Latest news with #Kerendia
Yahoo
15-05-2025
- Business
- Yahoo
Bayer US head says FDA chief reassured pharma executives of timely reviews
By Bhanvi Satija and Michael Erman NEW YORK (Reuters) -Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry executives that the Food and Drug Administration would meet its targets for reviews despite recent job cuts and a restructuring. "We're looking at an FDA and scientific review staff that is stable, engaged and meeting its deadlines," Sebastian Guth, who oversees Bayer's U.S. operations, said in an interview. Guth said that after a recent meeting between FDA Commissioner Marty Makary and industry executives, he was confident that the leadership wanted to maintain the agency's standards. Makary said last month the FDA will meet its targets for completing reviews of new drugs despite mass firings under the Trump administration. Reuters had reported in early April that firings at the FDA included employees critical to reviewing new medicines. "I heard an FDA commissioner who notes and acknowledged that the industry requires a stable and predictable regulatory environment," said Guth, adding that Makary underlined his intent to use technology to support FDA's work. The FDA is expected to decide whether to expand approval for Bayer's kidney disease drug Kerendia to patients with heart disease this year. Guth said Bayer's interactions with the FDA, predominantly its Center for Drug Evaluation and Research, had followed tight protocol and the agency had met its deadlines for experimental drugs under review. "We've seen the FDA responding within the timelines that are to be expected," he said. Bayer's experimental drug, elinzanetant, for treating menopause symptoms, is also under review. Guth said Bayer's first-quarter sales growth in the U.S., a key market, exceeded the 23% rise for North America reported earlier this week. Bayer does not break out sales by country. The U.S. accounted for a "significant chunk" of its sales of new prostate cancer drug Nubeqa and kidney treatment Kerendia, he said. On Tuesday, the company reported a combined 680 million euros ($760.51 million) in revenues from both drugs. ($1 = 0.8941 euros) Error 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
Reuters
15-05-2025
- Business
- Reuters
Bayer US head says FDA chief reassured pharma executives of timely reviews
NEW YORK, May 15 (Reuters) - Bayer ( opens new tab Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry executives that the Food and Drug Administration would meet its targets for reviews despite recent job cuts and a restructuring. "We're looking at an FDA and scientific review staff that is stable, engaged and meeting its deadlines," Sebastian Guth, who oversees Bayer's U.S. operations, said in an interview. Guth said that after a recent meeting between FDA Commissioner Marty Makary and industry executives, he was confident that the leadership wanted to maintain the agency's standards. Makary said last month the FDA will meet its targets for completing reviews of new drugs despite mass firings under the Trump administration. Reuters had reported in early April that firings at the FDA included employees critical to reviewing new medicines. "I heard an FDA commissioner who notes and acknowledged that the industry requires a stable and predictable regulatory environment," said Guth, adding that Makary underlined his intent to use technology to support FDA's work. The FDA is expected to decide whether to expand approval for Bayer's kidney disease drug Kerendia to patients with heart disease this year. Guth said Bayer's interactions with the FDA, predominantly its Center for Drug Evaluation and Research, had followed tight protocol and the agency had met its deadlines for experimental drugs under review. "We've seen the FDA responding within the timelines that are to be expected," he said. Bayer's experimental drug, elinzanetant, for treating menopause symptoms, is also under review. Guth said Bayer's first-quarter sales growth in the U.S., a key market, exceeded the 23% rise for North America reported earlier this week. Bayer does not break out sales by country. The U.S. accounted for a "significant chunk" of its sales of new prostate cancer drug Nubeqa and kidney treatment Kerendia, he said. On Tuesday, the company reported a combined 680 million euros ($760.51 million) in revenues from both drugs. ($1 = 0.8941 euros)
Yahoo
14-05-2025
- Business
- Yahoo
Bayer AG (BAYRY) Q1 2025 Earnings Call Highlights: Navigating Challenges and Capitalizing on ...
Revenue: Flat year-over-year, within the -3% to +1% corridor guidance for 2025. Core EPS: EUR2.49, on track to reach EUR4.50 to EUR5.00 at constant currencies. Free Cash Flow: Minus EUR1.5 billion, EUR1 billion improvement from last year. Crop Science Sales: Declined 3%, with regulatory impacts affecting higher margin sales. Pharmaceuticals Sales: Grew 4%, with Nubeqa and Kerendia increasing 80% year-over-year. Consumer Health Sales: Increased 2.5%, with 2% volume growth. EBITDA Before Special Items: EUR4.1 billion, 7% below prior-year quarter. Net Financial Debt: Increased by EUR1.7 billion to EUR34.3 billion since year-end 2024. Crop Science EBITDA Margin: 33.7%, 10% lower due to regulatory impacts and corn phasing. Pharmaceuticals EBITDA Margin: 29.5%, increased by 12% due to higher sales and efficiency gains. Consumer Health EBITDA Margin: 22.8%, slightly below prior year but within guidance range. Warning! GuruFocus has detected 3 Warning Sign with BAYRY. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Bayer AG (BAYRY) reported a strong performance in its Pharmaceuticals division with a 4% growth, driven by the exceptional momentum of Nubeqa and Kerendia, which grew 80% year-over-year. The company achieved a 12% increase in EBITDA before special items in the Pharmaceuticals division, indicating effective cost management and efficiency gains. Consumer Health division saw a 2.5% growth, with a 2% increase in volume, positioning the division well to meet its annual guidance. Bayer AG (BAYRY) is on track to meet its full-year guidance for 2025, with core EPS expected to be between EUR4.50 to EUR5.00 at constant currencies. The company has made significant progress in its strategic priorities, including the launch of Beyonttra in the EU and preparations for the launch of elinzanetant in the second half of the year. Bayer AG (BAYRY) reported a 3% decline in sales for its Crop Science division, primarily due to regulatory impacts affecting higher margin sales. The company's free cash flow was negative at EUR1.5 billion, attributed to the seasonality of the Crop business, although it showed improvement from the previous year. Xarelto sales declined by 31% due to continued generic pressure in Europe and Japan, impacting the Pharmaceuticals division's top and bottom line. The Consumer Health division experienced soft conditions in key markets, with a slight decline in margins compared to the previous year. Bayer AG (BAYRY) faces ongoing litigation challenges, including an adverse decision by the Superior Court of Pennsylvania, which may impact financial provisions and require further legal actions. Q: Could you discuss the expected growth in Crop Science for Q2 and any impacts from forward purchasing on crop protection products? A: Rodrigo Santos, Head of Crop Science, explained that excluding regulatory impacts, the core business would have grown by 2.4%. The corn business is expected to grow by 2.5% in Q1 due to accounting adjustments. Crop protection reported 2% growth, which would be 5% excluding regulatory impacts. The company remains confident in its guidance for the year, driven by innovation and core business health. Q: Can you provide an update on the glyphosate litigation and potential outcomes if the Supreme Court does not accept the case? A: William Anderson, CEO, stated that Bayer expects to hear from the Supreme Court in June or October. The company is not relying solely on this plan and is working with Congress for potential legislative solutions. Bayer is also considering structural options and remains open to settlements, provided they offer a high degree of finality. Q: How confident are you in the safety and efficacy of Asendexian, and what is the expected market potential? A: Stefan Oelrich, Head of Pharmaceuticals, expressed confidence in Asendexian's safety and efficacy, noting positive results from the Pacific program. The Phase III study targets populations with significant effects observed in Phase II. The market potential is substantial, especially if prevalent cases are included. Q: Could you elaborate on the state legislation efforts related to glyphosate and their significance? A: William Anderson highlighted that state legislation is crucial for providing certainty to manufacturers and signaling to Congress the need for federal clarification. Missouri is a key state due to the volume of lawsuits filed there. Bayer is pursuing legislation in additional states to support its position. Q: What are Bayer's expectations for corn acreage in the U.S., and how does it impact profitability compared to soy? A: Rodrigo Santos stated that Bayer is optimistic about high corn acreage in the U.S., potentially reaching 94-95 million acres. Corn is more profitable than soy, and Bayer expects growth in corn globally. The company is also focused on margin expansion through cost control and efficiency improvements. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error 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
Yahoo
13-05-2025
- Business
- Yahoo
Bayer shares soar as company records strong cancer drug demand
German pharmaceutical giant Bayer's shares jumped 10.5% on the London Stock Exchange on Tuesday morning following the company experiencing higher demand for its new cancer and kidney drugs in the first quarter of 2025. Earnings before interest, taxes, depreciation and amortisation (EBITDA) before special items was €4.1 billion for the first quarter of 2025. Although this was a 7.4% fall from the corresponding quarter a year ago, it was still above market expectations of €3.9bn, according to Bloomberg. Group sales for the first quarter was €13.7bn, which was a fall of -0.1% compared to the same quarter in 2024. Core earnings per share plunged 11.7% to €2.5. Bill Anderson, Bayer's chief executive officer (CEO) was optimistic that the earnings jump in the pharmaceuticals division was a sign that teams were learning to do more with less. He also reiterated his confidence in the fundamentals of the company and the momentum of its launches. The company also revealed that it is closely monitoring ongoing economic and geopolitical changes, as well as their impact on the company. Bayer confirmed its full-year 2025 outlook at constant currencies and expects that the pharmaceutical division will deliver at the higher end of the previously shared sales and profitability guidance range. Related US and China announce substantial reductions in tariffs for 90 days Saudi Arabian oil giant Aramco takes hit due to lagging oil prices Bayer's pharmaceuticals division's sales grew 4.4% in the first quarter of 2025, mainly boosted by North American sales, although the Europe, Middle East and Africa (EMEA) region lagged. The company's new hormone therapy drug for prostate cancer, Nubeqa, has seen considerable demand, along with Kerendia, used to treat chronic kidney disease. Eylea, mainly used to treat various eye conditions, has also seen sales increase, while Bayer's radiology business has been strong too. Similarly, contraceptive drugs such as YAZ and Mirena have recorded robust growth as well. However, the anticoagulant Xarelto has seen a decline mainly because of patent expirations. On the other hand, sales for Bayer's crop-science branch dropped 4.1% in the first quarter of the year, partly because of slowing pesticide demand. Ongoing low prices for glyphosate, which is the active ingredient in the Roundup weedkiller, has also contributed to lower crop-science performance. The company has previously shared that it could potentially stop producing glyphosate in Louisiana as Chinese competition intensifies. Bayer is also continuing to deal with significant litigation related to products that the company inherited in its Monsanto acquisition back in 2018. Error 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
RTÉ News
13-05-2025
- Business
- RTÉ News
Bayer posts smaller than expected drop in quarterly adjusted profit
Bayer has today posted a smaller decline in first-quarter adjusted earnings than investors had feared as strong prescription numbers for new drugs offset a drop in its seed businesses, boosting its shares. CEO Bill Anderson is under pressure from investors to deliver on restructuring efforts and to reverse what is projected to be the third consecutive annual drop in operating income in 2025. The debt-burdened group is grappling with costly US product liability litigation over weed killer Roundup. It said quarterly earnings before interest, tax, depreciation and amortisation (EBITDA), adjusted for one-off items, fell 7.4% to €4.09 billion, beating a consensus of €3.75 billion posted on the company's website. Shares jumped 11% to a seven-month high, with Deutsche Bank analysts saying the results were encouraging although some uncertainty and high legal risks remain. Revenue from new prostate cancer drug Nubeqa and kidney treatment Kerendia rose 80% to a combined €680m. But a delay in US approval for new soy and cotton seeds led to a revenue drop of 16% in those businesses to a combined €754m. Bayer said it had cut 2,000 full-time positions in the first quarter, on top of 7,000 jobs slashed last year. The German group, which is also cutting managerial jobs and red tape, has secured shareholder approval to raise fresh equity if needed for legal settlements, but reiterated today that such a move was not on the cards. It confirmed its currency-adjusted earnings outlook for 2025. This year's special items, however, would be at the upper end of the previous outlook range, or about minus €1.5 billion, given higher legal risks and severance pay for staff, it added. Bayer increased its legal provisions after an unfavourable verdict by a Pennsylvania appeals court last week over disputed claims that Roundup causes cancer. It still plans to petition the US Supreme Court to sharply limit claims that could run into the billions of dollars. For its pharmaceuticals division, it projected the currency-adjusted profit margin to come in at the upper end of its previous target range. Based on trade tariffs announced so far, Bayer said it expects "to manage the impact", even though there would be direct effects on pharmaceutical flows between the US and China. There is also a risk of tariffs on drugs made by Bayer in Europe and shipped to the US, but the CEO said the group is currently not revisiting its global manufacturing network.
