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    FDA approves Eli Lilly’s tirzepatide for weight loss, paving way for wider use of blockbuster drug

    The Food and Drug Administration approved Eli Lilly’s tirzepatide drug for weight loss, paving the way for even wider use of the blockbuster medication.
    The active ingredient in the drug, tirzepatide, has already been approved for the treatment of Type 2 diabetes under the name Mounjaro since May 2022.
    But the FDA’s new approval means adults who have obesity or are overweight with at least one weight-related condition can use the drug, which will be marketed as Zepbound, for chronic weight management.

    Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
    Cristina Arias | Cover | Getty Images

    The Food and Drug Administration on Wednesday approved Eli Lilly’s blockbuster drug tirzepatide for weight loss, paving the way for even wider use of the treatment in the U.S. 
    The active ingredient in the drug, tirzepatide, has already been approved for the treatment of Type 2 diabetes under the name Mounjaro since May 2022.

    But the FDA’s new approval means adults who have obesity or are overweight with at least one weight-related condition can use the drug, which will be marketed as Zepbound, for chronic weight management.
    Zepbound should be available in the U.S. by the end of the year, and will carry a list price of about $1,060 for a month’s supply, according to a release from Eli Lilly.
    Before Wednesday’s approval, many patients had used tirzepatide off-label for weight loss, adding to a frenzy of demand for treatments that can help patients shed pounds, such as Novo Nordisk’s Wegovy and Ozempic. All three drugs have faced supply constraints for months due to soaring demand. 
    The weight loss approval further establishes Eli Lilly as a formidable competitor to Novo Nordisk in the budding obesity drug market, which Wall Street analysts believe could grow to a $100 billion industry by 2030. The increased use of drugs has raised questions about how the changes will affect an array of industries — though it may be too early to tell how many people will use them.
    The approval also comes as obesity affects an estimated 650 million adults globally, and roughly 40% of the adult population in the U.S. 

    “Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” said Dr. John Sharretts, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.” 

    How well Zepbound works

    Zepbound is an injection administered once weekly, and the dosage must be increased over four to 20 weeks to achieve the target dose sizes of 5, 10 or 15 milligrams per week.
    The drug works by activating two naturally produced hormones in the body: glucagon-like peptide-1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.
    The combination is said to slow the emptying of the stomach, making people feel full for longer and suppressing appetite by slowing hunger signals in the brain.

    The FDA said the approval was based on two of Eli Lilly’s late-stage trials on tirzepatide, which evaluated its effects on weight loss after 72 weeks.
    In a late-stage study of more than 2,500 adults with obesity but not diabetes, those taking 5 milligrams of tirzepatide for 72 weeks lost about 16% of their body weight on average. Higher doses of the drug were associated with even more weight loss, with a 15-milligram dose leading to 22.5% weight loss on average.
    Another late-stage study found that tirzepatide caused up to 15.7% weight loss among people who are obese or overweight and have Type 2 diabetes.

    Pricing, supply constraints

    Still, access to tirzepatide and other diabetes and obesity treatments remains a big challenge. 
    The list price of tirzepatide for weight loss is $1,059.87 per month for six different dose sizes, which is about 20% lower than that of Wegovy, Eli Lilly said in a press release. The company noted that the amount a patient pays out of pocket will likely be less if they have insurance. 
    Eli Lilly also said it is launching a commercial savings card program to expand access to Zepbound, which could allow people with insurance coverage for the drug to pay as low as $25 for a one-month or three-month prescription. Meanwhile, those whose insurance does not cover Zepbound may be able to pay as low as $550 for those prescriptions.
    “Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it,” said Mike Mason, executive vice president and president of Eli Lilly Diabetes and Obesity, in a statement.

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    The bigger issue is that many insurance companies are dropping weight loss drugs from their plans. Those insurers cite the extreme costs of covering those medications, and some say they want to see more data demonstrating the health benefits of the drugs beyond losing weight. 
    Preliminary data is already available: A recent late-stage trial found that Novo Nordisk’s weight loss drug Wegovy reduced the risk of cardiovascular events such as heart attack and stroke by 20%. The results suggest that Wegovy and similar drugs like Mounjaro could have long-lasting heart health benefits. 
    It is unclear whether Zepbound will eventually encounter supply issues after the U.S. saw widespread shortages of Mounjaro.
    On Wednesday, Eli Lilly CEO David Ricks told reporters that the company is prepared to fully launch Zepbound and has the supply to do so. He also noted that all doses of Mounjaro are now listed as available on the FDA’s drug shortage website.
    The company is working to boost production capacity for tirzepatide, Ricks added.
    “We’re prepared for a big bold launch here toward the end of the year and we’ll work hard to continue to expand our supply capacity to meet the needs of people with obesity,” Ricks told reporters.

    Zepbound side effects

    Similar to other weight loss drugs, Zepbound is associated with side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, fatigue and allergic reactions, among others, according to the FDA’s approval label. 
    The agency also noted that Zepbound causes thyroid C-cell tumors in rats, but it’s unclear if the drug has that effect in humans.
    The FDA advises against the use of Zepbound in patients with a personal or family history of medullary thyroid cancer – a cancer that forms inside your thyroid gland – or in people with a rare condition called Multiple Endocrine Neoplasia syndrome type 2. 
    The agency also said that Zepbound should not be used in combination with Mounjaro or another weight loss or diabetes drug targeting GLP-1 because “the safety and effectiveness of coadministration” has not been established. 
    The agency’s other warnings about Zepbound include inflammation of the pancreas, gallbladder problems, acute kidney injury and suicidal behavior or thinking.
    “Anti-obesity medications in the past have been associated with suicidal ideation, and that’s really something that should be watched for when you’re treating somebody for weight loss,” Dr. Leonard Glass, Eli Lilly’s senior vice president of global medical affairs for diabetes and obesity, said during a call with reporters. “Therefore we encourage people to keep an eye on this and go to their health care provider for any side effects, they can be monitored.” More

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    ESPN shows strength as Disney’s other networks report lower revenue

    Disney broke out ESPN’s quarterly results for the first time on Wednesday.
    Both revenue and operating income rose in the quarter.
    Disney plans to make ESPN available as a direct-to-consumer service no later than 2025, CEO Bob Iger said.

    The worldwide leader in sports still has some juice.
    ESPN operating income surged 16% from a year ago to $987 million in Disney’s fiscal fourth quarter — the first time Disney has ever broken out the sports division’s finances. Revenue in the segment grew 1% year-over-year to $3.8 billion.

    Disney also revealed ESPN+ was profitable in the quarter, generating $33 million. That compares to Disney+ and Hulu, Disney’s other streaming services, which lost $420 million in the quarter.
    While Disney’s other linear network revenue fell 9%, ESPN’s gains in both operating income and revenue suggest the business isn’t foundering — even as sports rights makes up 40% of Disney’s overall content spend. That should come as a giant relief for investors.
    Disney CEO Bob Iger said last year that “linear TV and satellite is marching towards a great precipice and it will be pushed off,” declaring that traditional TV will eventually die off completely. The ESPN results suggest the sports network may not be in as dire shape as the rest of the linear universe.
    “It’s on a great trajectory,” Iger said about ESPN, in an interview with CNBC’s Julia Boorstin on Wednesday. “And the ratings are actually very strong, too. ESPN had one of the strongest years ratings wise, I think, in the last four or fiveyears in 2023. That’s a great thing. We obviously are planning to take ESPN out on a direct to consumer basis. We feel great about that.”
    While Disney is still a year away from breaking even in its streaming business, according to the company’s own estimates, ESPN+ already turns a profit. While linear network advertising fell, ESPN advertising had a “modest increase” in the quarter, Disney said in its earnings statement.

    None of this erases ESPN’s existential crisis of surviving in a streaming-first world rather than the cable bundle. But it does suggest that ESPN isn’t as much in crisis mode as some investors have may feared.
    Disney has held discussions with the four major U.S. professional sports leagues — the National Football League, the National Basketball Association, the National Hockey League and Major League Baseball — about them potentially taking minority equity stakes in ESPN, CNBC reported in July. Disney has also had discussions with other technology companies “that can add either marketing support, technology support or possibly content support,” Iger said in a CNBC interview Wednesday.
    Disney wants to transform ESPN into the preeminent digital sports distribution platform in the coming years, said Iger, who told CNBC that ESPN’s direct-to-consumer offering will launch no later than 2025.
    “ESPN is the No. 1 brand on TikTok with about 44 million followers, which is an incredible statistic,” Iger said during Disney’s earnings conference call. “We feel leaning into it is the smart thing to do because of its unique quality, how popular it is, and how profitable it’s been.”
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    Polestar cuts its guidance as it retools its business plan for lower EV sales, higher profits

    Swedish electric vehicle maker Polestar on Wednesday cut its longstanding 2025 deliveries target and said that despite cost cuts, it will still need to raise cash to break even that year.
    Polestar said it now targeting a gross profit margin “in the high teens” for 2025, with a total annual volume of roughly 155,000 to 165,000 vehicles.
    Polestar’s net loss for the third quarter was $155.4 million

    A Polestar 4 electric SUV is on display during the 20th Shanghai International Automobile Industry Exhibition at the National Exhibition and Convention Center (Shanghai) on April 18, 2023 in Shanghai, China.
    Vcg | Visual China Group | Getty Images

    Swedish electric vehicle maker Polestar on Wednesday cut its longstanding 2025 deliveries target and said that despite cost cuts, it will still need to raise cash to break even that year.
    The company also cut its guidance for the current year.

    Shares rose about 3% in after-hours trading.
    Polestar said it now targeting a gross profit margin “in the high teens” for 2025, with a total annual volume of roughly 155,000 to 165,000 vehicles. At the time of its initial public offering last year, Polestar was targeting annual sales of about 290,000 vehicles by the end of 2025.
    For 2023, Polestar now expects to deliver “approximately 60,000” vehicles, at the low end of its previous guidance range, with a positive gross margin of about 2%. The company had previously guided to deliveries of between 60,000 and 70,000 vehicles in 2023, with a gross margin of 4% for the year.
    Polestar’s gross margin was 1.1% in the first nine months of 2023 and 4.9% in 2022. It delivered 51,491 vehicles in 2022.
    Polestar also said it is taking additional steps to cut costs. It has received $450 million in new loans from its founding investors, Chinese automaker Geely Automobile Holding and Geely subsidiary Volvo Cars. It now expects it will need additional outside funding of about $1.3 billion to get to break-even cash flow in 2025.

    “By having taken the necessary steps to re-work our business plan, we are reducing costs and improving efficiencies to create a more resilient and profitable Polestar – and reducing our funding need at the same time,” CEO Thomas Ingenlath said in a statement.
    The news came as part of Polestar’s third-quarter earnings report.
    Polestar’s net loss for the third quarter was $155.4 million. A year ago, Polestar reported a net profit of $299.4 million, thanks to an accounting credit related to the decline of its stock price at the time.
    Revenue for the third quarter increased to $613.2 million from $435.5 million during the same period last year.
    Polestar delivered 13,976 vehicles in the third quarter, up 51% from a year ago, and a total of 41,817 vehicles in the first nine months of 2023.
    Polestar had $951.1 million in cash and equivalents at the end of the third quarter, down from $1.06 billion as of June 30.
    Polestar confirmed that its upcoming Polestar 3, a large electric SUV, is on track to begin production in China in the first quarter of 2024 and in the United States in the summer of next year. The Polestar 3 is based on a new platform developed by (and shared with) Volvo Cars. It was originally expected before the end of 2023, but delays with the platform’s software — developed by Volvo — pushed it into 2024.
    Production of the Polestar 4, a smaller crossover SUV, will begin in China next week as planned, the company said. Deliveries are expected to begin in China next month, and in the rest of the world early next year. An additional model, an upscale sedan called Polestar 5, is currently expected to go into production in China by the end of 2024. More

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    Virgin Galactic pausing flights next year and laying off 18% to focus on next-gen spacecraft

    Virgin Galactic plans to pause spaceflight operations next year to focus resources on developing its next-generation Delta-class spacecraft.
    It also laid off about 185 employees on Tuesday, or about 18% of its workforce, in order “to decrease its costs and strategically realign its resources.”
    The company has been spending heavily to expand its fleet beyond the current sole VSS Unity spacecraft, which has been flying at a monthly rate.

    Carrier aircraft VMS Eve releases spacecraft VSS Unity before firing its rocket engine during the Unity 25 spaceflight on May 25, 2023.
    Virgin Galactic

    Virgin Galactic plans to pause spaceflight operations next year to focus resources on developing its next-generation Delta-class spacecraft, the company announced Wednesday.
    Although Virgin Galactic has been flying commercial missions at a monthly rate since June, the space tourism company will reduce the rate its VSS Unity spacecraft is flying to a quarter rate, before pausing “in mid-2024” to focus resources on final assembly of new Delta ships, the company said in its third-quarter results.

    Virgin Galactic laid off about 185 employees on Tuesday, or about 18% of its workforce, in order “to decrease its costs and strategically realign its resources.” The reduction brings Virgin Galactic’s total headcount to 840 employees and is expected to generate about $25 million in annual cost savings.
    The space tourism company posted a net loss of $104.6 million, or 28 cents a share, compared with a loss of 43 cents a share expected, according to analysts surveyed by LSEG, formerly known as Refinitiv.
    Virgin Galactic generated $1.7 million in revenue during the quarter – up from $767,000 a year prior. Earlier this month Virgin Galactic completed its fifth commercial spaceflight.
    Virgin Galactic stock rose 8% in after-hours trading from its close at $1.56 a share. The stock is down 55% year-to-date.

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    Virgin Galactic had cash and securities totaling $1.1 billion at the end of the quarter.

    The company has been spending heavily to expand its fleet beyond the current sole VSS Unity spacecraft. Virgin Galactic is developing its Delta-class spacecraft to fly at an improved weekly rate. The company aims to open a new factory by mid-2024 in Phoenix for Delta production.
    “We forecast having sufficient capital to bring our first two Delta ships into service and achieve positive cash flow in 2026,” Virgin Galactic CEO Michael Colglazier said in a statement. More

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    Disney expands cost-cutting plan by $2 billion, posts better-than-expected profit

    Disney reported quarterly earnings after the closing bell.
    Profit topped expectations, but revenue came up short.
    Ad revenue slumped, but the streaming segment narrowed its loss.

    LOS ANGELES — Disney earnings topped expectations thanks in part to profit at ESPN+ and continued growth at theme parks, but a decline in ad revenue weighed on the top line.
    Disney also said it plans to continue to “aggressively manage” its cost base, increasing its cost-cutting measures by an additional $2 billion to a target of $7.5 billion.

    Shares of the company rose more than 4% after the closing bell Wednesday.
    The decrease in ad revenue was primarily from Disney’s ABC Network and other owned TV stations, which saw lower political advertising revenue during the quarter. Over the summer, CEO Bob Iger said the company could be open to selling its TV assets.
    Meanwhile, the company added 7 million new core Disney+ subscribers from the previous quarter, bringing its total number of users to 150.2 million, including Hotstar. The streaming business also narrowed its losses compared with a year earlier.
    Wall Street had expected Disney to report a total of 148.15 million subs for the quarter. The company touted the addition of theatrical titles such as “Elemental,” “Little Mermaid” and “Guardians of the Galaxy: Vol. 3” as well as the new Star Wars series “Ahsoka” as key streaming content during the last three months.
    The company continues to expect that its combined streaming businesses will reach profitability in the fiscal fourth quarter of 2024.

    “As we look forward, there are four key building opportunities that will be central to our success: achieving significant and sustained profitability in our streaming business, building ESPN into the preeminent digital sports platform, improving the output and economics of our film studios, and turbocharging growth in our parks and experiences business,” CEO Bob Iger said in a statement Wednesday.
    Here are the key numbers from Disney’s report:

    EPS: 82 cents per share adjusted vs. 70 cents per share expected, according to LSEG, formerly known as Refinitiv
    Revenue: $21.24 billion vs. $21.33 billion expected, according to LSEG
    Total Disney+ subscribers: 150.2 million vs. 148.15 million expected, according to StreetAccount.

    The company reported net income of $264 million, or 14 cents per share, for the fiscal fourth-quarter ended Sept. 30, up from a net income of $162 million, or 9 cents a share, during the year-ago period.
    Excluding impairments, the company earned 82 cents per share, higher than the 70 cents per share Wall Street had expected.
    Revenue increased 5% to $21.24 billion, just short of estimates, which called for revenue of $21.33 billion. This is the second consecutive revenue miss for Disney and the first time it has had a consecutive revenue miss since early 2018.
    This is also the first quarter that Disney is using its new financial reporting structure, which segmented the company into three divisions — entertainment, sports and experiences. Entertainment contains all of Disney’s streaming and media operations, sports includes ESPN, and experiences includes the company’s theme parks, hotels, cruise line and merchandising efforts.
    Disney’s experience division saw revenues jump 13% to $8.16 billion during the quarter as parks saw higher attendance and ticket prices domestically and abroad. The company reported that there are still lower hotel rates at its Florida resort and that area is experiencing higher operating costs. Parks represented around 66% of total revenue for this division. More

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    Rocket Lab pushes to get launch business back on track, with 22 Electron missions booked next year

    Rocket Lab is pushing to get its launch business back on track by the end of the year, reporting on Wednesday third-quarter results that saw continued strength in its space systems division.
    The company reported a net loss of $40.6 million, or 8 cents per share, just edging out a loss of 9 cents a share expected, according to analysts surveyed by LSEG (formerly Refinitiv).
    Rocket Lab has “fully” booked up its schedule of Electron missions for next year, with 22 launches currently expected in 2024.

    Peter Beck, chief executive officer of Rocket Lab, speaks during the US Chamber of Commerce’s Global Aerospace Summit in Washington, D.C., Sept 14, 2022.
    Valerie Plesch | Bloomberg | Getty Images

    Rocket Lab is pushing to get its launch business back on track by the end of the year, reporting on Wednesday third-quarter results that saw continued strength in its space systems division.
    The company reported a net loss of $40.6 million, or 8 cents per share, just edging out a loss of 9 cents a share expected, according to analysts surveyed by LSEG (formerly Refinitiv). Year over year, Rocket Lab’s third quarter net loss widened by about 17%.

    Revenue grew 7% year over year in the third quarter to $67.6 million, in line with Wall Street analysts’ expectations.
    Rocket Lab’s launch business saw $21.3 million in revenue in the third quarter, with a mid-September mission failure halting the company’s momentum. Rocket Lab expects to resume Electron launches as soon as Nov. 28, with a mission for Japanese satellite imagery company iQPS.
    Rocket Lab CEO Peter Beck said in a news release that the launch failure was due to “a highly complex set of conditions,” but that the company’s investigation identified an electrical issue in the rocket’s power supply system as the likely cause. The company is putting “corrective measures in place,” Beck said.
    “We’ve been laser-focused this quarter on the return to service of Electron,” Beck said in a statement, adding that the company expects “to formally close our investigation in the coming weeks.”
    The company has “fully” booked up its schedule of Electron missions for next year, with 22 launches currently expected in 2024.

    As has become typical, Rocket Lab’s space systems unit brought in the majority of its revenue, with $46.3 million this quarter, up 17% year over year.

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    Its contract backlog increased 9% from the previous quarter, rising by $48.1 million to $582 million.
    Beck highlighted that Rocket Lab is making progress in developing its next-generation Neutron vehicle, achieving recent milestones in both the structure and engines of the rocket.
    For the fourth quarter, Rocket Lab expects revenue between $65 million and $69 million, with just $16.5 million in revenue from its launch business. With its Electron launches expected to resume, Rocket Lab sees first quarter 2024 revenue climbing to between $95 million and $105 million. More

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    Warner Bros. Discovery stock sinks 19% as ad revenue falls, Zaslav warns of ‘generational disruption’

    Warner Bros. Discovery reported third-quarter earnings before the bell Wednesday.
    The company posted a decline in ad revenue.
    CEO David Zaslav said the media industry is going through a “generational disruption.”

    David Zaslav, President & CEO of Discovery Inc.
    Anjali Sundaram | CNBC

    Warner Bros. Discovery shares fell Wednesday after the company reported a decline in advertising revenue, a wider-than-expected loss and lackluster streaming subscriber numbers.
    Here’s what the company reported for the quarter ended Sept. 30, versus analysts’ estimates, according to LSEG, formerly known as Refinitiv:

    Loss per share: 17 cents vs. 6 cents expected
    Revenue: $9.98 billion vs. $9.98 billion expected

    Warner Bros. Discovery reported a net loss of $417 million for the third quarter, or 17 cents per share, an improvement from the $2.31 billion, or 95 cents per share, loss the company reported in the year-ago quarter. Revenue rose 2% to $9.98 billion.
    The company’s stock closed down 19% Wednesday. The slide comes after a media rally late last week driven by Roku and Paramount earnings. Rival media giant Disney is set to report earnings after the closing bell Wednesday.
    Warner Bros. Discovery’s results reflected dire trends in the legacy media industry. Ad revenue in Warner Bros. Discovery’s TV networks segment fell 12% compared with a year earlier, reflecting a decline in audiences for general entertainment and news programming, as well as soft ad trends in the U.S., the company said.
    The company also warned of a number of obstacles heading into 2024, including sluggish ad revenue and ongoing impacts from the actors’ strike.
    “This is a generational disruption we’re going through. Going through that with a streaming service that’s losing billions of dollars, it’s really difficult to go on offense,” CEO David Zaslav said during the earnings conference call.

    The third quarter marked the first full quarter since Warner Bros. Discovery launched its flagship streaming service Max in May, which merged content from HBO Max and Discovery+.
    The company reported 95.1 million global direct-to-consumer subscribers, a 700,000 decrease from the previous quarter, and less than the analyst projection of 95.4 million subscribers, according to StreetAccount.
    The “modest sequential loss” was largely a result of an “extraordinarily light content slate,” CFO Gunnar Wiedenfels said during the earnings call.
    The streaming business did swing to a profit in the quarter, however.
    Warner Bros. Discovery also made headway on paying off its debt load, with $2.4 billion of repayments made during the quarter, the company said. It still has $45.3 billion in gross debt.
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    Satellite imagery company BlackSky ekes out first quarterly profit

    Satellite imagery venture BlackSky delivered its first quarterly profit Wednesday.
    BlackSky reported net income of $675,000 for the third quarter, improving from a net loss of $13.1 million reported for the same period a year ago.
    Chief Financial Officer Henry Dubois said on the company’s earnings call the “primary driver for the positive net income” was the company’s accounting practices related to “warrant liability exposure.”

    The company’s banner on the front of the New York Stock Exchange.

    Satellite imagery venture BlackSky delivered its first quarterly profit Wednesday, as the company works to keep up momentum into the end of the year.
    BlackSky reported net income of $675,000 for the third quarter, improving from a net loss of $13.1 million reported for the same period a year ago. The company brought in $21.3 million in third-quarter revenue, up 26% from a year prior.

    Chief Financial Officer Henry Dubois said on the company’s earnings call the “primary driver for the positive net income” was the company’s accounting practices related to “warrant liability exposure.”
    Excluding that impact, BlackSky would have reported a third-quarter net loss of about $16.3 million.
    BlackSky tightened its 2023 revenue outlook to a range of between $84 million and $90 million, a reduction on the top end from its previously stated guidance of as much as $96 million. It had $51.5 million in cash and equivalents on hand at the end of the third quarter, with a contract order backlog of $252 million.

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    Shares of BlackSky slipped 4.2% in trading to close at $1.15 a share. Like many space stocks that went public in the past few years, BlackSky’s market cap today is a fraction of its debut valuation.
    Correction: This story has been updated to correct that BlackSky CFO Henry Dubois said the “primary driver for the positive net income” was the company’s accounting practices related to “warrant liability exposure” and that excluding that impact, the company would have reported a third-quarter net loss of about $16.3 million. More