DEA Waiver Expiration Threatens Hone
Hone Health
This risk is really about whether Hone stays a pure remote clinic or has to grow into a hybrid care network. Hone’s testosterone business works because a patient can order labs, review results with a clinician online, and receive an ongoing prescription without first visiting a doctor in person. That workflow supported growth from about $55M annualized revenue at the end of 2023 to $113.5M ARR by September 2025, while the company added women’s health, GLP-1s, and longevity products around the same lab and consult engine.
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Testosterone is harder than ED or hair loss telehealth because it is a controlled substance and treatment depends on repeat blood work, dose changes, and follow up consults. That makes Hone’s operating model more complex, but it also creates stickier revenue than simple mail order generics.
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The original regulatory cliff was real, because DEA and HHS had only extended COVID era remote prescribing flexibilities through December 31, 2025. But on December 31, 2025, DEA issued a fourth temporary extension through December 31, 2026, which pushed the operational deadline out by another year.
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Competitive pressure still rises if remote prescribing remains allowed. Hims announced in September 2025 that it plans to offer oral testosterone in 2026 through Marius, which means Hone is racing to turn TRT from a single product into a broader hormone and metabolic care subscription before scaled telehealth players arrive.
The next phase is about building enough non testosterone revenue and enough care infrastructure that regulation stops being existential. If remote rules tighten, the winners will be the companies that can add local exams or hybrid visits without breaking unit economics. If access stays open, the winners will be the ones that bundle hormones, labs, weight loss, and longevity into one long term subscription.