Regeneron (REGN): Assessing Valuation After FDA Postpones Key EYLEA HD Approval Decisions to Late 2025

Regeneron Pharmaceuticals (REGN) investors received news this week that the U.S. Food and Drug Administration has pushed back the target decision dates for two crucial EYLEA HD regulatory submissions to late 2025. This extension could delay the timeline for potential new approvals, adding more uncertainty to a product line that is central to Regeneron’s future business plans. Although this might seem like just another regulatory hurdle, the stakes are significant for those watching the portfolio of late-stage products that could influence Regeneron’s earnings over the next few years.

Looking at the bigger picture, this is not the only development shaping sentiment. Over the past year, Regeneron shares have declined around 50%, and last month’s 8% gain has not been enough to reverse the longer-term downtrend. Momentum has not yet shifted in a meaningful way, despite double-digit annual revenue and earnings growth. Recent conference presentations and ongoing research and development have kept Regeneron on investor radars, but the market clearly remains cautious with regulatory risk now a central consideration.

With the share price lagging and new uncertainties appearing in the near-term outlook, some investors may be wondering whether this is an opportunity to invest in Regeneron at a lower valuation, or if the market has already taken into account the challenges ahead for these important regulatory approvals.

Most Popular Narrative: 17.5% Undervalued

According to community narrative, Regeneron Pharmaceuticals is currently trading below its estimated fair value, with analyst consensus suggesting the stock is undervalued by a significant margin. This view is based on assumed future earnings growth and margin expectations that, if achieved, would support a higher valuation for the company.

The successful ramp of EYLEA HD, which is gaining physician adoption due to its clinical profile and durability, along with anticipated regulatory approvals for label enhancements (pending resolution of manufacturing site issues), could help offset patent and biosimilar pressures on legacy EYLEA. This may support stabilization and potential growth in core revenue and sustain healthy margins over the next several years.

What is the hidden engine driving Wall Street’s bullish view? The narrative points to potential future growth catalysts and assumptions about how new therapies could influence Regeneron’s financial results. Interested in which numbers could turn today’s uncertainty into tomorrow’s outperformance? The details behind this valuation surprise may challenge expectations set by the sector’s typical forecasts.

Result: Fair Value of $716.78 (UNDERVALUED)

Have a read of the narrative in full and understand what's behind the forecasts.

However, persistent regulatory delays and competitive threats to EYLEA could reduce optimism about long-term value and growth for Regeneron shareholders.

Find out about the key risks to this Regeneron Pharmaceuticals narrative.

Another View: Discounted Cash Flow Analysis

While analyst price targets suggest Regeneron is undervalued, our DCF model also points to the stock trading below its intrinsic value, suggesting potential upside. However, does this model account for all the real-world risks and uncertainty faced by the company?

Look into how the SWS DCF model arrives at its fair value.

Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Regeneron Pharmaceuticals for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity.

Build Your Own Regeneron Pharmaceuticals Narrative

If you see things differently or would rather base your view on your own deep dive, you are invited to develop your own narrative in under three minutes. So why not do it your way?

A good starting point is our analysis highlighting 4 key rewards investors are optimistic about regarding Regeneron Pharmaceuticals.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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