neil777
- 02 Apr 2007 15:26
BTG's upbeat close period update (imo) further confirms the turnaround.
With recurring royalty revenues expected to be up by about 5% and R&D spend in line, and a product pipeline to die for, i believe they are cheap, and a real growth stock for the future.
Any comments.
neil777
- 17 Mar 2008 09:44
- 34 of 93
BTG PLC
17 March 2008
BTG plc: Positive Interim Report of Varisolve(R) Phase II Safety Study to be
Presented at SIR 2008 Scientific Meeting
London, UK, 17 March 2008: BTG plc (LSE: BGC), the life sciences company,
announces that a positive interim report of the US Phase II safety study of
Varisolve(R), which is being developed to treat varicose veins and venous stasis
ulcers, is being presented today at the Annual Scientific Meeting of the Society
of Interventional Radiologists in Washington, DC.
The study is investigating whether treatment with Varisolve(R) polidocanol
microfoam can cause subclinical events such as microinfarctions in the brains of
varicose vein patients with right-to-left (R-L) cardiac shunts. R-L shunts, e.g.
patent foramen ovale, may allow bubbles to enter the brain by crossing from the
venous into the arterial circulation. The study finishes when 50 patients with
bubbles detected in the middle cerebral artery (MCA) have been treated and
followed up at 24 hours and 28 days using MRI scanning and other procedures.
Study investigator John Regan, M.D. will report that 40% of the patients with
great saphenous vein incompetence who were screened for enrolment into the study
were diagnosed with R-L shunts. In shunt-positive patients, 83% had detectable
MCA bubbles during the Varisolve(R) procedure, though the number of bubbles was
generally very low (median of 5 detectable bubbles). After evaluation of 28
eligible patients with MCA bubbles, none had developed new MRI lesions,
neurological or other visual field abnormalities, or elevated cardiac markers.
Dr Regan commented: 'It is clear that patients undergoing microfoam endovenous
occlusion are commonly exposed to gas bubbles in the cerebral arterial
circulation. Exposure to this proprietary microfoam, which has a controlled
density, bubble size and gas mix, has not been associated with evidence of
microinfarction.'
Louise Makin, BTG's chief executive officer, said: 'With over half the required
patients now treated, the study is progressing as planned and continues to
validate our belief in the unique attributes of Varisolve(R).'
In parallel with the Phase II study, BTG is advancing other aspects of the
product's development. Supply chain arrangements have been simplified and a
user-friendly single-can product presentation will be ready for use in the Phase
III studies. Having agreed with the FDA the Phase III plans in outline, BTG is
initiating a pilot Phase III study to test and finalise the procedures to be
incorporated into the pivotal Phase III trial protocols. Market research studies
underway confirm our belief that Varisolve(R) has the potential to be
competitive in an underserved market, with significant patient and physician
benefits over existing varicose vein treatments.
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations Ben Atwell
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals principally in the
areas of neuroscience and oncology. The company has a substantial and growing
revenue stream of royalties from out-licensed products and a broad, expanding
internal pipeline of development programmes. BTG operates from offices in
London, Philadelphia and Osaka. For further information, visit:
www.btgplc.com
.
neil777
- 18 Mar 2008 15:02
- 35 of 93
BTG PLC
18 March 2008
BTG PLC : NOTIFIABLE INTERESTS IN SHARES
BTG plc (LSE:BGC) has received notification today that Schroders plc has a
notifiable interest in 15,049,766 ordinary shares of BTG plc. This holding
represents 9.96% of the voting rights of the Company.
The shares are held in portfolios managed by Schroder Investment Management
Limited on a discretionary basis for clients under investment management
agreements.
- ends -
Contact for Queries: Andy Burrows
Telephone: 020 7575 1741
This information is provided by RNS
The company news service from the London Stock Exchange
neil777
- 02 Apr 2008 08:09
- 36 of 93
BTG PLC
02 April 2008
BTG plc: Close Period Update
Initial Results from Two Clinical Studies Announced Today
London, UK, 2 April 2008: BTG plc (LSE: BGC), the life sciences company, today
provides the following update for the year ended 31 March 2008, ahead of the
planned publication of its Preliminary Results on 19 May 2008. BTG also today
provides initial results from two clinical studies.
Trading update
BTG expects to report a strong financial performance for the year, in line with
the results reported in the Interim Report and with the Board's expectations.
Revenues are expected to increase significantly from the prior year with another
strong performance from marketed products and significant contributions from
one-off transactions. BeneFIX(R), the haemophilia B treatment, has shown
continued strong market penetration despite the previously reported termination
of Wyeth's marketing agreement with Baxter in the EU. Sales of the monoclonal
antibodies that underlie BTG's royalties from the Medical Research Council are
also showing good underlying growth. One-off revenues, including the proceeds of
two previously-announced licensing deals for the semiconductor chip memory
capacity technology and the milestone received from Tolerx, Inc, are expected to
contribute more than 17m in net revenues and gains before withholding taxes.
BTG's net cash at the year end was over 55m.
Operating and clinical update
With two programmes commencing clinical development during the year, BTG's
internal pipeline now comprises six programmes in clinical development. In
addition to these, BTG has nine programmes licensed to partners that are in
clinical development.
Varisolve(R) - polidocanol endovenous microfoam product for the treatment of
varicose veins
Positive interim data from the US Phase II safety study were reported in March
2008 at the annual meeting of the Society of Interventional Radiologists, with
no new MRI lesions, neurological or other visual field abnormalities or elevated
cardiac markers being observed in the first 28 of the required 50 patients with
bubbles detected in the middle cerebral artery following treatment with
Varisolve(R). The study continues to progress well.
The structure of the overall Phase III programme and the pivotal Phase III study
designs have been agreed with the FDA. To validate aspects of the study
protocols and to enable a Special Protocol Assessment to be sought later in
2008, BTG plans to conduct a Phase III pilot study and other key Phase III
planning activities over the coming 6 months.
Significant progress has also been made with the product's design and
manufacturing. A smaller, lower-cost, user-friendly single canister presentation
has now replaced the bulkier two-can product. Manufacturing has been contracted
to a third party, and the new process and pilot plant have been fully validated.
Given the design improvements and outsourcing of the manufacturing process, the
economics of BTG's existing manufacturing facility have been re-assessed. The
additional capital costs of up to 4m to commission and validate the existing
facility, together with ongoing running costs of over 1m per annum up until
product launch, are no longer considered viable. Accordingly, BTG intends to
terminate the lease on its existing facility and will write off its carrying
value of 7.5m. As a result of these changes, the overall economics and
flexibility of product manufacture will improve significantly in the period up
to launch and beyond.
Following the good progress made with Varisolve(R) in the current Phase II
safety study, the outline Phase III studies being agreed with the FDA and the
important manufacturing developments, BTG now intends to actively recommence
partnering discussions during the current quarter.
BGC20-0166 - sleep apnoea - study results
Encouraging results were obtained in a clinical proof of concept study of
BGC20-0166 in 39 subjects with mild to severe obstructive sleep apnoea. Subjects
received placebo, high or low-dose combinations of two generic serotonin
modulators or a single agent. The primary endpoint was a reduction in the
Apnoea-Hypopnea Index (AHI). The high-dose combination caused a statistically
significant 40% reduction in AHI (range 10-85%) compared to placebo at both day
14 and day 28. Three of ten subjects in the high-dose group were considered
complete responders, with a reduction in AHI of over 50% and a final AHI score
below 10. BGC20-0166 was well-tolerated and had no detrimental impact on sleep.
An expert advisory panel has reviewed the data and concluded that the results
with the high-dose combination are positive and therapeutically relevant. BTG is
continuing with non-clinical studies and formulation development in preparation
for US IND submission.
BGC20-0582 - head lice - study results
A single-centre Phase II study to investigate the safety, efficacy and
tolerability of BGC20-0582, a Generally Regarded As Safe compound, was completed
in 230 subjects (average age 13 years, 90% female) with newly diagnosed head
lice infestation. Subjects were treated with placebo or one of three doses of
BGC20-0582 (2.5%, 10% or 12.5% w/v) administered as a topical gel formulation.
Top-line results show that, although BGC20-0582 did not significantly increase
the cure rate at 14 days compared to placebo (64.7% cure rate at 10% dose
compared with 52.6% in placebo; p>0.05), when taking into account lice
re-infestation the modified combined cure / re-infestation measure of efficacy
was 76.5% for the 10% dose of BGC20-0582 compared with 56.1% for placebo, which
was statistically significant (p<0.05). This level of efficacy compares
favourably to the 40-50% efficacy rate exhibited by a leading OTC product in
studies of similar design and patient demographics. The high level of placebo
response was unexpected and detailed analysis of the results continues.
BGC20-1259 - Alzheimer's disease
BGC20-1259 is a multifunctional compound targeting the cognition and behavioural
aspects of Alzheimer's disease. A human positron emission tomography study in
healthy volunteers has now completed. Data from this study are being used to
estimate the efficacious dose range to take into a Phase IIa clinical study in
patients with mild-moderate Alzheimer's disease, which is anticipated to start
in H2 08.
BGC20-1531 - migraine
BGC20-1531 is an prostaglandin EP4 receptor antagonist that offers a potentially
novel mechanism to treat migraine headaches. Dosing of the first cohort in a
single ascending dose Phase I clinical study is complete, and safety and
pharmacokinetic data are being collected. Dosing has commenced for the second
cohort, and the full study report is expected in H2 08.
BGC20-0134 - multiple sclerosis
Dosing commenced in March 08 in a Phase I study of BGC20-0134, a novel
structured lipid being developed to treat relapsing multiple sclerosis. The
study is also due to report in H2 08.
Louise Makin, BTG's chief executive officer, commented: 'We are pleased with the
progress in the business during the year. With the Varisolve(R), sleep apnoea
and head lice studies yielding encouraging data and the first clinical studies
of both our multiple sclerosis and migraine treatments starting, we have built
good clinical momentum. With over 55m of cash we are also in a strong financial
position, and therefore able to support our goal of further strengthening our
pipeline through in-licensing and acquisition.'
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations Ben Atwell
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1596
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals principally in the
areas of neuroscience and oncology. The company has a substantial and growing
revenue stream of royalties from out-licensed products and a broad, expanding
internal pipeline of development programmes. BTG operates from offices in
London, Philadelphia and Osaka. For further information, visit:
www.btgplc.com
.
This information is provided by RNS
The company news service from the London Stock Exchange
neil777
- 02 Apr 2008 10:49
- 37 of 93
With 55m cash in the bank, and more on the way via milestone payments ect, Varisolve, with it's smaller, lower-cost, user-friendly single canister presentation which has now replaced the bulkier two-can product, ect, ect.
I also like the part, BTG now intends to actively recommence
partnering discussions during the current quarter.
The future looks progressive, and the chart looks a little better, lets hope it continues
neil777
- 07 Apr 2008 10:16
- 38 of 93
Things are looking up! Its also good to see a firm move through the 200 DMA. But with the RSI looking top heavy there will be a bit of a pullback at some stage , a time to top up perhaps ? Would like to see it through the 115p-120p though.
Neil.
neil777
- 19 May 2008 08:06
- 39 of 93
RNS Number : 7184U
BTG PLC
19 May 2008
BTG plc: Preliminary Results for the Year Ended 31 March 2008
London, UK, 19 May 2008: BTG plc (LSE: BGC), the life sciences company, today announces its preliminary results for the year ended 31 March 2008.
Financial highlights
3rd consecutive year of profit
Operating profit 16.6m (06/07:0.9m) before 8.1m Wrexham provision
Revenue net of revenue sharing 42.9m (06/07: 26.8m)
Net recurring royalties of 24.9m (06/07: 24.2m)
Surplus of net recurring royalties over operating expenses of 8.9m (06/07: 6.3m)
R&D investment increased to 10.7m (06/07: 9.7m)
Net one-off revenues and profits on assets & investments less direct taxes 16.6m (06/07: 5.3m)
Profit after tax 8.8m (06/07: 2.4m) and earnings per share 5.9p (06/07:1.6p)
Cash and cash equivalents of 57.0m (31/3/07: 43.0m)
Operating highlights
Continued growth in royalty income and good cost control supplemented by valuable one-off transactions generated 14m of cash flow in the period even after increased R&D spend:
Strong momentum in BTG's pipeline with six programmes now in active clinical development:
More than 40 of the 50 required patients treated in Varisolve phase II safety study, with no adverse MRI results; on track to finish treatments by June 2008
Positive results from clinical proof of concept study of BGC20-0166 in sleep apnoea
Phase I studies initiated for BGC20-1531 (migraine) and BGC20-0134 (multiple sclerosis)
BGC20-1259 progressing towards a European phase IIa study in patients with Alzheimer's disease starting in H2 08
Good progress with licensed programmes:
Genzyme's Campath label extended to include 1st-line treatment in chronic lymphocytic leukaemia
Two phase III trials of Campath initiated in multiple sclerosis
Encouraging phase I/II data published on Cougar Biotechnology's CB7630 in prostate cancer; enrolment for phase III trial commenced in April 08
Tolerx signed agreement with GlaxoSmithKline to develop TRX4 in type 1 diabetes and other inflammatory conditions: initial milestone paid to BTG of $10m
Louise Makin, BTG's chief executive officer, commented: 'We are reporting excellent financial results, with a third consecutive profitable year based on a strong underlying business with 14m of cash generated and cash reserves of 57m. We now have six clinical programmes in our active development pipeline with Varisolve moving forward as planned, encouraging results from our sleep apnoea study and our migraine and multiple sclerosis treatments starting clinical development. We are in a strong position to further build value by progressing our development programmes and seeking new opportunities that will help drive us towards sustainable profitability.'
For further information contact:
BTG
Financial Dynamics
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1596
Ben Atwell
+44 (0)20 7831 3113
About BTG BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit: www.btgplc.com.
Chairman's statement
I am pleased to report a very strong financial performance for the year. Net revenues after revenue sharing increased by 60% to 42.9m (06/07: 26.8m) based on gross revenues of 75.0m (06/07: 45.7m). Net recurring royalties grew to 24.9m (06/07: 24.2m) and net non-recurring revenues were significantly higher at 18.0m (06/07: 2.6m).
Research and development investment increased to 10.7m (06/07: 9.7m) while operating expenses reduced by 11% to 16.0m (06/07: 17.9m). As previously reported, following changes to the Varisolve product design and simplification of the supply chain, BTG decided to terminate the lease on the Wrexham manufacturing facility and as a result has taken a charge of 8.1m being the amounts written off the carrying value of the facility and estimated closure costs. Despite this charge, profit before tax increased from 2.6m to 10.7m and profit after withholding and other taxes increased to 8.8m (06/07: 2.4m). The Group ended the year with net cash of 57.0m (06/07: 43.0m).
There was also significant progress in our clinical development pipeline. Encouraging data were reported from clinical studies of Varisolve, the novel treatment for varicose veins, BGC20-0166, the combination product for sleep apnoea, and BGC20-0582, a non-insecticide treatment for head lice infestation. In addition, BGC20-1531, which is being developed to treat migraine headaches, and BGC20-0134, which is targeting multiple sclerosis, both commenced Phase I clinical studies. Many of our partners also saw good progress in their products, in particular Genzyme with Campath, Cougar Biotechnology with CB7630 and Tolerx with TRX4.
Board changes
Professor Colin Blakemore and Giles Kerr were appointed as non-executive directors in October 2007 and both bring extensive industry expertise to BTG's Board.
I joined the Board in January 2008 and became chairman in March, at which time Sir Brian Fender retired from the Board, having been a director since 1992 and chairman from 2003. My colleagues and I wish him well for the future and thank him for his many contributions to BTG over the years, in particular for guiding the Company as chairman successfully through a period of significant change.
Fred Weiss retired as a director in November 2007 after six years' service and Consuelo Brooke, having also served six years as a director, is not standing for re-election at the annual general meeting in July. Alison Wood has decided not to stand for re-election, due to commitments in her full-time position. The Board thanks each for their contributions to the Company's development and wishes them all success in future roles.
Outlook
We anticipate another strong financial performance in the current year. Good growth in recurring royalties from marketed products is anticipated, particularly driven by a change in revenue sharing arrangements on BeneFIX and the anticipated sales growth of key products. We aim to meet a number of important development milestones this year. In addition to completing the US phase II safety study of Varisolve, we plan to progress partnering discussions and to prepare for a special protocol assessment (SPA) for the phase III trials. The phase I studies of BGC20-1531 and BGC20-0134 are expected to finish this calendar year, with phase II studies planned to commence during the first half of 2009. A phase II study of BGC20-1259 is scheduled to begin by the end of 2008. We also anticipate development progress in our key partnered programmes.
Another priority is to further strengthen our pipeline, which may be achieved by licensing individual assets and through broader corporate transactions, moving us towards our goal of sustainable growth.
Dr John Brown
Operating review
We remain focused on maximising the cash flow from our pre R&D profits generated from royalties and licensing transactions in order to finance and facilitate the development of our drug pipeline.
This year we moved two further programmes into the clinic, bringing our current active pipeline to six clinical and two earlier stage programmes. In addition we have interests in 10 programmes under development by licensees.
Progress in the internal pipeline:
Varisolve - polidocanol microfoam treatment for varicose veins
The US Phase II safety study is progressing well. No new MRI lesions or neurological abnormalities have been found in any of the more than 40 patients who have been treated with Varisolve to date. The study is on track to complete treatment of the required 50 patients by the end of June 08.
Partnering discussions will be progressed in parallel with making preparations for the pivotal phase III trials. In making ready an application for a Special Protocol Assessment for these trials, BTG plans to conduct a pilot clinical study to validate the control procedure and a non-clinical study to validate a patient questionnaire. Updated market research shows a market potential of over $500m for the product from reimbursed procedures in the US alone with additional potential in the US self-pay and rest of world markets.
The product presentation has been improved with the development of a smaller, user-friendly single canister product, and the manufacturing supply chain has been simplified.
BGC20-1259 - Alzheimer's disease
BGC20-1259 is a multifunctional compound being developed for the treatment of Alzheimer's disease. It combines inhibition of acetylcholinesterase, serotonin transport and calcium channels to improve both cognitive and behavioural symptoms of the disease. Its neuroprotective properties and ability to stimulate neurogenesis suggest that BGC20-1259 also has the potential to slow disease progression.
A human positron emission tomography study was completed to aid dose selection in a planned European, 6 month, phase II proof of concept study in Alzheimer's disease patients scheduled to start in H2 08.
BGC20-0166 - sleep apnoea
BGC20-0166 is a proprietary combination of two marketed serotoninergic modulating drugs being developed for the treatment of obstructive sleep apnoea. The results of a clinical study in 39 patients were reported in April 2008. BGC20-0166 reduced the Apnoea Hypopnoea Index (AHI), a clinically accepted scale of apnoea severity, by a mean of 40% in patients with mild to severe obstructive sleep apnoea. BGC20-0166 was shown to be well-tolerated and had no impact on sleep architecture. BTG is continuing with both non-clinical studies and the development of a proprietary product formulation in preparation for US IND submission.
BGC20-0582 - head lice infestation
BGC20-0582 is a non-pesticidal product derived from a natural botanical source in development for the treatment of head lice infestation. The results of a phase II trial reported in April 2008 showed that although BGC20-0582 did not significantly increase the cure rate at 14 days compared to placebo, the modified combined cure / re-infestation measure of efficacy was 76.5% for the 10% dose compared with 56.1% for placebo, which was statistically significant (p<0.05). This was also superior to the efficacy rate exhibited by a leading over-the-counter product in studies of similar design and patient demographic. An in vitro study is underway to establish the product's resistance characteristics compared to other treatments.
BGC20-1531 - migraine headache
BGC20-1531 is an orally available EP4 receptor antagonist which inhibits prostaglandin-induced vasodilatation of cranial blood vessels via selective blockade of EP4 receptors, thereby reducing inflammation and migraine pain. With its novel mode of action, this compound targets those patients that do not respond to or cannot tolerate current treatments. In early 2008 dosing began in a randomised, double-blind, placebo controlled phase I study to assess the safety, tolerability and pharmacokinetic profile of single rising doses of oral BGC20-1531 in healthy volunteers. A phase II study is planned to begin in H1 09.
BGC20-0134 - multiple sclerosis
BGC20-0134 is a novel structured lipid designed to restore the balance between pro-inflammatory (tumour necrosis factor-, TNF-) and anti-inflammatory (transforming growth factor-1, TGF1) cytokines in patients with multiple sclerosis. As an oral therapy, BGC20-0134 could provide a significant advantage over current treatments. A combined single and repeat, rising dose phase I study in healthy male and female subjects commenced early in 2008. A phase II study is anticipated to commence in H1 09.
Pre-clinical programmes: BTG6001 - pain and BTG6228 - solid tumours
BTG6001 is an opioid agonist in preclinical development for the control of post-operative pain. In vitro and in vivo data suggest an improved side-effect profile and long duration of action compared with other opioid analgesics. BTG6228 is a novel, targeted, broad spectrum cancer therapeutic whose primary target is Na/K ATPase with effects on downstream pathways involved in tumour hypoxia including the Hif pathway. It has demonstrated in vivo efficacy in renal, pancreatic and chondrosarcoma xenograft models. Both programmes are moving towards development candidate selection.
Plevitrexed and BGC945 - cancer
Both are thymidylate synthase inhibitors targeting cancer. BTG has been seeking a licensee for plevitrexed and has held discussions with a number of companies, though no agreement has been reached. BTG remains open to interest from potential licensees. As previously announced, the development of BGC945 had been put on hold pending a review of its technical and commercial feasibility. Having completed this review, BTG has decided not to progress BGC945 any further.
Progress in key partnered programmes:
Campath - chronic lymphocytic leukaemia, multiple sclerosis
Licensed to Genzyme Corporation, Campath has been approved for the first-line treatment of CLL. Positive final data from a phase II trial in multiple sclerosis showed that Campath reduced the risk for relapse by 73% and the risk for sustained accumulation of disability by 71% compared with Rebif in patients with relapsing-remitting multiple sclerosis. Two phase III trials in RRMS are under way.
TRX4 - type 1 diabetes
TRX4 is a monoclonal antibody licensed to Tolerx, Inc, which has signed an agreement with GlaxoSmithKline to develop TRX4 in type 1 diabetes and a range of inflammatory conditions. BTG receives half of all the development and sales milestones due to Tolerx under that agreement. TRX4 is anticipated to start a phase III trial in type 1 diabetes in 2008.
CB7630 (abiraterone) - prostate cancer
BTG's licensee Cougar Biotechnology, Inc. announced the start of a phase III trial of CB7630 in patients with metastatic, castration-resistant prostate cancer in April 2008. The study, whose start triggered a milestone payment to BTG, is expected to enrol over 1100 patients and will have overall survival as the primary endpoint.
Financial Results for the year ended 31 March 2008
Revenues and gains
Net revenues after revenue sharing increased by 60% to 42.9m (06/07: 26.8m). Total gross revenues for the year increased by 64% to 75.0m (06/07: 45.7m) and revenue sharing averaged 43% (06/07: 41%). Revenues included recurring royalties from marketed products and milestone and other one-off transactions such as licensing payments or development milestones.
Gross recurring royalty revenues were slightly higher than in the previous year at 42.4m (06/07: 41.3m). Revenue-sharing payments on royalties averaged 41% in both years resulting in net recurring revenues of 24.9m (06/07: 24.2m). Underlying sales growth in a number of products was significant but the weak US dollar resulted in growth of just 3% upon translation into our sterling-denominated results.
BeneFIX, the treatment for haemophilia B marketed by Wyeth, performed well and contributed gross revenues of 16.9m (06/07: 15.8m). The hip cup continued to deliver steady underlying growth and generated 8.5m gross (06/07: 8.6m). Campath, the label for which was extended to include first-line treatment in late 2007, generated 5.0m (06/07: 4.5m) and gross revenues from the MRC humanisation patents were 4.1m (06/07: 3.4m).
The successful further licensing of BTG's patents on semiconductor chip memory capacity for net revenues after costs and taxes of 10m was the major factor in the significant increase in non-recurring revenues to 32.6m gross (06/07: 4.4m), which resulted in 18.0m net revenues after revenue sharing (06/07: 2.6m). Other one-off revenues included a $10m milestone payment from Tolerx, Inc. when it signed an agreement with GlaxoSmithKline to develop and commercialise TRX4, 2.7m gross from the MRC in relation to a paid-up licence it signed, and 1.5m gross from the assignment of AQ4N rights from KuDOS to Novacea, Inc.
Strong Operating Surplus and Operating Profit
During the year BTG generated an operating surplus of net recurring revenues over operating expenses of 8.9m (06/07: 6.3m) further supplemented by net financial income of 2.2m (06/07: 1.7m). These together funded the increased research & development costs of 10.7m. The one-off revenues further supplemented profits and cash reserves.
Total operating expenses decreased by 11% to 16.0m (06/07: 17.9m) and included employment costs of 8.3m (06/07: 10.1m). Operating costs were 2.4m (06/07: 2.4m) and included impairment and amortisation costs of 1.6m (06/07: 1.9m).
This operating surplus is expected to increase in the coming year with operating costs being held steady and expected increases in net recurring revenues, with growth forecast in all the major royalty-generating products and additional contributions expected from changes in the BeneFIX revenue sharing arrangements.
Group research and development costs of 10.7m (06/07: 9.7m) were lower than originally planned for the year owing to small delays in the start of a number of non-clinical and clinical studies. However, these are largely timing issues and many of the costs will roll forward into the current financial year. Varisolve costs were 4.6m (06/07: 3.5m).
Expenditure on other programmes under development was 5.4m (06/07: 5.5m), including costs related to the phase I clinical studies of BGC20-1531 in migraine, BGC20-0134 in multiple sclerosis and to completion of the sleep apnoea, head lice and BGC20-1259 PET clinical studies. BTG's share of the results of its associate companies involved in development activities was losses of 0.7m (06/07: 0.7m). Total R&D expenditure for 2008/09 is targeted in the 10m to 15m range.
Impairment Provision against Wrexham Facility
As previously announced, given the design improvements achieved and proven ability to outsource the manufacturing process for Varisolve, the economics of the leasehold manufacturing facility constructed to facilitate the product's development were re-assessed. The decision was taken to close this facility and as a result the overall economics and flexibility of product manufacture are expected to improve significantly in the period up to launch and beyond without adverse impact on our ability to develop or partner the programme. Of the 8.1m total charge, 7.5m is a non-cash expense being the write-off of the net book value of the manufacturing facility carried in fixed assets and the balance reflects the estimated costs to closure of 0.6m. Development costs of Varisolve in 08/09 and future years will be reduced as a result of this decision.
Profit for the year and earnings per share
The profit before tax was 10.7m (06/07: 2.6m) and the profit after tax was 8.8m (06/07: 2.4m). The tax charge of 1.9m arose primarily as a result of 1.8m of withholding taxes on the semi-conductor technology licensing deal. The Group expects to utilise certain of its brought forward tax losses against taxable profits achieved in the year.
Earnings per share based on an average 149.7m (06/07: 149.5m) shares in issue were 5.9p (06/07: 1.6p).
Position at year end
Total equity at 31 March 2008 increased during the year by 7.9m to 55.2m.
Non-current assets
Intangible assets at 31 March 2008 were 6.8m, with additions of 2.1m being offset by disposals and amortisation charges of 2.9m. Most of the intangible assets held are patents, which are written off over their remaining effective life - or their remaining useful economic life if shorter - and are subject to regular impairment reviews.
The net book value of the Group's property, plant and equipment reduced by 7.9m to 0.8m, largely as a result of the decision to terminate the lease on the Varisolve manufacturing facility. Additions of 0.6m were offset by charges of 1.0m in respect of depreciation and currency movements.
The value of investments and investments in associates increased by 0.3m in the year to 6.5m following additional investments offset by operating losses and impairment charges. During the year, BTG invested an additional 1.9m (06/07: 0.8m), including 0.7m in Senexis Ltd, which is developing small molecule drugs targeting CNS disorders. Other investments include Xention Discovery Ltd, a drug discovery company focused on ion channels, Protez, Inc, which is developing new antibiotics, and holdings in two venture funds.
Current assets, current and non-current liabilities
Trade and other receivables were 15.2m at 31 March 2008 (06/07: 10.5m), the increase being mainly due to remaining deferred payments totalling 5.5m due by December 2009 from the licensing of the semi-conductor technology patents.
Current liabilities increased from 21.9m at the previous period end to 24.2m at 31 March 2008. The increase relates mainly to revenue sharing payments due relating to revenues received and expected in respect of the semi-conductor technology licenses referred to above.
Non-current liabilities moved from 6.8m at the previous year end to 6.9m at 31 March 2008. They include 4.9m in relation to the BTG defined benefit pension plan and the remaining amounts payable against provisions for impairment charges under non-commercial leases.
Cash
Net cash and cash equivalents rose by 14.0m to 57.0m at 31 March 2008 (31 March 2007: 43.0m). The cash was generated primarily from the profit after tax of 8.8m which includes non-cash charges of 3.9m for depreciation, amortisation, share-related incentives and pension adjustments and the 8.1m Wrexham write-off charge. Cash outflows included funding of 2.2m for the deficit repair plan on the defined benefit pension plan, investments of 1.9m and acquisition costs of 1.7m on patents and fixed assets.
neil777
- 29 May 2008 17:14
- 40 of 93
RNS Number : 5516V
BTG PLC
29 May 2008
Directors Interests in the shares of BTG plc
The Company has made the following awards to Directors:
(a) On 28 May 2008 the Company made the following conditional awards of shares in BTG
plc under the BTG Performance Share Plan 2006:
Louise Makin 316,824
Christine Soden 193,180
The awards will normally vest after three years, subject to continued employment and the
satisfaction of performance conditions.
The Performance Share Plan 2006 was approved at the Companys AGM on 26 July 2006. The
performance conditions were set such that 60% are subject to a Total Shareholder Return condition
and 40% subject to a Cumulative Profit target. The Cumulative Profit target requires a minimum of
54m cumulative pre-tax profit (excluding R & D investment) over the three-year period before any
shares may vest, and a ceiling for full vesting of 88m.
(b) On 28 May 2008 the Company awarded the following shares in BTG plc, under the Companys
Deferred Share Bonus Plan, representing 50% of their annual bonus, the balance having been paid
in cash.
Louise Makin 85,185
Christine Soden 52,008
Under the terms of the Plan these shares will normally be released in full to the directors only after a
further three years service.
The total of 137,193 shares were bought in the Market on 28/29 May 2008 by the Companys
Employee Share Trust at an average cost of 119.8649p per share where they will be held until due
for release.
Contact for Queries: Andy Burrows
Telephone: 020 7575 1741
neil777
- 04 Jun 2008 10:44
- 41 of 93
RNS Number : 9412V
BTG PLC
04 June 2008
BTG plc: Acquisition of Protez Pharmaceuticals by Novartis
BTG to receive approximately $5 million in respect of its shareholding in Protez upon close of transaction with further potential payments
London, UK, 4 June 2008: BTG plc (LSE: BGC), the life sciences company, is pleased to note today's announcement by Novartis that is to acquire Protez Pharmaceuticals, a company focused on the discovery and development of novel antibiotics that was founded in 2003 by BTG alongside Protez management members Chris Cashman, Dr Klauss Esser and Dr Luigi Xerri.
Novartis is acquiring the entire share capital of Protez for an initial payment of $100 million, with potential for up to $300 million of additional payments contingent upon the success of PZ-601, a broad-spectrum antibiotic currently in phase II development for potentially fatal drug-resistant infections such as MRSA.
Upon the transaction closing, BTG will receive approximately $5 million, being its share of the initial $100 million, and will receive further sums of up to $15m being 5% of the additional contingent consideration of $300 million payable should PZ-601 achieve certain development and commercialisation targets. The closing is subject to customary conditions for a transaction of this type.
Louise Makin, BTG's chief executive officer, commented: 'We are delighted with the progress made by Protez and are confident that as part of Novartis its programmes will play a major role in the field of infectious diseases. It is also pleasing to see this investment deliver such a good return to BTG.'
For further information contact:
BTG
Financial Dynamics
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
Ben Atwell
+44 (0)20 7831 3113
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit: www.btgplc.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
ACQFKQKNCBKKAAK
neil777
- 06 Jun 2008 08:11
- 42 of 93
About time!
RNS Number : 1319W
BTG PLC
06 June 2008
BTG Reports Successful Completion of Treatments in Varisolve US Phase II Safety Study
No subclinical effects found in MRI scans to date
London, UK, 6 June 2008: BTG plc (LSE: BGC), the life sciences company, announces the completion of enrolment and treatment of patients in the US phase II safety study of Varisolve polidocanol endovenous microfoam, which is under development as a treatment for varicose veins.
A total of 82 patients with saphenous vein incompetence were treated with Varisolve, of whom 57 patients met the study requirement of having bubbles detected in the cerebral circulation during treatment. In line with the trial protocol, all 57 of these patients have had MRI brain scans 24 hours after treatment; 40 of these patients have also completed the required 28-day MRI scans with the remainder expected to complete their 28 day MRI scans by the end of June. To date, no MRI lesions, neurological abnormalities or elevated cardiac markers have been found as a result of the treatment in any of the patients.
Louise Makin, BTG's chief executive officer, said: 'We are delighted that we have found no evidence of subclinical effects in any patients following treatment with Varisolve in this study. This supports our objective of developing Varisolve for the widest possible patient base by enabling recruitment to the planned phase III trials without having to screen future patients for cardiac shunts. It also allows us to embark on commercialisation discussions with potential partners with a valuable product that has now been significantly de-risked.'
Right-to-left cardiac shunts, which are estimated to be present in at least 25% of the population, can allow particles present in the venous system to cross into the arterial system and then into the brain, where they have the potential to block small vessels and cause injury. Following treatment with Varisolve, transient residual microbubbles are present in the venous system. The study was conducted to investigate whether there was any evidence of subclinical effects in 50 patients with such shunts (more were treated to allow for possible late patient withdrawals from the study) following treatment with Varisolve.
The full study results will be submitted for presentation at the November 2008 meeting of the American College of Phlebology.
In parallel with commercialisation discussions, BTG will conduct pilot studies to validate the photographic scales and questionnaires to be used in the phase III pivotal trials.
For further information contact:
BTG
Financial Dynamics
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
Ben Atwell
+44 (0)20 7831 3113
neil777
- 09 Jun 2008 11:04
- 43 of 93
Have we turned the corner? who knows, but the chart looks better anyway!
Are you still in Hangon.
hangon
- 24 Jun 2008 17:41
- 44 of 93
neil777, YES and bought some in my ISA at 1.19 when the (banking) Markets were fearful....I thought there might be some good news prior to the AGM (Funny that.) as I see this as a Varisolve-play alone. If it fails I lose, if it wins then we are down to the abilities of the Execs to get a good deal ( their cash pile sure helps against any silly offers)....and "probably" double my investment, although in the past it has peaked near 12 on hopes. If we halve that excitement, and maybe take a bit off for the long-term income, I can see this could be pushed to 4-5 . . . when the Market factors-in the other products ...and potential yield.
What's yr take?
neil777
- 22 Jul 2008 13:13
- 45 of 93
RNS Number : 6140Z
BTG PLC
22 July 2008
BTG plc: Study Shows Abiraterone Can Successfully Treat Aggressive, Chemotherapy-Resistant Prostate Cancer
London, UK, 22 July 2008: BTG plc (LSE: BGC), the life sciences company, notes the publication of a new study in the Journal of Clinical Oncology showing that abiraterone caused significant tumour shrinkage and reduction in prostate specific antigen (PSA) levels in 70-80% of men with advanced, chemotherapy-resistant prostate cancer.
BTG acquired abiraterone from the Institute of Cancer Research and, having funded its early development and secured the intellectual property position, subsequently licensed it to Cougar Biotechnology, Inc. Earlier this year, Cougar commenced a 1200-patient phase III trial with abiraterone, also known as CB7630, in men with metastatic castration-resistant prostate cancer who have failed standard chemotherapy.
In this latest study, conducted by the Institute of Cancer Research and the Royal Marsden Hospital, patients were followed for two-and-a-half years and most had stable disease throughout the period with few side effects. It follows a number of other phase I and phase II studies supporting the role of abiraterone as an important new potential treatment option for aggressive prostate cancer.
Louise Makin, BTG's chief executive officer, commented: 'We are delighted that abiraterone continues to show excellent potential as a new treatment for these resistant forms of prostate cancer, which represent a significant unmet need.'
BTG will receive milestone payments and royalties on sales of CB7630 if it is successfully developed and approved for sale.
CB7630 is one of a number of products BTG has licensed to partners that are making progress through clinical studies. Campath, licensed to Genzyme Corporation, is already approved to treat chronic lymphocytic leukaemia and is under development as a potential treatment for multiple sclerosis; two phase III trials in patients with relapsing-remitting multiple sclerosis commenced earlier this year. TRX4, a monoclonal antibody licensed to Tolerx, Inc, has completed a successful phase II study in patients with type 1 diabetes and is expected soon to start a pivotal phase III trial. Tolerx also recently announced a collaboration with GSK to develop TRX4 for a range of autoimmune diseases.
BTG is also conducting clinical studies with several of its own programmes targeting the treatment of varicose veins, Alzheimer's disease, multiple sclerosis, migraine and obstructive sleep apnoea.
For further information contact:
BTG
Financial Dynamics
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
Ben Atwell
+44 (0)20 7831 3113
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit: www.btgplc.com.
This information is provided by RNS
The company news service from the London Stock Exchange
neil777
- 22 Jul 2008 13:20
- 46 of 93
Sorry for no reply Hangon, I have been away a fair bit and my attention has been elsewhere, ie, getting my nuts kicked in with AZM !
hangon
- 28 Jul 2008 21:01
- 47 of 93
AZM(off thread) was indeed a blow! It's not one I hold, but I watched the graph in disbelief. What's yr take? ( try AZM iteslf, pse).
EDIT 4Aug08
Wow! just look st BTG moving - the Bear-Market is somewhere else ( famous last words!) and I love it....This is now my no1 holding ( others badly battered). . . . now what if Vs is a Winner? - twice the current sp ( that's 4 ).....let's not forget this stock rose to 12 in daft days, 2000-ish.
Very conveniently I bought all of my ISA into BGC, and its gone up 50% - wow, thankyou market - but I'm not selling just yet. Oh no.
neil777
- 06 Aug 2008 17:08
- 48 of 93
RNS Number : 7801A
BTG PLC
06 August 2008
BTG plc: Tolerx initiates dosing of otelixizumab in a phase III clinical trial in type 1 diabetes
Tolerx to pay milestone of $7.5 million to BTG
London, UK, 6 August 2008: BTG plc (LSE: BGC), the life sciences company, notes today's announcement by Tolerx, Inc. that it has initiated a pivotal phase III clinical trial of otelixizumab (TRX4) in patients with new onset type 1 diabetes. Initiation of the DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes) triggers a milestone payment by Tolerx to BTG of $7.5m.
The DEFEND trial, which is being conducted at multiple centres in North America and Europe, will enrol approximately 240 people aged 18-35 who have been newly diagnosed with type 1 diabetes. It will evaluate whether a single course of TRX4, administered no later than 90- days after the diagnosis of autoimmune type 1 diabetes, can inhibit the destruction of pancreatic beta cells and thereby reduce the amount of administered insulin required to control blood glucose levels. The primary endpoint will be a measurement of C-peptide, which is a surrogate measure of beta cell function.
Louise Makin, BTG's chief executive officer, commented: 'We are delighted that Tolerx has commenced this pivotal phase III trial of TRX4, which could be a significant new treatment option for people with new onset type 1 diabetes. TRX4 is the third of our licensed programmes to enter phase III trials recently, alongside Campath for MS and abiraterone acetate for prostate cancer, underlining the value of our licensed pipeline.'
BTG granted Tolerx worldwide rights to develop and commercialise TRX4 in September 2001. In October 2007, Tolerx entered into an agreement with GlaxoSmithKline to develop and commercialise TRX4 in a range of autoimmune and immune-mediated inflammatory diseases. Under the terms of that collaboration, Tolerx may earn development and sales milestone payments of up to $525m and BTG is entitled to receive 50% of the development and sales milestones paid to Tolerx.
For further information contact:
BTG
Financial Dynamics
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; mobile: +44 (0)7990 530605
Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591
Ben Atwell
+44 (0)20 7831 3113
About BTG
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit: www.btgplc.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
BAYLIS
- 06 Aug 2008 20:27
- 49 of 93
just a bit of history/
over 16 pounds once
neil777
- 07 Aug 2008 13:20
- 50 of 93
18 to be exact! But that was in the stupid days.
hangon
- 26 Aug 2008 09:08
- 51 of 93
The dot-com days are gone and those silly prices are unlikely to re-appear. Many companies had little real value - but the MArket kept pushing onwward and upward.
Now, back in 2008, from 85p (Springtime) BTG has be rising to current 2.20 with just a slight drop recently from higher. That shows the fundamentals are-a-changing since this Market is "tough" - there may be some sillynes, but if it's doubled confortable in under 6-months, there is no reason to believe it cannot do the same when some "news" supports the potential. Therfore I'd be surprised if we don't see another 1 ( =4-bagger) before long and maybe more at the time of any Ann. Perhaps that will be time to sell and buy on any bounce, as there will be plenty that think that's enough.
Yet, after a +ve Ann. why sell? That Ann will define the potential and timescale - why would any Market treat you to a buying Op ?
Other than balancing yr portfolio it will be better to stay In. At least until the first Deal is struck, which might indicate any cash-returns to shareholders...for that is when pay-day should start.
If Management finds other uses for the profits, that will be time to question the pipeline and the way Execs want to reward shareholders - - - Grief we've been patient! I think all my purchases are in profit now, but more would be an extra comfort.
Looking at the Graph, it looks sensible to say that 6 looks possible - but IF you remove the Dot-Com bubble, then the graph doesn't look so good. And nor should it - the value has only appeared recently, so consider the graph from about 2004/5 and maybe 3-4 looks achievable.
That's not to say a spike cannot occur and that will depend on Management.
hangon
- 04 Sep 2008 15:44
- 52 of 93
BTG has been examined by "Shares" and found that the sp is higher than the all-time floor...funny that, eh?
What they don't say is that since last April)-ish), the Market has re-rated this because the prospects of Varisolve are much greater, and the Market sees the other products, the income-stream and the Cash - are worth the 2+
To suggest this will touch 85p begs this question - If you have any stock, will you sell them to me cheaply - many thanks.
DYOR
neil777
- 18 Sep 2008 10:35
- 53 of 93
UPDATE 1-BTG to buy Protherics in $390 mln UK biotech deal
AFX
LONDON, Sept 18 (Reuters) - BTG has agreed to buy Protherics for around 218.1 million pounds ($388.6 million) in an all-share deal, the companies said on Thursday, marking the further consolidation of Britain's biotech sector.
Biotechnology has seen a spate of takeover activity recently, spurred by large drugmakers seeking to acquire new products to fill their depleted drug development pipelines and smaller companies joining forces to stretch cash reserves.
Protherics shareholders will receive 0.291 new BTG shares for every one Protherics share held. That values Protherics at 60 pence a share -- a premium of 45.5 percent to the closing price on Sept. 17 -- based on a BTG share price of 206p.
Annualised merger cost synergies and rationalisation of the enlarged group's cost base are expected to be around 20 million pounds by 2010/11, the two companies said.
The acquisition is forecast to be earnings enhancing, on an EBITDA basis, and cash neutral from 2009/10 and significantly earnings enhancing thereafter.
Protherics first announced last month that it had received several bid approaches and there had been some speculation it might be bought by AstraZeneca Plc.
'I think people would have preferred a cash offer from Big Pharma rather than paper in a company whose shares have gone up 115 percent in the last year when everything else has gone down,' said KBC analyst Paul Cuddon.
AstraZeneca has a deal dating back to 2005 with Protherics covering its experimental drug CytoFab for sepsis, a deadly syndrome linked to serious bloodstream infections. The Anglo-Swedish group also has a 3.2 percent stake in the company.
Protherics also has an alliance with privately owned Swiss drugmaker Nycomed, which sells its CroFab treatment for rattlesnake bites and DigiFab for drug overdoses in the United States.
Rothschild is acting as financial adviser to BTG. Jefferies is acting as financial adviser to Protherics.
(Additional reporting by Ben Hirschler; Editing by Greg Mahlich) ($1=.5612 pounds) Keywords: PROTHERICS BTG/
tf.TFN-Europe_newsdesk@thomson.com
ak
COPYRIGHT