Latest news with #GeneticSignatures
News.com.au
15 hours ago
- Business
- News.com.au
Health Check: Bug buster Genetic Signatures' US expansion is a jumbo-sized task
Genetic's company-making US expansion proves harder than expected BTC Health makes a (literally) lifesaving sale The lessons from Sarepta's billion-dollar FDA woes Gut disease diagnostics provider Genetic Signatures (ASX:GSS) is finding its US market entry more elephantine than first envisaged and has made some changes 'to better align with current strategy and needs'. On June 4 last year the US Food and Drug Administration (FDA) approved Genetic's Easyscreen, which can detect eight gastrointestinal (GI) parasites accounting for 90% of all tummy bugs. On the same day the company launched a $30 million capital raise to support the US push and announced a new CEO (former Roche Diagnostics exec Allison Rossiter). Genetic expected to be selling in the US within 60 to 90 days. Today, Genetic says the US sales ramp-up has been 'impacted by prospective customers' internal processes, competing priorities, preference for enhanced workflow and uncertainty in the US healthcare environment.' In part, the company discovered that clients craved more automated sample processing. In response, Genetic has entered a three-way 'strategic partnership' with a mob called Tecan (lab automation) and Repado (compliant in vitro diagnostics). This threesome will result in a 'scalable suite of fully automated diagnostic platforms for syndromic testing labs'. Genetic doesn't mention any dollars, so we presume the financial impact is immaterial. Speaking of finances, Genetic today reported June quarter sales of $4.4 million. This was 52% higher than the March stanza, reflecting higher seasonal testing during the Australian flu season. But turnover was flat on a year-on-year comp. Having expended a net $5.95 million, Genetic ended the quarter with still-healthy cash of $30.9 million. Microba GI testing sales are on tract Still on tummy bugs, microbiome testing outfit Microba Life Sciences (ASX:MAP) has met its guidance with full-year revenue of $15.67 million, 30% higher year on year. June (fourth) quarter revenue fell 13.5% to $4.2 million, the result of the company shedding a non-core research services business. Microba has commercialised two clinical tests, to assess and manage GI patients. The flagship Metaxplore tests assess a range of markers to appraise the GI tract and presents the results in a clear report. Metapanel is the 'first line' test to determine whether the patient has a pathogen that can be treated simply with antibiotics. Currently Metaxplore is sold in Australia and the UK, while Metapanel is available locally via the company's partner and biggest shareholder, Sonic Healthcare (ASX:SHL). Microba chief Dr Luke Reid says Microba has a 'well considered plan' for US rollout, based on creating a beachhead in one city. Mayne they could swap notes with Genetic's management. Locally Microba sold 3451 Metaexplore tests during the quarter, up 88%. Microba also sold 266 Metapanel tests here (up 85%) and 429 in the UK (the test was only launched there in May). Microba recorded net cash outflows of $5.56 million for the quarter, but management affirms the Australian and UK ops should be break-even this year. BTC Health's PDF format suits investors One of the more unusual life science plays on the bourse, medical product distributor BTC Health (ASX:BTC) has secured a $500,000 equipment order with Adelaide's Women's and Children's Hospital. The order is for extracorporeal membrane oxygenation (ECMO) and follows a similar deal with Melbourne's Royal Children's Hospital. ECMOs take over the work of the heart and lungs when these organs cannot perform their duties. BTC Health is building a portfolio of diverse yet specialist medical devices, such as heart valves and infusion pumps. BTC is a valuable pooled development fund (PDF), a remnant of a Keating-era initiative to bolster investment in small business. PDFs pay only 15% tax on income and capital gains, but any returns to shareholders are tax free. Only 17 PFDs remain and – like coastal property – God is not creating any more of them. BTC chief Dr Richard Treagus previously headed generic drug play Acrux, the sector's only other PDF. BTC posted December half revenue of $5.3 million, with underlying earnings of $200,000. The company expects to have remained in the black for the full year to June 30 with a 'pathway to sustainable growth'. Sarepta 'is worth nothing' Could a $US1.31 billion company really be worth nothing? US investment bank H.C. Wainwright thinks so, having ascribed a 'price target' of yada and zip to the Sarepta Therapeutics on the back of the Nasdaq-listed entity's drug strife. Last week the FDA asked Sarepta to voluntarily halt shipments of its Elevidys gene therapy, for muscular dystrophy. This follows the death of two patients from liver toxicity issues and the third from a separate experimental gene therapy treatment. Defying the agency, Sarepta said it would continue to ship the therapy to ambulatory patients, but maintain a halt for wheelchair-bound ones. The deaths pertained to the latter. The FDA approved Elevidys two years ago for walking patients aged four or older, with the Duchenne muscular dystrophy (DMD) gene mutation. A year later the agency expanded the assent to non-ambulatory patients. Sarepta shares shed up to 40% on Friday and a further 5% overnight. Don't fight City Hall H.C. Wainwright previously had a US$10 valuation on Sarepta, compared with the stock's overnight close of US$13.32. The firm describes Sarepta's fight with the FDA as 'unwinnable' and – indeed – you can't beat City Hall. Elevidys generated US$384 million of net revenue in the December quarter, more than half of Sarepta's total revenue of US$638 million. The lesson for everyone is that even when drug makers have done the hard yards of developing and commercialising a therapy, success is still not guaranteed. In one of the best-known cases, in 1999 the FDA approved Merck's Vioxx, for osteoarthritis pain. After racking up billions in sales Merck withdrew the drug from sale in 2004, amid concerns it could cause heart attacks and strokes. Locally, Percheron Therapeutics (ASX:PER) is reinventing itself after its DMD therapy failed in phase IIb stage last December. Perhaps the company dodged a bullet by discovering the problems early in the piece, but wounded investors might disagree.
Yahoo
2 days ago
- Business
- Yahoo
Investors in Genetic Signatures (ASX:GSS) have unfortunately lost 85% over the last five years
Long term investing is the way to go, but that doesn't mean you should hold every stock forever. We don't wish catastrophic capital loss on anyone. Spare a thought for those who held Genetic Signatures Limited (ASX:GSS) for five whole years - as the share price tanked 85%. And we doubt long term believers are the only worried holders, since the stock price has declined 49% over the last twelve months. On the other hand the share price has bounced 8.2% over the last week. We really hope anyone holding through that price crash has a diversified portfolio. Even when you lose money, you don't have to lose the lesson. So let's have a look and see if the longer term performance of the company has been in line with the underlying business' progress. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Genetic Signatures wasn't profitable in the last twelve months, it is unlikely we'll see a strong correlation between its share price and its earnings per share (EPS). Arguably revenue is our next best option. Shareholders of unprofitable companies usually desire strong revenue growth. That's because fast revenue growth can be easily extrapolated to forecast profits, often of considerable size. Over half a decade Genetic Signatures reduced its trailing twelve month revenue by 2.3% for each year. While far from catastrophic that is not good. The share price fall of 13% (per year, over five years) is a stern reminder that money-losing companies are expected to grow revenue. It takes a certain kind of mental fortitude (or recklessness) to buy shares in a company that loses money and doesn't grow revenue. Fear of becoming a 'bagholder' may be keeping people away from this stock. You can see how earnings and revenue have changed over time in the image below (click on the chart to see the exact values). If you are thinking of buying or selling Genetic Signatures stock, you should check out this FREE detailed report on its balance sheet. A Different Perspective While the broader market gained around 13% in the last year, Genetic Signatures shareholders lost 49%. Even the share prices of good stocks drop sometimes, but we want to see improvements in the fundamental metrics of a business, before getting too interested. Unfortunately, last year's performance may indicate unresolved challenges, given that it was worse than the annualised loss of 13% over the last half decade. Generally speaking long term share price weakness can be a bad sign, though contrarian investors might want to research the stock in hope of a turnaround. I find it very interesting to look at share price over the long term as a proxy for business performance. But to truly gain insight, we need to consider other information, too. To that end, you should be aware of the 3 warning signs we've spotted with Genetic Signatures . But note: Genetic Signatures may not be the best stock to buy. So take a peek at this free list of interesting companies with past earnings growth (and further growth forecast). Please note, the market returns quoted in this article reflect the market weighted average returns of stocks that currently trade on Australian exchanges. 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.
