RNS Number:9089R
Galen Holdings PLC
11 November 2003
Craigavon, Northern Ireland/Rockaway, NJ 11 November 2003
Galen Holdings PLC
Results for the fourth quarter and full year ended 30 September 2003
Craigavon, Northern Ireland/Rockaway, New Jersey, USA - 11 November 2003: Galen
Holdings PLC ("Galen") (LSE: GAL.L, Nasdaq: GALN), announces its results for the
quarter and full year ended 30 September 2003.
Financial Highlights for the year
Year ended Year ended
30 September 2003 30 September 2002 Change
($ m) ($ m) (%)
Revenues
- Products 432 235 84%
- Services (Discontinued) - 61 -
_____ _____ _____
Total revenues 432 296 46%
_____ _____ _____
Operating profit(1)
- Products 187 95 97%
- Services (Discontinued) - 10 -
_____ _____ _____
Total operating profit 187 105 79%
_____ _____ _____
Statutory operating profit 125 64 95%
_____ _____ _____
Cents Cents
Adjusted earnings per share(1) 85.2 47.8 78%
_____ _____ _____
Statutory earnings per share 51.2 73.4(2) -30%
_____ _____ _____
1 Operating profit and adjusted earnings per share, which are the primary
performance measures used by management, are presented after excluding
amortisation of intangibles, goodwill and before exceptional item.
Reconciliations of statutory and adjusted items are given in the profit and loss
account and Note 2 to the results.
2 Includes the exceptional profit on the sale of our pharmaceuticals
services business in 2002.
* Earnings per ordinary share, before amortisation of goodwill, intangible
assets and exceptional items, (including the gain on the sale of our
Pharmaceutical Services business during 2002), increased to 85.2 cents, up
78% over the prior year.
* Operating profit, before amortisation of goodwill and intangibles, rose
to $187.0 million compared to $104.5 million in the prior year, an increase
of 79%.
* The results of the prior year include the Pharmaceutical Services
business, which was sold in the year ended 30 September 2002.
* Total pharmaceutical product revenues increased by 84% to $432.3 million
from $235.2 million reflecting strong underlying organic growth of 27% as
well as the addition of Sarafem(R), the US sales and marketing rights of
which were acquired from Eli Lilly and Company in January 2003, and the
addition of three products from Pfizer Inc., Estrostep(R), Loestrin(R) and
femhrt(R), acquired in March and April 2003 (see page 4 for breakdown).
* During the year, the Company invested approximately $650 million
acquiring products and product rights. These transactions were financed
through a combination of existing cash reserves and senior debt. The
Company generated $208 million in cash from operations and ended the year
with $253.3 million in net debt.
* The Board has recommended the payment of a final dividend of 2.4p per
ordinary share. This equates to a total dividend for the year of 3.6p, an
increase of 20% over the previous year.
Business Highlights for the year
* Purchased the US sales and marketing rights to Sarafem(R), which is
indicated for the treatment of pre-menstrual dysphoric disorder (PMDD), from
Eli Lilly and Company for approximately $295 million in December 2002.
* Acquired oral contraceptives Estrostep(R) and Loestrin(R) and the combined
estrogen-progestogen therapy femhrt(R) from Pfizer Inc. for approximately
$359 million in March and April 2003.
* Received FDA approval for Femring(R) in March 2003 and launched the
product in June 2003.
* Entered into an agreement with Bristol-Myers Squibb Company for the
co-promotion of and option to purchase BMS's US Dovonex(R) business in
April.
* Entered into a development agreement and license agreement with LEO Pharma
for Dovobet(R) in April.
* Initiated the deployment of a second salesforce, the 185 person Warner
Chilcott Specialty salesforce.
* Signed letters of intent with Barr Laboratories Inc. in September to
resolve outstanding patent challenges on Estrostep(R) and femhrt(R), license
the existing US and Canadian Loestrin(R) business to Barr, and obtain an
option to license the generic Ovcon(R) ANDA from Barr.
Commenting on the results, Roger Boissonneault, Chief Executive said:
"The past year established Galen's pharmaceutical products business as the focus
of the company. We have significantly strengthened our US presence through the
execution of our growth strategy, to continue organic growth, new product
development and selective acquisitions. Galen is well positioned to execute its
growth strategy into "04" and beyond".
For further information, please contact:
Galen Holdings PLC
David G. Kelly Today: + 44 (0) 207 831 3113
Thereafter: + 44 (0) 28 3833 4974
Financial Dynamics
Andrew Dowler / Francetta Carr Tel: + 44 (0) 20 7831 3113
For further information on Galen visit: www.galenplc.com
An analyst presentation will take place at 9.30am (GMT) today at the offices of
Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2. A
conference call will also take place at 2pm (GMT) today. Please call Mo Noonan
on 020 7269 7116 for further details.
Note:
Forward looking statements in this report, including, without limitation,
statements relating to Galen's plans, strategies, objectives, expectations,
intentions and adequacy of resources, are made pursuant to the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of 1995. These
forward looking statements involve known and unknown risks, uncertainties and
other factors that may cause the actual results, performance or achievements of
Galen to be materially different from any future results, performance or
achievements expressed or implied by such forward looking statements. These
factors include, among others, the following: Galen's ability to manage its
growth, government regulation affecting the development, manufacture, marketing
and sale of pharmaceutical products, customer acceptance of new products,
competitive factors in the industries in which Galen operates, the loss of key
senior management or scientific staff, exchange rate fluctuations, general
economic and business conditions, and other factors described in filings of
Galen with the SEC. Galen undertakes no obligation to publicly update or revise
any forward looking statement, whether as a result of new information, future
events or otherwise.
Commentary on the results for the fourth quarter and full year ended 30
September 2003
Sales & Marketing
The Group achieved significant growth in each of its key pharmaceutical products
as illustrated by the table below.
PRODUCTS Q4 2003 FY 2003 YOY Growth %
$M's $M's
Oral Contraception
Ovcon(R) 17.3 58.6 29%
Estrostep(R) 15.2 26.5 N/A
Loestrin(R) 18.2 34.9 N/A
HRT
Estrace Cream(R) 12.2 44.8 23%
femhrt(R) 13.4 22.6 N/A
Femring(R) 0.6 2.3 N/A
Estrace Tablets(R) 3.5 22.5 10%
Dermatology
Doryx(R) 10.3 54.1 28%
PMDD
Sarafem(R) 22.6 59.9 N/A
Other
U.S. 6.5 31.5 9%
U.K. & INTL. 18.9 74.6 20%
Total 138.7 432.3 84%
For the year ended 30 September 2003 total products sales were $432.3 million
compared to $235.2 million in the prior year, an increase of 84%. For the
quarter ended 30 September 2003 total product sales were $138.7 million, an
increase of 127% over the same quarter last year. This significant growth was
driven largely by the addition of recently acquired products which were not
included in the comparable sales numbers for last year, as can be seen in the
above table. However, revenues also grew strongly for existing products
promoted by our salesforce for which the comparable quarter's sales are
available, i.e. Ovcon(R), Estrace(R) Cream and Doryx(R), which showed combined
growth of 27% over the same quarter last year.
With regard to those products acquired during our fiscal year 2003, their impact
can now be seen on the results of the group. Sarafem(R), Estrostep(R) and femhrt
(R) all performed well in the quarter with sales of $22.6, $15.2 and $13.4
million respectively. This was the first quarter when we recorded a full
quarter's sales of femhrt(R), our combined estrogen-progestogen therapy product
acquired from Pfizer in mid April 2003.
In June we launched Femring(R), our vaginal ring for estrogen therapy. We had
initial stocking orders of approximately $1.7 million for this product and
recorded sales of $0.6 million for this product in the quarter.
Doryx(R) recorded sales of $10.3 million in the quarter, lower, as expected,
than other quarters in the year, as seasonal demand for acne treatments
typically declines during the summer months.
We now have our expanded salesforce largely in place. We have taken steps to
establish both our salesforces at approximately 185 persons, which we believe is
an optimum size. Our new Warner Chilcott Specialty salesforce is promoting
Estrostep(R) and Sarafem(R) to OB/GYNs and is also responsible for the promotion
of our dermatology products, Dovonex(R) and Doryx(R). We do not record any sales
of Dovonex(R), our treatment for mild to moderate psoriasis which we promote on
behalf of Bristol Myers Squibb, but we estimate in-market sales for the period
of our fiscal year were approximately $121 million.
Margins
The gross margin for the year was 82.2% compared to 69.6% for the prior year.
The gross margin for the quarter was 85.0% compared to 70.5% for the same period
last year. This improvement is largely attributable to the disposal of the
lower margin services businesses during the last financial year and as a result
of a greater proportion of our sales being generated from our US business.
Selling, General and Administrative expenses (S, G and A) were $139.5 million
for the full year and $44.4 million in the quarter, compared to $81.4 million
and $8.2 million in the prior year. This increase is due primarily to increased
selling, advertising and promotion costs being incurred as we expand our
salesforce and increase spending on promoting our broadened product offering.
It is also worth noting that in the fourth quarter of 2002, we netted off
realised exchange gains arising on the repayment of borrowings against our S, G
and A expenses, thus depressing last year's figure.
Operating profit, before amortisation of goodwill and intangibles, was $187.0
million (43.3% margin) for the full year and $65.5 million (47.2%) for the
quarter compared to $104.6 million (35.3%) and $31.8 million (49.3% margin) in
the same quarter last year. If one excludes the impact of the exchange gains
last year it is apparent that the Company continues to increase its operating
margins as it adopts the pharmaceutical products model.
Statutory operating profit for the year was $124.9 million (28.9% margin)
compared to $64.1 million (21.6% margin) in 2002, an increase of 94.9%.
Statutory operating profit includes amortisation of intangibles and goodwill.
Research & Development
Total research and development costs were $28.7 million for the year and $7.9
million for the quarter, compared to $20.6 million and $5.4 million respectively
in the same periods last year. This increase of 39.5% year on year reflects our
ongoing investment in our development pipeline.
During the quarter, we completed work on the New Drug Application (NDA) for our
oral estradiol acetate product (Femtrace(R)), for the treatment of the symptoms
of menopause. We submitted the NDA in mid-October. We continue in Phase III
clinicals for our vaginal ring containing metronidazole (MetroRingTM), for the
treatment of bacterial vaginosis, and we aim to submit the NDA in calendar 2004.
We expect the NDA submission for our Doryx(R) line extension to take place in
the first half of calendar 2004. Approval of the NDA for the new Ovcon(R)
product is expected prior to the end of calendar year 2003.
Liquidity
Cash generated from operations during the year was $207.8 million. Cash
generated from operations during the quarter was $70.7 million. During the
quarter we made the first $51.7 million repayment on our $350 million senior
loan. Cash on hand at 30 September 2003 was $89.1 million and net debt was
$253.3 million.
Chairman and Chief Executive Officer's statement
Letter to Shareholders
The year ended 30 September 2003 has been one of outstanding success at Galen
Holdings PLC, with continued excellent financial performance. We have
consistently delivered impressive year on year growth since our IPO in 1997.
Since the acquisition of Warner Chilcott in September 2000, your directors have
successfully transformed the business into a specialty pharmaceutical company
principally focused on the women's healthcare and dermatology markets in the
United States. Our relentless focus on implementation of our strategy to
continue organic growth of our pharmaceutical business, develop new proprietary
products and acquire products that complement and strengthen our existing
product range has positioned our business well for the future.
Financial Overview
Galen achieved record revenues of $ 432.3 million, a 45.8% increase over the
$296.5 million recorded for the prior year. The 2002 revenues include $61.3
million from the divested services businesses. Pharmaceutical product revenue
growth year on year was an outstanding 83.8%. Of our total revenues, 83% are
now generated from activities in the United States. Earnings per share before
amortisation of goodwill and intangible assets and exceptional items rose by
78.2% to 85.2 cents. Statutory earnings per share decreased by 30.2% to 51.2
cents reflecting in particular the exceptional gain on disposal of the
Pharmaceutical Services business in 2002.
Gross profit increased to $355.1 million from $206.6 million in the prior year,
notwithstanding the sale of our pharmaceutical services businesses, and reflects
continued strong growth in our U.S. business where margins are greater. Our
gross profit margin has now risen to 82.2% for the year.
Operating profit before amortisation of goodwill and intangible assets grew from
$104.6 million to $187.0 million, an increase of 78.8% over 2002. On a like for
like basis, excluding the divested services businesses, our operating profit
before amortisation rose by 97.4%. Our operating margin for the year was 43.3%,
an increase from the 35.3% recorded in last year's results. Our statutory
operating profit grew from $64.1 million to $124.9 million, an increase of 94.9%
over 2002 with an operating margin of 28.9% compared to 21.6% in 2002. Research
and development costs increased to $28.7 million as the development of our
product pipeline gained momentum and increased 39.5% from the previous year. S,
G and A costs rose to $139.5 million this year, attributable to launch costs of
Femring(R) and additional salesforce hired to support the larger product range
we now promote. For the year we generated cash of $207.8 million from our
operations, up from $93.4 million last year.
These excellent financial results reflect the strength and continued growth of
our underlying business and have encouraged your Board to recommend payment of a
final dividend of 2.4p per ordinary share, which represents a total for the year
of 3.6p, a 20% increase over the 3.0p declared for the previous year. The final
dividend of 2.4p will be paid on 26 February 2004 to shareholders on the
register on 23 January 2004.
Corporate Activity
Galen is committed to continued growth in its rapidly expanding US
pharmaceutical business, which is built around the sales and marketing
capabilities of Warner Chilcott. Last year, we divested our pharmaceutical
services businesses to free up resources for our ambitious growth plans in the
US pharmaceutical sector. These divestitures raised approximately $235 million
in the 2002 financial year.
During the year ended 30 September 2003, the Company completed two major product
acquisitions in the women's healthcare category and negotiated a major strategic
alliance in dermatology. Your directors believe that the impact of these
activities has greatly enhanced the Company's opportunities for growth.
In January 2003, we completed the acquisition of the US sales and marketing
rights for Sarafem(R) from Eli Lilly and Company. Sarafem(R) (fluoxetine
hydrochloride) is a prescription treatment for pre-menstrual dysphoric disorder
(PMDD), a severe form of pre-menstrual syndrome, and was the first FDA-approved
product for this condition. Launched by Lilly in 2000, Sarafem(R) had revenues
of approximately $80 million in the calendar year 2002. The cash consideration
for this transaction was approximately $295 million.
In March 2003, we acquired the oral contraceptives Loestrin(R) and Estrostep(R)
and in April an oral continuous estrogen-progestogen therapy, femhrt(R), from
Pfizer, Inc. The total consideration for the transaction was approximately
$359.0 million, with up to a further $125 million contingent on the maintenance
of market exclusivity for Estrostep(R) to 2008 and femhrt(R) to 2010. Loestrin
(R) is already subject to generic competition and is not subject to contingent
payments to Pfizer. Total revenues for these products in the calendar year 2002
were $228.3 million.
These acquisitions complement our existing women's healthcare franchise.
Sarafem(R) represents a new non-hormonal therapy in a developing therapeutic
area. Estrostep(R) and femhrt(R) were conceived by our CEO, Roger
Boissonneault, whilst at Warner-Lambert Company. These products complement our
existing product line and greatly strengthen our position in three important
therapeutic areas in women's health.
During the year the Company has been engaged in legal proceedings against Barr
Laboratories for patent infringement in respect of Estrostep(R) and femhrt(R)
and Teva Pharmaceuticals USA Inc. for patent infringement in respect of Sarafem
(R). In September 2003, Galen entered into letters of intent with Barr for a
transaction which would include a settlement of the femhrt(R) and Estrostep(R)
cases. The settlement would allow Barr to launch generic versions of those
products six months prior to patent expiry. These transactions are subject to
negotiation of definitive agreements, completion of due diligence and other
conditions, including Hart-Scott-Rodino antitrust review. The trial in Galen's
case against Teva Pharmaceuticals USA Inc. is scheduled to begin on November 12
in the United States District Court for Indiana.
On 1 April 2003 we entered into a co-promotion agreement with Bristol-Myers
Squibb Company for Dovonex(R) and a development agreement with LEO Pharma A/S
for Dovobet(R). This alliance represents a key milestone in the expansion of
our US dermatology franchise. Dovonex(R) is a leading non-steroidal product in
the treatment of psoriasis and Dovobet(R), which is a combination of the active
agent in Dovonex(R) (calcipotriene) and the steroid betamethasone diproprionate,
gives us access to new treatment technology through a formal relationship with
one of the world's leading dermatology R&D companies. Under the terms of the
agreement for Dovobet(R), Galen will pay LEO Pharma a total of $47 million by
the time Dovobet(R) progresses to full FDA approval, $40 million of which is
payable on approval. In the case of Dovonex(R), the term of the co-promotion
agreement ends 31 December 2007 and between now and 1 January 2006, Galen has an
option to purchase Bristol-Myers Squibb's US rights to the product under
pre-negotiated terms; however BMS can refuse to sell its rights to Dovonex(R)
prior to 1 August 2005. If Galen exercises its option on 1 August 2005
Bristol-Myers Squibb is obliged to conclude the purchase transaction by January
2006. This is an exciting development in the evolution of our US dermatology
franchise and pipeline.
During this intensive period of corporate activity our balance sheet has
remained robust. At 30th September 2003, net borrowings, including $48 million
of high yield (12.625%) bonds inherited at the time of the Warner Chilcott
acquisition, were $253.3 million. We have in place a senior debt facility of
$450 million. Of this, $200 million was drawn down at 31 March 2003 to finance
the acquisition of Estrostep(R) and Loestrin(R). During April 2003, an
additional $150 million was utilised to complete the acquisition of femhrt(R).
Cash generated during the year was $207.8 million and cash at hand on 30th
September 2003 was $89.1 million. The Company continues to generate strong
cashflow, complemented by the addition of the products acquired during the year.
Sales and Marketing
Our sales and marketing capabilities are the key contributor to our success. We
have a proven track record of revitalising acquired products and successfully
launching new products in the United States, utilising precision marketing
techniques. These techniques are used to target marketing of our key branded
products to high volume prescribing physicians and to employ our resources
effectively with a view to maximising growth in market share for our key
products.
During the past two years we have operated in the US with a salesforce of 226
persons. This has given us the reach and frequency to achieve growth for our
major promoted products. Your Board took the view that our continued strong
organic growth, combined with the expected impact of recent acquisitions of
products and product rights (Estrostep(R), femhrt(R) and Sarafem(R)), the launch
of a new product (Femring(R)) and our co-promotion agreement for Dovonex(R),
necessitated a re-organisation and expansion of our salesforce. In January
2003, we commenced a programme to expand our salesforce to approximately 400
representatives organised into two teams: Warner Chilcott Women's Healthcare
and Warner Chilcott Specialty. We believe that this sales organisation reflects
our present promotional needs with an expanded product portfolio in both women's
healthcare and dermatology.
During the year we continued to make sales gains in our core therapeutic areas.
Total pharmaceutical product revenues for the period were $432.3 million
representing a 83.8% increase on the previous year. Excluding the revenues for
products acquired during the year, the increase in promoted U.S. product
revenues over the previous period was a healthy 27%. Revenues from the United
States now represent 83% of total revenues.
In women's healthcare, Galen now has products in three categories important to
our target clinician, the obstetrician and gynaecologist (OBGYN):
contraception, hormone therapy and premenstrual dysphoric disorder (PMDD). Our
oral contraceptive Ovcon(R) continues to grow strongly, with revenues in the
period of $58.6 million, up 29% over the previous year. This is an excellent
platform for the launch of our new Ovcon(R) product, for which we received an
approvable letter in January 2003. Estrostep(R) is a graduated estrogen oral
contraceptive which is promoted by our Warner Chilcott Specialty salesforce.
Since its acquisition in March 2003, Estrostep(R) has achieved revenues of $26.5
million.
In estrogen therapy, we launched Femring(R) in 2003. To capitalise on
additional promotional platforms available we commenced a direct to consumer
(DTC) promotional campaign in September 2003 involving the use of both
television and print media. This is the first time we have supported our sales
organisation in this manner and reflects the growing substance of the Company.
Although subject to generic substitution since 1996 and not actively promoted by
the Company, Estrace(R) tablets remain one of the most widely prescribed oral
estrogen therapy products in the United States. Revenues for Estrace(R) tablets
in 2003 were $22.5 million, an increase of 10% on the previous year. Our
strategic objective is to maintain market position until the launch of our
proprietary second generation tablet (FemtraceTM) which will be promoted as an
alternative to Estrace(R) tablets. The NDA for FemtraceTM was submitted to the
FDA on October 14, 2003. Estrace(R) cream, which is indicated for local
treatment of the local symptoms of menopause, such as vaginal dryness, continues
to make good progress and recorded revenues of $44.8 million, an increase of 23%
on the previous year.
Femhrt(R), acquired from Pfizer, Inc. in April 2003, is a combined
estrogen-progestogen therapy indicated for patients with an intact uterus. This
completes our portfolio of hormone therapy products and complements Femring(R)
and eventually FemtraceTM tablets. Revenues for femhrt(R) since the acquisition
in April 2003 were $22.6 million.
In dermatology, our pelletised formulation of doxycycline, Doryx(R), is the #1
branded oral tetracycline prescribed by US dermatologists for the treatment of
acne. Revenues for this product, which is promoted by our Specialty salesforce,
increased to $54.1 million in the year ended 30 September 2003 representing a
28% increase over the previous year. The introduction of a new 75 mg. dose in
January 2002 has improved the flexibility in the prescribing of this product.
Dovonex(R) was added to our dermatology franchise in May 2003. In the early
years of the co-promotion programme, we do not anticipate major revenues from
this product. However the opportunity for eventual acquisition and access to
Dovobet(R) provides an exciting opportunity to extend our dermatology franchise.
Research and Development
New products from internal development are a key element of our growth strategy
and the continued strong performance of the business has enabled us to make
significant increases in our investment in research and development. This year
we invested $28.7 million in R&D, a 39.5% increase on the previous year.
Our R&D efforts are firmly focused on the development of proprietary products in
women's healthcare and dermatology. During the year, we received final approval
for Femring(R), our vaginal estrogen therapy, and an approvable letter for a new
version of our Ovcon(R) oral contraceptive.
In women's healthcare, we have ongoing projects in contraception, estrogen
therapy, hormone therapy, infection control and female sexual dysfunction. Our
estradiol acetate tablet (FemtraceTM) has completed phase III studies and an NDA
for the product was submitted to the FDA on October 14, 2003. Our metronidazole
vaginal ring for the treatment of bacterial vaginosis is an early example of the
use of vaginal ring technology in local infection control and is well into Phase
III development with a target NDA submission date in the first half of 2004.
Our testosterone vaginal ring remains in Phase II as we evaluate the developing
regulatory position for the registration of products for the treatment of female
sexual dysfunction.
In dermatology, our alliance with LEO Pharma A/S for the development and
commercialisation of Dovobet(R) in the US adds a significant product to our
pipeline. We are also progressing well with the development of a line extension
to further broaden our Doryx(R) franchise in acne with an NDA submission to the
FDA expected in early 2004.
Galen People
At the conclusion of our 2003 financial year Galen had 1,136 employees,
including 444 based in the US. This represents an increase of 176 people over
the previous year-end and particularly reflects the expansion of the Warner
Chilcott salesforces during the year. Galen Holdings has consistently delivered
financial performance in line with or in excess of expectation. This
outstanding record would be impossible without the skills and dedication of all
colleagues within the Galen organisation. We also recognise, with gratitude,
our non-executive Directors and their unstinting commitment to our shareholders,
as evidenced by the able discharge of their board duties, which have expanded
considerably during the past two years.
Outlook
The Galen Holdings business model is now firmly transformed to that of a
specialty pharmaceutical company with a clear geographic and therapeutic focus.
This transformation has been effected without any disruption in the expected
performance of the business, which is a great tribute to the strength and
commitment of our management team. Our strategy for growth remains constant and
comprises three elements:
* the continued growth of our pharmaceutical business;
* the internal development of new proprietary products;
* the acquisition and licensing of products that complement and strengthen
our existing product range.
During the year we have made outstanding progress in all elements of the
business as we continue to build position in our market. We have again achieved
record sales and profit growth. This year's corporate activity has expanded our
product portfolio with products complementary to our existing therapies and our
investment in R&D was rewarded by our first major NDA approval in the United
States. We believe our strategy is well set for the future and we approach our
2003/2004 financial year with much confidence.
Unaudited results for the year ended 30 September 2003
Consolidated profit and loss account (UK GAAP)
Unaudited Audited
Unaudited Year Year
Quarter ended ended ended
30 September 30 Sept 30 Sept
2003 2002 2003 2002
$'000 $'000 $'000 $'000
Turnover
Pharmaceutical products 138,670 61,035 432,262 235,221
Pharmaceutical services - discontinued operations - 3,339 - 61,325
_______ _______ _______ _______
Total turnover 138,670 64,374 432,262 296,546
Cost of sales 20,869 19,020 77,152 89,983
_______ _______ _______ _______
Gross profit 117,801 45,354 355,110 206,563
_______ _______ _______ _______
Net operating expenses
Selling, general and administrative expenses 44,406 8,196 139,471 81,433
Research and development 7,890 5,394 28,685 20,565
Goodwill amortisation 5,913 5,142 23,479 23,255
Intangibles amortisation 14,056 5,274 38,530 17,197
_______ _______ _______ _______
Total net operating expenses 72,265 24,006 230,165 142,450
_______ _______ _______ _______
Operating profit
Before amortisation of goodwill and intangibles:
Pharmaceutical products 65,505 32,332 186,954 94,690
Pharmaceutical services - discontinued operations - (568) - 9,875
_______ _______ _______ _______
Total before goodwill and intangibles amortisation 65,505 31,764 186,954 104,565
Goodwill amortisation (5,913) (5,142) (23,479) (23,255)
Intangibles amortisation (14,056) (5,274) (38,530) (17,197)
_______ _______ _______ _______
Total operating profit/(loss)
Pharmaceutical products 45,536 21,916 124,945 55,584
Pharmaceutical services - discontinued operations - (568) - 8,529
_______ _______ _______ _______
45,536 21,348 124,945 64,113
_______ _______ _______ _______
(Loss)/gain on sale of discontinued operations - (11,225) - 104,984
_______ _______ _______ _______
Investment income 327 3,851 3,188 10,894
_______ _______ _______ _______
Profit on ordinary activities before interest 45,863 13,974 128,133 179,991
Interest payable and similar charges 4,584 3,865 11,752 30,592
_______ _______ _______ _______
Profit on ordinary activities before taxation 41,279 10,109 116,381 149,399
Tax on profit on ordinary activities 7,280 5,147 22,345 13,461
_______ _______ _______ _______
Profit on ordinary activities after taxation 33,999 4,962 94,036 135,938
Minority interests - - - 46
_______ _______ _______ _______
Profit for the financial period 33,999 4,962 94,036 135,892
Dividends 7,330 5,718 10,804 8,353
_______ _______ _______ _______
Retained profit/(loss) for the financial period 26,669 (756) 83,232 127,539
_______ _______ _______ _______
Earnings per share (cents) 18.5 2.7 51.2 73.4
Diluted earnings per share (cents) 18.4 2.7 51.0 72.9
Adjusted earnings per share (cents) 29.6 15.9 85.2 47.8
Adjusted diluted earnings per share (cents) 29.3 15.9 84.8 47.5
_______ _______ _______ _______
Unaudited results for the year ended 30 September 2003
Consolidated balance sheet (UK GAAP)
Unaudited Audited
2003 2002
$'000 $'000
Fixed assets
Intangible assets 1,455,586 756,672
Tangible assets 62,094 60,840
_________ _________
1,517,680 817,512
_________ _________
Current assets
Stocks 32,808 26,902
Debtors 48,866 37,260
Cash at bank and in hand 89,073 313,012
_________ _________
170,747 377,174
Creditors: amounts falling due within one year 226,027 75,866
_________ _________
Net current (liabilities)/assets (55,280) 301,308
_________ _________
Total assets less current liabilities 1,462,400 1,118,820
Creditors: amounts falling due after more than one year 334,567 50,953
Provisions for liabilities and charges - 3,410
Deferred income 5,931 6,189
_________ _________
Net assets 1,121,902 1,058,268
_________ _________
Capital and reserves
Called up share capital 29,644 29,578
Share premium account 383,219 382,749
Capital redemption reserve 323 323
Merger reserve 457,800 457,800
Profit and loss account 250,916 187,818
_________ _________
Equity shareholders' funds 1,121,902 1,058,268
_________ _________
Unaudited results for the year ended 30 September 2003
Consolidated cash flow statement (UK GAAP)
Unaudited Audited
Unaudited Year Year
Quarter ended ended ended
30 September 30 Sept 30 Sept
2003 2002 2003 2002
$'000 $'000 $'000 $'000
Net cash inflow from operating activities 70,698 28,060 207,822 93,354
______ ______ _______ ______
Returns on investments and servicing of finance
Interest paid (6,969) (8,945) (11,502) (35,174)
Interest received 327 3,886 4,091 10,815
______ ______ _______ ______
(6,642) (5,059) (7,411) (24,359)
______ ______ _______ ______
Taxation
Corporation tax paid (22,672) (3,142) (31,243) (6,634)
______ ______ _______ ______
Capital expenditure
Purchase of tangible fixed assets (718) (2,976) (6,164) (17,086)
Sales of tangible fixed assets - - 40 -
Purchase of intangible fixed assets (1,586) (831) (669,229) (43,694)
Government grant received 29 1,348 530 2,161
______ ______ _______ ______
(2,275) (2,459) (674,823) (58,619)
______ ______ _______ ______
Acquisitions and disposals
Sale of businesses (net of costs) - 16,534 (324) 230,789
Acquisition costs and deferred consideration payments - (174) - (9,118)
______ ______ _______ ______
- 16,360 (324) 221,671
______ ______ _______ ______
Equity dividends paid (3,474) (2,800) (9,241) (7,352)
______ ______ _______ ______
Net cash flow before management of liquid resources and 35,635 30,960 (515,220) 218,061
financing
______ ______ _______ ______
Management of liquid resources
Decrease in short term deposits 13,900 83,286 215,400 27,523
______ ______ _______ ______
Financing
Issue of ordinary share capital (net of expenses) 240 114 535 247
Purchase of own shares - (11,813) - (11,813)
Loan notes repaid (2,925) (13,364) (2,925) (112,623)
Loans (repaid)/received (net) (51,518) (106,239) 294,085 (132,126)
Principal repayment under hire purchase agreements (139) (114) (414) (549)
______ ______ _______ ______
(54,342) (131,416) 291,281 (256,864)
______ ______ _______ ______
Decrease in cash in the period (4,807) (17,170) (8,539) (11,280)
______ ______ _______ ______
Unaudited results for the year ended 30 September 2003
Notes to results
1 Basis of preparation
The financial information set out in this announcement does not constitute the
Company's statutory accounts for the years ended 30 September 2003 or 2002. The
financial information for the year ended 30 September 2002 is derived from the
statutory accounts for that year which have been delivered to the Registrar of
Companies. The auditors reported on those accounts and their report was
unqualified and did not contain a statement under either Article 245(2) or
Article 245(3) of the Companies (Northern Ireland) Order 1986. The financial
information for the year ended 30 September 2003 has been prepared using the
same accounting policies as adopted in the Company's statutory accounts for the
year ended 30 September 2002. The statutory accounts for the year ended 30
September 2003 will be finalised on the basis of the financial information
presented by the directors in this preliminary announcement and will be
delivered to the Registrar of Companies following the Company's Annual General
Meeting.
2 Earnings per share
Earnings per ordinary share is based on profit for the financial year of
$94,036,000 (2002: $135,892,000) and on 183,574,057 ordinary shares (2002:
185,244,963) the weighted average number of ordinary shares in issue during the
year, excluding those held in the employee share trust.
Adjusted earnings per share reflects the results before the impact of
exceptional items and amortisation of goodwill and intangibles and in the
opinion of the directors provides a clearer understanding of the underlying
trading performance of the group.
Diluted earnings per share is calculated using an adjusted number of shares
reflecting the number of dilutive shares under option.
The weighted average numbers of shares used in the calculation of earnings per
share are as follows:
Quarter ended 30 September Year ended 30 September
2003 2002 2003 2002
Number of Number of Number of Number of
shares shares shares shares
Weighted average number of shares:
Basic 183,580,981 185,169,784 183,574,057 185,244,963
Diluted 185,186,185 185,712,518 184,504,240 186,330,634
2003 2002 2003 2002
Adjusted earnings per share cents cents cents cents
Statutory earnings per ordinary share 18.5 2.7 51.2 73.4
Adjustments (net of tax):
Loss/(gain) on sale of businesses - 7.0 - (54.5)
Goodwill and intangibles amortisation 10.9 5.6 33.8 21.8
Premium paid on notes redemption 0.2 0.6 0.2 7.1
_____ _____ _____ _____
Adjusted earnings per share - basic 29.6 15.9 85.2 47.8
_____ _____ _____ _____
3 Reconciliation of operating profit to net cash inflow from
operating activities
Quarter ended Year ended
30 September 30 September
2003 2002 2003 2002
$'000 $'000 $'000 $'000
Operating profit 45,536 21,348 124,945 64,113
Depreciation 2,289 1,610 6,791 8,769
Amortisation of intangibles 19,969 10,416 62,009 40,452
Capital grants release (305) (279) (1,135) (1,576)
Loss on sale of tangible fixed assets 144 - 240 -
(Increase)/decrease in stocks (4,086) 3,225 (5,906) (1,186)
Decrease/(increase) in debtors 23,966 (2,701) (8,399) (10,080)
(Decrease)/increase in creditors (16,872) (5,400) 29,897 89
Exchange difference 57 (159) (620) (7,227)
______ ______ _______ ______
Net cash inflow from operating activities 70,698 28,060 207,822 93,354
______ ______ _______ ______
4 Final dividend
The final dividend will be paid on 26 February 2004 to shareholders on the
register on 23 January 2004.
Summary of differences between UK and US Generally Accepted Accounting
Principles ("GAAP")
(1) Profit for the financial year and shareholders' funds
The group financial statements are prepared in accordance with UK GAAP which
differs in certain significant respects from US GAAP. The effect of the US GAAP
adjustments to profit for the financial period and equity shareholders' funds
are set out in the tables below:
Year ended
30 September
2003 2002
$'000 $'000
Unaudited
(a) Reconciliation of profit for the financial year to US GAAP
Profit for the financial period under UK GAAP 94,036 135,892
______ _______
US GAAP adjustments:
Amortisation of goodwill 23,479 23,255
Impact of discounted contingent consideration 500 -
Amortisation of intangibles (3,793) (2,300)
Capitalisation of interest (53) (53)
Deferred taxation (19,754) (11,735)
Compensation expense 1,301 (322)
Deferred tax effect of US GAAP adjustments 439 439
______ _______
US GAAP adjustments total 2,119 9,284
______ _______
Profit for the financial period under US GAAP 96,155 145,176
______ _______
As at
30 September
2003 2002
$'000 $'000
Unaudited
(b) Effect on equity shareholders' funds of differences between UK GAAP
and US GAAP
Equity shareholders' funds under UK GAAP 1,121,902 1,058,268
_________ _________
US GAAP adjustments:
Acquisition accounting (114,896) (133,382)
Impact of discounted contingent consideration 1,700 -
Functional currency adjustment 21,906 -
Capitalisation of interest 2,501 2,554
Deferred taxation (43,318) (24,200)
Employee benefit trust (11,459) (11,153)
Share premium account 11,459 11,153
Dividends 7,330 5,767
_________ _________
US GAAP adjustments total (124,777) (149,261)
_________ _________
Equity shareholders' funds under US GAAP 997,125 909,007
_________ _________
Unaudited consolidated balance sheets (US GAAP)
(In thousands of US dollars)
As at 30 September
2003 2002
Assets
Current assets:
Cash and cash equivalents 89,073 313,012
Accounts receivable, net 38,042 32,869
Inventories 32,808 26,902
Deferred tax asset - 7,718
Prepaid expense and other assets 6,808 4,397
_________ _________
166,731 384,898
_________ _________
Property, plant and equipment, net 64,594 63,394
Intangible assets, net 1,114,106 381,731
Goodwill 224,934 242,208
_________ _________
Total assets 1,570,365 1,072,231
_________ _________
Liabilities
Current liabilities:
Accounts payable 19,592 14,007
Accrued and other liabilities 75,848 44,053
Current instalments of long-term debt 103,088 616
Current instalments of obligation under capital leases 233 392
Income taxes 17,442 11,052
_________ _________
Total current liabilities 216,203 70,120
_________ _________
Other liabilities:
Long-term debt, excluding current instalments 239,065 50,729
Long-term obligations under capital leases, excluding current instalments 3 224
Deferred income taxes 112,038 35,962
Other non-current liabilities 5,931 6,189
_________ _________
Total liabilities 573,240 163,224
_________ _________
Shareholders' equity
Ordinary shares, par value (pounds sterling) 0.10 per share; 250,000,000 30,046 29,981
(September 30, 2002; 250,000,000) shares authorised 188,209,895 shares issued
and outstanding at September 30, 2003 and 187,805,263 issued and outstanding at
September 30, 2002
Additional paid in capital 676,841 677,475
Retained earnings 266,242 179,328
Treasury stock (11,473) (11,473)
Accumulated other comprehensive gains 35,469 33,696
_________ _________
Total shareholders' equity 997,125 909,007
_________ _________
Total liabilities and shareholders' equity 1,570,365 1,072,231
_________ _________
Unaudited consolidated statement of operations (US GAAP)
(In thousands of US dollars, except per share data)
Quarter ended Year ended
September 30 September 30
2003 2002 2003 2002
Revenues
Product revenue 138,670 61,035 432,262 235,221
_______ _______ _______ _______
Operating expenses
Cost of sales (excluding depreciation 19,638 15,814 72,656 51,550
shown separately below)
Selling, general and administrative 41,806 6,635 135,875 64,530
Research and development 7,890 5,374 28,685 19,783
Depreciation 2,302 1,401 6,844 5,323
Amortisation 14,612 5,517 42,323 19,497
_______ _______ _______ _______
Total operating expenses 86,248 34,741 286,383 160,683
_______ _______ _______ _______
Operating income 52,422 26,294 145,879 74,538
_______ _______ _______ _______
Other income (expense)
Interest income 326 3,850 3,188 10,816
Interest expense (4,083) (3,825) (11,252) (29,652)
_______ _______ _______ _______
Total other income (expense) (3,757) 25 (8,064) (18,836)
_______ _______ _______ _______
Income before taxes 48,665 26,319 137,815 55,702
_______ _______ _______ _______
Provision for income taxes 18,030 10,756 41,660 18,654
_______ _______ _______ _______
Income from continuing operations 30,635 15,563 96,155 37,048
Discontinued operations:
Earnings from discontinued operations (net - (218) - 7,037
of tax charge of $2,213)
(Loss)/gain on disposal of discontinued - (12,956) - 101,091
operations (net of tax charge of $3,893)
_______ _______ _______ _______
Net income 30,635 2,389 96,155 145,176
_______ _______ _______ _______
Basic and diluted net income per ordinary
share:
- continuing operations 0.17 0.08 0.52 0.20
- earnings and gain on discontinued - (0.07) - 0.58
operations
_______ _______ _______ _______
Basic and diluted net income per ordinary 0.17 0.01 0.52 0.78
share
_______ _______ _______ _______
Basic net income per ADS equivalent:
- continuing operations 0.67 0.34 2.10 0.80
- earnings and gain on discontinued - (0.29) - 2.33
operations
_______ _______ _______ _______
Basic net income per ADS equivalent 0.67 0.05 2.10 3.13
_______ _______ _______ _______
Diluted net income per ADS equivalent:
- continuing operations 0.66 0.33 2.09 0.80
- earnings and gain from discontinued - (0.28) - 2.32
operations
_______ _______ _______ _______
Diluted net income per ADS equivalent 0.66 0.05 2.09 3.12
_______ _______ _______ _______
Weighted average ordinary shares outstanding
Basic 183,580,981 185,169,784 183,574,057 185,244,963
_______ _______ _______ _______
Diluted 185,186,185 185,712,518 184,504,240 186,330,634
_______ _______ _______ _______
Weighted average ADS equivalents outstanding
Basic 45,895,245 46,292,446 45,893,514 46,311,241
_______ _______ _______ _______
Diluted 46,296,546 46,428,130 46,126,060 46,582,659
_______ _______ _______ _______
Unaudited consolidated statements of cash flows (US GAAP)
(In thousands of US dollars)
Quarter ended Year ended
September 30 September 30
2003 2002 2003 2002
Cash flows from operating activities
Net income 30,635 2,389 96,155 145,176
Adjustment to reconcile net income to net cash provided by
operating activities:
Depreciation 2,302 1,563 6,844 8,751
Amortisation of intangibles 14,612 5,517 42,323 19,497
Loss/(profit) on sale of businesses - 11,226 - (104,984)
Loss on sale of assets 144 - 240 -
Amortisation of government grants (305) (247) (1,135) (1,576)
Loan notes premium adjustment (122) (744) (265) (3,723)
Stock compensation expense (1,542) 81 (1,301) 323
Minority interest - - 47
Changes in assets and liabilities:
Decrease/(increase) in accounts receivable, prepaid expense 23,877 733 (7,584) (12,859)
and other assets
(Increase)/decrease in inventories (4,086) 2,343 (5,906) (3,005)
(Decrease)/increase in accounts payable, accrued (19,640) (8,786) 29,851 4,535
liabilities and other liabilities
Income taxes (4,515) 11,831 10,528 19,357
Foreign exchange (loss)/gain 18 (2,862) (673) 1,839
_____ _____ _____ _____
Net cash provided by operating activities 41,378 23,044 169,077 73,378
_____ _____ _____ _____
Cash flows from investing activities
Purchase of tangible fixed assets (718) (2,856) (6,164) (17,301)
Purchase of intangible fixed assets (1,586) - (669,229) (42,037)
Proceeds from sale of tangible fixed assets - - 40 -
Proceeds from sale of businesses - 12,448 - 228,574
Deferred consideration and acquisition costs - - (324) (8,772)
_____ _____ _____ _____
Net cash (used in) provided by investing activities (2,304) 9,592 (675,677) 160,464
_____ _____ _____ _____
Cash flows from financing activities
Loan notes repaid (2,925) (12,200) (2,925) (111,300)
Long term debt (repaid)/obtained (51,518) (111,781) 294,085 (138,010)
Payments under capital leases (139) (112) (414) (557)
Proceeds from share capital issue (net of expenses) 240 24 535 156
Purchase of own shares - (12,478) - (12,478)
Cash dividends paid (3,474) (2,887) (9,241) (7,352)
Government grants received 29 1,409 530 2,241
_____ _____ _____ _____
Net cash (used in) provided by financing activities (57,787) (138,025) 282,570 (267,300)
_____ _____ _____ _____
Net decrease in cash and cash equivalents (18,713) (105,389) (224,030) (33,458)
Cash and cash equivalents, beginning of period 107,779 410,367 313,012 326,076
Foreign exchange adjustment on cash and cash equivalents 7 8,034 91 20,394
_____ _____ _____ _____
Cash and cash equivalents, end of period 89,073 313,012 89,073 313,012
_____ _____ _____ _____
This information is provided by RNS
The company news service from the London Stock Exchange
END
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