Half Yearly Report

RNS Number : 1244K
Hikma Pharmaceuticals Plc
16 August 2012
 



 

 

PRESS RELEASE                                                                        

 

 

Hikma delivers a strong first half performance and remains on track to deliver revenue growth of 20% for the full year

 

London, 16 August 2012 - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ DUBAI: HIK), the fast growing global pharmaceutical group, today reports its interim results for the six months ended 30 June 2012.  

Group financial highlights

Summary P&L

$ million

H1 2012

 

H1 2011

 

Change

Revenue

532.3

394.8

+34.8%

Gross profit

234.1

172.6

+35.6%

Gross margin

44.0%

43.7%

+0.3





Operating profit

75.1

49.0

+53.1%





Adjusted operating profit 1

82.1

59.7

+37.4%

Adjusted operating margin

15.4%

15.1%

+0.3





EBITDA 3

103.7

70.5

+47.1%





Profit attributable to shareholders

40.4

33.1

+22.0%





Adjusted profit attributable to shareholders 3

46.0

40.7

+12.9%





Earnings per share (diluted) (cents)

20.4

16.7

+22.2%





Dividend per share (cents)

6.0

5.5

+9.1%





Net cash flow from operating activities

47.1

19.2

+144.9%

 

1 Before the amortisation of intangible assets (excluding software) and exceptional items (including acquisition and integration related expenses of $0.6  million (H1 2011: $6.7 million))

2 Earnings before interest, tax, depreciation and amortisation

3 Before the amortisation of intangible assets (excluding software) and exceptional items

 

·      Group revenue increased by 34.8% to $532.3 million, with organic  revenue up 7.6% 4

 

·      Branded revenue growth of 24.6% reflects strong demand across our MENA markets, with organicgrowth of 12.8%.  The Branded business remains on track for around 20% full year revenue growth, with gross and adjusted operating margins broadly in line with 2011 5

 

·      Excellent performance in global Injectables delivered 94.0% revenue growth, with organic revenue growth of 25.7%, and adjusted operating margin of 22.0% 6

 

·      Generics revenue decreased by 27.0% to $55.8 million, reflecting the impact of additional compliance work at the Eatontown facility and increased pricing pressure.  Full year revenue guidance is revised to around $115 million

 

4 Before the consolidation of the Multi-Source Injectables, Promopharm and Savanna businesses

5 Before the consolidation of the Promopharm and Savanna businesses

6 Before the consolidation of the Multi-Source Injectables and Promopharm businesses

 

·      Significant increase in Injectables margins more than offsets lower margins in the Generics business, with Group adjusted operating margin of 15.4%, compared to 15.1% in the first half of 2011

 

·      Profit attributable to shareholders up 22.0% to $40.4 million.  On an adjusted basis, profit attributable to shareholders is up 12.9% to $46.0 million

 

·      Net cash flow from operating activities up $27.9 million to $47.1 million, reflecting growth in profitability and an ongoing  focus on working capital management

 

·      Continued new product delivery across all countries and markets - launched 37 products and received 33 product approvals - and enhancement of the portfolio through product acquisitions

 

·      Increase in the interim dividend to 6.0 cents per share, up from 5.5 cents for the first half of last year

 

 

Said Darwazah, Chief Executive Officer of Hikma, said:

"We have had a strong start to the year in our Branded and Injectables businesses.  I am pleased with the growth we have achieved in our key MENA markets this year.  Our global Injectables business continues to deliver extremely strong growth, as we benefit from our increased scale and continued investment in quality and products.   In our Generics business, where operations have been disrupted by additional compliance work, we expect sales to gradually improve in the second half.

Overall, the Group is performing well and the outlook is positive for the second half.  I am pleased to be able to reiterate our Group guidance of around 20% revenue growth for the full year."

 

Enquiries

Hikma Pharmaceuticals PLC                                                               +44 (0)20 7399 2760

Susan Ringdal, Investor Relations Director                  

 

FTI Consulting                                                                                       +44 (0)20 7831 3113

Julia Phillips/Jonathan Birt/Matthew Cole

 

 

About Hikma

Hikma Pharmaceuticals PLC is a fast growing global pharmaceutical group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.  Hikma's operations are conducted through three businesses: "Branded", "Injectables" and "Generics" based primarily in the Middle East and North Africa ("MENA") region, where it is a market leader, the United States and Europe.  In 2011, Hikma achieved revenues of $918.0 million and profit attributable to shareholders of $80.1 million. 

 

A presentation for analysts and investors will be held today at 09:30 at FTI Consulting, Holborn Gate, 26 Southampton Buildings, London, WC2A 1PB. To join via conference call please dial: +44 (0) 203 140 0722.  Alternatively you can listen live via our website at www.hikma.com.  A recording of both the meeting and the call will be available on the Hikma website.  Video interviews of Said Darwazah, CEO and Khalid Nabilsi, CFO are available at www.hikma.com.  The contents of the website do not form part of this interim management report.

 

Interim management report

 

The interim management report set out below summarises the performance of Hikma's three main business segments, Branded, Injectables and Generics, for the six months ended 30 June 2012.

 

Group revenue by business segment (%)


H1 2012

H1 2011

Branded

46.7%

50.6%

Injectables

42.3%

29.4%

Generics

10.5%

19.3%

Others

0.5%

0.7%

 

Group revenue by region (%)


H1 2012

H1 2011

MENA

56.0%

58.2%

US

36.1%

30.4%

Europe and ROW

7.9%

11.4%

 

Branded

 

H1 2012 highlights:

 

•      Branded revenue increased by 24.6%, with organic revenue up 12.8%

•      Branded adjusted operating profit increased by 10.5%, with an adjusted operating margin of 21.1%

•      On track to meet guidance of around 20% revenue growth for the full year, with gross and adjusted operating margins broadly in line with 2011

 

Branded revenue increased by 24.6% in the first half of 2012 to $248.8 million.  Organic revenue grew 12.8% to $225.2 million, with the recently acquired Promopharm and Savanna 7businesses contributing a further $23.6 million. 

7Formerly Elie Pharmaceuticals in Sudan

 

During the first half we delivered strong growth in our key MENA markets.  In particular, we achieved an excellent performance in our Egyptian business, which grew by around 30%, reflecting increased manufacturing capacity, new product launches and our greater focus on strategic, higher value products.  In Algeria, growth of over 20% was driven by an increase in locally manufactured products, stronger brand recognition and the strength and focus of our sales and marketing team. 

 

In Saudi Arabia and Jordan we performed well in the first half, benefiting from a number of new product launches in Saudi Arabia and higher tender sales in both these markets.  In Libya, our recovery has been impressive and we have achieved excellent growth and a leading market position.  Our business in Morocco performed in line with our expectations, driven by its existing product portfolio.  We have begun the process of registering Hikma's key strategic products in Morocco to deliver future growth.  In Iraq, sales were disrupted in the first few months of the year as we changed our distributor.  Sales in Iraq are now accelerating and we expect a stronger second half.

 

In Sudan, a significant devaluation of the Sudanese pound created uncertainty around pharmaceutical pricing and disrupted product shipments.  Although we were able to offset some of the adverse currency impact, we achieved lower revenue in the first half compared to the first half of 2011.  Continued volatility with respect to the exchange rate could further impact revenue in the second half. 

 

In the first half of 2012, the Branded business launched a total of 30 products across all markets, including 2 new compounds and 4 new dosage forms and strengths.  The Branded business also received 24 regulatory approvals across the region, including 1 for a new product. 

 

Revenue from in-licensed products increased from $80.9 million to $89.2 million in the first half.  This represented 35.8% of Branded revenue compared to 40.5% of Branded revenue in the first half of 2011.  The change reflects strong growth in our branded generics portfolio and lower sales of Actos, which has been withdrawn in some of our markets.

Branded gross profit grew by 21.1% to $120.1 million in the first half and gross margin was 48.3% compared to 49.7%.  The decline in margin is primarily attributable to the impact of increased salaries and benefits driven by inflationary pressure in the wake of the Arab Spring, the consolidation of the lower margin Promopharm business and higher tender sales.  This is being partially offset by a greater focus on higher margin, strategic products and operational efficiencies.

 

Operating profit in the Branded business was $47.4 million, compared to $45.2 million in the first half of 2011.  Adjusted operating profit increased by 10.5% to $52.6 million.  Adjusted operating margin was 21.1%, compared to 23.8% in the first half of 2011, reflecting lower gross margin, an increase in salaries and benefits, higher R&D investment and the impact of adverse movements in the Sudanese pound and the Algerian dinar.  The devaluation of the Sudanese pound in the first half of 2012 resulted in a transactional loss of approximately $3.4 million. 

 

We continue to expect around 20% Branded revenue growth for the full year.  Due to the weighting of sales and the benefit of operating leverage, we expect gross margin and adjusted operating margin for the full year to be broadly in line with 2011.  However, if the Sudanese pound and the Algerian dinar remain at their current levels relative to the US dollar for the remainder of the year, we would expect a small negative impact on our margin outlook.

 

Injectables

 

H1 2012 highlights:

 

·      Injectables revenue grew by 94.0% to $225.2 million, with organic revenue up 25.7%

·      Strong performances across our US, MENA and European Injectables businesses

·      Significant expansion in Injectables adjusted operating margin, up from 14.0% to 22.0%

 

Injectables revenue by region

 


H1 2012

H1 2011

US

60.7%

37.6%

Europe and ROW

16.4%

31.3%

MENA

22.9%

31.1%

 

Revenue in our global Injectables business increased by 94.0% to $225.2 million, compared to $116.1 million in the first half of 2011. 

 

US Injectables revenue grew by $93.0 million, or 213.0%, to $136.6 million.  Organic revenue grew by $10.9 million, or 60.3%, to $29.0 million.  This excellent performance reflects the strength of our product portfolio including recent product launches, our strong manufacturing and sales platform in the US and growth in our contract manufacturing business.  Our quality track record means we are also benefiting from the favourable market conditions created by the supply constraints of our competitors.

 

In the MENA region, Injectables revenue increased by 42.9% to $51.6 million, compared to $36.1 million in the first half of 2011.  Excluding Promopharm, which added Injectables revenue of $3.6 million, organic MENA Injectables revenue grew by 32.7%.  This reflects strong demand in the private market, particularly in Saudi Arabia, Algeria and Libya and greater tender wins.

 

Revenue in our European Injectables business grew by 1.9% to $37.0 million.  On a constant currency basis, European Injectables revenue growth was 10.1%, reflecting growth from new contract wins for our contract manufacturing business, as well as good growth in sales of our own drugs and recent product launches.

 

Injectables gross profit increased by 125.4% to $98.2 million, compared to $43.6 million in the first half of 2011.  Gross margin increased to 43.6%, compared to 37.5% in the first half of 2011.  This reflects the successful restructuring of the Multi-Source Injectables business ("MSI"), lower unit costs from greater capacity utilisation and growth in our contract manufacturing business.

 

Operating profit of the Injectables business increased by 257.2% to $47.7 million.  Adjusted operating margin increased from 14.0% to 22.0%.  This excellent margin expansion reflects the improvement in gross margin, significantly better operating leverage and tight control of operating costs.  

 

We remain focussed on strengthening our Injectables product portfolio, with a particular emphasis on more differentiated products.  In January 2012 we received approval for a New Drug Application ("NDA") for argatroban injection.  In May 2012, we purchased the Abbreviated New Drug Application ("ANDA") for sodium ferrous gluconate injection from GeneraMedix Pharmaceuticals for a cash consideration of $16.0 million.   During the first half of 2012, the Injectables business launched a total of 7 products across all markets, including 3 new compounds and 3 new dosage forms and strengths.  The Injectables business also received a total of 15 regulatory approvals across all regions and markets, including 6 in MENA, 5 in Europe and 4 in the US.

 

Given the current market environment and the continued demand for our products, we expect the performance we achieved in Injectables in the first half will be sustained in the second half of the year.

 

Generics

 

H1 2012 highlights:

 

·      Generics revenue decreased by 27.0% to $55.8 million

·      Operating loss of $3.3 million reflects lower than expected sales resulting from the impact of additional compliance work at our Eatontown facility and increased pricing pressure

·      Revised revenue guidance to around $115 million for the full year

 

Generics revenue was $55.8 million, down 27.0% compared to $76.4 million in the first half of 2011.  This decline reflects an increase in pricing pressure and a slowdown in production at our Eatontown facility related to the additional compliance work we have undertaken to respond to FDA concerns raised in its warning letter of February 2012.  We expect sales to gradually improve in the second half of the year and now expect full year revenue of around $115 million. 

 

We continue to focus on our strategic priorities for this business, which include minimising our manufacturing costs and building our product portfolio.  We are accelerating the transfer of products for manufacture in our MENA facilities to improve efficiencies and reduce operating costs.  In the first half, 27.2% of Generics sales were manufactured in MENA, compared to 24.8% in the first half of 2011. 

 

We are also building our R&D pipeline of oral products for the US market.  In particular, we have made further progress in developing our relationship with Unimark in India with an agreement to collaborate on the development of fourteen ANDAs. 

 

Generics gross profit was $15.2 million, compared to $29.2 million in the first half of 2011 and gross margin was 27.3%, compared to 38.3% in the first half of 2011.  This reflects reduced operating leverage as a result of the significant slowdown in sales and an adverse change in product mix.

 

The Generics business made an operating loss of $3.3 million in the first half of 2012, compared to an operating profit of $10.2 million in the first half of 2011.  This is due to lower sales, high fixed operating costs and increased R&D expenditure.   With a better performance anticipated in the second half, we expect the business to breakeven for the full year.

 

Other businesses

 

Other businesses, which primarily comprise Arab Medical Containers, a manufacturer of plastic specialised packaging, International Pharmaceuticals Research Centre, which conducts bio-equivalency studies, and the chemicals division of Hikma Pharmaceuticals Limited, contributed revenue of $2.5 million, compared to $2.7 million in the first half of 2011. 

 

These other businesses delivered an operating loss of $2.0 million in the first half of 2012, compared to a loss of $1.6 million in the first half of 2011.

 

Group

 

Group revenue increased by 34.8% to $532.3 million in the first half of 2012.  Excluding the contribution of MSI, Promopharm in Morocco and Savanna in Sudan, organic revenue growth was 7.6%.  The Group is on track to meet its target of around 20% revenue growth for the full year. 

 

The Group's gross profit increased by 35.6% to $234.1 million, compared to $172.6 million in the first half of 2011.  Group gross margin was 44.0%, compared to 43.7%, with the significant gross margin improvement of the global Injectables business more than offsetting the lower Generics gross margin. 

 

Group operating expenses grew by 28.7% to $159.0 million, compared to $123.6 million in the first half of 2011.  Excluding the amortisation of intangible assets (excluding software) and exceptional items, 8 adjusted Group operating expenses grew by 33.2% to $152.0 million.  The paragraphs below address the Group's main operating expenses in turn.

8 In H1 2012, amortisation of intangible assets (excluding software) was $6.4 million (H1 2011: $4.0 million).  In H1 2012, exceptional items included within general and administrative expenses were $0.6 million (H1 2011: $5.5 million)

 

Sales and marketing expenses were $74.1 million, or 13.9% of sales, compared to $57.0 million and 14.4% of sales in the first half of 2011.  This reflects strong growth in our global Injectables business where relatively low incremental sales and marketing investment is required to generate new sales.  This more than offset an increase in MENA sales and marketing expenditure due to higher wages and employee benefits.

 

General and administrative expenses increased by $10.8 million, or 24.0%, to $55.9 million in the first half.  As a percentage of sales, general and administrative expenses reduced to 10.5%, compared to 11.4% in the first half of 2011.  Excluding non-recurring transaction and integration costs, G&A expenses as a percentage of sales were 10.4%, compared to 10.0% in the first half of 2011.  This increase primarily reflects an increase in employee salaries and benefits in MENA.

 

Investment in R&D grew by 49.2% to $17.1 million, with total investment in R&D representing 3.2% of Group revenue, compared to 2.9% in the first half of 2011.  We expect R&D spend will increase in the second half of the year as we continue to execute plans to develop our R&D pipeline, particularly for injectable products.

 

Other net operating expenses increased by $1.9 million to $11.9 million reflecting an increase in foreign exchange losses, primarily due to movements in the Sudanese pound and slow moving stock provisions.

 

Operating profit for the Group increased by 53.1% to $75.1 million in the first half of 2012.  Group operating margin increased to 14.1%, compared to 12.4% in the first half of 2011.  On an adjusted basis, Group operating profit increased by 37.4% to $82.1 million and operating margin increased to 15.4%, up from 15.1% in the first half of 2011. 

 

Research & Development 9 

9 Products are defined as pharmaceutical compounds sold by the Group.  New compounds are defined as pharmaceutical compounds not yet launched by the Group and existing compounds being introduced into a new segment

 

The Group's product portfolio continues to grow.  During the first half of 2012, we launched 5 new compounds, expanding the Group portfolio to 688 compounds in 1,696 dosage forms and strengths.  We manufacture and/or sell 207 of these compounds under-license from the originator.

 

Across all businesses and markets, a total of 37 products were launched during the first half.  In addition, the Group received 39 approvals. 

 


Total marketed products

Products launched in H1 2012


Compounds

Dosage forms and strengths

New compounds

New dosage forms and strengths

Total launches across all countries 10







Branded

446

1,225

2

4

30







Injectables

174

356

3

3

7







Generics

48

115

-

-

-







Group

688

1,696

5

7

37







 

               


Products approved in H1 2012

 

Products pending approval as at 30 June 2012


New compounds

New dosage forms and strengths

Total approvals across all countries 10

New compounds

New dosage forms and strengths

Total pending approvals across all countries 10








Branded

1

2

24

133

212

297








Injectables

3

5

15

74

122

255








Generics

-

-

-

22

22

22








Group

4

7

39

229

356

574








 

10 Totals include all compounds and formulations that are either launched, approved or pending approval across all markets

To ensure the continuous development of our product pipeline, we submitted 104 regulatory filings in the first half of the year across all regions and markets.  As of 30 June 2012, we had a total of 574 pending approvals across all regions and markets. 

 

At 30 June 2012, we had a total of 109 new products under development, the majority of which should receive several marketing authorisations for different strengths and/or product forms over the next few years.

 

Net finance expense

 

Net finance expense increased to $16.7 million, compared to $9.3 million in the first half of 2011 due to higher net debt, including an increase in loans in local currency that carry higher financing charges.  This is explained in more detail in the net cash flow, working capital and net debt section below.

 

Profit before tax

 

Profit before tax for the Group increased by 45.1% to $57.8 million, compared to $39.9 million in the first half of 2011.  Adjusted profit before tax increased by 28.3% to $64.8 million.

 

Tax

 

The Group incurred a tax expense of $15.0 million, compared to $4.8 million in the first half of 2011.  The effective tax rate was 25.9%, compared to 11.9% in the first half of 2011.  The increase in the tax rate is mainly attributable to the increased profitability of the US Injectables business.  We now expect the effective tax rate for the Group to be around 23% for the full year.

 

Profit for the period

 

The Group's profit attributable to equity holders of the parent increased by 22.0% to $40.4 million in the first half of 2012.  Adjusted profit attributable to equity holders of the parent increased by 12.9% to $46.0 million.

 

Earnings per share

 

Basic earnings per share increased by 20.3% to 20.6 cents, compared to 17.1 cents in the first half of 2011.  Diluted earnings per share increased by 22.2% to 20.4 cents, compared to 16.7 cents in the first half of 2011.   Adjusted diluted earnings per share was 23.3 cents, an increase of 13.1% over the first half of 2011.

 

Dividend

 

The Board has declared an interim dividend of 6.0 cents per share (approximately 3.8 pence per share), compared to 5.5 cents per share for the first half of 2011.  The interim dividend will be paid on 8 October 2012 to eligible shareholders on the register at the close of business on 31 August 2012.  The ex-dividend date is 29 August 2012 and the final date for currency elections is 14 September 2012.

 

Net cash flow, working capital and net debt

 

The Group generated operating cash flow of $47.1 million in the first half, up $27.9 million from $19.2 million in the first half of 2011.  This increase in operating cash flow reflects the improved profitability of the Group in the first half of 2012 and better working capital management.  Cash flow in the first half of 2011 was impacted by a non-recurring cash injection of $18.9 million to fund the initial working capital requirement of the MSI business at the time of its acquisition in May 2011.

 

The Group continued to deliver significant improvements in working capital in the first half, reducing its overall working capital cycle by 46 days to 208 days.  Group receivable days reduced by 9 days to 108 days at 30 June 2012 and payable days decreased by 18 days to 66 days.  Inventory days improved by 55 days to 166 days, reflecting lower inventories in MENA compared to the first half of 2011 when markets were disrupted by the Arab Spring.

 

Capital expenditure was $26.1 million, compared to $33.0 million in the first half of 2011.  Around $16 million of that was spent in MENA, principally to develop our chemical plant in Jordan and the recently acquired Savanna business in Sudan, and to maintain our manufacturing facilities across the MENA region.  Investment in the US of around $8 million was primarily to add new capacity at the Cherry Hill facility in New Jersey.  In Portugal, investments included warehouse improvements and new machinery purchases.  We now expect capital expenditure for the full year of around $65 million. 

 

Group net debt 11increased from $322.7 million at 30 June 2011 to $473.0 million at 30 June 2012.   Net debt on 31 December 2011 stood at $421.9 million.  The increase in borrowing in the first half of 2012 was primarily to finance capital expenditure, the purchase of intangible assets and the purchase of additional shares in Promopharm.

11 Net debt is calculated as bank overdrafts and loans, long term financial debts and obligations under finance leases, less cash and cash equivalents, collateralised cash and restricted cash

 

Balance sheet

 

During the period, shareholder equity was negatively impacted by unrealised foreign exchange losses of $25.1 million, reflecting the depreciation of the Euro, the Sudanese pound and the Algerian dinar against the US dollar and the revaluation of net assets denominated in these currencies.

 

Summary and Outlook

 

Hikma has delivered a strong performance in the first half of 2012.  The global Injectables business is delivering excellent growth and our Branded business is performing very well.  This is being partially offset by the decline in the Generics business.

 

The Group remains on track to meet our full year target of around 20% revenue growth. 

 

We are expecting stronger sales growth in the MENA region in the second half and we continue to expect our Branded business to deliver around 20% revenue growth for the full year, with gross margin and adjusted operating margin broadly in line with 2011.  However, if the Sudanese pound and the Algerian dinar remain at their current levels relative to the US dollar for the remainder of the year, we would expect a small negative impact on our margin outlook.

 

Given the current market environment and the continued demand for our injectable products, we expect the performance of the global Injectables business in the first half of 2012 will be sustained in the second half of the year.

 

In our Generics business, we now expect revenue of around $115 million and the business to break even for the full year.

 

Overall we are pleased with the progress of the Group in the first half and the outlook for the full year.

 

Going concern statement

 

As stated in note 2 to the condensed financial statements, the Directors are satisfied that the Group has sufficient resources to continue in operation for the foreseeable future, a period of not less than twelve months from the date of this report. Accordingly they continue to adopt the going concern basis in preparing the condensed financial statements.

 

Responsibility statement

 

The Board confirms that to the best of its knowledge:

 

(a)           the condensed set of financial statements has been prepared in accordance with IAS 34 'Interim Financial Reporting';

 

(b)           the interim management report includes a fair review of the information required by DTR 4.2.7R (indication of important events during the first six months including their impact on the financial statements and description of principal risks and uncertainties for the remaining six months of the year); and

 

(c)           the interim management report includes a fair review of the information required by DTR 4.2.8R (disclosure of related parties' transactions and changes therein which have had or could have a material financial effect on the financial position of the Group during the period).

 

 

By order of the Board

 

 

 

Said Darwazah

Chief Executive Officer

 

15 August 2012

 

 

Cautionary statement

This Interim Management Report ("IMR") has been prepared solely to provide additional information to shareholders to assess the Group's strategies and the potential for those strategies to succeed.  The IMR should not be relied on by any other party or for any other purpose.

 

Forward looking statements

 

Certain statements in this announcement are forward-looking statements - using words such as "intends", "believes", anticipates" and "expects".  Where included, these have been made by the Directors in good faith based on the information available to them up to the time of their approval of this announcement.  By their nature, forward-looking statements are based on assumptions and involve inherent risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements, and should be treated with caution.  These risks, uncertainties or assumptions could adversely affect the outcome and financial effects of the plans and events described in this announcement.  Forward-looking statements contained in this announcement regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future.  You should not place undue reliance on forward-looking statements, which speak as only of the date of the approval of this announcement.

 

Except as required by law, the Company is under no obligation to update or keep current the forward-looking statements contained in this announcement or to correct any inaccuracies which may become apparent in such forward-looking statements.

 

INDEPENDENT REVIEW REPORT TO HIKMA PHARMACEUTICALS PLC

 

We have been engaged by Hikma Pharmaceuticals PLC (the 'Company') to review the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2012 which comprises the condensed consolidated income statement, the condensed consolidated statement of comprehensive income, the condensed consolidated balance sheet, the condensed consolidated statement of changes in equity, the condensed consolidated cash flow statement and related notes 1 to 15. We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the condensed set of financial statements.

 

This report is made solely to the Company in accordance with International Standard on Review Engagements (UK and Ireland) 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity" issued by the Auditing Practices Board.  Our work has been undertaken so that we might state to the Company those matters we are required to state to it in an independent review report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company, for our review work, for this report, or for the conclusions we have formed.

 

Directors' responsibilities

 

The half-yearly financial report is the responsibility of, and has been approved by, the directors.  The directors are responsible for preparing the half-yearly financial report in accordance with the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority.

 

As disclosed in note 2, the annual financial statements of the Group are prepared in accordance with IFRSs as adopted by the European Union.  The condensed set of financial statements included in this half-yearly financial report has been prepared in accordance with International Accounting Standard 34, "Interim Financial Reporting," as adopted by the European Union.

 

Our responsibility

 

Our responsibility is to express to the Company a conclusion on the condensed set of financial statements in the half-yearly financial report based on our review.

 

Scope of review

 

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410, "Review of Interim Financial Information Performed by the Independent Auditor of the Entity" issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

 

Conclusion

 

Based on our review, nothing has come to our attention that causes us to believe that the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2012 is not prepared, in all material respects, in accordance with International Accounting Standard 34 as adopted by the European Union and the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority.

 

 

Deloitte LLP

Chartered Accountants and Statutory Auditor

London, United Kingdom

 

 15 August 2012

 

 

Condensed consolidated income statement


Notes


H1
2012


H1
2011


FY
2011




$000 (Unaudited)


$000 (Unaudited)


$000 (Audited)

Continuing operations








Revenue

3


       532,260


      394,759


     918,025

Cost of sales

3


     (298,180)


     (222,141)


  (522,676)

Gross profit

3


       234,080


       172,618


      395,349

Sales and marketing costs



       (74,084)


       (56,988)


  (125,295)

General and administrative expenses



       (55,893)


       (45,073)


  (107,540)

Research and development costs



       (17,097)


       (11,459)


    (31,218)

Other operating expenses (net)



       (11,937)


       (10,053)


    (12,608)

Total operating expenses



     (159,011)


      (123,573)


  (276,661)

Adjusted operating profit



         82,055


         59,717


     145,824

Exceptional items








 - Acquisition and integration related expenses

4


            (601)


         (5,455)


    (16,368)

 - Inventory related adjustment

4


                   -


        (1,203)


      (1,770)

Intangible amortisation*

4


         (6,385)


         (4,014)


      (8,998)









Operating profit



         75,069


         49,045


     118,688

Loss from associated companies



             (50)


                   -


      (1,164)

Finance income



             355


              154


            468

Finance expense



       (17,039)


         (9,484)


    (23,368)

Other (expenses)/income (net)



            (491)


              152


         (732)

Profit before tax



         57,844


         39,867


       93,892

Tax

5


       (14,976)


         (4,755)


    (10,423)

Profit for the period/year



         42,868


         35,112


       83,469

Attributable to:








Non-controlling interests



           2,468


           1,987


         3,362

Equity holders of the parent



         40,400


         33,125


       80,107




42,868


         35,112


       83,469

Earnings per share (cents)








Basic

7


             20.6


             17.1


           41.3

Diluted

7


             20.4


             16.7


           40.5

Adjusted basic

7


             23.5


             21.1


           52.0

Adjusted diluted

7


             23.3


             20.6


           51.0

 

 

On this page and throughout this interim financial information "H1 2012" refers to the six months ended 30 June 2012, "H1 2011" refers to the six months ended 30 June 2011 and "FY 2011" refers to the year ended 31 December 2011.

 

* Intangible amortisation comprises the amortisation of intangible assets other than software.

 

 

Condensed consolidated statement of comprehensive income



H1
2012


H1
2011


FY
2011




$000 (Unaudited)


$000 (Unaudited)


$000 (Audited)

Profit for the period/year



42,868


35,112


83,469

Cumulative effect of change in fair value of available for sale investments



              (19)


                (9)


         (42)

Cumulative effect of change in fair value of  financial derivatives



         (1,625)


            (601)


       (692)

Exchange difference on translation of foreign operations



       (29,375)


         14,381


  (15,294)

Total comprehensive income for the period/year



11,849


48,883


67,441

Attributable to:








Non-controlling interests



         (1,847)


           2,537


      3,557

Equity holders of the parent



13,696


         46,346


    63,884




11,849


         48,883


    67,441

 

 

Condensed consolidated balance sheet


Notes


30 June
2012


30 June
2011


31 December
2011




$000 (Unaudited)


$000 (Unaudited)


$000 (Audited)

Non-current assets








Intangible assets

8


       426,684


       294,804


         408,804

Property, plant and equipment



       413,410


       391,842


         421,357

Interests in associated companies



         37,395


         38,610


           37,445

Deferred tax assets



         34,839


         23,443


           36,072

Available for sale investments



              415


              468


                435

Financial and other non-current assets



         11,149


         11,050


           11,644




923,892


760,217


915,757

Current assets








Inventories

9


       271,862


       269,490


         239,260

Income tax asset



              915


           5,403


             1,486

Trade and other receivables

10


       343,949


       287,165


         315,856

Collateralised and restricted cash



           6,637


           2,510


             2,595

Cash and cash equivalents



       114,379


         89,526


           94,715

Other current assets



           1,722


           2,934


             5,973




739,464


657,028


659,885

Total assets



1,663,356


1,417,245


1,575,642

Current liabilities








Bank overdrafts and loans



       180,166


       159,119


         152,853

Obligations under finance leases



         17,149


           3,727


             3,300

Trade and other payables

11


       175,214


       146,747


         171,098

Income tax provision



         15,179


         10,652


           14,561

Other provisions



         10,508


           9,176


             9,398

Other current liabilities



         58,181


         34,583


           39,373




456,397


364,004


390,583

Net current assets



283,067


293,024


269,302

Non-current liabilities








Long-term financial debts

12


       393,842


       231,999


         344,895

Deferred income



              212


              318


                249

Obligations under finance leases



           2,861


         19,894


           18,134

Deferred tax liabilities



         22,514


         12,353


           23,147




419,429


264,564


386,425

Total liabilities



875,826


628,568


777,008

Net assets



787,530


788,677


798,634

Equity








Share capital



         35,063


         34,937


           34,904

Share premium



       278,528


       277,440


         278,094

Own shares



            (120)


         (2,292)


          (2,222)

Other reserves



       461,324


       469,029


         465,799

Equity attributable to equity holders of the parent



       774,795


       779,114


         776,575

Non-controlling interests



         12,735


           9,563


           22,059

Total equity



       787,530


       788,677


         798,634

 

The financial statements of Hikma Pharmaceuticals PLC, registered number 5557934, were approved by                                       the Board of Directors and signed on its behalf by:

 

Said Darwazah                                                             Breffni Byrne

Director                                                                         Director                                                                                15 August 2012

 

 

Condensed consolidated statement of changes in equity


Merger reserve
$000


Revaluation reserves
$000


Translation reserves
$000


Retained earnings
$000


Total
reserves
$000


Share
 capital
$000


Share
 premium
$000


Own
 shares
$000


Total equity attributable to equity shareholders of the parent
$000


Non-controlling interests
$000


Total
 equity
$000























Balance at 1 January 2011 (Audited)

   33,920


    4,085


    (12,080)


    409,724


  435,649


   34,525


  275,968


  (2,220)


     743,922


      6,378


    750,300

Profit for the period

              -  


                 -  


                  -  


         33,125


     33,125


               -  


                -  


             -  


       33,125


         1,987


        35,112

Cumulative effect of change in fair value of available for sale investments

              -  


                 -  


                  -  


               (9)


            (9)


              -  


                -  


             -  


               (9)


                 -  


              (9)

Cumulative effect of change in fair value of  financial derivatives

              -  


                 -  


                  -  


           (601)


         (601)


               -  


                -  


             -  


           (601)


                 -  


           (601)

Realisation of revaluation reserve

              -  


              (91)


                  -  


                91


            -  


               -  


                -  


             -  


              -  


                 -  


              -  

Currency translation loss

              -  


                 -  


         13,831


                  -  


     13,831


               -  


                -  


             -  


        13,831


            550


        14,381

Total comprehensive income for the period

              -  


              (91)


         13,831


         32,606


    46,346


               -  


                -  


             -  


       46,346


         2,537


      48,883

Issue of equity shares

              -  


                 -  


                  -  


                  -  


            -  


          412


        1,472


             -  


         1,884


                 -  


         1,884

Purchase of own shares

              -  


                 -  


                  -  


                  -  


            -  


               -  


                -  


     (112)


            (112)


                 -  


            (112)

Cost of equity settled employee share schemes

              -  


                 -  


                  -  


           3,634


      3,634


              -  


                -  


          -  


         3,634


                -  


        3,634

Exercise of employees long term incentive plan

              -  


                 -  


                 -  


             (40)


          (40)


               -  


                -  


          40


              -  


                 -  


              -  

Deferred tax arising on share-based payments

              -  


                 -  


                  -  


        (3,327)


     (3,327)


               -  


                -  


             -  


        (3,327)


                 -  


       (3,327)

Dividends on ordinary shares

              -  


                 -  


                  -  


      (14,497)


    (14,497)


         -  


             -  


           -  


      (14,497)


                 -  


      (14,497)

Adjustment arising from change in non-controlling interests

              -  


                 -  


                  -  


           1,264


       1,264


               -  


                -  


             -  


         1,264


            160


         1,424

Issue of equity shares of subsidiary

              -  


                 -  


                  -  


                  -


            -  


               -  


                -  


             -  


              -  


            488


           488

Balance at 30 June 2011 (Unaudited)

   33,920


    3,994


        1,751


    429,364


  469,029


   34,937


  277,440


  (2,292)


      779,114


      9,563


    788,677

Balance at 1 January 2011 (Audited)

   33,920


    4,085


    (12,080)


    409,724


  435,649


   34,525


  275,968


  (2,220)


     743,922


      6,378


    750,300























Profit for the  year

              -  


                 -  


                  -  


         80,107


     80,107


               -  


                -  


             -  


       80,107


         3,362


      83,469

Cumulative effect of change in fair value of available for sale investments

              -  


                 -  


                 -  


             (42)


          (42)


               -  


                -  


             -  


             (42)


                 -  


            (42)

Cumulative effect of change in fair value of  financial derivatives

              -  


                 -  


                  -  


           (692)


        (692)


               -  


                -  


         -  


           (692)


                -  


          (692)

Realisation of revaluation reserve

              -  


            (181)


                  -  


              181


            -  


               -  


                -  


             -  


              -  


                 -  


              -  

Currency translation loss

              -  


                 -  


      (15,489)


                  -  


    (15,489)


               -  


                -  


             -  


      (15,489)


            195


      (15,294)

Total comprehensive income for the period

              -  


            (181)


      (15,489)


         79,554


    63,884


               -  


                -  


             -  


       63,884


         3,557


       67,441

Issue of equity shares

              -  


                 -  


                 -  


                  -  


            -  


          379


        2,126


-


         2,505


                 -  


        2,505

Purchase of own shares

              -  


                 -  


                 -  


                  -  


            -  


               -  


                -  


     (115)


            (115)


                 -  


            (115)

Cost of equity settled employee share schemes

              -  


                 -  


                 -  


           7,507


      7,507


               -  


                -  


             -  


         7,507


                 -  


        7,507

Exercise of employees long term incentive plan

              -  


                 -  


                 -  


           (113)


         (113)


               -  


                -  


        113


              -  


                 -  


              -  

Deferred tax arising on share-based payments

              -  


                 -  


                 -  


        (5,644)


     (5,644)


               -  


                -  


             -  


        (5,644)


                 -  


       (5,644)

Current tax arising on share-based payments

              -  


                 -  


                  -  


           3,750


      3,750


               -  


                -  


             -  


         3,750


                 -  


        3,750

Dividends on ordinary shares

              -  


                 -  


                 -  


      (25,201)


    (25,201)


               -  


                -  


             -  


      (25,201)


          (100)


      (25,301)

Acquisition of subsidiaries

              -  


                 -  


                  -  


                  -  


            -  


               -  


                -  


             -  


              -  


       26,650


      26,650

Adjustment arising from change in non-controlling interests

              -  


                 -  


                  -  


      (14,033)


    (14,033)


               -  


                -  


             -  


      (14,033)


     (14,914)


     (28,947)

Issue of equity shares of subsidiary

              -  


                 -  


                 -  


                  -  


            -  


               -  


                -  


             -  


              -  


            488


           488

Balance at 31 December 2011 (Audited)

   33,920


    3,904


   (27,569)


    455,544


  465,799


   34,904


  278,094


 (2,222)


     776,575


    22,059


    798,634

Profit for the period

              -  


                 -  


                 -  


         40,400


    40,400


               -  


                -  


             -  


       40,400


         2,468


      42,868

Cumulative effect of change in fair value of available for sale investments

              -  


                 -  


                  -  


             (19)


           (19)


               -  


                -  


             -  


             (19)


                 -  


             (19)

Cumulative effect of change in fair value of  financial derivatives

              -  


                 -  


                  -  


        (1,625)


      (1,625)


               -  


                -  


             -  


        (1,625)


                 -  


        (1,625)

Realisation of revaluation reserve

              -  


              (91)


                  -  


                91


            -  


               -  


                -  


             -  


              -  


                 -  


              -  

Currency translation loss

              -  


                 -  


      (25,060)


                  -  


   (25,060)


               -  


                -  


             -  


      (25,060)


       (4,315)


     (29,375)

Total comprehensive income for the period

              -  


              (91)


      (25,060)


         38,847


     13,696


               -  


                -  


             -  


       13,696


       (1,847)


        11,849

Issue of equity shares

              -  


                 -  


                  -  


                  -  


            -  


          159


           434


             -  


            593


                 -  


           593

Purchase of own shares

              -  


                 -  


                  -  


                  -  


            -  


               -  


                -  


    (147)


           (147)


                 -  


           (147)

Cost of equity settled employee share schemes

              -  


                 -  


                  -  


           3,675


      3,675


               -  


                -  


             -  


         3,675


                 -  


        3,675

Exercise of employees long term incentive plan

              -  


                 -  


                  -  


           (117)


         (117)


               -  


                -  


        117


              -  


                 -  


              -  

Exercise of employees management incentive plan

              -  


                 -  


                  -  


        (2,132)


      (2,132)


               -  


                -  


    2,132


              -  


                -  


              -  

Deferred tax arising on share-based payments

              -  


                 -  


                  -  


             (18)


           (18)


               -  


                -  


             -  


             (18)


                 -  


             (18)

Dividends on ordinary shares

              -  


                 -  


                  -  


      (14,746)


    (14,746)


               -  


                -  


             -  


      (14,746)


         (301)


      (15,047)

Adjustment arising from change in non-controlling interests

              -  


                 -  


                  -  


       (4,833)


     (4,833)


               -  


                -  


             -  


        (4,833)


       (7,176)


      (12,009)

Balance at 30 June 2012 (Unaudited)

   33,920


     3,813


   (52,629)


    476,220


   461,324


   35,063


  278,528


     (120)


     774,795


     12,735


    787,530

 

 

Condensed consolidated cash flow statement

 


Notes


H1
2012


H1
2011


FY
2011




$000 (Unaudited)


$000 (Unaudited)


$000 (Audited)

Net cash from operating activities

13


         47,071


         19,220


    126,397

Investing activities








Purchases of property, plant and equipment



       (29,340)


       (33,199)


   (69,032)

Proceeds from disposal of property, plant and equipment



              417


              313


           696

Purchase of intangible assets



       (27,582)


         (7,179)


     (8,967)

Proceeds from disposal of intangible assets



              143


                66


           191

Acquisition of interest in associated companies



                 -  


       (38,610)


   (38,610)

Investment in financial and other non-current assets



              495


              307


        (287)

Acquisition of subsidiary undertakings, net of cash acquired



         (6,207)


     (105,825)


 

(217,779)

Payments of costs directly attributable to acquisitions

4


         (1,519)


         (3,892)


   (10,147)

Finance income



              348


              154


           468

Net cash used in investing activities



       (63,245)


     (187,865)


 (343,467)

Financing activities








(Increase)/decrease in collateralised and restricted cash



         (4,041)


           1,063


           978

Increase in long-term financial debts



         99,885


       197,695


    335,353

Repayment of long-term financial debts



       (50,034)


       (51,488)


   (68,364)

Increase in short-term borrowings



         35,961


         69,769


      59,095

Decrease in obligations under finance leases



         (1,215)


            (489)


     (2,028)

Dividends paid



       (14,717)


       (14,497)


   (25,201)

Dividends paid to non-controlling shareholders



            (301)


                  -  


        (100)

Interest paid



       (15,938)


         (9,555)


   (23,758)

Proceeds from issue of new shares



              446


           1,772


        2,390

Proceeds from non-controlling interest for capital

increase in subsidiary


                 -  


              488


           488

Acquisition of non-controlling interest in subsidiary



       (12,009)


                  -  


   (29,196)

Net cash from financing activities



         38,037


       194,758


    249,657

Net increase in cash and cash equivalents



         21,863


         26,113


      32,587

Cash and cash equivalents at beginning of period/year



         94,715


         62,718


      62,718

Foreign exchange translation movements



         (2,199)


              695


        (590)

Cash and cash equivalents at end of period/year



      114,379


         89,526


      94,715

 

Notes to the condensed set of financial statements (unaudited)

 

1.         General information

               

The financial information for the year ended 31 December 2011 does not constitute statutory accounts within the meaning of Section 434 of the Companies Act 2006. Statutory accounts for the year ended 31 December 2011, which were prepared under International Financial Reporting Standards (IFRSs) issued by the International Accounting Standards Board, have been filed with the Registrar of Companies. The auditor's report on those accounts was unqualified, did not draw attention to any matters by way of emphasis and did not contain any statement under Section 498 (2) or (3) of the Companies Act 2006.

 

2.         Accounting policies

 

The unaudited condensed set of financial statements for the six months ended 30 June 2012 have been prepared using the same accounting policies and on a basis consistent with the audited financial statements of Hikma Pharmaceuticals PLC (the 'Group') for the year ended 31 December 2011 which are prepared in accordance with IFRSs as adopted by the European Union.

 

Basis of preparation

The currency used in the preparation of the accompanying condensed set of financial statements is the US Dollar ($) as the majority of the Group's business is conducted in US Dollars.

The Group's condensed set of financial statements included in this half- yearly financial report have been prepared in accordance with International Accounting Standards 34 'Interim Financial Reporting' as adopted by the European Union.  They were approved by the Board on 16 August 2012.

Taxes on income for interim periods are accrued using the tax rate that would be applicable to expected total annual earnings.

Certain balances have been reclassified to conform with current period presentation, these include trade receivables as at 30 June 2011 which were shown net of $19,329,000 of provisions for expired goods, certain returns and other rebates, which have now been included in other current liabilities.

 

Going concern

 

The Group has $905.1 million of banking facilities of which $331.1 million were undrawn as at 30 June 2012. Of the undrawn facilities, $189.4 million was committed. These facilities are well diversified across the operating subsidiaries of the Group with a number of financial institutions.

About 50% of the Group's short-term and undrawn long-term facilities are of a committed nature.

We continue to expect the short-term facilities to be renewed upon maturity. In addition the Group maintained cash balances of $121 million as at 30 June 2012. The Group's forecasts, taking into account reasonable possible changes in trading performance, facility renewal sensitivities and maturities of long-term debt, show that the Group should be able to operate within the levels of its facilities.

Although the current economic conditions may affect short-term demand for our products, as well as placing pressure on customers and suppliers which may face liquidity issues, the Group's geographic spread, product diversity, large customer and supplier base substantially mitigate these risks.

In addition, the Group operates in the relatively defensive generic pharmaceuticals industry which we expect to be less affected compared to other industries that are subject to greater cyclical changes.

After making enquiries, the Directors believe that the Group is adequately placed to manage its business and financing risks successfully despite the current uncertain economic outlook. Accordingly, they continue to adopt the going concern basis in preparing the half-yearly condensed financial statement.

 

 

           Changes in accounting policy

 


      The same accounting policies, presentation and method of computation are followed in the

      condensed set of financial statements as applied in the Group's latest annual audited financial statements.

 



        Adoption of new and revised standards

 

        At the date of authorisation of these financial statements, the following Standards and Interpretations                     which have not been applied in these financial statements were in issue but not yet effective (and in some cases had not yet been adopted by the EU):

 

         IFRS 1(amended)                                                                Government Loans

         IFRS 1 (amended)                                                               Severe Hyperinflation and Removal of Fixed             Dates for First-time Adopters

         IFRS 7 and IAS 32(amended)                                            Offsetting Financial Assets and Financial Liabilities

         IFRS 9                                                                                    Financial Instruments and subsequent amendments to IFRS 9 and IFRS 7 issued 16 December 2011

         IFRS 10                                                                    Consolidated Financial Statements              

         IFRS 11                                                                                 Joint Arrangements

         IFRS 12                                                                                 Disclosure of Interests in Other Entities

         IFRS 13                                                                                 Fair Value Measurement

         IAS 1 (amended)         

Presentation of Items of Other Comprehensive Income

         IAS 12           

Deferred Tax Recovery of Underlying Assets

         IAS 19 (amended)

Employee Benefits

         IAS 28 (revised)          

Investments in Associates and Joint Ventures

         Improvements 2011

Annual Improvements to IFRSs: 2009-2011 Cycle

 

The Directors do not expect that the adoption of the standards listed above will have a material impact on the financial statements of the Group in future periods.

 

           

3.         Business and geographical segments

 

For management purposes, the Group is currently organised into three operating divisions - Branded, Injectables and Generics. These divisions represent the Group's reportable segments under IFRS 8 and are the basis on which the Group reports its primary segment information.

Segment information about these businesses is presented below.

 

 

Six months ended











30 June 2012 (Unaudited)













Branded


Injectables


Generics


Others


Group



$000


$000


$000


$000


$000

Revenue


   248,821


     225,215


     55,768


       2,456


   532,260

Cost of sales


 (128,691)


  (127,035)


   (40,560)


     (1,894)


 (298,180)

Gross profit


   120,130


       98,180


     15,208


          562


   234,080












Adjusted segment result


     52,554


       49,536


     (3,291)


     (2,042)


     96,757

Exceptional items :











 - Integration related expenses


        (601)


                -  


               -  


               -  


        (601)

Intangible amortisation*


     (4,521)


       (1,846)


          (18)


               -  


     (6,385)












Segment result


     47,432


       47,690


     (3,309)


     (2,042)


     89,771

Unallocated corporate expenses










   (14,702)

Operating profit










     75,069

Results from associated companies










          (50)

Finance income










          355

Finance expense










   (17,039)

Other expenses (net)










        (491)

Profit before tax










     57,844

Tax










   (14,976)

Profit for the period










     42,868

Attributable to:











Non-controlling interest










       2,468

Equity holders of the parent










     40,400











     42,868

 

 

 

           Segment result is defined as operating profit for each segment.

        

           *Intangible amortisation comprises the amortisation of intangible assets other than software.

 

"Others" mainly comprise Arab Medical Containers Ltd, International Pharmaceutical Research Center Ltd and the chemicals division of Hikma Pharmaceuticals Ltd (Jordan).

Unallocated corporate expenses are primarily made up of employee costs, office costs, professional fees and travel expenses.

 

Segment assets and liabilities











30 June 2012 (Unaudited)













Branded


Injectables


Generics


Corporate and Others


Group



$000


$000


$000


$000


$000

Additions to property, plant and equipment (cost)


        14,636


         9,198


      2,045


         197


     26,076

Additions to intangible assets


         1,972


       24,404


      4,762


               -  


     31,138

Total property, plant and equipment and intangible assets (net book value)


      513,725


     267,755


   51,023


         7,591


   840,094

Depreciation


       11,351


         5,905


      3,438


           391


     21,085

Amortisation (including software)


         5,071


         2,290


         162


             92


       7,615

Interest in associated companies


                -  


                 - 


            -  


      37,395


     37,395

Balance sheet











Total assets


   1,013,755


     402,575


 189,657


       57,369


1,663,356

Total liabilities


     567,572


     233,649


   28,450


      46,155


   875,826

 

 

 

Six months ended











30 June 2011 (Unaudited)













Branded


Injectables


Generics


Others


Group



$000


$000


$000


$000


$000

Revenue


  199,623


     116,105


     76,376


       2,655


   394,759

Cost of sales


 (100,447)


    (72,555)


     (47,161)


     (1,978)


 (222,141)

Gross profit


     99,176


       43,550


     29,215


          677


   172,618












Adjusted segment result


     47,548


       16,222


     10,173


     (1,591)


     72,352

Exceptional items :











 - Inventory related adjustments


               -  


       (1,203)


               -  


               -  


     (1,203)

Intangible amortisation*


     (2,345)


       (1,669)


               -  


               -  


     (4,014)












Segment result


45,203


13,350


10,173


(1,591)


     67,135












Adjusted Unallocated corporate expenses








   (12,635)

Exceptional items :











 - Acquisition related expenses










     (5,455)

Unallocated corporate expenses










   (18,090)

Operating profit










     49,045

Finance income










          154

Finance expense










     (9,484)

Other income (net)










          152

Profit before tax










     39,867

Tax










     (4,755)

Profit for the period










     35,112

Attributable to:











Non-controlling interest










       1,987

Equity holders of the parent










     33,125











     35,112

 

 

  Segment result is defined as operating profit for each segment.

 

 

 *Intangible amortisation comprises the amortisation of intangible assets other than software.

 

"Others" mainly comprise Arab Medical Containers Ltd, International Pharmaceutical Research Center Ltd and the chemicals division of Hikma Pharmaceuticals Ltd (Jordan).

Unallocated corporate expenses are primarily made up of employee costs, office costs, professional fees, donations, travel expenses and acquisition related expenses.

 

 

30 June 2011 (Unaudited)













Branded


Injectables


Generics


Corporate and Others


Group



$000


$000


$000


$000


$000

Additions to property, plant and equipment (cost)


      24,057


         3,048


        3,761


        2,119


      32,985

Acquisition of subsidaries' property, plant and equipment (net book value)


               -  


       50,342


               -  


                - 


      50,342

Additions to intangible assets


        6,191


            988


               -  


                - 


        7,179

Intangible assets arising on acquisition


               -  


       18,060


               -  


                - 


      18,060

Total property, plant and equipment and intangible assets (net book value)


   415,339


     226,018


      33,969


      11,320


   686,646

Depreciation


        9,648


         3,749


        2,363


           480


      16,240

Amortisation (including software)


        3,078


         1,904


             96


             98


        5,176

Interest in associated companies


               -  


                -  


               -  


      38,610


      38,610

Balance sheet











Total assets


   867,629


     370,882


   147,884


      30,850


 1,417,245

Total liabilities


   342,946


     246,534


      26,677


      12,411


   628,568

 

 

 

 

Year ended











31 December 2011 (Audited)
























Branded


Injectables


Generics


Others


Group



$000


$000


$000


$000


$000

Revenue


   441,907


     315,728


   154,813


       5,577


   918,025

Cost of sales


 (227,830)


  (188,151)


 (102,609)


     (4,086)


 (522,676)

Gross profit


   214,077


     127,577


     52,204


       1,491


   395,349












Adjusted segment result


   105,143


       54,938


     17,124


     (2,369)


   174,836

Exceptional items :











 - Integration related expenses


        (921)


       (4,551)


               -  


               -  


     (5,472)

 - Inventory related adjustments


               -  


       (1,770)


               -  


               -  


     (1,770)

Intangible amortisation*


     (5,763)


       (3,186)


          (39)


          (10)


     (8,998)

Segment result


     98,459


       45,431


     17,085


     (2,379)


   158,596












Adjusted Unallocated corporate expenses








   (29,012)

Exceptional items :











 - Acquisition related expenses










   (10,896)

Unallocated corporate expenses










   (39,908)

Operating profit










   118,688

Results from associated companies










     (1,164)

Finance income










          468

Finance expense










   (23,368)

Other expenses (net)










        (732)

Profit before tax










     93,892

Tax










   (10,423)

Profit for the period










     83,469

Attributable to:











Non-controlling interest










       3,362

Equity holders of the parent










     80,107











     83,469

 

 

Segment result is defined as operating profit for each segment.

 

 

*Intangible amortisation comprises the amortisation of intangible assets other than software.

 

"Others" mainly comprise Arab Medical Containers Ltd, International Pharmaceutical Research Center Ltd and the chemicals division of Hikma Pharmaceuticals Ltd (Jordan).

Unallocated corporate expenses are primarily made up of employee costs, office costs, professional fees, donations, travel expenses and acquisition related expenses.

 

 

31 December 2011 (Audited)













Branded


Injectables


Generics


Corporate and Others


Group



$000


$000


$000


$000


$000

Additions to property, plant and equipment (cost)


      44,869


       11,926


      12,925


           975


      70,695

Acquisition of subsidaries' property, plant and equipment (net book value)


      24,125


       50,071


               -  


                -  


      74,196

Additions to intangible assets


        5,054


         2,520


        1,106


           287


        8,967

Intangible assets arising on acquisition


    110,900


       40,324


               -  


                -  


    151,224

Total property, plant and equipment and intangible assets (net book value)


    527,240


     244,725


      50,759


        7,437


    830,161

Depreciation


      18,205


       10,521


        6,250


           684


      35,660

Amortisation (including software)


        7,064


         3,748


           307


          224


      11,343

Interest in associated companies


               -  


                -  


               -  


      37,445


      37,445

Balance sheet











Total assets


    958,709


     389,819


    168,526


      58,588


 1,575,642

Total liabilities


    490,523


     197,271


      31,514


      57,700


    777,008

 

 

The following table provides an analysis of the Group's sales by geographical market, irrespective of the origin of the goods/services:

 

 

 











H1 2012


H1 2011


FY 2011


$000


$000


$000


(Unaudited)


(Unaudited)


(Audited)

Middle East and North Africa


          229,849


     508,776

United States


          120,013


     317,334

Europe and Rest of the World


            43,922


       87,622

United Kingdom


                 975


         4,293


            532,260


            394,759


       918,025

 

 

 

       

Included in revenues arising from the Branded and Injectables segments are revenues of approximately        $54,365,000 (30 June 2011: $43,301,000 and 31 December 2011: $101,900,000) which arose from the Group's largest customer which is located in Saudi Arabia.

 

 

4.   Exceptional items and intangible amortisation

 

Exceptional items are defined as those items that are material in nature or amount and are non-recurring; those are disclosed separately in the condensed consolidated income statementto assist in the understanding of the Group's underlying performance.










H1 2012


H1 2011


FY 2011



$000


$000


$000

Acquisition related expenses


              -  


   (5,455)


   (10,896)

Integration related expenses


      (601)


              -  


     (5,472)



      (601)


   (5,455)


   (16,368)

Inventory related adjustments


              -  


   (1,203)


     (1,770)

Exceptional items


      (601)


   (6,658)


   (18,138)

Intangible amortisation*


   (6,385)


   (4,014)


     (8,998)

Exceptional items and intangible amortisation


   (6,986)


 (10,672)


   (27,136)

Tax effect


      1,395


      3,055


       6,374

Impact on profit for the period/ year


   (5,591)


   (7,617)


   (20,762)

 

 

 

*Intangible amortisation comprises the amortisation of intangible assets other than software.

During the period, the Group incurred $0.6 million in integrating Promopharm and Savanna in the Group.

In the previous year, acquisition and integration-related expenses are costs incurred in acquiring the Multi-Source Injectables business ("MSI"), Promopharm, and Savanna. Acquisition-related expenses are included in the unallocated corporate expenses while integration-related expenses are included in segment results.

Acquisition-related expenses mainly comprise third party consulting services, legal and professional fees.

$1.5 million (30 June 2011: $3.9 million and 31 December 2011: $10.1 million) of costs have been classified as investing activities in the cash flow statement relating to the cash outflow in respect of these costs in the period.

The inventory-related adjustments in previous year reflect the fair value uplift of the inventory acquired as part of the MSI acquisition.

 

5. Tax                                                                                                                                                                   



H1 2012


H1 2011


FY 2011



$000


$000


$000



(Unaudited)


(Unaudited)


(Audited)

Current tax:







    Foreign tax


         14,969


           4,423


      15,541

    Prior year adjustments


              397


              450


     (1,358)

Deferred tax


            (390)


            (118)


     (3,760)



         14,976


           4,755


      10,423

 

 

6. Dividends                                                                                                                                                              

            



H1 2012


H1 2011


FY 2011



$000


$000


$000



(Unaudited)


(Unaudited)


(Audited)

Amounts recognised as distributions to equity holders in the period:







Final dividend for the year ended 31 December 2011 of 7.5 cents (2010: 7.5 cents) per share


       14,746


       14,497


   14,497

Interim dividend for the year ended 31 December 2011 of 5.5 cents per share


                -  


                -  


   10,704



       14,746


       14,497


   25,201

                                                                                                                                                       

The proposed interim dividend for the period ended 30 June 2012 is 6.0 cents (30 June 2011: 5.5 cents) per share.

 

 

7.         Earnings per share

Earnings per share is calculated by dividing the profit attributable to equity holders of the parent by the weighted average number of ordinary shares. The number of ordinary shares used for the basic and diluted calculations are shown in the table below. Adjusted basic earnings per share and adjusted diluted earnings per share are intended to highlight the adjusted results of the Group before exceptional items and intangible amortisation*. A reconciliation of the basic and adjusted earnings used is also set out below:

 

 

 



H1 2012


H1 2011


FY 2011



$000


$000


$000



(Unaudited)


(Unaudited)


(Audited)

Earnings for the purposes of basic and diluted earnings per share being net profit attributable to equity holders of the parent


          40,400


         33,125


      80,107

Exceptional items


               601


           6,658


      18,138

Intangible amortisation*


            6,385


           4,014


        8,998

Tax effect of adjustments


         (1,395)


         (3,055)


      (6,374)

Adjusted earnings for the purposes of adjusted basic and diluted earnings per share being adjusted net profit attributable to equity holders of the parent


          45,991


         40,742


    100,869



Number


Number


Number

Number of shares:


'000


'000


'000

Weighted average number of Ordinary Shares for the purposes of basic earnings per share


        195,954


       193,330


    194,135

Effect of dilutive potential Ordinary Shares :







Share-based awards


            1,819


           4,878


        3,633

Weighted average number of Ordinary Shares for the purposes of diluted earnings per share


        197,773


       198,208


    197,768



H1 2012


H1 2011


FY 2011



 Earnings per share


Earnings

per share


Earnings per share



Cents


Cents


Cents

Basic


              20.6


             17.1


          41.3

Diluted


              20.4


             16.7


          40.5

Adjusted basic


              23.5


             21.1


          52.0

Adjusted diluted


              23.3


             20.6


          51.0

 

 

 

*Intangible amortisation comprises the amortisation of intangible assets other than software.

 

 

8. Intangible assets


Goodwill


                   Marketing rights     


 Customer relationships


Product related intangibles    


In process R&D


Trade names


Other acquisition related intangibles


Software


Total


$000


$000


$000


$000


$000


$000


$000


$000


$000

Cost


















Balance at 1 January 2011

  177,685


      8,352


       62,737


        25,391


     4,318


   6,949


        2,982


   14,014


  302,428

Additions

               -  


            521


                    -  


             6,170


              -  


            -  


                  -  


         488


        7,179

Acquisition of subsidiaries

        5,804


                -  


                    -  


           12,195


              -  


            -  


                61


             -  


      18,060

Disposals

               -  


                -  


                    -  


               (50)


              -  


            -  


                  -  


             -  


           (50)

Translation adjustments

        3,243


            468


                694


                771


           11


        528


              244


         197


        6,156

Balance at 30 June 2011

  186,732


       9,341


       63,431


       44,477


    4,329


   7,477


        3,287


  14,699


  333,773

Balance at 1 January 2011

  177,685


      8,352


       62,737


        25,391


     4,318


   6,949


        2,982


   14,014


  302,428

Additions

               -  


         1,155


                    -  


             6,831


              -  


            -  


                  -  


         981


        8,967

Acquisition of subsidiaries

      99,311


                -  


           17,216


          30,275


              -  


     4,286


                73


           63


    151,224

Disposals

               -  


                -  


                    -  


             (100)


              -  


            -  


                  -  


             -  


         (100)

Translation adjustments

     (6,983)


         (197)


          (1,259)


             (715)


        (51)


     (268)


             (65)


      (179)


      (9,717)

Balance at 31 December 2011

  270,013


       9,310


       78,694


        61,682


    4,267


  10,967


        2,990


  14,879


  452,802

Additions

               -  


            316


                    -  


           22,288


              -  


            -  


                  -  


      8,534


      31,138

Adjustments*

           606


                -  


                    -  


                    -  


              -  


            -  


                  -  


             -  


           606

Transfers

               -  


                -  


                    -  


                686


      (686)


            -  


                  -  


             -  


                -  

Disposals

          (31)


                -  


                    -  


             (150)


              -  


            -  


                  -  


             -  


         (181)

Translation adjustments

     (4,797)


         (196)


             (370)


             (813)


        (31)


       (73)


           (113)


      (145)


      (6,538)

Balance at 30 June 2012

  265,791


      9,430


       78,324


       83,693


    3,550


  10,894


        2,877


  23,268


  477,827

Amortisation


















Balance at 1 January 2011

       (608)


     (3,094)


      (14,079)


       (5,597)


      (912)


     (127)


         (919)


  (7,972)


  (33,308)

Charge for the period

               -  


         (440)


          (2,118)


          (1,161)


      (140)


       (57)


             (98)


   (1,162)


      (5,176)

Translation adjustments

               -  


         (135)


                  39


             (182)


        (24)


         (5)


             (59)


      (119)


         (485)

Balance at 30 June 2011

       (608)


     (3,669)


      (16,158)


       (6,940)


   (1,076)


     (189)


       (1,076)


  (9,253)


  (38,969)

Balance at 1 January 2011

       (608)


     (3,094)


      (14,079)


       (5,597)


      (912)


     (127)


         (919)


  (7,972)


  (33,308)

Charge for the year

               -  


      (1,033)


          (4,488)


          (2,768)


      (279)


     (228)


           (202)


   (2,345)


    (11,343)

Translation adjustments

               -  


           100



                139


           30


          12


                29


         117


           653

Balance at 31 December 2011

       (608)


     (4,027)


      (18,341)


       (8,226)


   (1,161)


     (343)


       (1,092)


 (10,200)


  (43,998)

Charge for the period

               -  


         (436)


          (2,635)


          (2,819)


      (117)


     (276)


           (102)


   (1,230)


      (7,615)

Transfers

               -  


                -  


                    -  


             (207)


         207


            -  


                  -  


             -  


                -  

Translation adjustments

               -  


              85


                  42


                180


           29


          12


                38


           84


           470

Balance at 30 June 2012

       (608)


     (4,378)


     (20,934)


       (11,072)


   (1,042)


     (607)


       (1,156)


 (11,346)


   (51,143)

Carrying amount


















At 30 June 2012

  265,183


      5,052


       57,390


        72,621


    2,508


  10,287


         1,721


   11,922


  426,684

At 31 December 2011

  269,405


      5,283


       60,353


       53,456


     3,106


  10,624


        1,898


    4,679


  408,804

At 30 June 2011

   186,124


      5,672


       47,273


       37,537


    3,253


   7,288


         2,211


    5,446


  294,804

 

The current period additions within product related intangible relate to licenses for products with an indefinite useful life. The software additions relate to the Group's ongoing SAP implementation.

*An adjustment of $0.6 million has been made to the provisional goodwill recognised on the acquisition of MSI. The measurement period for MSI closed on 2 May 2012.

  

 

9.      Inventories



30 June 2012


30 June 2011


31 December 2011



$000


$000


$000



(Unaudited)


(Unaudited)


(Audited)

Finished goods


          84,129


         85,670


      77,862

Work-in-progress


          41,097


          33,329


      28,039

Raw and packing materials


        130,952


        136,561


    114,449

Goods in transit


          15,684


          13,930


      18,910



        271,862


        269,490


    239,260

 

 

 

Goods in transit include inventory held at third parties whilst in transit between Group companies.

 

10.      Trade and other receivables

 

 


30 June 2012


30 June 2011


31 December 2011


$000


$000


$000


(Unaudited)


(Unaudited)


(Audited)

Trade receivables*

     314,999


     253,200


    292,100

Prepayments

       19,984


       24,239


      16,015

Value added tax recoverable

         5,968


         6,656


        5,188

Interest receivable

             433


             701


           490

Employee advances

         2,565


         2,369


        2,063


         343,949


         287,165


      315,856

 

*See note 2.

 

11.      Trade and other payables


30 June 2012


30 June 2011


31 December 2011


$000


$000


$000


(Unaudited)


(Unaudited)


(Audited)

Trade payables

     108,626


     102,341


      97,756

Accrued expenses

       52,176


       31,973


      60,276

Employees' provident fund *

         4,779


         3,072


        4,181

VAT and sales tax payables

         1,291


             845


           535

Dividends payable **

         2,525


         2,228


        2,207

Social security withholdings

         1,587


         1,230


        1,107

Income tax withholdings

         2,492


         2,456


        2,482

Other payables

         1,738


         2,602


        2,554


         175,214


         146,747


      171,098

 

 

 

 

* The employees' provident fund liability represents outstanding contributions to the Hikma Pharmaceuticals Ltd (Jordan) retirement benefit plan, on which the fund receives 5% interest.

 

** Dividends payable includes $2,009,000 (30 June 2011: $2,045,000 and 31 December 2011: $2,022,000) due to the previous shareholders of Arab Pharmaceutical Manufacturing.

 

 

 12.      Long-term financial debts







 


30 June 2012


30 June

2011


31 December 2011


$000


$000


$000


(Unaudited)


(Unaudited)


(Audited)

Long-term loans

       474,978


              285,809


     410,197

Less: current portion of loans

       (81,136)


             (53,810)


    (65,302)

Long-term financial loans

       393,842


              231,999


     344,895

Breakdown by maturity:






Within one year

         81,136


                53,810


       65,302

In the second year

         80,976


                70,930


       84,488

In the third year

         75,569


                45,271


       63,732

In the fourth year

         83,127


                54,454


       65,490

In the fifth year

         53,369


                49,987


       58,069

Thereafter

       100,801


                11,357


       73,116


       474,978


              285,809


     410,197

13.        Net cash from operating activities

                             


Notes


H1
2012


H1
2011


FY
2011




$000 (Unaudited)


$000 (Unaudited)


$000 (Audited)

Profit before tax



         57,844


          39,867


      93,892

       Adjustments for:








       Depreciation, amortisation of:








                 Property, plant and equipment



         21,085


          16,240


      35,660

                 Intangible assets



           7,615


            5,176


      11,343

Loss on disposal of property, plant and equipment



                93


                 17


             22

Losses/(Gain) on disposal of intangible assets



                38


              (17)


          (91)

Movement on provisions



           1,109


               535


           757

Movement on deferred income



              (37)


              (16)


          (87)

Cost of equity-settled employee share schemes



           3,675


            3,634


        7,507

Payments of costs directly attributable to acquisitions


4

           1,519


            3,892


      10,147

Finance income



            (348)


            (154)


        (468)

Interest and bank charges



         17,033


            9,484


     23,368

Results from associates



                50


                    -  


        1,164

Cash flow before working capital



      109,676


          78,658


   183,214

Change in trade and other receivables



      (30,799)


       (35,947)


   (59,898)

Change in other current assets



           2,610


         (1,775)


     (4,570)

Change in inventories



      (47,751)


       (31,145)


     (8,199)

Change in trade and other payables



         11,164


          15,486


      15,987

Change in other current liabilities



         16,427


         (1,220)


        1,958

Cash generated by operations



         61,327


          24,057


   128,492

       Income tax paid



      (14,256)


         (4,837)


     (2,095)

Net cash generated from operating activities



         47,071


          19,220


   126,397

 

14.        Foreign exchange rates


Period end rates


Average rates


30 June 2012


30 June 2011


31 December 2011


H1 2012


H1 2011


FY 2011

























USD/EUR

0.7950


0.6949


0.7722


0.7704


0.7127


0.7180

USD/Sudanese Pound

5.3135


2.9000


2.8918


2.9727


3.0746


2.9869

USD/Algerian Dinar

78.8770


71.7025


76.0061


75.4000


72.3008


72.8147

USD/Saudi Riyal

3.7495


3.7495


3.7495


3.7495


3.7495


3.7495

USD/British Pound

0.6403


0.6242


0.6470


0.6340


0.6186


0.6233

USD/Jordanian Dinar

0.7090


0.7090


0.7090


0.7090


0.7090


0.7090

USD/Egyptian Pound

6.0790


5.9869


6.0481


6.0533


5.9361


5.9648

USD/Japanese Yen

79.5406


80.9900


77.4136


79.7230


81.9398


79.7414

 USD/Moroccan Dirham

8.7514


8.7430


8.6133


8.8542


8.4910


8.3682

15.     Related party balances

Transactions between the Company and its subsidiaries have been eliminated on consolidation and are not disclosed in this note. Transactions between the Group and its associate and other related parties are disclosed below.

Trading transactions:

 During the period, Group companies entered into the following transactions with related parties:

Darhold Limited: is a related party of the Group because it is one of the major shareholders of Hikma Pharmaceuticals PLC with an ownership percentage of 29.0% at 30 June 2012 (30 June 2011: 29.3% and 31 December 2011: 29.2%).

Other than dividends (as paid to all shareholders), there were no transactions between the Group and Darhold Limited during the period.

Capital Bank - Jordan: is a related party of the Group because during the period two board members of the Bank were also board members of Hikma Pharmaceuticals PLC. Total cash balances at Capital Bank - Jordan were  $2,991,000 (30 June 2011: $462,000 and 31 December 2011: $610,000). Loans and overdrafts granted by Capital Bank to the Group amounted to $8,448,000 (30 June 2011: $372,000 and 31 December 2011: $3,841,000) with interest rates ranging between 9 % and 3 month LIBOR + 1%. Total interest expense incurred against Group facilities was $165,000 (H1 2011: $9,000 and FY 2011: $7,000). No interest income was received in any period and total commission paid in the period was $38,000 (H1 2011: $16,000 and 2011: $8,000).

Jordan International Insurance Company: is a related party of the Group because one board member of the insurance company is also a board member of Hikma Pharmaceuticals PLC. Total insurance premiums paid by the Group to Jordan International Insurance Co during the period were $1,797,000 (H1 2011: $2,329,000 and FY 2011: $3,035,000). The Group's insurance expense for Jordan International Insurance Co contracts in the period was $2,715,000 (H1 2011: $1,953,000 and FY 2011: $2,902,000). The amounts due to Jordan International Insurance Co at 30 June 2012 were $577,000 (30 June 2011: $272,000 and 31 December 2011: Due from $109,000).

Mr. Yousef Abd Ali: Mr. Yousef Abd Ali is a related party of the Group because he holds 33% of Hikma Liban SARL in Lebanon. The amount owed to Mr. Yousef by the Group as at 30 June 2012 was $150,000 (30 June 2011: $161,000 and 31 December 2011: $150,000).

Labatec Pharma SA: is a related party of the Group because it is owned by Mr. Samih Darwazah.

The Group sells to Labatec Pharma and purchases from Labatec Pharma certain products for resale which gives both companies access to additional markets. During the period to 30 June 2012 the Group's total sales to Labatec Pharma amounted to $215,000 (H1 2011: Nil and FY 2011: $338,000) and the Group total purchases from Labatec Pharma amounted to $1,396,000 (H1 2011: $1,177,000 and FY 2011: $3,805,000). At 30 June 2012 the amount owed to Labatec Pharma from the Group was $892,000 (30 June 2011: $1,269,000 and 31 December 2011: $753,000).

King and Spalding: is a related party of the Group because a partner of the firm is a board member and company secretary of West-Ward Pharmaceutical Corp. King and Spalding is an outside legal counsel firm that handles general legal matters for West-Ward. During the period to June 2012 fees of $45,000 (H1 2011: $951,000 and FY 2011: $1,216,000) were paid for legal services provided.

 

Principal risks and uncertainties

 

The Group's business faces risks and uncertainties which could have a significant effect on its financial condition, results of operation or performance over the remaining six months of the financial year and could cause actual results to differ materially from expected and historical results.

 

Operational risks

 

Risk

Potential impact

Mitigation

Compliance with regulatory requirements



>      Failure to comply with applicable regulatory requirements and manufacturing standards (often referred to as 'Current Good Manufacturing Practices' or cGMP)

>      Delays in supply or an inability to market or develop the Group's products

>      Delayed or denied approvals for the introduction of new products

>      Product complaints or recalls

>      Bans on product sales or importation

>      Disruptions to operations

>      Potential for litigation

 

>      Commitment to maintain the highest levels of quality across all manufacturing facilities

>      Strong global compliance function that oversees compliance across the Group

>      Remuneration and reward structure that helps retain experienced personnel

>      Continuous staff training and know-how exchange

>      On-going development of standard operating procedures

Regulation changes



>      Unanticipated legislative and regulatory actions, developments and changes affecting the Group's operations and products

>      Restrictions on the sale of one or more of our products 

>      Restrictions on our ability to sell our products at a profit

>      Unexpected additional costs required to produce, market or sell our products

>      Increased compliance costs

 

>      Strong oversight of local regulatory environments to help anticipate potential changes

>      Local operations in all of our key markets

>      Representation and/or affiliation with local industry bodies

>      Diverse geographical and therapeutic business model

Commercialisation of new products



>      Delays in the receipt of marketing approvals, the authorisation of price and re-imbursement

>      Lack of approval and acceptance  of new products by physicians, patients and other key decision-makers

>      Inability to confirm safety, efficacy, convenience and/or  cost-effectiveness of our products as compared to competitive products

>      Inability to participate in tender sales

>      Slowdown in revenue growth from new products

>      Inability to deliver a positive return on investments in R&D, manufacturing and sales and marketing

 

>      Experienced regulatory teams able to accelerate submission  processes across all of our markets

>      Highly qualified sales and marketing teams across all markets

>      A diversified product pipeline with 229 compounds pending approval, covering a broad range of therapeutic areas

>      A systematic commitment to quality that helps to secure approval and acceptance of new products and mitigate potential safety issues

Product safety



>      Unforeseen product safety issues for marketed products, particularly in respect of in-licensed products

>      Interruptions to revenue flow

>      Costs of recall, potential for litigation

>      Reputational damage

>      Diversification of product portfolio across key markets and therapies

>      Working with stakeholders to understand issues as they arise

 

 

Product development



>      Failure to secure new products or compounds for development

>      Inability to grow sales and increase profitability for the Group

>      Lower return on investment in research and development

 

>      Experienced and successful in-house R&D team, with specifically targeted product development pathways

>      Continually developing  and multi-faceted approach to new product development

>      Strong business development team

>      Track record of building in-licensed brands

>      Position as licensee of choice for our key MENA geography

Co-operation with Third parties



>      Inability to renew or extend in-licensing or other co-operation  agreements  with third parties

>      Loss of products from our portfolio

>      Revenue interruptions

>      Failure to recoup sales and marketing and business development costs

 

 

>      Investment in long-term relationships with existing in-licensing partners

>      Experienced legal team capable of negotiating robust agreements with our partners

>      Continuous development of new partners for licensing and co-operation

>      Diverse revenue model with in-house R&D capabilities

Increased competition



>      New market entrants in key geographies

>      On-going pricing pressure in increasingly commoditised markets

 

>      Loss of market share

>      Decreasing revenues on established portfolio

 

>      On-going portfolio diversification, differentiation and renewal through internal R&D, in-licensing and product acquisition

>      Continuing focus on expansion of geographies and therapeutic areas

Disruptions in the manufacturing supply chain



>      Inability to procure active ingredients from approved sources

>      Inability to procure active ingredients on commercially viable terms

>      Inability to procure the quantities of active ingredients  needed to meet market requirements

>      Inability to develop and/or commercialise new products

>      Inability to market existing products as planned

>      Lost  revenue streams on short notice

>      Reduced service levels and damage to customer relationships

>      Inability to supply finished product to our customers in a timely fashion

 

 

 

>      Alternate approved suppliers of  active ingredients

>      Long-term relationships with reliable raw material suppliers

>      Corporate auditing team continuously monitors regulatory compliance of API suppliers

>      Focus on improving service levels and optimising our supply chain

Economic and political and unforeseen events



>      The failure of control, a change in the economic conditions (including the Eurozone), political environment or sustained civil unrest in any particular market or country

>      Unforeseen events such as fire or flooding could cause disruptions to manufacturing or supply

>      Disruptions to manufacturing and marketing plans

>      Lost revenue streams

>      Inability to market or supply products

>      Geographic diversification, with 25 manufacturing facilities and sales in more than 40 countries

>      Product diversification, with 688 products and 1,696 dosage strengths and forms

 

Litigation



>      Commercial, product liability and other claims brought against the Group

>      Financial impact on Group results from adverse resolution of proceedings

>      Reputational damage

>      In-house legal counsel with relevant jurisdictional experience

 

 

Financial risks

 

Risk

Impact

Mitigation

Foreign exchange risk



>      Exposure to foreign exchange movements, primarily in the European, Algerian, Sudanese and Egyptian currencies

>      Fluctuations in the Group's net asset values and profits upon translation into US dollars

>      Entering into currency derivative contracts where possible

>      Foreign currency borrowing

>      Matching foreign currency revenues to in-jurisdiction costs 

Interest rate risk



>      Volatility in interest rates

>      Fluctuating impact on profits before taxation

>      Optimisation of fixed and variable rate debt as a proportion of our total debt

>      Use of interest rate swap agreements

Credit Risk



>      Inability to recover trade receivables

>      Concentration of significant trade balances with key customers in the MENA region and the US

 

>      Reduced working capital funds

>      Risk of bad debt or default

>      Clear credit terms for settlement of sales invoices

>      Group Credit policy limiting credit exposures

>      Use of various financial instruments such as letters of credit, factoring and credit insurance arrangements

Liquidity Risk



>      Insufficient free cash flow and borrowings headroom

>      Reduced liquidity and working capital funds

>      Inability to meet short-term working capital needs and, therefore, to execute our long term strategic plans

>      Continual evaluation of headroom and borrowing

>      Committed debt facilities

>      Diversity of institution, subsidiary and geography of borrowings

 

 

Tax



>      Changes to tax laws and regulations in any of the markets in which we operate

>      Negative impact on the Group's effective tax rate

>      Costly compliance requirements

>      Close observation of any intended or proposed changes to tax rules, both in the UK and in other key countries where the Group operates

 

 

 

 

 

 

           

 


This information is provided by RNS
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