Bayer is applying its new operating model for key drugs elinzanetant and Nubeqa.
Bayer’s massive reorganization championed by CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team, shaking up its structure, personnel and operations.
“We are transforming from a company that has been largely focused on hierarchy within functions to an organization—and supporting design—that really focuses on customers and products,” Christine Roth, head of global commercialization at Bayer’s pharmaceutical division, said in a recent interview with Fierce Pharma.
Roth’s promotion to her current position was part of the restructuring as Bayer shrank its pharma executive team. The former oncology business chief officially started to lead a newly formed commercialization organization on June 1.
The purpose of the groupwide overhaul was to reduce Bayer’s levels of bureaucracy, as job reductions were expected to mainly affect managerial roles. The new operating model, dubbed “dynamic shared ownership,” or DSO, promises fewer organizational layers and more agility for employees.
While layoffs across Bayer are not expected to finish until 2025, Roth said headcount reductions in the pharma commercialization unit will largely be done at the beginning of the fourth quarter.
A new operating model
As a result of the streamlining, “the span of coaching for every leader in the organization is going to double and, in some cases, triple,” Roth told Fierce Pharma on the sidelines of the American Society of Clinical Oncology annual meeting in Chicago in late May.
“One of the tenets of DSO is, managers need to be less involved in the day-to-day,” Roth said. “Our role is as visionaries, architects, catalysts and coaches.”
Within Bayer’s pharma unit, staff responsibilities across late-stage development, registration, commercialization and lifecycle management are being reshaped, with regulatory and development functions shifting over to the R&D organizations.
For commercialization, Bayer previously had product sales teams and parallel functional teams, which may have operated on separate strategies. Now, those functions, such as marketing, market access, medical affairs and patient advocacy sit unified in the global capabilities group—instead of being dispersed across each product. Under that model, Roth explained, the product teams will set goals, and then everyone else, including Roth herself, will provide resources in service of those goals.
The new DSO model still needs some honing, but Bayer expects to install people in their new jobs and functions by the end of the year across the company, Roth said.
“The beauty of this system is, we’re not perfecting it before we start,” Roth said. “We’re getting to a good place where we can start to experiment and go. And we will learn and adjust as we go.”
To help test out DSO, Bayer has designated several “front-runner” teams.
“The front runners have been really critical in helping us do that, because their job was to try out the new system—we did our best to completely leave them alone—to let us know what’s working to support them and what’s not working, and then feed real-time learnings back into the organization,” Roth said.
The team for Bayer’s prostate cancer drug Nubeqa is one of the front-runners groups. Bayer has pegged the androgen receptor inhibitor to reach peak sales of more than €3 billion a year.
Bayer is trying to expand Nubeqa’s reach in part through the phase 3 ARANOTE trial in metastatic hormone-sensitive prostate cancer. The study reached primary completion on June 7, according to clinicaltrials.gov. A Bayer spokesperson said the company plans to announce the topline results soon.
While preparing for potential regulatory filings for ARANOTE, the team identified many unnecessary processes from the old practice, including around 80 tables that would have previously been produced. Eliminating those processes will save time and costs, Roth said.
DSO is also coming into play with Bayer’s possible launch of the hot flash drug elinzanetant, which has three positive phase 3 trials in the bag and an FDA filing on the horizon. The new model has allowed the elinzanetant staffers to tap into digital resources that traditionally have not been dedicated to a specific product team, Roth said.
Novel channel marketing resources were brought in “because they see this launch as not so much the traditional boots-on-the-ground, reach-and-frequency, face-to-face with physician, but much more patient engagement and much more policy engagements,” Roth said.
Direct-to-consumer patient marketing will be critical for elinzanetant launch, Roth added. Bayer wants to empower women to have an open dialogue with doctors about their symptoms and potential treatment options, and to make sure medical policies are in place so that patients can have access to the meds.
Bayer is evaluating DSO system in 90-day cycles. According to Roth, employees are getting the hang of the new model and need no more convincing.
“We are going to have to get our hands dirty and let teams really struggle through some of these things before we see what kind of adjustments we need to make,” Roth said. “What I am very focused on achieving between now and the end of the year is, as people complete multiple 90-day cycles, I will be listening and checking to make sure that it feels different for employees. They feel empowered. They feel like there are fewer barriers to getting the job done. They feel like they’re closer to the customer.”
Bayer’s oncology ambition: ‘A moving target’
Roth had experience working in women’s health and cardiometabolic diseases. But before she came to lead Bayer’s entire pharma commercial operations, she had spent nearly two decades in oncology, including at GSK, Novartis and Bristol Myers Squibb.
Last year, Bayer laid out an ambition to reach $10 billion in revenue from cancer drugs by 2030 and to become a top 10 oncology player. It’s a bold target considering none of the pharma division’s top 3 products last year were in oncology, while Nubeqa is expected to hit above $1 billion sales this year. So at last year’s ASCO annual meeting, Roth told Fierce Pharma that Bayer would need a “midsize acquisition” to reach its revenue goal.
This time around, Roth argued that there’s no magic formula on how to achieve an ambitious target in pharma, and that a midsize deal may not be absolutely necessary.
“I would not so much focus on the $10 billion anymore,” Roth said during this year’s ASCO conference. “The goal is to become a top oncology player, and it’s a moving target anyway.”
“All we need, to be quite honest with you, is [for] one of the assets from Vividion—one of the assets in our pipeline—to be our next $2-to-$3-billion drug,” she said hypothetically. “And all of a sudden, the picture changes.”
Bayer acquired Vividion Therapeutics in 2021 and made the discovery engine an independently operating subsidiary. In oncology, the unit is working on candidates to inhibit NRF2 and STAT3, and it has an anti-WRN program in collaboration with Roche. But all of those programs are in early-stage testing and currently don’t have data in their clinical profiles.
Roth also pointed to Bayer’s HER2 program, a reversible tyrosine kinase inhibitor coded BAY 2927088, which recently received an FDA “Breakthrough Therapy” designation in previously treated HER2-mutated non-small cell lung cancer. It also has a new PSMA-targeted radioligand therapy coded BAY 3563254. But those are also in phase 1 development.
Compared with other therapeutic areas, Bayer’s oncology pipeline is composed of newer assets that are relatively unproven. In women’s health, the company is looking to introduce elinzanetant soon. And it just bought European rights to BridgeBio’s near-to-market heart disease drug acoramidis. But in oncology, it has no phase 2 or phase 3 therapeutic programs in sight for novel molecules, while Nubeqa was first introduced about five years ago.
The Bayer pharma team has had discussions with CEO Anderson—a pharma veteran—about the need to balance between early-stage and later-stage assets in the oncology pipeline, Roth said. For one thing, the DSO model is expected to advance early-stage programs faster.
“The core of the strategy is really to continue investing and filling the funnel,” Roth said.
As for M&A deals, Roth argued that the ongoing restructuring wouldn’t impair Bayer’s ability to pursue external transactions in oncology, pointing to the BridgeBio deal. But the drugmaker simply hasn’t identified the right target.
“[If] we find the right one, I’m fairly optimistic that we’ll be successful if that’s what we want to bring in,” Roth said. “We’ve looked at a lot of things that have transacted recently and just decided for one reason or another that they weren’t the right deal for us.”
