Category: 3. Business

  • Industry claims about Queensland coal mine royalty rates don’t add up

    Industry claims about Queensland coal mine royalty rates don’t add up

    Contrary to claims made by several mining companies and industry groups, Queensland’s coal royalty rate is not 40%. The average rate based on average Queensland coal prices in 2024 was actually much lower, at 20%. 

    Queensland’s coal royalty regime is a tiered system that applies a different royalty rate depending on the price of coal. Since 2024, coal prices have continued to fall further through 2025, meaning so too have the amount of royalties owed. Based on Australian average coal prices from January to September 2025 the average royalty rate in Queensland would be 10%. Based on the old royalty regime prior to July 2022, this would have been 9%, a difference of only one percentage point.

    The change to the Queensland royalty rate implemented in July 2022 addressed the decoupling of royalties paid from coal prices, which began during the coal price spikes in 2021 and 2022. Prior to July 2022, the highest Queensland royalty rate applied was 15% for coal sold above AU$150 per tonne. This meant that the average royalties paid generally corelated closely with prices, particularly when coal sold for AU$200 or less. As coal prices spiked during 2021 and 2022 in response to global commodity supply shocks and geopolitical events, the amount of royalties paid did not increase at the same rate as prices.

    Average Queensland coal prices increased AU$302 or 246% per tonne between 2020 and 2022. Based on the old royalty rate, the amount owed per tonne would have increased AU$45 or 60% during the same period. Applying the new rates would mean royalties owed in 2022 compared to 2020 increased 236%, which is more closely in line with the 246% increase in prices during the same period.

    Therefore, the change in 2022 can be understood as bringing the royalty rate back in line with coal prices. As coal prices have fallen, so too have the royalties owed ( as shown in Figure 1).

    Figure 1: Queensland average annual coal prices and royalty rates, 2010 to 2024, AU$

    Source: IEEFA; Queensland government.

    Figure 2: Australian monthly average coal prices, Jan 2019 to Sep 2025

    Australian monthly average coal prices, Jan 2019 to Sep 2025

    Source: IEEFA; World Bank.
    Note: Nominal prices. Prices converted to AU$ from US$ using Reserve Bank of Australia historical F1 exchange rates monthly average.

    Under Queensland’s tiered system, the 40% royalty rate referenced frequently in the media is not applied to the entire value. The 40% royalty rate is only applied when coal is sold above AU$300 per tonne, and only the balance above AU$300 is taxed at this rate. 

    For instance, if a miner in Queensland sells its coal at AU$350 per tonne, the total royalty rate applied would be 24%, not 40%. The 40% rate would only apply to AU$50 per tonne in this instance, with a lower rate applied overall. 

    This is similar to our income tax system. The first AU$18,200 for most Australian workers is tax-free, meaning a 0% tax rate is applied to this amount. The remaining income is then taxed based on the tax bracket it falls within. For coal miners operating in Queensland, the first AU$100 is only taxed at 7% and then a higher rate is applied for each price bracket depending on the overall coal price. 

    Additionally, the changes to Queensland’s coal mine royalties implemented in July 2022 only increased the royalty rate for coal sold at more than AU$150 per tonne. Any coal sold for less than AU$150 per tonne still has the same royalty rate applied. The difference between the old and new royalty rates are shown below, along with an example of the royalty rate for coal sold at the highest monthly average Australian coal price observed in 2022 of AU$663.

    Table 1: Queensland royalty rates, prior to July 2022

    Queensland royalty rates, prior to July 2022

    Source: IEEFA; Queensland Mineral Resources (Royalty) Regulation.

    Table 2: Queensland royalty rates, July 2022 onwards

    Queensland royalty rates, July 2022 onwards

    Source: IEEFA; Queensland Mineral Resources (Royalty) Regulation.

    Multiple companies in Australia have criticised Queensland’s 2022 royalty rate change as the reason behind their decision to lay off workers and as a risk to investment in the industry. However, IEEFA recently discussed how sustained, high operating costs and labour shortages are putting pressure on margins for coalminers across both NSW and Queensland, more so than government royalty rate increases. In addition to rising labour costs, coal miners face a range of other rising cost factors. These include higher financing and borrowing costs, partly caused by increased barriers to accessing traditional finance options; increasing environmental and emissions reduction obligations; increasing frequency and severity of extreme weather; and the subsequent damages and production disruption costs.

    Given that the change to royalty rates in 2022 only affects coal sold for over AU$150 per tonne, if companies are claiming this is the primary cause of their worker layoffs and financial difficulties, this calls into question why coal miners’ business models aren’t viable when coal prices are below this level. It also highlights the impact other rising cost factors are having on the sector.

    Despite these rising pressures, overall Australian coal mining industry income remained higher in 2024 than in 2021 and 2022, prior to the change in Queensland royalty rates (Figure 4). Additionally, the level of foreign direct investment in Australian mining has continued to rise since 2020, with AU$44 billion received between 2020 and 2024 (Figure 5). 

    Figure 3: Coal mining industry income FY2012-24

    Coal mining industry income FY2012-24

    Source: IEEFA; Australian Bureau of Statistics (ABS).

    Figure 4: Level of foreign direct investment in Australian mining industry

    Level of foreign direct investment in Australian mining industry

    Sources: IEEFA; ABS.
    Note. Mining sector categorised as Australian and New Zealand Standard Industrial Classification (ANZSIC) classification “Mining”. 

    Overall, there is not sufficient data or evidence to support the claim that Queensland royalty rates are causing a decrease in income and investment across the industry. However, there are indicators showing the rise of other risk factors for the industry, that far outweigh royalty costs.

     

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  • Assessing Valuation After Recent Share Price Volatility

    Assessing Valuation After Recent Share Price Volatility

    Brown & Brown (BRO) continues to attract attention from investors interested in the insurance sector’s performance and resilience. Recent price movement shows some volatility, which prompts questions around valuation and the company’s recent growth numbers.

    See our latest analysis for Brown & Brown.

    Brown & Brown’s share price has taken a hit recently, dropping over 18% in the last month after some volatility in the broader insurance sector. While the 1-year total shareholder return sits at -29.7%, the bigger picture shows a strong recovery streak with gains of 41% and 72% over the past three and five years respectively. This reflects momentum that has cooled off lately but has not erased the longer-term growth story.

    Curious where the next opportunity might come from? Now could be the perfect time to broaden your scope and discover fast growing stocks with high insider ownership

    With shares trading below analyst targets after recent declines, the key question remains: is Brown & Brown now undervalued, or has the market already accounted for future growth in the current price?

    The fair value calculated in the most closely followed market narrative comes in at $97.08, which is significantly above Brown & Brown’s last close at $78.54. This valuation sets an optimistic tone that contrasts with recent price pressure, hinting at substantial upside potential if assumptions hold true.

    Brown & Brown’s strategic focus on acquisitions, having completed 13 acquisitions with projected annual revenues of $36 million, could significantly enhance future revenue streams and market presence. This aligns with their goal of sustained revenue growth through expansion.

    Read the complete narrative.

    Curious about the foundation of this punchy price target? There is a bold set of financial predictions guiding this view, including various growth projections and a premium valuation multiple. This narrative relies on more than just headline numbers. Uncover the blueprint now that drives this aggressive estimate.

    Result: Fair Value of $97.08 (UNDERVALUED)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, persistent inflation and potential declines in key market segments could challenge Brown & Brown’s growth expectations and dampen the current bullish valuation narrative.

    Find out about the key risks to this Brown & Brown narrative.

    While the latest fair value estimate paints Brown & Brown as undervalued, looking at price ratios tells a more cautious story. Its price-to-earnings ratio stands at 27.1x, which is quite a bit higher than both the US insurance industry average of 13.2x and its fair ratio of 17.8x. Compared to peers, Brown & Brown looks cheaper than the group average of 47.1x, but against broader market and fair value benchmarks, the stock is on the expensive side. This gap raises questions about what could happen if market sentiment shifts. Will the price come into line, or is there more risk than meets the eye?

    See what the numbers say about this price — find out in our valuation breakdown.

    NYSE:BRO PE Ratio as at Nov 2025

    If you think there’s more to the story, or want to dig into the details yourself, you can easily build your own view from the ground up in just a few minutes, and Do it your way

    A great starting point for your Brown & Brown research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision.

    Don’t let great opportunities slip by. The smartest investors always keep an eye out for new trends and sectors that are about to surge.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include BRO.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • Evaluating Whether Shares Still Trade Below Fair Value After Strong Multi-Year Gains

    Evaluating Whether Shares Still Trade Below Fair Value After Strong Multi-Year Gains

    Griffon (GFF) shares are drawing attention as investors weigh recent movements in the capital goods sector. The company has shown a mix of gains and dips in the past month. The stock’s longer-term performance has caught some eyes as well.

    See our latest analysis for Griffon.

    After a solid run over the past few years, Griffon’s 1-year total shareholder return of 4.9% might look modest. However, it follows a dramatic 3-year total return of over 130%. This signals that momentum may be pausing while investors reassess recent gains and future growth. The latest share price at $72.15 keeps Griffon in the spotlight for those tracking shifts in the capital goods space.

    If you’re curious where other growth stories might emerge, why not broaden your search and discover fast growing stocks with high insider ownership

    With the share price cooling off after years of outperformance and analysts still seeing upside, is Griffon currently trading at a discount, or is the market correctly factoring in its next growth phase?

    Griffon’s widely followed narrative points to a sizeable gap between its current share price and fair value, setting up a compelling debate over its long-term potential. The calculation relies on assumptions about robust future earnings and improved profitability in the coming years.

    “Ongoing investments in automation and modernization projects, particularly in HBP, are expected to further improve operating efficiencies and gross margins over the next several years, bolstering future earnings and cash generation.”

    Read the complete narrative.

    Think the price target is too optimistic? The math behind this bullish call is built on impressive profit expansion and substantial margin improvement. Want to see which key variables drive this premium valuation and why? The answer lies in bold assumptions the market has not fully priced in yet.

    Result: Fair Value of $100.29 (UNDERVALUED)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, persistent weak consumer demand or heightened tariff pressures could challenge Griffon’s outlook. These factors may limit upside potential as assumptions are put to the test.

    Find out about the key risks to this Griffon narrative.

    If you see the story differently or want to put your own analysis to the test, you can dive in and shape your own insights in just minutes with Do it your way

    A great starting point for your Griffon research is our analysis highlighting 3 key rewards and 3 important warning signs that could impact your investment decision.

    Smart investors know opportunity moves fast. Make sure you’re not left behind by expanding your watchlist with inspired picks tailored to your goals and interests.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include GFF.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Adults with Heterozygous Familial Hypercholesterolemia (HeFH) in Phase 3 CORALreef HeFH Trial

    Enlicitide has the potential to be the first approved oral PCSK9 inhibitor designed to deliver antibody-like efficacy and help address critical unmet needs for patients with HeFH to help combat the ongoing CV epidemic

    Results were presented today at AHA Scientific Sessions 2025 and simultaneously published in the Journal of the American Medical Association


    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the pivotal Phase 3 CORALreef HeFH trial demonstrating that treatment with enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, resulted in a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) of 59.4% compared to placebo at week 24 (95% CI: -65.6, -53.2; p<0.001) in adults with heterozygous familial hypercholesterolemia (HeFH). The effect size and safety profile was comparable to that observed in the pivotal Phase 3 CORALreef Lipids study. These late-breaking data will be presented for the first time today at the American Heart Association (AHA) Scientific Sessions 2025 (Abstract #4391641) and published simultaneously in the Journal of the American Medical Association.

    In CORALreef HeFH, enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C at week 24 (primary endpoint) and statistically significant reductions in secondary endpoints including LDL-C at one year (week 52), and non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) (Lp(a)) at week 24, in adults with HeFH receiving stable background lipid-lowering therapy including at least moderate or high intensity statin therapy. The overall safety profile was comparable to placebo. High adherence with study intervention (97%) and dosing instructions (96%) were observed across treatment groups.

    “Data from CORALreef HeFH demonstrate the potential for enlicitide to help address critical unmet needs for adults with heterozygous familial hypercholesterolemia are at risk for premature atherosclerotic cardiovascular events yet a significant portion of patients do not achieve guideline-recommended LDL-C level despite available lipid-lowering therapies,” said Dr. Christie M. Ballantyne, a lead author of the CORALreef HeFH study and Professor of Medicine at Baylor College of Medicine. “As the potentially first approved oral PCSK9 inhibitor, enlicitide was designed to provide efficacy similar to anti-PCSK9 monoclonal antibodies and may be an important new treatment option to help adults with heterozygous familial hypercholesterolemia reach their guideline-recommended LDL-C goal. Lowering elevated LDL-C levels helps reduce the risk of atherosclerotic cardiovascular disease.”

    “Results from the CORALreef HeFH study demonstrated statistically significant and sustained reductions in LDL-C, ApoB, non-HDL-C, and Lp(a) over one year in a diverse population of adults with heterozygous familial hypercholesterolemia receiving stable background lipid-lowering therapies,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We look forward to sharing the totality of the results from the CORALreef program presented at AHA with regulatory authorities and progressing enlicitide’s ongoing clinical development program to bring forward the potential first approved oral PCSK9 inhibitor to help address the growing CV epidemic.”

    In CORALreef HeFH, LDL-C reductions were observed as early as week 4 and maintained through one year. Treatment with enlicitide resulted in a sustained statistically significant reduction in LDL-C of 61.5% compared to placebo (95% CI: -69.4, -53.7, p<0.001) at one year. At week 24, enlicitide demonstrated statistically significant reductions in non-HDL-C of 53.0% (95% CI: -58.5, -47.4, p<0.001), ApoB of 49.1% (95% CI: -54.0, -44.3, p<0.001) and Lp(a) of 27.5% (-95% CI: -34.3, -20.6, p<0.001) compared to placebo. The study also showed that 67.3% of patients treated with enlicitide achieved at least a 50% reduction in LDL-C along with an LDL-C <55 mg/dL (1.42 mmol/L) compared to 1.0% in the placebo arm at week 24.

    Enlicitide had a safety profile similar to placebo. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs were similar between groups. Discontinuations due to AEs were low and similar between enlicitide (2.0%) and placebo (3.0%).

    Merck plans to share data from this trial, along with data from CORALreef Lipids and CORALreef AddOn with regulatory authorities worldwide.

    About CORALreef HeFH

    CORALreef HeFH (NCT05952869) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of enlicitide compared to placebo in adults with HeFH who had a history of or were at risk for a major ASCVD event and received stable background lipid-lowering therapy including at least moderate or high intensity statins. The study enrolled 303 participants who were randomized 2:1 to receive either 20 mg of enlicitide orally once daily or placebo. The primary endpoints were mean percent change in LDL-C from baseline at week 24 versus placebo, number of participants with one or more AEs, and number of participants who discontinued study drug due to an AE. Key secondary multiplicity-controlled efficacy endpoints included change in LDL-C at one year (week 52) and changes in non-HDL-C, ApoB and Lp(a) at week 24. Non-multiplicity-controlled secondary endpoints included LDL-C goal attainment of at least a 50% reduction in LDL-C and an LDL-C <70 mg/dL (1.81 mmol/L) and at least 50% reduction in LDL-C and an LDL-C <55 mg/dL (1.42 mmol/L).

    About enlicitide and PCSK9

    Enlicitide has the potential to be the first FDA approved oral PCSK9 inhibitor. It is designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody, injectable PCSK9 inhibitors but in a daily pill form. Enlicitide is a novel small molecule macrocyclic peptide candidate that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.

    PCSK9 plays a key role in cholesterol homeostasis by regulating levels of the LDL receptor, which is responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 is designed to prevent the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood.

    About CORALreef Clinical Trial Program

    The efficacy and safety profile of enlicitide is being evaluated through the comprehensive CORALreef Clinical Trial program evaluating over 19,000 participants who have hypercholesterolemia. As previously announced, enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in three pivotal Phase 3 studies: CORALreef Lipids (NCT05952856), CORALreef HeFH (NCT05952869) and CORALreef AddOn (NCT06450366). Enlicitide is continuing to be evaluated in the large cardiovascular outcomes trial, CORALreef Outcomes (NCT06008756), which has completed enrollment with over 14,500 participants. Additional CORALreef clinical trials include CORALreef Extension (NCT06492291), CORALreef Pediatric (NCT07058077) and CORALreef Combination (NCT07216482).

    About heterozygous familial hypercholesterolemia (HeFH)

    Heterozygous familial hypercholesterolemia (HeFH) is a common genetic disorder that affects approximately 1 in 250 individuals and is characterized by elevated levels of LDL-C. Patients with HeFH typically present with substantially elevated LDL-C levels and face an increased risk of premature atherosclerotic cardiovascular disease (ASCVD) due to cumulative lifetime exposure to LDL-C. HeFH cannot be managed through lifestyle and diet changes alone, and cholesterol-lowering medication is typically needed for patients to manage this condition. A large proportion of patients with HeFH fail to achieve guideline-recommended LDL-C goals despite available therapies and have a 13-fold higher risk for coronary artery disease compared with the general population.

    About the CV epidemic and atherosclerotic cardiovascular disease

    The silent CV epidemic is the leading cause of deaths globally, contributing to the majority of heart attacks and strokes, and deaths related to CV continue to rise. ASCVD accounts for 85% of CV deaths. It is caused by the buildup of plaque within the arteries, leading to narrowed or blocked blood vessels that can result in serious CV events such as heart attacks and strokes as well as coronary artery disease, peripheral artery disease and cerebrovascular disease.

    Merck’s focus on cardiovascular disease

    Merck has a long history of developing treatments for cardiovascular disease. Nearly 70 years ago, we introduced our first cardiovascular therapy—and our scientific efforts to understand and treat cardiovascular-related disorders have continued. Cardiovascular disease continues to be one of the most serious health challenges of the 21st century and is the leading cause of death worldwide. Approximately 18 million people across the globe die from cardiovascular disease every year; in the United States, one person dies every 36 seconds from cardiovascular disease.

    At Merck, we strive for scientific excellence and innovation in all stages of research, from discovery through approval and life cycle management. We work with experts throughout the cardiovascular and pulmonary community to advance research that can help improve the lives of patients globally.

    Information for other currently enrolling cardiovascular studies can be found by visiting: https://www.merckclinicaltrials.com/cardiovascular.

    About Merck

    At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

    This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).


    Source: Merck & Co., Inc., Rahway, NJ, USA


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  • Egypt’s foreign reserves hit record high of 50.07 bln USD by Oct.-Xinhua

    CAIRO, Nov. 9 (Xinhua) — The Central Bank of Egypt (CBE) announced on Sunday that the country’s net international reserves (NIRs) reached a record high of 50.07 billion U.S. dollars by the end of October, up from 49.53 billion dollars recorded at the end of September.

    The figure represents the highest level of foreign reserves in the country’s history, underscoring the success of recent financial reforms and significant inflows of foreign investment, analysts say.

    “The milestone is particularly notable as it comes after a period of intense economic strain and a critical shortage of foreign currency,” said Abu Bakr al-Deeb, an economic researcher and advisor to the Cairo-based Arab Center for Research and Studies.

    He viewed the increase as a powerful indicator of renewed investor confidence in the Egyptian economy and a critical buffer against global market volatility.

    He noted that the sharp rise reflects several factors, including proceeds from recent large-scale investment deals, efforts to boost non-petroleum exports, and a sustained increase in remittances from Egyptian expatriates.

    NIRs are the foreign assets held by a central bank, including currencies, gold, and International Monetary Fund special drawing rights, excluding any liabilities. They are used to service external debt, pay for imports, and help stabilize the national currency.

    Rising reserves are generally seen as a sign of stronger financial stability and an increased ability to withstand potential external shocks.

    Egypt’s foreign exchange reserves are built up through various sources, including gold reserves, revenues from the Suez Canal and tourism, remittances from Egyptians abroad, export proceeds, and foreign investments.

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  • Australia’s ANZ Bank Posts 10% Drop in Annual Profit — Update

    Australia’s ANZ Bank Posts 10% Drop in Annual Profit — Update

    By Stuart Condie

    SYDNEY--ANZ Group held its final dividend despite a 10% drop in the Australian bank's annual profit driven by impairments, redundancy costs and other one-off expenses.

    Australia's fourth-largest bank by market capitalization on Monday reported a net profit for the 12 months through September of 5.89 billion Australian dollars, equivalent to US$3.82 billion.

    Revenue rose 8% to A$22.19 billion but the bottom line was weighed by A$1.11 billion of impairments and other previously declared one-off items.

    The average analyst forecast had been for a net profit of A$6.18 billion from revenue of A$22.18 billion, according to data compiled by Visible Alpha.

    Analysts had cautioned ahead of the result that consensus forecasts might not fully reflect the significant items reported by ANZ on Oct. 31.

    ANZ reported cash profit, which is closely watched by analysts, of A$5.79 billion, down 14% on a year earlier and well short of consensus for A$6.17 billion. Stripping out one-off items, cash profit was flat at A$6.90 billion.

    Net interest margin--a key measure of lending profitability--fell two basis points to 1.55%, in line with analysts' expectations for a 1.55% margin.

    ANZ held its dividend at A$0.83.

    The largest component of the one-off items was a A$585 million pretax charge for 3,500 redundancies announced in September by Chief Executive Nuno Matos, who took charge in May.

    The cost of trimming about 8% of ANZ's workforce exceeded the bank's initial A$560 million estimate.

    "We are going to create a very lean and a very agile company. At the same time, we are going to invest for growth that will come later," Matos said.

    Other one-off expenses included a A$285 million impairment of ANZ's stake in PT Bank Pan Indonesia and A$271 million in penalties and costs related to regulatory issues.

    Write to Stuart Condie at stuart.condie@wsj.com

    (END) Dow Jones Newswires

    November 09, 2025 16:36 ET (21:36 GMT)

    Copyright (c) 2025 Dow Jones & Company, Inc.

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  • Baxdrostat demonstrated a statistically significant and highly clinically meaningful placebo-adjusted reduction of 14.0 mmHg in 24-hour ambulatory systolic blood pressure in patients with resistant hypertension in the Bax24 Phase III trial

    *The main analyses of ambulatory BP endpoints include patients with valid ambulatory blood pressure monitoring at both baseline and Week 12, without imputation of missing data.

    LS, least squares; n Number of subjects in analysis; N Number of subjects per treatment group

    Notes

    Hard-to-control hypertension
    Hypertension is a medical condition characterized by consistently high blood pressure levels, affecting an estimated 1.4 billion people worldwide.6,21,22 Over time, this can damage blood vessels and vital organs, increasing the risk of serious health problems such as heart attack, stroke, heart failure and kidney disease.20,21 An observational study of nearly 60,000 patients studied over a median of 9.7 years showed that a 9.5 mmHg increase in 24-hour ambulatory SBP was associated with a 30% increase in risk of all-cause mortality and 41% increase in risk of cardiovascular death.4 Studies have shown that increased night-time blood pressure is associated with higher cardiovascular risk,8,11 and patients with hypertension have a higher risk of cardiovascular events like heart attack, stroke and death around the time of their morning blood pressure surge.2,3

    Hard-to-control (uncontrolled and resistant) hypertension remains a major public health challenge.23 Despite lifestyle changes and the use of multiple medications, approximately 50% of patients in the US who are being treated for hypertension still do not have their blood pressure under control.7 Uncontrolled hypertension refers to persistently elevated blood pressure despite the use of two or more medications, while resistant hypertension, a more severe form, remains elevated despite treatment with three or more medications.7,21 Guidelines currently recommend that in patients with hypertension, treated BP values should be targeted to 130/80 mmHg or lower in most patients.21,22

    A key contributor to hard-to-control hypertension is aldosterone, a hormone that raises blood pressure by promoting sodium and water retention.24,25 Elevated aldosterone levels, along with factors such as obesity, high salt intake, and various genetic or secondary conditions,26 are strongly associated with poor blood pressure control. When left untreated, hypertension significantly increases the risk of cardiovascular and kidney-related complications.21,22

    Bax24 trial
    The Phase III Bax24 trial16 is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of 2mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP, as well as safety and tolerability in participants with resistant hypertension. A total of 218 patients were randomized in a 1:1 ratio to receive baxdrostat 2mg or placebo once daily during a 12-week double blind period. The primary efficacy endpoint was the change from baseline in ambulatory 24-hour average SBP at Week 12.

    Additional secondary endpoints include the effect of baxdrostat versus placebo on change from baseline in ambulatory night-time average SBP, change from baseline in ambulatory daytime average SBP, change from baseline in seated SBP, the number of participants achieving ambulatory 24-hour average SBP of less than 130 mmHg , change from baseline in ambulatory 24-hour average diastolic blood pressure (DBP), change from baseline in ambulatory night-time average DBP, change from baseline in the average ambulatory daytime average DBP, change from baseline on seated DBP and the number of participants achieving a nocturnal SBP dipping of greater than or equal to 10%, all measured at Week 12. Occurrence of adverse events was evaluated during the 12-week treatment period as well as during a 2-week safety follow-up period.

    Baxdrostat
    Baxdrostat is a potential first-in-class, highly selective and potent, oral, small molecule that inhibits aldosterone synthase,12 an enzyme encoded by the CYP11B2 gene, which is responsible for the synthesis of aldosterone in the adrenal gland.24 In clinical trials, baxdrostat was observed to significantly lower aldosterone levels without affecting cortisol levels across a wide range of doses.13,27 Baxdrostat is currently being investigated in clinical trials as a monotherapy for hypertension13-16 and primary aldosteronism,17 and in combination with dapagliflozin for chronic kidney disease and hypertension,18,19 and the prevention of heart failure in high-risk patients.20

    AstraZeneca acquired baxdrostat through its purchase of CinCor Pharma, Inc. in February 2023.28

    AstraZeneca in CVRM
    Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys, liver and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way towards regenerative therapies. The Company’s ambition is to improve and save the lives of millions of people, by better understanding the interconnections between CVRM diseases and targeting the mechanisms that drive them, so we can detect, diagnose and treat people earlier and more effectively.

    AstraZeneca
    AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca.

    Media Inquiries

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    References

    1. Williams B, et al. Effect of baxdrostat on 24-hour ambulatory blood pressure in patients with resistant hypertension: the Bax24 trial. Presented at: American Heart Association Scientific Sessions 2025; November 7–10, 2025; New Orleans, LA.

    2. Renna NF, et al. Morning blood pressure surge as a predictor of cardiovascular events in patients with hypertension. Blood Press Monit. 2023;28(3):149-157 

    3. Kario K et al. Morning hypertension: the strongest independent risk factor for stroke in elderly hypertensive patients. Hypertens Res. 2006;29(8):581-7. 

    4. Staplin N, et al. Relationship between clinic and ambulatory blood pressure and mortality: an observational cohort study in 59 124 patients. Lancet. 2023;401(10393):2041-2050.  

    5. Flack JM, et al. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. N Engl J Med. 2025. Aug 30:10.1056/NEJMoa2507109. doi: 10.1056/NEJMoa2507109. 

    6. World Health Organization. Global report on hypertension 2025: high stakes: turning evidence into action. 2025.  https://iris.who.int/handle/10665/382841. Accessed September 2025. 

    7. Carey RM, et al. Prevalence of Apparent Treatment-Resistant Hypertension in the United States. Hypertension. 2019;73(2):424-431.

    8. Narita K, et al. Nighttime Home Blood Pressure Is Associated With the Cardiovascular Disease Events Risk in Treatment-Resistant Hypertension. Hypertension. 2022;79(2):e18-e20 

    9. Kario K, et al. Nighttime Blood Pressure Phenotype and Cardiovascular Prognosis. Circulation. 2020;142(19):1810-1820 

    10. Williams B, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). European Heart Journal. 2018;39(33):3021-3104. 

    11. Niiranen TJ, Mäki J, Puukka P, Karanko H, Jula AM. Office, home, and ambulatory blood pressures as predictors of cardiovascular risk. Hypertension. 2014 Aug;64(2):281-6. 

    12. Bogman K, et al. Preclinical and early clinical profile of a highly selective and potent oral inhibitor of aldosterone synthase (CYP11B2). Hypertension. 2017;69(1):189-196.

    13. Freeman MW, et al. Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. Hypertens Res. 2023;46(1):108-118.

    14. ClinicalTrials.gov.A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN). Available at: https://clinicaltrials.gov/study/NCT06034743. Accessed October 2025. 

    15. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxAsia). Available at: https://clinicaltrials.gov/study/NCT06344104. Accessed October 2025. 

    16. ClinicalTrials.gov. A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24). Available at:  https://clinicaltrials.gov/study/NCT06168409. Accessed October 2025. 

    17. ClinicalTrials.gov. A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism (BaxPA). Available at: https://clinicaltrials.gov/study/NCT07007793. Accessed October 2025. 

    18. ClinicalTrials.gov. A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. Available at: https://clinicaltrials.gov/study/NCT06268873. Accessed October 2025. 

    19. ClinicalTrials.gov. A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure (BaxDuo-Pacific). Available at: https://clinicaltrials.gov/study/NCT06742723. Accessed October 2025. 

    20. ClinicalTrials.gov. Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin (Prevent-HF). Available at:  https://clinicaltrials.gov/study/NCT06677060. Accessed October 2025. 

    21. McEvoy JW, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024;45(38):3912-4018.

    22. Jones DW, et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2025;152:e114–e218.

    23. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957-980.

    24. Cannavo A, et al. Aldosterone and mineralocorticoid receptor system in cardiovascular physiology and pathophysiology. Oxid Med Cell Longev. 2018;2018:1204598.

    25. Inoue K, et al. Serum aldosterone concentration, blood pressure, and coronary artery calcium: The multi-ethnic study of atherosclerosis. Hypertension. 2020;76(1):113-120.

    26. van Oort S, et al. Association of cardiovascular risk factors and lifestyle behaviors with hypertension: a mendelian randomization study. Hypertension. 2020;76(6):1971-1979. 

    27. Freeman MW, et al. Phase 2 trial of baxdrostat for treatment-resistant hypertension. N Engl J Med. 2023;388(5):395-405.

    28. AstraZeneca 2023. Acquisition of CinCor Pharma complete. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html. Accessed October 2025.  

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  • Week Ahead for FX, Bonds: Focus on U.S. Shutdown -2- – Morningstar

    Week Ahead for FX, Bonds: Focus on U.S. Shutdown -2- – Morningstar

    1. Week Ahead for FX, Bonds: Focus on U.S. Shutdown -2-  Morningstar
    2. Lenskart listing, Infosys buyback and FII trends among 7 factors to steer markets this week  The Economic Times
    3. ‘Mkts learning to live with Trump; sentiment split’  metroindia.net
    4. Week Ahead for FX, Bonds : Focus on U.S. Shutdown -2-  MarketScreener
    5. Stock market outlook for the week: Inflation, corporate earnings and more in focus; key factors to look o  The Times of India

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  • Elafibranor Benefits Fatigue-Related Pathways Linked to Mitochondrial Function in PBC

    Elafibranor Benefits Fatigue-Related Pathways Linked to Mitochondrial Function in PBC

    New research is shedding light on a significant association between changes in the expression of 10 proteins with a potential role in fatigue or mitochondrial function and the severity of fatigue in patients with primary biliary cholangitis (PBC) treated with elafibranor.1

    The data were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025 by Mark Swain, MD, a professor of medicine at Cumming School of Medicine and full member of The Calvin, Phoebe and Joan Snyder Institute for Chronic Diseases at the University of Calgary, and highlight expression changes of proteins linked to fatigue or mitochondrial function following treatment with elafibranor. Of note, these changes significantly correlated with each other and with fatigue improvement, suggesting that PPARα/δ agonism beneficially impacts fatigue-associated pathways linked to mitochondrial function.1

    “Fatigue, a common, debilitating symptom in patients with primary biliary cholangitis, has poorly understood pathophysiology,” Swain and colleagues wrote.1 “Elafibranor, a PPAR α/δ agonist approved for PBC second-line treatment, has shown clinically meaningful improvements in fatigue.”

    In a previous analysis presented at the European Association for the Study of the Liver (EASL) Congress 2025, expression levels of 10 proteins associated with a potential role in fatigue or mitochondrial function were found to be impacted in patients treated with elafibranor, including ATAD3B, BAX, CA14, CA5A, ECI1, GRPEL1, HPD, KYNU, MECR, and SOD2.2

    To build upon this research and examine the relationship between changes in expression of these proteins and fatigue severity with elafibranor, investigators assessed serum samples collected from patients in the phase 3 ELATIVE trial at baseline and week 52 and analyzed them using the Olink® Explore HT proteomic panel. Spearman correlations were evaluated between Patient-Reported Outcome (PRO) Measurement Information System (PROMIS) Fatigue Short Form 7a (PFSF 7a), PBC-40 Fatigue domain (PBC-40 F), and expression levels of the 10 proteins impacted by elafribanor treatment.1

    Analyses were conducted in the overall population and in patients with baseline moderate-to-severe fatigue, defined as PFSF 7a T-score ≥60 or PBC-40 F score ≥29.1

    Of 161 patients in ELATIVE, samples were included from 119. Of these patients, 46 and 63 had baseline moderate to severe fatigue according to PFSF 7a and PBC-40 F, respectively.1

    At baseline, in the overall population, significant moderate-to-strong correlations were observed between the expression of all proteins (r=0.29–0.89; P <.05). In patients with baseline moderate to severe fatigue according to both PROs, expression of CA5A, ECI1, GRPEL1, KYNU, MECR, and SOD2 were significantly correlated with fatigue at baseline (r=0.25–0.39; P <.05). Of these patients treated with elafribanor (baseline moderate to severe fatigue, PFSF 7a, n = 33; PBC-40 F, n = 41), moderate-to-strong correlations (r=0.27–0.88) were observed between expression changes from baseline to week 52 of all proteins, which were all significant (P <.05) except for CA5A and ATAD3B, and MECR and CA14.1

    In the 33 elafibranor-treated patients with baseline moderate to severe fatigue according to PFSF 7a, significant correlations between CfB to W52 in BAX, ECI1, GRPEL1, HPD, KYNU, MECR, and SOD2 expression and PFSF 7a were observed (r=0.35–0.54; P <.05). Changes from baseline to week 52 in SOD2 and PBC-40 F were significantly correlated in the 41 patients with baseline moderate to severe fatigue according to PBC-40 F (r=0.32; P <.05).1

    “Elafibranor treatment led to expression changes of proteins linked to fatigue or mitochondrial function, significantly correlated with each other and with fatigue improvement,” investigators concluded.1 “This suggests that PPARα/δ agonism beneficially impacts fatigue-associated pathways linked to mitochondrial function, providing a foundation for further research into the mechanistic contribution of PPARα/δ agonism to fatigue improvement in PBC.”

    References

    1. Swain M, del Pilar Schneider M, Plas P, et al. Elafibranor-associated changes in proteins linked to mitochondrial function correlate with fatigue improvement: Proteomic results from the ELATIVE® trial. Presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025. Washington, DC. November 7-11, 2025.
    2. Swain M, Plas P, del Pilar Schneider M, et al. LBP-025 Elafibranor impacts inflammatory, fibrotic and symptom-associated markers in patients with primary biliary cholangitis: Proteomic results from the ELATIVE® trial. Journal of Hepatology. doi:10.1016/S0168-8278(25)00444-1

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  • Pembrolizumab Regimen May Show Synergy in Melanoma Populations

    Pembrolizumab Regimen May Show Synergy in Melanoma Populations

    Promising progression-free survival (PFS) outcomes were observed among patients with HLA-A*02:01–negative and HLA-A*02:01–positive uveal melanoma who received pembrolizumab (Keytruda) plus lenvatinib (Lenvima), according to data from the phase 2 PLUME trial (NCT05282901) presented at the European Society for Medical Oncology (ESMO) Congress 2025.1

    The study met its primary end point in both patient cohorts, with an observed PFS rate of 31.8% at 27 weeks (95% CI, 13.9%-54.9%) in patients who were HLA-A*02:01–negative and naïve for treatment with tebentafusp (Kimtrak). In patients who were HLA-A*02:01–positive and were pretreated with tebentafusp, the PFS rate at 27 weeks was 60.7% (95% CI, 40.6%-78.5%).

    “It was observed in phase 3 studies of tebentafusp2 that treatments administered after tebentafusp might display improved activity compared [with] historical data,” said Manuel Rodrigues, MD, medical oncologist at Institut Curie and presenter of the PLUME data.1

    The combination of lenvatinib and pembrolizumab “showed encouraging activity, especially in patients previously treated with tebentafusp, suggesting potential synergy between these treatments,” Rodrigues added.

    Regarding safety, the overall profile was consistent with prior trials involving pembrolizumab and lenvatinib. There were no treatment-related deaths. With lenvatinib, 76% of patients held the dose, 26% had dose reductions, and 4% discontinued. With pembrolizumab, 22% of patients held the dose and 4% discontinued.

    The most common any-grade treatment-related adverse events were fatigue (81.8% in the tebentafusp-naive cohort vs 69% in the pretreated cohort), hypertension (77.3% vs 69%), diarrhea (45.5% vs 65.5%), hypothyroidism (45.5% vs 65.5%), arthralgia (40.9% vs 58.6%), cytolytic hepatitis (40.9% vs 58.6%), mucositis (45.5% vs 41.4%), dysphonia (31.8% vs 44.8%), and abdominal pain (27.3% vs 44.8%).

    While the findings were promising, Rodrigues urged caution when interpreting the results, due to the small sample size and single-arm design. Rodrigues noted that biomarker analyses and real-world comparisons were ongoing to further refine patient selection.

    What Was the Design of the PLUME Study?

    PLUME was an academic, monocentric, single-arm phase 2 trial conducted at the Institut Curie in Paris, France.A total of 51 patients who were naïve to immune checkpoint inhibitors were enrolled and split into 2 cohorts by HLA-A*02:01–negative (n = 22) and –positive/pretreated with tebentafusp (n = 29).

    Treatment consisted of pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles and lenvatinib 20 mg orally daily until progression. Chest, abdomen, and pelvic CT scans and liver MRIs were mandatory every 9 weeks. The primary end point was 27-week PFS (after 9 cycles).

    What Was the Rationale for the PLUME Study?

    As Rodrigues explained in his presentation, uveal melanoma has a unique biology to melanoma of the skin, with one-third of patients developing metastases and over 90% of those patients developing liver metastases. The current median overall survival (OS)is about 20 months.

    Tebentafusp, a bispecific TCR–anti-CD3 fusion protein targeting gp100, was the first therapy to improve OS in patients with metastatic uveal melanoma; however, the benefit is limited to patients who are HLA-A*02:01–positive, which is about 45% of patients. Further, checkpoint inhibitors like pembrolizumab have shown limited efficacy due to low mutational burden and an immunosuppressive microenvironment.

    The rationale of adding lenvatinib lies in its VEGFR/FGRF blockade that can normalize vasculature, reduce tumor-associated macrophages, and enhance T-cell infiltration. The combination of lenvatinib and pembrolizumab has shown promise in endometrial and renal cancers, where the combination has outperformed monotherapy.

    DISCLOSURES: Rodrigues declared personal financial interests with Immunocore, GSK, AstraZeneca, and Abbvie; institutional financial interests with Johnson & Johnson, Merck, and Daiichi-Sankyo; and nonfinancial interests with Merck, which provided product samples for the PLUME trial.

    References

    1. Rodrigues M. PLUME: A single-arm phase II trial of pembrolizumab plus lenvatinib in metastatic uveal melanoma (mUM). Presented at: 2025 ESMO Congress; October 17–20, 2025; Berlin, German. Abstract LBA58.
    2. Nathan P, Hassel JC, Rutkowski P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.

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