As an endcap to the Q4 2025 earnings season, we asked our RC Resolve colleagues to provide some perspective on how companies navigated the geopolitical shifts and policy headwinds facing the industry through their investor messaging. 

The Q4 2025 earnings season played out against one of the most turbulent policy backdrops the health care industry has faced in years. Drug pricing negotiations, Most Favored Nation agreements, Medicare Advantage rate uncertainty, IRA headwinds and looming tariffs weren’t just regulatory footnotes – they were front and center on investor calls. And how companies talked about them mattered just as much as the numbers themselves.

What stood out across biopharma and payer earnings wasn’t panic; it was discipline. Companies largely framed sweeping policy changes as “manageable headwinds” – a phrase that appeared with striking consistency. Leaders stayed composed, acknowledging uncertainty, then pivoting hard to pipeline strength, commercial momentum and long-term growth. One major company’s management told investors directly that the “majority of macro headwinds are in the rear-view mirror.” Another CFO closed her remarks by saying the company “entered 2026 with confidence in the outlook for our business, driven by global demand for our innovative medicines and vaccines.” The message was clear: We see the storm, and we’re steering through it.

On tariffs and manufacturing, some companies reframed government deals as strategic wins entirely. One CEO pointed to a three-year government contract that secured a tariff exemption alongside a $50 billion U.S. investment commitment – positioning regulatory compliance as a growth catalyst, not a constraint. Another CEO alluded to “strategic actions” on pricing and tariffs without confirming deal specifics, projecting control without overexposure.

The GLP-1 space offered another example of sharp narrative architecture. Major manufacturers described potential Medicare market access through a government pilot program not as a pricing compromise, but as an opportunity – trading near-term concessions for long-term market expansion. Similarly, PBMs under regulatory pressure leaned into internal reform programs, essentially telling investors: We already do what Washington is asking for. One CEO went further, arguing that incoming legislation was “oriented around improving affordability and predictability” and that his company’s innovation “squarely goes in that direction.”

The lesson here is clear: Earnings season is not just a finance event. It is a reputation event. Companies that managed this well didn’t just protect their stock price, they reinforced trust with every audience at once: investors, regulators, patients and the public.

– Sherry Pudloski and Leslie Isenegger

A cascade of leadership upheavals and erratic regulatory decisions across the nation’s top health agencies is raising urgent alarms about the future of vaccines in the United States – in terms of public health and pharmaceutical innovation.

At the center of the storm is the FDA’s handling of Moderna’s mRNA flu vaccine application. The agency abruptly rejected the submission last week, a decision reportedly made by CBER Director Vinay Prasad over the objections of career agency scientists. But two days ago, the FDA reversed course and agreed to resume review after meeting with Moderna and the White House. The whiplash has drawn swift condemnation, with the Wall Street Journal editorial board calling it “arbitrary government at its worst.”

The episode has become a symbol of broader dysfunction that is now impacting vaccine manufacturers where it hurts most. Moderna has shelved programs, lost contracts and cut jobs. Executives of vaccine manufacturers have begun sounding the alarm, with Pfizer’s CEO calling the environment “anti-science.” Sanofi expects vaccine sales to decline again in 2026. Merck’s CEO, while calling the financial impact manageable, warned of serious public health consequences.

The clear message from industry: Sustained regulatory unpredictability discourages the long-term investment that brings new vaccines to market.

Meanwhile, the CDC’s February ACIP meeting was postponed amid an ongoing lawsuit challenging the committee’s composition under Secretary Kennedy. And NIH Director Jay Bhattacharya has been appointed to simultaneously lead the CDC – an arrangement that former agency officials warn leaves the nation dangerously exposed to emerging health threats.

– Megan Hickey

We were on the ground at the second annual PhRMA Forum in Washington, D.C., which brought together leaders from across the health care ecosystem to discuss the hot policy topics and innovation trends impacting the biopharma industry.

One message rang clear across multiple panels: The American pharmaceutical industry is at a critical crossroads, facing significant policy headwinds and intense competition from China. It’s a make-or-break moment for American innovation.

Throughout the afternoon, many experts were critical of the stifling effect that Trump administration policies, such as most favored nation pricing and Medicare drug price cuts, have had on innovation, claiming price controls actually shift savings to middlemen rather than patients. In his opening remarks, PhRMA President and CEO Stephen Ubl noted, “As a result of the IRA, early-stage investment in small molecule medicines has plummeted by nearly 70%, and post-approval clinical trials for cancer medicines dropped 40%.”

Meanwhile, China is racing ahead of America in clinical research capacity, with the nation able to complete Phase 1 clinical trials 50% faster and 40% cheaper than the U.S. Former FDA Commissioner Scott Gottlieb remarked during a panel, “46% of the development around mRNA vaccines right now is taking place in China, a technology that was largely invented here in the U.S.”

This rapid expansion of clinical trial capacity didn’t happen by chance. China has made biopharmaceutical R&D a national priority, triggering massive government investment and a national strategy from the Chinese government. Multiple experts at the PhRMA Forum called for similar steps to be taken by the U.S. government through incentives to support renewed investment in innovation.

Multiple speakers, including CMS Administrator Mehmet Oz and FDA Commissioner Marty Makary, also pointed to the promise of AI in helping close the innovation gap emerging between the U.S. and China. Both officials posited using AI to speed clinical trials and shorten the lengthy timeline between discovery and patient access. However, it will only be possible if reforms at the FDA come to fruition, something that remains to be seen amid the current chaotic environment at the agency.

The other hot topic of the afternoon: vaccines. Fresh off the FDA’s rejection of Moderna’s mRNA flu vaccine (that was later reversed), administration officials were asked about HHS’ seemingly growing anti-vax positioning. Both Oz and Makary doubled down on the concept of encouraging everyone to get “core vaccines,” with Oz vowing that CMS will continue to cover these vaccines in an effort to allay fears from industry and consumers alike.

One thing is clear: There is no shortage of challenges facing the biopharmaceutical industry right now. The question remains if the Trump administration and industry leaders can find enough common ground to make the investments and policy changes needed to restore America’s role as a leader in innovation.

– Bridget Walsh and Rachel Bridges

• Feb. 22-25 – event where “the business of healthcare meets the future of technology,” ViVE
• Feb. 23 – news conference on Rare Disease Day to debut agency guidance, FDA
• Feb. 25 – hearing on the nomination of Casey Means to be Surgeon General, Senate HELP
• Feb. 26 – hearing on “how FDA bureaucracy stifles innovation,” Senate Special Committee on Aging

• “Lawsuits eventually drove Napster into bankruptcy, and the era of totally free music came to an end. But the genie was out of the bottle. Once consumers experienced instant, frictionless access to music, there was no going back… Pharma now faces a similar transformation.” – David Wainer, The Wall Street Journal
• “Sound policy is best developed through legislation because it requires group decisions. Prior executive actions to rein in drug prices by this president and his predecessors have not fared well.” – Wendell Primus and Kristi Martin, The Hill
• “At a time when the U.S. is moving to lower drug prices for domestic consumers, Canada needs to read the room and help shoulder the cost of innovation to ensure Canadians can access critical drugs moving forward.” – Jay Goldberg, Toronto Sun

• The substance of the FDA’s new “single pivotal trial” posture may matter less than the process: Former officials and policy veterans say announcing such a major shift via a short journal article, without clear agency input or an accompanying draft guidance, risks confusion across the board. Regulatory Focus: Experts react to FDA’s shift to single pivotal trials for most drugs.
• Critics argue direct-to-consumer ads for prescription drugs often “push” high-cost drugs with limited added benefit, while industry allies say the ads can prompt care-seeking for underdiagnosed conditions. The New York Times: Should Drug Companies Be Advertising to Consumers?
• The rejection of Disc Medicine’s bitopertin is forcing biopharma to rethink the FDA’s Commissioner’s National Priority Voucher program, after a decision that took twice longer than expected and hinged on issues that were already known when the voucher was granted. BioSpace: Disc’s FDA Rejection Raises Questions About Commissioner’s Vouchers.
• As Europe tries to reshore essential drug production via the Critical Medicines Act, some say an EU-India free-trade agreement could deepen reliance on the “pharmacy of the world” rather than reduce it. Politico: EU trade deal threatens to undermine Europe’s home-grown medicines ambition.
• Two of RFK Jr.’s highest-ranking deputies – HHS Deputy Secretary Jim O’Neill and HHS General Counsel Mike Stuart – are expected to change roles as the White House reshuffles leadership ahead of the midterm elections. CNN: Two top aides to RFK Jr. leaving HHS as part of leadership shakeup.
• The Trump administration is moving quickly to revive a court-stalled pilot to replace 340B’s upfront discounts with after-the-fact rebates, with HRSA reopening the process and asking for broad input. Fierce Healthcare: Trump administration restarts its efforts to pilot 340B rebates.
• Secretary Kennedy’s first year running HHS has been defined by sweeping governance changes, most notably a “clean sweep” of the CDC’s vaccine advisory committee. The Hill: 1 year of RFK Jr.: How his MAHA agenda has reshaped US public health.
• Elevidys, a micro-dystrophin gene therapy produced by Roche, Sarepta and Chugai, is now available in Japan at a list price rarely seen on the national health insurance scheme. Pink Sheet: Elevidys Becomes Japan’s Highest-Priced Drug Nine Months After Approval.