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Agency is expected to release two analyses, one from its own staff scientists and one from the vaccine’s manufacturers

The Food and Drug Administration is set to release detailed analyses of the first Covid-19 vaccine being considered for U.S. distribution, providing the foundation for Thursday’s pivotal meeting of a panel that will advise on its possible approval for emergency use.

The agency is expected Tuesday to release two separate analyses, one from its own staff scientists and one from the vaccine’s manufacturers, Pfizer Inc. PFE 2.26% and German partner BioNTech SE. BNTX 4.75%

Both are likely to number in the hundreds of pages, and will document findings that show the vaccine’s effectiveness. Pfizer reports its vaccine is 95% effective at protecting against symptomatic Covid-19, and the U.K. approved its use last week.

Among other issues, the data are expected to show how the vaccine works with different age, ethnic and other demographic groups. The FDA has advised vaccine companies that these subgroup analyses will help overcome any hesitancy among Americans to be vaccinated.

A positive recommendation from the advisory panel is likely to lead to the FDA’s formally granting an emergency-use authorization of the vaccine in a matter of days.

There is limited information available about the vaccine’s safety and efficacy beyond Pfizer’s announcement last month, which was made via press release. The data hasn’t been published in a medical journal, as Pfizer says it will monitor subjects in the 44,000-person study for two years to assess how long protection provided by the vaccine may last.

The analysis released Tuesday could include more insight into the two months of safety data on about 19,000 study subjects requested by the FDA. No serious side effects were observed in the late-stage study, and the vaccine appears to be well tolerated, Pfizer has said.

The efficacy was determined after 170 subjects in the 44,000-person trial became sick with symptomatic Covid-19, triggering an analysis by an outside panel of experts that found that most of those subjects had received a placebo rather than the vaccine. Researchers looked at how well the shots worked seven days after a study volunteer got a second dose.

The sick participants included 10 whose cases of Covid-19 were severe. Nine had received the placebo and one the vaccine.

The FDA has held advisory-committee hearings on hundreds of products over the years, but rarely has there been the kind of intense interest as in this week’s planned hearing. This is largely due to the fast increase in cases of the illness, which has created the largest pandemic in a century.

Johns Hopkins University on Monday reported that U.S. cases were approaching 15 million, and that U.S. deaths already topped 283,000.

The FDA has sped up its traditional monthslong approval processes by considering Pfizer’s Covid-19 vaccine for emergency-use authorization. These authorizations, in essence, involve balancing risks and benefits.

But because vaccines, unlike most drugs, are given to healthy people, the FDA has still insisted on rigorous standards—including opening this Thursday’s meeting to the public and making public the companies’ and agency’s analyses.

The FDA insisted it wouldn’t consider a vaccine unless it lowered the rate of disease by 50% or more when compared with a placebo. And it said that half of patients in any vaccine study would need to be followed for at least two months after inoculation to ensure that major side effects didn’t occur and that the vaccine’s effectiveness lasted.

Federal officials have estimated that U.S. vaccine deliveries during December will be enough for about 20 million people. That compares with 24 million people in the U.S., such as health-care workers and residents of long-term care facilities, who are in priority groups for vaccines.

In an interview with WWD, Ruffini shied away from the idea that he was setting up a fashion group following the revelation earlier on Monday that Moncler was taking over Sportswear Company SpA, owner of the Stone Island brand, in a deal valued at 1.15 billion euros. “Just as I never excluded anything last year [when speculation swirled that Kering was eyeing the acquisition of Moncler], I don’t see a pole [in the future]; I want to create value for the brand,” he said.

Ruffini spoke about a personal relationship with Carlo Rivetti, chairman and ceo of Stone Island, after his son Romeo pointed out that hearing Rivetti speak was like listening to his own father, with “the same vision and obsession for quality.” The acquisition reflects the “union of two families and this is the only target that I have always liked and the Rivettis will reinvest in my holding.”

Indeed, speculation about Ruffini’s interest in Stone Island emerged periodically over the past months, and he admitted working on the deal for about a year, although it was slowed down by the coronavirus pandemic.

Ruffini took the time to underscore that the deal is more than just an acquisition — it’s a step toward “shaping a new world of luxury, beyond luxury and beyond fashion.”

Together, Moncler and Stone Island are “stronger and in a new, unique positioning, outside of traditional luxury, in an area between Hermès and Nike. It’s a new luxury, we must be part of it, with new energy — just as the one we felt when we started Genius.”

Ruffini cited Gucci’s turnaround with Alessandro Michele, attracting younger customers; Louis Vuitton with Virgil Abloh, and Kim Jones at Dior as examples of this seismic change. “Moncler, together with Stone Island, will offer to new generations a new concept of luxury, far from the traditional stereotypes in which young people no longer recognize themselves. We believe in an open and engaged universe, which thrives on community, experiences and cultural exchanges, where communication is always interaction and where the aspirational goes beyond possession to become being part of and belonging,” he said.

The deal opens “a new chapter” for Moncler and Stone Island, he continued. “I always believed luxury is not what you wear, it’s a language, belonging to a community, it’s an experience, and luxury should open its doors,” he said, citing cross-pollination with other industries such as music. “If music can move to Spotify, why should fashion remain the same? Luxury needs to change.”

Analysts agreed with Ruffini, and so did the market, as Moncler’s shares on Monday climbed as high as 5 percent to then settle and close up 1.85 percent at 44 euros.

Swetha Ramachandran, investment manager, luxury brands equities at GAM Investments, said the deal allows Moncler to extend its lead into the world of luxury streetwear and will in time “further ‘de-seasonalize’ the enlarged entity to a greater extent with Stone Island being a year-round purchase,” as well as increasing its exposure to men’s ready-to-wear, which is growing at a faster pace than women’s.

The acquisition “prepares Moncler for its next leg of growth even as it pursues organic brand expansion. I’ve believed that instead of being a deal target, Moncler’s ceo Remo Ruffini wants to create a version of an Italian luxury conglomerate but in a modern vein, with brands that resonate more with a younger, and Asian-led consumer. This could well be the start of this shift,” continued Ramachandran. “Stone Island’s appeal to Moncler is its presence in the fast-growing luxury streetwear market,” citing previous examples of the same strategy: VF Corp. buying Supreme last month and Farfetch buying New Guards Group in 2019.

Equita Sim analysts believe the operation is “strategically opportune” since it allows Moncler to “accompany Stone Island in a geographic expansion,” since the brand relies mainly on business in Europe, which accounts for 80 percent of sales. Moncler will also be able to strengthen Stone Island’s direct distribution. Wholesale accounts for 78 percent of revenues. Equita praised Stone Island’s “strong and distinctive positioning” which can be leveraged to expand digitally. It also estimated Moncler’s liquidity to amount to 883 million euros by the end of 2020, and a positive impact on profits from the operation in the medium-high, single digit range.

Kepler Cheuvreux believes the Stone Island brand is a “good addition” to Moncler in terms of positioning and that it “shows significant potential both in terms of geographic diversification and in retail integration.”

As reported, the agreement was signed between Moncler and Rivetex Srl, a company referable to Carlo Rivetti, owner of a stake equal to 50.1 percent of Sportswear Company’s capital and other shareholders of SPW, referable to the Rivetti family, owners of a stake equal to 19.9 percent of SPW’s capital.

The agreement values Stone Island at 1.15 billion euros, corresponding to a multiple of 16.6 times 2020 earnings before interest, taxes, depreciation and amortization and a multiple of 13.5 times the estimated 2021 EBITDA.

The consideration for the purchase of the shares will be paid in cash by Moncler.

Carlo Rivetti and his family will subscribe for an amount equal to 50 percent of the consideration, or 10.7 million new Moncler shares, at a set price of 37.51 euros a share, which corresponds to the average price of shares in the last three months.

Moncler then aims to acquire the entire share capital of Stone Island, buying the further 30 percent held by Singapore’s state investor Temasek Holdings Private Ltd.

Temasek will also be given the choice of taking newly issued Moncler shares for up to 50 percent of the cash consideration.

If Temasek decides to be paid in cash only, Moncler will pay 748 million euros. Otherwise, Temasek may subscribe up to a maximum of 4.6 million newly issued shares of Moncler, at the same price per share of 37.51 euros.

Temasek owns shares in SPW and Moncler, both directly and through Ruffini Partecipazioni.

The deal is expected to close by the first half of 2021.

At the same time, Rivetti and the other SPW shareholders have reached an agreement with Ruffini Partecipazioni Holding Srl, wholly owned by Remo Ruffini, whereby all newly issued Moncler shares received by them will be transferred to Ruffini Partecipazioni Srl, which owns a 22.5 percent stake in Moncler, with the goal to contribute to the integration between the two companies.

It is also expected that Rivetti, following the closing of the transaction, will join the board of Moncler.

Ruffini will continue to exercise control over Ruffini Partecipazioni, which is expected to change its name to Double R Srl.

Ruffini praised the management of Stone Island, and the “purity” of the brand, saying that each label will remain totally independent and unique. He underscored Stone Island’s appeal to its 1.7 million Instagram followers. “I really respect what [Rivetti] has done in 10 years, its unique positioning, I don’t see any competitor, and I think Stone Island is perfect for Moncler. I love the brand, and we share common roots, the same obsession for purity and innovation. Stone Island reminds me of Moncler 10 years ago.”

While shying away from “creating dreams,” he can see a similar growth path for Stone Island, he mused.

In a conference call with analysts and reporters on Monday morning, Ruffini said of Moncler that “the first important day was in 2003 when we acquired the brand, followed by 2013, with the initial public offer. I did not want to wait until 2023 for another historic moment because time goes by fast, so we did it in 2020.

“Why not now, we don’t have to wait for the crisis to be over, we must fight, everything is speeding up,” he said, adding that he wants to be ready for when the pandemic will be over.

“This is a good message for Italy. We join two Italian brands together, despite the many uncertainties of this moment, I hope it can also be read as an expression of Italian resilience,” said Ruffini.

Rivetti said that he had been contacted by a lot of private equity funds, declining to sell for years but that he agreed to Ruffini’s proposal because he was presented with an industrial project.

Men’s wear brand Stone Island was established in 1982, and it is known for its extensive research on fibers and textiles, experimenting with dyes and treatments.

In the November 2019 to October 2020 period, Stone Island recorded revenues of 240 million euros, edging up 1 percent compared to 237 million euros in the previous year.

In 2020, Stone Island generated 28 percent of revenues in the domestic market, 52 percent in the rest of Europe and 20 percent in the rest of the world. The wholesale channel accounted for 78 percent of revenues while the remaining 22 percent was generated by the online channel and by a network of 24 directly managed stores.

Rivetti said the company’s headquarter in Ravarino “will remain the beating heart of the brand and a center of excellence that will be further enhanced and my team and I will continue, in our current roles, to do what we have been doing with great passion for many years. This is a partnership that represents a great opportunity for the continued development of both companies and which will help Stone Island accelerate its international growth thanks to Moncler’s experience in both the physical and digital retail world.”

Ruffini admitted Stone Island’s product offer was “more balanced” and diversified than Moncler’s with spring/summer and fall/winter accounting for half of sales each, for example.

Chief marketing and operating officer Roberto Eggs said during the call that one of the goals of the acquisition is to help Stone Island have “more direct to consumer control and more presence in retail.” He sees “strong potential in malls and department stores,” and said that, while Stone Island has strong wholesale distribution in Europe, Moncler will be able to help the brand penetrate the Asian market, where its presence is still “low.” He also pointed to potential in North America, given the success of Stone Island’s past partnerships with Nike and Supreme. He praised Stone Island’s “very high level” of full-price sales, “above industry average. Their business model is working.”

Asked by an analyst if he saw an expansion into women’s wear for Stone Island, Ruffini demurred, saying it was too early to discuss strategies, but that he did not envision that specific development for the brand.

Chief corporate and supply officer Luciano Santel said Stone Island will have more direct control of the market, and that marketing investments will increase, also raising the visibility of the brand.

AstraZeneca’s COVID-19 vaccine partner in China plagued by scandal

Shenzhen Kangtai Biological Products — one of China’s biggest vaccine makers — recently inked a deal to become the exclusive manufacturer of AstraZeneca’s COVID-19 shot there, according to The New York Times.

While the partnership gives Kangtai an important role in rolling out a coronavirus vaccine in the world’s second-largest economy, it’s just the latest chapter in the checkered history of the company led by billionaire chairman Du Weimin, the paper reported Monday.

Kangtai reportedly made headlines in 2013 when 17 infants died after taking its vaccine for hepatitis B. Regulators cleared the company of wrongdoing and the vaccine is still used safely, but the incident sparked an outrage that led Chinese media and the public to brand Du a “baby-killer,” according to the Times.

Three years earlier, dozens of elementary school students in China’s Guangdong Province came down with vomiting, headaches and limb weakness after receiving the same shot, the report says. Health officials reportedly downplayed concerns that the vaccine was linked to the illnesses but didn’t explain how they’d reached that conclusion before test results had come out.

One global health expert reportedly said the spate of infant deaths “raises legitimate concerns” about Kangtai at a crucial time for the vaccine industry.

“Imagine if a similar scandal is reported again in China,” Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations, told the Times. “It’s not just going to undermine the confidence of the company manufacturing the vaccine, it’s also going to hurt the reputation of AstraZeneca itself and their vaccine, too.”

AstraZeneca didn’t immediately respond to a request for comment Monday. But the British drugmaker stood by its deal with Kangtai in a statement to the Times, saying it “conducts appropriate and thorough due diligence prior to entering an agreement with any entity.”

“Safety, efficacy and quality of the vaccine is of utmost importance, and AstraZeneca has partnered with capable, established organizations to help ensure broad and equitable global access, at no profit during the pandemic,” AstraZeneca told the paper.

Kangtai’s alleged sketchy behavior is not unusual in a Chinese vaccine industry that suffers from corruption and a lack of confidence in its products among the Chinese public, according to the Times, which identified 59 corruption lawsuits involving vaccine companies from 2018 to 2020.

Du — who has been dubbed the “King of Vaccines” in China and is one of the country’s richest men — acknowledged in court documents that he handed drug regulator Yin Hongzhang a paper bag filled with $44,000 in cash in an effort to get Kangtai’s vaccines approved, the paper reported.

The company was cleared several months later to start clinical trials for two vaccines that were ultimately approved and generated tens of millions of dollars in revenue, the report says.

Yin, the regulator, was sent to jail in 2016 for taking bribes from Du and other vaccine producers — but Du himself was not charged, according to the Times.

The same year, a Chinese court reportedly convicted the journalist Du Taoxin of hurting Du Weimin’s reputation by publishing a critical article about Kangtai.

The journalist had reported that regulators had delayed their 2010 announcement that roughly 180,000 doses of a rabies vaccine made by company Du Weimin owned were ineffective so he would have time to sell a majority stake in the firm and deflect blame for the problems, according to the Times.

Du Weimin successfully sued Du Taoxin and his newspaper, Democracy and the Rule of Law, which had to delete the story, the Times reported.

Kangtai did not immediately respond to an email seeking comment Monday.

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Elon Musk is now worth more than $150 billion.

The Tesla and SpaceX CEO, already the world’s second-richest man, reached the milestone Monday after Tesla shares surged more than 7 percent to an all-time high, bringing the company’s market cap above $600 billion.

The electric automaker’s stock has been on a tear since mid-November when the S&P 500 index announced that it would include Tesla in December. Shares of Tesla are up 57 percent since Nov. 16.

With his $152.9 billion net worth, Elon Musk is now more than $20 billion ahead of No. 3 Bill Gates, who has a $129 billion fortune, and $47 billion ahead of Facebook CEO Mark Zuckerberg, who Musk originally passed the day after the S&P’s announcement.

After adding more than $120 billion to his net worth in 2020 alone, Musk now plays second fiddle only to Jeff Bezos, who is the richest man on earth with a net worth pegged at $185 billion.

Musk’s Tesla 170.4 million Tesla shares are worth more than $109 billion, with the rest of his fortune coming from additional Tesla options as well as his holdings in rocket company SpaceX and drilling company Boring, according to data from Bloomberg.

The upward trajectory could continue ahead of Tesla’s Dec. 21 debut in the benchmark index because big investment funds that duplicate the S&P’s holdings must buy Tesla shares to accurately track its performance.

Shares of Tesla finished the day up 7.1 percent Monday, at $641.76.