and being suitable for out-licensing. Our fourth
product, ATL-104 for mucositis, is due to commence Phase IIa clinical trials
around the end of 2003.
In advance of the ATL-962 Phase IIb results, we have today separately announced
the grant of the rights to a licence and development agreement with Takeda
Chemical Industries, Ltd. ("Takeda"), for the Japanese rights to ATL-962, the
first step in the commercialisation of our product portfolio.
RENZAPRIDE
During the period we reported preliminary results from our successful Phase IIb
clinical trial of renzapride in 510 patients with c-IBS. The robust design of
this Phase IIb trial established renzapride's clinical and competitive profile
and allows us to prepare for Phase III development, whilst initiating dialogue
with potential licensing partners.
We are also conducting a 170 patient trial of renzapride in patients with
alternating or mixed-symptom IBS (m-IBS), which has completed patient enrolment
and is expected to report preliminary results in October this year. The m-IBS
patient population is distinct from that of c-IBS, representing approximately
40% of the total IBS population, and is therefore a significant commercial
opportunity. In addition, a pharmacokinetic/ pharmacodynamic clinical trial at
Mayo Clinic in the USA is also ongoing; this trial aims to establish the
relationship between the levels of drug absorbed and gastrointestinal motility
in c-IBS patients.
Successful results from these ongoing trials would complement our c-IBS Phase
IIb results and would significantly expand the commercial value of this product
and its potential for licensing. We have already initiated preliminary
discussions with a number of potential licensees with the view to
commercialising renzapride prior to commencing Phase III clinical development.
COLAL-PREDTM
Activity in the period has concentrated on optimising the formulation and on
scaling up the manufacturing process for COLAL-PREDTM?, in preparation for the
commencement of a Phase III clinical trial in Europe in patients with active
ulcerative colitis around the end of 2003 and for eventual product marketing. As
part of our commitment to achieving the best possible deal for our shareholders
this year, we intend to manufacture COLAL-PREDTM? and retain the manufacturing
rights to the marketed product.
ATL-962
During the period we reported the completion of patient recruitment in a Phase
IIb clinical trial of ATL-962 for the treatment of obesity. Preliminary results
of this trial, which are anticipated to be announced in October 2003, are
expected to contribute substantially to defining the product profile relating to
efficacy, safety and tolerability and, given positive results, will assist in
the design of a Phase III programme.
Following the signing of the agreement with Takeda for Japan, announced
separately today, positive results from the Phase IIb trial would facilitate
further commercial exploitation of ATL-962 for the rest of the world.
ATL-104
During the period we progressed the development of ATL-104, by developing and
evaluating a range of mouthwash formulations for delivering the product locally
to the mouth. We are now preparing to carry out a Phase IIa proof of concept
clinical trial in cancer patients with the mouthwash formulation and expect to
receive regulatory approval to commence this trial around the end of 2003.
Financial Review
In the six months ended 30 June 2003, Alizyme made a net loss of #7.1 million
(six months ended 30 June 2002 - #4.5 million). Net cash outflow before
management of liquid resources and financing for the period was #5.0 million
(six months ended 30 June 2002 - #4.1 million). Cash and liquid resources were
#15.4 million at 30 June 2003 (#11.3 million at 30 June 2002).
In the first six months of 2003, research and development expenditure was #7.3m
(2002: #4.6m), reflecting the high level of late stage clinical trial activity.
Although the trials were substantially completed in the period, cash outflow
does not fully reflect this level of expenditure, as the timing of payments to
contractors will fall into the second half of 2003. Research and development
expenditure in the second six months is expected to be significantly lower, as
the Phase IIb trials report and complete. Additionally, in the second half, we
will have generated the Company's first income, as a result of the agreement
signed with Takeda.
Prospects
We were extremely pleased to announce separately today the first commercial deal
from our portfolio of products. The agreement signed with Takeda endorses the
progress Alizyme has made to date and begins to allow us to realise the value
that is within our portfolio of later stage products.
With Phase IIb results due in October for both our renzapride m-IBS trial and
our ATL-962 obesity trial, we anticipate further significant news flow over the
coming months. Successful results from the ATL-962 trial would enhance Alizyme's
ability to out-license ATL-962 for the rest of the world. Successful results in
the m-IBS trial would confirm the scope of the role of renzapride in the
treatment of IBS, increasing its overall commercial potential. The outcome of
these and other activities expected to be reported in the next period should
have a significant impact on Alizyme's profile, and future potential.
The team at Alizyme have again made a significant contribution to the
achievements in the period and we would therefore like to take this opportunity
to thank everyone for their commitment and effort.
Sir Brian Richards CBE
Chairman
Dr Richard Palmer
Chief Executive Officer
08 August 2003
Consolidated Profit and Loss Account
For the six months ended 30 June 2003
Six months Six months Twelve months
ended ended ended
30 June 30 June 31 December
2003 2002 2002
#000's #000's #000's
Turnover - - -
Operating expenses:
Research and development (7,256) (4,635) (9,692)
Management and administration (509) (567) (1,176)
__________ __________ __________
Operating loss (7,765) (5,202) (10,868)
Interest receivable 226 246 396
__________ __________ __________
Loss on ordinary activities before (7,539) (4,956) (10,472)
taxation
Taxation on loss on ordinary 427 430 710
activities
__________ __________ __________
Loss for the period being the
retained loss for the
period attributed to the members of (7,112) (4,526) (9,762)
Alizyme plc
__________ __________ __________
__________ __________ __________
========== ========== ==========
Loss per share - basic and diluted (5.9p) (5.7p) (12.3p)
(note 2)
__________ __________ __________
========== ========== ==========
There were no recognised gains and losses in any period other than the loss for
that period.
All amounts relate to continuing activities.
Consolidated Balance Sheet
As at 30 June 2003
As at As at As at
30 June 30 June 31 December
2003 2002 2002
#000's #000's #000's
Fixed assets
Tangible fixed assets 167 299 231
__________ __________ __________
Current assets
Debtors 1,009 1,762 1,659
Short term investments 15,364 11,132 5,204
Cash at bank and in hand 26 210 116
__________ __________ __________
16,399 13,104 6,979
Creditors: Amounts falling due within (4,131) (3,743) (2,796)
one year
__________ __________ __________
Net current assets 12,268 9,361 4,183
__________ __________ __________
Total assets less current 12,435 9,660 4,414
liabilities
Provisions for liabilities and (64) (10) -
charges (note 3)
__________ __________ __________
Net assets 12,371 9,650 4,414
__________ __________ __________
========== ========== ==========
Capital and reserves
Called-up share capital 2,738 1,587 1,587
Share premium account 49,904 35,986 35,986
Capital reserve 1,530 1,530 1,530
Profit and loss account (41,801) (29,453) (34,689)
__________ __________ __________
Equity shareholders' funds 12,371 9,650 4,414
__________ __________ __________
========== ========== ==========
Consolidated Cash Flow Statement
For the six months ended 30 June 2003
Six months Six months Twelve months
ended ended ended
30 June 30 June 31 December
2003 2002 2002
#000's #000's #000's
Net cash outflow from operating
activities
(note 4) (5,898) (4,984) (11,188)
__________ __________ __________
Returns on investments and
servicing of finance
Interest received 195 287 470
__________ __________ __________
Net cash inflow from returns on
investments and
servicing of finance 195 287 470
__________ __________ __________
Taxation
Research and development tax credit 710 693 693
received
__________ __________ __________
Net cash inflow from taxation 710 693 693
__________ __________ __________
Capital expenditure and financial
investment
Purchase of tangible fixed assets (6) (70) (71)
__________ __________ __________
Net cash outflow from capital
expenditure and
financial investment (6) (70) (71)
__________ __________ __________
Cash outflow before management of
liquid
resources and financing (4,999) (4,074) (10,096)
__________ __________ __________
Management of liquid resources
Cash placed on money market (15,069) - -
deposits
Cash withdrawn from money market 4,909 3,949 9,877
deposits
__________ __________ __________
Net cash (outflow)/inflow from
management of
liquid resources (10,160) 3,949 9,877
__________ __________ __________
Financing
Issue of ordinary share capital 15,069 99 99
(net)
__________ __________ __________
Net cash inflow from financing 15,069 99 99
__________ __________ __________
__________ __________ __________
========== ========== ==========
Decrease in cash in the period (90) (26) (120)
__________ __________ __________
========== ========== ==========
Notes to the financial information
1 Basis of preparation
The interim financial information has been prepared on the basis of the
accounting policies set out in the Group's statutory financial statements for
the year ended 31 December 2002.
These interim financial statements do not constitute statutory financial
statements within the meaning of section 240 of the Companies Act 1985. Results
for the six-month periods ended 30 June 2003 and 30 June 2002 have not been
audited. The results for the year ended 31 December 2002 have been extracted
from the statutory financial statements, which have been filed with the
Registrar of Companies and upon which the auditors reported without
qualification.
Copies of the interim results for the six months ended 30 June 2003 are being
sent to all shareholders. Details can also be found on the Company's website at
www.alizyme.com. Further copies of the interim results and copies of the full
financial statements for the year ended 31 December 2002 can be obtained by
writing to the Company Secretary at Alizyme plc, Granta Park, Great Abington,
Cambridge CB1 6GX or by sending an electronic mail to info@alizyme.com.
2 Loss per share
The diluted loss per share takes into account the dilutive effect of share
options. Ordinary shares which are potentially issuable are only included in the
calculation of diluted earnings per share if their issue would decrease net
profit per share or increase net loss per share. The exercise of share options
do not increase the basic loss per share and therefore the basic and diluted
loss per share are the same. The loss per share is based on the loss of
#7,112,000 for the six months ended June 2003 (six months ended June 2002 -
#4,526,000; twelve months ended December 2002 - #9,762,000) and on 120,821,000
ordinary shares (June 2002 - 79,227,000; December 2002 - 79,291,000) being the
weighted average number of equity shares in issue.
3 Provision for employer's National Insurance on gains on share options
A provision of #64,000 (30 June 2002 - #10,000; 31 December 2002 - Nil) has been
recognised for National Insurance contributions that will be payable on gains
realised upon the exercise of share options issued or amended after 6 April
1999. The provision is based upon the closing share price of the Company on 30
June 2003, which was 48p (30 June 2002 - 57.5p; 31 December 2002 - 34p) and
calculated at a National Insurance rate of 12.8% (30 June 2002 - 11.8%; 31
December 2002 - 11.8%). The provision has been allocated over the performance
period of each employee, where the performance period is the period during which
the employee must perform the services necessary to become unconditionally
entitled to the options.
4 Reconciliation of Operating Loss to Operating Cash Flows
Six months Six months Twelve months
ended ended ended
30 June 30 June 31 December
2003 2002 2002
#000's #000's #000's
Operating loss (7,765) (5,202) (10,868)
Depreciation charge 70 63 132
Decrease/(increase) in debtors 398 (785) (435)
Increase/(decrease) in creditors 1,335 938 (9)
Increase/(decrease) in provisions
for liabilities and
charges 64 2 (8)
__________ __________ __________
Net cash outflow from operating (5,898) (4,984) (11,188)
activities
__________ __________ __________
INDEPENDENT REVIEW REPORT TO ALIZYME PLC
Introduction
We have been instructed by the Company to review the financial information for
the six months ended 30 June 2003 which comprises the profit and loss account,
the balance sheet, the cash flow statement and related notes 1 to 4. We have
read the other information contained in the interim report and considered
whether it contains any apparent misstatements or material inconsistencies with
the financial information.
This report is made solely to the company in accordance with Bulletin 1999/4
issued by the Auditing Practices Board. Our work has been undertaken so that we
might state to the company those matters we are required to state to them in an
independent review report and for no other purpose. To the fullest extent
permitted by law, we do not accept or assume responsibility to anyone other than
the company, for our review work, for this report, or for the conclusions we
have formed.
Directors' responsibilities
The interim report, including the financial information contained therein, is
the responsibility of, and has been approved by, the directors. The directors
are responsible for preparing the interim report in accordance with the Listing
Rules of the Financial Services Authority which require that the accounting
policies and presentation applied to the interim figures should be consistent
with those applied in preparing the preceding annual accounts except where any
changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with the guidance contained in Bulletin
1999/4 issued by the Auditing Practices Board for use in the United Kingdom. A
review consists principally of making enquiries of group management and applying
analytical procedures to the financial information and underlying financial data
and, based thereon, assessing whether the accounting policies and presentation
have been consistently applied unless otherwise disclosed. A review excludes
audit procedures such as tests of controls and verification of assets,
liabilities and transactions. It is substantially less in scope than an audit
performed in accordance with United Kingdom auditing standards and therefore
provides a lower level of assurance than an audit. Accordingly, we do not
express an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that
should be made to the financial information as presented for the six months
ended 30 June 2003.
Deloitte & Touche LLP
Chartered Accountants
Cambridge
08 August 2003
This information is provided by RNS
The company news service from the London Stock Exchange
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