<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------------------------
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13A-16 OR 15D-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 1999.
PROTHERICS PLC
(Translation of Registrant's Name Into English)
Beechfield House
Lyme Green Business Park
Macclesfield Cheshire SK11 0JL
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.)
Form 20-F [ X ] Form 40-F [ ]
(Indicate by check mark whether the registrant by furnishing the
information contained in this form is 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-____________________.
Attached to the Registrant's Form 6-K for the month of December 1999
and incorporated by reference herein are the Registrant's announcements each as
reported to the Company Announcements Office of the London Stock Exchange on
December 16, 1999.
<PAGE> 2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
PROTHERICS PLC
Date: December 21, 1999 By: /s/ Andrew J. Heath
---------------------------
Andrew J. Heath, M.D., Ph.D.
Chief Executive Officer
<PAGE> 3
[PROTHERICS LOGO]
16 December 1999
PROTHERICS TO COLLABORATE WITH LILLY ON ANTI-THROMBOTICS
Protherics PLC and Eli Lilly and Company today announced an exclusive research
collaboration and licensing agreement to discover, develop and commercialize
compounds for the treatment of thrombosis. The multi-year collaboration will
focus on optimizing Protherics' existing Factor Xa inhibitor leads, identifying
new leads through use of Protherics' proprietary Computer Aided Molecular Design
(CAMD) technology and investigating other anti-thrombotic targets and compounds.
During the initial two years of the agreement, Protherics may receive more than
$5m in initial license fees, research funding and milestone payments based on
achievement of specific objectives. Total payments to Protherics over the
lifetime of the agreement have the potential to reach much higher values. Sales
royalties will be paid on commercialised products emerging from the
collaboration.
Arthur Rushton, Protherics Chief Operating Officer, said, "This deal is a goal
we have been working towards for the last 3 years since we reorganized and
strengthened our CAMD research efforts. Our research team has met challenging
targets, delivered promising results and we anticipate further interest in our
CAMD technology and projects."
Factor Xa inhibitors are a new class of compounds targeted at a key enzyme in
the blood-clotting process with the aim of preventing or limiting clot
formation. Blood clots cause serious and often fatal diseases including heart
attacks, strokes, and deep vein thrombosis. The latter presents a major danger
following surgery or trauma if clots lodge in the lung, leading to the life
threatening condition of pulmonary embolism.
Management of thrombotic diseases encompasses both prevention and treatment.
Current therapies for these diseases rely mainly on injectable drugs such as
unfractionated heparins, low molecular weight heparins and on oral warfarin,
which all have drawbacks in clinical usage. There is a medical need for new oral
treatments offering a predictable response and lack of side effects. Over 10
million people worldwide are eligible to receive oral anticoagulants for
prevention or treatment of thrombotic diseases. Oral factor Xa inhibitors, if
successful, stand to become a new standard of anticoagulant therapy and have
tremendous market potential.
<PAGE> 4
"Our agreement with Protherics will significantly enhance our efforts in
thrombosis research, an area of continuing focus," said Michael D. Clayman M.D.,
Vice President of Cardiovascular Research and Clinical Investigation for Eli
Lilly and Company. "The development of improved treatments for thrombosis is
clearly needed in the marketplace, and partnering with a quality scientific
company like Protherics will increase our likelihood of success."
"This level of endorsement by a major pharmaceutical company provides strong
external validation of our drug discovery capabilities," said Andrew Heath,
Protherics' Chief Executive Officer. "It is an excellent match, combining
Lilly's research and development skills with Protherics' CAMD expertise and
technology. We look forward to progressing the Factor Xa project and to
developing the potential for further collaboration".
FOR FURTHER INFORMATION, PLEASE CONTACT:
Andrew Heath, Chief Executive Tel: 01625 500555
Protherics PLC Mobile: 0468 256595
James Kappel, Corporate Communications Tel: 001 317 276 5795
Eli Lilly and Company
Laura Frost Tel: 0171 379 5151
The Maitland Consultancy
PROTHERICS PLC
Protherics PLC was formed on 15 September 1999 from the merger of Proteus
International plc and Therapeutic Antibodies Inc. Protherics, an international
biopharmaceutical company, has two platform technologies, the development and
production of immunotherapeutics and computer aided molecular design.
The Company's ordinary shares are listed on the London Stock Exchange.
An electronic version of this news release is available at
http://www.protherics.com.
This release, and oral statements made from time to time by Company
representatives concerning the subject matter hereof, may contain so-called
"forward looking statements." These statements can be identified by introductory
words such as "expects," "plans," "will," "estimates," "forecasts," "projects,"
or words of similar meaning, and by the fact that they do not relate strictly to
historical or current facts. Forward-looking statements frequently are used in
discussing the Company's growth strategy, operating and financial goals, plans
relating to regulatory submissions and approvals and development programs. Many
factors may cause actual results to differ from the Company's forward-looking
statements, including inaccurate assumptions and a broad variety of risks and
uncertainties, some of which are known and others of which are not. Those and
other risks are described in the Company's filings with the Securities and
Exchange Commission, copies of which are available from the SEC or may be
obtained upon request from the Company. No forward-looking statement is a
guarantee of future results or events, and one should avoid placing undue
reliance on such statements.
<PAGE> 5
[PROTHERICS LOGO]
16 DECEMBER 1999
PROTHERICS PLC
INTERIM RESULTS
Protherics PLC, a UK drug discovery and immunotherapeutics company, today
announces its results for the six months to 30th September 1999. Protherics was
formed in September from the merger of Proteus International PLC and Therapeutic
Antibodies Inc. The Interim Results are restated as though the companies had
been merged throughout the periods under review.
Highlights
- - Merger of Proteus International and Therapeutic Antibodies completed on 15
Sept.
- - Collaboration deal signed with Eli Lilly and Co. to research and develop
Factor Xa inhibitors using Protherics' Computer Aided Molecular Design
(CAMD) technology
- - DigiTAb(R) marketing applications accepted for review by FDA
- - TriTAb(R) application submitted for FDA clearance of pivotal Phase III
clinical trial
- - Promising results from CytoTAb(R) Phase IIb Sepsis study - partner being
sought for Phase III trial
- - Additional information on CroTAb(R) being submitted to FDA with product
approval expected in second half of 2000
- - First half loss of (pound)9.2m, 6.75p per share, includes exceptional
charge of (pound)1.9m related to merger
- - Cash balance at 30 September 1999 of (pound)11.9m before merger costs
Commenting on the results, Chairman Stuart Wallis said:
"We are very encouraged by our success in achieving the agreement with Eli Lilly
and Company, which validates the Computer Aided Molecular Design concept. In
addition, the Group now has two New Drug Applications filed with the FDA and 4
other products in clinical
<PAGE> 6
trials. This solid pipeline of products and projects throughout the various
stages of the development cycle gives me confidence in the outlook for the
Group."
CHAIRMAN'S STATEMENT
This is the first report since the merger on 15 September 1999 of Proteus and
Therapeutic Antibodies. I am particularly pleased that it coincides with the
announcement of our collaboration with Eli Lilly and Company which will further
the research and development of our Factor Xa inhibitors. The endorsement of our
Computer Aided Molecular Design technology by one of the world's leading
pharmaceutical companies is a great reward for the work which has taken place
over the last three years.
Since the merger, there has been significant rationalisation, total headcount
has been reduced by 71 to 135, and the new Group's headquarters is based in
Macclesfield. These cost reductions, together with the revenues from the Lilly
agreement, will significantly augment our cash position, although they will not
fully compensate for the delay in approval by the Food and Drug Administration
of our CroTAb(R) rattlesnake antivenom. As announced recently, this may produce
the need for additional financing towards the latter part of 2000. We believe
that further consolidation of the biopharmaceutical sector is desirable and in
line with our stated strategy we are actively pursuing further business
combinations.
As indicated in the Notes to the Interim Statements, following merger accounting
principles, the financial information for the current and prior periods has been
presented as if the companies had been merged throughout. Turnover in the six
months to September 1999 fell to (pound)0.5 million from (pound)2.7 million in
the same period a year earlier due to the irregular timing of milestone payments
from licensing agreements. Both research and development expenditure and
administrative expenses were largely unchanged from the earlier period.
Including an exceptional charge of (pound)1.9 million relating to costs
associated with the merger, loss per share increased to 6.7p from 4.1p.
Following the share placing, but before the settlement of merger expenses, the
closing cash balance at 30 September 1999 was (pound)11.9 million.
The merger was accomplished by the issue of 60,542,545 Proteus shares in
exchange for Therapeutic Antibodies issued shares. A further 23,325,000 shares
were placed for cash concurrent with the merger.
PRODUCT DEVELOPMENT UPDATE
I COMPUTER AIDED MOLECULAR DESIGN (CAMD)
The Factor Xa inhibitor project is aimed at developing drugs which prevent or
limit blood clot formation. Existing treatments have drawbacks, and there is
tremendous potential for a new type of treatment. The Lilly agreement will
provide not only funding, but significant additional research and development
capability in this area.
<PAGE> 7
Our Tryptase inhibitor projects, which target allergic responses and asthma,
have also progressed. Compounds suitable for both topical applications and oral
delivery are under development and optimisation.
We have strengthened our marketing efforts in support of the commercialisation
of our CAMD technology and a high level of interest is being shown.
II IMMUNOTHERAPY
We continue to work with the FDA in supplying further information in support of
the Establishment Licence Application for the CroTAb(R) manufacturing process.
The FDA will formalise its additional information requirements by mid January.
However, as previously stated, final approval may not now take place before the
second half of 2000.
The other antibody products are progressing in their clinical and regulatory
stages.
- - The DigiTAb(R) (anti-digoxin overdose treatment) marketing application was
accepted for review by the FDA in October.
- - An application (IND) for a pivotal Phase III trial of the tricyclic
antidepressant overdose treatment, TriTAb(R), was also submitted in
October.
- - On the back of the positive results from the Phase IIb study of CytoTAb(R)
in patients with life-threatening infections, efforts are underway to find
a partner to progress a Phase III trial.
A further Phase I trial is planned for the Angiotensin anti-hypertensive vaccine
in early 2000, with the aim of providing an initial proof of concept in healthy
volunteers. If successful, the project will enter Phase II trials towards the
end of 2000.
Prolog, the GnRH Immunotherapeutic licenced to ML Laboratories, is in Phase IIa
trials in prostate cancer patients. The development of an alternative
formulation necessary to allow for enhanced dosing has now been completed and
the vaccine has been manufactured in anticipation of the next phase of the
trial.
CONCLUSION
We are very encouraged by our success in achieving the agreement with Eli Lilly
and Company, which validates the Computer Aided Molecular Design concept. In
addition, the Group now has two New Drug Applications filed with the FDA and 4
other products in clinical trials. This solid pipeline of products and projects
throughout the various stages of the development cycle gives me confidence in
the outlook for the Group.
<PAGE> 8
FOR FURTHER INFORMATION, PLEASE CONTACT:
Stuart Wallis, Chairman Tel: 01625 500 555
Protherics PLC
Andrew Heath, Chief Executive Tel: 01625 500 555
Protherics PLC Mobile: 0468 256595
Laura Frost Tel: 0171 379 5151
The Maitland Consultancy
ANALYSTS CONFERENCE CALL
A conference call with executives of Protherics PLC to discuss the collaboration
with Eli Lilly and the Company's Interim Results will be held at 2:30pm GMT. For
access to the conference call please contact Emma Brown or Laura Frost at The
Maitland Consultancy on 0171 379 5151 for details.
PROTHERICS PLC
Protherics PLC was formed on 15 September 1999 from the merger of Proteus
International plc and Therapeutic Antibodies Inc. Protherics, an international
biopharmaceutical company, has two platform technologies, the development and
production of immunotherapeutics and computer aided molecular design.
The Company's ordinary shares are listed on the London Stock Exchange.
An electronic version of this news release is available at
http://www.protherics.com.
This release, and oral statements made from time to time by Company
representatives concerning the subject matter hereof, may contain so-called
"forward looking statements." These statements can be identified by introductory
words such as "expects," "plans," "will," "estimates," "forecasts," "projects,"
or words of similar meaning, and by the fact that they do not relate strictly to
historical or current facts. Forward-looking statements frequently are used in
discussing the Company's growth strategy, operating and financial goals, plans
relating to regulatory submissions and approvals and development programs. Many
factors may cause actual results to differ from the Company's forward-looking
statements, including inaccurate assumptions and a broad variety of risks and
uncertainties, some of which are known and others of which are not. Those and
other risks are described in the Company's filings with the Securities and
Exchange Commission, copies of which are available from the SEC or may be
obtained upon request from the Company. No forward-looking statement is a
guarantee of future results or events, and one should avoid placing undue
reliance on such statements.
<PAGE> 9
PROTHERICS, PLC AND SUBSIDIARIES
CONSOLIDATED PROFIT AND LOSS ACCOUNTS (UNAUDITED)
For the six months ended 30 September 1999
<TABLE>
<CAPTION>
SIX MONTHS SIX MONTHS TWELVE MONTHS
30 SEPTEMBER 30 SEPTEMBER 31 MARCH
1999 1998 1999
(As Restated) (As Restated)
(pound)'000 (pound)'000 (pound)'000
<S> <C> <C> <C>
TURNOVER 452 2,658 2,847
Cost of Goods (48) (246) (276)
Research and development expenses (4,806) (4,804) (9,865)
Administration expenses (2,917) (2,784) (5,574)
------ ------ -------
OPERATING LOSS (7,319) (5,176) (12,868)
Merger expenses (1,908) -- --
Interest receivable 198 318 671
Interest payable (189) (486) (820)
------ ------ -------
LOSS ON ORDINARY ACTIVITIES BEFORE AND AFTER
TAXATION FOR THE PERIOD (9,218) (5,344) (13,017)
====== ====== =======
LOSS PER SHARE (PENCE) (6.75p) (4.14p) (9.89p)
====== ====== =======
</TABLE>
CONSOLIDATED BALANCE SHEET (UNAUDITED)
At 30 September 1999
<TABLE>
<CAPTION>
30 SEPTEMBER 30 SEPTEMBER 31 MARCH
1999 1998 1999
(As restated) (As restated)
(pound)'000 (pound)'000 (pound)'000
<S> <C> <C> <C>
FIXED ASSETS
Tangible assets 7,019 8,122 8,270
------- ------- -------
CURRENT ASSETS
Debtors 535 1,670 756
Cash at bank 11,927 10,169 9,572
Inventories 90 155 190
Prepayments 95 94 357
------- ------- -------
12,647 12,088 10,875
CREDITORS - AMOUNTS FALLING DUE WITHIN ONE YEAR (4,390) (7,063) (3,648)
------- ------- -------
NET CURRENT ASSETS 8,257 5,025 7,227
------- ------- -------
TOTAL ASSETS LESS CURRENT LIABILITIES 15,276 13,147 15,497
CREDITORS - AMOUNTS FALLING DUE AFTER MORE
THAN ONE YEAR (3,895) (4,148) (3,623)
======= ======= =======
NET ASSETS 11,381 8,999 11,874
======= ======= =======
CAPITAL AND RESERVES
Called up equity share capital 3,157 2,691 2,691
Share premium account 55,350 47,171 47,171
Other reserves 51,163 40,425 51,163
Profit and loss account (98,289) (81,288) (89,151)
======= ======= =======
EQUITY SHAREHOLDERS' FUNDS 11,381 8,999 11,874
======= ======= =======
</TABLE>
<PAGE> 10
CONSOLIDATED RECONCILIATION OF MOVEMENTS IN SHAREHOLDERS FUNDS (UNAUDITED)
<TABLE>
<CAPTION>
SHARE MERGER PROFIT
PREMIUM RESERVE AND LOSS
(pound)'000 (pound)'000 (pound)'000
<S> <C> <C> <C>
At 1 April 1999 (As previously reported)
Proteus 47,171 - (40,969)
Therapeutic Antibodies 52,342 - (47,737)
Alignment of accounting policy (431)
Merger adjustment (52,342) 52,342
Consolidation adjustment (1,179)
----------------------------------------------------
As restated 47,171 51,163 89,151
Placing of 23,325,000 ordinary shares at
40 pence per share 8,864
Expenses paid in connection with share issue (685)
Retained loss for the 6 months (9,218)
Exchange movements 80
----------------------------------------------------
At 30 September 1999 55,350 51,163 (98,289)
----------------------------------------------------
</TABLE>
<PAGE> 11
CONSOLIDATED CASH FLOW STATEMENTS (UNAUDITED)
for the 6 months ended 30 September 1999
<TABLE>
<CAPTION>
6M TO 6M TO 6M TO 6M TO 12M TO 12M TO
30-SEP-99 30-SEP-99 30-SEP-98 30-SEP-98 31-MAR-99 31-MAR-99
(pound)'000 (pound)'000 (pound)'000 (pound)'000 (pound)'000 (pound)'000
<S> <C> <C> <C> <C> <C> <C>
NET CASH OUTFLOW FROM OPERATING ACTIVITIES (5,208) (4,953) (10,828)
RETURNS ON INVESTMENT AND SERVICING OF FINANCE
NET CASH (OUTFLOW)/INFLOW FROM RETURNS ON INVESTMENTS
AND SERVICING OF FINANCE 3 (197) (125)
CAPITAL EXPENDITURE AND FINANCIAL INVESTMENT
NET CASH OUTFLOW FROM CAPITAL EXPENDITURE AND
FINANCIAL INVESTMENT 125 (650) (1,337)
NET CASH OUTFLOW BEFORE MANAGEMENT OF LIQUID
RESOURCES AND FINANCING (5,080) (5,800) (12,290)
MANAGEMENT OF LIQUID RESOURCES
NET CASH (OUTFLOW)/INFLOW FROM MANAGEMENT OF
LIQUID RESOURCES (3,440) (5,650) (4,079)
FINANCING
Issue of share capital, net of expenses 8,646 7,813 15,485
Payments on notes payable and finance leases (4,074) (510) (2,445)
Proceeds on notes payable 2,894 3,709 3,751
------ ------- -------
NET CASH INFLOW/(OUTFLOW) FROM FINANCING 7,466 11,012 16,791
------ ------- -------
(DECREASE)/INCREASE IN CASH (1,054) (438) 422
------ ------- -------
</TABLE>
<PAGE> 12
RECONCILIATION OF OPERATING LOSS TO NET CASH OUTFLOW FROM OPERATIONS
<TABLE>
<CAPTION>
30 SEPTEMBER 30 SEPTEMBER 31 MARCH
1999 1998 1999
(pound)'000 (pound)'000 (pound)'000
(AS RESTATED) (AS RESTATED)
<S> <C> <C> <C>
OPERATING LOSS (7,319) (5,176) (12,868)
Depreciation 967 988 1,921
Merger expenses (1,908) - -
Loss on disposal of tangible fixed assets 105 - -
Movement in net working capital 2,947 (765) 119
========== ============ ============
NET CASH OUTFLOW FROM OPERATING ACTIVITIES (5,208) (4,953) (10,828)
========== ============ ============
</TABLE>
<PAGE> 13
NOTES TO THE INTERIM STATEMENTS
1. The interim financial statements which have been approved by the directors,
have been prepared on the basis of the accounting policies set out in the
Group's 1999 financial statements. The interim financial statements are
unaudited and do not constitute full financial information as defined in
Section 240 of the Companies Act 1985 (as amended). The comparatives for
the year ended 31 March 1999 and the six months ended 30 September 1999 do
not comprise full financial statements.
2. Loss per share for the six months ended 30 September 1999 is based on
attributable losses of (pound)9,218,000 (1998: (pound)5,344,000) and on the
weighted average number of shares in issue during the period of 136,580,209
(1998: 128,970,078). Loss per share for the 12 months ended 31 March 1999
is based on attributable losses of (pound)13,017,000 and a weighted average
number of shares in issue of 131,747,841. Comparative losses per share have
been changed from those previously reported to take account of the merger
announced on 20 May 1999.
3. Exceptional Item (Merger Costs)
The exceptional item relates to the transaction costs associated with the
merger of Proteus International Plc and Therapeutic Antibodies Inc on 15
September 1999.
4. Basis of Preparation
The merger of Proteus International Plc and Therapeutic Antibodies Inc has
been accounted for using the merger principles set out in Financial
Reporting Standard 6. Accordingly, the financial information for the
current period has been presented, and that for prior periods restated as
if the businesses had been merged throughout the current and comparative
reporting periods. The Group has utilised the merger relief provisions
available and the issue of shares in respect of the merger has been
recorded at nominal value.
5. Accounting policy adjustment
The accounting policies of Proteus International Plc and Therapeutic
Antibodies Inc have been compared following the merger. As a result,
(pound)431,000 of previously capitalised patent fees on the books of
Therapeutic Antibodies Inc were written off in accordance with the group
accounting policy regarding patents.
Except for accounting for patent costs, there were no significant
adjustments required to the results or the net assets of the business prior
to the merger in order to harmonise accounting policies.
6. Copies of this statement are being sent to all shareholders and will be
available to the public at the Company's registered office at Beechfield
House, Lyme Green Business Park, Macclesfield, Cheshire, SK11 0JL.
