Latest news with #Cochlear

News.com.au
3 days ago
- Business
- News.com.au
Health Check: Medical device makers Trump drug developers in volatile US healthcare climate
Medical device makers – including ASX-listed heart plays – are the likely winners from the US healthcare chaos Painchek hopes for US device approval by September Mayne Pharma flags legal action over Cosette bid but also waves an olive branch Medical device makers are better placed than drug companies to withstand the volatile US healthcare climate, according to broker Canaccord. In a report, the firm notes that while the US biotech sector has fallen in value over the past 12 months, medtechs have gained ground. The overall measure, the Nasdaq Biotechnology Index, has lost 8% over the past year and 1.25% over the past month. But the benchmark Ishares US Medical Devices ETF (IHI) has gained 10% over the past year and 12% over the past month. The firm says the performance is supported by recent earnings announcements, with 15 of the top 16 stocks reporting higher than expected profits. The firm opines the device makers look a safer bet because they are not caught up in the debate about lower drug prices, following Donald Trump's 'Most Favoured Nation' (MFN) decree (see below). 'Medical device/tech companies also appear to have more clarity regarding how/if tariffs may or may not impact their businesses.' ASX device makers active in the US include the ginormous ResMed (ASX:RMD) and Cochlear (ASX:COH), as well as Telix Pharmaceuticals (ASX:TLX). In April EBR Systems (ASX:EBR) won US approval for its Wise pacemaker, the world's first ventricular assist device. Also in the heart space, the agency approved Echo IQ (ASX:EIQ) aortic stenosis tool, Echo AS. In April 2023 Cardiex (ASX:CDX) won FDA assent for Conneqt Pulse, its vascular biometric heart monitor. This week, the local Therapeutic Goods Administration followed suit. Drug makers 'in the dark' on pricing MFN means US drug prices would be benchmarked against the lowest prevailing price across developed countries. The drug debate originated in the Biden era, with the Inflation Reduction Act (IRA) requiring the Medicare system to negotiate prices for certain high-cost drugs. 'Pharma/biotech companies seem somewhat in the dark regarding proposed MFN policies, but recent discussions have suggested decisions may be set to come through in the next 30 to 60 days,' Canaccord says. 'The push to lower drug prices could be a long-drawn-out legal battle, which may ultimately fail to move beyond the IRA, or contain a number of exemptions and loopholes.' The firm says ASX healthcare stocks 'have not been immune to the chaos' engulfing the US. But US biotech earnings momentum has turned positive. This likely will result in improved share valuations 'which the ASX is likely to follow.' Painchek has nice chat with FDA Still on Trumpian shores, PainChek (ASX:PCK) said it has a 'successful' follow-up meeting with the FDA that sought feedback ahead of its intended US marketing application. Painchek is the world's first mobile-based pain assessment and monitoring device for patients unable to enunciate their discomfort (such as dementia patients). Held on June 3, the second meeting focused on Painchek addressing the FDA's final questions about the company's recent US trial results. 'The meeting was a positive two-way conversation providing feedback and clarity for both parties.' The company hopes to lodge its submission this month, under the new device pathway. Under the FDA's timelines, the company should have an answer by late September. FDA consent would be a company maker for Painchek, which already has a foothold in the local and UK aged-care sectors. Share fever as Clarity trial proves a DISCO hit Shares in radiotherapy play Clarity Pharmaceuticals (ASX:CU6) today bounded up to 11% after the company reported top-line results from its groovily-monikered DISCO trial. The study blew the (strobe) lights out by showing its copper-isotope based candidate to be highly effective in detecting neuroendocrine tumours (NETs) NETs most commonly occur in the gastrointestinal tract, lung and pancreas, but may also originate in other areas including the breast, prostate and skin. The phase II study compared Clarity's 64Cu-Sartate against standard of care imaging. 64 Cu-Sartate 'substantially outperformed' the standard gallium isotope-based therapy, detecting 393 to 488 lesions among 45 participants. Of these lesions, 230-251 were deemed 'discordant', that is, identified on only one of the scans. And guess what? Clarity's method accounted for 93% of them. Clarity initially designed the trial to enrol up to 63 patients. But after early analysis the company was able to reduce the sample size to 45 and thus expedite the study. Clarity is now eyeing FDA assent for a phase III registrational trial. And if you really want to know, DISCO stands for 'Diagnostic Imaging Study of 64COpper-Sartate'. Who would have predicted a 'massive oversubscription'? Predictive diagnostics play Proteomics International Laboratories (ASX:PIQ) says its $7.5 million share purchase plan (SPP) was 'massively oversubscribed' – a rare event for such funding mechanisms. The SPP follows a $4.5 million into raising and a $500,000 board and management whip 'round. The funds were raised at 37 cents a share, a 17% discount, with an attached option on every second share subscribed for. The $12 million will support the company's commercialisation of its three tests. These are for diabetic kidney disease (PromarkerD), Promarker Eso (esophageal cancer) and endometriosis (Promarker Endo). Also today, the company pointed to a write up of its Promarker Eso study in the peer-reviewed tome Proteomes. For the few of us who don't subscribe, the assay detected esophageal carcinomas accurately across 259 serum samples. As we opined last week, its hard to know whether peer-reviewed pronouncements reiterate old announcements, or are 'new news'. In this case, the company says the published stuff 'builds upon and extends' earlier announced study results. Mayne, Mayne won't go away Mayne Pharma (ASX:MYX) is far from conceding that its $600 million takeover has been blown away, despite suitor Cosette terminating the deal on the grounds of 'material adverse events'. The company releasetoday noted the scheme meeting would go ahead on June 18, as scheduled. 'Mayne Pharma directors continue to unanimously recommend that vote in favour of the scheme resolution at the scheme meeting, in the absence of a superior proposal," intoned chairman Frank Condella. There's a big proviso, though: the company needs a court decision to affirm its view that the 'material adverse events' were not, in fact, material. While the company will go legal if needs be, it is open to 'seeking to find a path forward with the scheme that does not involve pursuing litigation'. Mayne shares today edged up around 3%, having plunged 14% yesterday after Cosette's withdrawal.
Yahoo
5 days ago
- Business
- Yahoo
Cochlear introduces the Baha® 7 Sound Processor and Baha SoundBand™
NEW Baha® 7 Sound Processor: First in bone conduction to enable Bluetooth® LE Audio* and Auracast™ broadcast audio streaming capabilities1,2. NEW Baha SoundBand™: Improved look and fitting options over current Baha Softband to help children with hearing loss thrive. NEW Bluetooth™ LE Audio Accessories: AutoStreaming, LE Audio functionality, and updated design. NEW Baha Fitting Software 7: Improved data logging and new features aimed to support pediatric fittings for clinicians and for patient self-care and improved Baha Smart App with intuitive design and Hearing Tracker. LONE TREE, Colo., June 2, 2025 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today the commercial release of the new Cochlear™ Baha® 7 Sound Processor and the new non-surgical Baha SoundBand™. Cochlear's bone conduction hearing solutions are designed to improve hearing outcomes for children and adults with conductive hearing loss, mixed hearing loss and single-sided deafness (SSD). The Baha 7 Sound Processor builds upon the same great hearing performance of its predecessor while advancing Cochlear's industry-leading connectivity.1 We've also added a bright new lavender color to our range of seven natural and bold sound processor color options. The Baha 7 Sound Processor boasts a 55 db HL fitting range in a small form factor, offering powerful hearing without compromising on discretion. With new Bluetooth LE Audio and Auracast broadcast audio compatibility2, the Baha 7 Sound Processor leads the hearing implant industry in streaming technology. As more venues adopt Auracast technology, Baha 7 Sound Processor recipients can access audio streams in places like theaters, concert halls, lecture halls and airports, through an LE Audio-enabled smartphone. "Auracast is set to become the next standard in audio streaming and accessibility," said Ryan Lopez, Head of Portfolio Strategy & Professional Marketing. "With LE Audio, Bluetooth is expanding the world's direct-to-device streaming capabilities, and over time we expect Auracast to be the new standard for public and group listening. We are excited to be able to offer this technology first to our Baha 7 Sound Processor recipients." The Baha 7 Sound Processor is also able to stream directly from any compatible** Apple® and Android™ device, as well as a range of wireless accessories. Our non-surgical Baha Start portfolio now includes the Baha 7 Sound Processor and the new Baha SoundBand. Baha Start is designed to help babies and young children experience the fullness of clear, rich and natural sound as early as possible. Early access to sound is critical to helping children learn and develop on par with their hearing peers.3,4 "The whole world is a classroom, and parents want to feel confident their child is always tuned in, ready to learn and grow," said Natasha McDougald, Director of Product Marketing. "Our aim is to give parents peace of mind as their children learn to thrive in a world of sound." The new SoundBand features a slimmer band with improved adjustability, a lower profile, moveable connector discs and more color options to help young children be as comfortable and confident as possible. The Baha Smart App*** and Baha Fitting Software 7 also have new features aimed to help parents and clinicians treat children for the best possible hearing outcomes. The Baha 7 Sound Processor and Baha SoundBand will be available in the United States in late summer 2025. For further information, please visit: About Cochlear Limited (ASX: COH) People have always been Cochlear's inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant after seeing his father struggle with hearing loss. Since 1981, Cochlear has provided more than 700,000 devices in more than 180 countries, helping people of all ages around the world to hear. As the global leader in implantable hearing solutions, Cochlear connects people with life's opportunities, and welcomes them to the world's largest hearing implant community. Cochlear has a global workforce of close to 5,000 people, with a passion for progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than AUD$3 billion to date in research and development to push the boundaries of technology and help more people hear. References: For information regarding the compatibility of Cochlear's sound processors with Apple or Android devices, visit Auracast™ broadcast audio capability is subject to third-party adoption of the Auracast protocol. Yoshinaga-Itano C. Early Intervention after universal neo-natal hearing screening: impact on outcomes. Dev Disabil Res Rev. 2003;9(4):252-66. Ching TY, Dillon H, Day J, Crowe K, Close L, Chilsholm K, Hopkins T. Early language outcomes of children with cochlear implants: interim findings of the NAL study on longitudinal outcomes of children with hearing impairment. Cochlear Implants International. 2019, 10 (S1): 28-32. *As Bluetooth LE Audio compatible devices become available, a sound processor firmware update will be required to use certain features.**For a full list of smartphone and app compatible devices, visit: Cochlear Baha® Smart App Smart App is available on App Store and Google Play. For compatibility information, visit The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear is under license. Apple, the Apple logo, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Android is a trademark of Google LLC. The Android robot is reproduced or modified from work created and shared by Google and used according to terms described in the Creative Commons 3.0 Attribution License. In the United States and Canada, the placement of a bone-anchored implant is contraindicated in children below the age of five. 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Yahoo
13-04-2025
- Business
- Yahoo
Institutional investors may adopt severe steps after Cochlear Limited's (ASX:COH) latest 4.0% drop adds to a year losses
Significantly high institutional ownership implies Cochlear's stock price is sensitive to their trading actions The top 25 shareholders own 46% of the company Recent purchases by insiders AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. A look at the shareholders of Cochlear Limited (ASX:COH) can tell us which group is most powerful. With 51% stake, institutions possess the maximum shares in the company. That is, the group stands to benefit the most if the stock rises (or lose the most if there is a downturn). And institutional investors endured the highest losses after the company's share price fell by 4.0% last week. This set of investors may especially be concerned about the current loss, which adds to a one-year loss of 21% for shareholders. Often called 'market movers", institutions wield significant power in influencing the price dynamics of any stock. Hence, if weakness in Cochlear's share price continues, institutional investors may feel compelled to sell the stock, which might not be ideal for individual investors. In the chart below, we zoom in on the different ownership groups of Cochlear. Check out our latest analysis for Cochlear Many institutions measure their performance against an index that approximates the local market. So they usually pay more attention to companies that are included in major indices. Cochlear already has institutions on the share registry. Indeed, they own a respectable stake in the company. This suggests some credibility amongst professional investors. But we can't rely on that fact alone since institutions make bad investments sometimes, just like everyone does. When multiple institutions own a stock, there's always a risk that they are in a 'crowded trade'. When such a trade goes wrong, multiple parties may compete to sell stock fast. This risk is higher in a company without a history of growth. You can see Cochlear's historic earnings and revenue below, but keep in mind there's always more to the story. Since institutional investors own more than half the issued stock, the board will likely have to pay attention to their preferences. We note that hedge funds don't have a meaningful investment in Cochlear. Our data shows that BlackRock, Inc. is the largest shareholder with 7.2% of shares outstanding. For context, the second largest shareholder holds about 7.2% of the shares outstanding, followed by an ownership of 5.7% by the third-largest shareholder. A deeper look at our ownership data shows that the top 25 shareholders collectively hold less than half of the register, suggesting a large group of small holders where no single shareholder has a majority. While it makes sense to study institutional ownership data for a company, it also makes sense to study analyst sentiments to know which way the wind is blowing. Quite a few analysts cover the stock, so you could look into forecast growth quite easily. The definition of company insiders can be subjective and does vary between jurisdictions. Our data reflects individual insiders, capturing board members at the very least. Company management run the business, but the CEO will answer to the board, even if he or she is a member of it. I generally consider insider ownership to be a good thing. However, on some occasions it makes it more difficult for other shareholders to hold the board accountable for decisions. Our information suggests that Cochlear Limited insiders own under 1% of the company. It is a very large company, so it would be surprising to see insiders own a large proportion of the company. Though their holding amounts to less than 1%, we can see that board members collectively own AU$65m worth of shares (at current prices). Arguably recent buying and selling is just as important to consider. You can click here to see if insiders have been buying or selling. The general public, who are usually individual investors, hold a 48% stake in Cochlear. This size of ownership, while considerable, may not be enough to change company policy if the decision is not in sync with other large shareholders. While it is well worth considering the different groups that own a company, there are other factors that are even more important. I like to dive deeper into how a company has performed in the past. You can access this interactive graph of past earnings, revenue and cash flow, for free . But ultimately it is the future, not the past, that will determine how well the owners of this business will do. Therefore we think it advisable to take a look at this free report showing whether analysts are predicting a brighter future . NB: Figures in this article are calculated using data from the last twelve months, which refer to the 12-month period ending on the last date of the month the financial statement is dated. This may not be consistent with full year annual report figures. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) 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. Sign in to access your portfolio
Yahoo
15-03-2025
- Business
- Yahoo
Cochlear's (ASX:COH) Dividend Will Be Increased To A$2.15
Cochlear Limited (ASX:COH) has announced that it will be increasing its dividend from last year's comparable payment on the 14th of April to A$2.15. This takes the annual payment to 1.6% of the current stock price, which is about average for the industry. View our latest analysis for Cochlear While it is always good to see a solid dividend yield, we should also consider whether the payment is feasible. Before making this announcement, Cochlear was paying out quite a large proportion of both earnings and cash flow, with the dividend being 112% of cash flows. Paying out such a high proportion of cash flows certainly exposes the company to cutting the dividend if cash flows were to reduce. Looking forward, earnings per share is forecast to rise by 50.3% over the next year. If the dividend continues along recent trends, we estimate the payout ratio will be 52%, which would make us comfortable with the sustainability of the dividend, despite the levels currently being quite high. The company has a long dividend track record, but it doesn't look great with cuts in the past. Since 2015, the annual payment back then was A$2.54, compared to the most recent full-year payment of A$4.30. This implies that the company grew its distributions at a yearly rate of about 5.4% over that duration. It's good to see the dividend growing at a decent rate, but the dividend has been cut at least once in the past. Cochlear might have put its house in order since then, but we remain cautious. Given that the dividend has been cut in the past, we need to check if earnings are growing and if that might lead to stronger dividends in the future. Unfortunately, Cochlear's earnings per share has been essentially flat over the past five years, which means the dividend may not be increased each year. Cochlear's earnings per share has barely grown, which is not ideal - perhaps this is why the company pays out the majority of its earnings to shareholders. When a company prefers to pay out cash to its shareholders instead of reinvesting it, this can often say a lot about that company's dividend prospects. Overall, we always like to see the dividend being raised, but we don't think Cochlear will make a great income stock. The payments are bit high to be considered sustainable, and the track record isn't the best. We would be a touch cautious of relying on this stock primarily for the dividend income. It's important to note that companies having a consistent dividend policy will generate greater investor confidence than those having an erratic one. Still, investors need to consider a host of other factors, apart from dividend payments, when analysing a company. Earnings growth generally bodes well for the future value of company dividend payments. See if the 15 Cochlear analysts we track are forecasting continued growth with our free report on analyst estimates for the company. If you are a dividend investor, you might also want to look at our curated list of high yield dividend stocks. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) 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. Sign in to access your portfolio
Yahoo
17-02-2025
- Business
- Yahoo
ASX climbs to new record high
The Australian sharemarket trimmed its early day gains, but still closed at a fresh record high on Friday, as markets traded on hope Australia could be spared from the worst of the Trump tariffs. The benchmark ASX 200 index gained 15.80 points or 0.19 per cent to finish the week at a fresh highest of 8555.80 points. The broader All Ordinaries also rose, up 20.90 points or 0.24 per cent to close at 8825.10 points. Australia's dollar firmed and was trading late on Friday around US63.17c. Eight of the 11 sectors finished in the green, led by strong gains out of consumer staples, utilities and technology stocks. Helping to drive the consumer staples section higher were the two major supermarkets, with Woolworths gaining 1.75 per cent to finish at $30.79 while Coles Group grew 1.28 per cent to $19.71. It was also a good day for Treasury Wine Estate, reversing Thursday's falls by gaining 3.04 per cent to finish at $10.83. Retail drinks network and pub owner Endeavour group rose 4 per cent to $4.42. Part of the narrative for Friday's market was Australia's response to the current steel and aluminium tariffs suggested by President Donald Trump's administration. While Mr Trump initially announced a blanket 25 per cent tariffs on all imports, the White House is reportedly conducting a review into trade imposed on the US and if it should be done on a country by country basis. Capital Economics senior ANZ economist Abhijit Surya said Australia imposes far lower tariffs and value-added taxes on American goods than other major economies, meaning we could be spared from the worst of a trade tariff. 'Australia could even end up being one of the 'winners' of the US's trade war if Mr Trump follows through on his pledge to institute reciprocal tariffs on all of the US's trading partners,' he said. 'US exports to Australia face a weighted average tariff rate of just 0.2 per cent, well below the average 6.7 per cent most-favoured nation tariff rate charged by America's top 15 trading partners. senior financial market analyst Kyle Rodda said the market was holding onto hope that a full-on trade war could be avoided. 'While clearly the risks remain elevated of a tit-for-tat dynamic, with tariffs and the uncertainty they evoke a drag on growth, the fact this is a slow burn approach from Trump with the chance many of the tariffs will be extinguished is supporting market sentiment,' he said. BlueScope Steel continues to march higher, as part of its operations are in the US, gaining another 1.64 per cent to $22.35 on Friday. Earnings results released by AMP and Cochlear saw shares in the two major companies tumble during Friday's trading. AMP dropped 14.83 per cent to $1.49 after reporting a 43 per cent reduction in statutory net profit after tax from $265m to $150m. Cochlear also fell to its lowest levels since December 2023, down 13.79 per cent to $262.73 after missing consensus on revenue, net profits and interim dividend. Clarity Pharmaceuticals was also heavily traded, sinking 9.01 per cent to $3.30. In positive news, Sigma Healthcare continued its surge higher after a reverse takeover by Chemist Warehouse, with shares rising 7.21 per cent to $3.12 to be the best performing share on the ASX. Sign in to access your portfolio