Zoster vaccine recombinant, adjuvanted (GlaxoSmithKline)

With quarterly earnings underway, BioPharma Dive is providing a snapshot of some companies results and how theyre being received by investors. Today, were offering insight into the latest numbers from Bristol Myers Squibb, GSK and AbbVie.AbbVie angstAbbVie reported $16.6 billion worth of net revenue in the final three months of 2025, a 10% year-over-year increase. The total was a bit above what analysts generally predicted, with the vast majority of revenue upside coming from a surprise performance by Humira, according to David Risinger of Leerink Partners.Once the worlds best-selling drug, Humira has been in decline since generic competition entered the market a few years ago. But in the fourth quarter, the $1.2 billion the drug brought in was almost 30% higher than Wall Street expectations.Most of AbbVies other products were roughly in-line with estimates, with one exception being Rinvoq, which fell below with a quarterly revenue of nearly $2.4 billion. Those performances may be why company shares were, at one point Wednesday, down more than 6%.Phipps, of William Blair, highlighted how it was the second quarter in a row that Rinvoq didnt meet analyst forecasts. At the same time, Skyrizi the other immune system-regulating drug AbbVie has pegged as a partial successor to Humira had only a slight beat.Investors continue to have concerns about growing competition for the companys [immunology] franchises, Phipps wrote in a note to clients. One particular point of worry, he added, is how Rinvoq and Skyrizi will fare in the inflammatory bowel disease market since the relatively recent entries of Johnson & Johnsons Tremfya and copycat versions of Stelara.AbbVie recorded $61.2 billion in net revenue across all of 2025, reflecting an 8.6% annual gain. For this year, the company said adjusted diluted earnings per share will land somewhere between $14.37 to $14.57.Though such a range should be viewed positively by investors, Cantor Fitzgeralds Carter Gould argues that the focus is more on the revenue and product-level guides, especially for Skyrizi. Jacob BellA bifurcated vaccine marketVaccine makers are facing a unique challenge in one of their largest markets. The sudden, drastic shift in U.S. vaccine policy, combined with growing skepticism and declining immunization rates, has imperiled sales as well as future vaccine research.Moderna CEO Stephane Bancel has already reportedly said his company wont invest in late-stage vaccine trials due to the contentious climate. Now, some of the worlds top vaccine manufacturers are reporting slowing sales numbers that could provide insight into how the situation will play out in the coming years.Last week, French pharmaceutical Sanofi said that vaccine sales fell 2.5% in the fourth quarter and are anticipating negative sales growth next year. Thats in large part due to performance in the U.S., where revenue dipped for immunizations against polio, meningitis, influenza and respiratory syncytial virus.GSK is now reporting similar trends.The British drugmaker said Wednesday that while overall vaccine sales were up 2% in the fourth quarter, its growth was driven by sales in Europe and elsewhere, while U.S. numbers tumbled for its influenza, RSV and shingles vaccines. Its shingles vaccine, Shingrix, faced the sharpest decline, with sales plummeting 17% in the U.S. due to heightening difficulty reaching unvaccinated individuals.While the earnings for adult shots were the most affected, GSK has yet to see how the new changes to the U.S. childhood immunization schedule will affect the rest of GSKs vaccines. Nina Mojas, head of the companys global product strategy, said the impact should be manageable given its broad vaccine portfolio.“We continue to monitor the evolving pediatric vaccine landscape in the U.S, Mojas said during an earnings call.Last month, the Centers for Disease Control and Prevention rolled back six immunization recommendations for children in response to a directive from President Trump. The schedule was scaled down to recommend 11 vaccines from the previous 17.At least so far, however, insurance coverage remains as before, Mojas added. GSK expects vaccine sales to either be stable or decline by a low-single digits percent in 2026. Delilah AlvaradoBristol Myers waiting gameBristol Myers growth portfolio lived up to its name in 2025, helping the company deliver fourth-quarter and full-year revenues that were a tick higher than analyst estimates.The portfolio spans 18 products, most of which are used to treat cancer or regulate the immune system. Collectively, revenue from this group rose 17% last year, and accounted for 55% of the total $48.2 billion Bristol Myers recorded. Standout performances, according to William Blair analyst Matt Phipps, came from the anemia shot Reblozyl, the heart drug Camzyos and the cell therapy Breyanzi.Wall Street had hoped to see Cobenfy, a first-of-its-kind treatment for schizophrenia that generated $51 million in the fourth quarter, bring in a bit more during that three-month period. Bristol Myers took control of Cobenfy back in 2024, through an acquisition worth $14 billion. The company has been looking to ramp up sales by notching additional approvals in more common conditions like bipolar disorder or the agitation, psychosis and cognition problems that often accompany Alzheimers disease.A trio of late-stage studies evaluating Cobenfy against Alzheimers psychosis are set to produce results this year. Analysts have pinpointed those trials as some of Bristol Myers most important near-term catalysts, along with Phase 3 readouts for the companys experimental myeloma drugs iberdomide and mezigdomide and its blood thinner milvexian.We see the continued outperformance of the growth portfolio as a positive signal on execution, with attention pointing to [back half of the year] datasets for further confidence on the mid- to long-term revenue trajectory, wrote Raymond James analyst Sean McCutcheon in a note to clients.Bristol Myers is under pressure to further build out that portfolio, given the steep declines across most of its legacy drugs like Revlimid and Pomalyst. Its top-seller, Eliquis, is also poised to lose key patent protections in 2028, putting more than a quarter of Bristol Myers annual revenue in jeopardy.For 2026, the company forecasts revenue reaching around $46 billion to $47.5 billion and non-GAAP earnings per share in the range of $6.05 to $6.35. Those figures are in line to moderately above Wall Street expectations, McCutcheon wrote.Shares of Bristol Myers climbed more than 3% Thursday. Jacob Bell '

Luke Miels inherited the GSK CEO role as the company posted what he called strong performance last year. In his first investor update as GSK’s CEO, Luke Miels defined a core of his vision for the company’s next chapter: “We need to be more product-centric as a company.”Being product-centric means everyone at GSK, from R&D and manufacturing to commercialization and administrative functions, should be clear about how their role drives the company’s goal of making drugs that improve clinical outcomes for patients, Miels said during a press call Wednesday.“When you look at the level of communication, discussions, focus time that a company spends, I want to really see that to be massively dominated by products,” he said.In addition to product-centricity, Miels also wants GSK to have more “scientific courage” to accelerate its pipeline and be “more agile to capitalize on opportunities.” Miels succeeded Emma Walmsley to become GSK’s new CEO at the beginning of 2026, inheriting the role as GSK posted what he called strong performance last year. Full-year revenue grew 7% at constant exchange rates to 32.7 billion pounds sterling ($44.9 billion), and a fourth-quarter haul of 8.6 billion pounds came 2% ahead of analysts’ consensus.Even though GSK expects milder sales growth—between 3% and 5%—this year, Miels stood by the company’s ambitious target of generating more than 40 billion pounds by 2031, which was set when he was chief commercial officer.  GSK will test its new CEO’s product-centric approach this year with two key launches: long-acting respiratory disease biologic Exdensur and multiple myeloma antibody-drug conjugate Blenrep, both approved by the FDA in the fourth quarter of 2025.With Exdensur, GSK has transferred its Nucala sales force to detail the new half-yearly regimen, leaving Nucala’s chronic obstructive pulmonary disease (COPD) launch to the Trelegy team, Miels said on an investor call Wednesday.“We need to place our bets on the future, and the ultimate future with IL-5 and higher [eosinophils] is gonna be long-acting Exdensur for COPD,” he said.Exdensur’s current FDA approval covers its use as an add-on therapy for severe eosinophilic asthma. In COPD, GSK has two phase 3 trials, Endura-1 and -2, for testing the anti-IL-5 antibody as an add-on therapy to treat moderate to severe COPD with type 2 inflammation. In the fourth quarter, GSK launched a third phase 3 trial, dubbed Vigilant, to assess early use of Exdensur in COPD patients who have had one exacerbation and are at a high risk for future exacerbations.Despite the many biologics available for respiratory diseases, GSK still sees “a significant opportunity in the bio-naïve population, as only 27% of U.S. eligible patients are on a biologic, and market research shows that 97% of patients would prefer or like to switch to a biologic with six-monthly dosing,” Nina Mojas, GSK’s president of global product strategy, said on the investor call.As for Blenrep, the BCMA agent remains a show-me story after making a comeback from a previous market withdrawal. Despite lofty peak sales figures, Mojas acknowledged that the product’s launch will be a slow ramp as GSK supports prescribers and patients to ensure a positive first experience.Despite its being an off-the-shelf option compared with BCMA CAR-T therapies, Blenrep comes with notable eye toxicity and is therefore only available through an FDA-mandated REMS safety program. To mitigate that side effect, GSK has educated about 18,000 eye care professionals in the U.S., enabling their collaboration with oncologists, Mojas said. GSK launched Blenrep in the U.K. before securing an FDA go-ahead in late October, and the company expects to see similar interest in the drug albeit slow uptake because of the need for coordination with eye care professionals.Still, Miels highlighted a roughly 50-50 split between academic and community practices during early adoption of Blenrep.“Our strategy is to focus on the community,” he said. “With a product that is being relaunched and not a lot of experience in the community, I think this is an encouraging trajectory.” Meanwhile, the vaccines business at GSK is undergoing significant uncertainty due to disruptive U.S. policy changes.In the fourth quarter, GSK’s sales from vaccines grew 4% year over year to 2.3 billion pounds, bringing the full-year total to nearly 9.2 billion pounds ($12.6 billion).The company’s flagship shingles vaccine Shingrix delivered a 20% sales increase during the fourth quarter thanks to Europe and international markets, while the U.S. logged a 17% decrease as the remaining unvaccinated market proves difficult to penetrate.The U.S. Department of Health and Human Services, under the leadership of Secretary Robert F. Kennedy Jr., has challenged many longtime vaccine practices, including recently walking back recommendations for six immunizations for children. The moves have dealt a number on overall vaccines sales at several companies, although GSK expects the impact to be “manageable.”“We continue to monitor the evolving pediatric vaccine landscape in the U.S.,” Mojas said. “At this time, insurance coverage remains as before, and we expect the recent HHS changes to be manageable.”For 2026, GSK expects sales from vaccines to decline in the low-single-digit percentage or remain stable.