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Bayer Jaardraadje 2024

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  1. forum rang 7 LL 2 september 2024 09:06
    September 01, 2024
    Not intended for U.S. and UK - Media Late-Breaking data from pivotal Phase III FINEARTS-HF study presented at ESC Congress 2024
    Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure with high unmet medical need

    Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of =40%, i.e. mildly reduced or preserved LVEF / Finerenone showed a 16% relative risk reduction of the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure events compared to placebo / The primary endpoint results were consistent across all prespecified subgroups including those based on comorbidities, hospitalization status, ejection fraction or baseline use of SGLT2-inhibitors / Results from FINEARTS-HF were simultaneously published in the New England Journal of Medicine / Unmet medical need is high for patients with heart failure (HF) and a LVEF of =40%: Hospitalization and mortality rates are comparable to those in patients with HF with reduced ejection fraction (LVEF=40%), however, only limited approved and guideline-directed treatment options are currently available

    Berlin, September 1, 2024 – Detailed results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone (Kerendia™/ Firialta™) showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%. Finerenone significantly reduced the risk of the composite primary endpoint of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits, by 16 % (relative risk reduction, rate ratio (RR) 0.84 [95% CI, 0.74-0.95; p=0,0072]) over a median duration of 32 months. Based on the results of FINEARTS-HF, finerenone is the first MR antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with this common form of heart failure. The FINEARTS-HF findings were presented today during a Hot Line session at ESC Congress 2024 and simultaneously published in the New England Journal of Medicine.

    “Treating heart failure patients with LVEF = 40% has provided a significant challenge for many physicians, and there is a high unmet medical need as these patients have a substantial risk for serious cardiovascular events. Unlike heart failure with reduced ejection fraction, where many treatments are now available, for heart failure with LVEF = 40%, we currently have limited treatment options with proven efficacy,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Senior Physician at Brigham and Women’s Hospital and Chair of the study’s Executive Committee. “With FINEARTS-HF as the first large-scale study of a non-steroidal, selective mineralocorticoid receptor antagonist in these underserved heart failure patients, finerenone, if approved, has the potential to help these vulnerable patients.”

    The benefits shown in the primary endpoint were consistent across all prespecified subgroups, regardless of background therapy, comorbidities, or hospitalization status, including those based on disease state (ejection fraction) or baseline use of SGLT2-inhibitors. Finerenone also significantly reduced the secondary endpoints of total HF events (RR 0.82 [95% CI, 0.71-0.94; p=0.0062]) and improved patient-reported health status as measured by the change from baseline in Total Symptom Score of Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS), (between-group difference 1.6 points [95% CI, 0.8-2.3; p<0.0001]).

    Heart failure (HF) affects over 60 million people worldwide; approximately half of these patients suffer from HF with a LVEF of =40%. HF with a LVEF =40% is associated with multimorbidity, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF. Patients with HF LVEF =40% have similar hospitalization and mortality rates as those with HF LVEF =40% (HF with reduced ejection fraction, HFrEF). More than half of patients with HF LVEF =40% will die within 5 years. The high residual risk of CV events and mortality remains high despite available treatments in patients with HF LVEF =40%.

    “Bayer has a strong heritage in cardiology, and heart failure is a key focus area for us, with these promising results underpinning our ongoing commitment to patients with this devastating condition. In FINEARTS-HF, finerenone reduced cardiovascular outcomes in a complex to treat patient population. This confirms the potential of finerenone, if approved, as a valuable treatment option in heart failure with mildly reduced or preserved ejection fraction irrespective of background therapy and disease state,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division. “FINEARTS-HF included a high percentage of hospitalized or recently hospitalized patients, which means the results are highly relevant for improving cardiovascular outcomes for patients who do not have enough options.”

    Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist. By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses hallmarks of HF with a LVEF =40%, such as fibrotic drivers.

    Finerenone was well-tolerated in the FINEARTS-HF study, which is consistent with the well-established safety profile of finerenone. The overall incidence of treatment-emergent serious adverse events was comparable between finerenone and placebo groups. Hyperkalemia-related adverse events occurred more frequently with finerenone than placebo (9.7 % and 4.2%, respectively). There were no fatal adverse events of hyperkalemia in either treatment group, and hospitalization or discontinuation due to hyperkalemia was rare. The occurrence of increased potassium and creatinine levels was also more frequent in the finerenone group, but the incidence of potassium above 6.0 mmol/L was generally low.

    Bayer plans to submit applications for marketing authorization for finerenone for an indication in heart failure with a LVEF of =40% to health authorities in due course.

    bron:
    www.bayer.com/media/en-us/finerenone-...
  2. forum rang 7 LL 9 september 2024 06:26
    BofA upgrades Bayer on favorable litigation outlook
    Investing.com
    Fri, Sep 6, 2024, 12:16 PM GMT+23 min read

    Investing.com -- BofA Securities in a note dated Friday upgraded Bayer's (ETR:BAYGN) rating to 'neutral' from 'underperform' reflecting a more favorable outlook on the company’s litigation challenges and overall business prospects.

    This upgrade is accompanied by an increase in the price objective to EUR 31 per share (ADR $8.55), up from EUR 21 (ADR $7.60). This is driven by a reassessment of Bayer's litigation provisions and an optimistic outlook for the resolution of key legal battles concerning glyphosate and PCB.

    “The recent favourable ruling in Schaffner v. Monsanto (NYSE:MON) creates a circuit split on the issue of federal pre-emption (essentially Bayer can’t be at fault in state litigation for failure to warn on glyphosate cancer risk when no federal agency had issued a cancer warning),” the analysts said.

    BofA Securities estimates that there is a 40-50% chance that the Supreme Court of the United States (SCOTUS) will take up the case, with a likelihood exceeding 50% of a favorable outcome for Bayer if the case is accepted.

    A positive SCOTUS decision would resolve the glyphosate litigation and potentially remove the EUR 6 billion provision currently associated with it, which represents approximately 25% of Bayer's valuation.

    Additionally, the company has received a favorable appeal ruling in the Sky Valley Education Center (SVEC) cases. The next step is the Washington State Supreme Court's decision on whether to review the Erickson case, expected by October 8, 2024.

    Should the court choose not to review, it would represent a significant win for Bayer, potentially concluding the SVEC litigation. Although personal injury lawsuits related to PCB persist in other states, the overall litigation environment is becoming less challenging for Bayer.

    Reflecting these developments, BofA Securities has adjusted its valuation model for Bayer. The previously considered additional litigation provision of EUR 10 billion has been reduced to EUR 5 billion, influencing the increase in the price objective.

    The revised price objective now incorporates a 6x multiple on FY25 estimated earnings per share (PE), up from 5.5x previously.

    BofA Securities characterizes Bayer as a well-diversified life sciences company with significant operations in Pharma and Crop Sciences, alongside a smaller Consumer division.

    Although the company faces a challenging business environment, particularly with projected declines in Pharma performance and a stable overall outlook, the recent favorable developments in litigation are expected to positively influence Bayer’s share price in the upcoming year.

    The analysts emphasize two critical components affecting Bayer’s valuation. First, the reduction in litigation provisions offers a potential EUR 10 per share net present value (NPV) upside, which represents around 40% of the valuation.

    Second, the sum-of-the-parts (SOTP) valuation supports the EUR 31 price objective. This valuation includes a 5x EV/EBITDA multiple for Pharma, reflecting cautious expectations for its pipeline, a 12x EV/EBITDA multiple for Consumer Health, and a 9.5x EV/EBITDA multiple for Crop Sciences, with a 20% conglomerate discount applied.

    Each additional multiple on EV/EBITDA could contribute approximately EUR 3 per share to the NPV.
  3. forum rang 6 4finance 9 september 2024 10:11
    quote:

    LL schreef op 9 september 2024 06:26:

    BofA upgrades Bayer on favorable litigation outlook
    Investing.com
    Fri, Sep 6, 2024, 12:16 PM GMT+23 min read

    Investing.com -- BofA Securities in a note dated Friday upgraded Bayer's (ETR:BAYGN) rating to 'neutral' from 'underperform' reflecting a more favorable outlook on the company’s litigation challenges and overall business prospects.

    This upgrade is accompanied by an increase in the price objective to EUR 31 per share (ADR $8.55), up from EUR 21 (ADR $7.60). This is driven by a reassessment of Bayer's litigation provisions and an optimistic outlook for the resolution of key legal battles concerning glyphosate and PCB.

    “The recent favourable ruling in Schaffner v. Monsanto (NYSE:MON) creates a circuit split on the issue of federal pre-emption (essentially Bayer can’t be at fault in state litigation for failure to warn on glyphosate cancer risk when no federal agency had issued a cancer warning),” the analysts said.

    BofA Securities estimates that there is a 40-50% chance that the Supreme Court of the United States (SCOTUS) will take up the case, with a likelihood exceeding 50% of a favorable outcome for Bayer if the case is accepted.

    A positive SCOTUS decision would resolve the glyphosate litigation and potentially remove the EUR 6 billion provision currently associated with it, which represents approximately 25% of Bayer's valuation.

    Additionally, the company has received a favorable appeal ruling in the Sky Valley Education Center (SVEC) cases. The next step is the Washington State Supreme Court's decision on whether to review the Erickson case, expected by October 8, 2024.

    Should the court choose not to review, it would represent a significant win for Bayer, potentially concluding the SVEC litigation. Although personal injury lawsuits related to PCB persist in other states, the overall litigation environment is becoming less challenging for Bayer.

    Reflecting these developments, BofA Securities has adjusted its valuation model for Bayer. The previously considered additional litigation provision of EUR 10 billion has been reduced to EUR 5 billion, influencing the increase in the price objective.

    The revised price objective now incorporates a 6x multiple on FY25 estimated earnings per share (PE), up from 5.5x previously.

    BofA Securities characterizes Bayer as a well-diversified life sciences company with significant operations in Pharma and Crop Sciences, alongside a smaller Consumer division.

    Although the company faces a challenging business environment, particularly with projected declines in Pharma performance and a stable overall outlook, the recent favorable developments in litigation are expected to positively influence Bayer’s share price in the upcoming year.

    The analysts emphasize two critical components affecting Bayer’s valuation. First, the reduction in litigation provisions offers a potential EUR 10 per share net present value (NPV) upside, which represents around 40% of the valuation.

    Second, the sum-of-the-parts (SOTP) valuation supports the EUR 31 price objective. This valuation includes a 5x EV/EBITDA multiple for Pharma, reflecting cautious expectations for its pipeline, a 12x EV/EBITDA multiple for Consumer Health, and a 9.5x EV/EBITDA multiple for Crop Sciences, with a 20% conglomerate discount applied.

    Each additional multiple on EV/EBITDA could contribute approximately EUR 3 per share to the NPV.
    Bij BAYER koop ik nog steeds niets bij. Het risico is hoog hier. Te veel claims en rechtszaken met mogelijke forse gevolgen voor de aandelenkoers. Mogelijk heb ik over 1 jaar spijt ;-)
  4. forum rang 5 Altijd prijs 14 september 2024 22:47
    quote:

    N audio schreef op 13 september 2024 12:56:

    Short is de afgelopen 3 dagen druk geweest met het lenen van de stukken.
    Nou, dan weet je het wel weer.

    Nieuws is er ook:

    www.finanzen.net/nachricht/aktien/erf...
    Ik zie bij Bayer geen grote aantallen short uitstaan. Welke site gebruik jij daarvoor N audio?

    Overigens is het wel merkwaardig dat het aandeel zo laag blijft hangen onder de 27 euro. Na alle positieve berichten (en dat zijn er echt veel) zou je een betere performance mogen verwachten, ook al zou het maar omhoog kruipen. Wonderlijk dat we de 30 nog niet gepasseerd zijn.
  5. forum rang 5 Altijd prijs 16 september 2024 16:39
    En vanmorgen weer een positief bericht over een onderzoeksresultaat en dus? levert het aandeel weer een procent in. Je hebt wel verbeeldingskracht nodig bij het aandeel.

    BAYER AG SAYS DAROLUTAMIDE PLUS ADT SIGNIFICANTLY REDUCED RISK OF RADIOLOGICAL PROGRESSION OR DEATH COMPARED TO PLACEBO PLUS ADT IN PATIENTS WITH MHSPC
    Source text for Eikon: [ID:] Further company coverage: [BAYGn.DE]

    BRIEF-Bayer AG Says Darolutamide Plus Adt Significantly Reduced Risk Of Radiological Progression Or Death Compared To Placebo Plus Adt In Patients With Mhspc
    10:32 16/09/2024
  6. forum rang 6 N audio 18 september 2024 12:51
    Ik gebruik Fintel.
    Dat is uiteraard maar één bron.
    Maar ik ga gemakshalve uit van grote eendracht onder het gilde vwb hun strategie.
    Uiteraard zie je nauwelijks short uitstaan. Wanneer een lener zijn stukjes keurig einde handelsdag weer teruggeeft, verandert er niets in de zichtbare lijstjes.
    Aan shortvolumeratios kan je wat meer zien hoe men bezig is.

    Ik kijk er waarschijnlijk nogal Jip en Janneke naar, echter druk op de koers gaat te vaak hand in hand met meer uitgeleende stukken. En in een rustige markt is het makkelijk sturen, of enkel aan de korte lijn leggen zodat de koers nauwelijks iets doet op goed nieuws.
    Koers loopt inmiddels aardig achter bij de goede niewsbericht(jes) van de afgelopen tijd. Geen enorm nieuws an sich wellicht, maar 30+ zou toch inmiddels gerechtvaardigd zijn.
    Dat is mijn subjectieve mening. Waren diezelfde berichten niet goed geweest, hadden we vermoedelijk akelig dicht bij de 20 gestaan.
518 Posts
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