President Donald Trump’s tax overhaul, growing competition among drug developers, and new sources of capital will drive this year's merger-and-acquisition (M&A) activity well past the $200 billion annual volume of deals seen last year, EY has concluded in a report released today.
EY's 2018 M&A Outlook and Firepower Report: Life Sciences Deals and Data found that the tax overhaul—especially its one-time tax cut for U.S. companies that shift or “repatriate” profits from overseas back into the U.S.—will end a period of uncertainty that was reflected in a nearly 20% decline in the total value of life sciences deals last year compared with 2016.
That decline occurred as drug developers, especially the largest ones, largely sat on the sidelines rather than gobble up smaller companies—as Johnson & Johnson did in the year’s priciest deal, its $30 billion acquisition of Actelion, completed in June 2017. EY expects more M&A activity in 2018, based on an earlier survey in which 60% of life sciences leaders said they planned to actively pursue mergers and acquisitions, up from 46% in April. EY published findings from the survey in Global Capital Confidence Barometer (CCB): Life Sciences.
“The larger deals were definitely held up by the uncertainty over tax reform, particularly repatriation,” Jeff Greene, EY global life sciences transaction advisory services leader, told GEN. According to an EY analysis, the top 10 U.S. life sciences companies have roughly $160 billion in cash overseas, some of which is expected to be used toward M&A in the U.S.
“I think there has definitely been a shift toward more encouragement of M&A as a result of the tax law changes,” Greene said.
Greene said the tax overhaul was not the only uncertainty faced by the biopharma industry. Top executives were also concerned that the Trump administration would try to curb sky-high drug prices—no such crackdown occurred—and were worried about the future of the FDA and the Affordable Care Act.
Fewer U.S. M&A Deals
Policy uncertainty, EY reported, accounted for a decline in the percentage of M&A deals carried out by U.S. biopharmas in recent years—from 52% in 2015, to 39% in 2016, to 30% last year. That percentage should bounce back, Greene said, as the biopharma industry finds more certainty, and support coming from Washington.
Trump’s FDA commissioner, Scott Gottlieb, M.D., presided over an agency that approved 46 new drugs last year, more than double the 22 novel drugs approved in 2016 under predecessor Robert Califf, M.D., nominated by Barack Obama. Califf stepped down in January, upon the change in administrations.
The uptick in approvals could drive up M&A activity, the report said, by heightening competition among biopharmas, especially in increasingly crowded categories. By the end of 2017, for example, the FDA had approved no fewer than five programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) cancer immunotherapies.
“In certain therapeutic areas, a segment might get overcrowded “It is possible that parts of oncology are heading in that direction. That could lead to more consolidation and more M&A,” Greene said.
The surge of approvals could also stimulate M&A, Greene added, by validating the assets of companies, giving potential buyers greater confidence in the companies they wish to acquire.
M&A activity declined last year despite a surge of more than $100 billion in capital the biopharmas have available for M&A deals, what EY calls “firepower.” Big pharma accounted last year for about two thirds or nearly $800 billion of the more than $1.2 trillion in firepower measured by the report.
Partnerships and Platforms “Beyond the Pill”
However, a growing source of firepower for M&A deals is coming from outside the life sciences industry—notably from the largest tech companies. The report offered several examples: Alphabet’s Verily Life Sciences has partnered with GlaxoSmithKline to create the bioelectric medicine company Galvani Bioelectronics; Apple has disrupted clinical trials through its ResearchKit; and Amazon.com has invested in liquid biopsy developer Grail and partnered with Merck in diabetes management.
The planned CVS/Aetna merger, according to EY, reflects the emergence of “customer-centric” care platforms that are expected to spark further consolidation and M&A activity by manufacturers, payers, and others.
The platforms offer the potential for reshaping biopharma M&A activity through deals that go beyond drug developers buying other drug developers. The role of biopharmas and device companies in such platforms is the topic of an EY report set to be released later this year.
“It’s not clear, particularly on the biopharma side, how much they will be able to evolve or be willing to evolve their businesses beyond the pill,” Greene said.
He said device developers may be more likely than biopharmas to be acquired to become part of care platforms: “It may be a smaller leap for them to get more involved in services, to capture data, particularly in diagnostics, and combine it with other data, in order to have a more holistic influence on both the wellness and the health of patients.”
Pricing Pressure and High Prices
Another factor likely to drive M&A activity in 2018, according to Greene, is continued pricing pressure by payers, since that limits the ability of drug developers to grow through sales of existing products. That pressure is especially felt by larger biopharmas with more established drugs—which in turn may be more tempted to pursue megamergers in order to protect profitability, maintain competitiveness in key therapeutic areas and build scale to confront new challenges in the supply chain, the report said.
The pricing pressure seen with larger companies has not been apparent among biopharmas with newer categories of treatments, which have been able to set high prices: Spark Therapeutics has set an $850,000 price for its Luxturna™ (voretigene neparvovec), a gene therapy for a rare type of hereditary blindness, while Novartis set a $475,000 price for its Kymriah™ (tisagenlecleucel), a treatment for some forms of B-cell acute lymphoblastic leukemia that was the first chimeric antigen receptor T-cell (CAR-T) therapy to win FDA approval in August 2017. Both companies emphasize that they have launched patient access programs and other initiatives, allowing many patients to be treated with the new therapies at reduced cost.
However, for smaller biotechs, drug approvals may help them stave off would-be buyers and attract new investors, according to EY, as more sources of capital have emerged beyond public markets, notably from China and other Asian nations. China’s Sanpower Group, for example, last year acquired the Dendreon cancer vaccine business of Valeant Pharmaceuticals International for $820 million.
That additional capital, the report added, gives the biotechs more opportunities to take products deeper into development and stay independent for longer, reducing their need to pursue sales.
“These other sources of capital can help those companies take products farther along themselves toward commercialization, and delay an M&A exit, so it could be a counterbalancing force,” Greene said.