Bayer Juggles FDA Fast Track for Asundexian with €2.3 Billion Quarterly Cash Drain

A glimmer of pipeline progress has emerged for Bayer, but the company’s legal hangover continues to swallow its cash. The U.S. Food and Drug Administration granted priority review to the pharma giant’s application for Asundexian, a stroke-prevention drug, while first-quarter results underscored the persistent cost of America’s class-action machinery.

Shares climbed 1.79% on Wednesday to €39.24, up from Tuesday’s close of €38.55. That still leaves the stock well off its recent high, even as analysts point to a roughly 23% upside to the consensus target of €48.58. The gap between price and potential reflects a market that is cautiously pricing in operational improvement without ignoring the legal millstone.

FDA Cuts Review Timeline by Months

The priority-review designation means the FDA will rule on Asundexian in roughly six months rather than the standard ten. Bayer submitted data from the Phase 3 OCEANIC-STROKE trial, which tested the drug’s ability to prevent strokes and reduce thrombotic events without significantly raising major bleeding risks. That safety profile is precisely what makes Asundexian strategically critical: if approved, analysts see annual sales eventually reaching the billions, helping fill the revenue hole left by expiring patents on key medicines.

Regulatory reviews are also progressing in China, which granted similar priority status, and in Japan, where the process continues. Each approval milestone increases visibility into Bayer’s future pharma earnings power — a narrative the company badly needs alongside its still-robust but cash-draining current operations.

Should investors sell immediately? Or is it worth buying Bayer?

Agribusiness Powers Operating Profit, Legal Bills Devour Cash

The underlying business is performing well. First-quarter EBITDA before special items rose 9% to between €4.45 billion and €4.5 billion. Crop Science, the agricultural division, drove the gain with currency-adjusted revenue up 6.8% to €7.5 billion. Company-wide sales edged down to €13.4 billion on a nominal basis but grew solidly when currency swings are stripped out. Earnings per share came in at €2.71.

The flip side is brutal. Free cash flow sank to minus €2.3 billion for the quarter, almost entirely due to roughly €2 billion in payments for glyphosate and PCB settlements. The company’s net debt is expected to hit around €32 billion for the full year. A one-time settlement income of €448 million from the Corteva deal provided minor relief, but the underlying drag from litigation persists. Shareholders felt the pinch: the dividend for the past year was just €0.11 per share.

Management stuck to its full-year guidance. The next detailed quarterly update is due on August 4, 2026, when Crop Science will need to sustain its momentum.

Bayer at a turning point? This analysis reveals what investors need to know now.

Analysts See Value Despite Legal Cloud

Despite the cash drain, the stock looks cheap on forward multiples. The estimated price-to-earnings ratio for 2027 stands at about 11.9, well below competitors like Corteva (over 25) and Novartis (17.7). Several houses have recently raised their targets: DZ Bank upgraded to buy with a €51 price objective, while mwb research sees the shares reaching €52.

At around €38.71, Bayer’s stock trades comfortably above its 200-day moving average and has gained roughly 65% year to date. Yet the discount to peers reflects the balancing act between pharma pipeline promise, operational strength, and an unresolved legal bill that continues to shape both cash flow and balance sheet strategy. The next concrete catalyst is the FDA’s accelerated decision on Asundexian, with a potential Supreme Court ruling on glyphosate liability looming as a longer-term swing factor for debt reduction.

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