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Tuesday, January 14, 2020

M&A for 2019 was Big; Will 2020 Be Even Bigger?

Consulting firm EY released its annual report on mergers and acquisitions (M&A) to coincide with the JP Morgan Healthcare conference this week. For 2019, EY indicates there were $357 billion in life science deals, an “all-time record,” surpassing the previous high in 2014.
“2019 has been a ‘mega’ year driven by pharma buyers,” said EY consultant Peter Behner. “In 2020, firepower remains plentiful and we expect to see more activity in medtech and big biotech, with megamergers coming from companies with acute growth gaps.”
2019 started off in January when Bristol-Myers Squibb announced plans to acquire Celgene for about $75 billion. In June, AbbVie announced plans to acquire Allergan for $63 billion. AbbVie noted that a deal of this size was planned to deliver immediate scale to its growth platform and meet its strategic goal of decreasing reliance on Humira. The company noted at the time, “Smaller bolt-on acquisitions provide opportunities for future growth, but also require significant R&D investment amid scientific and clinical uncertainty. This transaction offers immediate compelling financial and strategic value to our shareholders with a much lower risk profile.”
Other notable deals included Roche’s acquisition of Spark Therapeutics for $4.8 billion. In 2017, the FDA approved Spark’s gene therapy, Luxturna (voretigene neparvovec), a gene therapy for a rare, genetic type of blindness. After 10 months, the deal was finally completed on December 17. Roche saw Spark’s gene therapies for hemophilia as complementary to its own hemophilia treatment, Hemlibra. In November, Roche also acquired Promedior for up to $1.4 billion.
In late November, Novartis bought The Medicines Company for $9.7 billion. Under the terms of the deal, Novartis paid $85 per share in cash, which is about a 41% premium of The Medicines Company’s 30-day volume weighted average of $60.33 on November 22 and about 24% of its closing share price of $68.55 on the same day. The boards of both companies unanimously approved the acquisition.
Roivant Sciences, Vivek Ramaswamy’s umbrella companies, sold ownership of five Vant companies to Japan’s Sumitomo Dainippon Pharma for $3 billion. Sumitomo Dainippon also was buying an equity stake of more than 10% of Roivant shares. The five Vant companies are Myovant Sciences, Urovant SciencesEnzyvant Sciences, Altavant Sciences, and Spirovant Sciences. Spirovant is a new Vant that focuses on developing gene therapies for cystic fibrosis.
And Eli Lilly and Company announced it was buying Loxo Oncology for $235 per share in cash, which comes to about $8 billion. Under the terms of the deal, Lilly acquired all outstanding Loxo shares for $235 in cash.
EY does not think 2020 will be as big a year for M&A as 2019, calling it “highly unlikely.” The consultancy firm believes there will be plenty of dealmaking, though, noting the industry has about $1.4 trillion—yes, trillion!— in financial capacity for acquisitions. But EY believes the big biotech companies and medical devices firms that weren’t particularly active in 2019 will step up to the front and start spending this year.
Bolt-on acquisitions will be common, but the EY report suggests about a third of the industry leaders could go after megamergers, which are more than $40 billion each. Some of the companies that have the capacity, however, seem uninterested. That includes RocheNovartis and Merck & Co.
Big pharma that might be looking at big deals includes Johnson & JohnsonNovo NordiskPfizerAstraZeneca and Eli Lilly. Other big companies that closed big deals in the last few years are unlikely to go big again so soon, including TakedaAbbVie and Bayer.
Last year, the report notes, big pharma companies tended to focus more on share buybacks and paying out dividends rather than buying up acquisitions. The report found that leading biotech companies spent 39% of their capital on research and development, 39% on stock buybacks, 13% on dividends and only 9% on M&A.
“Such behavior may please shareholders in the short term,” the report noted, “but it has long-term downsides, suggesting companies are uncertain about how best to invest for future growth.”
Some of that may be related to political and economic uncertainty. Although the Trump administration proclaims a strong economy despite a current $22 trillion in national debt, there have been persistent fears of a recession. And the Trump administration’s tenure has been, to say the least, volatile. It’s also likely that Brexit concerns in Europe have made European biopharma companies more cautious about making big deals.
Time will tell as to whether big pharma will start wheeling-and-dealing, but analysts at SVB Leerink think GileadAmgen and Biogen are likely to be considering bigger deals this year. There was also some surprise on the part of the EY report on a lack of deals around digital technologies, with most drug companies instead choosing partnerships instead of acquisitions to bolster their data analysis and artificial intelligence capabilities. Of note were partnerships between Novartis and Microsoft and Gilead and Glympse Bio.
The EY report suggests that the deal drivers of 2019 will be the deal drivers of 2020—buying innovation and diversifying from an over-reliance on drugs that will be losing patent protection, for example, AbbVie’s dependence on Humira.

Bigfoot Biomedical Gets $45 Million of Financing Led by Abbott Labs

Abbott Laboratories (ABT) led $45 million of financing for Bigfoot Biomedical, the initial tranche of a Series C round.
The funding also included Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management.
Bigfoot is developing the Bigfoot Unity Diabetes Management Program, an insulin dosing platform that integrates Abbott’s FreeStyle Libre glucose sensing technology.

Oklahoma sues three drug distributors for ‘major oversupply of opioids’

The Oklahoma Attorney General’s office filed a lawsuit today against Cardinal Health (NYSE:CAH), McKesson (NYSE:MCK) and AmerisourceBergen (NYSE:ABC) for their alleged role in fueling the opioid epidemic in the state, adding to the several lawsuits the companies already face across the country.
The AG office says the companies distributed opioids primarily to hospitals and pharmacies and were obligated to have a systems of checks and balances to alert them if there was a sharp, unexplained increase in opioid orders.
The defendants “distributed what can only be called a major oversupply of opioids into Oklahoma,” the lawsuit said.
The lawsuit comes after the state AG won a lawsuit last year against Johnson & Johnson, which was ordered to pay $465M; the state reached settlements last year with Purdue Pharma and Teva Pharmaceuticals.

Monday, January 13, 2020

Welltower to form JV with Thomas Jefferson University

Welltower  (WELL +1.4%) signs a memorandum of understanding to form a joint venture with Philadelphia-based Thomas Jefferson University and Jefferson Health.
Under the MOU, Welltower would acquire a stake in certain real estate assets of Jefferson, allowing Jefferson to reduce some of its fixed asset investments and redeploy the capital to other clinical and academic strategic areas.
In addition to the joint venture, Welltower would help Jefferson accelerate its ambulatory care growth strategy through capital support and its predictive analytics to guide future real estate investments based on where Jefferson clinical services would best serve the public.
Also, Jefferson’s clinicians would provide care at the Welltower senior housing, assisted living, and memory-care communities in the Philadelphia region.
The two companies expect to sign a definitive agreement within 90 days.

Vanda Pharma prevails in Fanapt patent challenge

The U.S. Supreme Court has denied the petition for a writ of certiorari (orders a lower court to deliver its record in a case so the higher court may review it) from a subsidiary of Hikma Pharmaceuticals related to U.S. Patent No. 8,586,610 covering Vanda Pharmaceuticals’ (VNDA -5.2%) Fanapt (iloperidone) tablets.
The denial means that the patent will remain in effect through November 2, 2027 (unless successfully challenged beforehand).

FDA Ad Com Tuesday for Nektar’s oxycodegol

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet tomorrow, January 14, to review and discuss Nektar Therapeutics’ (NKTR +1.2%) marketing application seeking approval to use opioid oxycodegol (NKTR-181) to treat adults with chronic low back pain.

Taro Pharmaceuticals recalls epilepsy drug

Taro Pharmaceuticals, a Hawthorne, N.Y.-based drugmaker, is recalling one lot of its drug, Lamotrigine, designed to treat epilepsy and bipolar disorder, after discovering it was cross-contaminated with a small amount of another drug substance.
The drugmaker said Jan. 10 it discovered the lot contained a small amount of Enalapril Maleate, a drug substance used to manufacture another drug at the same facility. Enalapril Maleate is used to treat congestive heart failure and hypertension.
Chronic exposure to Enalapril Maleate increases the risk of birth defects in a developing fetus.
Taro has not received any reports of adverse events related to the recall.
Consumers with the affected lot should return the Lamotrigine tablets to their pharmacy. Retailers, pharmacies and distributors should stop distributing or dispensing the affected product and return it to Taro.
Read the full news release here.