Novavax, Inc.

On a Thursday conference call, Moderna executives found themselves fielding multiple questions about vaccine policy uncertainties under HHS Secretary Robert F. Kennedy Jr. Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the larger U.S. vaccine market faces new uncertainties under the Trump administration.Moderna aims to reduce its GAAP operating costs by 1.4 billion to $1.7 billion between 2025 and 2027, the company announced Wednesday. The Massachusetts biotech now targets $4.7 billion to $5 billion in GAAP costs in 2027, versus $7.2 billion last year.On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its cash operating costs from about $6.3 billion in 2024 to about $5.5 billion this year, and then further to $4.7 billion and $4.2 billion in the two subsequent years.Compared with cash operating costs, GAAP costs also include stock-based compensation for executives and asset value depreciation. The new cost-cut target comes as Moderna reported first-quarter revenues of $100 million and a net loss of $1 billion. The company is maintaining its full-year revenue projection range of $1.5 billion to $2.5 billion, with only about $200 million expected in the first half of the year given the seasonal demand for its COVID and RSV vaccines. As one analyst noted during the investor call, Moderna had said it would look for top-line signals to adjust its cost-cutting program. But “nothing has changed” from a revenue perspective, Mock said, despite the new cuts unveiled Thursday.In the first quarter, sales from Moderna’s COVID vaccine Spikevax reached $84 million, which came in well below analysts’ consensus estimates of $115 million, according to Jefferies. The haul included $29 million from the U.S. Pointing to prescription data, Mock noted that Spikevax’s U.S. market share has remained stable at about 38%.“Our customers are trying to manage their working capital better, so their inventory levels are down,” Mock explained.As for the company’s newly launched RSV vaccine mRESVIA, sales were negligible at just $2 million in the first quarter. The number missed analysts’ $6 million average forecast.Although the CDC’s immunization committee is expanding its recommendation for rival RSV shots from Pfizer and GSK to include high-risk adults between the ages of 50 and 59, Moderna’s FDA application for that group likely won’t come in time for the company to negotiate contracts for the upcoming RSV season, Jefferies analyst Michael Yee wrote in a Thursday note to clients. Earlier this year, Moderna laid out a plan to slash about $1 billion in its annual cash spend this year and another $500 million in 2026. Rather than a dramatic shift in direction or escalation of planned cuts, the new GAAP target is about “extending our guidance out a year,” Mock said.The large majority of the cost reductions will come from R&D, which currently represents nearly two-thirds of Moderna’s expense base, he said. That’s because many phase 3 trials are expected to be completed or wind down by 2027. Procurement savings from renegotiating contacts and other process efficiency measures will also contribute toward the savings target, he said.One such reduction will come from Moderna’s investigational flu-COVID combo shot mRNA-1083. On Thursday, the biotech said it's deprioritizing development of the asset in individuals between 18 and 49 years of age.“It’s an uncertain environment,” Mock said. “But we need to focus on what we can control, and that is our cost base.” Potential vaccine policy shifts spell uncertainty“Uncertain” is a key theme for the entire vaccines market during President Donald Trump’s second term with Robert F. Kennedy Jr., a known vaccine skeptic, serving as the secretary of the Department of Health and Human ServicesThis week, the HHS said the FDA would require all new vaccines to undergo safety testing in placebo-controlled trials prior to licensure. It remains unclear whether this “radical departure from past practices”—as described by the HHS—would delay the process of updating seasonal COVID and flu shots.The HHS has not directly communicated the policy with Moderna, the company’s president, Stephen Hoge, M.D., said on Thursday’s call.Moderna’s vaccines for COVID and RSV, as well as experimental products for cytomegalovirus and norovirus, are all tested in placebo-controlled trials, Hoge noted. Some other pipeline programs have portions of their development that happen under such a design, he said.“It will really depend upon, ultimately, what the FDA and HHS feel is appropriate, and their guidance at a program-by-program level of what that will require,” Hoge said.“Our responsibility as a manufacturer and drug developer is to make sure that we provide the data that regulators and public health officials feel like they need so that they can stand behind our products,” he added. “We will absolutely engage constructively in making sure we understand what those needs are, and that we fulfill that.” The FDA recently delayed its decision on Novavax’s COVID-19 vaccine after a reportedly unconventional intervention from the FDA’s principal deputy commissioner, Sara Brenner, M.D., a political appointee. Industry watchers are concerned that the hiccup reflects a broader policy shift in the agency’s vaccine review practice, given RFK Jr.’s anti-vaccine stance and the ouster of Peter Marks, M.D., Ph.D., who until recently led oversight of vaccines as director of the FDA’s Center for Biologics Evaluation and Research.Moderna has a next-generation COVID vaccine, mRNA-1283, under review at the FDA, with a target decision date at the end of this month on May 31.For Moderna, its interactions with the FDA have been nothing but “business as usual,” Hoge said.“We really view it as our responsibility to provide high-quality data to all of our regulators, including the FDA, so that they can conduct their assessments,” Hoge continued. “To date, those assessments have, we believe, been constructive and positive, and we have seen no signs that there’s any question about our ability to make the existing PDUFA date.”In response to the delay to grant Novavax a full license during an April interview with CBS, RFK Jr. raised another unorthodox view that single-antigen vaccines have never worked for respiratory illnesses.Moderna believes that its clinical trials demonstrate the benefits of its products, including those that are single antigen, Hoge said. Some of Moderna’s projects are multi-antigen in nature, such as its CMV candidate, he noted.“We do believe that sometimes single-antigen makes sense and sometimes multiple-antigen makes sense, and we do both,” he said.In the case of mRNA-1283, Mock highlighted that the FDA’s review is based on an 11,000-person multiyear randomized efficacy study.“We remain confident that those reviews will be consistent with prior practice,” Hoge said.

The FDA will require new vaccines to undergo placebo-controlled trials, a spokesperson told several news outlets. Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in "radical" changes to how it signs off on new vaccines.“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN. It isn't immediately clear which "new" vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.An HHS spokesperson did not respond to Fierce Pharma’s request for comment. The Washington Post was the first to report the FDA policy change.An HHS official told CNN the new policy pertains to COVID shots rather than flu vaccines. Flu shots have been "tried and tested” for decades, while COVID-19 vaccines are "new and must have more gold standard science to ensure safety and efficacy for the public," the official told the news outlet.For years now, the FDA has allowed COVID-19 vaccine manufacturers to leverage prior clinical efficacy data—rather than results from new trials—when routinely updating their shots to match the latest variants. When the FDA endorsed updated COVID-19 vaccines last summer, for example, the agency said it considered “manufacturing and nonclinical data” to grant the OKs. Last year, FDA advisors recommended variants for the updated shots in June, and the agency endorsed the tweaked vaccines in August. It's not immediately clear whether COVID-19 vaccine makers could meet the agency's new requirement in order to release their updated vaccines by the time virus circulation typically ramps up in the fall and winter.Representatives for the two largest COVID-19 vaccine producers, Pfizer and Moderna, did not immediately respond to Fierce Pharma's request for comment. While the announcement may come as somewhat of a surprise, in hindsight, there were indications this sort of policy change was in the works.Before the official word came out from the HHS, FDA Commissioner Marty Makary, M.D., seemed to hint at changes happening behind the scenes at the agency.  Speaking with CBS News’ chief Washington correspondent Major Garrett earlier this week, Makary said the FDA is "taking a look" at whether to approve a new set of COVID-19 shots this year. While that statement alone raised some eyebrows, Makary went on to add that companies are being asked to run a “basic clinical study, so we can educate the population and have information to work with.”  Before that interview, Novavax had a high-profile regulatory mix-up with its COVID-19 vaccine. The company believed—and still does—that its shot was ready for approval by April 1. When the date came and went with no action from the FDA, reports emerged that the agency had issued a last-minute request for more data.Later, Makary commented on X that the company was "trying to introduce" a new product "with a study of a different product from 2021." He added that the Trump administration would prioritize the "gold standard of science."In response to the Novavax situation, former FDA officials Phil Krause, M.D., and Luciana Borio, M.D., wrote in BioCentury this week that the agency should "stick to its normal processes and trust its review teams."

The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.Its unclear whether Moderna will be able to submit the data as a major amendment to its current submission, or whether the company will have to refile the application, executives said on a conference call with analysts.Moderna is also deprioritizing development of the vaccine in younger adults as part of a push by the company already hurt by slowing product sales and a declining stock price to cut $1.5 billion in annual spending by 2027.On the conference call, Moderna president Stephen Hoge stressed that so far the companys recent interactions with the FDA following the appointments of vaccine skeptic Robert F. Kennedy Jr. as Health and Human Services Secretary and new commissioner Martin Makary have been business as usual. The company isnt expecting significant changes to the approval process or review timelines, he added, while noting that the agencys request for additional flu shot data makes good scientific sense.We continue to have productive exchanges across all of our ongoing reviews, Hoge said.Some Wall Street analysts arent as optimistic. Modernas announcement comes amid an unusual regulatory delay for fellow COVID-19 vaccine developer Novavax and as HHS indicates new shots will need to be tested in placebo-controlled trials prior to regulatory approval. (The HHS policy, which spokesperson Andrew Nixon confirmed to BioPharma Dive, was first reported Wednesday by The Washington Post.)The news highlights increased scrutiny and (potentially) a higher bar for success in vaccine development especially novel vaccines, wrote Leerink Partners analyst Mani Foroohar. That higher bar could negatively impact the regulatory path for Modernas combination shot, he added.Cory Kasimov, of Evercore ISI, wrote in a separate note that the upcoming decisions on Modernas new COVID shot, and expanded use of its respiratory syncytial virus vaccine in younger adults are near-term litmus tests for vaccine regulation. Both are expected by the middle of June.When asked about the apparent shift in approval requirements, Hoge said he could not comment on a policy change that either hasnt happened or that hasnt been communicated directly to Moderna. He also noted that many of its experimental shots have been tested in placebo-controlled studies.It will really depend on what the FDA and the HHS find appropriate and their guidance on a program by program level on what that will require, he said. Our responsibility as a manufacturer and drug developer is to make sure that we provide the data that regulators and public health officials feel like they need so that they can stand behind our products.Moderna recorded $108 million in revenue in the first three months of the year, down from $167 million in the same period in 2024. Shares fell by about 5% Thursday and, at roughly $27 apiece, have lost half of their value over the last six months. '