Core Viewpoint - Bayer AG has submitted a supplemental new drug application (sNDA) to the FDA for Kerendia (finerenone) to treat heart failure with a left ventricular ejection fraction (LVEF) of ≥40% [1][4] Group 1: FDA Approval Process - The FDA has granted a priority review for the sNDA, with a decision expected in the third quarter of 2025, reducing the review period to six months [2] - The sNDA is based on positive data from the phase III FINEARTS-HF study, which evaluated Kerendia's safety and efficacy in patients with symptomatic heart failure [4][5] Group 2: Market Context and Product Information - Finerenone is already marketed as Kerendia in over 90 countries for chronic kidney disease associated with type 2 diabetes [3] - A potential approval for the heart failure indication could expand Bayer's market reach, addressing a broader patient population with limited treatment options [8] Group 3: Clinical Study Insights - The FINEARTS-HF study demonstrated that Kerendia significantly improved cardiovascular outcomes in patients with heart failure and LVEF of ≥40% compared to placebo [5][6] - Finerenone is noted as the first drug targeting the mineralocorticoid receptor pathway to show cardiovascular benefits in a phase III study for this patient group [6]

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Has Bayer Aktiengesellschaft (BAYRY) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Bayer Aktiengesellschaft is one of 1012 individual stocks in the Medical sector. Collectively, these companies sit at #4 in the Zacks Sector Rank. The Zacks Sector ...

Core Viewpoint - Bayer AG reported a decline in core earnings and sales in the fourth quarter of 2024, primarily due to challenges in its Crop Science and Pharmaceuticals divisions, while the overall performance showed some resilience in the Pharmaceuticals segment [1][12][16]. Financial Performance - Core earnings for Q4 2024 were 28 cents per ADR, down from 50 cents per ADR in the same quarter last year, reflecting a 43.2% year-over-year decline [1]. - Total sales for the quarter were $12.5 billion (€11.7 billion), a decrease of 1.1% year-over-year, but exceeded the Zacks Consensus Estimate of $12.02 billion [2][12]. - For the full year 2024, revenues totaled $50.4 billion, surpassing the Zacks Consensus Estimate of $48.94 billion, with core earnings per ADR of $1.36 also beating expectations [12]. Segment Performance - Crop Science sales fell by 2.3% to €5.4 billion, impacted by lower prices in the crop protection business due to competitive pressures [4]. - Pharmaceuticals segment revenues increased by 2.4% to €4.6 billion, driven by strong sales of Nubeqa and Kerendia, which surged by 73.4% and 62% respectively [7][8]. - Consumer Health sales decreased by 0.9% to €1.6 billion, with declines in Nutritionals and Allergy & Cold categories, although Dermatology and Pain & Cardio categories showed growth [11]. Future Guidance - Bayer expects 2025 sales to range between €45-€47 billion, with Crop Science projected to have a currency and portfolio-adjusted sales growth of -2% to +2%, and Pharmaceuticals expected to decline by -4% to -1% [13]. - Core EPS for 2025 is projected to be between €4.50 and €5 [13]. Pipeline Developments - Bayer announced positive results from its phase III OASIS 4 study for elinzanetant, which is under review in the U.S. and EU [14]. - The company has submitted regulatory applications for finerenone for heart failure treatment in the U.S. and China [15]. Market Context - Bayer's stock has underperformed, losing 14.3% over the past year compared to the industry growth of 2.4% [2]. - The company faces ongoing challenges, including litigation related to Roundup, which has impacted its financials and dividend policies [16][17].

Jost Reinhard Good afternoon and good morning, everybody, and welcome to our conference call to discuss the fourth quarter and full year results for 2024. To begin, we will share his perspective on our business development, the progress we've made in our transformation and the path ahead of us. Wolfgang will then provide an overview of our financial performance in 2024 along with the outlook for 2025. We will then hear from our divisional heads, who will delve into last year's performance of their businesse ...

Core Insights - The article discusses the investment potential of Bayer AG, highlighting its long-term growth prospects and recent financial performance [1]. Financial Performance - Bayer AG reported a revenue of €44.1 billion in the last fiscal year, showing a year-over-year increase of 5% [1]. - The company's net income rose to €4.2 billion, reflecting a significant improvement compared to the previous year [1]. Market Position - Bayer holds a strong position in the pharmaceutical and agricultural sectors, with a diverse product portfolio that supports its competitive advantage [1]. - The company is focusing on innovation and research, which is expected to drive future growth and market share expansion [1]. Strategic Initiatives - Bayer is investing heavily in R&D, with an allocation of approximately €5 billion annually to enhance its product offerings and technological capabilities [1]. - The company is also pursuing strategic partnerships and acquisitions to bolster its market presence and operational efficiency [1].

Group 1 - Bayer AG's stock price has fallen below €20 for the first time in over 20 years, indicating a significant decline [1] - The analysis emphasizes the importance of high-quality companies that can outperform the market due to competitive advantages and defensibility [1] Group 2 - The focus of the analysis is on companies in Europe and North America, without restrictions on market capitalization [1]

Core Viewpoint - Bayer has received FDA acceptance for its supplemental new drug application (sNDA) for Nubeqa, aiming to expand its label for treating metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy [1][3]. Bayer's Drug Development Efforts - Nubeqa is an androgen receptor inhibitor that has shown positive results in the late-stage ARANOTE study, significantly reducing the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer compared to placebo plus ADT [3][4]. - The current indication for Nubeqa includes treatment for adult patients with metastatic hormone-sensitive prostate cancer in combination with docetaxel and for non-metastatic castration-resistant prostate cancer [4]. - Bayer is conducting a broad development program for darolutamide, which includes the phase III ARASTEP trial and the collaborative phase III DASL-HiCaP trial for various stages of prostate cancer [5][6]. Financial Performance and Strategic Moves - Bayer's pharmaceutical portfolio is under pressure due to generic competition for Xarelto, prompting efforts to strengthen its offerings, with Nubeqa being a key drug that generated over €1 billion in sales in the first nine months of 2024 [7]. - Bayer has entered a collaboration with Cytokinetics for the development of aficamten in Japan and acquired marketing rights for acoramidis in Europe, with an NDA filed with the FDA and a target action date set for November 29, 2024 [8][9]. Regulatory Developments - Bayer has submitted a Marketing Authorization Application (MAA) to the EMA for elinzanetant, which seeks approval for treating moderate to severe vasomotor symptoms associated with menopause [10].

Core Insights - Bayer AG reported third-quarter 2024 core earnings of 7 cents per ADR, missing the Zacks Consensus Estimate of 17 cents, and down from 10 cents per ADR in the same quarter last year [1] - Core earnings of €0.24 per share decreased by 36.8% year over year due to impairment losses in the Crop Science division [1] - Total sales for the quarter were $10.9 billion (€9.9 billion), reflecting a 3.6% decline on a reported basis, although sales increased by 0.6% year over year on a currency and portfolio-adjusted basis [1][2] Segment Performance - Crop Science sales fell by 3.6% to €4 billion, with herbicides down 11.5% due to volume declines in glyphosate-based products, primarily due to normalized purchasing patterns in Latin and North America [3] - Fungicides sales increased by 13.1%, while Corn Seed & Traits sales decreased by 19.3% due to acreage declines in Latin America [4] - Pharmaceuticals segment revenues rose by 2.3% to €4.5 billion, with Nubeqa sales surging 83.2% to €417 million and Kerendia sales increasing by 96.4% [5] - Sales of Xarelto decreased by 23% to €802 million due to competitive pressure from generics [6] - Eylea sales increased by 8.6% to €848 million, driven by higher volumes in Europe and Japan [7] - Consumer Health sales rose by 5.7% to €1.4 billion, supported by strong demand in Dermatology and Pain & Cardio categories [8] Guidance and Forecast - Bayer reiterated its 2024 sales guidance, expecting total sales between €47 billion and €49 billion [9] - The company revised its forecast for divisional sales, expecting Crop Science sales growth to decline by 1% to 3%, while Pharmaceuticals is expected to grow flat to 3% [10][11] Pipeline Updates - Bayer received regulatory approval for the Eylea 8 mg pre-filled syringe in the EU and filed a new drug application for Nubeqa for a new cancer indication [12] - The FDA accepted the NDA for elinzanetant, an investigational compound for treating menopause-related symptoms [13] Overall Performance Assessment - Bayer's third-quarter performance showed a decline in earnings due to impairment losses in the Crop Science division, but the Pharmaceuticals division exhibited encouraging sales growth [14] - New products like Nubeqa and Kerendia are expected to drive future growth, despite challenges in the Crop Science segment [15]

Bayer AG (OTCPK:BAYZF) Q3 2024 Earnings Conference Call November 12, 2024 8:00 AM ET Company Participants Bill Anderson - Chairman & CEO Wolfgang Nickl - CFO Julio Triana - President, Consumer Health Division Stefan Oelrich - President, Pharmaceuticals Division Rodrigo Santos - President, Crop Science Division Jost Reinhard - IR Conference Call Participants Vincent Andrews - Morgan Stanley Sachin Jain - Bank of America Joel Jackson - BMO James Quigley - Goldman Sachs Christian Faitz - Kepler Cheuvreux Richa ...

///////////// Health for all, Hunger for none Q3 2024 Investor Call N o v e m b e r 1 2 , 2 0 2 4 Cautionary Statements Regarding Forward-Looking Information This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. ...