JPM25: Bayer gears up for 'must-win battles' as Xarelto's decline is in full swing, pharma chief says

Although Bayer’s top-selling drug Xarelto lost market exclusivity in most geographies in 2024, the company still predicts it will see strong growth from the pharma business unit beginning in 2027.

The optimism is rooted in new launches, Stefan Oelrich, head of Bayer’s pharma division, said Tuesday at the J.P. Morgan Healthcare Conference.

Besides label expansions for in-market products such as prostate cancer drug Nubeqa and kidney disease therapy Kerendia, the German pharma is prepping for the potential rollouts of two key drugs: BridgeBio-partnered transthyretin amyloid cardiomyopathy (ATTR-CM) therapy acoramidis and menopause candidate elinzanetant.

These launches are what Oelrich called “must-win battles” at Bayer as the Xarelto loss of exclusivity reaches “full swing” in 2025. In the third quarter of 2024, Xarelto already saw its sales drop about 24% to 802 million euros in what Oelrich called “a harbinger” for what to expect of the blood thinner in the following quarters.

Bayer in-licensed European rights to acoramidis in April 2024 and secured a positive opinion from the European Medicines Agency in December.

In the U.S., following an FDA approval in November and an official launch Dec. 11, BridgeBio this week revealed that it has recorded 430 Attruby (acoramidis) prescriptions for patients with the rare disease.

BridgeBio’s early launch progress, which analysts viewed as a strong start, gives Bayer confidence in its own efforts.

“It’s certainly a fast-growing, billion-plus type of market opportunity that we will address right where the sweet spot for us is,” Oelrich said.

Bayer will leverage its existing commercial infrastructure to support the drug’s launch, which is initially planned for Germany and Switzerland, he said.

With elinzanetant, Bayer is handling the drug’s commercialization globally, including the U.S. If approved—the FDA has set a target decision date for July—the drug would go up against Astellas’ Veozah.

But, just a few months after an FDA nod in 2023, Astellas slashed its Veozah peak sales projection in half to between 150 billion Japanese yen ($1 billion) and 250 billion yen ($1.6 billion). The Japanese pharma cited insurance coverage as a major challenge to uptake for now, plus a lower-than-expected treatment rate in the overall vasomotor symptoms market. These market-wide insights have led to questions around elinzanetant’s potential.

“We see this as a blockbuster candidate,” Oelrich said of elinzanetant. “And, quite frankly, otherwise we shouldn't be launching.”

“But I think I mentioned it last year already: This is not a walk in the park, because there is a clear understanding by physicians that [hormone replacement therapy] is an effective treatment,” Oelrich continued. “So we need to find the right place where this is acceptable, both to women, [who] I think are more open to nonhormonals, but also to physicians.”

Oelrich argued elinzanetant’s mechanism of action could help it differentiate itself. While Veozah is a neurokinin 3 (NK3) receptor antagonist, elinzanetant is a NK-1 and -3 receptor blocker. Besides, while women’s health is a new area for Astellas, it’s not for Bayer, which has a contraceptive portfolio, including the Mirena device family.

“I have personally been part of a launch of HRT,” Oelrich said. “Because we have been a leader in the segment for over 100 years and have been also a leader for many, many years in the women’s health care space in the United States, we’re looking at this, eyes wide open.”