European Central Bank's Holzmann says rate cuts must wait for more tariff certainty
Austrian central bank chief Robert Holzmann on Thursday said euro zone interest rates should be held until more clarity emerges on the path of U.S. tariffs and European Union countermeasures.
"We have not seen this uncertainty now for years... unless the uncertainty subsides, by the right decisions, we will have to hold back a number of our decisions, and hence, we don't know yet in what direction monetary policy should be best moved," Holzmann told CNBC's Carolin Roth in an interview at the IMF World Bank Spring Meetings.
Holzmann is widely viewed as one of the most hawkish voting members of the European Central Bank, in favor of a slow approach to easing monetary policy as inflation eases. The ECB's Governing Council voted unanimously to cut by a quarter percentage point at its April meeting, its seventh reduction in the current cycle, but Holzmann confirmed he took the decision with caution and had seen a need to wait for more data.
He told CNBC that there was a "broad consensus" around lowering rates, but some disagreement at the margins.
"My assessment is that at this time, it wasn't clear yet to what extent [tariff] countermeasures were being taken. Because with countermeasures in Europe, prices may have increased. Without countermeasures, quite likely the price pressure is downward. And for the time being, we don't know yet the direction," he said.
Under President Donald Trump's market-rocking tariff policies, the European Union is facing blanket 20% duties on its U.S. exports, along with the 25% U.S. tariffs on aluminum, steel and autos that most countries have been slapped with. Trump on April 9 announced a 90-day pause on the universal tariffs, prompting the EU to pause its own initial tranche of counter measures while negotiations take place.
Holzmann told CNBC that while various scenarios remained possible with regard to prices and the movement of rates, for the time being the direction was downward.
"Before looking at data in detail, the question is, what kind of political decisions will be taken? Is it that we will have some tariff increases? Is it that we will have strong tariff increases? Is it that we will have retribution by high counter tariffs?"
"This high uncertainty, what we currently have, you can find everywhere. You can find it at the level of growth. You find it at the level of exchanges, in financial markets indicators. So at the moment, we look at everything and try to make sense out of it. But for the time being, it's too early to say, this is the data to look at. We need the decisions."
In an interview with CNBC earlier this week, European Central Bank President Christine Lagarde said monetary policy had done its job and the disinflation process in the euro zone was "nearing completion."
"We need to continue checking the data," she added, saying the central bank would be "data dependent to the extreme."
Overnight index swap pricing on Thursday suggested market expectations for another 25-basis-point rate cut at the ECB's next meeting in June, taking its key rate to 2%, and another cut of the same size before the end of the year.
"There may be further cuts this year, but the number is still outstanding," Holzmann said Thursday.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNBC
32 minutes ago
- CNBC
JPMorgan hired NOAA's chief scientist to advise clients on navigating climate change
Sarah Kapnick started her career in 2004 as an investment banking analyst for Goldman Sachs. She was struck almost immediately by the overlap of financial growth and climate change, and the lack of client advisory around that theme. Integrating the two, she thought, would help investors understand both the risks and opportunities, and would help them use climate information in finance and business operations. With a degree in theoretical mathematics and geophysical fluid dynamics, Kapnick saw herself as uniquely positioned to take on that challenge. But first, she had to get deeper into the science. That led her to more study and then to the National Oceanic and Atmospheric Administration (NOAA), the nation's scientific and regulatory agency within the U.S. Department of Commerce. Its defined mission is to understand and predict changes in climate, weather, oceans and coasts and to share that knowledge and information with others. In 2022, Kapnick was appointed NOAA's chief scientist. Two years later, JPMorgan Chase hired her away, but not as chief sustainability officer, a role common at most large investment banks around the world and a position already filled at JPMorgan. Rather, Kapnick is JPMorgan's global head of climate advisory, a unique job she envisioned back in 2004. Just days before the official start of the North American hurricane season, CNBC spoke with Kapnick from her office at JPMorgan in New York about her current role at the bank and how she's advising and warning clients. Here's the Q&A: Diana Olick, CNBC: Why does JPMorgan need you? Sarah Kapnick, JPMorgan global head of climate advisory: JPMorgan and banks need climate expertise because there is client demand for understanding climate change, understanding how it affects businesses, and understanding how to plan. Clients want to understand how to create frameworks for thinking about climate change, how to think about it strategically, how to think about it in terms of their operations, how to think about it in terms of their diversification and their long-term business plans. Everybody's got a chief sustainability officer. You are not that. What is the difference? The difference is, I come with a deep background in climate science, but also how that climate science translates into business, into the economy. Working at NOAA for most of my career, NOAA is a science agency, but it's science agency under the Department of Commerce. And so my job was to understand the future due to physics, but then be able to translate into what does that mean for the economy? What does that mean for economic development? What does that mean for economic output, and how do you use that science to be able to support the future of commerce? So I have this deep thinking that combines all that science, all of that commerce thinking, that economy, how it translates into national security. And so it wraps up all these different issues that people are facing right now and the systematic issues, so that they can understand, how do you navigate through that complexity, and then how do you move forward with all that information at hand? Give us an example, on a ground level, of what some of that expertise does for investors. There's a client that's concerned about the future of wildfire risk, and so they're asking, How is wildfire risk unfolding? Why is it not in building codes? How might building codes change in the future? What happens for that? What type of modeling is used for that, what type of observations are used for that? So I can explain to them the whole flow of where is the data? How is the data used in decisions, where do regulations come from. How are they evolving? How might they evolve in the future? So we can look through the various uncertainties of different scenarios of what the world looks like, to make decisions about what to do right now, to be able to prepare for that, or to be able to shift in that preparation over time as uncertainty comes down and more information is known So are they making investment decisions based on your information? Yes, they're making investment decisions. And they're making decisions of when to invest because sometimes they have a knowledge of something as it's starting to evolve. They want to act either early or they want to act as more information is known, but they want to know kind of the whole sphere of what the possibilities are and when information will be known or could be known, and what are the conditions that they will know more information, so they can figure out when they want to act, when that threshold of information is that they need to act. How does that then inform their judgment on their investment, specifically on wildfire? Because wildfire risk is growing, there've been a few events like the Los Angeles wildfires that were recently seen. The questions that I'm getting are could this happen in my location? When will it happen? Will I have advanced notice? How should I change and invest in my infrastructure? How should I think about differences in my infrastructure, my infrastructure construction? Should I be thinking about insurance, different types of insurance? How should I be accessing the capital markets to do this type of work? It's questions across a range of trying to figure out how to reduce vulnerability, how to reduce financial exposure, but then also, if there are going to be risks in this one location, maybe there are more opportunities in these other locations that are safer, and I should be thinking of them as well. It's holistically across risk management and thinking through risk and what to do about it, but then also thinking about what opportunities might be emerging as a result of this change in physical conditions in the world. But you're not an economist. Do you work with others at JPMorgan to augment that? Yes, my work is very collaborative. I work across various teams with subject matter experts from different sectors, different industries, different parts of capital, and so I come with my expertise of science and technology and policy and security, and then work with them in whatever sphere that they're in to be able to deliver the most to the bank that we can for our clients. With the cuts by the Trump administration to NOAA, to FEMA, to all of the information gathering sources — we're not seeing some of the things that we normally see in data. How is that affecting your work? I am looking to what is available for what we need, for whatever issue. I will say that if data is no longer available, we will translate and move into other data sets, use other data sets, and I'm starting to see the development out in certain parts of the private sector to pull in those types of data that used to be available elsewhere. I think that we're going to see this adjustment period where people search out whatever data it is they need to answer the questions that they have. And there will be opportunities. There's a ton of startups that are starting to develop in that area, as well as more substantial companies that have some of those data sets. They're starting to make them available, but there's going to be this adjustment period as people figure out where they're going to get the information that they need, because many market decisions or financial decisions are based on certain data sets that people thought would always be there. But the government data was considered the top, irrefutable, best data there was. Now, how do we know, when going to the private sector, that this data is going to be as credible as government data? There's going to be an adjustment period as people figure out what data sets to trust and what not to trust, and what they want to be using. This is a point in time where there is going to be adjustment because something that everyone got used to working with, they now won't have that. And that is a question that I'm getting from a lot of clients, of what data set should I be looking for? How should I be assessing this problem? Do I build in-house teams now to be able to assess this information that I didn't have before? And I'm starting to see that occurring across different sectors, where people are increasingly having their own meteorologist, their own climatologist, to be able to help guide them through some of these decisions. Final thoughts? Climate change isn't something that is going to happen in the future and impact finance in the future. It's something that is a future risk that is now actually finding us in the bottom line today.
CNBC
32 minutes ago
- CNBC
DoorDash CEO Tony Xu is taking on the role of industry consolidator in food delivery
During the depths of the Covid pandemic, with restaurants around the country facing an existential crisis, DoorDash CEO Tony Xu had an unconventional proposal. He wanted to cut commissions. Chief Business Officer Keith Yandell worried that such a move would result in a massive hit to profits ahead of the company's planned IPO. But Xu made a persuasive case. "If restaurants don't thrive, we cannot," Yandell told CNBC in a recent interview, recalling Xu's perspective at the time. "We need to take a leadership position." The company ended up sacrificing over $100 million in fees, Xu later said. Since starting DoorDash on the campus of Stanford University in 2013, the now 40-year-old CEO has navigated the notoriously cutthroat and low-margin business of food delivery, building a company that Wall Street today values at close to $90 billion. The stock has emerged as a tech darling this year, jumping 23%, while the Nasdaq is still down for the year largely on tariff concerns. More than four years after its IPO, net profits remain slim. But that's not getting in the way of Xu's mission to become an industry consolidator, using a combination of cash and new debt to fuel an acquisition spree at a time when big tech deals remain scarce. Earlier this month, DoorDash scooped up British food delivery startup Deliveroo for about $3.9 billion and restaurant technology company SevenRooms for $1.2 billion. "What we've delivered for a customer yesterday probably isn't good enough for what we will deliver for them today," Xu told CNBC's "Squawk Box" after the deals were announced. This week DoorDash announced the pricing of $2.5 billion in convertible debt, and said the proceeds could be used in part for acquisitions. The San Francisco-based company has a history with scooping up competitors to grow market share. In 2019, it bought food delivery competitor Caviar for $410 million from Square, now known as Block. About two years later, DoorDash said it was paying $8.1 billion for international delivery platform Wolt. The deal was its last big transaction until this month. When DoorDash entered the food delivery market, it had to face off against the likes of GrubHub and Seamless, which later joined forces. That combined entity was bought late last year by restaurant owner Wonder Group. In 2014, Uber launched Uber Eats, which is now DoorDash's biggest competitor in the U.S. "It's a very competitive market, and I think merchants do have choice," Xu said in the CNBC interview. "What we're focused on is always trying to innovate and bring new products to match increasing standards and expectations from customers." DoorDash didn't make Xu available for an interview for this story, but provided a statement about the company's acquisition strategy. "We're very picky, very patient, and conscious that, for most companies, deals don't work out in hindsight," the company said. "When we see an opportunity that brings value to customers, expands our potential to empower local economies around the world, and has a path to strong long-term returns on capital, we tend to push our chips in." DoorDash differentiated itself early on by cornering suburban markets that had fewer delivery options, while other players attacked city centers. When Covid shut down restaurant dining in early 2020, DoorDash capitalized on the booming demand for deliveries. Revenue more than tripled that year, and grew 69% in 2021. Colleagues and early investors credit a customer-first focus for much of Xu's success. Gokul Rajaram, who joined DoorDash through its Caviar acquisition, described Xu as "the best operational leader in the U.S." after Amazon founder Jeff Bezos. Restaurants haven't universally viewed DoorDash as an ally. Commissions can reach as high as 30%, which is a hefty cut to fork over. Many restaurants have reluctantly paid the high fees because of DoorDash's dominant market share, which reached an estimated 67%. In 2021, the company introduced three tiers of pricing, with a basic option at 15% for more price-sensitive businesses. DoorDash needs the high fees in order to stay in the black. The company's contribution profit as a percentage of total marketplace volume hovers below 5%. Colleagues who have known Xu for decades say the food delivery entrepreneur hasn't changed much since the early days of the company. Yandell said Xu once took advice from his young daughter, who complained about a routing issue while accompanying him on food delivery orders. All employees, including Xu, are required to complete orders and handle support calls every year as part of the company's WeDash program. In a part of the country known for the pomp of its wealthy founders, Xu has a very different reputation. Early workers recall memories of Xu pulling up in a dilapidated green 2001 Honda Accord to team events, or participating in company knockout basketball games referred to as "knockys," next to the animal hospital in Palo Alto, which DoorDash briefly called its headquarters. Xu also personally approved every offer for the company's first 4,000 employees. Xu spends many mornings answering customer service complaints. He often drops his kids off at school and, after tucking them in at night, hops on calls with international regions, colleagues say. Xu is an avid Gold State Warriors basketball fan but has a soft spot for the Chicago Bulls, having spent many years in Illinois. Once or twice a week, Xu squeezes in a morning run, and will often do so while traveling to explore different neighborhoods and stores. Xu was born in China and moved with his family to Champaign, Illinois, in 1989. Growing up, he played basketball and mowed lawns to save up for a Nintendo. He told Stanford's View From the Top podcast in 2021 that the experience, and watching his parents hustle, taught him how to "earn your way into better things." His "characteristics became the company's values," said Alfred Lin, an early DoorDash investor and partner at venture firm Sequoia. Xu often attributes his entrepreneurial spirit to his parents. His mother worked as a doctor in China, and juggled three jobs in the U.S. for over a decade, saving up enough to eventually open a medical clinic. His father worked as a waiter while pursuing a Ph.D. Xu said on the podcast that watching his mom gave him a deep understanding of what it takes to run a small business, which came in handy in DoorDash's early years as he was trying to convert restaurants into customers. Employees say Xu has a reputation for detecting hidden talents among his colleagues. Jessica Lachs, the company's chief analytics officer, was working as a general manager assisting with DoorDash's Los Angeles launch when Xu guided her toward her passion for data. "He believes in leaning into the things you're really good at, rather than trying to be mediocre at a lot of things," she said. After Toby Espinosa, DoorDash's ads vice president, lost a deal with a major fast food company during his early years at the startup, Xu told him to work "10 times harder" and become an expert in his field. A few years later, the company secured the partnership, Espinosa said. Grit and struggle defined the early years of DoorDash. The founding team of four managed deliveries around Stanford and Palo Alto though a Google Voice number directed to their cellphones. DoorDash emerged out of a Stanford business school course known as Startup Garage, taught by Professor Stefanos Zenios. The class requires students to present a business idea, test it, and then pitch it to investors. Zenios said Xu stood out with his data-driven approach and natural leadership qualities. The team tested two different ideas, including a platform that helped small businesses better track the effectiveness of their marketing, he recalls. Zenios called the idea to target suburban areas a "brilliant insight." Xu and his team entered Y Combinator in the summer of 2013. The three-month startup accelerator program is known for spawning companies like Airbnb, Stripe and Reddit. Every session culminates with a demo day in front of some of Silicon Valley's biggest investors. The DoorDash idea excited Paul Buchheit, creator of Gmail and a partner at Y Combinator. But like many other potential investors, Buchheit was skeptical about the economic model. "You had a talented team of founders working on what I thought was an idea that had potential," he said. "That's basically the formula for a good startup." On pitch day, the company failed to lure any venture firms, but Buchheit later participated as a seed investor. Shortly after demo day, DoorDash encountered Saar Gur of Charles River Ventures. Gur had been looking for a food delivery platform to back and was conducting due diligence on another company when a friend led him to DoorDash. By the end of their first meeting, they were "finishing each other's sentences," Gur said. Sequoia's Lin initially passed on DoorDash after the Y Combinator pitch, but kept in touch with the team. Lin said he wanted to see data that showed the platform could penetrate beyond Stanford and Palo Alto, and retain customers. He ended up leading two institutional rounds, attaining a 20% stake for Sequoia at the time of the IPO. "Tony always believed that his company would succeed, or they'll find a way to succeed," Lin said. Shortly after its Y Combinator stint, DoorDash hit an early roadblock. Following a Stanford football game, a rush of orders bombarded its delivery system causing massive delays, Xu told Y Combinator's CEO Garry Tan in an interview this year. The founders refunded the orders and spent the night baking cookies, then driving them to customers early the next morning. Oren's Hummus co-owner Mistie Boulton said DoorDash still takes that approach. The team comes to meet with her every quarter and she serves as a beta tester for new products. The restaurant, which started in Palo Alto and has since expanded to a half-dozen locations across the Bay Area, was one of DoorDash's first clients, latching onto the opportunity to reach more customers beyond its small establishment that frequently had lines snaking out the door. "We just fell in love with the idea," Boulton said. "The number one thing that encouraged and enticed me to want to work with them was Xu's passion. He really is one of those people that you can count on." Wall Street is now counting on Xu's ability to execute big deals, even with the company having this month surpassed $10 billion in delivery orders worldwide. The acquisition of Deliveroo, based in London, marks a renewed effort by DoorDash to expand its presence overseas, following the purchase of Finland's Wolt three years ago. The cash deal for SevenRooms, a New York City-based data platform for restaurants and hotels to manage booking information, takes DoorDash into an entirely new category. Xu told CNBC that DoorDash is a "multi-product company now that's operating on a global scale." Following the acquisition announcements, which coincided with a disappointing earnings report in March, analysts at Piper Sandler reiterated their hold recommendation on the stock. One reason for concern, they said, was that "integrating multiple acquisitions at once may create some noise near-term."
Yahoo
39 minutes ago
- Yahoo
Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001) Libtayo also demonstrated 80% and 65% reductions in the risk of locoregional and distant recurrence, respectively, compared to placebo Detailed results presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in the Regulatory applications have been submitted in the United States and European Union TARRYTOWN, N.Y., May 31, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced detailed analyses from the Phase 3 C-POST trial, which evaluated PD-1 inhibitor Libtayo® (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. The results, shared during an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM), include additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes. 'While surgery and radiotherapy remain the cornerstones of treatment for high-risk cutaneous squamous cell carcinoma, there is a critical unmet need for systemic therapies to help prevent relapse and metastasis to ultimately drive better outcomes for patients,' said Danny Rischin, M.D., M.B.B.S., F.R.A.C.P., Research Lead, Head and Neck Cancer and Cutaneous SCC, Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, and lead investigator of the trial. 'The Phase 3 C-POST trial demonstrates that cemiplimab is a highly active therapy in high-risk CSCC, with clinically meaningful outcomes across primary and secondary endpoints and exceptionally low rates of locoregional and distant recurrence.' Results from the C-POST trial shared earlier this year established Libtayo as the first immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting. In contrast, negative results with another PD-1 are presented at ASCO. The data with Libtayo at this year's ASCO provide additional insights for the primary endpoint of DFS – defined as time from randomization to the first documented disease recurrence or death – as well as first results for the secondary endpoints of freedom from locoregional recurrence, freedom from distant recurrence and overall survival (OS). With a median duration of follow-up of 24 months (range: 2-64 months), efficacy results for Libtayo compared to placebo, were as follows: 68% reduction in the risk of disease recurrence or death (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.20-0.51; p<0.0001), with median DFS not reached for Libtayo-treated patients (versus 49 months for placebo) At two years, DFS was 87% with Libtayo versus 64% with placebo 80% reduction in the risk of locoregional recurrence (HR: 0.20; 95% CI: 0.09-0.40) 65% reduction in the risk of distant recurrence (HR: 0.35; 95% CI: 0.17-0.72) Updated OS data from a recent data cut, with approximately six months of additional follow up after the primary analysis for DFS, suggest an emerging OS benefit for Libtayo (HR: 0.78; 95% CI: 0.39-1.56) versus placebo. 'These results show the continued promise of Libtayo in non-melanoma skin cancers,' said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. 'Libtayo is the first medicine to demonstrate a statistically significant benefit in patients who have high-risk features for recurrence after resection of cutaneous squamous cell carcinoma and has the potential to become a new standard of care in the adjuvant setting. We are working with global regulatory authorities to bring this new option to patients as quickly as possible.' Additionally, an exploratory analysis of the C-POST results showed similar rates of DFS regardless of PD-L1 expression level. Specifically, Libtayo reduced the risk of disease recurrence or death by 72% in tumors with PD-L1 ≥1% (HR: 0.28; 95% CI: 0.15-0.52; n=309) and by 68% in tumors with PD-L1 <1% (HR: 0.32; 95% CI: 0.12-0.86; n=85), compared to placebo. Safety was assessed in 205 patients in the Libtayo arm and 204 patients in the placebo arm. Adverse events (AEs) of any grade occurred in 91% and 89% of patients in the Libtayo arm and the placebo arm, respectively. Grade ≥3 AEs occurred in 24% and 14% of patients in the Libtayo arm and the placebo arm, respectively. The most common AEs occurring in at least 10% of patients in the Libtayo arm were fatigue, pruritus, rash, diarrhea, arthralgia, hypothyroidism and maculo-paplar rash. The only grade ≥3 AE that occurred in more than 2% of patients in the Libtayo arm was hypertension. Treatment discontinuations due to AEs, regardless of attribution, occurred in 10% and 2% of patients in the Libtayo arm and the placebo arm, respectively. Two patients experienced an AE leading to death in each arm. The potential use of Libtayo described above is investigational, and its safety and efficacy has not been evaluated by any regulatory authority for this indication. Regulatory applications have been submitted for Libtayo in the treatment of adjuvant CSCC in the United States and European Union. About the Phase 3 TrialC-POST is one of several trials from Regeneron's oncology portfolio and pipeline being shared at ASCO. C-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. Trial participants were at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features). The trial enrolled 415 patients who were randomized to receive either Libtayo (n=209) or placebo (n=206) for up to 48 weeks. For the first 12 weeks, Libtayo 350 mg or placebo was administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks. About Regeneron in Cancer We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we're pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron's pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), advanced CSCC, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat: People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation. People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal 'EGFR,' 'ALK,' or 'ROS1' gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high 'PD-L1,' and your tumor does not have an abnormal 'EGFR,' 'ALK,' or 'ROS1' gene. It is not known if Libtayo is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS What is the most important information I should know about LIBTAYO? LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems: cough, shortness of breath, or chest pain Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects. Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you: have immune system problems such as Crohn's disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatment You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of LIBTAYO when used alone include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296. Please see full Prescribing Information, including Medication Guide. About Regeneron's Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spend decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation Libtayo® (cemiplimab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Libtayo as an adjuvant treatment for patients with high-risk cutaneous squamous cell carcinoma following surgery as discussed in this press release as well as Libtayo as a monotherapy or in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products (such as Libtayo) and Regeneron's Product Candidates; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Libtayo) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Contacts: Media Relations Investor Relations Taylor Ramsey Skott Mark Hudson Tel: +1 914-409-2381 Tel: +1 914-847-3482 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
