Pneumococcal 7-valent conjugate vaccine(Pfizer Inc.)

Major vaccine makers reported significant declines in U.S. sales and demand in the third quarter. Anti-vaccine sentiment is alive and well, especially in the U.S. And it was evident in recent weeks as drugmakers revealed their third-quarter earnings, replete with declining vaccine sales.Pfizer’s numbers (PDF) were particularly indicative of the erosion in demand for immunizations in the U.S. While sales of its Prevnar franchise of pneumococcal vaccines were up 18% year over year outside of the U.S., they were down 12% in the U.S. The same was true of COVID shot Comirnaty, which saw a 9% sales increase internationally and a 25% decline domestically.Meanwhile, sales of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo were up 81% outside of the U.S. and down 34% in the U.S., with CEO Albert Bourla, Ph.D., saying the company was “experiencing the headwind of a more difficult-to-activate population as we enter the third season of RSV.”Sanofi, for its part, sustained an 8% year-over-year decline in its vaccine revenues, with Chief Financial Officer François Roger noting a “negative buzz” around the jabs. In the company's earnings announcement, CEO Paul Hudson attributed the shortfall to “increased price competition and lower vaccination rate.”GSK managed to squeak out a 2% overall increase in vaccine revenue despite a 15% decline of sales in the U.S., which the company chalked up largely to plummeting demand for its shingles jab Shingrix.As for Merck, which has been hindered for more than a year by declining demand in China for its HPV shot Gardasil, sales of each of its vaccines were down in the third quarter except for Capvaxive, which CFO Caroline Litchfield said is off to a “very strong launch.” The shot, which is the first designed specifically to prevent pneumococcal disease in adults, has generated sales of $530 million in its first four quarters on the market. The third-quarter results were even more grim for companies that specialize in vaccines and depend largely on U.S. sales. Moderna sustained a 45% year-over-year decrease in revenue during the quarter as its RSV shot mResvia drummed up sales of just $2 million and its COVID vaccine Spikevax pulled in $971 million, which was down from $1.8 billion during the same period last year. With the result, Moderna reduced the top end of its 2025 guidance from $2.2 billion to $2 billion.Another company that has been impacted by declining demand for vaccines has been CSL. Last month, the Australian drugmaker backtracked on its plan to spin out its vaccine division, CSL Seqirus, because of the “heightened volatility in the current U.S. influenza vaccine market,” Chairman Brian McNamee explained. He added that the timing of the transaction would “not fully capture Seqirus’ value potential.”Citing insurance claims data, CSL’s leaders said they expect this season's flu vaccination rates in the U.S. to decline by 12% overall and by 14% for people ages 65 and older compared with last year.  Lilly is No. 1 again Among the industry's largest companies, there was no surprise at the top of the growth rankings as Eli Lilly pulled off a whopping 54% increase. It was the fourth straight period in which the Indianapolis company delivered the highest sales bump among large biopharma companies. It also was the largest quarterly sales bump for a top-25 drugmaker since the COVID years.The performance is more evidence that Lilly has widened the gap on its rival in the diabetes and obesity market, Novo Nordisk. The Danish company had just a 5% revenue increase in the third quarter. Novo also saw a 2% quarter-to-quarter sales slide, which was its second straight period with a sequential revenue decline.Lilly’s boost was fueled by sales of its tirzepatide products, which exceeded $10 billion for the quarter. The figure included $6.5 billion sales for diabetes drug Mounjaro and $3.6 billion for obesity treatment Zepbound.The only time in history that a single drug has exceeded sales of $10 billion in a quarter came in the COVID years, when Pfizer and BioNTech’s Comirnaty passed the threshold in three straight periods, maxing out at $13.2 billion in the first quarter of 2022. On its current trajectory, sales of tirzepatide products figure to increase again in the coming periods. The scale-up has been remarkable this year, starting at $6.1 billion in the first quarter. In the second quarter, tirzepatide’s combined sales finally topped those of Novo’s semaglutide products, which was significant because Novo’s Ozempic was first to the market in 2017, compared to Mounjaro, which came along five years later.Tirzepatide also has supplanted Merck’s cancer treatment Keytruda as the current top-selling drug, a crown it has held since 2023. Through the first three quarters of the year, tirzepatide has generated sales of $24.8 billion compared to $23.2 billion for Keytruda. Big gainers in Q3 No company in the industry approached Lilly’s revenue bump in the quarter. The only other top-25 companies by sales that achieved a double-digit increase in the third quarter were the Japanese duo of Astellas (13%) and Daiichi Sankyo (12%), followed by Amgen (12%), AstraZeneca (11%) and Vertex (11%).Another company that thrived in the third quarter was AbbVie, with a 9% sales gain thanks in large part to Skyrizi, which the company is now projecting will achieve sales of $17.3 billion this year, up from $11.7 billion in 2024. The Illinois company also is back in the good graces of investors as it enjoyed a 25% increase in its market cap in the third quarter, according to a report from GlobalData.Johnson & Johnson, meanwhile, turned in a 7% sales increase, which was its largest quarterly boost since 2023. The showing is further evidence that J&J’s shedding of its consumer health unit has helped facilitate growth. Two of the catalysts for the performance were autoimmune star Tremfya, which grew sales 41% to $1.4 billion, and depression drug Spravato, which became a blockbuster last year and accomplished a 61% sales increase in the third quarter.Amgen’s double-digit increase (PDF) came on top of 9% increases in the first two quarters of this year as the company appears to be hitting its stride after its 2023 acquisition of Horizon Therapeutics. There were many plusses with Amgen, including its biosimilars, which were up 52% thanks largely to its Eylea knockoff, Pavblu. Its older medicines, like Prolia and Repatha—both on the market for more than a decade—had big surprise sales boosts in the third quarter. AbbVie, J&J and Amgen were among the group of drugmakers that bumped up their annual revenue projection after reporting third-quarter numbers. The only top-25 companies that reduced their annual revenue estimates were Takeda (PDF) and Merck, which dropped its projection by $300 million as Keytruda’s sales in the third quarter failed to meet expectations.Lilly increased (PDF) its guidance by more than $2 billion, while Bristol Myers Squibb bumped up (PDF) its estimate by $1.2 billion. Despite its U.S. vaccine sales struggles, GSK boosted (PDF) the top end of its 2025 revenue projection from an increase of 5% to 7%. Astellas and Daiichi each increased (PDF) their revenue projection by 100,000 million Japanese yen, which works out to about $650 million. U.S. rebound continued in Q3 Aside from the decline in vaccine sales, it was a strong quarter for biopharma overall as 21 of the world’s top 25 drugmakers achieved year-over-year revenue increases.It was another period of recovery following an unusual first quarter in which seven of the world’s top 25 companies saw falling sales, with each of the seven decliners based in the U.S. In the second quarter, the trend faded as four of the seven U.S. companies accomplished sales increases. Then, in the third quarter, Pfizer was the only U.S. company that sustained a revenue decrease.Of the non-U.S. companies that saw their sales decline in the third quarter, none were a surprise. Takeda had the largest sales falloff (PDF) among the industry’s top 25 companies at 8%, which matched its decline in the previous quarter. Meanwhile, Roche was down by 1% after a flat performance in the second quarter. Bayer was the other decliner (PDF), at 3%, following a trend that has been in place since 2023.

Addressing the performance of Pfizer’s vaccines business Tuesday, CEO Albert Bourla indicated an interest in opportunities outside the U.S. Even without accounting for the COVID declines that have punctuated Pfizer’s earnings in recent years, the company’s vaccines business appeared to be on the back foot in the third quarter, brought low by a U.S. market that is currently proving unfavorable for immunizations.Among the shots that receive top billing in Pfizer’s earnings reports, only Pfizer’s tick-borne encephalitis shot TicoVac posted sales gains (PDF) for the three months that ended in September.Meanwhile, Pfizer’s Prevnar family of pneumococcal vaccines, its respiratory syncytial virus (RSV), shot Abrysvo, its COVID-19 prevention shot, Comirnaty, all suffered sales declines compared to the same period in 2024, according to a Nov. 4 earnings announcement.Notably, in the case of Prevnar and Abrysvo, ex-U.S. sales of the vaccines increased—and in Abrysvo’s case at a significant 75%—but revenues in the U.S. brought down their overall performance.Taking a closer look at the numbers, Comirnaty sales slipped 19% globally to $1.15 billion, the Prevnar franchise experienced a 3% global sales decline to $1.7 billion, and Abrysvo’s performance decreased 22% to sales of $279 million in Q3. Slipping COVID-19 vaccine sales are nothing new for Pfizer, which has struggled to meet tough COVID-era revenue comparisons ever since the market for its vaccine and coronavirus antiviral, Paxlovid, transitioned from pandemic to endemic. Nevertheless, the company grappled with a new constraint in the third quarter, noting in a press release that Comirnaty has struggled of late thanks to a “narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population.”Pfizer won an FDA nod for an updated version of its BioNTech-partnered COVID vaccine in late August. But unlike with past FDA endorsements, the new nod carries restrictions on the vaccine’s use in many age groups, to include only people with underlying health conditions.Addressing the performance of Pfizer’s vaccines business more broadly Tuesday, CEO Albert Bourla indicated an interest in opportunities outside the U.S. The company’s roster of immunizations is a “key area of focus in international markets,” the chief executive said on a call with analysts.Speaking to Abrysvo’s recent struggles in the U.S. specifically, Bourla admitted that Pfizer is “experiencing the headwind of a more difficult-to-activate population as we enter the third season of RSV.”“Still,” he continued, “we are continuing to strengthen our position with a 59% market share in the U.S.”And despite the sales slump in the U.S. this past quarter, Pfizer’s Prevnar dynasty still leads in pediatric pneumococcal vaccination worldwide and among conjugated pneumococcal vaccines for adults in the U.S., Bourla emphasized.Beyond Comirnaty, Pfizer’s COVID treatment Paxlovid endured a precipitous sales decline in the third quarter, falling a staggering 55% to $1.2 billion. The antiviral took a one-two punch in the period stemming from “reduced demand from lower levels of disease incidence,” as well as an unfavorable comparison to a government stockpiling order for the drug that Pfizer booked last year, the company’s chief financial officer, Dave Denton, said on the earnings call.Speaking to Pfizer’s overall performance in the quarter and through the rest of the year, Denton admitted that there is currently some “softness in our COVID products due to lower vaccination rates and COVID infection rates.”The low end of the drugmaker’s 2025 forecast “would assume that the COVID franchise continues a very modest uptake for the balance of this year, particular in the U.S.,” Denton said in response to an analyst question about Pfizer’s ability to meet its financial guidance, which sits in a range between $61 billion and $64 billion for the full year.“However, as you know, the COVID franchise is subject to peaks and valleys,” he added. “If there happens to be a wave of COVID in the next several months, you can see utilization spike up.”Removing COVID from the equation, Pfizer’s innovative drug franchises performed better overall in the third quarter. Without the negative effects from Comirnaty and Paxlovid, Pfizer’s portfolio of branded medicines grew sales 4% for the period.In particular, the drugmaker spotlighted the momentum behind Bristol Myers Squibb-partnered anticoagulant Eliquis, which grew 22% in Q3 to $2 billion; Nurtec ODT in migraine, which was up 22% to $412 million; and the company’s Vyndaqel family of drugs for amyloidosis, which increased revenues by 7% globally to nearly $1.6 billion.Vyndaqel is now facing fresh competition in the shape of Alnylam’s Amvuttra, which passed muster at the FDA in March. While Pfizer’s drug has continued to hold its own for the time being, analysts on the company’s call were curious to hear how the competitive dynamics in the transthyretin amyloid cardiomyopathy (ATTR-CM) market are evolving.“There’s obviously new competition in the category,” Aamir Malik, Pfizer’s chief U.S. commercial officer, admitted. That said, the Vyndaqel franchise “is still the only ATTR-CM product that has statistically significant reductions in both mortality and [cardiovascular]-related hospitalizations together and as a standalone,” the commercial chief stressed.“And it’s also the only product where there is a once-daily capsule, placebo-like safety and near complete [transthyretin] TTR stabilization, and we’ve got 90% access for Vyndamax across the U.S. now,” Malik added. Vyndamax is a single-capsule presentation of Pfizer’s drug that uses the same active ingredient as Vyndaqel.In Q3 specifically, Pfizer’s Vyndaqel franchise benefited from “very strong demand growth,” reinforced by the medicine’s “continued market share leadership,” Malik explained.Nevertheless, that volume growth was offset by a pair of “gross-to-net headwinds,” Malik pointed out, spotlighting IRA manufacturer rebates and “payer contracting” during the earnings period.“So Vyndamax is performing exactly where we thought it would, and consistent with what we guided,” Malik said. “And performance continues to reflect strong diagnosis, broad access, improving affordability dynamics—and that’s going to continue to grow our volume.”Even though the Vyndaqel franchise is now facing some competition among treatment-naïve patients, “Amvuttra has driven minimal switching to date,” Malik added, calling out Alnylam’s ATTR-CM rival by name. Pfizer reported its earnings as it grapples with Novo Nordisk over the companies’ competing efforts to purchase obesity biotech Metsera. While Pfizer’s planned $4.9 billion purchase of the company appeared solidly in the books as of late September, Novo Nordisk swooped in last week with a $6.5 billion counterbid.Pfizer has launched legal efforts to scupper Novo’s offer and has also raised its initial bid for Metsera, which Novo countered again with its own higher proposal Tuesday morning. For now, leadership at Pfizer appears steadfast in their belief that Novo’s attempt to cut in on the deal will fail on legal grounds, accusing their Danish rival of violating U.S. antitrust laws to stymie an emerging obesity rival.“Novo Nordisk's offer is illusory and cannot constitute a superior proposal under the terms of our merger agreement with Metsera, because it violates antitrust law and there is a high risk it will never be consummated,” Bourla said of the situation Tuesday.