Novo Nordisk’s One-Two Punch: FDA Crackdown and Oral Ozempic Launch Set Stage for Earnings

Novo Nordisk enters a pivotal week with an FDA shortage-list victory, oral Ozempic rollout, and partnerships to capture former compounding pharmacy customers amid rising Eli Lilly competition.

The Danish pharmaceutical giant is entering a defining week, armed with a regulatory victory and a landmark product rollout that could reshape its competitive standing in the $100 billion-plus GLP-1 market.

On the regulatory front, the US Food and Drug Administration has delivered a decisive blow to the grey market for weight-loss drugs. The agency is removing semaglutide, tirzepatide, and liraglutide from its shortage list, effectively barring compounding pharmacies from producing cheap, unregulated copies of blockbusters like Wegovy and Ozempic. With Novo Nordisk now able to fully meet US demand, the FDA concluded there is no longer a medical justification for these knockoffs.

The move ends months of uncertainty for Novo, whose shares jumped more than 4% to €37.45 on the news. While the stock remains deeply in the red year-to-date, it has clawed back from its recent lows.

Targeting the Copycat Customer Base

Novo is wasting no time converting former compounding pharmacy customers. The company has forged new partnerships with telemedicine platforms GoodRx and WeightWatchers, offering eligible self-pay patients access to the branded drugs from around $150. The pricing strategy is a direct assault on the segment previously dominated by compounding pharmacies, which had undercut Novo on price during supply constraints.

This push coincides with the rollout of oral Ozempic, now available in more than 70,000 US pharmacies since May 4. It is the only FDA-approved oral GLP-1 medication for type 2 diabetes, giving Novo a unique foothold in the pill-based segment. Partners GoodRx and WW International — the latter through its Med+ program — are expected to broaden distribution further.

Early prescription data offers encouragement. The oral version of Wegovy racked up 18,410 prescriptions in its comparable launch week. By contrast, Eli Lilly’s newly launched Foundayo managed just 3,707 scripts in its second week on the market — a clear, if early, advantage for Novo.

Lilly Looms Large

The launch comes at an awkward time, however. Eli Lilly reported first-quarter revenue growth of 56% and raised its full-year guidance to between $82 billion and $85 billion. Lilly now commands 60.1% of the US obesity and diabetes market, versus Novo’s 39.4%.

Foundayo also has a practical edge: the pill can be taken anytime, with no restrictions on food or drink. That is a direct challenge to Novo’s oral semaglutide, which requires stricter dosing protocols.

Earnings Expectations and Valuation Debate

On May 6, Novo Nordisk will report its first-quarter results. Analysts expect revenue of roughly $11 billion and earnings per share of $0.86 — representing an 8% year-over-year revenue decline and a 16% drop in EPS. The numbers will provide the first concrete evidence of how expanded production capacity is translating into financial performance.

Wall Street is split. Citi recently downgraded the stock, and Bernstein initiated coverage with an underperform rating, citing pricing pressure and shrinking margins. The bear case paints Novo as a value trap.

But there is a contrarian view. On CNBC’s Fast Money in late April, analysts argued that after a roughly 68% decline from its mid-2024 peak, Novo offers a more attractive risk-reward profile than Lilly. Novo trades at about 12 times earnings, versus Lilly’s 26 times. Optimists point to a projected free cash flow yield above 6.5% for 2027, coupled with a dividend yield of around 4%.

Buybacks and Options Signal Bullish Bets

Novo has been buying back shares aggressively, repurchasing 3.44 billion Danish kroner worth of stock recently under a 15 billion kroner program. In the options market, nearly 78% of traded contracts were calls — suggesting a segment of the market is betting on a positive surprise from the earnings report.

The key questions for management on May 6 at 7:30 AM CET will be pricing dynamics under Medicare Part D and whether Foundayo has already begun to eat into Wegovy prescriptions. The answers could determine whether this week marks a turning point or just another chapter in Novo’s long battle to reclaim its narrative.