Latest news with #Polynovo
News.com.au
2 days ago
- Business
- News.com.au
Health Check: Opthea investors have $80m less to fight for after cash-burning quarter
Eye drug developer Opthea's cash balance has more than halved as the company wraps up its failed trials Poynovo shares gain 10% after a cracker full-year result Microx leads today's sector gains after a US deal with a mystery party The financial fallout from Opthea's (ASX:OPT) two failed eye disease trials has become starkly apparent. Despite ceasing its two pivotal phase III trials, Opthea recorded US$53.5 million ($82 million) of outflows in the June quarter. This takes residual cash to US$48.4 million, from US$101.4 million as at the end of March. The costs mainly related to the winding down of the Coast and Shore trials, for wet age-related macular degeneration. Each of them enrolled close to 1000 patients, so they were meaty studies. Following the March 24 trial bombshell, in April the company shed its workforce by 65%. In June four directors – half the board – departed. Future uncertain Under the terms of a development funding agreement (DFA), Opthea could owe investors somewhere between nothing and US$680 million. Given Opthea has US$170 million of debt, any bumper return would be hypothetical. Opthea 'remains in active negotiations with its DFA investors to deliver an outcome that is in the best interests of the company and its shareholders'. Opthea shares have not traded since the March disaster, so any passer-by from Mars would think they are still valued at 60 cents for a $738 million market cap. The only bright note is the company earned US$700,000 of interest. Microx shares surge on US deal Microx shares this morning went on a 33% share romp after the device maker announced a US customer for its Rover mobile X-ray units. The customer has requested anonymity, but it's a "top tier US healthcare group" that runs 700 hospitals. The company says the three year deal is subject to normal commercial conditions, but it does not quantify the expected revenue. Given the share surge, investors presume it's kinda, like, material. Polynovo shakes off The Troubles Wound repair house PolyNovo (ASX:PNV) has shrugged off corporate governance issues by reporting a strong recovery in revenue and profits. At its full-year results later next month, Polynovo should report sales of $118.6 million for the year to June 2025, up 30% year on year. Second (June) half cash flow swung to a positive $15.7 million, compared with a $12.5 million deficit in the first half. Management expects full-year earnings before interest tax depreciation and amortisation of $11.2-12.4 million. This compares with the previous year's $3.6 million. Of the revenue, $88.4 million derived from the US, up 29%. The company gleaned most of its sales from its flagship product, Novosorb BTM. 'I like to review the year and the go-forward from a high level and all I see is growth and opportunity,' chairman David Williams chirps. In mid-March the company said CEO Swami Raote would depart, amid claims of bullying and inappropriate behaviour against Williams. The board engaged independent lawyers to probe the claims. It also bought in former Westpac chairman Lindsay Maxsted to advise the board on governance matters. The unashamedly outspoken Williams denies any wrongdoing and like the Irish, The Troubles seem to be forgotten. Macquarie Equities similarly is enthused, ascribing a $2.45 per share valuation relative to yesterday's closing value of $1.22. 'We see several near-term positive catalysts for Polynovo, with a significant longer-term opportunity in additional indications.' Yesterday, peer Kiwi wound repair house Aroa Biosurgery (ASX:ARX) also found investor favour after reporting its third successive quarter of positive cash flow, of NZ$1.7 million. Aroa has guided to revenue of NZ$92-100 million for the year to March 2026, with normalised underlying earnings of NZ$5-8 million. Emvision's Emu trial is in full stride… Portable brain (stroke) detection device maker EMvision Medical Devices (ASX:EMV) says its pivotal trial to support FDA approval is 'progressing well'. Pertaining to the company's lightweight bedside unit Emu, the trial is recruiting up to 300 stroke patients across four US and two Australian high-volume stroke centres. A variant for road and air ambulances, First Responder has been trialled by the Royal Flying Doctor Service. A Melbourne stroke ambulance has also had a look-see. Emvision recorded June quarter outflows of $2 million, taking cash to $10.5 million. But the company will benefit from a non-dilutive $5 million grant from the Industry Growth Program, to develop First Responder. The aforementioned Microx is also developing a portable head CT scanner to diagnose strokes. … while Actinogen's trial recruitment passes halfway mark Actinogen Medical (ASX:ACW) reports that its keenly anticipated phase 2b/3 Alzheimer's disease study has enrolled 123 of the targeted 220 patients. Dubbed Xanamia, the trial has recruited across 20 US and 15 Australian sites, targeting patients with mild to moderate progressive Alzheimer's. Actinogen's compound Xanamem targets elevated levels of a protein called pTau181. The novel mechanism of action inhibits production of cortisol, which is toxic to the brain in excessive amounts. Having recruited its 100 th patient, Xanamia is subject to an interim 'futility' review next January. This will determine whether the trial is worth continuing. With Xanamia hotting up, Actinogen disclosed June quarter cash outflows of $5.1 million, leaving June-end cash of $16.5 million. The company also has access to a $3 million loan, the first component of a $13.8 million advance of expected research and development tax incentives. Often a supplement to equity raisings, R&D loans have become increasingly popular with biotechs seeking to bring forward cash flow. Ozempic maker's fat profits become thinner The fate of Europe's biggest drug maker shows that boom conditions in the drug-making game rarely last – even with miracle fat-busting drugs. The maker of the anti-obesity and diabetes drugs Ozempic and Wegovy, Denmark's Novo Nordisk overnight issued a profit warning that sent the shares tumbling up to 28% on the Nasdaq Copenhagen exchange. The company slashed its outlook for 2025 sales growth to between 8-14%, from between 13-21% previously. According to Reuters, sales have been affected by custom-made compounded drugs that emulate the branded versions. The US bars pharmacies from replicating approved drugs, but allows 'compounding' for patients needing custom doses or formulations. Dial 'L' for loophole. The company also faces turmoil from the abrupt removal in May of CEO Lars Fruergaard Jorgensen. The board replaced him with veteran insider Maziar Mike Doustdar. Slowing fat drug sales aside, Doustdar also faces the prospect of a 15% tariff on goods imported into the US. 'We need to increase the sense of urgency and execute differently,' Doustdar told investors. Sounds about right.
Business Insider
07-07-2025
- Business
- Business Insider
Polynovo (CALZF) Receives a Buy from Morgans
In a report released today, Scott Power from Morgans maintained a Buy rating on Polynovo , with a price target of A$1.69. The company's shares closed last Wednesday at $0.74. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Power covers the Healthcare sector, focusing on stocks such as Polynovo , Imricor Medical Systems, Inc. Shs Chess Depository Interests Repr 1 Sh, and EBOS Group Limited. According to TipRanks, Power has an average return of -4.6% and a 35.66% success rate on recommended stocks. The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Polynovo with a $1.16 average price target. Based on Polynovo 's latest earnings release for the quarter ending December 31, the company reported a quarterly revenue of $59.54 million and a net profit of $3.34 million. In comparison, last year the company earned a revenue of $47.15 million and had a net profit of $2.69 million
News.com.au
13-05-2025
- Business
- News.com.au
Health Check: Polynovo naysayers face the (short) squeeze ahead of ‘significant' news
Investors with a short position in wound care house Polynovo face a nervous wait Oz drug stocks partly recover after swooning yesterday on Trump drug-pricing edict Wellnex Life rediscovers its sales mojo, while Elinixol Wellness goes to the well Spare a thought for the short sellers of PolyNovo (ASX:PNV) – the bourse's eighth most 'shorted' stock – ahead of a potentially groundbreaking announcement tomorrow. Until then Polynovo shares are in trading halt, pending the results of a 'significant collaboration' between the company and the private Adelaide-based entity Beta-Cell Technologies. For some years, Polynovo and Beta-Cell have worked on a novel intracutaneous ectopic pancreas, which would stimulate insulin production for type 1 diabetes sufferers. Polynovo's foam-like material Novosorb BTM (biodegradable temporising matrix) would create a skin-based implant to house donor islet cells. The parties had promised human trial results by late 2024, but none have been announced yet. We can't be sure the announcement pertains to this, but the declaration of a trading halt implies something substantive. Any diabetes treatment advancement would pique the excitement of investors and clincians alike. Beta-Cell Technologies was co-founded by Professor John Greenwood, Polynovo's former medical director and Novosorb developer. In the meantime, Polynovo has been recovering from its corporate governance woes that resulted in the March departure of CEO Swami Raote. This followed claims of bullying and inappropriate levelled against chairman David Williams, which became subject to a third-party board review. Polynovo this month reported record March sales of $11.9 million, up 71%, taking year to date turnover to $84.4 million, up 31%. But back to those short sellers, who account for 10% of Polynovo's register compared with 1.5% at the start of 2025. Shorters are trapped in the stock until tomorrow, when we can expect a short-squeeze stampede as they cover their positions by buying. Polynovo shares have lost 34% of their value over the last year, but they have also gained 31% in the last month. Local biotechs shrug off Trump's war on drugs (pricing) After being hammered yesterday, ASX drug developers potentially exposed to Donald Trump's proclaimed 'most favoured nation' (MFN) policy on drug pricing staged tentative recoveries today. These included Neuren Pharmaceuticals (ASX:NEU), Mesoblast (ASX:MSB), Clinuvel Pharmaceuticals (ASX:CUV) and Botanix Pharmaceuticals (ASX:BOT). Radioimaging plays Telix Pharmaceuticals (ASX:TLX) and Clarity Pharmaceuticals (ASX:CU6) were also under the pump yesterday and duly saluted. In an executive order, the Prez said drug pricing would be referenced to the cost in the lowest-priced countries, with vaunted costs savings of 30% to 80%. We should add that the benchmarks are OECD (developed) countries, not Belize or Botswana (no offence). The only ASX exponent to comment explicitly on the measures so far, Botanix asks a salient question: what if a drug company does not sell outside of the US? In the US Botanix has started marketing its drug Sofdra, for excess underarm sweating (primary axillary hyperhidrosis). The company says it's not privy to the details of the Trump Decree, but notes that Sofdra is only approved in the US – or so far at least. A variant is sold in Japan by Botanix's partner Kaken Pharmaceutical, but it's a different concentration and formulation. 'Based on the limited information currently available … Botanix does not consider that it is likely that it will be subject to price reductions based on sales of Sofdra outside the US, as there are none." In the case of CSL (ASX:CSL), Morgan Stanley notes that plasma products were excluded from MFN last time around. The firm opines that 25% of CSL's revenue may be exposed to MFN pricing. This is because CSL derives half of its revenue from the US, half of that from public payors such as Medicare and Medicaid. While our heavy hitters swooned yesterday, the New York Stock Exchange Arca biotechnology and pharmaceuticals indices soared 3% and 1.5% respectively overnight. Commentary from over the waters suggests this is because past efforts to rein in drug imports have failed, while the measure is open to negotiation. Sound familiar? Wellnex Life shrugs off sales slump House of pharma brands Wellnex Life (ASX:WNX) has shrugged off a slow start to the financial year with a perkier performance for the January to April period. Over this timeline, revenue rose 46% to $8 million, year on year. The gross margin improved 55% to $2.99 million. In the month of April, revenue gained 75% to $2.57 million, with the margin improving 75% to $1.13 million. Wellnex's 'hero' own brands include Nighty Night, an ashwagandha (herb) based sleep aid and the caffeine and guarana-based antidote, Wakey Wakey. Last year the company acquired the 25-year-old Pain Away range of topical pain relief for around $22 million. Management says the problems of stock outages and delays in new products have abated. On March 21 the company listed on London's AIM exchange, after raising $16.5 million. These funds have been used mainly for a $13 million debt demolition. Wellnex shares popped around 15% this morning. Meanwhile, shares in Elixinol Global (ASX:EXL) today entered trading halt, pending a 'potential financing/capital raising arrangement' to be announced on or before May 15. Elixinol runs a suite of cannabis focused human and pet brands, including Healthy Chef, Mt Elephant and Hemp Foods Australia (Byron Bay based, of course). The company had $600,000 of cash at the end of March, so it's time it went to the well.
Business Insider
12-05-2025
- Business
- Business Insider
Polynovo (CALZF) Gets a Buy from Morgans
Morgans analyst Scott Power maintained a Buy rating on Polynovo (CALZF – Research Report) today and set a price target of A$1.69. The company's shares closed last Thursday at $0.94. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. According to TipRanks, Power is ranked #8478 out of 9472 analysts. Polynovo has an analyst consensus of Moderate Buy, with a price target consensus of $1.47. Based on Polynovo 's latest earnings release for the quarter ending December 31, the company reported a quarterly revenue of $59.54 million and a net profit of $3.34 million. In comparison, last year the company earned a revenue of $47.15 million and had a net profit of $2.69 million
