Health Check: ‘Forgotten' drug maker AFT Pharma aims high with revenue
AFT Pharmaceuticals boosts revenue, but profits still lag
Telix Pharmaceuticals chair and CEO reflect on a prosperous 2024 – and promise more riches to come
Dimerix's pivotal trail passes another safety check
The bourse's 'forgotten' drug maker, Kiwi-based AFT Pharmaceuticals (ASX:AFP) is confident of reaching its 'aspirational' target of $NZ300 million ($270 million) of revenue within the next two years.
This comes after the company posted a record turnover of $NZ208 million for the year to March, up 6%.
'AFT is well positioned to achieve this target,' said CEO and co-founder Dr Hartley Atkinson.
'While the global trading environment is looking more difficult, we are confident that we can continue to overcome these challenges by focusing on what we do best.'
'What we do best' is identifying unmet needs and then in-licensing or developing medicines to commercialisation. Often these are drugs for conditions overlooked by big pharma.
AFT reported operating profit came in at NZ$17.6 million, as per guidance but down 27% year on year.
Net profit declined 23% to NZ$12 million.
The company said its performance was crimped by some significant 'one off' events flagged in the first half.
These included destocking by customers and the prolonged doctors' strike in South Korea.
Bulging medicine cabinet
AFT's products cover everything from pain, eyecare, dermatology, gut disorders, medicated vitamins and hospital injectables.
The company's best sellers are Maxigesic – a paracetamol and ibuprofen combination – and Hylo eye drops.
Atkinson says AFT has 'significantly advanced' its push into multiple geographies and expanding its research and development pipeline.
'These efforts have come at the cost of short-term earnings growth, but we are convinced they will deliver growth in long term shareholder value.'
During the year AFT launched Maxigesic tablets in the US, having already introduced the intravenous version.
AFT also launchd proprietary antiseptic cream in mainland China, the world's second biggest pharma market behind the US.
Atkinson cites a pipeline of injectable drugs with a potential market value of over US$400 million.
'I am confident … AFT has reached an inflexion point and can further extend its decades long record for growth and value creation,' Atkinson says.
That said, some investors would like earnings to grow at a faster clip.
Telix says 2024 was big, 2025 will be bigger
Eight years ago, Telix Pharmaceuticals (ASX:TLX) was merely a gleam in the eye of co-founder Dr Chris Behrenbruch, who convinced former Macquarie Banker Kevin McCann to chair the fledgling business.
At yesterday's AGM, the board revelled in the progress of Telix, which recorded revenue of $800 million in calendar 2024.
This was on the back of the company's flagship prostate cancer imaging agent, Illuccix.
'Last year I stood at this same lectern and said that 2024 would be the biggest year yet for Telix, and that proved to be the case,' Behrenbruch told the gathered faithful.
'I make a similar prediction again for 2025, as we continue to execute on our strategy and continue the momentum we've built.'
The US aside, regulators in the UK, several European countries and Brazil have also approved Illucix.
'The Telix brand now stretches as far as the tropical heat of Rio de Janeiro to the wintry climes of Scandinavia,' said McCann, whose literary flourish can be excused given he retired at the meeting.
While most of Telix's revenue derives from Illucix, the company has also commercialised Gozellix (also for prostate cancer imaging) and a lesser-known offering called Scintimun (for imaging bone infections).
The company awaits an FDA decision on approving its kidney cancer imaging agent on or before August 27.
Telix's holy grail is to develop therapeutic – as opposed to imaging – products.
'We have one of the deepest therapeutic radiopharmaceutical pipelines in the industry,' Behrenbruch said.
'We are poised to have three assets in pivotal trials by the end of this year, comprised of our lead prostate, kidney and brain cancer therapy candidates.'
Re-doing the homework
Not everything has gone Telix's way, with the FDA last month knocking back the company's US marketing approval application for its brain cancer imaging agent, Pixclara.
The FDA issued complete response letter, which demands that an applicant do more homework.
Behrenruch said the company met with the FDA to glean what is required.
'At this stage, we believe resubmission in 2025 is achievable,' he said.
Behrenbruch adds Telix has focused on developing its supply of isotopes, which need to be manufactured close to the patient.
'As most investors understand by now, there is no 'magic isotope store in the sky' and no 'man with a van' that turns up with a product,' he said.
'Radiopharma is a logistically and supply-chain intensive field of medicine.
"The network of capabilities that we have built – and bought – is critical for the reliable delivery of just-in-time manufactured products like ours.'
Manufacturing in the US – where most of Telix's patients currently reside – has a flow-on benefit of 'managing the risk of tariffs and other trade barriers affecting the supply and cost of our products.'
As of the end of March, Telix had cash of $710 million.
Given the company has set a minimum cash buffer of US$100m ($156 million), that implies plenty more firepower for acquisitions or shareholder returns.
Dimerix trial passes safety audit – again
Long-running and expansive trials are all about the little moments along the way – and Dimerix (ASX:DXB) has chalked up another one with its pivotal phase III kidney disease study.
In its sixth review of the trial, the US-based Independent Data Monitoring Committee (IDMC) recommends the trial, dubbed Action3, continue unchanged.
'The IDMC has again noted no safety concerns to date, consistent with their prior reviews and the existing and emerging strong safety profile of (the drug candidate) DMX-200,' the company says.
The IDMC will take another peek in the December quarter.
DMX-200 tackles the rare kidney disease focal segmental glomerulosclerosis, for which there is no effective treatment.
Meanwhile, Blinklab (ASX:BB1) has secured its first clinical site for its pivotal trial of its autism detection algorithm, pitched at FDA approval.
The company has enrolled 100 patients in the initial stage, with an additional 750 to 900 participants undergoing testing thereafter.
The first site is the Arizona based Southwest Autism Research & Resource Center.
Blinklab expects to be able to file an FDA submission in the March quarter of next year, using the 510(k) route.
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