M&A: Fundamental to Pharma Industry Growth

The Executive Issue Feature: Mergers & Acquisitions

Mergers and acquisitions play a crucial role in the growth strategies for most pharmaceutical companies. Over the last few decades, waves of M&A have led to significant consolidation. Recently, big pharma has once again turned to megadeals to address pipeline, therapeutic, and geographic expansion needs. Bolt-on acquisitions have also increased as large biopharma firms snap up emerging/specialty companies with promising novel drug candidates.

M&A: A Key Component of the Biopharma Business Model

The biopharmaceutical industry is one of the most active sectors for mergers and acquisitions.¹ Greater numbers of deals and larger transactions are completed by pharmaceutical companies than are seen in other industries, including the tech sector. Both mega-deals and bolt-on acquisitions are a key component of the biopharma business model and crucial for achieving growth and competitive advantage.

Change in the pharma industry generally occurs slowly, except during periods where large numbers of drugs approach the patent cliff at the same time. In 2018, for instance, only one (Gilead) of the top 10 pharmaceutical companies had a history reaching back less than 100 years.¹ The other nine have survived by continually reinventing themselves, often via M&A in one form or another. M&A also enables biopharma firms to achieve strategic company repositioning under challenging conditions.

Megamergers have been particularly important. An analysis of 17 megamergers completed between 1995 and 2011 revealed that these large deals, on average, created shareholder value two to five years after the announcement of the transactions.² Returns were higher than the industry average, and, in general, the acquired firms contributed significantly to both overall and new-product revenues. With greater revenues and leaner cost structures, the acquiring companies increased their economic profit by an average of more than 50% two years after deal closure.

The most successful megamergers were those that involved the consolidation of companies with significant overlaps, with economic growth achieved in various ways, including accelerating revenue, reducing the cost of goods and overhead, rationalizing R&D activities, and improving working capital.²

While these deals were common in the mid- to late 1990s, the trend today is toward more growth-oriented deals designed to create new growth platforms. These transactions, however, are more complex and expensive and tend to generate lower-cost synergies. Historically, though, both types of megadeals have created shareholder value.

Many Drivers of M&A

All biopharmaceutical companies are looking to grow their businesses. M&A is an important mechanism for achieving growth when opportunities for organic expansion are limited or nonexistent. Consolidation, and megadeals in particular, provide drug companies with the level of income necessary to fund R&D and new drug development.¹ It is estimated that a biopharma company must spend $2 billion to $4 billion annually on R&D to establish a meaningful pipeline of candidates. Over the long term, most drug companies invest 20% of revenues in R&D. A revenue stream of greater than $10 billion is therefore needed to achieve successful organic growth.

Realizing that kind of revenue is increasingly challenging in the face of growing generic and biosimilar competition, downward pricing pressure, and shrinking pipelines due to patent expiries or R&D failures, and more complex regulatory requirements. M&A provides a means for gaining access to new revenue streams, particularly for companies with significant cash reserves.

In addition, emerging and specialty biotech/pharma companies, funded by venture capital/private equity firms, are responsible for a rapidly growing percentage of new drug development.¹ These companies are ideal targets for acquisition by big pharma organizations looking to expand their pipelines and gain access to next-generation technologies without needing to directly invest in R&D. As a result, the level of M&A activity has been quite high in recent years.

Most large pharma companies are also outsourcing clinical trial management and the manufacture of clinical trial materials and commercial products.¹ This approach eliminates the need to invest in capital-intense activities that provide a lower return. The growing interest in outsourcing across the entire drug development cycle is, in turn, driving consolidation among contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) seeking to position themselves as full-service, strategic suppliers.

A Look at the Top Deals

The largest pharmaceutical industry mergers and acquisitions have been valued at many tens of billions of dollars. Pfizer’s takeover of Warner-Lambert tops the list at nearly $90 billion.³ The next closest surpassed the $70 billion market, including the recent acquisition of Celgene by Bristol-Myers Squibb (BMS), Aventis by Sanofi, and SmithKline Beecham by Glaxo. Several deals have been valued above $60 billion, including the recent acquisition of Allergan by AbbVie, transactions implemented by Pfizer with Pharmacia, and Wyeth and Takeda’s purchase of Shire.

Other deals in the $30 to $60 billion range include the acquisitions of Allergan by Actavis, Genentech by Roche, and Covidien by Medtronic.⁴ More recent deals worth noting include Teva Pharmaceutical’s purchase of Allergan’s generics division in 2015, Shire’s acquisition of Baxalta, Bayer’s purchase of Monsanto in 2016, and Johnson & Johnson’s takeover of Actelion in 2017.⁵

Too Many Other Deals to Count

Nearly 50 biopharma industry M&A deals with a value (the highest transaction dollar value, not the inflation-adjusted value) greater than $10 billion were completed between 1995 and 2015.⁶ Nearly 1,350 M&A transactions with disclosed values totaling nearly $700 billion that involved pharmaceutical assets companies were announced during the first 10 years of this century.⁷ Most of the acquiring companies completed five or more deals during this period.

By 2015, pharma M&A deals completed in the first 10 months of the year were valued at $367.6 billion, with $271.4 billion taking place in the United States.⁸ The top deals that year (in reverse order) included Abbott-Alere, Mylan-Meda, Celgene-Receptos, Endo International-Par Pharmaceutical, Alexion Pharmaceuticals-Synageva BioPharma, Valeant-Salix Pharmaceuticals, Pfizer-Hospira, AbbVie-Pharmacyclics, and Teva-Allergan Generics and had values ranging from just under $6 billion to slightly more than $40 billion.

These lists reveal how many of the top pharma companies that exist today were born through M&A.⁴ Pfizer, the leading revenue earner, is the most obvious example with its multiple megadeals. Roche has completed small and large deals to establish a global presence, while Novartis has expanded its position in a variety of different therapeutic areas through numerous acquisitions, including eye-care company Alcon and gene therapy firm AveXis. Sanofi also completed a series of mergers to expand its reach geographically and into biologics, most notably with Synthelabo, Aventis (which was formed via the merger of Hoechst AG with Cassella, Roussel Uclaf, and Marion Merrell Dow), and Genzyme.

Similar stories can be told for the other leading biopharma companies, including Merck & Co., Johnson & Johnson, AstraZeneca, GSK, Gilead Sciences, and generic company Teva. Many of these firms have each completed 10–20 M&A deals in the last two decades.⁴

Evaluation of these transactions reveals a few interesting trends. During the beginning of the M&A wave, most deals were completed between firms based in the same country: Glaxo, Welcome, Smith and Kline in England, for instance.³ The case was the same in France, Japan, and the United States. International deals did not become popular until domestic transactions were no longer available. Today, the U.S. accounts for the largest percentage of deals, with not only other U.S. firms, but European and Asian companies as well.

While most companies integrate acquired entities, some, such as J&J, prefer to keep their acquired businesses relatively independent but within the overall group. Chemical industry–based firms played a role initially, but most have since exited the biopharma space.

There has also been a trend in recent years for very large pharma companies to spin-off or sell specific divisions with different business models or revenue streams (consumer and animal health, for instance) to create greater opportunities for growth.³ Further such activity can be expected as companies look to find the best solution for achieving optimum value.

Quite a Few Memorable Missteps Too

Not all pharma M&A deals have gone smoothly. Some have failed, and done so spectacularly, with consequences for the entire industry.

Interestingly, the company that has successfully completed the most megadeals — Pfizer — has also been responsible for several of the largest failures. The takeover of Warner-Lambert by Pfizer disrupted a deal already in place between the former and American Home Products (AHP), which Pfizer saw as a potential threat to its business. At the last minute, Pfizer offered a price sufficiently higher to tempt Warner-Lambert. AHP garnered a $2.1 billion payment from Warner-Lambert for reneging on the deal. AHP later changed its name to Wyeth, which was acquired in 2009 — by Pfizer.

Five years later, Pfizer was involved in a failed attempt to takeover AstraZeneca, for which it offered a record $105 billion (its third offer). The offer was rejected as being too low and also based on concerns that the merger would lead to significant job losses in the UK.

Valeant Pharmaceuticals made several offers for Allergan over a six-month period in 2014 but failed to reach a deal.⁶ The issue went to court, with Pershing Square Capital Management hedge fund owner Bill Ackman fighting against the deal. The fund owned 10% of Allergan at the time. Subsequently, in 2016, Pfizer’s $156+ billion bid for Allegan failed to reach completion. Pfizer planned to locate the new company’s headquarters in Dublin, Ireland, to avoid higher U.S. taxes. Legislation passed by the U.S. government in April 2016 to prevent such maneuvering nixed the deal. Allergan received a $128 million penalty from Pfizer for backing out. Allergan finally found a buyer in AbbVie, which paid $63 billion in 2019.

Dramatically Changing Landscape 

Between 1995 and 2005, most of the top 20 pharma companies were involved in deals valued above $10 billion.⁹ M&A, in fact, was essential to the success of the biopharma companies that existed 20 years ago; they could not have succeeded without it.¹ All told, 60 of the pharmaceutical companies that existed in 1999 have been consolidated into 10 big pharma firms.² Even more strikingly, over the last three decades, 110 companies have consolidated to about 30.¹⁰

In 1990, Merck & Co. was the number one pharmaceutical firm in the world based on prescription drug sales, followed by BMS (due to the merger of Bristol-Myers and Squibb), Glaxo, and SmithKline Beecham.¹¹ Ten years later, Pfizer held the top spot, with the newly formed GlaxoSmithKline in second place. Merck & Co. was in third, followed by AstraZeneca and BMS.

Also in the mid-1990s, several chemical companies owned leading pharma operations, including Ciba-Geigy, Hoechst, Sandoz, and Rhone Polenc.¹¹ These business units were spun off and acquired by other pharma companies, leading to the formation of bigger organizations and thus were not on the list by 2000. By 2011, Pfizer was still number one, but Novartis — formed from the merger of the pharmaceutical businesses of Ciba-Geigy and Sandoz — held the second position. Merck was still in the third spot, followed by Sanofi and AstraZeneca.

Consolidation in the Service Sector

Merger and acquisition activity has not been limited to drug manufacturers. As outsourcing of clinical research studies and development and manufacturing efforts has increased, service providers have been actively consolidating to meet the global, comprehensive, and evolving needs of their customers. Outsourcing provides cost and time efficiencies, as well as access to unique technologies, and many pharma companies, particularly small/emerging firms with limited expertise and resources, are relying more heavily on service partners for a greater percentage of activities across the development cycle.

Within the contract research space, global expansion and access to technology have become key drivers of M&A activity. The merger of North American CRO Quintiles with the European information and technology consultancy group IMS Health to form IQVIA is a prime example. The company not only manages clinical trials, but data too, and bills itself as an explorer of “Human Data Science.”¹² LabCorp is another large CRO that has pursued multiple small to large acquisitions in recent years in order to establish a leadership position in the CRO and testing markets, while also improving trial efficiency and patient recruitment. Icon’s acquisition of MAPI, meanwhile, established a firm specialized in late-phase research on a global scale.

In 2016, all CRO M&A deals together were valued at $24 billion, including the $13.3 billion Quintiles/IMS Health transaction.¹³ The total in 2017 was a healthy $13 billion. M&A is being pursued to broaden the range of services offered across different R&D phases (preclinical through phase III, as well as post-marketing and life cycle management) and to build out capabilities in data analytics and/or key CRO functions, such as patient recruitment and site management.¹⁴ Private equity is also getting more involved — evidenced by the buyout of Parexel in 2017 by Pamplona Capital.¹³ In 2018, the top ten CROs accounted for approximately 57% of pharma spending on CRO services.¹⁴

The CDMO market is fairly fragmented, comprising approximately 600 companies,¹⁵ with the largest holding just 2% to 4% market share.¹⁶ As in the CRO space, CDMOs are pursuing M&A to broaden their capabilities across the development cycle, access specialized technologies, and expand their global presence to be closer to their customers. Others are seeking to gain greater financial stability. They want to be able to meet the needs of pharmaceutical customers who are seeking fewer and more strategic outsourcing partnerships as a means to simplify their supply chains.

From 2012 to 2016, the number of publicly announced M&A deals increased by approximately 12% per year. Similarly, the value of deals in 2016 reached $12 billion, more than double the $5.5 billion observed in 2012.¹⁵ Notable deals in recent years have included the acquisitions of Capsugel by Lonza; Patheon and Brammer Bio by Thermo Fisher Scientific; Sigma Aldrich by Millipore; Paragon Bioservices, Juniper Pharma, and Cook Pharmica by Catalent; AMRI by the PE firms The Carlyle Group and GTCR; and Cambrex by an affiliate of the Permira funds.

Smaller deals of interest included Lonza’s acquisition of cell and gene therapy CDMO PharmaCell B.V., Evotec’s purchase of Aptuit, Eurofins Scientific’s acquisition of Alphora Research, the formation of AGC Biologics with the merger of CMC Biologics and Asahi Glass Company Bioscience with Biomeva GmbH, and the acquisition by various Chinese CDMOs of North American companies.

2017 was a pivotal year for the industry, when 12 significant M&A deals were completed in the CDMO space.¹⁷ Since that time, major deal activity has declined, with five in 2018 and two through the middle of 2019. This decline in big CDMO deals is in part due to the limited number of targets available for such transactions. The emergence of “mega-CDMOs” — CDMOs with revenues of $3 billion to $5 billion, including Catalent, Lonza, Thermo Fisher Scientific, and WuXi AppTec — is another factor.¹⁷

No major targets are left, and small acquisitions by these large firms add little to their bottom line. They are continuing nonetheless. Each firm must offer the same range of services to meet the comprehensive expectations of its customers, which is driving M&A activity, particularly in emerging therapeutic areas, such as cell and gene therapy.¹⁷

M&A in the past was also used as a means for expanding capacity. With capacity utilization at high levels today, that avenue is no longer open. Most CDMOs are, therefore, purchasing facilities that biopharma companies no longer need.¹⁷

2019 Another Big Year

All of the factors driving M&A in the pharma sector came to a head in 2019, which was a record-setting year in terms of both deal value and volume. Both megadeals and bolt-on transactions occurred at a tremendous pace. On a global basis, deal value and volume increased compared to 2018, with 1,276 deals totaling $411 billion completed through early December 2019 versus 1,230 deals totaling $298 billion in 2018.

Through the 10^th of the month, the number of deals in the United States alone totaled 484 — up from 365 for all of 2018.¹⁸ Those deals added up to $342 billion in M&A activity, a level not seen since 1995, the first year that Dealogic began tracking transactions. Just $97 billion was spent on M&A in 2018 — the lowest level observed in some time.

Interestingly, while the cumulative values of both megadeals and bolt-on acquisitions have increased dramatically over the last five years, the magnitude of those increases is noticeably different. In 2019, the total value of mega-combination deals was $137 billion — approximately 1.69 times the previous five-year average of $81 billion. For bolt-on acquisitions, the cumulative value in 2019 reached $56 billion, just 1.2 times the average for the last five years ($46 billion).

The biggest deals of the year included AbbVie’s acquisition of Allergan and BMS’ purchase of Celgene. Both moves were designed to boost pipelines. In AbbVie’s case, the company is preparing for the loss of patent protection for its blockbuster drug Humira. As a sidebar to the BMS’s Celgene deal, Amgen acquired Celgene’s leading drug Otezla for $13.4 billion.

Other notable deals included Eli Lilly/Loxo Oncology, Roche/Spark Therapeutics, Novartis/the Medicines Co., Novartis/AveXis, Sanofi/Synthorx, and Astellas Pharma/Audentes Therapeutics. Merck made or announced five deals in 2019: ArQule, Immune Design, Peloton Therapeutics, Versum Materials, and Tilos Therapeutics.

Many of these transactions are related to immuno-oncology or gene therapy. Developers of RNA interference (RNAi)–based therapies were also popular targets.¹⁹ Most also reflect the trend in the industry for big pharma to acquire pipeline candidates rather than invest heavily in discovery efforts of their own. They are all hoping to be as successful as Merck was with its $41 billion acquisition of Schering-Plough in 2009, through which the company gained Keytruda, a drug that has generated $103 billion in revenue since receiving FDA approval in 2014.¹⁸

Significant Implications

The high level of M&A reflects the incredibly dynamic nature of the biopharmaceutical industry today. Biologics are becoming more prevalent. Blockbusters are being replaced by niche medicines targeting small populations with rare diseases or limited subpopulations of patients with specific forms of widespread disorders, such as breast cancer and diabetes. Governments and payers are demanding reduced drug prices at a time when drug development costs are rising. Lower-cost generics and biosimilars are establishing a growing foothold, constantly raising the level of competition for branded drugs.

Meanwhile, patients are better informed and much more involved in healthcare decisions. Disease-focused support groups and charitable organizations are actively engaged in the drug development process. Digital technologies, such as artificial intelligence, machine learning, and natural language processing, are providing tools for analysis and synthesis of vast pools of data previously not accessible. The information garnered from these efforts is being applied in novel approaches to drug discovery and development. At the same time, next-generation medicines including cell and gene therapies require transformation with respect to manufacturing and logistics systems.

To stay competitive, drug makers must reduce costs and increase efficiencies across all business operations. Many have jettisoned non-core businesses, such as animal health and OTC products, and exited therapeutic areas in which they have limited expertise and minimal pipelines through asset swaps and portfolio deals.²⁰ Others have split off businesses to allow different segments the opportunity to build on their disparate strengths.

The high level of M&A activity reflects these turbulent times. Mergers and acquisitions are fundamental to the development of the pharmaceutical industry and a core component of growth strategies under the complex and challenging conditions that exist today.

While it has been demonstrated that M&A does provide financial benefits,² these transactions do involve a long and time-consuming administrative process that can add cost.²⁰ They can also impact employee morale and disrupt R&D, manufacturing, and other operations.

The key is to treat M&A as another business activity and provide expert support, either in-house or through a third-party service. A dedicated team with knowledge of not just regulatory requirements, but standardized processes and efficient approaches to integration, can facilitate mergers, acquisitions, and divestments throughout their full life cycles.²⁰ This type of multifunctional team should be able to work with all of the different individuals and groups impacted by transactions to minimize disruptions and speed the process. Data analysis assistance can contribute to effective strategic growth plans and identify potential divestment candidates.

References

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4. Back, Matthias. “The Top 10 Largest Pharmaceutical Mergers in History.” Process Worldwide. 17 May 2019. Web. 

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6. “List of largest pharmaceutical mergers and acquisitions.” Wikipedia. n.d. Web.

7. Ten-Year Data on Pharmaceutical Mergers and Acquisitions, from DealSearchOnline.com, Reveals Top Deals and Key Companies. Irving Levin Associates, Inc. 26 Mar. 2010. Web.

8. Hogg, Peter. “Top mergers and acquisitions in the pharmaceutical industry.” oclinical. 13 Apr. 2016. Web.

9. Visnji, Margaret. “Pharma Industry Merger And Acquisition Analysis 1995 To 2015.” Revenues and Profits. 11 Feb. 2019. Web.

10. Davidovic, David. “The History of Bio-Pharma Industry M&As, Lessons Learned and Trends to Watch.” PM360 Online. 23 May. 2014. Web.

11. Van Arnum, Patricia. “Decades of Change for the Top Pharmaceutical Companies.” Pharmaceutical Technology Sourcing and Management. 11 Jul. 2012. Web.

12. Challener, Cynthia A., Emilie Branch, Guy Tiene. “An Industry Stacked: Mergers & Acquisitions in Discovery, Manufacturing and Fill/Finish.” Pharma’s Almanac. 12 Mar. 2018. Web.

13. Roy, Pierre-Georges. “M&A trends in the CRO industry.” Results Healthcare Insights. 18 Dec. 2018. Web.

14. Objective Capital Partners. “CRO Sector Fundamentals Remain Hot for M&A Consolidation.” Life Sciences Insights. 3 Jul. 2019. Web.

15. Leewe, Jörn and Matthias Groh. “The pharmaceutical CDMO industry is consolidating: Opportunities for current players and new entrants.” Ernst & Young. Sep. 2017. Web. 

16. Garguilo, Louis. “M&A Crucible in Contract Drug Development And Manufacturing.” Outsourced Pharma. 6 Mar. 2017. Web.

17. Miller, Jim. “CDMO Market Forces Re-shape of M&A Activity.” DCAT Value Chain Insights. 11 Jun. 2019. Web.

18. Lee, Jaimy. “Drug manufacturers have spent a record $342 billion on M&A in 2019.” Market Watch. 10 Dec. 2019. Web.

19. Rexaline, Shanthi. “A Perspective On Biopharma’s Record M&A Run In 2019.” Benzinga. 23 Dec. 2019. Web.

20. Colville, Claire. “How can pharma companies adapt to the current mergers and acquisitions environment?” Genpact Pharmalink. 23 Feb. 2017. Web.