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02 April 2014

Hikma announces successful resolution to US FDA warning letter at Eatontown facility

London, 2 April 2014 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces that we have received a close-out letter from the US Food and Drug Administration (“US FDA”) that lifts the warning letter received in February 2012 in respect of its Eatontown facility in New Jersey, which provides oral products for the US market.

London, 2 April 2014 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces that we have received a close-out letter from the US Food and Drug Administration (“US FDA”) that lifts the warning letter received in February 2012 in respect of its Eatontown facility in New Jersey, which provides oral products for the US market. This communication follows the US FDA’s re-inspection of the facility in February 2014 to complete its evaluation of the corrective actions we have taken in response to the warning letter. This successfully resolves all issues raised by the US FDA in February 2012 and all subsequent communications.

Said Darwazah, Chief Executive Officer of Hikma commented:
“I am pleased to report that we have brought the Eatontown facility back into compliance with the US FDA. The investment we have made to complete the remediation work, upgrade our manufacturing processes and strengthen our operations, provides greater quality and support for our customers and we are committed to continuing to invest in the highest quality standards. We are gradually re-introducing products to the US market from the Eatontown facility, adding to the products we supply from our US FDA approved facilities in Jordan and Saudi Arabia. We believe there are an increasing number of attractive market opportunities for our Generics business and we are investing in our pipeline of oral and other non-injectable product forms, whilst continuing to look for further product acquisition opportunities.”

We expect the Generics business to deliver revenue of around $170 million in 2014, with an adjusted operating margin of above 25%.

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Lucinda Henderson, Deputy Head of Investor Relations +44 (0)20 7399 2765/
+44 7818 060211
FTI Consulting  
Ben Atwell/ Matthew Cole/ Julia Phillips +44 (0)20 7831 3113


About Hikma

Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma operates through three businesses: “Branded”, “Injectables” and “Generics”, based principally in the Middle East and North Africa ("MENA"), where it is a market leader, the United States and Europe. In 2013, Hikma achieved revenues of $1,365 million and profit attributable to shareholders of $212 million.

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12 March 2014

Hikma Pharmaceuticals Preliminary Results

Hikma Pharmaceuticals PLC ("Hikma", "Group") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today reports its preliminary results for the year ended 31 December 2013.

Hikma Pharmaceuticals PLC ("Hikma", "Group") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today reports its preliminary results for the year ended 31 December 2013.

Hikma Pharmaceuticals Preliminary Results 2013
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04 March 2014

Notice of Prelim Results Announcement – Analyst Presentation

Notice of Prelim Results Announcements for the year ended 31 December 2013. A presentation and webcast for analysts will take place at 9:30am GMT at FTI, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB.

Notice of Prelim Results Announcements for the year ended 31 December 2013. A presentation and webcast for analysts will take place at 9:30am GMT at FTI, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB.

Wednesday 12 March 2014

9.30am (London time)/ 11.30am (Jordan time)

FTI Consulting, Holborn Gate, 26 Southampton Buildings, London, WC2A 1PB.

To join via conference call please dial: +44 (0) 203 139 4830
UK Toll-Free Number: 0808 237 0030
Participant PIN Code: 59706264#

Alternatively you can listen live via our website: www.hikma.com or www.cantos.com

Playback facility:
A playback of the conference call will be available via our website later that www.hikma.com

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18 February 2014

Hikma signs license and supply agreement with SK Chemicals for its Rivastigmine transdermal patch

London, 18 February 2014 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces the signing of a license and supply agreement with SK Chemicals Co., Ltd. for its reformulated generic Rivastigmine transdermal patch, the first approved transdermal product for the treatment of mild to moderate dementia in patients with Alzheimer’s disease.

London, 18 February 2014 – Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces the signing of a license and supply agreement with SK Chemicals Co., Ltd. for its reformulated generic Rivastigmine transdermal patch, the first approved transdermal product for the treatment of mild to moderate dementia in patients with Alzheimer’s disease.

Under the terms of the agreement, Hikma will have the exclusive licensing rights to register, distribute and market Rivastigmine transdermal patch (4.6mg/24hr, 9.5mg/24hr and 13.3mg/24hr) in 18 MENA markets.  The agreement will leverage Hikma’s strong local presence and regulatory expertise in MENA, with over 1,600 sales and marketing reps across the region.  SK Chemicals’ product is the first generic of Rivastigmine transdermal patch and its launch in MENA will help to increase patients’ access to this important medicine.

Said Darwazah, CEO of Hikma said, "We are pleased to be partnering with SK Chemicals to bring Rivastigmine transdermal patch to patients in MENA.  This is an excellent product and will enhance our growing portfolio of central nervous system products.  Bringing the first generic of this innovative product to the MENA region supports our strategy of increasing patients’ access to high quality, affordable medicines."

Inseork Lee, CEO of SK Chemicals added, "It’s an honour to be co-operating with Hikma and I am very confident that we can achieve success with this product through a combination of SK Chemicals’ accumulated R&D ability and Hikma’s outstanding sales and marketing capabilities in MENA."

--- ENDS ---

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/ +44 7776 477050
Lucinda Henderson, Investor Relations Manager +44 (0)20 7399 2765/ +44 7818 060211
   
FTI Consulting +44 (0)20 7831 3113
Ben Atwell /Julia Phillips/Matthew
Cole
 

About Hikma

Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.  Hikma operates through three businesses: "Branded", "Injectables" and "Generics", based principally in the Middle East and North Africa ("MENA"), where it is a market leader, the United States and Europe.  In 2012, Hikma achieved revenues of $1,108.7 million and profit attributable to shareholders of $100.3 million.

About SK Chemicals

Since its formation in 1969, SK Chemicals Co., Ltd. has grown into one of the major healthcare and chemical companies in Korea through a series of continuous innovations, achieving revenue of $1,484.6 million in 2013.  The company is now trying to leap forward by reorganising its corporate structure into Green Chemicals and Life Science, under the mandate, ‘Becoming a global leader of eco-friendly materials and total healthcare solutions provider.’

In its Life Science business, SK Chemicals is deploying a portfolio of diverse products in a push for value-oriented development activities including reformulated generic, vaccines and plasma products.  The accumulated key competency through consistent R&D investment to expand into the global marketplace, enables SK Chemicals to succeed in a series of out-licensing deals and achievements.  These include a patentable PPI oral tablet, a reformulated anticancer injectable and human recombinant factor and the marketing authorisations for a few products in Europe and the United States.  For further information, please visit www.skchemicals.com/en/sub1-3-3.asp.

Press Release
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14 February 2014

Trading Update

London, 14 February 2014 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, will announce its full year results to 31 December 2013 on 12 March 2014. In advance of this, the company is providing an update to the market on the strong performance of its Injectables and Generics businesses towards the end of 2013.

London, 14 February 2014 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, will announce its full year results to 31 December 2013 on 12 March 2014. In advance of this, the company is providing an update to the market on the strong performance of its Injectables and Generics businesses towards the end of 2013.

Since issuing our Interim Management Statement on 8 November 2013, the Injectables and Generics businesses continued to perform very well and, as a result, Group revenue growth for the full year in 2013 will now be around 23%, ahead of our previous guidance of around 20%.

Injectables

Our global Injectables business has performed very well, with revenue growth of around 14%. Profitability has improved and we now expect an adjusted operating margin of around 30%. This reflects a particularly strong performance in the US, where we are focusing on higher value products, improved pricing, new product launches and tight cost control. We are confident that our Injectables business will continue to deliver strong revenue growth and an adjusted operating margin above 30% in 2014.

Generics

Our Generics business has benefited from strong doxycycline sales and we now expect Generics revenue of around $270 million for the full year. Looking ahead, we expect Generics revenue to be lower in 2014 due to increased competition in the US doxycycline market.

Branded

Our Branded business has performed in line with expectations, with revenue growth of around 5% for the full year, or 8% in constant currency. We continue to expect adjusted operating margin of around 24%, up more than 50 basis points from last year, as a result of our strategic decision to cut low margin tender sales, a focus on higher value products and greater emphasis on operational efficiencies.

We will provide our regular detailed guidance in respect of 2014, both for the business segments and the Group overall, when we announce our 2013 Preliminary Results on 12 March 2014.

- ENDS -

Enquiries:

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Lucinda Henderson, Investor Relations Manager +44 (0)20 7399 2765/
+44 7818 060211
     
FTI Consulting  
Ben Atwell/ Julia Phillips/ Matthew Cole +44 (0)20 7831 3113

About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma operates through three businesses: “Branded”, “Injectables” and “Generics”, based principally in the Middle East and North Africa ("MENA"), where it is a market leader, the United States and Europe. In 2012, Hikma achieved revenues of $1,108.7 million and profit attributable to shareholders of $100.3 million.

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11 February 2014

Board Changes

London, 11 February 2014 Hikma Pharmaceuticals PLC (LSE: HIK) (DIFX: HIK) (“Hikma”), the FTSE 250 pharmaceuticals company, is today announcing the following changes to its Board composition.

London, 11 February 2014 Hikma Pharmaceuticals PLC (LSE: HIK) (DIFX: HIK) (“Hikma”), the FTSE 250 pharmaceuticals company, is today announcing the following changes to its Board composition.

With effect from the Annual General Meeting on 15 May 2014, the following changes will occur:

  • Mr. Samih Darwazah, non-executive Chairman, is to retire from the Board and become honorary Life President;
  • Mr. Said Darwazah, Chief Executive, is to be appointed Chairman & Chief Executive;
  • Sir David Rowe-Ham, Senior Independent Director, is to retire from the Board; and
  • Mr. Robert Pickering, non-executive director, is to be appointed Senior Independent Director and Chairman of the Nomination Committee. Mr. Pickering will become a member of the Remuneration Committee and cease to be a member of the Compliance, Responsibility and Ethics Committee (“CREC”).

The Board is further developing its medium term succession plans for the independent non-executive directors, with the aim of ensuring an orderly transfer of the committee chairmanship responsibilities. The Board is currently undertaking a recruitment process for an additional non-executive director and expects to be able to make a further announcement shortly.

Samih Darwazah said:

“Whilst the leadership is changing, we are doing this in a way that promotes continuity and ensures the people who are taking Hikma forward have a proven track record. I am delighted that I am handing over my responsibilities to the Chief Executive. He and his very efficient team have significantly improved the business over the last seven years and are perfectly positioned to take it forward. I will always have strong and emotional ties with Hikma.

I also want to note the debt of gratitude we owe Sir David, a great friend of Hikma and mine. Sir David has been a constant source of wisdom and guidance to Hikma as we have grown from listing in 2005 to the international group we are today.

Robert has forged strong links with the board and management team over the past three years and has demonstrated sound and clear judgement. I am delighted that he has kindly accepted to expand his role.”

Said Darwazah said:

“The Board and I consider that these changes are the best method on ensuring the continued entrepreneurial success of Hikma. From an executive point of view, this will be business as usual, with the divisional heads continuing to drive their businesses forward. My role will continue to focus on overall group strategy and I am very ably assisted in this by the strong executive team.

Those of you who know me will know that my style is to always listen to others and understand their views, with the aim of making the best decision in a consensual manner. My father has always been committed to the highest standards of transparency and openness and I will continue that commitment. Additionally, we always have had and, in Robert, will continue to have, a very strong senior independent director.”

- ENDS -

Enquiries:

Hikma Pharmaceuticals PLC  
Peter Speirs, Company Secretary      +44 (0)20 7399 2772
Susan Ringdal, Investor Relations Director   +44 (0)20 7399 2760
     
Financial Dynamics   
Ben Atwell /Julia Phillips/Jonathan Birt/Matthew Cole   +44 (0)20 7831 3113

Notes to Editors:

About Hikma

Hikma Pharmaceuticals PLC is a fast growing 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 2012, Hikma achieved revenues of $1,108.7 million and profit attributable to shareholders of $100.3 million.

Governance

Before considering recommending the appointment of Mr. Said Darwazah to his new role, the Nomination Committee undertook a full consultation with major shareholders and governance bodies. The views expressed were taken into account in the nature of changes announced today and the additional governance safeguards being implemented. As part of Hikma’s commitment to the highest levels of transparency, below is a summary of the main reasons for the Code departures and safeguards that are being implemented. A full explanation will be included in the annual report, which is due to be published in April.

Reasons for Appointment
The key reasons for making the Chairman and Chief Executive appointment are:

  • Chairman’s Role: The Chairman position is highly visible within Hikma, acting as an ambassador with our business partners and adviser to our divisions. It is essential the Chairman intimately understands MENA culture and has strong relationships in the region, can speak Arabic and has extensive pharmaceutical knowledge.
  • Entrepreneurial Leadership: Hikma is an entrepreneurial company and we believe that the combination of board and strategic leadership is the best method of maintaining our growth success and corporate nimbleness.
  • Business Partners: A significant number of the Company’s key political and commercial relationships across the MENA region are built on the long-term trust and respect for the Darwazahs where the role of the Chairman remains key.
  • Said Darwazah: The combining of the Chairman and CEO role is only because the unique skill set, experience, style and position of Said within Hikma. Said joined Hikma in 1981 and devoted his career to the development of Hikma where he gained experience in all the broad roles of Hikma, from sales representative to Chief Executive. He served as Chairman and Chief Executive of the Hikma Group holding company from 1994 to 2003 before Hikma’s listing on the London Stock Exchange. Said has an industrial engineering degree from Purdue University and an MBA from INSEAD.

Governance Safeguards
The key governance safeguards in place to ensure appropriate checks and balances are:

  • Enhanced SID Role: The Senior Independent Director will continue to be the point of contact for investors and the role will now include:
    • Joint responsibility, with the Chairman and Chief Executive, for setting the board agenda, agreeing actions points and the minutes of the meeting.
    • Responsibility for board composition, effectiveness and evaluation.
    • Independent access to executive management and vice versa.
    • A dotted reporting line from the Company Secretary.
  • Independent Majority: The Board is committed to maintaining a majority of independent non-executive directors at all times. The Nomination Committee has a medium-term plan for the orderly succession of non-executive directors, including the handover of responsibilities of the Committee chairmen.
  • Governance Structure Review: The independent directors meet at least bi-annually in a separate session chaired by the Senior Independent Director to review and consider the governance structure of the group.
  • Transparency and Engagement: Hikma has always had the highest regard for external shareholders, many of our original business partners from before listing still invest, lend and support the Company today. We have won and been shortlisted for several transparency and governance awards, particularly over the past three years.
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28 January 2014

Hikma Globalizes its Pharmacovigilance Activities

Amman, 28 January 2014 – Hikma Pharmaceuticals (LSE:HIK) (NASDAQ Dubai: HIK), the fast growing multinational pharmaceutical group, today announces that it has entered into a new service agreement with PrimeVigilance, a leading international company that provides pharmacovigilance (PV) and medical information services, to gain access to top quality and global-scale PV services.

Amman, 28 January 2014 – Hikma Pharmaceuticals (LSE:HIK) (NASDAQ Dubai: HIK), the fast growing multinational pharmaceutical group, today announces that it has entered into a new service agreement with PrimeVigilance, a leading international company that provides pharmacovigilance (PV) and medical information services, to gain access to top quality and global-scale PV services.

Pharmacovigilance or Drug Safety, is the pharmacological science relating to the monitoring, detection and prevention of adverse effects with pharmaceutical products.

This agreement will enable Hikma to globalize all its PV operations across its worldwide group of companies, and assist Hikma in covering all the regulatory and scientific elements of PV required by health authorities in different countries.

In addition, Hikma will better monitor and evaluate the benefit-risk balance of its products, and will be more compliant with the highest standards of quality, international regulations, and codes of best practices. The agreement will also re-enforce Hikma’s commitment to compliance with laws and regulations.

Mr. Said Darwazah, Hikma Pharmaceuticals’ CEO said, “I am pleased to announce this partnership with PrimeVigilance, which will enable us to maintain our highest standards of quality. Through this partnership, we fulfill our commitment to the safety of our patients wherever we operate in compliance with all applicable laws and regulations.”

Mr. Neil Clark, PrimeVigilance CEO, said “We are very pleased to be working with Hikma and providing a range of important safety services to support their fast-growing, international operations.”

 

-END-

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17 December 2013

Samih Darwazah Tops Scrip Emerging Markets Leaders

Amman, 17 December 2013 – Hikma Pharmaceuticals (LSE:HIK) (NASDAQ Dubai: HIK), is pleased to announce that its Founder and Chairman, Mr. Samih Darwazah, was selected as the first Emerging Markets Leader of the Scrip 100 list.

Amman, 17 December 2013 – Hikma Pharmaceuticals (LSE:HIK) (NASDAQ Dubai: HIK), is pleased to announce that its Founder and Chairman, Mr. Samih Darwazah, was selected as the first Emerging Markets Leader of the Scrip 100 list.

The list recognizes company heads that are shaping the future of pharma in their respective countries and includes a number of significant emerging market pharmaceutical leaders such as Bill and Melinda Gates for the Gates foundation, Takeda’s Head of Commercial Operations, and the CEO of Samsung Biologics.

The Scrip 100 is a list of the top 100 leaders in the pharmaceutical business compiled by the Scrip editorial team. The top 100 leaders selected include philanthropists, regulators and company heads that have shaped the future of pharma in their countries with a global view of the biopharmaceutical industries.

Further details can be found on www.scrip100.com/leaders

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