Hikma Pharmaceuticals Regulatory News (HIK)

London, 15 August 2018 - Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable), the multinational generic pharmaceutical company, today reports its interim results for the six months ended 30 June 2018.

· Group revenue of $989 million, up 11% and in constant currency up 10%1

· Operating profit of $174 million, up 54%

· Core2 Group operating profit of $214 million, up 22% and up 23% in constant currency

· Core basic earnings per share of 61.4 cents, up 35% and up 38% in constant currency 

· Basic earnings per share of 44.0 cents, up 53% and up 57% in constant currency

· Cashflow from operations of $185 million

· Net debt reduced to $501 million (31 Dec 2017: $546 million) and healthy leverage ratios maintained

· Interim dividend of 12 cents per share, up from 11 cents per share

· Guidance raised for Injectables and Generics businesses and reiterated for Branded business

Siggi Olafsson, Chief Executive Officer of Hikma, said:

"I am pleased with our first half performance, with each of our three business segments achieving revenue and, importantly, profit growth.

Our Injectables business continues to demonstrate resilience. Our broad portfolio, extensive manufacturing capabilities and geographic footprint are enabling us to respond quickly to changing market dynamics and grow our market share. In our Generics business, we are successfully driving demand for our more differentiated in-market products and are making progress reducing our cost base. We achieved good results in the Branded business, taking into consideration the usual seasonality.

In the first half, we renewed our focus on advancing our pipeline, enhancing our corporate R&D team and accelerating new projects. More broadly, we are strengthening key functions across the Group and bringing new capabilities to ensure we have the right teams in place to take the business forward.

Our performance in the first half exceeded our expectations and we are pleased to be able to raise our guidance for both our Injectables and Generics businesses for the full year.

The measures we have taken and investments we have made across the Group over the past year are delivering results, but we still have work to do. Our markets are competitive and we don't expect the same demand for some of our injectable products to continue into 2019. This means we must remain focused on strengthening our customer relationships, improving profitability and advancing our pipeline to ensure future growth."

Summary financials

Enquiries

Hikma Pharmaceuticals PLC

FTI Consulting

About Hikma

Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. We're a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner in the MENA region, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit www.hikma.com.

A presentation for analysts and investors will be held today at 09:30 UK time at FTI Consulting, 200 Aldersgate, Aldersgate Street, London EC1A 4HD. To join via conference call please dial: +44 (0) 20 3936 2999 or 020 3936 2999 (UK toll free), password 911652. Alternatively, the results presentation and a webcast recording of the event will be available on the Company's website at www.hikma.com or http://webcast.openbriefing.com/hikma_interim_results_2018/. The contents of the website do not form part of this interim results announcement.

Business and financial review

The business and financial review set out below summarises the performance of Hikma's three main business segments, Injectables, Generics and Branded, for the six months ended 30 June 2018.

Group revenue by business segment

Group reported revenue by region

Injectables

In H1 2018, global Injectables revenue increased by 14% to $414 million. In constant currency, global Injectables revenue was up 13%.

Of this total, US Injectables revenue was $312 million, up 10% (H1 2017: $283 million). As expected, revenue from top products declined in the first half as competition continued to accelerate. This was more than offset by strong demand for our other in-market products and recent product launches. In the first half, US hospitals faced a critical shortage of certain pain management products when a significant supplier to the US market temporarily ceased manufacturing. In response to this shortage, we leveraged the scale and flexibility of our operations to prioritise the manufacturing of affected products. It is not clear how long these shortages will persist and we don't expect to see the same level of demand continue into 2019.

MENA Injectables revenue was $51 million in H1 2018, up 46% (H1 2017: $35 million). In constant currency, MENA Injectables revenue increased by 49%, reflecting a strong performance in Saudi Arabia, our largest market, and a significant increase in sales for our biosimilar product, Remsima®, which we have now launched in six markets.

European Injectables revenue was $51 million in H1 2018, up 16% (H1 2017: $44 million). Before the appreciation of the euro against the US dollar, European Injectables revenue increased by 3%, reflecting the contribution from recently acquired products.

Injectables gross profit increased to $260 million in H1 2018 (H1 2017: $228 million). Gross margin remained relatively stable at 62.8% (H1 2017: 63.0%). A decline in gross margin in the US, due to the change in product mix, was mostly offset by strong margin improvement in Europe and MENA, reflecting the appreciation of the euro and an improving product mix, respectively.

Core operating profit, which excludes the amortisation of intangible assets other than software and exceptional items of $13 million, was $173 million in H1 2018 (H1 2017: $144 million). Core operating margin increased to 41.8% (H1 2017: 39.8%), reflecting a continued focus on efficient operations, which more than offset additional costs associated with strengthening the management team in the US.

During H1 2018, the Injectables business launched nine products in the US, 16 in MENA and 17 in Europe. We submitted 38 filings to regulatory authorities across all markets.

In H1 2018, we signed a licensing agreement with Laboratorios Farmaceúticos Rovi SA (Rovi) for their enoxaparin. Under the terms of the agreement, we have the exclusive rights to distribute and market enoxaparin across our MENA markets.

We now expect full year Injectables revenue to be in the range of $775 million to $825 million and core operating margin for the full year to be in the mid to high 30s. This assumes core operating margin normalises in the second half.

Generics

While the US generics market remains competitive, we are gradually seeing the benefits of the commercial and operational improvements we have rolled-out over the past year. In the first half, Generics revenue was up 11% to $338 million (H1 2017: $305 million), as price erosion was offset by increased demand for our more differentiated in-market products and new product launches.

Generics gross profit was $123 million in H1 2018 (H1 2017: $119 million). Excluding the impact of severance costs associated with the previously announced restructuring of our Columbus manufacturing facility and closure of our Eatontown manufacturing facility, core gross profit was $128 million (H1 2017: $121 million). Gross margin was 36.3% (H1 2017: 39.0%), and core gross margin decreased to 37.9% (H1 2017: 39.7%), reflecting price erosion and a change in product mix. We expect gross margin to improve in the second half, in part due to cost savings related to the consolidation of our manufacturing and distribution facilities.

Core Generics operating profit, which excludes the amortisation of intangible assets other than software and exceptional items of $24 million, increased to $30 million in H1 2018 (H1 2017: $21 million). This primarily reflects the increase in gross profit and a reduction in research and development (R&D) expenses, partially offset by an increase in product-related legal expenses. The reduction in R&D expenses was due to the timing of projects and we expect a step-up in spending in the second half of the year. Core operating margin was 8.8% (H1 2017: 6.9%).

During H1 2018, the Generics business launched three products, including ritonavir, the first AB-rated generic to Norvir® tablets, and methylergonovine maleate tablets, through a partnership with Granules Pharmaceuticals Incorporated. The Generics business also submitted six filings to regulatory authorities.

We initiated a repeat clinical endpoint study for generic Advair Diskus® during H1 20184. The study is proceeding as planned and we expect to submit a response to the FDA with the new clinical data as early as possible in 2019.

We now expect Generics full year revenue to be in the range of $600 million to $650 million and core operating margin to be in the mid to high single digits.

Branded

On a reported basis, Branded revenue was $232 million, up 4% (H1 2017: $223 million). On a constant currency basis, Branded revenue increased 5% to $234 million.

In our largest market, the GCC, which includes Saudi Arabia and the UAE, our businesses delivered a good performance, with revenue up 7%. In Egypt, our second largest market, revenue grew 31% in constant currency due to strong underlying market growth, an improvement in our product mix and new product launches. In Algeria, our third largest market, revenue decreased 14% in constant currency, as we temporarily closed one of our general formulation facilities for upgrades. We expect sales to improve in Algeria in the second half of the year as capacity comes back on line. Revenue from in-licensed products represented 38% of Branded revenue (H1 2017: 40%).

During H1 2018, the Branded business launched 36 products and submitted 59 filings to regulatory authorities.

Branded gross profit was $116 million, up 10% and gross margin was 50.0% (H1 2017: 47.1%). In constant currency, gross profit increased by 11% and gross margin increased to 50.1% (H1 2017: 47.2%) due to growth in sales and an allowance from a supplier to compensate for changing market dynamics.

Core operating profit, which excludes the amortisation of intangibles of $3 million, was $45 million, up 10% (H1 2017: $41 million), and core operating margin was 19.4%. In constant currency, core operating profit grew 10% and core operating margin increased to 19.4%, up 100 basis points. This improvement in profitability reflects the increase in gross profit, partially offset by an expected increase in sales and marketing expenses.

In H1 2018, we entered into a new partnership agreement with Omega Pharma Trading NV, an affiliate of Perrigo Company PLC (Perrigo), one of the largest providers of over-the-counter (OTC) healthcare solutions in Europe. Under the terms of the agreement, we have the exclusive right to license and distribute more than 30 consumer healthcare products across the MENA, with the exception of current agreements in place. In addition, we have the right of first refusal to the full range of Perrigo's OTC medicines in the region.

In line with the usual seasonality, we expect Branded revenues to be higher in the second half of the year and we continue to expect full year Branded revenue growth in constant currency to be in the mid-single digits as we benefit from new launches of our branded generics and in-licensed products.

Other businesses

Other businesses, which is primarily comprised of Arab Medical Containers, a manufacturer of plastic specialised medicinal sterile containers, and International Pharmaceuticals Research Centre, which conducts bio-equivalency studies, contributed revenue of $5 million in H1 2018 (H1 2017: $5 million). These other businesses made an operating loss of $1 million (H1 2017: $(1) million).

Group

Group revenue was $989 million in H1 2018 (H1 2017: $895 million). Group gross profit was $500 million (H1 2017: $454 million). Excluding exceptional items related to severance costs in the US of $5 million, core gross profit was $505 million (H1 2017: $456 million). Group gross margin was 50.6% and core gross margin was 51.1% (H1 2017: 50.9%).

Group operating expenses decreased by 4% to $326 million. Excluding $15 million related to the amortisation of intangible assets other than software (H1 2017: $24 million) and exceptional items of $20 million (H1 2017: $37 million), core Group operating expenses were $291 million (H1 2017: $280 million). The paragraphs below address the Group's main operating expenses in turn.

Sales and marketing (S&M) expenses were $120 million (H1 2017: $117 million). Excluding the amortisation of intangible assets other than software and severance costs, core S&M expenses were $104 million, up 13% due to investment in our Branded and Injectable S&M teams.

General and administrative (G&A) expenses increased 7% to $115 million in H1 2018 (H1 2017: $107 million), reflecting an increase in product-related legal expenses in our Generics business and higher corporate G&A expenses.

R&D expenses were $63 million in H1 2018 (H1 2017: $63 million). This included $15 million of exceptional items related to the repeat clinical endpoint study for generic Advair Diskus®.5 Excluding exceptional items, core R&D expenses were $47 million, down from $60 million. This primarily reflects a reduction in R&D expenditure in our Generics business following a detailed review of our R&D pipeline in H2 2017, which reprioritised high-value products and identified opportunities for cost savings and efficiencies. We expect investment in R&D will increase in the second half.

The combined core R&D expense and product-related investment was 5% of Group revenue6 compared with 7% of Group revenue in H1 2017.

Other net operating expenses were $28 million in H1 2018 (H1 2017: $54 million). Excluding exceptional items of $3 million, core other net operating expenses were $25 million (H1 2017: $22 million).

The Group reported operating profit of $174 million in H1 2018 (H1 2017: $113 million). Excluding the impact of amortisation other than software and exceptional items, core Group operating profit increased by 22% to $214 million and core operating margin was 21.6% (H1 2017:19.7%), reflecting the strong performance across our business segments.

Unallocated corporate expenses increased to $33 million in H1 2018 (H1 2017: $29 million), as we strengthened our corporate functions and launched our refreshed brand. We expect corporate expenses to increase in the second half, reflecting further investment in the development of corporate functions, specific groupwide projects and higher employee benefits.

Research and development

The Group's product portfolio continues to grow due to our product development efforts. During H1 2018, we had 81 new launches and received 60 approvals.

To ensure the continuous development of our product pipeline, we submitted 103 regulatory filings.

Net finance expense

Core net finance expense was down 14% to $24 million (H1 2017: $28 million), due to lower borrowings. For the full year, we expect Group net finance expense to be around $55 million. Finance expense is expected to increase in the second half, reflecting our expectation of higher MENA sales and related factoring charges.

Profit before tax

The Group reported a profit before tax of $141 million in H1 2018 (H1 2017: $100 million). Core profit before tax was $189 million (H1 2017: $148 million).

Tax

The Group incurred a tax expense of $32 million (H1 2017: $30 million). Excluding the tax impact of exceptional items, core Group tax expense was $38 million in H1 2018 (H1 2017: $38 million). The core effective tax rate was 20.1% (H1 2017: 25.7%). The decrease in the effective tax rate is primarily due to the Tax Cuts and Jobs Act which was enacted in the US on 22 December 2017, reducing the statutory rate of US federal corporate income tax to 21%, and a release of provisions for various uncertain tax positions as the statute of limitations expired.

We continue to expect the core effective tax rate to be in the range of 21% to 22% in 2018.

Profit attributable to shareholders

Profit attributable to shareholders was $106 million, compared with profit of $69 million in H1 2017. Core profit attributable to shareholders increased by 36% to $148 million, compared with $109 million in H1 2017.

Earnings per share

Basic earnings per share was 44.0 cents (H1 2017: 28.8 cents). Core basic earnings per share increased by 35% to 61.4 cents (H1 2017: 45.4 cents). Core diluted earnings per share increased by 35% to 61.2 cents (H1 2017: 45.2 cents).

Dividend

The Board is recommending an interim dividend of 12 cents per share (approximately 9.4 pence per share) for H1 2018 (H1 2017: 11 cents per share). The interim dividend will be paid on 21 September 2018 to eligible shareholders on the register at the close of business on 24 August 2018. The ex-dividend date is 23 August 2018 and the final date for currency elections is 7 September 2018.

Net cash flow, working capital and net debt

The Group generated operating cash flow of $185 million in H1 2018 (H1 2017: $225 million), reflecting normalised levels of working capital. Group working capital days were down eight days to 222 days, primarily driven by an increase in payable days and the reduction in inventory days.

Capital expenditure was $53 million (H1 2017: $47 million). Of this, around $28 million was spent in the US to expand the manufacturing capacity and capabilities of our Generics and Injectables businesses. In the MENA region, around $16 million was spent on building a new dedicated oncology facility in Algeria and upgrading our facilities in Jordan and Algeria to manufacture new in-licensed products. Approximately $9 million was spent in Europe, expanding our manufacturing facilities in Portugal, which we expect to complete in the second half of the year. We continue to expect Group capital expenditure in the range of $120 million to $140 million in 2018.

The Group's net debt (excluding co-development agreements and contingent liabilities) stood at $501 million at the end of June 2018 (31 December 2017: $546 million).10 The reduction reflects the paydown of debt during H1 2018. We continue to have a very strong balance sheet with a net debt to core EBITDA ratio of 0.99.

Balance sheet

Net assets at 30 June 2018 were $1,542 million (31 December 2017: $1,528 million). Net current assets were $731 million (31 December 2017: $777 million).

Outlook

We now expect full year Injectables revenue to be in the range of $775 million to $825 million and core operating margin for the full year to be in the mid to high 30s. This assumes core operating margin normalises in the second half. Over the longer term, we expect our markets to remain competitive and we do not expect the same demand for some of our injectable products to continue into 2019.

We now expect Generics full year revenue to be in the range of $600 million to $650 million and core operating margin to be in the mid to high single digits.

In line with the usual seasonality, we expect Branded revenues to be higher in the second half of the year and we continue to expect full year Branded revenue growth in constant currency to be in the mid-single digits as we benefit from new launches of our branded generics and in-licensed products.

Statement of Directors' responsibilities

We confirm that to the best of our knowledge:

· the condensed set of financial statements has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union and as issued by the International Accounting Standards Board, and;

· the Interim Results Press Release includes a fair review of the information required by:

a) DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed set of financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and

b) DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the enterprise during that period; and any changes in the related party transactions described in the last annual report that could do so.

The Board

The Board of Directors that served during all or part of the six-month period to 30 June 2018 and their respective responsibilities can be found on the Leadership team section of www.hikma.com.

By order of the Board

Cautionary statement

This preliminary announcement has been prepared solely to provide additional information to the shareholders of Hikma and should not be relied on by any other party or for any other purpose.

Definitions

We use a number of non-IFRS measures to report and monitor the performance of our business. Management uses these adjusted numbers internally to measure our progress and for setting performance targets. We also present these numbers, alongside our reported results, to external audiences to help them understand the underlying performance of our business. Our core numbers may be calculated differently to other companies.

Adjusted measures are not substitutable for IFRS numbers and should not be considered superior to results presented in accordance with IFRS.

Core results

Reported results represent the Group's overall performance. However, these results can include one-off or non-cash items that mask the underlying performance of the Group. To provide a more complete picture of the Group's performance to external audiences, we provide, alongside our reported results, core results, which are a non-IFRS measure. Reconciliation between core and reported results is provided in the table below. Our core results exclude the exceptional items and other adjustments set out in Note 4.

Constant currency

As the majority of our business is conducted in the US, we present our results in US dollars. For both our Branded and Injectable businesses, a proportion of their sales are denominated in a currency other than the US dollar. In order to illustrate the underlying performance of these businesses, we include information on our results in constant currency.

Constant currency numbers in H1 2018 represent reported H1 2018 numbers re-stated using average exchange rates in H1 2017, excluding price increases in the business which resulted from the devaluation of currencies.

EBITDA

EBITDA is earnings before interest, tax, depreciation, amortisation and impairment charge.

Working capital days

We believe Group working capital days provides a useful measure of the Group's working capital management and liquidity. Group working capital days are calculated as Group receivable days plus Group inventory days, less Group payable days. Group receivable days are calculated as Group trade receivables x 365, divided by trailing 12 months Group revenue.

Group net debt

We believe Group net debt is a useful measure of the strength of the Group's financing position. Group net debt is calculated as Group total debt less Group total cash. Group total debt excludes co-development agreements and contingent liabilities.

Forward looking statements

This announcement contains certain statements which are, or may be deemed to be, "forward looking statements" which are prospective in nature with respect to Hikma's expectations and plans, strategy, management objectives, future developments and performance, costs, revenues and other trend information. All statements other than statements of historical fact may be forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of forward looking words such as "intends", "believes", "anticipates", "expects", "estimates", "forecasts", "targets", "aims", "budget", "scheduled" or words or terms of similar substance or the negative thereof, as well as variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved.

By their nature, forward looking statements are based on current expectations and projections about future events and are therefore subject to assumptions, risks and uncertainties that are beyond Hikma's ability to control or estimate precisely and which could cause actual results or events to differ materially from those expressed or implied by the forward looking statements. Where included, such statements have been made by or on behalf of Hikma in good faith based upon the knowledge and information available to the Directors on the date of this announcement. Accordingly, no assurance can be given that any particular expectation will be met and Hikma's shareholders are cautioned not to place undue reliance on the forward-looking statements. 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.

Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulation ((EU) No. 596/2014) and the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), Hikma does not undertake to update the forward looking statements contained in this announcement to reflect any changes in events, conditions or circumstances on which any such statement is based or to correct any inaccuracies which may become apparent in such forward looking statements. Except as expressly provided in this announcement, no forward looking or other statements have been reviewed by the auditors of Hikma. All subsequent oral or written forward looking statements attributable to the Hikma or any of its members, directors, officers or employees or any person acting on their behalf are expressly qualified in their entirety by the cautionary statement above. Past share performance cannot be relied on as a guide to future performance. Nothing in this announcement should be construed as a profit forecast.

Neither the content of Hikma's website nor any other website accessible by hyperlinks from Hikma's website are incorporated in, or form part of, this announcement.

Principal risks and uncertainties

The principal risks and uncertainties have not changed from 31 December 2017. It is not anticipated that the nature of the principal risks and uncertainties that affect the business, which are set out on pages 61 to 64 of the 2017 Annual Report, will change in respect to the second six months of the financial year. Further information on our key risk management and assurance process are set out on pages 59 to 60 of the 2017 Annual Report.

A summary of the principal risks and uncertainties listed in the 2017 Annual Report are set out below. Hikma continues to manage these risks in accordance with our risk appetite.

1. Industry earnings: the commercial viability of the industry and business model we operate may change significantly as a result of political action, economic factors, societal pressures, regulatory interventions or changes to participants in the value chain of the industry.

2. Product pipeline: identifying, developing and registering supply of new products from the pipeline that meet market needs to provide continuous source of future growth.

3. Organisational development: developing, maintaining and adapting organizational structures, management processes and controls, and talent pipeline to enable effective delivery by the business in the face of rapid and constant internal and external change.

4. Reputation: building and maintaining trusting and successful partnerships with our many stakeholders relies on developing and sustaining our reputation as one of our most valuable assets.

5. Ethics and compliance: maintaining a culture underpinned by ethical decision making, with appropriate internal controls to ensure staff and third parties comply with our Code of Conduct, associated principles and standards, as well as all applicable legislation.

6. Information, technology and infrastructure: ensuring integrity of data, securing information stored and/or processed internally or externally, maintaining and developing technology systems that enable business processes, and in ensuring infrastructure supports the organisation effectively.

7. Legal, regulatory and intellectual property: adapting to changes in laws, regulations and their application, managing litigation, governmental investigations, sanctions, contractual terms and conditions and potential business disruptions.

8. Inorganic growth: identifying, accurately pricing and/or realising expected benefits from acquisitions or divestments, licensing, or other business development activities.

9. Supply chain and API sourcing: maintaining continuity of supply of finished product and managing cost, quality and appropriate oversight of third parties in our supply chain. API and raw materials represent one of the Group's largest cost components. As is typical in the pharmaceuticals industry, a significant proportion of the Group's API requirements is provided by a small number of API suppliers.

10. Crisis response and continuity management: preparedness, response, continuity and recovery from crisis events such as natural catastrophe, economic turmoil, operational issues, political crisis, regulatory intervention.

11. Product quality: maintaining compliance with current Good Practices for Manufacturing (cGMP), Laboratory (cGLP), Distribution (cGDP) and pharmacovigilance (GVP) by staff, and ensuring compliance is maintained by all relevant third parties involved in these processes.

12. Financial control and reporting: effectively managing treasury activities, tax position, income, expenditure, assets and liabilities, and debtors, and in reporting accurately and in a timely manner in compliance with statutory requirements and accounting standards.

1 Constant currency numbers in 2018 throughout the document represent 2018 numbers re-stated using average exchange rates in H1 2017, excluding price increases in the business which resulted from the devaluation of currencies.

2 Core results throughout the document are presented to show the underlying performance of the Group, excluding the exceptional items and other adjustments set out in Note 4. Core results is a non-IFRS measure, see page 13 for reconciliation of core results to reported IFRS results.

3 Core results are presented to show the underlying performance of the Group, excluding the exceptional items and other adjustments set out in Note 4. EBITDA is earnings before interest, tax, depreciation, amortisation and impairment charge. Core results and EBITDA are non-IFRS measures. Reconciliation to reported IFRS measures are provided on pages 13 and 14 respectively.

4 In H1 2018, Hikma incurred R&D costs related to a repeat clinical endpoint study for generic Advair Diskus®. In 2017, Hikma recognised a contingent consideration gain from Boehringer Ingelheim as compensation for failure to receive FDA approval of generic Advair Diskus® before 24 December 2017. To obtain approval, the FDA requires the completion of an additional clinical endpoint study. Both the contingent consideration and repeat clinical study have been treated as exceptional items. See Note 4 for further information.

5 In H1 2018, Hikma incurred $15 million of R&D costs related to a repeat clinical endpoint study for generic Advair Diskus®. In 2017, Hikma recognised a $29 million contingent consideration gain from Boehringer Ingelheim as compensation for failure to receive FDA approval of generic Advair Diskus® before 24 December 2017. To obtain approval, the FDA requires the completion of an additional clinical endpoint study. Both the contingent consideration and repeat clinical study have been treated as exceptional items. See Note 4 for further information.

6 The Group did not make any product-related investments in H1 2018.

7 Submissions for new products, including Marketing Authorisations, NDA, ANDA, supplements, line extensions, and re-introduction of legacy products by country.

8 New products (approvals, technical approvals, and tentative approvals), line extensions, and re-introduction of legacy products by country.

9 New products, line extensions and re-introduction of legacy products by country.

10 Group net debt is calculated as Group total debt less Group total cash. Group net debt is a non-IFRS measure. See page 13 for reconciliation of Group net debt to reported IFRS figures in the interim financial statements.

Independent review report to Hikma Pharmaceuticals PLC

Report on the condensed consolidated interim financial statements

We have reviewed Hikma Pharmaceuticals PLC's condensed consolidated interim financial statements (the "interim financial statements") in the Interim Results Press Release of Hikma Pharmaceuticals PLC for the six month period ended 30 June 2018. Based on our review, nothing has come to our attention that causes us to believe that the interim financial statements are not prepared, in all material respects, in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as adopted by the European Union and as issued by the International Accounting Standards Board (IASB) and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.

The interim financial statements comprise:

· the consolidated balance sheet as at 30 June 2018;

· the consolidated income statement and consolidated statement of comprehensive income for the period then ended;

· the consolidated cash flow statement for the period then ended;

· the consolidated statement of changes in equity for the period then ended; and

· the explanatory notes to the interim financial statements.

The interim financial statements included in the Interim Results Press Release have been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as adopted by the European Union and as issued by IASB and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.

As disclosed in note 2 to the interim financial statements, the financial reporting framework that has been applied in the preparation of the full annual financial statements of the Group is applicable law and International Financial Reporting Standards (IFRSs) as adopted by the European Union and as issued by the IASB.

The Interim Results Press Release, including the interim financial statements, is the responsibility of, and has been approved by, the Directors. The Directors are responsible for preparing the Interim Results Press Release in accordance with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.

Our responsibility is to express a conclusion on the interim financial statements in the Interim Results Press Release based on our review. This report, including the conclusion, has been prepared for and only for the company for the purpose of complying with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority and for no other purpose. We do not, in giving this conclusion, accept or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing.

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 enquiries, 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, 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.

We have read the other information contained in the Interim Results Press Release and considered whether it contains any apparent misstatements or material inconsistencies with the information in the interim financial statements.

PricewaterhouseCoopers LLP

Chartered Accountants

London

14 August 2018

Hikma Pharmaceuticals PLC

Consolidated income statement

On this page and throughout this financial information "H1 2018" refers to the six months ended 30 June 2018, "H1 2017" refers to the six months ended 30 June 2017.

Hikma Pharmaceuticals PLC

Consolidated statement of comprehensive income

*During 2017 the Group acquired the remaining stake in Ibn Al Baytar, bringing the total ownership to 100%.

*\* The Group adopted IFRS 9 and IFRS 15 from 1 January 2018 (see note 2).

* Available-for-sale investments have been re-classified to investments fair valued through other comprehensive income as per IFRS 9.

** Includes $5 million payments from Boehringer Ingelheim received in respect of the price adjustment receivable to the Columbus business acquisition (H1 2017: $1 million).

1. General information

Hikma Pharmaceuticals PLC is "the Company" a public limited liability company incorporated and domiciled in England and Wales under the Companies Act 2006. The registered office address is 1 New Burlington Place, London W1S 2HR, UK.

The Group's principal activities are the development, manufacturing, marketing and selling of a broad range of generic, branded and in-licensed pharmaceuticals products in solid, semi-solid, liquid and injectable final dosage forms.

The information for the year ended 31 December 2017 does not constitute statutory accounts as defined in section 435 of the Companies Act 2006. A copy of the statutory accounts for 2017 have been delivered to the Registrar of Companies. The auditors' 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 interim condensed consolidated financial statements "financial statements" for the six months ended 30 June 2018 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 2017, except for the adoption of new standards effective from 1 January 2018.The Group has not opted for the early-adoption of any standard, interpretation or amendment that has been issued but not yet effective.

Basis of preparation

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

These financial statements for the six months ended 30 June 2018 have been prepared in accordance with the Disclosure and Transparency Rules of the Financial Conduct Authority and with IAS 34,"Interim financial reporting", as adopted by the EU and as issued by the IASB. The financial statements should be read in conjunction with the annual financial statements for the year ended 31 December 2017, which have been prepared in accordance with IFRSs issued by the IASB and the IFRSs adopted by the EU.

Adoption of new and revised standards

The Group applied, for the first time, IFRS 15 Revenue from Contracts with Customers and IFRS 9 Financial Instruments. These new Standards have not had a significant impact on the reported results.

Several other amendments and interpretations apply for the first time in 2018, but do not have an impact on the financial statements of the Group.

IFRS 15

IFRS 15 'Revenue from Contracts with Customers' is effective for accounting periods beginning on or after 1 January 2018 and replaces existing accounting standards. It provides enhanced detail on the principle of recognising revenue to reflect the transfer of goods and services to customers at a value which the Company expects to be entitled to receive. The standard also updates revenue disclosure requirements.

The key revenue recognition policy impacted under IFRS 15 is the accounting of free goods. Previously free goods were recorded at cost only and no transaction price was allocated to the free goods revenue. Under IFRS 15 an option to acquire additional goods or services gives rise to a separate performance obligation, if the option provides a material right that the customer would not receive without entering into that contract. IFRS 15 requires management to estimate the transaction price to be allocated to the separate performance obligations and to recognise a contract liability for the performance obligations that will be satisfied in the future. The Group recognises revenue for the option when those future goods or services are transferred to the customer.

The Group has adopted IFRS 15 applying modified retrospective approach on 1 January 2018 with a cumulative adjustment as an increase to other current liabilities of $27 million, increase of trade receivables by $1 million, tax adjustments of $2 million and the corresponding net adjustment to decrease retained earnings by $25 million. There is no restatement to prior periods as permitted in the transition rules for IFRS 15. The impact of initial application has resulted in the deferral of revenues that had previously been recognised.

IFRS 9

IFRS 9 Financial Instruments replaces IAS 39 Financial Instruments: Recognition and Measurement is effective for annual periods beginning on or after 1 January 2018, bringing together all three aspects of the accounting for financial instruments: classification and measurement; impairment; and hedge accounting.

Classification

The principal impact is that the portfolio investments (quoted securities portfolio) previously designated as available for sale financial assets have been re-categorised on initial application as Investments fair valued through profit or loss (FVTPL). The Group will record fair value movements for such investments through the consolidated income statement from 1 January 2018.

Upon transition the available for sale reserve relating to quoted equity securities of $1 million, which had been previously recognised under accumulated other comprehensive income (OCI), was reclassified to retained earnings.

Furthermore, fair value movements on other un-quoted equity investments (i.e. venture capital investments) are continued to be recorded in other comprehensive income. There will be no future recycling of such gains and losses to the consolidated income statement. This category only includes equity instruments, which the Group intends to hold for the foreseeable future and which the Group has irrevocably elected to classify upon transition or initial recognition as equity instruments designated as measured at fair value through other comprehensive income (FVOCI). Under IAS 39, the Group's unquoted equity instruments were classified as available for sale financial assets.

Impairment

The adoption of IFRS 9 has changed the Group's accounting for impairment losses for financial assets by replacing IAS 39's incurred loss approach with a forward-looking expected credit loss (ECL) approach.

IFRS 9 requires the Group to record an allowance for ECLs for all loans and other debt financial assets not held at fair value through profit or loss (FVTPL).

The adoption of the ECL requirements of IFRS 9 resulted in an increase in impairment allowance of the Group's debt financial assets.

The Group has adopted IFRS 9 retrospectively, but with certain permitted exceptions. As a result, prior year results are also not restated, but a cumulative adjustment as a decrease in trade receivables and a corresponding adjustment to decrease equity at 1 January 2018 by $3 million has been made.

The other changes introduced in IFRS 9 have not had a significant impact on the Group. 

IFRS 16

IFRS 16 was issued in January 2016 and it replaces IAS 17 'Leases', IFRIC 4 'Determining whether an Arrangement Contains a Lease', SIC-15 'Operating Leases-Incentives' and SIC-27 'Evaluating the Substance of Transactions Involving the Legal form of a Lease'.

IFRS 16 sets out the principles for the recognition, measurement, presentation and disclosure of leases and requires lessees to account for all leases under a single on-balance sheet model similar to the accounting for finance leases under IAS 17. The standard includes two recognition exemptions for lessees - leases of 'low-value' assets (e.g., personal computers) and short-term leases (i.e., leases with a lease term of 12 months or less). At the commencement date of a lease, a lessee will recognise a liability to make lease payments (i.e., the lease liability) and an asset representing the right to use the underlying asset during the lease term (i.e., the right-of-use asset). Lessees will be required to separately recognise the interest expense on the lease liability and the depreciation expense on the right-of-use asset.

Lessees will be also required to remeasure the lease liability upon the occurrence of certain events (e.g., a change in the lease term, a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee will generally recognise the amount of the remeasurement of the lease liability as an adjustment to the right-of-use asset.

IFRS 16 also requires lessees and lessors to make more extensive disclosures than under IAS 17. IFRS 16 is effective for annual periods beginning on or after 1 January 2019.

Early application is permitted. A lessee can choose to apply the standard using either a full retrospective or a modified retrospective approach. The standard's transition provisions permit certain reliefs.

In 2018, the Group will continue to assess the potential effect of IFRS 16 on its consolidated financial statements.

Going concern

The Directors have considered the going concern position of the Company during the period and at the period end as they have in previous years. The Directors believe that the Group is well diversified due to its geographic spread, product diversity and large customer and supplier base. The Group operates in the relatively defensive generic pharmaceuticals industry, which the Directors expect to be less affected by economic downturns compared to other industries.

The Group's business activity, together with the factors likely to affect its future development, performance and position are set out in Interim Result Press Release. The Interim Result Press Release also includes a summary of financial position, cash flow and borrowing facilities.

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 and political outlook. Having reassessed the principal risks, the Directors considered it appropriate to adopt the going concern basis of accounting in preparing the interim financial information.

3. Business and geographical segments

For management reporting purposes, the Group is organised into three principal operating divisions - Injectables, Generics and Branded. These divisions are the basis on which the Group reports its segmental information.

Operating profit, defined as segment result, is the principal measure used in the decision-making and resource allocation process of the chief operating decision maker, who is the Group's Chief Executive Officer.

Information regarding the Group's operating segments is reported below:

'Others' mainly comprise Arab Medical Containers LLC, International Pharmaceutical Research Center LLC, Hikma Emerging Markets and Asia Pacific FZ LLC and the chemicals division of Hikma Pharmaceuticals LLC (Jordan).

In H1 2018, Unallocated corporate expenses mainly comprise of employee costs, third party professional fees and travel expenses. In H1 2017, Unallocated corporate expenses also included donations and acquisition-related expenses.

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

The top selling markets were as below:

Included in revenue arising from the Generics and Injectables segments is revenue of approximately $152 million (H1 2017: $103 million), which arose from the Group's largest customer, located in the United States.

4. Exceptional items and other adjustments

Exceptional items are disclosed separately in the consolidated income statement to assist in the understanding

of the Group's core performance.