Tag Archives: corporate strategy

FDA Plans to Warn J&J Covid-19 Vaccine Raises Risk of Rare Neurological Condition

U.S. health regulators are expected to warn that the

Johnson & Johnson

JNJ -0.16%

Covid-19 vaccine is linked to a very small incidence of cases of a rare neurological disorder associated with other shots.

The U.S. Food and Drug Administration plans to add the warning language to the J&J shot’s label, after finding a handful of cases of Guillain-Barré syndrome among the millions of people who have gotten the vaccine, according to a person familiar with the matter.

Guillain-Barré syndrome is a rare neurological disorder in which the immune system attacks nerves, causing temporary but potentially severe paralysis. The risk is a known one with vaccines, including some influenza vaccines and a leading shot to prevent shingles.

J&J didn’t immediately provide a comment.

The warning would be the latest for a vaccine that federal health officials had cautioned raises the risk of a rare blood-clotting condition.

The risk of Guillain-Barré, however, is very low, the person said, with a rate of about three to five cases per million recipients. The risk in the general population is about 1 in one million.

Some 12.7 million people in the U.S. have gotten the one-dose J&J vaccine, according to the Centers for Disease Control and Prevention.

As more U.S. adults get their Covid-19 vaccines, a variety of side effects are emerging. WSJ’s Daniela Hernandez speaks with an infectious disease specialist on what is common, what isn’t and when to seek medical attention. Photo: Associated Press

The Johnson & Johnson vaccine uses a harmless type of common-cold virus called an adenovirus. It is engineered to carry a piece of genetic code instructing the body’s cells to make something resembling the spike protein that juts from the surface of the coronavirus.

Production of the spikelike protein, in turn, triggers an immune response that can protect a vaccinated person from Covid-19.

Another Covid-19 vaccine, from

AstraZeneca

PLC, which isn’t authorized in the U.S. but used in the U.K. and other countries, uses a technology similar to J&J’s. AstraZeneca’s shot also is linked to an increased risk of Guillain-Barré, federal health officials said.

AstraZeneca didn’t immediately respond to a request for comment.

The U.S. authorized the Johnson & Johnson vaccine in late February. Its rollout has struggled after regulators ordered a temporary pause in its administration as investigators studied the rate of the rare clotting disorder among vaccinated people.

The FDA recommends use of the vaccine, saying the benefits outweigh the risks. The agency, however, attached a warning to the vaccine’s label about the risk of the disorder and made recommendations for treatment.

The vaccine requires only one dose and doesn’t need to be stored at ultralow temperatures like messenger RNA vaccines do, which makes it a more straightforward and easier shot for vaccinating people, especially in places for which the freezer conditions and patient follow-up for a second shot would be more difficult to achieve.

Write to Thomas M. Burton at tom.burton@wsj.com and Felicia Schwartz at felicia.schwartz@wsj.com

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Pfizer Goes It Alone to Expand Vaccine Business Beyond Covid-19 Pandemic

Pfizer Inc. aims to expand its vaccine business by becoming a leader in the new gene-based technology behind its successful Covid-19 shots.

Pfizer will develop new shots using the technology, called mRNA, to target other viruses and pathogens beyond the coronavirus, Chief Executive Albert Bourla said in an interview. He said the company’s scientists and engineers gained a decade’s worth of experience in the past year working on the Covid-19 vaccine with Germany’s BioNTech SE , and is ready to pursue mRNA on its own.

“There is a technology that has proven dramatic impact and dramatic potential,” Mr. Bourla said. “We are the best positioned company right now to take it to the next step because of our size and our expertise.”

Pfizer will increase R&D in the technology, including adding at least 50 employees whose assignments will include mRNA, and it will harness the new mRNA manufacturing network it assembled in the past year to compete.

“We are now ahead and we plan to maintain the gap,” he said of the mRNA vaccine market.

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Short Sellers Boost Bets Against SPACs

Short sellers are coming for SPACs.

Investors who bet against stocks are targeting special-purpose acquisition companies, one of the hottest growth areas on Wall Street. The dollar value of bearish bets against shares of SPACs has more than tripled to about $2.7 billion from $724 million at the start of the year, according to data from S3 Partners.

Some of the stocks under attack belong to large SPACs that surged in recent months, in part because they were backed by high-profile financiers. A blank-check company created by venture capitalist

Chamath Palihapitiya

that plans to merge with lending startup Social Finance Inc. is a popular target, with 19% of its shares outstanding sold short, according to data from S&P Global Market Intelligence. The short interest in

Churchill Capital Corp. IV,

a SPAC created by former investment banker

Michael Klein

that is merging with electric-vehicle startup Lucid, more than doubled in March to about 5%.

Others are wagering against companies after they combine with SPACs. Muddy Waters Capital LLC announced last week it was betting against

XL Fleet Corp.

, a fleet electrification company that went public in December after merging with a SPAC. XL has since said Muddy Waters’s report, which alleged XL inflated its sales pipeline and made misleading claims about its technology among other issues, had “numerous inaccuracies.” 

XL’s stock price dropped the day Muddy Waters released its report by about 13%, to $13.86, from its prior close on March 2. Shares closed Friday at $12.79.

Shares of

Lordstown Motors Corp.

fell nearly 17% Friday after Hindenburg Research released a report saying the electric-truck startup had misled investors on its orders and production. The company, which merged with a SPAC in October, said the report contained half-truths and lies. The short interest in Lordstown shares rose to 5% from 3.4% in the week before the report’s publication, according to data from S&P.

“SPACs are an area of focus,” said Muddy Waters’s

Carson Block.

The veteran short seller said SPACs largely make up the universe of companies he views as both “abysmal” and relatively free from technical challenges, such as high short interest, which can make betting against them difficult.

SPACs are shell firms that raise capital by issuing stock with the sole purpose of buying or merging with a private company to take it public. They are dominating the market for new stock issues, becoming a status symbol for celebrities while pumping the value of acquisitions, like betting company

DraftKings Inc.,

into the tens of billions of dollars.

Hedge funds that buy into SPACs early see them as a way to make lofty returns without much risk. Individual investors are attracted by the chance to get positions in newly public companies that they could rarely purchase through traditional IPOs. The Securities and Exchange Commission issued a statement on Wednesday warning that it “is never a good idea to invest in a SPAC just because someone famous sponsors or invests in it.”

A monthslong rally in the stocks lost steam recently amid a broad selloff in technology and high-growth companies. An index of SPAC stocks operated by Indxx fell about 17% from mid-February to March 10, while the Nasdaq Composite Index declined about 7.3% over the same period.

“These are all momentum stocks, and a lot of people want to short them,” said

Matthew Tuttle,

whose firm Tuttle Tactical Management runs an exchange-traded fund that allows investors to hold a portfolio of SPAC stocks. Mr. Tuttle is preparing to launch an ETF that bets against “de-SPAC” stocks of companies that have merged with a SPAC—like electric-truck manufacturer

Nikola Corp.

and baked-goods maker

Hostess Brands Inc.

—and a separate fund that invests in the stocks.

Private companies are flooding to special-purpose acquisition companies, or SPACs, to bypass the traditional IPO process and gain a public listing. WSJ explains why some critics say investing in these so-called blank-check companies isn’t worth the risk. Illustration: Zoë Soriano/WSJ

Postmerger companies are particularly attractive to short because they have larger market capitalizations, making their shares easier to borrow, and because early investors in the SPACs are eager to sell shares to lock in profits, analysts and fund managers said.

Short sellers borrow stocks they believe are overvalued and immediately sell them, hoping to repurchase the shares for a lower price when they need to be returned and to pocket the difference. The strategy proved dangerous in recent months when individual investors organized on social media to push up stocks like GameStop Corp., forcing short sellers to buy shares and cap their losses, helping to drive prices still higher.

Continued strong investor demand for SPACs could catch short sellers in a similar squeeze. Shorting SPACs can also be risky because their shares have a natural floor at $10, the price at which they can be redeemed before a merger, and because they are prone to sharp price moves, analysts said.

Still, the portion of shares sold short in SPACs and their acquisitions is climbing.

A blank-check company created by venture capitalist Chamath Palihapitiya that plans to merge with lending startup Social Finance Inc. is a popular target.



Photo:

Brendan McDermid/Reuters

Some are betting against stocks they believe rose too fast, to unsustainable valuations. The price of bioplastics company

Danimer Scientific Inc.

nearly tripled to $64 in the first six weeks of the year after it was bought by a SPAC. The short interest in Danimer stock has climbed to 8.5% from around 1% in January, and its share price has traded down to about $42, according to data from S&P.

Others are making bearish bets to hedge against potential losses in SPAC stocks they own.

Veteran short seller

Eduardo Marques

cited SPACs and their boosting the number of U.S.-listed stocks as a short-selling opportunity, according to a pitch for a stock-picking hedge fund called Pertento he plans to launch this year. America’s roster of public companies had shrunk from the mid-1990s onward, but that trend has recently reversed, partly because of SPACs.

Their popularity has helped spark new Wall Street offerings.

Goldman Sachs Group Inc.

this year started offering clients set baskets of similar stocks to short, pitching them as a way to hedge SPAC exposure, people who have seen the offering said. Clients typically customize the baskets Goldman offers, which are thematic and sector-focused, such as on bitcoin and electric vehicles.

Kerrisdale Capital founder

Sahm Adrangi

started shorting postmerger SPAC companies earlier than most, with a public bet in November against the stock of frozen-food maker

Tattooed Chef Inc.,

which still trades above its price at that time. But the stock has fallen about 13% during the recent market slump.

“We saw these stocks go up a lot and now that people are de-risking, these highflying SPACs are coming down to earth,” Mr. Adrangi said.

SHARE YOUR THOUGHTS

How long do you think the SPAC boom will continue, and why? Join the conversation below.

Write to Matt Wirz at matthieu.wirz@wsj.com and Juliet Chung at juliet.chung@wsj.com

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GE Nears Deal to Combine Aircraft-Leasing Unit With AerCap

General Electric Co. is nearing a $30 billion-plus deal to combine its aircraft-leasing business with Ireland’s

AerCap

AER 1.62%

Holdings NV, according to people familiar with the matter, the latest in a string of moves by the industrial conglomerate to restructure its once-sprawling operations.

Though details of how the deal would be structured couldn’t be learned, it is expected to have a valuation of more than $30 billion, some of the people said. An announcement is expected Monday, assuming the talks don’t fall apart.

The

GE

GE 0.29%

unit, known as GE Capital Aviation Services, or Gecas, is the biggest remaining piece of GE Capital, a once-sprawling lending operation that rivaled the biggest U.S. banks but nearly sank the company during the 2008 financial crisis. GE already took a major step back from the lending business in 2015 when it said it would exit the bulk of GE Capital, and a deal for Gecas would represent another big move in that direction.

It would also represent another significant move by GE Chief Executive Larry Culp to right the course of a company that has been battered in recent years by souring prospects for some of its top business lines and a structure that has fallen out of favor with investors.

With more than 1,600 aircraft owned or on order, Gecas is one of the world’s biggest jet-leasing companies, alongside AerCap and Los Angeles-based Air Lease Corp. It leases passenger aircraft made by Boeing Co. and

Airbus SE

as well as regional jets and cargo planes to customers ranging from flagship airlines to startups. Gecas had $35.86 billion in assets as of Dec. 31.

AerCap has a market value of $6.5 billion and an enterprise value—adjusted for debt and cash—of about $34 billion, according to S&P Capital IQ, and around 1,400 owned or ordered aircraft. The company has experience in deal making, paying around $7.6 billion in 2014 to buy International Lease Finance Corp. AerCap’s revenue last year was about $4.4 billion, down from around $5 billion in the previous few years.

The aviation business has been hit hard by the Covid-19 pandemic, which has resulted in a sharp drop in global travel and prompted airlines to ground planes. Some airlines have sought to defer lease payments or purchases of new aircraft. Gecas had an operating loss of $786 million on revenue of $3.95 billion in 2020. GE took a roughly $500 million write-down on the value of its aircraft portfolio in the fourth quarter.

Combining the companies could afford cost-cutting opportunities and help the new entity weather the downturn.

Separating Gecas could help GE with its efforts to shore up its balance sheet and improve cash flows. Despite a recent increase, GE’s share price remains below where it was before significant problems in the company’s power and finance units emerged in recent years.

The Boston company has a market value of around $119 billion after the shares more than doubled in the past six months as it posted improving results. Still, the stock has fallen by about three-quarters from the peak just over 20 years ago.

Mr. Culp became the first CEO from outside of GE in late 2018 after the company was forced to slash its dividend and sell off businesses. The former

Danaher Corp.

boss has sought to simplify GE’s wide-ranging conglomerate structure further, as other industrial giants such as Siemens AG and

Honeywell International Inc.

have done in recent years.

Activist investor Trian Fund Management LP, which has owned a significant position in the company since 2015 and holds a seat on its board, has supported such changes.

Early in his tenure, Mr. Culp said he had no plans to sell Gecas, a move his predecessor

John Flannery

had considered after the unit drew interest from private-equity firms pushing further into the leasing business.

Mr. Culp has sought to even out cash flows and refocus on core areas. Operations he has parted with include the company’s biotech business, which was purchased by Danaher in a $21 billion deal that closed last year. GE also sold its iconic lightbulb business in a much smaller deal last year, and previously said it was unloading its majority stake in oil-field-services firm Baker Hughes Co.

GE has cut overhead costs and jobs in its jet-engine unit while streamlining its power business. The pandemic continues to pressure the jet-engine business, GE’s largest division, however.

The company also makes healthcare machines and power-generating equipment, and the rest of GE Capital extends loans to help customers purchase its machines and contains legacy insurance assets too.

AerCap is based in Ireland and Gecas has headquarters there as well. The aircraft-leasing industry has long had a significant presence in Ireland due to the country’s favorable tax regime and the importance of Guinness Peat Aviation in the development of the sector. (A deal between GE and AerCap would reunite two companies that bought their main assets from GPA.) The industry has gotten more competitive as Chinese companies have gained market share, however, and the combination could help the new group stem that tide.

Shares in aircraft-leasing companies plummeted along with much of the market in the early days of the pandemic as demand from major airlines, who lease planes to avoid the costs of owning them, evaporated. But many of the major lessors’ stocks have recovered lost ground and then some in the months since as lockdowns ease and the outlook for travel improves.

AerCap’s Chief Executive Aengus Kelly said on its fourth-quarter earnings call this month that he expects airlines to shift more toward leasing planes as they rebuild their balance sheets, in what would be a boon to the company and its peers.

“Their appetite for deploying large amounts of scarce capital to aircraft purchases will remain muted for some time,” he said. “The priority will be to repay debt or government subsidies.”

Write to Cara Lombardo at cara.lombardo@wsj.com and Emily Glazer at emily.glazer@wsj.com

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