Eli Lilly’s Foundayo Launch Opens a New Front as Long-Term Data Bolsters the Pipeline

80% of Foundayo users are new to GLP-1s; FDA move may curb compounded rivals; Medicare access opens in July.

The early numbers from Eli Lilly’s oral weight-loss drug Foundayo tell a story that goes far beyond the product’s first weeks on the market. Fully 80% of patients who have filled initial prescriptions for the drug had never taken a GLP-1 medication before. That statistic, disclosed by the company as it rolls out the newly approved treatment, suggests the drug is tapping into a pool of patients that the injectable blockbusters Zepbound and Wegovy have largely left untouched — people who either dislike needles or have been priced out of the market.

The FDA cleared Foundayo in early April, and the launch has been swift. The drug is already available in pharmacies and on more than a dozen telehealth platforms. Two of the three largest US pharmacy benefit managers have confirmed coverage, and roughly 45% of early sales are flowing through LillyDirect, the company’s own patient channel. Broad consumer advertising, including television campaigns, is slated for the third quarter.

A Regulatory Tailwind Against Copycats

That pricing dynamic is about to get a regulatory boost. On April 30, the FDA proposed permanently removing semaglutide, tirzepatide, and liraglutide from the 503B bulk list. If finalized, the move would strip compounding pharmacies of the legal basis for producing cheaper knockoff versions of these drugs, regardless of future market conditions. Public comments can be submitted until June 29, after which the FDA will make a final decision.

For Lilly, the stakes are high. Compounded versions of tirzepatide have been eroding the company’s pricing power, and a ban would remove a significant competitive headache. The timing aligns neatly with Foundayo’s market entry, potentially channeling price-sensitive patients toward the branded oral option.

Medicare Opens a New Patient Pool

Starting this summer — no later than July 1, according to CEO David Ricks — eligible Medicare Part D beneficiaries will be able to access Foundayo, Wegovy, and the Zepbound KwikPen for a monthly copay of $50. The program runs through the end of 2027 and unlocks a patient segment that has been largely closed to GLP-1 therapies.

International expansion is also gathering pace. Mounjaro is now fully launched in more than 55 countries and commands roughly 60% market share in places like Brazil and South Korea. Across the global GLP-1 market, Lilly leads with a 53.2% share, ahead of Danish rival Novo Nordisk. Zepbound, by contrast, generated just $26 million outside the US in the first quarter on total revenue of nearly $4.2 billion — a sign that its international rollout is still in its infancy.

Pipeline Strength Beyond Weight Loss

While the GLP-1 story dominates headlines, Lilly is quietly building out its immunology franchise. This week, the company presented long-term data from the LUCENT program showing that its ulcerative colitis drug Omvoh (mirikizumab) can maintain clinical and endoscopic remission for four years. That makes it the first and only IL-23p19 antagonist to demonstrate sustained disease-free status over that timeframe.

In the fiercely competitive inflammatory bowel disease market, mucosal healing and durable remission are the gold standard, particularly for patients switching after other biologics have failed. Analysts see the data as evidence that Lilly is serious about diversifying its revenue base beyond metabolic drugs, with Omvoh and the dermatology drug Ebglyss positioned to contribute meaningfully over time.

A Liver Case Creates Noise, but Analysts Stay Bullish

Not everything has gone smoothly. A report of a hepatic event in the FDA database tied to Foundayo briefly rattled investors. Lilly has stated that the incident bears no plausible relationship to the drug, a view shared by several Wall Street firms. Goldman Sachs reiterated its “Buy” rating with a $1,283 price target, calling the recent volatility overblown. Barclays raised its target to $1,400, citing the rapid international uptake of tirzepatide products.

Earnings Momentum and a Dividend Declaration

The financial picture remains robust. Mounjaro brought in $8.7 billion in the first quarter, up 125% year over year, while Zepbound contributed $4.2 billion, an 80% increase. Adjusted earnings per share came in at $8.55. Management has raised full-year guidance to a revenue range of $82 billion to $85 billion, with adjusted EPS between $35.50 and $37 — both well above prior forecasts.

The company also declared a second-quarter dividend of $1.73 per share, payable in June. The stock closed recently at around €845, roughly 12% below its 52-week high. The relative strength index of 35 suggests the shares are not yet overbought from a technical perspective.

Ricks has projected that the global number of GLP-1 patients will rise from 20 million to 30 million by the end of 2026. Whether Foundayo, the Medicare program, and a potential compounding ban concentrate that growth at Lilly will become clearer with second-quarter results — and with the pace at which the third major PBM extends coverage for the new oral drug.