Centers for Disease Control & Prevention

iStock, Sundry Photography Despite steep budget and staffing cuts at the FDA in recent weeks and other headwinds, Gilead CEO Daniel O’Day assured investors that the pharma’s plans and preparations for lenacapavir’s launch remain on track. Gilead is gearing up to capture a huge chunk of the rapidly growing HIV pre-exposure prophylaxis market with the potential approval of the twice-yearly injection lenacapavir despite macro uncertainty and concerns about how the new drug will affect the company’s existing medicines. “We are absolutely ready for the launch,” Chief Commercial Officer Johanna Mercier said during a first-quarter earnings call on Thursday afternoon. She noted that a verdict from the FDA is just “around the corner.” The U.S. pre-exposure prophylaxis (PrEP) market, according to Mercier, has surged “about 16% year-over-year” in the quarter, which she attributes at least partly to Gilead’s “market development initiatives” in preparation for lenacapavir. Gilead is proposing a twice-yearly injection of lenacapavir, an HIV-1 capsid inhibitor, to prevent HIV infection. Data from the Phase III PURPOSE program show that the regimen could reduce the risk of HIV by at least 96% in various patient populations. The FDA is currently reviewing Gilead’s application, with a target action date of June 19 . According to Gilead, the regulatory review seems to be on track, despite steep cuts and high-level HIV disruptions at the Department of Health and Human Services in recent weeks. Gilead’s review also comes amid potential macro headwinds for the HIV space. In mid-March, reports broke that President Donald Trump was considering a major reduction to the Centers for Disease Control and Prevention’s HIV prevention budget, a move that would hamstring the agency’s surveillance and community outreach services. Last week, several news outlets reported that Trump was eyeing a $40 billion budget cut to the HHS as part of the sweeping structural overhaul at the agency. “We haven’t heard or seen anything that would cause us to alter our plans or expectations,” CEO Daniel O’Day said during the investor call, adding that the pharma also doesn’t expect these macro uncertainties to “adversely affect . . . our HIV business.” Some analysts also raised concerns about lenacapavir cannibalizing the business of Gilead’s Descovy, which is also indicated for the prevention of HIV but is taken orally once daily. The worries are warranted, given that sales of the drug, which dominates the PrEP market with a 40% share, jumped 38% in the quarter to bring in $586 million worldwide, according to Mercier. She declined to give product-specific guidance on the investor call, instead emphasizing the rapid growth of the PrEP market, which lenacapavir can capitalize on given its more convenient dosing schedule. “There really is an opportunity when you think about a switch strategy,” Mercier said, noting that some of the first patients on lenacapavir would be coming from oral PrEP, which includes Descovy. In the first quarter, Gilead reported $6.7 billion in revenue , which is largely flat from the same period last year. The HIV business contributed heavily to this outcome, bringing in nearly $4.6 billion in the quarter, a slight year-on-year increase. Gilead’s heaviest hitter, the HIV drug Biktarvy, earned $3.15 billion in Q1, falling short of analyst forecasts by 2%. Analysts at BMO Capital Markets were unperturbed by the slight miss, calling it “sticker shock” rather than finding issues with Gilead’s underlying business. All eyes remain on lenacapavir’s launch, the analysts told investors on Thursday. Gilead’s shares dipped 3% after the earnings release, according to SeekingAlpha , which analysts attributed to a miss for COVID-19 antiviral Veklury. BMO Capital Markets said this is actually a positive, as it means fewer patients needed the intervention. Also contributing to the miss were inventory and demand issues for Trodelvy. But BMO still expressed confidence in Gilead, especially as the lenacapavir launch nears: “our bullishness [is] rooted in the strength of Gilead’s HIV franchise and a positive view of the launch of lenacapavir in PrEP,” the analysts wrote.

Drug sales boomed in 2024, with Bayer being the only company among the top 20 in the biopharma industry to post a sales decline. With only one of the biopharma industry’s top 20 revenue companies seeing a year-over-year decline in sales, 2024 was a remarkable year of revenue growth for the industry. Compare that to 2023, when eight of the top 20 drugmakers experienced revenue declines.Six of the top 20 drugmakers had double-digit increases in 2024, compared to just two in 2023. Five others saw a revenue bump of between 7% and 9%, compared to two reaching those figures in 2023.For the second year in a row, Eli Lilly (32%) and Novo Nordisk (26%) posted Big Pharma's largest year-over-year sales bumps, though their positions were flipped from 2023 when Novo (31%) topped Lilly (20%).Expect the same form in 2025 as Lilly—boosted by sales of its diabetes and obesity drugs Moujaro and Zepbound—projects its sales to fall between $58 billion and $61 billion. At the midpoint of the projection, it would be a 32% increase, matching the sales boom it saw last year. Meanwhile, Novo—which also has been powered by sales of its diabetes and obesity treatments—is projecting sales to increase by a range of between 16% and 24%.As for their places in the industry rankings, Lilly’s success has allowed it to jump from No. 15 in the revenue rankings in 2020 to No. 9 last year, with sales over that period increasing from $24.5 billion to $45 billion. Novo, meanwhile, has made a similar surge, jumping from No. 17 in 2022 to No. 11 last year as sales over the period jumped from 177 billion Danish kroner ($25 billion) to 290 billion Danish kroner ($42.1 billion).Top of the rankings For the second straight year, there was no change at the top as No. 1 Johnson & Johnson, No. 2 Roche, No. 3 Merck, No. 4 Pfizer and No. 5 AbbVie each held their positions. Each company delivered modest revenue increases in 2024 of between 3% and 7%.Getting back to growth was significant for Pfizer and Roche as they were coming off sales decreases of 41% and 7%, respectively, in 2023, largely due to declining sales of COVID-19 products. Last year was a course correction of sorts for the companies as they returned to their pre-pandemic growth trajectories. AbbVie’s 4% increase was noteworthy as well. It came after the company saw a 6% revenue decline in 2023 as autoimmune superstar Humira faced generic competition in the U.S. The Illinois-based company has come full circle, with next-gen treatments Skyrizi and Rinvoq primed to provide growth over the next decade. In its fourth-quarter earnings presentation, AbbVie estimated combined sales of the Humira follow-ons would reach $31 billion in 2027.The No. 1 rank for J&J was the 12th time in the last 13 years that the New Jersey powerhouse has finished on top. In 2012, J&J ended the more than decade-long run by Pfizer as the top-selling drugmaker. Lately, J&J’s lone year not in the top spot came in 2022, when Pfizer set an industry record by generating more than $100 billion in sales, with more than $56 billion coming from revenue from its COVID products.Slides in the rankings Sanofi and GSK were the only companies in the top 20 that fell by at least two slots in the rankings. Sanofi dropped from No. 6 in 2023 to No. 10 last year because of a reorganization in which it is separating from its consumer health business. In its financial reports, the company is accounting for the spinoff as if it has happened, even though the sell-off has yet to be completed. Aside from the effects of the divestment, Sanofi’s pharma products accomplished a 9% sales increase in 2024.Despite consecutive years with a 3% revenue increase, GSK has dropped from No. 10 to No. 12 in the rankings as it has been surpassed by Lilly and Novo. Holding back the British company were plummeting (PDF) sales of respiratory syncytial virus (RSV) vaccine Arexvy after the Centers for Disease Control and Prevention narrowed its guidance on who should receive RSV shots. Falling out of the rankings was Viatris, which was No. 20 in 2023 and has seen three straight years of revenue declines, including a 4% drop in 2024.Crashing the rankings for the first time and replacing Viatris is CSL. The Australian plasma specialist has had nine straight years of growth, boosted by acquisitions including an $11.7 billion buyout of Vifor Pharma in 2021.Other big gainers in 2024 Other companies with double-digit revenue gains in 2024 were AstraZeneca (18%), Amgen (17%), Novartis (11%) and Takeda (10%). Each of the four improved upon single-digit increases in 2023, with AZ making the largest jump as it was up from 3% in 2023 and moved up a notch in the rankings, from No. 7 to No. 6.Other companies that had significant turnarounds from 2023 to 2024 were Germany’s Merck KGaA, which went from a 5% revenue decline to a 2% gain; Merck, which had a 7% revenue increase compared to a 1% gain in 2023; Gilead Sciences, which was up 6% after sales were flat in 2023; and Bristol Myers Squibb, which saw a 7% bump after a 2% decline in 2023.While Bayer was the only company with a year-over-year revenue decline, be it minuscule at 0.4%, it was a significant improvement over its 5% drop in 2023.Editor's note: For the purpose of this ranking, company revenues outside of the health sciences arena were excluded. Examples include Bayer's crop science sales and Merck KGaA's electronics business. For companies reporting in foreign currencies, conversion to U.S. dollars is based on the annual average exchange rate.

A CDC advisory group has expanded its recommendation for who should receive RSV vaccines. The broadened population is a potential boost for sales of RSV shots from GSK and Pfizer. The ACIP also voted to endorse a new meningococcal vaccine from GSK and a new shot from Bavarian Nordic which defends against the emerging chikungunya virus. A year after narrowing its recommendation for who should use vaccines to defend against respiratory syncytial virus (RSV), a panel of experts advising the Centers for Disease Control and Prevention (CDC) has expanded its endorsement.The reversal from the Advisory Committee on Immunization Practices (ACIP) is a potential boost for GSK and Pfizer. Both companies saw sales of their RSV vaccines for adults tumble last year after the CDC ruled that the shots should be limited to people age 75 and older and those ages 60-74 who are at risk of developing severe RSV-linked lower respiratory tract disease (LRTD).The ACIP’s new recommendation expands the eligible at-risk group to people ages 50 and older. The new guidance is pending final approval from the director of the CDC and the Department of Health and Human Services (HHS).After the FDA approved GSK’s Arexvy and Pfizer’s Abrysvo in 2023, the CDC recommended the shots for all people 60 and older, pending a doctor’s endorsement.From 2023 to last year, sales of Arexvy tumbled (PDF) 51%, from 1.2 billion pounds ($1.6 billion) to 590 million pounds ($754 million). Meanwhile, revenue from Abrysvo fell (PDF) 15% from $890 million to $755 million during the same stretch. The new direction from the ACIP comes after a review of positive results of a phase 3 trial evaluating the immune response and safety of Arexvy in adults ages 50-59, including those at increased risk for severe RSV-LRTD due to certain underlying medical conditions, compared to adults aged 60 and above.According to the CDC, between 15,000 and 20,000 RSV-associated hospitalizations occur annually (PDF) in the U.S. among adults ages 50 to 59. Those with chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from an RSV infection.GSK’s Chief Scientific Officer Tony Wood said in a release that the new guidance would increase the RSV vaccine-eligible patient population by 13 million.Other ACIP vaccine guidanceThe CDC experts also endorsed GSK’s 5-in-1 shot Penmenvy, advising that it should be part of the adolescent meningococcal vaccination schedule for people ages 16 to 23. The recommendation also applies to kids ages 10 to 15 who are at increased risk.The ACIP also unanimously endorsed Penmenvy for the Vaccines for Children (VFC) program, which provides free doses for eligible children.The vaccine, which was approved by the FDA in February, is an alternative to separate administration of two shots that cover five meningococcal serogroups. Penmenvy will challenge Pfizer’s pentavalent option Penbraya, which hit the market in 2023. Because of their convenience, these vaccines are expected to increase immunization rates in the U.S.   The ACIP also signed off on Bavarian Nordic’s chikungunya vaccine Vimkunya for people age 12 and older who are traveling to a country where there is an outbreak of the mosquito-borne virus. The shot, which also was approved by the FDA in February, may also be considered for those traveling or moving to a country without an outbreak but with elevated risk for U.S. travelers. ACIP also recommends Vimkunya for laboratory workers with potential for exposure to the virus.According to CDC, there has been evidence of chikungunya virus transmission to humans in more than 50 countries within the last five years.The ACIP meeting was the first under new HHS Secretary Robert F. Kennedy Jr. On Tuesday, the panel discussed potentially narrowing the recommendations for COVID-19 and HPV vaccines. The ACIP will vote on its guidance for those shots at its next meeting, set for June 25-26.