global pharmaceutical and biotechnology report...

GLOBAL PHARMACEUTICAL AND BIOTECHNOLOGY REPORT 2017

A CLE ARWATER INTERNAT IONAL HEALTHCARE TEAM REPORT

Major acquiring nations and attractive destinations

Deal values

US, China and the UK are top of the league in terms of the most prolific acquirers and favourite target destinations over the past 12 months.

2017 began on a slow note due to various factors including uncertainties around Trump’s financial policies, a lack of clarity on UK–EU relations and regulatory changes in India and China. However, gradually, deal volume picked up and in the first nine months of 2017 we recorded a total of 401 deals, a 1% increase over the first nine months of 2016.

31% deals as acquiring nation

36% as target destination



€116bn

Quintiles/IMS health

€7.9bn

Johnson & Johnson/Actelion

€26.6bnBoehringer

Ingelheim/Merial

€11.3bn

Deals completed over the past

12 months

A 6% decrease on the previous 12-month figure

563

Segment breakdown Top four segments that recorded the most M&A activity over the past 12 months

Pharma 23%

Outsourcing services 22%

Biotech 21%

Generics 18%

M&A in pharma was focussed on boosting drug pipelines of large pharma companies which have been under immense pressure from investors due to rising competition from generics and eroding top-line figures. Activity in the biotech sector suggested movement towards speciality medicine. A majority of deals were focussed on acquiring clinical-stage companies that have a few drugs in development, mainly for treating cancer and rare diseases. The outsourcing sector is witnessing consolidation to boost capabilities and geographic presence.

Past 12 months represents data for Oct 2016 - Sep 2017

Previous 12 months represents data for Oct 2015 - Sep 2016

2%1%1%

US Scandinavia

CEE

5%

Financial investor deals

India and China

France and Germany

UK RoW

Iberia

27%of deals were in

pharma

Total deal value past 12 months



UKUS

China

17%of all deals involved

financial investors

34%30%

14%

13%

4 GLOBAL PHARMACEUT I C AL AND B I OTEC H NOLOG Y R EP ORT 20 17

Welcome

A year ago this report warned of the impact that Brexit, the slowdown in tax inversion practises, and elections in the US and Europe, could all have on global M&A activity in the pharmaceutical and biotechnology market. Twelve months on these concerns have been borne out as global headwinds have put a distinct brake on corporate activity across the sector. We do however expect to see M&A activity pick up going forward.

The impact has been most keenly felt in the US, the world’s largest pharmaceutical market and centre of M&A activity. Ongoing political and economic uncertainties have dampened the M&A environment amid continued uncertainty over proposed changes to Obamacare, alongside efforts to bring down drug prices and the wider move to bring manufacturing back to the US. However, with an increased confidence in home markets, acquirers have largely focussed on domestic deals.

Across Europe investors continue to be strongly influenced by the lack of clarity over Brexit. However with the clock ticking on the UK’s withdrawal from the EU, leading players in the market will be looking to make serious M&A moves in the year ahead.

Regulatory changes are having a major impact on the Indian and Chinese markets, although increasing healthcare budgets and growing investment in the Chinese medical sector are likely to lead to increased spending on drugs.

However the global market still recorded 563 deals in the year to September with a total deal value of €116bn. And the last quarter of 2017 looks set to provide a strong finish to the year with two significant deals set to complete – Fresenius’ €3.8bn acquisition of multi-source and branded pharmaceutical manufacturer Akorn, Inc., and Amneal Pharmaceuticals’ €1.8bn purchase of controlled-release and speciality generics developer IMPAX Laboratories Inc.

Particular segments are also seeing very strong dealflow, such as the outsourcing services market which is consolidating rapidly. And as pharma and biotech companies shift their R&D focus to niche drugs based on personalised therapies, this is creating a myriad of M&A opportunities too.

4

@CWICF

/company/clearwater-international-corporate-finance

Meet the team

Ramesh JassalInternational Head of Healthcare, UK+44 845 052 [email protected]

Franc KaiserPartner, China + 86 21 6341 0699 x [email protected]

Louise Kamp NørbækAssociate Director, Denmark+45 40 17 86 [email protected]

Philippe GuezenecPartner, France+33 1 53 89 [email protected]

Markus OttoPartner, Germany+49 611 360 39 [email protected]

John CurtinPartner, Ireland+353 1 517 58 [email protected]

Rui MirandaPartner, Portugal+351 918 766 [email protected]

Miguel Ángel LorenzoDirector, Spain +34 659 094 [email protected]

ContentsGLOBAL MARKET 6Top 10 transactions (by transaction size)

Segment breakdown

US 13

UK 15

IRELAND 18

IBERIA 19

FRANCE AND GERMANY 21

SCANDINAVIA 23

CEE 25

INDIA AND CHINA 26

RECENT CLEARWATERINTERNATIONAL DEALS 28

For the purpose of this report, we have quoted all the figures in euros using the following average exchange rates:

Oct 2016 – Sep 2017 USD to EUR: 0.907Oct 2015 – Sep 2016 USD to EUR: 0.901Oct 2016 – Sep 2017 GBP to EUR: 1.148Oct 2015 – Sep 2016 GBP to EUR: 1.287Oct 2016 – Sep 2017 CNY to EUR: 0.133Oct 2015 – Sep 2016 CNY to EUR: 0.138Oct 2016 – Sep 2017 INR to EUR: 0.014Oct 2015 – Sep 2016 INR to EUR: 0.013

Source for graphs: Market intelligence and proprietary databases

This report is published by Clearwater International Editors: Ruth Farrington and Jim PendrillDesign: Creative BridgeSubscription: [email protected] part of this publication may be reproduced or used in any form without prior permission of Clearwater International

A CL E A RWA TE R IN TE RN A T ION A L HE A L THCA RE TE AM REPORT 5

Segment breakdown

Others

Companies offering infusion products, compounding services, reagents, radiopharma agents and pharma IT solutions.

Animal health

Offers IP and non IP protected pharmaceuticals, vaccines and nutritional products for animals including poultry, swine, beef and dairy cattle, and aquaculture.

OTC

Includes manufacturers and distributors of over-the-counter (OTC) drugs. These drugs are safe and effective for use by the general public without a prescription and may be available in non-pharmacy outlets. Most common OTC drugs are allergy medicines, pain relievers, weight loss products, vitamins, minerals and supplements, and nutraceutical products.

Pharma

Firms engaged in R&D and manufacturing of IP protected pharmaceuticals using a chemical basis and artificial materials.

Biotech

Firms engaged in research and development (R&D) and manufacturing of IP protected drugs, pharmaceutical or biological drugs using a biological basis, live organisms or derivatives such as bacteria or enzymes, also known as biopharmaceuticals.

Generics

Includes manufacturers and distributors of drugs, finished dose formulations and active pharmaceutical ingredients (non-innovator). The drug is identical or bioequivalent to a branded drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. These drugs are typically sold at discounts from the intellectual property (IP) protected branded drugs.

Outsourcing services

Provides contract outsourcing services to others. Includes contract research organisation (CRO), contract manufacturing organisation (CMO), contract development and manufacturing organisation (CDMO), contract sales organisation (CSO), logistics and distribution, packaging and labelling, as well as other outsourcing services such as consulting, testing, auditing, medical communications, regulatory, compliance and safety.

Global market

In the first nine months of the year the global market registered 401 deals, representing a 1% increase compared to the same period last year. Meanwhile the past 12 months (October 2016 – September 2017) registered a slowdown compared to the preceding year. However, the M&A environment is expected to gain momentum.

M&A deals – by volume and value (Oct 2015–Sep 2017)

Oct 15 – Sep 16

Oct 16 – Sep 17

Deal count 601 563

Total value (€bn) 171 116

A major factor has been the US election in November 2016, on which hinged several issues critical to the pharma industry – such as drug pricing, the regulatory environment, insurance and tax rates.

As the US is the largest pharma market in the world ongoing political and economic uncertainties have dampened the global M&A environment. Pharma companies and investors are keeping a close watch on key policies including proposed changes to Obamacare, a reduction of corporate tax rates, and repatriation tax holiday plans designed to encourage US firms to bring overseas profits back home.

Additionally, a lack of clarity on UK–EU relations in the wake of Brexit, regulatory changes in India and China, and a decline in tax-inversion deals due to the implementation of new rules in the US, have all hindered deal activity.

Despite a slowdown in the number of deals across the global pharmaceutical and biotechnology market, we have continued to see robust M&A activity in 2017.

6

US

China

UK

France

India

Canada

RoW

31%

6%6%5%

3%

38%

GLOBAL PHARMACEUT I C AL AND B I OTEC H NOLOG Y R EP ORT 20 17

M&A acquirer by country

Over the past year the US remained the most active country, both as an acquirer and acquisition target. US companies were acquirers in 31% of total global M&A deals, followed by Chinese (11%) and UK companies (6%). In terms of acquisition targets, the US constituted 36% of total global M&A activity, followed by China (9%) and the UK (6%).

The majority of M&A activity in the US was driven by domestic transactions, accounting for 70% of closed deals. This was largely propelled by two factors – tax-inversion laws that now inhibit US-based companies from shifting headquarters to a country with a lower tax rate (such as Ireland), and the Trump administration’s impetus on promoting local manufacturing of goods (including drugs) through its 'buy American' policy.

M&A acquirer by country (Oct 2016–Sep 2017)

11%

7A CL E A RWA TE R IN TE RN A T ION A L HE A L THCA RE TE AM REPORT

China, the second largest pharmaceutical market with around €97.5bn revenue in 2016, is undergoing transition. The country is grappling with an inflating medical budget due to an ageing population and increasing prevalence of chronic diseases such as type 2 diabetes and cardiovascular disorders.

To curb its mounting expenditure on drugs, the country is negotiating hard with pharma companies, asking them to cut drug prices by 10% to 30% as a requirement for participating in tenders for procuring medicines for public hospitals. In response, in order to increase its negotiating power and counter the rising pressure, the industry is consolidating. Over the past year, 94% of deals with a Chinese target had a domestic acquirer while half of these deals were focussed on boosting presence in the generics market.

A major force driving global consolidation is the patent cliff. To recover loss in revenue due to patent expiry of blockbuster drugs, large pharma companies are aggressively acquiring companies with promising molecules in pipeline.

Ireland-based Allergan is one such prolific acquirer. During the past 12 months it has purchased four companies – Tobira Therapeutics, Vitae Pharmaceuticals, Motus Therapeutics and Chase Pharmaceuticals – to bolster its pipeline.

M&A targets by country (Oct 2016–Sep 2017)

Meanwhile we are still seeing plenty of mega-deals. The top 10 deals accounted for 66% of the total disclosed deal value in the last 12 months. Most of these were trade deals involving outsourcing service providers, emphasising their need for strategic repositioning.

US

China

UK

France

India

Canada

RoW

36%

6%5%4%

3%

37%

9%

26.6

11.3

Top 10 largest transactions by deal size (Oct 2016-Sep 2017)

7.9

6.1

5.2

5.1

Enterprise value (€bn)

J&J/Actelion

Boehringer Ingelheim/Merial

Quintiles/IMS Health

Thermo Fisher Scientific/Patheon

Nidda Healthcare Holding/STADA

Takeda/Ariad Pharmaceuticals

Lonza/Capsugel

Pamplona Capital Management/PAREXEL

INC Research/inVentive Health

Celgene/Acetylon Pharmaceuticals 1.6

3.9

4.3

4.8


Global financial investor deals

Trade buyers remained the most active buyers, representing 83% of total transactions over the last 12 months, compared with 87% in the preceding 12 months.

However despite lower M&A activity investor confidence has remained strong with a wall of money to invest. Deals involving financial investors increased by 19% compared with the previous 12 months, showing that investors still have a strong appetite for high-quality assets.

The US was the preferred destination for financial investors with 31% of total closed deals in the last 12 months, followed by India and China (14%), and France and Germany (12%). Backed by strong growth prospects in a dynamic global environment, pharma was the most attractive segment for financial investors, accounting for 27% of total deals in the last 12 months, followed by outsourcing (24%).

For instance, Thermo Fisher Scientific, a US-based provider of clinical trials services and bioproduction technologies acquired Netherlands-based CDMO (contract development and manufacturing organisation) Patheon, for €6.1bn (8.5x EBITDA). Patheon has significant operational presence in the US and Europe. The acquisition is expected to bolster Thermo Fisher Scientific’s service capabilities and geographic presence, strengthening its position in the consolidating CDMO market.

30% of the top 10 deals were focussed on enriching pharma pipelines. Notable deals included:

US-based Celgene acquired Acetylon Pharmaceuticals for €1.6bn to gain worldwide rights to the latter’s selective HDAC6 inhibitor programmes and intellectual property in oncology, autoimmune disease and neurodegeneration, including its lead drug candidates citarinostat and ricolinostat.

Allergan’s aforementioned acquisition of Tobira Therapeutics for €1.3bn to boost its pipeline with the latter’s clinical-stage molecules targeted at non-alcoholic steatohepatitis (NASH) and other liver diseases. The acquisition added Tobira’s pipeline drugs – Cenicriviroc (CVC) and Evogliptin – for the treatment of NASH, inflammation, metabolic syndromes and fibrosis, to Allergan's gastroenterology R&D pipeline.

Deals by investor type – trade vs financial investors (Oct 2016–Sep 2017)

17%

83%

Trade

Financial investors

Oct 15 - Sep 16 Oct 16 - Sep 17

90

0

10

20

30

40

50

60

70

8080

95

100

Note: Financial investors includes private equity, family office, and other funds.

No

. of

fina

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l inv

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r d

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Notable financial investor deals:

US-based CRO (contract research organisation) PAREXEL was acquired by UK-based PE firm Pamplona Capital Management. The deal was valued at €4.3bn (14x EBITDA).

French PE firm Ardian has been a particularly active investor in the outsourcing segment. In late 2016 it acquired a majority stake in CiToxLAB Group, a French provider of pre-clinical services to pharma companies. In early 2017 it invested in Unither Pharmaceuticals, a German CMO (contract manufacturing organisation), acquiring a majority stake alongside Keensight Capital and Parquest Capital.

Another PE firm active in the market has been UK-based Charterhouse Capital Partners. In 2016 it acquired Vemedia Pharma, a Dutch manufacturer of OTC products, for €325m (8.5x EBITDA). This year it acquired a majority interest in Serb SAS, a French manufacturer of pharmaceutical preparations, in a leveraged buyout transaction.

Segment breakdown

Pharma and Biotech

Pharma and biotech have been active segments in the last 12 months, accounting for 23% and 21% of total global M&A activity respectively.

Some 60% of deals in the pharma segment were focussed on boosting drug pipelines of large pharma companies - such as US-based Johnson & Johnson (J&J) and Switzerland-based Novartis - which have been under immense pressure from investors due to rising competition from generics. Up to 30% of deals involved the purchase of companies with commercial drugs in the market.

Recent notable pharma deals include:

J&J acquired Switzerland-based Actelion for €26.6bn (32.5x EBITDA), adding its innovative products for pulmonary arterial hypertension (PAH) to its portfolio of specialty medicine. J&J expects to retain Actelion’s presence in Switzerland and leverage its complementary capabilities in shaping medical paradigms.

Novartis acquired Selexys Pharmaceuticals, a US-based clinical-stage company developing drugs to treat inflammatory and thrombotic diseases, for €618m.

The majority of biotech deals (82%) were focussed on acquiring clinical-stage companies that have a few drugs in the development phase, mainly for treating cancer and rare diseases. This trend suggests that the biotech sector is moving towards speciality medicine. Key advantages of having a robust drug portfolio in speciality medicine include:

Drugs are generally developed for therapeutic areas with high unmet needs. Due to high requirement and low competition, manufacturers are able to facilitate faster regulatory approvals and negotiate high prices for their drugs.

A majority of speciality medicines are biologics, which are less prone to generic competition. Compared with small molecule drugs, biosimilars have a much lower post-patent expiry price reduction.

A CL E A RWA TE R IN TE RN A T ION A L HE A L THCA RE TE AM REPORT

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Some recent key deals in biotech include:

Japanese company Astellas acquired Germany-based Ganymed Pharmaceuticals for €449m – the developer of monoclonal antibody IMAB362. The Phase-II drug candidate is being developed for treating gastrointestinal adenocarcinomas and pancreatic tumours.

Ireland-based Horizon Pharma acquired River Vision, a clinical stage company based in the US, for €131m. The latter is developing a fully human monoclonal antibody – teprotumumab (RV001) – for the treatment of Thyroid Eye Disease (TED), a rare, autoimmune inflammatory disorder. The acquisition is in line with Horizon’s strategy of investing in late- stage medicines for the treatment of rare diseases.

Deals by segment (Oct 2016–Sep 2017)


Oncology Competition in the therapeutic market is driving the biotech and pharma sectors to acquire oncology assets. For instance, France-based Ipsen acquired Onivyde, Merrimack Pharmaceutical’s pancreatic cancer drug.

Another noteworthy transaction was the €4.3bn acquisition of ARIAD Pharmaceuticals, a US-based pharma company focussed on the discovery and development of medicines for rare cancers, by Japan's Takeda Pharmaceuticals.

With this acquisition Takeda acquired two innovative assets, Alunbrig and Iclusig. From Takeda’s initial estimates Alunbrig, an ALK (anaplastic lymphoma kinase) inhibitor currently being developed for the treatment of non-small cell lung cancer, has the potential to achieve peak annual sales of over €800m.

Rare diseases Pharma and biotech companies are shifting their R&D focus to niche drugs based on personalised therapies. Orphan drugs offer various legal, legislative and financial benefits which are attracting various companies to the market. The orphan drug market is expected to grow at a 9.2% CAGR from 2016–20221.

A noteworthy deal in this space was the acquisition of True North Therapeutics, a US-based clinical–stage biotechnology company focussed on the development of product candidates in rare diseases, by Bioverativ for €722m.

Bioverativ, a biotechnology company focussed on haemophilia and other rare blood disorders, was launched in 2017 by Biogen. It obtained global rights to True North’s lead candidate, TNT009, a monoclonal antibody which has received a breakthrough therapy designation for the treatment of haemolysis in patients with cold agglutinin disease – a rare and chronic autoimmune haemolytic condition.

1 Market Research Future, July 2017

22%

18%23%

11%

4%

1%


Generics

Biotech

Pharma

OTC

Animal health

Others

21%


Outsourcing

Due to increasing competition and demand from biopharmaceutical companies, outsourcing providers are looking to M&A to enhance their capabilities, services, therapeutic expertise and geographical presence.

Recent notable deals include:

Quintiles Transnational Holdings acquired IMS Health Holdings in a deal worth €7.9bn (13.3x EBITDA) which creates the largest CRO globally. QuintilesIMS will now target outsourcing services including drug development, clinical research, patient access, real world analytics and consulting.

INC Research Holdings acquired InVentiv Health in a deal valued at €3.9bn (11.0x EBITDA), creating the second largest biopharmaceutical outsourcing provider in terms of net revenue. INC Research mainly provides services to small and mid-sized pharma companies, while InVentiv works with large biopharmaceutical companies.

Switzerland-based Lonza Group, a contract manufacturer of custom APIs (Active Pharmaceutical Ingredients), acquired Capsugel, a US-based designer and developer of innovative dosage forms for biopharmaceutical companies. With the deal (worth €4.8bn, 15.1x EBITDA), Lonza aims to accelerate its growth by adding oral dosage delivery technologies to its portfolio.

Meanwhile with the strong involvement of private equity firms, the outsourcing segment is consolidating. Several investors have purchased outsourcing service providers from other PE or financial investing firms in secondary buyout deals such as:

A consortium led by AGIC Capital acquired Ritedose from Olympus Partners in a deal valued at €543m. US-based Ritedose is one of the largest providers of blow fill seal (BFS) manufacturing services for pharma companies. The pharma packaging market is expected to grow at a CAGR of 6.4% from 2016–20212.

Metalmark Capital acquired a majority stake in Premier Research Group (PRC) from Indigo Capital for €32.7m. PRG is a UK-based CRO that provides clinical development services to biotech and specialty pharma companies. With Metalmark’s investment, PRC plans to hire more experts in neurology, oncology and rare diseases, and upgrade its technological footprint.

Generics

Increased pricing pressure in the US and Europe continues to act as a catalyst for global M&A activity. With more generics entering the market and consolidation of drug distribution channels, the segment is significantly impacted by pricing pressure, further cutting manufacturer margins. To protect profits many businesses are consolidating to add scale, reach and achieve cost savings through synergies.

2 MarketsandMarkets, February 2017

Recent notable deals include:

Japan-based Sawai Pharmaceutical acquired the generics business of US-based Upsher-Smith Laboratories for €951m. Upsher-Smith has an established, extensive portfolio of 30 approved drugs, as well as a pipeline of about 30 products. Sawai will also get two manufacturing sites and plans to maintain the Upsher-Smith name in the US.

Pfizer acquired AstraZeneca’s antibiotic division for €1.5bn, which will now become part of Pfizer’s Essential Medicines business. The AstraZeneca divestment forms part of a larger restructuring under which it is gradually selling-off assets that do not align with its focus on its key therapeutic areas – respiratory, diabetes and cancer.

Animal health

The sector recorded 24 deals globally with a total value of €12.6bn in the last 12 months, compared with 25 deals and a deal value of €2bn in the 12 months before. The value of disclosed deals has risen significantly, while the number of deals has remained constant, suggesting that we might be starting to see increased competition for scarce assets.

The US was the most active market with 39% of total closed deals, compared with 36% in the preceding 12 months. A drop in M&A activity was observed in China, with just one transaction in the past year, compared with three during the previous year.

Some 89% of deals with a US company as a target were domestic, while one of the largest deals saw the acquisition of the feline, canine and rabies vaccines portfolio of Boehringer Ingelheim Vetmedica by Eli Lilly and Company Limited, through its subsidiary Elanco. The deal was valued at €804m.

Companies in France and Germany were among the most active in terms of cross-border purchases, while an interesting trend has also been the swapping of assets between pharmaceutical companies in an effort to strengthen their portfolios and shed non-core assets.

12

Notable recent deals:

The largest transaction over the past 12 months was the €11.4bn business swap deal between Boehringer Ingelheim (BI) and France-based Sanofi. BI acquired Merial (Sanofi’s animal health business) in exchange for its consumer health business. Merial has three business segments – farm animals, pets and veterinary public health. The deal makes BI the second largest player in the animal health domain and expands Sanofi’s geographical presence in the non-prescription medicine market.

In a deal valued at €374m, US-based Merck Animal Health acquired a 93% stake in Vallée – a Brazilian manufacturer of animal health products. Vallée offers more than 100 products, including animal vaccines, anti-infectives and parasiticides. With strong growth in the cattle industry in South America, this deal significantly strengthens Merck’s presence in the Latin American market.


Global animal health deals (Oct 2016–Sep 2017)

39%

4%

9%

26%

22%

US

India and China

UK

France and Germany

RoW


US

204 deals worth €47.5bn have been recorded in the last 12 months, compared with 230 deals worth €127bn in the previous 12-month period.

Decline in deal activity is due to the uncertainties caused by President Trump’s administration with many acquirers waiting for a clearer picture of the various amendments to existing policies and the formation of new policies.

For instance, Trump’s proposed one-time mandatory repatriation of cash held overseas at a 10% tax rate, as opposed to the 35% rate companies currently pay in the US, could bring over €100bn of US pharma company cash back into the US, spurring the M&A environment.

Drug pricing has also been a major agenda for the Trump administration and the President has been extremely vocal against high-priced drugs. The administration aims to increase competition among pharma companies through bidding wars, thereby exerting pressure on the bottom lines of pharma companies.

Another issue is the use of various cost-containing mechanisms by Pharmacy Benefit Managers (PBMs). For example, CVS/Caremark excluded 17 drugs from its 2018 formulary and introduced a new programme, Transform Value, aimed at controlling cost in managing chronic diseases such as oncology and obesity.

Deals by investor type – trade vs. financial

Trade buyers constituted the largest share representing 86% of total deals in the last 12 months, a 3% reduction in share from the same period in the previous year. Financial institutions and private equity firms continued to invest due to readily available capital and low interest rates.

The majority (48%) of deals occurred in outsourcing with the segment forecast to witness strong growth. However some investors did not actively pursue targets in pharma as they waited for the regulatory and political environment to become clearer.

During the first nine months of 2017, there have been 150 deals with a combined value of €33.7bn.

0

10

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30

40

50

25

29

Oct 15 - Sep 16 Oct 16 - Sep 17

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Segment breakdown

Almost a third of M&A activity was registered in the biotech segment, with companies focussing on strengthening pipelines to remain competitive. Other segments that have witnessed a significant number of deals include outsourcing services (28%) and pharma (18%).

In terms of deals values, the US market saw three mega deals in the outsourcing segment, which involved two mergers in the CRO/CDMO space with the acquisition of Capsugel by the Lonza Group, and IMS Health by Quintiles.

Mega deals also included large investments by financial firms. For instance, a consortium comprising the Carlyle Group and GTCR acquired Albany Molecular Research, a global CDMO, for €1.3bn (22x EBITDA).

14


Private equity firm Linden acquired ProPharma Group, a provider of outsourcing services to biotechnology, pharma and medical device customers. Linden has also acquired MeriCal, a contract manufacturer for nutraceutical manufacturers, and Chesapeake IRB, a provider of independent institutional review board services to pharma companies.

Switzerland-based Partners Group Holding acquired an undisclosed majority stake in PCI Pharma Services,

a provider of drug development, manufacturing, and packaging services for pharma companies. The acquisition allows PCI to expand its product portfolio and grow the company both organically and through bolt-on acquisitions.

Sweden-based investment firm EQT Partners acquired US-based Certara for €738m. Certara provides drug development modelling software and regulatory services to global pharma companies.


Notable deals:

Sumitomo Dainippon Pharma America acquired Tolero Pharmaceuticals, a clinical-stage biotechnology company that focusses on oncological and haematological diseases. Through the acquisition Sumitomo acquired six compounds, including alvocidib, with orphan drug designation. The deal strengthens Sumitomo’s oncology pipeline and was valued at €734m.

In a deal worth €730m Dendreon Pharmaceuticals, a Valeant Pharmaceuticals subsidiary, was acquired by privately owned Chinese conglomerate Sanpower Group Company. Dendreon Pharmaceuticals markets Provenge which is the only FDA-approved vaccine for prostate cancer.


28%

9%

18%

10%

4%

1%

30%


Generics

Biotech

Pharma

OTC

Animal health

Others


UK

The slowdown in UK deals shows the uncertainty surrounding UK-EU relations in the wake of Brexit discussions, with a large number of the deals focussing on acquiring strategic assets rather than entire companies. However, with rising government investments to boost medical research, investor confidence is likely to increase M&A activity over the medium term.

As an acquirer the UK accounted for 35 deals, a 29% decline compared to the preceding 12 months. Eighteen of the 35 deals were in the outsourcing services segment, indicating efforts by CROs/CMOs to strengthen their presence inside and outside the UK.

For instance drug development services provider Quotient Clinical acquired US-based CDMO QS Pharma for €71m. Another deal saw CRO Ergomed expand its presence in the Czech Republic with the acquisition of European Pharminvent Services, a CRO focussed on providing clinical development services to the pharma industry.

The last 12 months has also seen a big increase in the proportion of deals involving financial investors, rising to 15% compared to 6% last year. This is largely due to the immense interest the consolidating outsourcing services segment has generated among UK investors.

Europe is the second largest M&A market after the US. Led by the UK, France and Germany, the continent saw 192 deals over the last 12 months. In terms of acquisition targets, the UK saw 33 deals as targets in the last 12 months – a 3% decrease compared to the previous 12 month period.

Deals by investor type – trade vs. financial (Oct 2016–Sep 2017)


LDC acquired Fishawack Communications for €44m, in a management buyout deal that represented an exit for Growth Capital Partners. Fishawack Communications provides medical communications, pharmacovigilance and market access services to pharma companies. Clearwater International advised LDC on the transaction.

Graphite Capital acquired medical animation and digital content producer Random42. Random42 expects to grow its revenue by 20% per annum, reaching more than €100m by 2021, representing almost 40% of the overall healthcare animation market.

Trade

Financial investors

15%

85%



The outsourcing segment witnessed the most deals, representing 49% of total deals in the UK. A quarter of the deals in the outsourcing segment involved a CRO/CDMO with the remainder focussed on companies providing services such as regulatory consulting, medical communication and market access research.

Notable Deals

Pharma services provider Cyprotex was acquired by Evotec, a German CDMO providing integrated drug discovery and development services, for €59m. The acquisition enables Evotec to meet the market’s increasing requirement to screen drug liabilities.

Bionical, a clinical services provider, acquired Emas Pharma, a CRO that provides clinical research, pharmacovigilance, regulatory, medical information and medical affairs services. The acquisition helps Bionical expand its presence in the UK, US, Canada, Australia and Ireland, countries where Emas has a strong client base.

Accord Healthcare acquired the generic assets and operations of Actavis in the UK and Ireland from Teva Pharmaceutical Industries, for €685m. The transaction was part of the European Commission’s anti-trust divestiture requirements that arose following Teva’s acquisition of Allergan’s generics business in 2016.

In a deal worth €323m, South Africa-based Aspen acquired the anaesthetics portfolio of GlaxoSmithKline (GSK). Aspen gained global rights to Ultiva, Nimbex, Tracrium, Mivacron and Anectine. In 2016, the anaesthesia portfolio generated revenues of more than €70m and this transaction is part of a move by GSK towards focussing on its core therapies.

49%

18%

15%

9%

6%3%


Generics

Biotech

Pharma

OTC

Animal health


Brexit

Ahead of Brexit the UK government has plans to boost the pharma sector with fresh investments and public-private collaborations. The aim is to strengthen areas such as the funding of basic science, provide new incentives for manufacturing, and promote increased co-operation between drugmakers and the National Health Service (NHS).

In a study commissioned by the UK government, in consultation with the NHS, the Association of the British Pharmaceutical Industry and the BioIndustry Association, the following strategies were highlighted to bolster the industry:

The creation of a Health Advanced Research Programme which will help

support ambitious, long-term projects in the fields of genomics, diagnostics, digital health technology, artificial intelligence and healthy ageing.

Over the next decade attract the investment needed to create four UK-based companies with a market capitalisation of more than €20bn and attract 10 large (€50-250m capital investment) and 10 smaller (€10-50m) life sciences manufacturing facilities.

Increase funding until 2022 to ensure the UK is in the upper quartile of OECD R&D investment, and enhance the country’s clinical trial capabilities to increase the number of trials by 50%.

“With demand for outsourcing services still strong and despite uncertainties around Brexit negotiations and general R&D funding, UK companies continue to turn to M&A, especially outbound, which made up two thirds of deals in the last year, to stay competitive.”

Ramesh Jassal, International Head of Healthcare, Clearwater International UK


Ireland

M&A activity

Due to anti-tax inversion laws introduced by the US government, Ireland has seen a considerable drop in M&A activity with a notable absence of high value acquisitions from overseas. Indeed, over the past 12 months there were just two deals with Irish targets, both in the outsourcing segment. However, in terms of acquisitions, Irish acquirers accounted for 13 closed deals with a total deal value of €2.6bn over the past year.

Allergan, fresh from the sale of its generics business to Teva in 2016, continued to pursue substantial M&A activity with four deals worth a total of €2.1bn. UDG Healthcare was another active acquirer, completing three acquisitions in the past 12 months, one in Ireland and two in the US. All of its acquisitions provide business research and marketing outsourcing services to pharma companies.

The UK remains Ireland’s biggest trading partner and over the past year companies such as UDG Healthcare and Uniphar have continued to invest in the country’s outsourcing services sector. However, M&A activity in Ireland could be significantly impacted by Brexit due to its close economic ties with the UK.

That said, it is thought that a significant number of UK pharma companies might

relocate their operations to ensure they have access to the European market, which could present a number of potential opportunities for Ireland.

Notable deals:

UDG Healthcare, a clinical development, commercialisation and packaging provider, acquired UK-based STEM Marketing, a provider of commercial, marketing and medical audits to pharma companies in a deal worth €67m (10.8x EBITDA).

Uniphar acquired UK-based OUTiCO, a provider of business research and consulting services. The former will benefit from the latter’s expertise in providing multi-channel outsourced sales and marketing programmes for pharma companies across the UK.

ICON boosted its presence in commercialisation services and outcomes research with the acquisition of the German Mapi Group. The acquisition will enhance ICON’s presence in Germany, France, UK, Italy, the Netherlands, Spain, Sweden and Poland.

Ireland is one of the fastest growing economies in the EU and has been an attractive destination for global pharma and biotech companies, mainly due to low corporate tax rates.

“We expect major Irish companies to remain acquisitive in the global pharma market. Brexit represents a significant challenge, however it could also present considerable opportunities in relation to UK pharma companies relocating their operations to Ireland in order to access the European market.”

John Curtin, Partner, Clearwater International Ireland

Of these deals 71% involved domestic players, a significant increase over the previous year when under half of deals were domestic.

The majority of transactions occurred in the generics segment (29%), followed by pharma (23%) and OTC (18%). Of the 17 deals all involved trade buyers apart from a single financial investor transaction. This compares to six financial investor deals during the previous year, and is likely to be as a result of current political uncertainty in the region which has led to a lack of a stable government, difficulty in forecasting, and an ambiguous regulatory environment.


18%

29%

23%

12%

18%


Iberia

The market has seen 17 deals in the last 12 months with 71% of the acquisition targets located in Spain and the remainder in Portugal.

Notable deals:

Faes Farma acquired Laboratories Diafarm, a food supplements and cosmetics manufacturer, for €70m.

US group Archer Daniels Midland acquired 90% of the shares of Biopolis, a biotechnology company developing microorganisms and metabolites for the pharma, public research and cosmetics industries.

Exeltis, part of the Chemo Group, acquired the Juste Farma division of Juste SAQF. Juste Farma is involved in the research and sale of pharma products for gynaecology, the central nervous system and primary care, featuring drugs used to treat insomnia, depression and epilepsy.

Kern Pharma, a pharma company manufacturing generics and biosimilars, acquired Actafarma, the personal care product developer.

HC Clover was acquired by MCH Private Equity Investments. Clover manufactures and supplies soft gelatine capsule products for clients in Spain and internationally. Clover has expanded production seven-fold in the last five years and the investment from MCH will help it set up a new industrial facility and support its growth.

Spain

With the Spanish economy showing modest growth, the introduction of tax incentives by the government is expected to contribute to the growth of the pharma sector. An ageing population, new clinical trial regulations, R&D infrastructure and a quality workforce are expected to be further drivers.

Over the previous year there were 12 deals involving Spanish targets with transactions across all segments of the market.


Generics

Pharma

Biotech

OTC


Portugal

Portuguese targets featured in five transactions in the last 12 months, of which three were from the generics segment. Thus far there has only been one deal involving a Portuguese acquirer, a signal of significant inbound investment into Portugal.

“Within the generics market the need for relevant economies of scale could result in acquisitions of Spanish companies by multinationals. In the OTC market, the available liquidity of funds could lead to concentration moves in a highly fragmented market.”

Miguel Angel Lorenzo, Director, Clearwater International Spain

Notable transactions

Agile Pharma, a subsidiary of Aurobindo Pharma Ltd, acquired Generis Farmacêutica, a generics manufacturer, from Magnum Capital Industrial Partners, for approximately €135m. With the acquisition Aurobindo Pharma expands its portfolio to 271 products in the EU, making it the largest generics manufacturer in Portugal.

Spanish pharma company Uriach acquired Theralab, a company specialising in dietary supplements, dietary products, teas, medicinal plants, and cosmetic and hygiene products.


France and Germany

Total deal count has increased by 5% with 43 deals in the last 12 months. Almost 60% of the deals were domestic with outsourcing being the most active segment.

This represents a significant change from the previous 12 months when a majority (54%) of deals were cross-border with UK and US-based companies being particularly active. The decline in cross-border deals is likely to be as a result of the ongoing Brexit negotiations and wider political uncertainty.

There were 12 financial investor deals compared to eight in the preceding 12 month period, reflecting rising investor confidence in the region.

France

France is the second largest pharma market in Europe but due to the recent shift of the government towards the use of generics to reduce cost, as well as patent expiries and fluctuating foreign exchange rates, the market is expected to witness a negative CAGR of 1% from 2017-20211.

France follows external reference pricing, whereby drug costs are linked to price reductions in other EU countries. Hence pharma companies need to focus on innovative therapies that can generate a premium price. This is likely to drive M&A activity as pharma and biotech companies look to acquire clinical-stage assets to replenish their pipelines.

In terms of inbound M&A, France recorded 27 deals over the last 12 months worth €12.2bn, a 50% increase in deal number on the previous year. Outsourcing services accounted for the majority of deal volume representing 33% of closed transactions, followed by pharma with eight closed deals.

2017 has so far seen 34 deals with 23 acquisition targets located in France and 11 in Germany.

Notable deals:

Ipsen acquired five consumer healthcare products from Sanofi to further develop and strengthen its portfolio of prescription and OTC products in France and Central Europe, in a deal valued at €85m. The acquired products include Prontalgine, an analgesic only available in France for the treatment of moderate to severe pain, antispasmodic Buscopan, a laxative Suppositoria Glycerini, and Mucothiol and Mucodyne for cough and flu.

Oncodesign, a company involved in pre-clinical research for cancer therapies, acquired The François Hyafil Research Centre from GSK, for €53m, enabling it to accelerate its diagnostic and therapeutic research.

To strengthen its portfolio in oral pathology Vectans Pharm acquired two drugs, Sitavig and Loram, for the treatment of labial herpes and oropharyngeal candidiasis from Onxeo. Onxeo divested these non-core products to focus on orphan drugs related to oncology.

Ceva Santé Animale completed three acquisitions in the last 12 months, two of which were in Brazil and one in Germany. All three were aimed at boosting presence in the animal health segment. Its last acquisition was of Boehringer Ingelheim’s portfolio of Merial swine and cattle vaccines and anti-inflammatories.


Germany

Germany is the largest pharma market in Europe and has become highly attractive due to the increasing prevalence of chronic and lifestyle disorders and the rising ageing population. Improved health awareness has also increased demand for medical products and innovative therapies, such that the German pharma market is expected to grow at a CAGR of 4.9% from 2017-20211.

Low corporate taxes and interest rates, and a transparent regulatory system further encourage foreign investors to enter the market.

As such there has been significant M&A activity with 16 deals in the last 12 months, the generics segment being the most active.

1 GlobalData, May 2017

Notable deals:

A Cinven-Bain consortium acquired a 63.9% stake in German generics manufacturer STADA Arzneimittel AG. The offer values the company at €5.2bn, making it Europe’s largest buyout in four years.

China-based financial investor Chutian Asset Management acquired a 75.1% stake in Romaco Holding, a manufacturer of packing and process technology, for €97m.

IK Investment Partners acquired APOSAN Dr. Künzer, a pharma homecare company, for €18m. The APOSAN group of companies offers services to patients that require long-term infusion for diseases, as well as ophthalmic and nutrition solutions. The acquisition allows IK to target niches within the German homecare market and continue to build on its expertise in the sector.

“Globally competitive German companies continue to interest financial sponsors, attracted by the significant growth expectations. We anticipate add-on acquisitions in many cases.”

Markus Otto, Partner, Clearwater International Germany


Scandinavia

There have been 14 deals in Scandinavia over the past 12 months with the vast majority of acquisition targets located in Sweden (64%), followed by Denmark (21%) and Norway (15%).

The OTC segment, with a total of five deals, was the most active segment followed by pharma which registered four deals.

Sweden

The life sciences industry in Sweden is home to around 1,500 companies operating within the pharma and biotech sector. The pharma industry is the second largest export industry in Sweden with about 800 companies focussed on research and development programmes based in the country.

As of late 2016, Sweden had c. 140 projects in Phase I to Phase III clinical development, with oncology being the most dominant area, and some 45 projects targeting orphan diseases.

In the wake of Brexit discussions, Sweden has made an official offer to become the new headquarters of the European Medicines Agency, which would be a major boost for Sweden's thriving pharma and biotech sector.

Meanwhile M&A activity declined slightly with nine deals recorded in the last 12 months with Sweden as an acquisition target, compared to 12 deals in the previous year. The most active segment was pharma, accounting for four deals.

So far in 2017 we have recorded seven deals in the region with Sweden leading the way.

Notable deals:

Insmed acquired exclusive rights to compound AZD7986 for the treatment of non-cystic fibrosis (CF) bronchiectasis from AstraZeneca, for €169m. AZD7986 had reported positive results in Phase-I studies and it plans to develop the drug for treatment of non-CF bronchiectasis, a lung disorder with a global prevalence of around 2 million people, of which more than 100,000 cases are estimated to be in the US.

AstraZeneca sold its antacid brand Neksium to Pfizer for €10.6m. Pfizer, which already has brands such as Gelusil and Mucaine in the antacid space, expanded its portfolio in gastrointestinal therapy.

Karo Pharma acquired Biophausia, a proprietor of a portfolio of 13 Nordic brands and a subsidiary of Medivir, for €98m. With this divestment, Medivir intends to focus its research and development on oncology and infectious diseases.

Norway and Denmark

Pharma prices in Norway are among the lowest in Europe while the market is receptive to new therapies and is growing strongly due to increased consumption as a result of the ageing population and the introduction of new drugs. International reference pricing has had a moderating effect on pharma price levels, and a step-price system for off-patent drugs has ensured that generic drug prices are reduced.

Over the last year Norway saw two deals, one of which was from a financial investor. Three deals were seen in Denmark where pharma products are the country’s largest export and the Medicon Valley life science cluster represents around 60% of the Scandinavian pharma industry.

Various factors are likely to continue to drive global pharma companies to set up operations in Denmark. These include: shorter registration periods for pharma products compared to the US and the rest of Europe; and low corporate taxes and the absence of capital duty, share transfer duty or wealth taxes.


Notable deals:

CMC Biologics, a CDMO manufacturing monoclonal antibodies, coagulation factors and other therapeutic proteins, was acquired by AGC Asahi Glass, for €661m. With the acquisition, Asahi plans to strengthen its presence in the Danish and US CDMO markets. Recently Asahi also acquired Biomeva, a German clinical supply producer. With these acquisitions Asahi intends to become an integrated provider of contract drug development services for biopharma companies.

Investment firm EQT Partners acquired Fertin Pharma for €270m. Fertin is a producer of medicated chewing gum mainly for nicotine replacement therapy. It is one of the largest manufacturers that develops pharmaceutical chewing gum with different APIs and nutraceutical chewing gum products. Fertin was acquired from the Bagger-Sorensen family that reinvested part of their proceeds to keep a 30% stake in the company.

“We expect M&A growth in the Nordic region, as big pharma companies face the challenge of obtaining organic growth, and thereby look towards other strategic opportunities.”

Louise Kamp Nørbæk, Associate Director, Clearwater International Denmark


CEE marketThe market is dominated by generic drug companies due to the reimbursement policies put in place by governments that provide access to drugs at affordable prices. There are a large number of generic companies in CEE such as Zentiva (Czech Republic), Gedeon Richter (Hungary), Polpharma (Poland), Krka, and Lek (Slovenia).

The governments in this region are focussed on expanding healthcare access by encouraging cross-border trade, regulating drug prices and improving healthcare policies.

For instance the pharma market in Poland is expected to increase from $9.4bn in 2016 to around $11bn by 20211. Factors such as mandatory universal healthcare coverage and reimbursement policies, and increasing compliance and access to medicines, are boosting the market.

Under the Operational Programme for Infrastructure and Environment developed by European agencies, around €2bn has been earmarked for promoting healthcare which is likely to boost foreign investment in the country.

M&A activity

So far we have recorded 12 deals in the last 12 months compared to 14 deals in the previous year. OTC was the largest segment accounting for 33% of the total deals. The robust activity recorded in the OTC segment is in line with the global trend of growing OTC sales in developing countries due to rising incomes. Acquisition targets were primarily from Bulgaria (three), Czech Republic (three), Romania (three), followed by Latvia, Hungary and Poland with one each.

1 PharmaExec.com, June 2017

Notable deals:

Serum Institute of India acquired Czech Republic-based Nanotherapeutics Bohumil, an injectable polio vaccine manufacturer, for €72.2m. The acquisition will make the company the world’s largest such manufacturer by increasing its production capacity four-fold by 2019.

Ascendis Health Limited, an OTC manufacturer, acquired Romania-based Sunwave Pharma for €16.6m, enabling the company to enter the high-growth OTC market in Romania and other Eastern European countries.

Sopharma has been one of the most active companies in Bulgaria, buying four companies in the past 12 months. These acquisitions were domestic trade deals in segments such as OTC, outsourcing services and generics.


India and China

India and China have together seen 78 deals in the last 12 months compared with 89 in the previous 12-month period. China accounted for 53 deals worth €3.7bn, while India recorded the remaining 25 deals worth €762m. Some 94% of the acquisition deals in China were domestic and 72% of deals in India were among domestic players.

India

The pharma industry is expected to reach €46bn by 2020 at a CAGR of 15.9%1. Due to the large number of US FDA-approved manufacturing sites and low operating costs, India has a strong position in the global generics market. With several branded drugs expected to go off-patent in the US and EU, the Indian generics market is going to be positively impacted.

Mid-sized Indian companies are particularly emerging as attractive acquisition targets for global players. For instance Baxter acquired Indian generics manufacturer Claris Injectables for €542m. Claris Injectables manufactures generic analgesics, renal medicines and anti-infectives.

There is also growing interest among Indian companies in the biosimilar market, with about 25 companies operating in the sector. The recently implemented Goods and Services Tax (GST), and the government’s effort to curb rising drug prices, has had a major effect on the Indian pharma industry.

There has also been noteworthy activity in the sterile injectables segment with two large inbound deals. These include the acquisition of an 86% stake in Gland Pharma Limited by Shanghai Fosun Pharmaceutical, and the aforementioned acquisition of Claris Injectables by Baxter.

So far 2017 has seen 51 deals with a combined value of €2.9bn.

Notable deals:

The Indian operations of Kemwell Biopharma, including FDA-approved API manufacturing, were acquired by Swedish CDMO Recipharm in a deal worth €99m. The deal was two-staged, with the first acquisition comprising operations in the US and Sweden, and the second including Indian operations.

Advanced Enzyme Technologies, a company manufacturing enzymes, acquired a 70% stake in JC Biotech which manufactures a proteolytic enzyme serratiopeptidase.

Strides Shasun, an API manufacturer, acquired Perrigo’s FDA-approved API facility in India, in a deal worth €14m. With the acquisition all the integrated DMFs (Drug Master Files) filed for captive consumption will be transferred to the acquired facility.


China

The Chinese pharma market is the second largest after the US with an annual growth of c. 10%. About 80% of the market is dominated by generic drugs with the remaining 20% filled by patented drugs.

China is the biggest producer of pharma ingredients accounting for roughly 40% of global API production due to low cost and bulk production capacity. However recently manufacturers have become more interested in the development of finished pharma products due to their higher profit margins. The market is highly fragmented with approximately 500 biopharmaceutical companies and multinational CROs in operation.

China has been an attractive target for global players, both in terms of R&D and manufacturing facilities. In the past 12 months, the majority of M&A activity was seen in the generics segment accounting for about half of closed deals. While the majority of deals featured domestic acquirers there were three cross-border deals, one each from the UK, Canada and Hong Kong.

1 Economic Times, August 2017

Notable deals:

CSL Behring acquired an 80% stake in Wuhan Zhongyuan Ruide Biological Product, a plasma manufacturer, for €306m. CSL Behring is a provider of imported Albumin in China and this transaction will strengthen its presence in the plasma fractionation market.

Shandong Jincheng Pharmaceutical acquired Beijing Laneva Pharmaceutical, a pharma company providing clinically tested steroids, for €272m.

Financial investors Changjiang Runfa Zhangjiagang Bonded Area Pharmaceutical acquired Hainan Hailing Chemipharma, an antibiotic manufacturer, for €232m.

Shanghai Modern Pharmaceutical has been the most active acquirer in the country with five acquisitions in the last 12 months, with a total value of €721m. All of them were domestic deals involving pharma manufacturers, in deals which strengthen its manufacturing capabilities.

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