Raphael Stevens

Vertex Pharmaceuticals said its experimental painkiller, which is being tested as an alternative to addictive opioids, significantly decreased post-surgery pain in late-stage trials.
The drug, known as VX-548, did not work better than a popular opioid, however.
Still, the trial results bring the biotech company one step closer to developing a drug that can provide strong pain relief without the addictive potential of opioids.

A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston on Oct. 23, 2019.
Brian Snyder | Reuters

Vertex Pharmaceuticals on Tuesday said its experimental painkiller, which is being tested as an alternative to addictive opioids, significantly decreased post-surgery pain in late-stage trials
The drug, known as VX-548, did not work better than a popular opioid, however.

Still, the trial results bring the biotech company one step closer to developing a drug that can provide strong pain relief without the addictive potential of opioids, which have caused a horrific epidemic in the U.S. Plenty of other similar painkillers never reached the market.
Vertex said it would file for Food and Drug Administration approval of the painkiller for the treatment of moderate-to-severe acute pain by the middle of this year.
Acute pain is usually caused by injury, surgery, illness, trauma or painful medical procedures and is likely to ease with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., Vertex said in a release.
Wall Street analysts have said that the drug, which works by blocking pain signals at its origin before they reach the brain, could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion.
“We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings,” Vertex CEO Dr. Reshma Kewalramani said in a release.

Shares of Vertex rose more than 2% on Tuesday following the data release. The company, best known for developing drugs to treat the serious genetic disorder cystic fibrosis, has a market value of about $115 billion.
Last year, the company’s painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a chronic nerve condition. The stock also saw a boost from U.S. approval of the first-ever gene-editing therapy for sickle cell disease from Vertex and its partner CRISPR Therapeutics.
Vertex said Tuesday its painkiller was more effective in reducing the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also known as “tummy tucks,” and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in studies of people with acute pain.
The company’s painkiller, however, failed to meet the secondary goal in both trials of reducing pain when compared to a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the basis for popular pain medications like Tylenol.
Jefferies analyst Michael Yee said the drug’s failure to meet that goal is in line with expectations and that overall, the late-stage trial results released Tuesday are positive.
VX-548 was also safe and well-tolerated in the two trials and an additional study examining the safety and tolerability of the drug in people experiencing pain from a variety of conditions. Common side effects included nausea and constipation. More

General Motors is changing its product lineup strategy to include plug-in hybrid electric vehicles, CEO Mary Barra told investors Tuesday.
Barra did not disclose specific details of the plans other than that plug-in hybrids will be rolled out on select vehicles in North America to assist in meeting more stringent federal fuel economy regulations.
GM led the way in plug-in electric vehicles with the Chevrolet Volt during the 2010s. The company discontinued the vehicle in early 2019, citing demand and cost concerns.

General Motors reveals the new 2016 Chevrolet Volt to the media at the 2015 North American International Auto Show on January 12, 2015 in Detroit, Michigan.
Getty Images

DETROIT – General Motors is changing its product lineup strategy to include plug-in hybrid electric vehicles, CEO Mary Barra told investors Tuesday.
Barra did not disclose specific details of the plans other than that PHEVs, which include an internal combustion engine along with battery technologies, will be rolled out on “select vehicles” in North America to assist in meeting more stringent federal fuel economy regulations.

More companies are reconsidering the viability of hybrid vehicles to appease consumer demand and avoid costly penalties related to those federal fuel economy and emissions standards. Most of GM’s main competitors offer traditional hybrids as well as plug-in hybrid electric vehicles.
“Let me be clear, GM remains committed to eliminating tailpipe emissions from our light-duty vehicles by 2035, but, in the interim, deploying plug-in technology in strategic segments will deliver some of the environment or environmental benefits of EVs as the nation continues to build this charging infrastructure,” Barra said during the automaker’s quarterly and 2023 earnings call.
Barra alluded to the automaker using plug-in hybrid technology that the company has already adopted overseas in countries such as China. The only hybrid GM currently offers in the U.S. is a traditional hybrid version of the Chevrolet Corvette.
GM led the way for plug-in electric vehicles with the Chevrolet Volt during the 2010s. The company discontinued the vehicle in early 2019, citing demand and cost concerns.
The Detroit automaker previously planned to forgo plug-in hybrid vehicles and move all of its traditional cars and trucks with internal combustion engines to all-electric models for consumers.

The shifting strategies are counterintuitive to the industry’s recent messaging on EVs. Many auto companies have begun to invest billions of dollars in all-electric vehicles, and the Biden administration has made a push to get more EVs on U.S. roadways as quickly as possible.
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Good afternoon! This is Annika Kim Constantino, and I cover the biotech and pharmaceutical industry for CNBC.com. 

Three names in the industry – Johnson & Johnson, Merck and Bristol Myers Squibb – face a pivotal few weeks ahead. 
CEOs from those companies are slated to testify at a Senate hearing on high prescription drug prices in the U.S. on Feb. 8 at 10 a.m. ET, Sen. Bernie Sanders announced Friday.
It took subpoena threats from the senator, but J&J CEO Joaquin Duato and Merck CEO Robert Davis have agreed to testify after both executives declined earlier requests to appear at the Senate HELP committee’s hearing. They join Bristol Myers Squibb CEO Chris Boerner, who agreed to the panel’s initial invitation to appear. 
Sanders hopes the hearing could bear some fruit for Americans, especially after Eli Lilly’s CEO promised not to raise the prices of the company’s insulin products during a similar grilling the panel held in May. 
But why is the committee targeting Merck, J&J and Bristol Myers Squibb in the first place? Sanders noted that all three companies manufacture some of the most expensive drugs sold in the U.S.: Merck’s diabetes drug Januvia, Bristol Myers Squibb’s blood thinner Eliquis and J&J’s immunosuppressive medication Stelara. 

He’s not wrong: 

The average retail price for a month’s supply of Januvia can range from $500 to $700 before insurance and other rebates.
Eliquis’ retail price for a month’s supply is nearly $600 before insurance.
The retail price for one dose of Stelara taken every eight weeks is nearly $25,500.

Those prices don’t reflect the exact cost people with insurance pay out of pocket.
Still, data from the Biden administration suggests that some older adults with Medicare Part D coverage still pay hundreds of dollars for those medications. On average, Medicare enrollees paid $2,058 for Stelara, $441 for Eliquis and $270 for Januvia out of pocket in 2022, a fact sheet from the administration said. 
That’s why the three drugs will be subject to the first round of Medicare drug price negotiations, a key policy under the Inflation Reduction Act that aims to make costly medications more affordable for seniors. J&J, Merck and Bristol Myers Squib are all suing to halt the talks, which will establish new prices that will go into effect in 2026. 
Those discussions are going to heat up on Thursday, when Medicare will make initial price offers for each of the 10 drugs selected for negotiations. 
Merck, J&J and Bristol Myers Squibb are also facing pressure for another reason: billions of revenue will be at risk after some of their blockbuster drugs tumble off a “patent cliff” over the next few years. 
That refers to when a company’s patents for one or more leading branded products expire, which allows for competitors to sell copycats of those drugs, often at a lower price. That usually causes revenue to fall for drugmakers and costs to drop for patients, who can access similar but more affordable drug options.
I did a deep dive on patent cliffs this weekend and zeroed in on some of the biggest medicines with key upcoming patent expirations: 

Merck’s Keytruda, an immunotherapy that treats melanoma, head and neck, lung and other certain types of cancers.
Bristol Myers Squibb’s Opdivo is an immunotherapy used to treat cancers, including melanoma and lung cancer. 
Bristol Myers Squibb’s Eliquis 
J&J’s Stelara

 “When you step back from it all, lowering drug costs for patients and opening it up to a broader set of people is a great thing,” Mike Perrone, Baird’s biotech specialist, told CNBC. “So, while it’s a problem for these pharma companies, it’s a help to the system and that’s why it’s created.”

The latest in health-care technology

This is Ashley Capoot, and I cover health tech for CNBC.com.
Apple to reportedly explore health applications for Vision Pro headset 
It’s a big week for Apple, as the company’s highly anticipated mixed reality headset, the Vision Pro, launches Friday. The $3,500 headset is Apple’s first big new product since the Apple Watch launched in 2015, and the company has reportedly set its sights on health care as a growth market for the technology.  
In a video to Apple employees earlier this month, executives said the headset could “hopefully improve patient outcomes” and allow surgeons to look at displays during procedures, according to a report from Bloomberg. 
Many health systems are already using virtual and augmented reality headsets like the Meta Quest 2 to train surgeons and treat patients, as CNBC reported in September. The U.S. Department of Veterans Affairs, for instance, uses headsets across more than 160 facilities in at least 40 different ways. 
The question remains whether health systems will be willing to cough up the cash for Apple’s expensive new technology, or if they’ll choose cheaper options like Meta’s Quest 2, which starts at $250. 
Testing a consumer-facing CGM from Signos 
It’s been a week since I started testing out a continuous glucose monitor, or a CGM, from the startup Signos. CGMs are small sensors often worn on the upper arm that track blood sugar levels. People with diabetes primarily use the devices, since the data can be wirelessly sent to a smartphone and help prevent emergencies.
Signos’ CGM system is meant for the average consumer, so it is not intended for diabetes management. The startup has its own app that shows users how their bodies respond to specific foods, what causes their glucose to spike and when they should exercise to get the best results for weight loss. I’m trying it out for 30 days to see what I learn.
Since the CGM relies on a small sensor under the skin to get a reading, I was slightly nervous about putting the device on my arm. Much to my relief, the application was actually easy and painless, and Signos’ app walked me through all the steps to get set up.
I’ve been logging my meals, sleep and exercise and completing a series of activities to learn how to interpret my data. I’ll have more reporting on this in the coming weeks, so stay tuned!
Feel free to send any tips, suggestions, story ideas and data to Annika at [email protected] and Ashley at [email protected] More

Home prices started to fall in November, after nine straight months of gains, according to the S&P CoreLogic Case-Shiller national home price index.
Seattle and San Francisco reported the largest monthly declines, falling 1.4% and 1.3%, respectively.
Prices nationally were still higher compared with the year before, and those annual gains increased again.
For the second straight month Detroit reported the highest year-over-year gain among the 20 cities, with prices rising 8.2% in November, followed again by San Diego with an 8% increase.

A sign stands outside an upscale home for sale in the Lake Pointe Subdivision of Austin, Texas.
Ed Lallo | Bloomberg | Getty Images

Home prices in November fell 0.2% from October, according to the S&P CoreLogic Case-Shiller national home price index.
While that may not seem like a lot, it is the first monthly drop since January 2023. Mortgage rates rose sharply in October to their highest level in more than 20 years, making houses hard to afford.

Seattle and San Francisco reported the largest monthly price declines, falling 1.4% and 1.3%, respectively. Meanwhile, six cities registered a new all-time high in November. Those were Miami; Tampa, Florida; Atlanta; Charlotte, North Carolina; New York; and Cleveland.
Prices nationally were still higher than the year before, and those annual gains increased again relative to the prior month. They rose 5.1% from November 2022, up from a 4.7% annual increase in October. The 10-city composite climbed 6.2%, up from a 5.7% advance in October. The 20-city composite rose 5.4%, up from a 4.9% increase in the previous month.
“The house price decline came at a time where mortgage rates peaked, with the average Freddie Mac 30-year fixed rate mortgage nearing 8%, according to Federal Reserve data,” said Brian Luke, head of commodities, real and digital assets at S&P DJI. “The rate has since fallen over 1%, which could support further annual gains in home prices.”
For the second straight month, Detroit reported the highest year-over-year gain among the 20 cities. Prices rose 8.2% in November, followed again by San Diego with an 8% increase.
Portland, Oregon, was the only city showing prices lower from the prior year, down 0.7%, compared with November 2022.

Regionally, the November report showed the narrowest price performance spread across the country since the first part of 2021.
“The tight disparity speaks to a rising tide across the country, with less evidence of micro-markets bucking the trend. The days of markets in the South rising double digits with markets in the Midwest remaining flat are over,” added Luke.
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Pfizer posted a surprise adjusted fourth-quarter profit, as the company’s declining Covid business performed better than expected.
The results come after a rocky year for the company, which grappled with plummeting demand for its Covid products as the world emerged from the pandemic.
Pfizer will hold an earnings call with investors at 10 a.m. ET on Tuesday.

Pfizer on Tuesday posted a surprise adjusted fourth-quarter profit, as the company’s declining Covid business performed better than expected.
The company reversed roughly $3.5 billion in revenue related to the expected return of 6.5 million doses of its Covid drug, Paxlovid, from the U.S. government. That hit is less than the $4.2 billion Pfizer initially expected for the return of nearly 8 million doses of Paxlovid.

Pfizer’s Covid vaccine raked in $5.36 billion in revenue for the quarter, down 53% from the same period last year. Analysts had expected the shot to bring in $4.99 billion in sales, according to FactSet estimates.
The results come as Pfizer tries to blunt the rapid decline of its Covid business, which saw demand plummet to new lows and transitioned to the commercial market in the U.S. last year. As revenue suffers, the company is trying to improve its bottom line and boost investor confidence through a broad $4 billion cost-cutting plan.
Here’s what Pfizer reported for the fourth quarter compared to what Wall Street was expecting, based on a survey of analysts by LSEG, formerly known as Refinitiv:

Earnings per share: 10 cents per share adjusted vs. loss of 22 cents expected
Revenue: $14.25 billion vs. $14.42 billion expected

The pharmaceutical giant also reiterated its full-year 2024 guidance, which it first outlined in mid-December. 
Pfizer expects revenue to come in between $58.5 billion and $61.5 billion this year, which includes roughly $8 billion in revenue from its Covid products and contributions from its recently closed acquisition of cancer drug developer Seagen.

The company expects to book adjusted earnings of $2.05 to $2.25 per share.
Pfizer recorded fourth-quarter revenue of $14.25 billion, down 41% from the same period a year ago, due to the plunge in sales of its Covid products.
For the fourth quarter, Pfizer booked a net loss of $3.37 billion, or 60 cents per share. That compares to a net income of $4.99 billion, or 87 cents per share, during the same period a year ago. 
Excluding certain items, the company’s posted earnings per share of 10 cents for the quarter.
Still, Pfizer’s Covid business had a dismal 2023.
Revenue from its Covid vaccine and Paxlovid came in at $12.5 billion in 2023. That’s down 78% from their $57 billion peak in 2022. 

Pfizer’s non-Covid drugs

Excluding Covid products, Pfizer said revenue for the fourth quarter grew 8% operationally.
The company said that growth was partly fueled by its new vaccine against respiratory syncytial virus, which entered the market during the third quarter for seniors and expectant mothers. The shot, known as Abrysvo, posted $515 million in sales for the fourth quarter. 
The company said revenue also got a boost from strong sales of Vyndaqel drugs, which are used to treat a certain type of cardiomyopathy, a disease of the heart muscle. Those drugs booked $961 million in sales, up 41% from the fourth quarter of 2022.
Pfizer also said its blood thinner Eliquis, which is co-marketed by Bristol Myers Squibb, helped drive that growth. The drug posted $1.61 billion in revenue for the quarter, up 9% from the same period a year ago. Analysts had expected Eliquis to rake in $1.52 billion in sales, according to FactSet.
One non-Covid product class fared worse than Pfizer hoped. A group of shots to protect against pneumococcal pneumonia brought in $1.60 billion in sales for the fourth quarter. That was down 8% from the same quarter a year ago due to lower demand and what the company called “unfavorable timing of customer orders.” Analysts had expected that group of shots to book $1.97 billion in sales, according to FactSet.
Wells Fargo analyst Mohit Bansal said the disappointing sales for that group of shots, which Pfizer calls the Prevnar family, could be a concern.
Bansal noted that Merck has offered encouraging commentary on prospects for its own pneumococcal pneumonia vaccine franchise, so he expects Pfizer to receive questions during its fourth-quarter earnings call about how it plans to defend that part of its business.
The results cap a rocky year for a company that once saw revenue soar after it delivered the world’s first Covid vaccine. 
Shares of Pfizer fell roughly 40% in 2023 as demand for its shot and other Covid products plummeted worldwide, causing the company to dramatically slash its full-year revenue forecast, record multi-billion dollar charges related to inventory write-offs and launch a sweeping cost-cutting program. 
What’s more, Pfizer’s future in the booming weight loss drug market began to look bleak last month. The company scrapped a twice-daily version of its experimental weight loss pill after patients with obesity taking the drug lost significant weight but had trouble tolerating the drug in a mid-stage clinical study. 
Investors are waiting for the company to unveil data on a once-daily form of that drug, called danuglipron, during the first half of the year.
Pfizer hopes its $43 billion acquisition of Seagen, which officially closed during the fourth quarter, will restore investor confidence. Last month, the company made it clear that it was doubling down on cancer treatments after it revealed plans to create a new oncology division that includes Seagen in early 2024.
But Wall Street is still skeptical about whether Pfizer can turn things around: The company’s stock is already down more than 4% for the year, putting its market value at roughly $155 billion. 
Pfizer will hold an earnings call with investors at 10 a.m. ET on Tuesday. More

JetBlue Airways swung to a loss in the fourth quarter and forecast lower capacity this year as it scrambles to return to profitability.
JetBlue said it expects 2024 capacity to be down in the low single digits and that its adjusted margins could approach breakeven.
The carrier didn’t mention its merger agreement with Spirit, a deal a federal judge blocked earlier this month.

JetBlue Airways swung to a loss in the fourth quarter and forecast lower capacity this year as it scrambles to return to profitability.
The New York-based airline reported a net loss of $104 million for the last three months of 2023, compared with a $24 million profit a year earlier. On a per-share basis, JetBlue lost 31 cents during the fourth quarter, or 19 cents on an adjusted basis, compared with a 7-cent profit during the year-earlier period.

The airline expects revenue to drop between 5% and 9% in the first three months of the year, more than the 5.5% decline Wall Street analysts were predicting. Capacity in the first quarter will be down as much as 6%, the airline said.
JetBlue said it expects 2024 capacity to be down in the low single digits and that its adjusted margins could approach breakeven.
The airline has been grappling with higher costs, operational challenges and changing travel patterns, just as a federal judge earlier this month barred its plan to acquire Spirit Airlines for $3.8 billion. JetBlue warned last week the agreement with Spirit could be terminated, but it didn’t provide further detail in Tuesday’s filing.
Here’s what JetBlue reported for the fourth quarter, compared with Wall Street expectations complied by LSEG, formerly known as Refinitiv:

Adjusted loss per share: 19 cents vs. 28 cents expected
Revenue: $2.33 billion vs. $2.29 billion expected

Revenue for the fourth quarter was down 3.7% year over year, though still slightly ahead of Wall Street estimates.

JetBlue has been tweaking its network to focus on more profitable flights. CNBC reported JetBlue’s planned flight cuts earlier this month.
“Demand during peak periods remains strong, and we continue to manage our capacity during off-peak periods to reflect evolving demand trends,” said Joanna Geraghty, JetBlue’s COO and incoming chief executive, in a release. “We plan to continue to refine our network and product offering to better serve our leisure customers while diversifying revenues with margin-accretive initiatives.”
Other airlines including Southwest have also slowed their growth or refined their networks to avoid overcapacity — and low fares — during off-peak periods, while discounting less popular flights.
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General Motors beat Wall Street’s top- and bottom-line expectations for the fourth quarter, while forecasting another strong year despite potential economic and sales head winds.
China – GM’s second-largest market – continued to struggle, with a 34% decline in equity income for the year, including a 54% drop during the fourth quarter.
GM expects to spend roughly $1 billion less this year on its majority-owned autonomous vehicle subsidiary Cruise.

DETROIT — General Motors beat Wall Street’s top- and bottom-line expectations for the fourth quarter, while forecasting another strong year despite potential economic and sales head winds.
The Detroit automaker’s 2024 guidance calls for net income attributable to stockholders of $9.8 billion to $11.2 billion, or $8.50 to $9.50 earnings per share; adjusted earnings before interest and taxes (EBIT) of $12 billion to $14 billion, or $8.50 to $9.50 adjusted EPS; and adjusted automotive free cash flow between $8 billion and $10 billion.

The earnings guidance is largely better than GM’s 2023 results and in line or higher than many Wall Street analysts’ expectations of flat results compared with 2023.
Shares of GM on Tuesday were up more than 7% during premarket trading.
Here’s how the company performed in the fourth quarter, compared with average estimates compiled by LSEG, formerly known as Refinitiv:

Adjusted earnings per share: $1.24 versus $1.16, estimated
Revenue: $42.98 billion versus $38.67 billion, estimated

For the fourth quarter, GM reported net income for stockholders of $2.1 billion, or $1.59 per share, compared with $2 billion, or $1.39 per share a year earlier. Adjusting for one-time items, GM earned $1.24 per share, topping Wall Street expectations.
Revenue was largely flat year over year, at $42.98 billion compared with $43.11 billion for the final three months of 2022.

GM’s full-year 2023 revenue was about up 10% compared with the prior year, at $171.84 billion, with net income attributable to stockholders of $10.13 billion and adjusted earnings before interest and taxes of $12.36 billion. That compares with 2022 revenue of $156.74 billion, net income attributable to stockholders of $9.93 billion and adjusted EBIT of $14.47 billion.
“As we begin 2024, I believe GM is well positioned for another year of strong financial performance,” GM CFO Paul Jacobson told the media during a call to discuss the results.
GM’s 2023 earnings included several special charges, including $1.1 billion in North American strike costs and $792 million for new commercial agreements between GM and LG Electronics and LG Energy Solution.
Shares of GM are down less than 2% this year after rising about 7% last year, lifted by an accelerated $10 billion share repurchase program that was announced in late November.

Regional results

GM’s North American adjusted earnings were off 45% during the fourth quarter from a year earlier to $2.01 billion. Its international operations declined by 1.1% to $269 million.
China – GM’s second-largest market – continued to struggle, with a 34% decline in equity income for the year to $446 million, including a 54% drop during the fourth quarter.
Jacobson said GM expects its China operations this year to be roughly flat from last, including an anticipated loss in the first quarter.
“The team is doing a good job of managing through a challenging situation but we’re going to have a tough first quarter,” he said.
For the year, GM’s North American operations were off 5.3% to $12.31 billion, while international operations were up 5.9% to $1.21 billion.

Cruise

GM expects to spend roughly $1 billion less this year on its majority-owned autonomous vehicle subsidiary Cruise. In 2023 it spent $2.7 billion on the embattled business unit, excluding special items such as severance packages for layoffs.
Cruise remains under several state and federal investigations following an Oct. 2 accident involving a pedestrian in San Francisco.
GM CEO Mary Barra, who chairs Cruise’s board, said officials have “already begun to implement significant changes” at Cruise following the findings of internal, third-party probes into the incident and operations.
Cruise and GM last week released findings of internal investigations that outlined cultural issues, regulatory ineptitude and poor leadership at the company, but found that officials did not intentionally deceive or mislead regulators.
The companies also disclosed Cruise remains under investigation by several entities, including the U.S. Department of Justice and the U.S. Securities and Exchange Commission.
“At Cruise, we are committed to earning back the trust of regulators and the public through our commitments and our actions,” Barra said in a letter to shareholders Tuesday.

EVs

Both Barra and Jacobson acknowledged that the adoption of electric vehicles in the U.S. has been slower than originally expected but said the company remains committed to expanding its EV lineup and sales in 2024.
“Consensus is growing that the U.S. economy, the job market and auto sales will continue to be resilient, and at GM, we expect healthy industry sales of about 16 million units with the mix of EVs continuing to grow,” Barra said.
The automaker last year pulled its near-term sales guidance for EVs but maintained plans to add 1 million units worth of EV production capacity in North America and achieve a mid-single-digit EBIT EV margin, both by 2025.
GM’s EV sales totaled 75,883 units, or 2.9% of the company’s overall sales, last year. A vast majority of those were sales of its now discontinued Chevrolet Bolt models.
The company has experienced problems in ramping up production of its newer “Ultium” EVs, including a major issue with battery module assembly.
GM has said it plans to keep its North American plants “flexible” to produce EVs and traditional vehicles with internal combustion engines, based on consumer demand.
This is breaking news. Please check back for additional updates.
— CNBC’s Michael Bloom contributed to this report. More