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J&J halts COVID-19 vaccine trial due to unexplained illness – BNN

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Johnson & Johnson shares fell after the drugmaker was forced to pause its late-stage study of a coronavirus vaccine, overshadowing an improved financial outlook for the year.

The temporary halt in the trial after one participant became ill unnerved investors in spite of the company’s sound business performance and could add to concern about the rapid pace of coronavirus vaccine research. J&J said adverse events are an expected part of drug studies and that it’s investigating. The shares fell 1.9 per cent at 11:15 a.m. in New York.

J&J was notified about the person’s illness 36 hours ago and immediately approached the independent Data Safety Monitoring Board to conduct an analysis, Chief Financial Officer Joseph Wolk said. The company also paused dosing other participants.

J&J doesn’t know whether the person received the vaccine or a placebo, as patient information remains blinded to the company at this time, Wolk said in an interview. “We need to let the independent board do their research,” he added.

Based on what is known about the trial, some information about the person who became sick could be outlined, according to analysts.

“Although we can’t pin down the age group, we can safely conclude from trial design that the participant with illness was healthy coming into the trial, and did not have comorbidities,” Evercore ISI analyst Umer Raffat said in a note.

The company is sticking to its plan to expand manufacturing capability to producing 1 billion doses a year of the adenovirus-based vaccine, Wolk said. It expects to have data about the drug’s safety and effectiveness from the 60,000-subject study before the end of the year, with potential for an emergency-use authorization in the U.S. at the outset of 2021.

J&J notified Operation Warp Speed, the White House-led effort to accelerate Covid vaccine development, and also contacted regulators in the U.S. and international markets of its plan to pause the trial. “It’s simply a notification at this point until we find out more from the independent board,” Wolk said.

The company said it had paused the trial on its own, and that it wasn’t on a regulatory hold ordered by the U.S. Food and Drug Administration.

Virus Headwinds

The rosy forecast alongside the research setback underscored the health-care conglomerate’s reliance on blockbuster cancer drugs and consumer products even as the pandemic creates upheaval in other areas.

Multiple myeloma therapy Darzalex brought in US$1.1 billion in third-quarter revenue, the company said Tuesday in a statement, beating analysts’ expectation of US$1 billion. U.S. sales of Tylenol, the over-the-counter pain reliever and fever fighter, rose as Americans restocked their medicine cabinets for the pandemic.

The outbreak continued to take a toll on J&J’s medical-device unit, as persistent delays in elective procedures eroded sales in its surgery, orthopedics and vision businesses. The unit reported third-quarter revenue of US$6.2 billion, a 3.9 per cent decline year-over-year. The results were still better than analysts expected, and the company said it sees a strong recovery in the business this year.

“I think everybody kind of feared the worst back in April,” Wolk said. “We’ve seen the hospital systems react remarkably well.”

Guidance Boost

J&J boosted its full-year adjusted earnings forecast by 10 cents to US$7.95 to US$8.05 a share and increased its sales outlook. It’s the second time this year J&J has raised its financial guidance. Wolk said the raise reflected the company’s “balanced optimism.”

“Even if a second wave or re-emergence of Covid happened selectively, we think in pockets and hotspots, hospital systems and the health-care system overall is in a better position to manage that,” Wolk said.

Third-quarter sales at the News Brunswick, New Jersey-based company beat Wall Street expectations at US$21.08 billion.

J&J also announced Tuesday that it will contribute up to an additional US$1 billion to an all-in settlement amount to resolve opioid lawsuits filed and future claims by states, cities, counties and tribal governments. That’s on top of an earlier US$4 billion agreement announced by a committee of state attorneys general a year ago.

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TC Energy cuts cost estimate for Southeast Gateway pipeline project in Mexico

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CALGARY – TC Energy Corp. has lowered the estimated cost of its Southeast Gateway pipeline project in Mexico.

It says it now expects the project to cost between US$3.9 billion and US$4.1 billion compared with its original estimate of US$4.5 billion.

The change came as the company reported a third-quarter profit attributable to common shareholders of C$1.46 billion or $1.40 per share compared with a loss of C$197 million or 19 cents per share in the same quarter last year.

Revenue for the quarter ended Sept. 30 totalled C$4.08 billion, up from C$3.94 billion in the third quarter of 2023.

TC Energy says its comparable earnings for its latest quarter amounted to C$1.03 per share compared with C$1.00 per share a year earlier.

The average analyst estimate had been for a profit of 95 cents per share, according to LSEG Data & Analytics.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:TRP)

The Canadian Press. All rights reserved.

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BCE reports Q3 loss on asset impairment charge, cuts revenue guidance

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BCE Inc. reported a loss in its latest quarter as it recorded $2.11 billion in asset impairment charges, mainly related to Bell Media’s TV and radio properties.

The company says its net loss attributable to common shareholders amounted to $1.24 billion or $1.36 per share for the quarter ended Sept. 30 compared with a profit of $640 million or 70 cents per share a year earlier.

On an adjusted basis, BCE says it earned 75 cents per share in its latest quarter compared with an adjusted profit of 81 cents per share in the same quarter last year.

“Bell’s results for the third quarter demonstrate that we are disciplined in our pursuit of profitable growth in an intensely competitive environment,” BCE chief executive Mirko Bibic said in a statement.

“Our focus this quarter, and throughout 2024, has been to attract higher-margin subscribers and reduce costs to help offset short-term revenue impacts from sustained competitive pricing pressures, slow economic growth and a media advertising market that is in transition.”

Operating revenue for the quarter totalled $5.97 billion, down from $6.08 billion in its third quarter of 2023.

BCE also said it now expects its revenue for 2024 to fall about 1.5 per cent compared with earlier guidance for an increase of zero to four per cent.

The company says the change comes as it faces lower-than-anticipated wireless product revenue and sustained pressure on wireless prices.

BCE added 33,111 net postpaid mobile phone subscribers, down 76.8 per cent from the same period last year, which was the company’s second-best performance on the metric since 2010.

It says the drop was driven by higher customer churn — a measure of subscribers who cancelled their service — amid greater competitive activity and promotional offer intensity. BCE’s monthly churn rate for the category was 1.28 per cent, up from 1.1 per cent during its previous third quarter.

The company also saw 11.6 per cent fewer gross subscriber activations “due to more targeted promotional offers and mobile device discounting compared to last year.”

Bell’s wireless mobile phone average revenue per user was $58.26, down 3.4 per cent from $60.28 in the third quarter of the prior year.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:BCE)

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Canada Goose reports Q2 revenue down from year ago, trims full-year guidance

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TORONTO – Canada Goose Holdings Inc. trimmed its financial guidance as it reported its second-quarter revenue fell compared with a year ago.

The luxury clothing company says revenue for the quarter ended Sept. 29 totalled $267.8 million, down from $281.1 million in the same quarter last year.

Net income attributable to shareholders amounted to $5.4 million or six cents per diluted share, up from $3.9 million or four cents per diluted share a year earlier.

On an adjusted basis, Canada Goose says it earned five cents per diluted share in its latest quarter compared with an adjusted profit of 16 cents per diluted share a year earlier.

In its outlook, Canada Goose says it now expects total revenue for its full financial year to show a low-single-digit percentage decrease to low-single-digit percentage increase compared with earlier guidance for a low-single-digit increase.

It also says it now expects its adjusted net income per diluted share to show a mid-single-digit percentage increase compared with earlier guidance for a percentage increase in the mid-teens.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:GOOS)

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