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Medeva PLC Reports Preliminary Results for the Year Ended December 31, 1998; Hepagene Vaccine Submission in USA Today.


LONDON--(BUSINESS WIRE)--Feb. 10, 1999--Medeva PLC (NYSE NYSE

See: New York Stock Exchange
: MDV MDV

mucosal disease virus.
), the international pharmaceutical company, today announced its preliminary results for the year ended December 31, 1998.

HIGHLIGHTS

- Income from continuing non-CNS (Central Nervous System) products

and royalties grew 11% to (pound)230 million ($382 million(a))

with a profit contribution of (pound)61.6 million ($102 million),

up 24%.

- CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
 sales, impacted as anticipated by methylphenidate methylphenidate /meth·yl·phen·i·date/ (meth?il-fen´i-dat) a central stimulant, used in the form of the hydrochloride salt in the treatment of attention-deficit in children and narcolepsy.

competition, declined 39% to (pound)76 million ($126 million).

Profit contribution was (pound)52 million ($86 million), down 44%.

- Operating profit Operating profit (or loss)

Revenue from a firm's regular activities less costs and expenses and before income deductions.


operating profit

See operating income.
(pound)78.7 million ($131 million)

(1997:(pound)114.2 million), profit before tax(pound)59.3 million

($98 million) (1997: (pound)110.9 million).

- EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format.  before exceptional items 15.4 p ((cent)25.6)(1997: 21.4p),

11.1p ((cent)18.4) after exceptional items (1997: 21.4p).

- Proposed final dividend of 3.75p; total for the year of 5.75p

(1997: 5.50p), up 5%.

- Hepagene: pan-European license application for vaccine submitted;

: US license application for vaccine to be submitted to the Food

and Drug Administration ("FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
") today.

- New products Valstar and Asmabec Clickhaler launched; first

revenues received in 1999.

- Two new projects added to pipeline: tgAAV-CF, gene therapy for

cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. , and ConXn(R), recombinant human relaxin re·lax·in
n.
A female hormone secreted by the corpus luteum that helps soften the cervix and relax the pelvic ligaments in childbirth.


relaxin,
n
, for

scleroderma scleroderma
 or progressive systemic sclerosis

Chronic disease that hardens the skin and fixes it to underlying structures. Swelling and collagen buildup lead to loss of elasticity. The cause is unknown.
.

- Commenced major infrastructure investment to expand vaccine

facility at Speke.

(a) US Dollar equivalents are provided for reader convenience at an

assumed exchange rate of (pound)1 = $1.66

Commenting on the results, Chairman John Baker said:

"With the exception of the CNS category, the rest of Medeva's business performed well in 1998 and we took advantage of our good cashflow to invest substantially in new products and facilities. In particular, we have considerably strengthened the potential of our new product development pipeline.

The anticipated decline of methylphenidate as our main revenue earner is taking place. The primary focus in 1999 is on the products in our pipeline which we believe have the potential to return Medeva to profits and earnings growth in subsequent years. Provided we continue to meet our milestones successfully, the pipeline has clear potential to generate significant long term value for shareholders."

EXTRACTS FROM THE ANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED DECEMBER 31, 1998

OVERVIEW

Operating profit for 1998 has declined by (pound)35 million to (pound)79 million due to the anticipated competition to methylphenidate in the USA. The decline in methylphenidate sales was partially offset by a strong performance from a number of other products, notably Tussionex, Zaroxolyn and Fluvirin. Factors leading to the change in operating profit were as follows:

- a (pound)10.5 million increase in profit contribution from

non-CNS products excluding royalties to (pound)53.2 million,

resulting from a 11% increase in sales to (pound)221 million and

a contribution margin improvement to 24% (1997: 21%); the

majority of our profits now come from non-CNS products;

- a 24% increase in royalty income to (pound)8.4 million;

- a (pound)41 million decline in profit contribution from CNS

products to (pound)52 million as a consequence of a 39% fall in

sales to (pound)76 million and a decrease in contribution margin

to 68% (1997: 75%); and

- a (pound)5 million increase in central and development costs to

(pound)35 million mainly due to increased expenditure on the

Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  development of Hepagene.

Profit before tax for the year of (pound)59 million is after exceptional charges totalling (pound)17 million arising principally from the recycling recycling, the process of recovering and reusing waste products—from household use, manufacturing, agriculture, and business—and thereby reducing their burden on the environment.  of goodwill on the disposal of our International Medications Systems Limited ("IMS (1) See IP Multimedia Subsystem.

(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS.
") business in the USA. For analysis of profit contribution see note 1.

EXTRACTS FROM CHAIRMAN'S, CHIEF EXECUTIVE'S AND NEW PRODUCT DEVELOPMENT REPORTS

We continued to invest in and refine our infrastructure. We are supporting our vaccine business and our commitment to quality with a major investment program to expand our vaccine development and production facility at Speke in the UK and an initial (pound)21 million has already been committed to the project. This will add significantly to Medeva's capabilities. We sold the US hospital products business, IMS, and, in April 1999, we will divest To deprive or take away.

Divest is usually used in reference to the relinquishment of authority, power, property, or title. If, for example, an individual is disinherited, he or she is divested of the right to inherit money.
 some of the assets of our Swiss manufacturing operation in order to keep our resources tightly focussed on our core businesses. We continue to market the IMS products in Europe where they complement our European hospital range.

Of increasing significance to the Group's future prosperity is the progress and strengthening of our new product development pipeline. We have met some significant milestones during 1998 and early 1999 and we are investing further in our development infrastructure. In summary, we:

- filed a pan-European license application for Hepagene Vaccine;

- prepared a Biologics License Application for Hepagene Vaccine

which is being submitted in the USA today USA Today

National U.S. daily general-interest newspaper, the first of its kind. Launched in 1982 by Allen Neuharth, head of the Gannett newspaper chain, it reached a circulation of one million within a year and surpassed two million in the 1990s.
;

- reported encouraging results in our second Exploratory

Development study with Hepagene Immunotherapy Immunotherapy

The treatment of cancer by improving the ability of a tumor-bearing individual (the host) to reject the tumor immunologically. There are molecules on the surface of tumor cells, and perhaps in their interior, that are recognized as different from
;

- received a license for Valstar in the USA as an Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the  for

the treatment of bladder cancer bladder cancer

Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor.
;

- received a Marketing Authorization in the UK for Asmabec

Clickhaler for the treatment of asthma;

- added a partnership with Targeted Genetics Corporation ("Targeted

Genetics") to develop the gene therapy tgAAV-CF for cystic cystic /cys·tic/ (sis´tik)
1. pertaining to or containing cysts.

2. pertaining to the urinary bladder or to the gallbladder.


cys·tic
adj.
1.


fibrosis fibrosis /fi·bro·sis/ (fi-bro´sis) formation of fibrous tissue.fibrot´ic

congenital hepatic fibrosis
;

- added a partnership with Connetics Corporation ("Connetics") to

develop ConXn(R) (recombinant human relaxin), as a treatment for

scleroderma;

- commenced Commercial Development of a

codeine/chlorpheniramine-based cough treatment;

- moved our hep B cores Platform Technology successfully into

Exploratory Development; and

- moved our enteric-coated, delayed-release nicotine nicotine, C10H14N2, poisonous, pale yellow, oily liquid alkaloid with a pungent odor and an acrid taste. It turns brown on exposure to air.  tartrate tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid.

tar·trate
n.
A salt or ester of tartaric acid.



tartrate

a salt of tartaric acid.


treatment for ulcerative colitis ulcerative colitis

Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus.
 into Commercial Development.

STRATEGIC DEVELOPMENT Medeva's opportunity in a changing pharmaceutical industry

There is a growing trend for larger pharmaceutical companies to license products for development from smaller biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
 and other research organizations. These research-based enterprises need partners to provide the later stage development, manufacturing scale-up and marketing capabilities which they lack. At the same time, the outsourcing of specialist services, such as clinical research and specialist manufacture, is also increasing. Overall these trends are contributing to a degree of fragmentation in the traditional vertically integrated process of discovering new, innovative medicines and bringing them to the market.

Medeva believes this diversification in the industry will continue, and that these changes validate its strategy and highlight the opportunity for it to create value from its particular combination of skills and capabilities.

Bringing new products to the market - Four stages of value creation

The changes taking place in the industry mean that, increasingly, two or more parties may be involved in four stages of value creation in bringing a pharmaceutical product through development and to the market. These are:

- primary research or `discovery';

- development, including clinical development, handling of

regulatory submission work and manufacturing scale-up;

- commercial manufacturing;

- sales and marketing.

Since its foundation, Medeva has built the infrastructure, skills and expertise needed to exploit the last three of these four stages, on an international scale.

Medeva's attraction as a partner for research-based organizations

With sales and marketing infrastructure in place, the potential for Medeva to create the greatest value for its shareholders lies in its ability to acquire new products and deliver them through its development pipeline to the market. This is now the primary focus of our strategy.

In sourcing innovative new development projects, Medeva looks particularly to research-based organizations whose skills and capabilities complement Medeva's, creating fertile ground for partnerships.

Two such partnerships were established in November 1998 and in January 1999: with Targeted Genetics, in the development of a gene therapy, tgAAV-CF, for the treatment of cystic fibrosis, and with Connetics, in the development of ConXn(R), (recombinant human relaxin), as a treatment for scleroderma.

Releasing unexploited value locked within large pharmaceutical companies

Medeva can also add value by acquiring existing products which are not being fully exploited by their current owners and regenerating re·gen·er·ate  
v. re·gen·er·at·ed, re·gen·er·at·ing, re·gen·er·ates

v.tr.
1. To reform spiritually or morally.

2. To form, construct, or create anew, especially in an improved state.
 their growth through its own sales and marketing infrastructure. Medeva enables large pharmaceutical companies to divest products which are no longer core to their activities in a way which generates value from otherwise wasting assets Wasting Asset

A derivative security that loses value due to time decay.

Notes:
If wasting assets are held for too long, they will ultimately lose all their value.
.

While the flow of such products has been slower to emerge than had been anticipated, and competition is now such that prices can reach levels which are not, in our view, justified by the underlying value, our belief remains that we can continue to make a steady flow of these acquisitions over time.

The criteria defining Medeva's targeted product opportunities

Through these symbiotic relationships This is an incomplete list of notable mutualistic symbiotic relationships, in which different species have a cooperative or mutually dependent relationship.
  • Humans and cultivated plants
  • Humans and domesticated animals
  • Humans and intestinal bacteria
 in the industry, Medeva can secure the product opportunities it needs. Before financial criteria are applied, the three principal non-financial criteria used to define the products which Medeva targets and which it is particularly well qualified to exploit are:

- Technological Expertise: Medeva has built considerable expertise in the development and manufacture of biological products and is one of few medium-sized development and marketing companies with the capabilities to handle such projects. Medeva looks for products in the particular areas where it has technological experience and where it can therefore add value.

- Time-to-Market: Medeva looks for projects which are, ideally, up to five years from the market. In conventional terminology, this can mean projects in Phase III, II or even I where circumstances, such as Orphan Drug status, mean that the normal time-to-market is shortened.

- Target Markets: Medeva seeks products in markets where we have sales forces or which can be accessed by small specialist teams. In these areas, Medeva is able to compete effectively with larger companies.

Medeva entering a new phase of its development

Medeva is entering the next stage in its development. It is now bringing products through its own pipeline which, if successful, have the potential to fuel a renewed period of strong growth. With a profitable, international infrastructure already in place and the high overheads inherent in a research-based pipeline avoided, the potential exists for each additional product launched to generate high returns for shareholders.

REGIONAL REVIEW

USA

In September 1998, the FDA granted a license for the bladder cancer treatment, Valstar, and the product was launched by the US sales force, nationally, in January 1999. Valstar is one of Medeva's lead development projects, which was pursued in partnership with Anthra Pharmaceuticals Inc., this launch represents an important milestone for the Company.

The year end saw the commencement of the final phase of the Rochester investment program, on time and to budget. Some initial manufacturing has already commenced in the new facility and full commissioning is scheduled to be completed in 1999. The new facility provides us with high quality solid and liquid dose manufacturing capacity for the foreseeable future.

As part of our restructuring, we had planned to close IMS, our hospital products business in California. We were pleased, therefore, that our efforts to sell this business during the year were successful, thereby enabling jobs to be preserved.

EUROPE

The steroid version of our dry powder inhaler The Dry Powder Inhaler is generally a proprietary device to deliver medications for the treatment or maintenance management of respiratory diseases and conditions. These conditions or diseases may include Asthma, Bronchitis, Emphysema, COPD and Diabetes.  product, Asmabec Clickhaler, was granted a license in the UK and the product was launched in November 1998. Asmabec contains beclomethasone dipropionate bec·lo·meth·a·sone di·pro·pi·o·nate
n.
A corticosteroid usually used as an inhalant to treat asthma.


beclomethasone dipropionate (bek´l
 and is used for the prophylactic treatment prophylactic treatment
n.
The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive treatment.
 of asthma. Early indications are that the product is being well received in the market and is also having a beneficial impact on sales of the salbutamol salbutamol /sal·bu·ta·mol/ (sal-bu´tah-mol) albuterol.

sal·bu·ta·mol
n.
A sympathomimetic agent used as a bronchodilator, especially in the treatment of asthma.
 (albuterol albuterol /al·bu·ter·ol/ (al-bu´ter-ol) a ß agonist used as the base or sulfate salt as a bronchodilator.

al·bu·ter·ol
n.
) version of the product, Asmasal Clickhaler. This version, used for the relief of acute asthma attacks, was launched at the end of 1997.

A significant development in the European arena was the beginning of construction work on a new facility at Speke. When complete, this 125,000 sq. ft. building will provide additional capacity for our existing vaccine business which we expect to continue to grow, supported in part by sustained demand from third parties for our specialist expertise in vaccine manufacture.

Work on the first phase of the project, comprising a syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity.  filling and packaging line, warehousing facilities and new administrative offices, is progressing on schedule and to budget with completion due in mid-1999.

In addition, we are currently at an advanced stage of discussions to acquire a further site, immediately adjacent to the existing facility. This site would house dedicated biotechnology facilities, including analytical laboratories and manufacturing pilot plants. If this plan proceeds, the addition of the two new facilities would result in a near trebling in the size of our current facility and give us substantial additional physical infrastructure to support our vaccine business and, significantly, our growing biotechnology interests.

At the beginning of February 1999 we announced that our Swiss manufacturing facility and certain related assets are to be sold to a company owned by members of the present local management team. Under the agreement, Medeva retains the rights to the royalty revenues from Asacol in the USA and Canada and to the intellectual property associated with the development of nicotine as a potential treatment for ulcerative colitis.

EXTRACTS FROM THE OPERATING AND FINANCIAL REVIEW

COMPARABILITY WITH 1997

This review compares the1998 Group financial performance with 1997 using like-for-like exchange rates. Since the majority of the Group's profits arise in the USA, the results as reported in sterling can be materially influenced by changes in the US dollar exchange rate. The average US dollar/sterling exchange rate for 1998 was $1.658, compared with $1.638 for 1997. Applying the 1997 historic exchange rates would increase 1998 reported sterling profit before tax by approximately (pound)1.5 million.

SALES

Overall CNS sales declined by (pound)48 million ($79 million) (39%) and non-CNS sales increased by (pound)22 million ($37 million) (11%).

Sales by Category (rounded)

                     1998             1997(a)          Inc.(dec.)(b)
                    (pound)m         (pound)m

Methylphenidate        68               112               (39%)
Ionamin                8                12                (31%)
                       --------------   --------------

CNS                    76               124               (39%)
                       --------------   --------------

Respiratory            72               67                7%
Vaccines               56               54                3%
Hospital
 Products              38               32                18%
General                56               46                20%
                       --------------   --------------

Total non-CNS          221              199               11%
                       --------------   --------------

Royalties              8                7                 24%

Disposals and
 other(c)              16               22
                       --------------   --------------

Group turnover         321              352               (9%)
                       --------------   --------------

(a)  at 1998 average exchange rates.

(b)  % calculated to (pound)0.1 million and numbers rounded to nearest
     million.

(c)  IMS US products disposed of on October 8, 1998 and Swiss products
     to be disposed of in April 1999.


Central Nervous System ("CNS")

The CNS category comprises two products, methylphenidate and Ionamin. Sales of methylphenidate, which is a generic drug generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name.  prescribed primarily for the treatment of attention deficit hyperactivity disorder attention deficit hyperactivity disorder (ADHD), formerly called hyperkinesis or minimal brain dysfunction, a chronic, neurologically based syndrome characterized by any or all of three types of behavior: hyperactivity, distractibility, and impulsivity.  ("ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition

Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or
"), fell by 39% to (pound)68 million and accounted for 21% (1997: 32%) of total Group sales Group sales

Block sale (of large amounts) of securities to institutional investors.


group sales

The distribution of a new security issue to institutional clients.
. As anticipated, the decline resulted from the entry into the market of further generic competition leading to loss of market share, price erosion and a reduction in pipeline inventories.

Medeva's share of total prescriptions written (both generic and branded) fell to 55% (1997: 72%), in a period in which there was no market growth. The fall in market share and a reduction in pipeline inventory resulted in a 30% fall in sales volume. This together with an average price decline of 13% led to the overall 39% decline in revenues. At least one more generic competitor is expected to enter the market in early 1999 and another is awaiting approval, both are likely to erode Erode (ĕrōd`), city (1991 urban agglomeration pop. 361,755), Tamil Nadu state, S India, on the Kaveri River. The city is located in a cotton-growing region, and its industries include cotton ginning and the manufacture of transport equipment.  further Medeva's market share and increase the pressure on price. Accordingly, sales are expected to continue to decline.

Sales of Ionamin, our anti-obesity product, have shown some further decline in the second half of 1998, with market share of prescriptions falling to 6% for the year (H1 1998: 7%). There continues to be no significant recovery in anti-obesity prescriptions following the concerns raised in mid-1997 about the health risks associated with the so-called "fen-phen diet".

Respiratory

Sales of products in the respiratory category grew by 7% to (pound)72 million. Our main brand, Tussionex, the unique 12-hour anti-tussive, achieved sales of (pound)29 million a 48% increase on 1997 levels. The increase was due to a 24% increase in prescriptions written, price increases and the reversal of low pipeline inventories at the end of December 1997. Delsym, the OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 extended-release paediatric Adj. 1. paediatric - of or relating to the medical care of children; "pediatric dentist"
pediatric
 cough product and our second largest respiratory product, achieved sales of (pound)7 million which was in line with 1997, in what was a weak "cough and cold" season. Semprex-D sales of (pound)6 million benefited from an almost empty product pipeline in December 1997 and price increases, which compensated for a decline in prescriptions written (12% down on 1997 levels) in the face of direct-to-consumer advertising direct-to-consumer advertising Drug industry The use of mass media–eg, TV, magazines, newspapers, to publicly promote drugs, medical devices or other products which, by law, require a prescription, which targets consumers, with the intent of having a Pt  from the main competitors in this market.

The performance of these three brands more than offset the continued generic erosion seen by our branded guaifenesin products, where sales of (pound)6 million showed a 48% decline over 1997.

Sales of generic albuterol MDI (1) (Multiple Document Interface) A Windows function that allows an application to display and lets the user work with more than one document at the same time. , marketed by Apothecon, at (pound)6 million (1997: (pound)4 million), benefited from a full year in the growing US generic market albeit at depressed prices Depressed price

In the context of stocks, stock whose market price is low in comparison to stocks in its sector.
. This compensated for the decline in our lower margin US respiratory contract manufacturing business, where sales declined by (pound)2 million to (pound)6 million, mainly as one of our key customers moved production in-house during 1998.

The launch of the Asmabec Clickhaler in November 1998 enhanced our dry powder inhaler range; a full marketing campaign will support these products in 1999.

Vaccines

Fluvirin sales increased again this year by 7% to (pound)29 million as increased production was sold into the US market. We estimate that we have grown our share in the US market to 20% this year. Sales of our US diphtheria diphtheria (dĭfthēr`ēə), acute contagious disease caused by Corynebacterium diphtheriae (Klebs-Loffler bacillus) bacteria that have been infected by a bacteriophage. It begins as a soreness of the throat with fever.  and tetanus tetanus (tĕt`nəs, –ənəs) or lockjaw, acute infectious disease of the central nervous system caused by the toxins of Clostridium tetani.  products and trivax were disappointing with sales declining (pound)4 million to (pound)7 million. US diphtheria and tetanus sales suffered from restricted availability from our US suppliers, ahead of the transfer of production to Speke which we expect to complete in mid-2000. Other vaccines sales increased 27% to (pound)20 million with a continued strong performance from our highly specialised contract manufacturing business based at Speke. Overall vaccine sales increased by 3%.

Hospital Products

Sales of hospital products grew by 18% to (pound)38 million with Zaroxolyn accounting for just under 50% of sales in this category. Zaroxolyn is a well established diuretic diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying  which is responding to active promotion in the USA for resistant oedema oedema

see edema.
, a significant problem in congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time.  and severe renal disease Renal disease
Kidney disease.

Mentioned in: Glycogen Storage Diseases

hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg
. Prescription growth in 1998 was 12% (1997: 9%) and this, together with price increases and the reversal of 1997 low pipeline inventories, increased sales by (pound)6 million to (pound)18 million.

Sales of other hospital products have grown by 2% with increased sales of diamorphine diamorphine

see heroin.
 compensating for the reduced sales from IMS products in Europe due to a reduction in the number of products in this range. Prices in the US human market for isoflurane remain disappointing, although expansion in the export market continues.

General Products

General product sales rose 20% to (pound)56 million and continue to represent a significant proportion of total sales (17% in 1998). This category contains many of our niche products and in 1998 includes both the gastrointestinal and dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin.  ranges, which grew by 12% and 11% respectively. Our principal products in this category, Pediapred in the USA and Coracten in the UK, both achieved double-digit growth in sales, with 1998 sales of (pound)6 million being achieved by both products. In 1999 we will launch Coracten XL (extended-release) which will grow sales. This product category will also benefit from sales of Valstar in the USA in 1999.

Royalties

The Group's royalty income grew by 24% to (pound)8.4 million (1997: (pound)6.8 million). Royalties arise principally on Asacol, which is licensed to Proctor A person appointed to manage the affairs of another or to represent another in a judgment.

In English Law, the name formerly given to practitioners in ecclesiastical and admiralty 
 & Gamble in the USA and Canada, and Pertactin (69kDa) which is licensed to SmithKline Beecham for inclusion in their acellular pertussis vaccine acellular pertussis vaccine
n. Abbr. DTaP
A diphtheria, tetanus, pertussis vaccine containing two or more antigens but no whole cells.
, Infanrix (trademark of SmithKline Beecham).

GROSS PROFIT

Sales in 1998 generated a gross profit of (pound)197 million and a gross margin of 61% (1997: 65%). The decline is due to the lower margins and sales of methylphenidate in 1998. Gross margin is likely to continue to decline as methylphenidate sales decline, our target is to achieve gross margins of around 60% in the future, although the achievement of this depends on the extent of price erosion in the methylphenidate market and the speed at which new products from our pipeline achieve significant sales.

OPERATING EXPENSES Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.


Selling, marketing and distribution expenses declined by 7% to (pound)53 million and absorbed 17% of sales revenues. The level of expenses benefited from lower US marketing costs following the major marketing campaigns in 1997 for newly acquired brands. These expenses are likely to increase in 1999 due to the launch of our new products, in particular Valstar in the USA and the Clickhaler range in Europe.

Administration costs at (pound)33 million show a decline from 1997 levels as the benefits of the US restructuring are continuing to show through. Administration costs now represent 10% of sales.

Development costs at (pound)32 million have risen by 18%, principally due to the Hepagene development program and represent 10% of sales. We expect these costs to increase in the future due to our expanding development pipeline and co-development agreements such as those with Targeted Genetics and Connetics. Under the Targeted Genetics agreement to develop tgAAV-CF we have agreed to pay 50% of their development costs up to a maximum of $15 million over the estimated three years of the project. In addition, we will allocate members of Medeva's development team to the project. The Connetics partnership is similar in that, in addition to providing Medeva expertise, we have also agreed to share Connetics' development costs up to a maximum of $10 million over the estimated three years of that project.

OPERATING PROFIT

In 1998, sales of (pound)321 million ($533 million), gross profit of (pound)197 million ($327 million) and total expenses of (pound)118 million ($196 million) produced an operating profit of (pound)79 million ($131 million) and an operating margin Operating Margin

A ratio used to measure a company's pricing strategy and operating efficiency.

Calculated by:
 of 24% (1997: 32%) in 1998. The contribution analysis is shown in note 1.

EXCEPTIONAL ITEMS

Exceptional charges for the year of (pound)17.3 million relate to a (pound)15.1 million loss on the disposal of IMS before the related tax credit of (pound)1.7 million and after charging (pound)16.3 million of goodwill write back. Together with a (pound)2.2 million loss on the disposal of fixed assets fixed assets nplactivo sg fijo

fixed assets nplimmobilisations fpl

fixed assets fix npl
 before the related tax credit of (pound)0.7 million (see note 2).

TAXATION

The underlying tax charge of (pound)23 million, before exceptional items equates to a fall in the tax rate for the year from 32% to 30% principally as a result of tax allowances on prior year acquisitions and the changing balance of our business. Based on current expectations and existing tax legislation in the Group's principal operating territories, this rate is not expected to rise.

EARNINGS

Profit after tax before exceptional items was (pound)54 million ($90 million) compared with (pound)76 million in 1997, resulting in earnings per share of 15.4p ((cent)25.6), a decrease of 28% over 1997. Earnings per share after exceptional items was 11.1p ((cent)18.4), a 48% reduction on the 21.4p in 1997.

The weighted average number of shares in issue of 347 million decreased due to the buy back of 17.4 million shares which equated to 5% of the issued share capital.

The final dividend proposed by the directors is 3.75p per share, which results in a total for the year of 5.75p per share, an increase of 5% over 1997. The dividend is covered 2.7 times by earnings before exceptional items. The final dividend is not a Foreign Income Dividend and a share dividend alternative will be available.

CASHFLOW AND INVESTING ACTIVITIES

The Group generated funds from operations Funds From Operations (FFO)

Used by real estate and other investment trusts to define the cash flow from trust operations; earnings with depreciation and amortization added back.
 in 1998 of (pound)98 million which is (pound)19 million in excess of operating profit. Resources absorbed by working capital were (pound)4 million so that operating activities generated (pound)94 million before the restructuring cash spend of (pound)22 million.

Capital expenditure during the second half of the year was (pound)11 million bringing the expenditure in the full year to (pound)28 million (1997: (pound)42 million). Capital expenditure relates mainly to the Rochester facility. The new plant is now undergoing an extensive validation program before it is brought fully on-stream during 1999. Capital expenditure is expected to remain at similar levels in 1999 as we continue the extensive development of our Speke facility where we plan an expansion of our vaccine production capabilities.

Restructuring spend in the period was on target at (pound)22 million. The large cash spend in the second half of 1998 related to validation work at the new Rochester facility and the restructuring costs at the IMS US facility. The final (pound)5 million of restructuring expenditure will be incurred in the first half of 1999. Investments in intangible assets Intangible Asset

An asset that is not physical in nature.

Notes:
Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets.
 were (pound)11 million in the year and consist principally of the milestone payment of (pound)5 million following the receipt of the first licence for the cancer product Valstar; an initial payment of (pound)4 million to Targeted Genetics for the rights to tgAAV-CF; and a (pound)1 million payment to ML Laboratories following the approval of the Asmabec Clickhaler for the UK market.

At the Annual General Meeting in April 1998, shareholders approved a resolution authorising the Directors to repurchase up to 10% of Medeva's issued share capital. To date, 17.4 million shares representing 5% of Medeva's issued share capital have been repurchased at a cost of (pound)27 million. The authority remains valid until the AGM AGM annual general meeting

AGM n abbr (= annual general meeting) → AG f

AGM n abbr (= annual general meeting) → JHV f 
 in April 1999 when renewal of the authority will be sought.

BORROWINGS

In December 1998 we completed a Private Placement of $50 million Senior Loan Notes. The Notes, which were placed with a group of US qualified institutional investors qualified institutional investor

An institutional investor that is permitted by the Securities and Exchange Commission to trade private placement securities without registering the securities with the SEC.
 via the agency of Greenwich NatWest Limited, carry a fixed coupon of 6.51%. The Notes are unsecured and are repayable in full in December 2003. This diversifies our funding through a new source of long term capital and complements our 5-year unsecured (pound)125 million syndicated multi-currency medium term facility which is due to expire in February 2001. The syndicated loan Syndicated Loan

A very large loan in which a group of banks work together to provide funds for one borrower. There is usually one lead bank that takes a small percentage of the loan and syndicates the rest to other banks.

Notes:
Also known as a "syndicated bank facility.
 is drawn down in US$ and the interest rate is 0.35% above US$ LIBOR LIBOR

See: London Interbank Offered Rate


LIBOR

See London interbank offered rate (LIBOR).
. The increase in borrowings during the year amounted to (pound)27 million resulting in net debt at December 31, 1998 of (pound)78 million which includes (pound)3 million of finance leases. Interest paid was covered 19 times by operating profit of (pound)78.7 million (1997: 29 times). The weighted average cost of capital Weighted average cost of capital (WACC)

Expected return on a portfolio of all a firm's securities. Used as a hurdle rate for capital investment. Often the weighted average of the cost of equity and the cost of debt The weights are determined by the relative proportions of equity
 for 1998 was 9% (1997: 11%).

FORWARD-LOOKING STATEMENT forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.


This release contains certain forward looking statements made pursuant to he US Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. In particular certain statements with regard to (a) management's aims and objectives, (b) product development (including particularly to the conduct of clinical trials, studies and investigations regarding various products, the filing of product license applications in various countries, and the anticipated launch of specified products in various markets) and product acquisition, (c) anticipated levels of demand for existing products and products in development, (d) the effect of competition, (e) anticipated efficiencies, (f) planned expansion and investment in facilities, (g) trends in results of operations, margins, the overall pharmaceutical market and foreign exchange and tax rates, and (h) the availability of exclusive marketing rights based on patents or governmental regulations are all forward looking in nature. By their nature forward looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward looking statements. The following factors, although not exhaustive, could cause actual results to differ materially from those the Company expects: (1) pricing and product initiatives of the Company's competitors, including the introduction of branded competition or generic substitution for the Company's products, (2) legislative and regulatory changes relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 pharmaceutical products including the pricing of such products, (3) unanticipated difficulties in the design or implementation of clinical trials, studies and investigations, failure to obtain required approval from governmental authorities, including the U.S. Food & Drug Administration, and results from such trials, studies and investigations that are inconsistent with previous results and the Company's expectations, (4) the failure of demand to develop as anticipated, (5) unavailability of raw materials or other interruptions in production, (6) unexpected difficulties in the design and construction of production facilities and the scale-up of production to viable commercial levels, (7) loss of or inability to obtain patent or trademark protection for certain products, (8) inability of the Company to market existing and new products effectively, (9) the failure of the Company's development, manufacturing and marketing partners to perform their contractual obligations and (10) the unavailability of products for acquisition at reasonable prices. The forward looking statements included in this document represent the Company's best judgment as of the date hereof based in part on preliminary information and certain assumptions which management believes to be reasonable. The Company disclaims any obligation to update these forward looking statements.

Medeva PLC is an international company developing, manufacturing, and marketing prescription pharmaceutical products in the following main therapeutic areas: respiratory care, vaccines, CNS therapies (attention deficit disorder attention deficit (hyperactivity) disorder (ADD or ADHD)
 formerly hyperactivity

Behavioral syndrome in children, whose major symptoms are inattention and distractibility, restlessness, inability to sit still, and difficulty concentrating on one thing for any
 and anti-obesity), gastroenterology gastroenterology

Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833.
, hospital products (pain management and anaesthetics) and dermatology. In the UK, Medeva is the sole producer of human vaccines, including flu, childhood and traveler's vaccines. In the US, Medeva is the leading manufacturer and distributor of methylphenidate. 6 Medeva also has operations in France, Spain, Belgium, the Republic of Ireland.

Medeva's ordinary shares trade on the London Stock Exchange London Stock Exchange

London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses.
 and its ADRs, each equal to four ordinary shares, trade on the New York Stock Exchange New York Stock Exchange (NYSE)

World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City.
 under the symbol MDV. Additional information on Medeva can be accessed on the company's home page: http://www.medeva.com.

For tabular tab·u·lar
adj.
1. Having a plane surface; flat.

2. Organized as a table or list.

3. Calculated by means of a table.



tabular

resembling a table.
 results, please contact Taylor Rafferty Associates at 212-889-4350
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Geographic Code:4EUUK
Date:Feb 11, 1999
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