Mesoblast shares soar 35pc on strong cell therapy sales data
The US Food and Drug Administration approved the therapy to treat children for complications that can occur during bone marrow transplants last December, paving the way for the first commercial sales in March.
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News.com.au
29-07-2025
- News.com.au
ASX Health Quarterly Wrap: Dimerix inks fourth licensing deal, Audeara nails record revenue year
As the quarterly reporting season kicks into gear, investors are again tuning in to see how ASX-listed companies fared over the final stretch of FY25 and what clues they're offering for the financial year ahead. It's a key moment for investors to assess how businesses are tracking and what lies ahead, especially for the long-suffering healthcare sector, which has lagged in recent years despite strong fundamentals. After falling 4% over FY25 – while the broader market climbed 10% – there are signs the tide may finally be starting to turn. The S&P/ASX 200 Health Care index (ASX:XHJ) jumped 5.4% last week following a 5% gain the week before, sparking talk of a rotation back into the sector. Throughout FY25 and during the last quarter many ASX healthcare names have taken steps to improve efficiency, reduce costs, advance trials or establish key partnerships in a bid for long-term growth. Here's how a selection of ASX health stocks performed in the June quarter and what they're signalling for FY26. Dimerix (ASX:DXB) Late-stage clinical biotech Dimerix continued to progress its lead program ACTION3 phase III clinical trial of DMX-200 in focal segmental glomerulosclerosis (FSGS) during the quarter, including a positive Type C meeting with the US Food and Drug Administration (FDA). The meeting confirmed acceptability of proteinuria as an appropriate endpoint for full marketing approval in the US for DMX-200 in FSGS. During the quarter Dimerix announced a licensing agreement for DMX-200 with Amicus Therapeutics for DMX-200 in the US, its fourth for the drug across multiple territories. The company banked an upfront payment of US$30 million (~A$48m) in May. Collectively the licensing deals provide up to ~$1.4 billion in total upfront payments and potential milestone payments, plus royalties on net sales with more than $65m in total payments received to date. During the quarter Dimerix received its first development milestone payment of ¥400 million (~A$4.2m) from FUSO Pharmaceutical Industries Ltd, its exclusive licensee of DMX-200 for FSGS in Japan after the first trial site opened. Additionally, during the quarter, Dimerix received ~$6m from the exercise of listed options which expired on June 30. The sixth Independent Data Monitoring Committee (IDMC) review of ACTION3 has been completed, with 219 patients currently randomised/dosed in the trial. Dimerix ended the quarter with $68.3m. The company said it continued to focus on patient recruitment into ACTION3 trial, as well as licensing opportunities with potential partners in territories not already licensed. Audeara (ASX:AUA) Personalised audio technology provider Audeara achieved record full-year cash receipts of $4.9m, up 38.4% on FY24, driven by the expanding global sales profile for the AUA Technology division. Audeara achieved quarterly unaudited revenues of $722,000 with record-high unaudited annual revenues of ~$3.79m, up 21.9% on FY24. Cash receipts of $957,000 in Q4 FY25 were consistent with pcp of $982,000 and contributed to the record annual cash receipts. Quarterly group cash receipts were underpinned by accelerating momentum for Audeara's core domestic wholesale channel, which rose by 34.9% QoQ and 115% YoY. Net operating cash outflows of $757,000 were largely driven by strategic focus on R&D and stock purchasing. The company had $1.42m cash at bank as at June 30, 2025. Strategic inventory build is expected to flow through to increased net operating cash flows next quarter, with the start of product delivery for a follow-up purchase order by Avedis Zildjian. In its outlook Audera noted renewed momentum in its core wholesale markets was being supported by continued growth opportunities for AUA Technology across global markets. The Zildjian purchase order is expected to contribute to a significant increase in cash receipts for the September quarter, reflecting timing of payments. LTR Pharma (ASX:LTP) LTR Pharma kicked off a distribution partnership deal for its Spontan intranasal spray for erectile dysfunction (ED) with Symbion in May with initial pharmacy orders and prescriber feedback "encouraging, supporting broader market uptake in future quarters". Patients can now have Spontan prescriptions filled at Symbion's 3900 pharmacies Australia-wide. A pharmacy training program was delivered to Sympbion's pharmacists nationwide on Spontan's unique benefits and patient counselling. In May urologist associate professor Darren Katz was appointed to LTR Pharma's scientific advisory board, bringing extensive ED treatment expertise as medical director of Men's Health Melbourne and immediate past leader of USANZ Andrology Special Advisory Group. During the quarter LTR Pharma advanced its new ED product Roxus. As Spontan moves through the formal FDA process, Roxus offers a fast-track pathway to serve patients through personalised care channels. The company said development of a scalable, GMP-compliant manufacturing process for Roxus was being progressed in collaboration with its Australian pharmaceutical partner. Key formulation milestones have been achieved bringing Roxus closer to market readiness ahead of its planned US launch in H1 CY26 with manufacturing optimisation underway. In May LTR signed a collaborative development agreement with Strategic Drug Solutions (SDS) to develop Oroflow for oesophageal motility disorders, a debilitating group of conditions affecting swallowing function. The program leverages LTP's proven intranasal delivery platform and patent rights from Spontan and Roxus. LTR Pharma had a cash balance of $31.8m as at June 30, 2025, which it said provided substantial runway to execute strategic objectives across multiple markets. EZZ Life Science (ASX:EZZ) EZZ achieved a major strategic milestone during the quarter with the official launch of EZZDAY, a US-focused brand, with the initial product range including four FDA-registered health supplements. All four products are manufactured in the United States to align with consumer preferences, reduce tariffs and freight costs, and enhance supply chain efficiency. In June, EZZ entered a three-year distribution agreement with ROFA Enterprises, securing a minimum purchase value of A$21 million over the contract term. ROFA will distribute EZZ-branded products across Thailand, Vietnam and Singapore, managing local logistics and marketing, while ensuring compliance with EZZ's brand and operational standards. During the quarter EZZ expanded its domestic retail footprint via a new partnership with Australian pharmacy chain Direct Chemist Outlet. Under the agreement, EZZ's flagship products will be stocked in a selection of DCO's 130 stores nationwide. The company launched a new consumer health product EZZ Liquid Calcium Soft Gel for key international and domestic markets to further capitalise on its strong performance in the calcium supplement category. During the quarter EZZ engaged the University of Sydney to undertake a two-year in vitro research project into the effects of a novel multi-ingredient nutritional supplement on bone growth. Receipts from customers totalled $21.3m, representing a 46% increase from the previous quarter with a positive cash inflow of $1.4m. Cash reserves reached $20.8m as at 30 June 2025 after paying $900,000 in dividends during the quarter. EZZ remains debt-free, excluding lease liabilities.
Sky News AU
21-07-2025
- Sky News AU
ASX 200 sheds more than $25 billion on Monday after surging about 2.3 per cent over late last week
The ASX 200 has sank on Monday, clawing back a massive surge late last week that pushed the index to new record highs. The index fell 0.8 per cent in the first 50 minutes of trading, wiping more than $25 billion off local investors' portfolios. It follows the index rising 0.9 per cent on Thursday and another 1.4 per cent on Friday Australian regenerative medicine company Mesoblast shed 7.9 per cent after surging more than 32 per cent on Friday when it revealed strong results from the commercial launch of children's drug Ryoncil. Regis Resources has shed four per cent, while Insignia Financial is down 5.3 per cent and Lifestyle Communities has sank 2.5 per cent. Buy-now-pay-later company Block, which is led by Twitter-founder Jack Dorsey and listed on the Nasdaq, jumped about 10.9 per cent after news emerged it would join the S&P 500. Other strong performers include AMP, which jumped 5.5 per cent after revealing a strong second-quarter performance, and Clarity Pharmaceuticals which is up 4.9 per cent. Investors await the RBA meeting minutes due on Tuesday which will reveal the thinking behind the central bank's shock rate hold. Josh Gilbert, a market analyst with trading platform eToro, said further explanation of the decision, which three of the nine RBA board members disagreed with, will be critical for a better understanding of Australia's economy. 'We know RBA chair Michele Bullock leans towards quarterly (inflation) readings, not the monthly ones, for a more stable indicator of economic health and that this caution likely motivated her to vote for a pause, but analysts will be keen to get a deeper understanding of the board's broader perspective,' Mr Gilbert said. It was a mixed bag on Wall Street on Friday with both the S&P 500 and the Nasdaq finishing flat while the Dow Jones sank 0.3 per cent. London's FTSE 250 Index jumped 0.6 per cent, Germany's DAX shed 0.3 per cent and the STOXX Europe 600 finished flat. New Zealand's NZX 50 Index is up 0.4 per cent since trading began on Monday while Japan's Nikkei 225 is down 0.2 per cent.
AU Financial Review
18-07-2025
- AU Financial Review
Mesoblast shares soar 35pc on strong cell therapy sales data
Biotech Mesoblast has reported strong initial sales of its cell therapy, Ryoncil, its first commercial product since the company was founded two decades ago, sending its shares soaring. The US Food and Drug Administration approved the therapy to treat children for complications that can occur during bone marrow transplants last December, paving the way for the first commercial sales in March.
