We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Register for streaming realtime charts, analysis tools, and prices.
| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Phoqus | LSE:PQS | London | Ordinary Share | GB00B0M4CD64 | ORD 10P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 8.00 | 0.00 | 01:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
Hot Features
Premium
RNS Number:1105R
Phoqus Pharmaceuticals PLC
31 March 2008
31 March 2008
Phoqus Pharmaceuticals plc
(formerly Phoqus Group plc)
Preliminary results for the year ended 31 December 2007
Phoqus Pharmaceuticals plc (AIM: PQS) ("Phoqus Pharmaceuticals" or "Group")
today announces its preliminary results for the year ended 31 December 2007.
Operational Highlights
* New Chief Executive Officer appointed in May 2007
* Developed new strategy to transform Phoqus Pharmaceuticals into a
specialty pharmaceutical company
* Successful completion of Chronocort(R) Phase I clinical trials programme
in healthy volunteers
* Phase II clinical trial of Chronocort(R) in patients with congenital
adrenal hyperplasia initiated at the National Institutes of Health ("NIH")
* Manufacturing operations streamlined and appointment of Patheon as
contract manufacturing partner for Chronocort(R) Phase II clinical trial
supply
* Appointment of Patrick Round as Chief Medical Officer and Michel Grandjean
as Chief Operations Officer
Financial Highlights
* Revenue for the year £51,000 (2006: £167,000) representing residual
service business income
* Operating loss £7.0 million (2006: £5.1 million)
* Cash and cash equivalents at the year end £5.4 million (2006: £4.4
million)
* Successful Placing raising £5.2m (gross) to fund the development of
Chronocort(R)
* Received £2.5m (gross) from drawn down loan and warrants
Post Year-end Highlights
* March 2008 announced positive results from Chronocort(R) Phase II study
Dr Richard Mason, Chief Executive Officer of Phoqus Pharmaceuticals, said:
"The last year has been one of tremendous change for Phoqus Pharmaceuticals,
with the implementation of a new vision and strategy to be a specialty
pharmaceutical company and the excellent progress of our lead product
Chronocort, which holds great promise for the treatment of patients with
congenital adrenal hyperplasia and adrenal insufficiency due to conditions such
as Addison's Disease. We look forward to exploring the commercial options over
the next few months to exploit the exciting potential this product has."
Enquiries:
Phoqus Pharmaceuticals plc
Dr Richard Mason, Chief Executive Officer Tel: 01732 870227
Dr Peter Johnson, Chief Financial Officer Tel: 01732 870227
Nomura Code Securities
Phil Walker Tel: 020 7776 1200
www.phoqus.com
Chairman's Statement
The year under review has been a period of significant change and real progress
for Phoqus Pharmaceuticals. Our new CEO led the Company through a thorough
strategic review leading to an exciting new strategy and vision for the Company.
As a result Phoqus Pharmaceuticals is now an emerging specialty pharmaceutical
company that is planning to develop differentiated products, for use in
high-value, specialist indications where patients are currently underserved.
Our strategy to do this is laid out below:
Drug refocusing
Our strategy is to focus on the further development of known drugs in new
indications, thereby avoiding the high risk of failure typically associated with
new chemical entities ("NCEs"). Some NCEs fail principally due to safety issues
encountered during early development. Our first such drug is Chronocort(R), a
novel delayed and sustained release tablet formulation of hydrocortisone.
By focusing on the development of known drugs, Phoqus Pharmaceuticals will avoid
the great unknown of NCE toxicity and safety testing.
Collaborating with leading academics and universities
Phoqus Pharmaceuticals does not engage in expensive and high-risk new drug
discovery. Instead the company aims to in-license product development
opportunities from academia and university spin-out companies. The concept of
Chronocort(R) was invented by a leading endocrinologist at the University of
Sheffield and has been licensed to the Group by Diurnal Ltd, a University of
Sheffield spin-out company.
Building networks with clinicians and patients
Phoqus Pharmaceuticals seeks to work collaboratively with both clinicians and
patients in the development of new products so that they are most likely to be
of real benefit when they reach the market. The Group has built a key opinion
leader ("KOL") board for Chronocort(R) and has appointed world-renowned
clinicians to be principal investigators (PIs) for the clinical development of
Chronocort(R). The Group established dialogue with patient groups around the
world early on in the development of Chronocort(R). It was through a
relationship with a patient support group in the US that the Group was
introduced to leading endocrinologists at the US National Institutes of Health
(NIH) who are now engaged in the conduct and funding of Chronocort(R)'s clinical
studies in the US.
Investor proposition
The Group strategy aims to generate significant returns for our investors
through new therapeutic product development, but at lower risk. We aim to
maximise return on investment by trying to reduce the risk-return ratio of new
product development at every step of the process, through applying the strategy
described above.
Significant events during the year
In May 2007 we announced the appointment of Dr. Richard Mason as the new Chief
Executive Officer of the Company. The Board is delighted to have appointed
someone with Richard's experience and enthusiasm as our new Chief Executive
Officer. His strong skills in business development and track record in
collaborating with large pharmaceutical companies make him an ideal CEO to lead
Phoqus through the next stage of its development.
In July 2007, the Company successfully concluded a Placing raising £5.2 million
(gross) to fund its new strategy as a specialty pharmaceutical drug development
company focused on the development of new therapeutic products for patients with
significant unmet medical needs. The net proceeds of the Placing has allowed the
Company to continue the development of its lead product Chronocort(R) to the end
of Phase II, with a view to maximising value for shareholders.
In August 2007, the Company announced that its proposal to change the Company's
name to Phoqus Pharmaceuticals plc had been approved at an extraordinary general
meeting ("EGM").
Significant events after the year end
On 3 March 2008, we announced positive results from a Phase II study of our
novel Cortisol replacement therapy, Chronocort(R) in Congenital Adrenal
Hyperplasia ("CAH"). Primary and secondary endpoints successfully demonstrate
clinical proof of concept in patients with CAH. The Company now plans to proceed
to a Phase III pivotal trial.
Business Review
Phoqus Pharmaceuticals is a speciality pharmaceutical company whose strategy is
to develop differentiated products for use in high-value, specialist
indications. It seeks to accelerate the rate and lower the risk of new drug
development by applying its novel re-formulation expertise and drug delivery
technologies to finding new indications for known, approved drugs. This avoids
the high failure rate typically associated with new chemical entities (NCEs),
which often founder due to safety issues encountered early in development.
The Group's first product is Chronocort(R) for the treatment of patients with
cortisol deficiency due to diseases such as Congenital Adrenal Hyperplasia ("CAH
") and Addison's Disease. It is differentiated from existing therapies because
it is designed to release the steroid in a pattern that mirrors a healthy
subject. At present Chronocort(R) is scheduled to reach the market in 2010,
subject to the successful completion of the clinical trials and regulatory
approval. The Group now plans to seek commercial partners for Chronocort(R) to
enable the product to be developed as planned.
The Group aims to in-license further product development opportunities from
academia and university spin-out companies. By collaborating with these third
parties the Group will access fundamental biological and clinical insights into
existing drug action and apply this knowledge to develop new indications for
those drugs. The Group aims to capitalise on accelerated regulatory pathways
such as the Priority Review Process to further fast-track products to market.
Proprietary Technologies and Intellectual Property
Phoqus Pharmaceuticals has an extensive portfolio of over 250 granted patents
and in-process patent applications which protect the Group's proprietary drug
delivery technologies and the core electrostatic deposition technology and its
applications, encompassing processes, materials, apparatus and machines,
methods, formulations and products.
The Group's core technology platform is called QtrolTM, which is derived from
electrostatic deposition, the well-proven technology behind photocopying.
QtrolTM enables solid oral dosage forms such as tablets to be coated in a
controlled and precise manner that can then be used to modify the way that a
drug is released into the body.
Chronocort(R)
Hydrocortisone steroid (the synthetic analogue of the natural hormone cortisol)
is specially formulated to enable sustained release and is then housed in a
coating 'bucket', topped by an inactive, eroding layer. Only after the latter
has been digested is the drug released. This design secures a 3-4 hour delay in
drug release in order to mimic the normal pattern of circulating cortisol
release, wherein levels are very low on going to bed and gradually increase
during the night, peaking at around 7am. It means patients can take their tablet
before bed and be woken by a normal cortisol 'high'.
Chronocort(R) Potential Market Size
Phoqus Pharmaceuticals estimates that there are around 140,000 to 240,000 people
with cortisol deficiencies in the EU, with between 100,000 and 172,000 sufferers
in the US and Canada. In Japan, the numbers are around 40,000 - 60,000. This
gives an estimated total population in the three main pharmaceutical markets of
between 280,000 and 470,000.
Chronocort(R) Development Status
Chronocort(R) is scheduled for launch in 2010, subject to the successful
completion of the clinical trials and regulatory approval. It already has
Orphan Drug Designation for both CAH and acquired adrenal insufficiency
(Addison's disease, hypopituitarism) in Europe. The Group is applying for the
same in the US. Orphan Drug Status, if granted upon approval, will provide the
Group with 10 and 7 years of market exclusivity in the EU and US respectively.
Chronocort(R) Phase II results
On 3 March 2008, the Group announced positive results from a Phase II study
evaluating its delayed, sustained release hydrocortisone therapy Chronocort(R),
in patients with CAH.
In healthy subjects, cortisol is produced in a distinct circadian rhythm:
building over night, peaking early in the morning and declining throughout the
day to its lowest point around midnight. CAH patients lack the enzyme to convert
17-Hydroxyprogesterone ("17-OHP") into cortisol. In the absence of cortisol,
which acts as a brake to 17-OHP production, 17-OHP and other androgens
accumulate. 17-OHP levels are used to adjust the dose of steroid replacement
but with conventional therapy it is very difficult to replicate the natural
circadian rhythm and to get the balance right between under and over treatment.
This leaves patients at chronic risk of steroid excess which may lead to
obesity, high blood pressure, diabetes and osteoporosis.
The Phase II trial, which was conducted at the National Institutes of Health in
Bethesda, Maryland, showed that treatment with Chronocort(R) gave an overnight
cortisol profile much closer to the normal physiological profile than
conventional immediate release hydrocortisone. In addition, the majority of
patients had lower morning levels of 17-OHP when treated with Chronocort(R)
compared with conventional therapy.
Fourteen patients with CAH received a 7 day run-in period of immediate release
hydrocortisone given three times a day. They then switched to a single dose of
Chronocort(R) at 10.00pm for 28 days. A 24 hour pharmacokinetic ("PK") profile
was performed at the end of each treatment period. The primary endpoint was the
24 hour cortisol profiles which, during the Chronocort(R) treatment period, more
closely matched the overnight physiological pattern than with conventional
immediate release treatment. An important secondary endpoint (and key
pharmacodynamic measure) was the morning 17-OHP level which showed reduced mean
levels with Chronocort(R) compared with conventional treatment. These results
give confidence that Chronocort(R) has performed as designed and allow the
design of an appropriate dosing regimen for a Phase III pivotal trial, subject
to regulatory approval. The Group is now preparing to discuss such a trial with
regulatory authorities. The data will be submitted for publication in a peer
reviewed journal in due course.
Manufacturing
Appropriate manufacturing capacity is being accessed through third party
manufacturers to meet the requirements of the Chronocort(R) product in
development and ultimately for commercial supply expected from 2010.
Human resources
Throughout the year we have continued to seek to recruit experienced new staff
in clinical development and product development to ensure we continue to be
successful in delivering new business.
In November 2007 the Group announced the appointment of Dr Patrick Round as
Chief Medical Officer. Dr Round's appointment is a key part of the
strengthening of Phoqus Pharmaceuticals' senior management team as the Group
progresses its lead product candidate Chronocort(R) towards pivotal Phase III
trials. Dr Round will lead the Chronocort(R) development programme and will
also play a key role in building the Group's future product pipeline.
Also in November 2007 the Group announced the appointment of Michel Grandjean to
the new position of Chief Operating Officer, effective 1 January 2008. Michel's
appointment completes the strengthening of the Group's senior management team
outlined during the fundraising in July 2007 in which the Group raised £5
million to progress the in-house development of Chronocort(R). As Chief
Operating Officer, Michel will be responsible for leading the manufacturing and
supply chain operations at Phoqus Pharmaceuticals, including the commercial
manufacture of Chronocort(R) in preparation for its launch planned in 2010,
subject to regulatory approval.
Financial Review
Results
In the year ended 31 December 2007, the Group's revenue was £51,000 (2006:
£167,000) which was derived mainly from fees arising from collaborations with
pharmaceutical companies.
The operating loss of £7.0m (2006: £5.1m) included research and development
expenses which qualify for additional tax allowances from the HMR&C, amounting
to £2.5m (2006: £1.7m). Other research and development expenditure amounted to
£1.7m (2006: £1.5m).
The £0.2m expenditure associated with the secondary placing has been charged
against share premium and is not included in the operating loss.
There was a charge of £0.3m in respect of share based payment (non cash effect)
and an accrual of £0.6m which will result in cash flows over the next three
years. Other additional costs were partially offset by a higher than expected
Research and Development tax credit.
Taxation includes a Research and Development tax credit of £0.6m (2006: £0.4m).
The loss per share at 15.9p (2006: 14.3p) was based on the weighted average
number of Ordinary Shares in accordance with IAS 33 'Earnings per Share'.
Financial position and cashflow
The Group's net cash outflow from operating activities in the year ended 31
December 2007 was £5.6m (2006: £4.6m). The Group raised £5.2m (gross) from a
secondary placing during the year and also raised £2.5m from loans and warrants.
This increased the cash and cash equivalents figure to £5.4m (2006: £4.4m).
The receipt of £0.4m in respect of the 2006 Research and Development tax credit
which had been expected in December was received in early January.
All surplus cash is kept on deposit in accordance with the Group's policy to
maximise returns on low risk cash or cash-equivalent investments that safeguard
the principal whilst ensuring that cash resources are available to fund the
Group's operations when required.
International Financial Reporting Standards
From 1 January 2007 Phoqus Pharmaceuticals plc has produced its consolidated
accounts in accordance with International Financial Reporting Standards and
applicable interpretations as adopted by the European Union ("IFRS"). These are
the first full financial statements to be prepared on this basis.
The net effect of presenting the consolidated financial statements for the year
ended 31 December 2006 under IFRS rather than UK GAAP is to increase the net
loss after tax for the year from £4.743m to £4.747m and reduce net assets at
that date from £6.080m to £6.059m. There were no changes to the cash flow other
than to reclassify liquid investments as cash or cash equivalents.
PHOQUS PHARMACEUTICALS PLC
Consolidated Income Statement
for the year ended 31 December 2007
2007 2006
Note £'000 £'000
Revenue 2 51 167
Cost of sales - -
__________ _________
Gross profit 51 167
Administrative expenses 3 (7,008) (5,293)
__________ _________
Operating loss (6,957) (5,126)
Finance revenue 270 192
Finance charges (260) (209)
__________ _________
Loss on ordinary activities before taxation (6,947) (5,143)
Income tax credit 4 586 396
_________ _________
Loss attributable to equity holders (6,361) (4,747)
======== ========
Basic and diluted loss per ordinary share (pence) 5 15.9 14.3
All operations are continuing activities.
PHOQUS PHARMACEUTICALS PLC
Consolidated Balance Sheet
at 31 December 2007
2007 2006
£'000 £'000
Assets
Non current assets
Property, plant and equipment 1,959 2,119
________ ________
1,959 2,119
________ ________
Current assets
Trade and other receivables 361 420
Prepayments 245 185
Current tax asset 989 402
Cash and cash equivalents 5,444 4,395
________ ________
7,039 5,402
________ ________
________ ________
Total Assets 8,998 7,521
======== =======
Equity and Liabilities
Capital and reserves
Called up share capital 4,637 3,596
Share premium account 25,802 21,839
Merger reserve 18,295 18,295
Other reserve: warrants 260 206
Retained earnings (43,963) (37,877)
_________ ________
Total Equity 5,031 6,059
_________ ________
Non-current liabilities
Trade and other payables 334 -
Interest-bearing loans and borrowings 1,694 344
_________ ________
2,028 344
_________ ________
Current liabilities
Trade and other payables 877 551
Interest-bearing loans and borrowings 1,062 567
_________ ________
1,939 1,118
_________ ________
Total Liabilities 3,967 1,462
_________ ________
Total Equity and Liabilities 8,998 7,521
======== =======
PHOQUS PHARMACEUTICALS PLC
Consolidated Statement of Changes in Equity
for the year ended 31 December 2007
Exchange
difference
Share Share Merger Warrant reserve Retained Total
capital premium reserve reserve equity
£'000 earnings
£'000 £'000 £'000 £'000 £'000
£'000
At 1 January 2006 3,260 19,048 18,295 206 - (33,176) 7,633
Loss for the period - - - - - (4,747) (4,747)
Exchange difference - - - - 1 - 1
______ _______ ______ ______ _______ _______ ______
Total recognised income - - - - 1 (4,747) (4,746)
and expense for period
New share issues 336 2,964 - - - 3,300
Share issue costs - (173) - - - (173)
Share based payment - - - - - 45 45
______ _______ ______ ______ _______ _______ ______
At 31 December 2006 3,596 21,839 18,295 206 1 (37,878) 6,059
Loss for the period - - - - - (6,361) (6,361)
Exchange difference - - - - (5) - (5)
______ _______ ______ ______ _______ _______ ______
Total recognised income - - - - (5) (6,361) (6,366)
and expense for the
period
New share issues 1,041 4,164 - - - - 5,205
Share issue costs - (201) - - - - (201)
Grant of warrants - - - 54 - - 54
Share based payment - - - - - 280 280
______ _______ ______ ______ _______ _______ ______
At 31 December 2007 4,637 25,802 18,295 260 (4) (43,959) 5,031
====== ====== ====== ====== ====== ====== ======
PHOQUS PHARMACEUTICALS PLC
Consolidated Cash Flow Statement
for the year ended 31 December 2007
2007 2006
£'000 £'000
Operating Activities
Loss before tax from continuing operations (6,947) (5,143)
Adjustment to reconcile loss before tax to net cash flow from
operating activities
Non-cash:
Depreciation of property, plant and equipment 379 356
Loss on disposal of property, plant and equipment 1 98
Share-based payment expense 280 45
Interest income (270) (192)
Interest expense 260 209
Working capital adjustments:
(Increase)/decrease in debtors - 164
Increase/(decrease) in creditors 659 (717)
Overseas tax paid (2) (6)
Research and development tax credit received - 601
________ ________
Net cash flows from operating activities (5,640) (4,585)
________ ________
Investing activities
Purchase of fixed assets (178) (164)
Interest received 270 192
________ ________
Net cash flows from investing activities 92 28
________ _________
Financing activities
Proceeds from issue of ordinary share capital 5,205 3,300
Transaction costs of issue of shares (201) (140)
Proceeds from borrowing 2,379 -
Warrants granted to lender 54 -
Repayment of capital element of finance leases and hire (575) (529)
purchase contracts
Interest element of payments under finance leases (96) (173)
Interest paid (164) (36)
________ ________
Net cash flows used in financing activities 6,602 2,422
________ ________
Net (decrease)/increase in cash and cash equivalents 1,054 (2,135)
Net foreign exchange difference (5) -
Cash and cash equivalents at 1 January 4,395 6,530
________ ________
Cash and cash equivalents at 31 December 5,444 4,395
======= =======
Notes to the preliminary announcement
1. Basis of preparation of financial information
This financial information has been prepared in accordance with the accounting
policies set out in the annual report of the Group for the year ended 31
December 2007. The financial information disclosed in this announcement does
not constitute the Group's statutory accounts. The financial information for
the year ended 31 December 2006 has been extracted from the statutory accounts
for that year which have been delivered to the registrar of companies. The
audit report on those accounts was unqualified but was modified concerning the
fundamental uncertainty as to the Group's medium-term viability until its
technology is commercially successful and is capable of revenue generation. The
report did not contain a statement under s237 (2) or (3) of the Companies Act
1985.
The financial information for the year to 31 December 2007 has been extracted
from the statutory accounts for that year which have not as yet been delivered
to the Registrar of Companies. The report of the auditors was unqualified but
was modified concerning the fundamental uncertainty as to the Group's viability
until its technology is commercially successful and is capable of revenue
generation. The report did not contain a statement under s237 (2) or (3) of the
Companies Act 1985.
2. Turnover and segmental analysis
The Directors have assessed that substantially all of the Group's operations
relate to the principal activity of the development for the manufacture of
pharmaceutical tablets with tailored appearance and medical properties using
inter alia its own proprietary electrostatic deposition technology. The
Directors believe that all turnover, losses and net assets relate to continuing
activities performed in the Group's principal activity as stated above.
3. Administrative expenses
2007 2006
£'000 £'000
Inland Revenue qualifying research and development expenses 2,482 1,674
Other research and development expenses 1,718 1,462
Share based payments 280 45
Contract termination expenses 559 -
Other expenses 1,969 2,112
_________ _________
7,008 5,293
======== ========
4. Income tax credit
2007 2006
£'000 £'000
Current income tax
Current income tax charge (2) (6)
Research and development tax credit 596 402
Research and development tax credit - prior period (8) -
_________ _________
586 396
======== ========
The Group has taken advantage of the Research and Development corporation tax
credits introduced in the Finance Act 2000 whereby the Group may surrender
corporation tax losses incurred on research and development expenditure for a
corporation tax refund.
5. Loss per share
2007 2006
Loss (£'000) 6,361 4,747
Weighted average number of shares (thousands) 39,979 33,144
Loss per ordinary share (pence) 15.9 14.3
Basic loss per ordinary 10p share amounts are calculated by dividing net loss
for the year attributable to ordinary equity holders of the parent by the
weighted average number of ordinary shares outstanding during the year.
Diluted loss per ordinary 10p share is the same figure as the basic loss per
share because the Share Options and Warrants are not dilutive since if they were
exercised they would reduce the loss per share.
This information is provided by RNS
The company news service from the London Stock Exchange
END
FR BIGDXIUXGGIG
1 Year Phoqus Chart |
1 Month Phoqus Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions
