When Congress passed a business-friendly tax package last year, pharma prognosticators predicted 2018 would be the year that mergers and acquisitions in the sector would finally gain steam. They were wrong. Despite the industry’s newfound ability to repatriate cash at a 15.5% tax rate versus the 35% rate they had to pay before, biopharma companies did not make 2018 the year of M&A.
But 2019 will most certainly be that year, analysts say. Sure, many of the worries that kept potential acquirers on the sidelines last year still exist, but biotech valuations have come way down—the Nasdaq Biotechnology Index has dropped nearly 7% in the year ended Dec. 16, in fact—and that could make all the difference.
“We think there’s been a pent-up demand for acquisitions, especially with many companies preparing for patent cliffs,” Michael Levesque, senior vice president at Moody’s, said in an interview with FiercePharma. “The combination of that, plus lower valuations and increasing levels of cash—these are all signals for M&A.”
RELATED: With tax reform passed, pharma's dealmakers likely to pick up the pace in 2018
Total cash holdings by the 10 largest U.S. pharmaceutical companies grew by $15 billion in the third quarter of 2017, reaching a total of $155 billion, according to Moody’s. Add in the cash held by overseas pharma giants—Novartis has $14 billion, for example, and Novo Nordisk $16 billion—and you get a lot of companies that are well-positioned for shopping sprees. In a November note to investors, Levesque called the growing pharma cash pile “considerable dry powder for acquisitions.”
Deal volume is already picking up as 2018 comes to a close. There were 74 pharma and life sciences deals in the third quarter of the year—the second quarter in a row that saw an M&A volume increase after nearly two years of declines, according to PwC. Since then, Takeda has won shareholder approval for its $58 billion megamerger with Shire, and GlaxoSmithKline has agreed to pay a 62% premium to acquire oncology drugmaker Tesaro, laying out $5.1 billion so it can get into the red-hot market for PARP inhibitors. In late December, Japan’s Taisho agreed to pay $1.6 billion to acquire Bristol-Myers Squibb’s consumer business.
Several likely acquisition targets have emerged in the last few weeks, as well. Bayer announced in late November that it would cast off its animal health unit amid a major restructuring. And reports emerged that PARP maker and Tesaro rival Clovis Oncology is under pressure from a major shareholder to pursue a sale. Given the rich valuation GSK put on Tesaro and the fact that Clovis has a marketed drug with plenty of expansion potential, it could fetch a high price, too.
What could dampen the M&A appetite? If federal lawmakers pass legislation that puts limitations on drug pricing, that could be a risk, Glenn Hunzinger, a partner in PwC’s deals practice, said in an interview. It’s a legitimate worry, considering President Donald Trump and congressional representatives on both sides of the aisle have rallied around the issue of bringing down drug prices.
“The capital markets assume companies can charge a certain amount for drugs, and [acquirers] may realize they just can’t do that,” Hunzinger said. “That creates uncertainty around the M&A environment.”
RELATED: Senator to Pfizer CEO: Stop playing 'political games' with drug prices
Pharma CEOs might also be exercising extreme discipline when it comes to making big acquisitions, particularly in the wake of some notable deals that didn’t live up to their rich valuations. Celgene, for one, bought Receptos for $7.2 billion in 2015, only to get slapped with an FDA rejection of its multiple sclerosis drug ozanimod this past summer.
In oncology, AbbVie paid $10 billion to buy Stemcentryx and its lung cancer drug, Rova-T a few years back, only to suffer one setback after another as it tried to get the asset to market. Most recently, AbbVie had to halt enrollment in a phase 3 trial of the drug due to poor survival rates.
Then there was Gilead’s $11.9 billion acquisition of Kite Pharma, which developed Yescarta, the personalized cell-based therapy for some blood cancers. The product has been slow to take off because of reimbursement hurdles, both at home and abroad.
Hunzinger predicts that despite such setbacks, oncology will continue to be a hot area for M&A in 2019. Executives may be wary of past missteps, but they’re likely to see them as more of a learning opportunity than as a deterrent to future deals, he says. “With CAR-T, they’re buying into a different business model,” he said. Manufacturing CAR-T treatments involves taking immune cells from patients and engineering them to be able to recognize and attack their particular cancers. “It’s really exciting and innovative, but companies have to learn how to integrate those business models and figure out how to scale them. It’s different from standard drug manufacturing.”
But the opportunity to shake up the pipeline with truly innovative products will continue to be irresistible to companies with the cash to make large acquisitions—particularly now that biotech valuations have come down—Hunzinger said. “These larger, more established companies are really trying to figure out how to grow in different therapeutic areas,” he said. “They want the secret sauce. We’re going to see a lot of thoughtfulness and a lot of learning. But the volume of deals will be there.”
但分析师表示，2019年肯定会是那一年。当然，去年让潜在收购方袖手旁观的许多担忧依然存在，但生物技术的估值已经下降——事实上纳斯达克生物技术指数( Nasdaq Biotechnology Index )在截至12月16日的一年里下跌了近7%——这可能会产生所有的影响。
穆迪( Moody's )高级副总裁迈克尔•莱维克( Michael Levesque )在接受 FiercePharma 采访时表示：“我们认为，收购需求被压抑，尤其是许多公司正准备专利悬崖。”“这两者的结合，再加上估值降低和现金水平提高——这些都是并购的信号。”
根据穆迪的数据，2017年第三季度，美国十大制药公司持有的现金总额增加了150亿美元，达到1,550亿美元。加上海外制药巨头持有的现金——例如，诺华拥有140亿美元，诺和诺德( Novo Nordisk )拥有160亿美元——你可以看到很多公司在收购狂潮中处于有利地位。在11月发给投资者的一份报告中， Levesque 称不断增长的制药公司现金储备“相当大的用于收购的干火药”。
随着2018年接近尾声，交易量已经开始回升。普华永道( PwC )的数据显示，今年第三季度有74笔医药和生命科学交易，在经历了近两年的下滑后，并购交易量连续第二季度出现增长。此后，武田制药( Takeda )以580亿美元收购 Shire 获得了股东批准，葛兰素史克( GlaxoSmithKline )同意支付62%的溢价，收购肿瘤制药商泰索罗( Tesaro )，计划斥资51亿美元进入 PARP 抑制剂的红热市场。去年12月底，日本大正同意斥资16亿美元收购百时美施贵宝( Bristol-Myers Squibb )的消费者业务。
过去几周也出现了几个可能的收购目标。去年11月底，拜耳宣布将在重大重组中剥离其动物保健部门。有报道称， PARP 制造商和 Tesaro 竞争对手 Clovis Oncology 正面临大股东要求出售的压力。考虑到 GSK 对 Tesaro 的估值很高，而且 Clovis 有很大的扩张潜力，因此它也可能卖出高价。
什么能抑制并购欲望？普华永道( PwC )交易业务合伙人格伦•赫恩辛格( Glenn Hunzinger )在接受采访时表示，如果联邦立法者通过对药品定价施加限制的立法，这可能是一个风险。考虑到唐纳德?特朗普( Donald Trump )总统和走道两边的国会代表围绕降低药品价格的问题团结一致，这是一个合理的担忧。
制药公司的首席执行官在进行大规模收购时可能也会运用极端的纪律，尤其是在一些显著的交易没有达到他们的高估值之后。以 Celgene 为例，该公司在2015年以72亿美元收购了 Recepts ，但去年夏天却遭到了 FDA 对其多发性硬化症药物 ozanimod 的拒绝。
在肿瘤学方面， AbbVie 花了100亿美元收购了 Stemcentryx 及其肺癌药物 Rova-T ，几年前，当它试图将该资产推向市场时，却遭遇了一次又一次挫折。最近，由于生存率低， AbbVie 不得不停止该药物的第三阶段试验。
随后， Gilead 以119亿美元收购了 Kite Pharma ，后者开发了 Yescarta ，一种针对某些血癌的个性化细胞疗法。由于国内外的偿付障碍，该产品起步缓慢。
Hunzinger 预测，尽管出现了这样的挫折，但肿瘤学在2019年仍将是并购的热门领域。他表示，高管们或许对过去的失误持谨慎态度，但他们可能认为，这些失误与其说是对未来交易的威慑，不如说是一个学习机会。“有了 CAR-T ，他们正在购买另一种商业模式，”他说。制造 CAR-T 疗法涉及从患者身上提取免疫细胞，并设计它们能够识别和攻击他们的特定癌症。“这真的令人兴奋和创新，但企业必须学会如何整合这些业务模式，并确定如何扩大规模。它不同于标准药物制造。”