Continue Reading With Our 7-Day Free Trial
Hims & Hers used the Super Bowl stage to push its latest offering: a $689 early cancer detection test. It’s a bold move that signals the company’s push into higher-stakes medicine—at a time when it’s already under federal investigation for its compounded weight-loss treatments.
Investors see aggressive marketing and topline growth. But behind the splashy rollout is a mounting set of questions about regulatory exposure, scientific readiness, and the risks of consumer misinterpretation. The stock is down, and the disconnect is widening.
Cancer Test Rollout
Hims & Hers is now offering direct access to the Galleri test from Grail, a multi-cancer early detection screen that isn’t yet FDA-approved. The company is marketing it to consumers at $689 via telehealth, bypassing traditional doctor referrals and insurance frameworks. That places it between cheaper competitors like Cologuard and premium-priced panels that promise broader detection.
Management framed the move as a proactive leap into the future of diagnostics. But the test is still in premarket review, with no endorsement from standard screening guidelines. Launching a product like this through a direct-to-consumer channel—especially one promoted during the Super Bowl—raises the stakes on liability, false reassurance, and brand risk. Unlike hair loss or ED, this category doesn’t tolerate ambiguity.
What’s harder to quantify is how this move might shift consumer expectations from wellness convenience toward unproven clinical shortcuts.
That’s the scenario skeptics fear most—and one that could invite not just reputational fallout, but legal scrutiny.
Scientific & Clinical Uncertainty
While the promise of multi-cancer early detection is exciting, clinical experts are urging restraint. Tests like Galleri can detect DNA signals of cancers in the blood—but it’s unclear whether that leads to better survival outcomes. The data simply isn’t there yet.
Dr. Carmen Guerra from the University of Pennsylvania cautioned that “we do not yet know if these tests reduce mortality.” Dr. Elizabeth O’Donnell, who runs Dana-Farber’s MCED clinic, emphasized they should not be considered replacements for established screenings like mammograms or colonoscopies. Even more damning, renowned scientist Eric Topol criticized the rollout, citing high false-negative rates in early studies. He advised against recommending Galleri in its current use case—especially for people without known risk factors.
There’s a risk here: Consumers might skip established screenings or get false reassurance from a test that isn’t definitive. Even if Galleri improves over time, promoting it as ready for prime-time could create unrealistic expectations. The phrase “Hims and Hers cancer test” might draw clicks, but clinical credibility could suffer if the results don’t match the marketing.
Escalating Regulatory Scrutiny
The cancer test launch isn’t happening in a vacuum. It’s unfolding as Hims & Hers faces federal scrutiny over another core business—its compounded weight-loss treatments. Just days before the Super Bowl ad aired, the Department of Health and Human Services referred the company to the DOJ for possible violations of the Federal Food, Drug, and Cosmetic Act. The referral came after Hims began offering a non-FDA-approved version of Novo Nordisk’s blockbuster drug Wegovy.
Hims insists it’s operating within compounding rules and sources ingredients from FDA-registered suppliers. But regulators have warned companies that marketing unapproved copycat drugs as equivalents to branded ones could be misleading—and potentially illegal.
The company’s aggressive posture hasn’t softened. Its CEO framed the pushback as “Big Pharma” trying to suppress access. But when you’re offering unapproved versions of GLP-1s and non-FDA-approved cancer tests, the narrative shifts from innovation to regulatory brinkmanship.
It’s clear Hims sees itself as a disruptor. But operating in high-stakes, FDA-regulated categories comes with higher risks—both legal and reputational. If the DOJ probe intensifies, it could restrict future product rollouts and sour partnerships with pharma players like Novo Nordisk.
Investor & Market Reaction
Investors have noticed. Shares of Hims & Hers are down 29% year-to-date, underperforming not only the broader market but also the biotech sector. Some of that drop reflects concern about FDA pushback on its compounded weight-loss offerings. But the cancer test launch, rolled out amid intensifying regulatory heat, has added a fresh layer of risk.
To be fair, revenue is growing fast—up 49% year-over-year in Q3 to nearly $600 million. The company projects $2.3+ billion in revenue for 2025. But this rapid topline growth hasn’t yet translated into robust profitability. Its trailing LTM enterprise value to EBITDA multiple sits at 34.71x, with a P/E of 42.88x, both far above the average for health-tech peers. Meanwhile, its LTM EV/Gross Profit multiple is 3.52x, down sharply from a high of 8.29x last year.
That declining multiple suggests the market is questioning the sustainability of its margins and growth. Bulls argue the company is investing in long-term infrastructure—like its peptide manufacturing facility and lab testing stack. Bears worry it’s overextended. High valuation multiples require flawless execution, especially when diving into riskier clinical territory.
Final Thoughts: Balancing Growth Ambition With Healthcare Accountability
Hims & Hers is no longer just a men’s wellness brand selling ED pills and hair spray. It’s now marketing a non-FDA-approved cancer test to the public, while also under federal investigation for its GLP-1 offerings. This dual-track expansion raises legitimate questions about whether the company is outpacing the medical and regulatory systems it now depends on.
On the plus side, Hims is trying to make proactive care more accessible and affordable. It’s vertically integrating infrastructure, investing in partnerships like Grail, and reaching new audiences through the Hers brand. But the stakes are higher when the product involves potential life-or-death outcomes—like cancer or compounded injections.
With LTM valuation multiples still well above sector norms (34.71x EV/EBITDA, 42.88x P/E), investors may need more than just growth. They’ll want clarity on regulatory risk, data transparency, and the durability of customer trust. Whether Hims can sustain its pace—or needs to hit pause—will shape its next chapter.
Disclaimer: We do not hold any positions in the above stock(s). Read our full disclaimer here.
