Health Check: CSL’s departing chairman leaves ‘big shoes to fill

• The epic Life of Brian era is due to end at CSL
• At Echo IQ, a bird in the hand is worth two in the bush
• Mayne cleans up legal issues amid revenue and earnings decline

Having unveiled its new CEO last week, CSL (ASX:CSL) has continued its management overhaul by announcing the departure of chairman Dr Brian McNamee.

Of course, McNamee is not just any ol’ chairman, but part of CSL’s body and soul.

McNamee held the CEO role from 1990 to 2013, steering the company through its 1994 privatisation and listing.

After a five-year interregnum – during which he served on the federal Financial System Inquiry – he became a CSL director and then chairman in 2018.

Some corporate governance purists viewed the succession as controversial, given the potential to create difficult power dynamics between chairman and CEO, and perpetuate cultural inertia.

The more unkind investors viewed McNamee as part of the problem when the company’s fortunes soured last year.

Mind you, CSL’s chairman-elect Gordon Naylor is a company veteran as well, having run the Seqirus vaccines division and been interim CEO since February.

Naylor will continue to run the show until February 1 next year, when new CEO Deborah Waterhouse clocks on.

Waterhouse has three decades of experience at drug giant GSK.

Also, current board member Carolyn Hewson becomes senior independent director, effective from March 31 next year.

This recognises that Naylor can’t be viewed as an independent chair until then, given the proximity to his interim CEO role.

“Brian leaves big shoes to fill and few people understand plasma, vaccines and this company as well as Gordon,” Hewson said.

Broker Citi says the transition “cements a senior leadership bench with experience across all of CSL’s key commercial areas and competencies”.

Echo IQ focuses on what it has …

Having been rebuffed by the US Food and Drug Administration (FDA) on marketing approval for a second heart disease tool, Echo IQ (ASX:EIQ) is doubling down on selling its first product.

This refers to the approved, AI-enabled EchoSolv AS, for detecting aortic stenosis.

Echo IQ had expected follow-on FDA assent for EchoSolv HF, for a broader heart failure indication.

The FDA early last month declared the device as not “substantially equivalent” to EchoSolv AS.

The company has appealed this verdict, which sent the shares tumbling 60%.

“Following the [FDA’s] initial decision, we moved quickly to sharpen the team’s focus on EchoSolv AS commercial subscriptions,” CEO Dustin Haines said.

The company will then introduce EchoSolv HF to the sites – if and when the FDA approves the product.

Echo IQ reports that hospitals carried out 997 full-result EchoSolv AS assessments during the quarter, 193% more than the prior corresponding period.

That takes year-to-date assessments to 29,117, more than 400% higher than the first nine months of calendar 2025.

This usage is yet to flow through to banked receipts. The company reported outflows for the quarter of $5.9 million, leaving $110m of cash.

As for EchoSolv HF, Echo IQ is still vying for the streamlined 510(k) ‘substantially equivalent’ pathway.

The company “considers the matters cited by the FDA to relate to aspects of the statistical analysis supporting clinical validation”.

Echo IQ’s assessment “has not identified concerns regarding the underlying technology or core functionality of Echosolv HF”.

… while Artrya crosses the Ts and dots the Is

No doubt cognisant of Echo IQ’s FDA experience, fellow AI-driven heart disease play Artrya (ASX:AYA) has decided to do more work before submitting a second module for approval.

Artrya has already commercialised its Salix coronary plaque detection tool in the US, but eyes a coronary heart flow module.

Previously management said an FDA submission was “imminent”, with approval by the end of calendar 2026.

“A subsequent review of clinical study data identified inconsistencies in expert reader assessments within a clinical substudy,” the company said today.

“Together with recent regulatory outcomes in the sector, we have now decided to strengthen the evidence package and undertake an additional reader study before filing”.

This creates “the strongest prospects of a successful regulatory outcome”.

Meanwhile, Artrya reports strong interest in its Salix Coronary Plaque detection tool, in the early days of its US rollout.

Artrya reported receipts of $84,000 and outflows of $6.9m, leaving a September-end cash balance of $67.2m.

(Pro) marker my words, we’ve launched t 

Today marks a commercial milestone for Proteomics International Laboratories (ASX:PIQ) with the national launch of its blood-based predictive Promarker D (diabetes) and Promarker Eso (oesophageal cancer) tests.

This is in collaboration with pathology giant Healius (ASX:HLS), which has distribution dibs on all Promarker tests.

Earlier this year, the company began a “controlled market release” in Western Australia and the Northern Territory.

Priced at $495 each, the Promarker D assays look out for kidney disease up to four years before the clinical symptoms appear.

At $997 per test, Promarker Eso aims to rule out oesophageal cancer in patients with chronic reflux. These assays are not reimbursed.

Proteomics CEO David Morris dubbed the rollout as “a significant milestone in bringing our Promarker portfolio to Australian clinicians and patients”.

Mayne-ly positive results

Mayne Pharma’s (ASX:MYX) September quarter was not so much about the numbers, but resolving multiple legal matters.

On October 14 the NSW Court of Appeal upheld an earlier judgment, rejecting suitor Cosette Pharmaceuticals’ claim that Mayne engaged in misleading conduct.

Cosette had sought to terminate the parties’ takeover scheme of arrangement, but the Foreign Investment Review Board kyboshed the proposal anyway.

The court awarded costs to Mayne.

Last month the company also settled with 49 US states and territories over claims of uncompetitive conduct in the generics sector.

The settlement involved Mayne paying a one-off US$650,000, with no admission of liability or wrongdoing.

The company then solved patent spats with Sun Pharma and Teva over its vaginal atrophy treatment, Imvexxy. These did not involve any monetary payments.

Meanwhile, Mayne reported unaudited September quarter revenue of $95.7m, down 2% year on year and underlying earnings of $5.3m (53% lower).

The company cited strong demand across its women’s health portfolio. However, this was offset by a decline in branded dermatology drug sales owing to “anticipated competitive erosion”.

“With a clearer legal backdrop and focused investment behind our growth opportunities, Mayne Pharma is well positioned for the remainder of [the current financial year],” CEO Aaron Gray declared.

Paradigm wins more time to mull Plan B 

Paradigm Biopharmaceuticals’ (ASX:PAR) voluntary administrators have applied to the court to extend a proposed second creditors’ meeting for up to three months.

The company says it will also redeem and cancel a further US$348,900 of convertible notes, held by the major creditor Obsidian Global GP LLC.

Paradigm already has cancelled two million of notes and remitted US$2 million to Obsidian, with just over 2.83 million remaining.

The company went into administration last month after its 538-patient, phase III knee osteoarthritis pain failed a ‘futility’ test.

If the WA Supreme Court approves the creditors’ meeting delay, the administrators will have more time to assess the board-led revival proposal.

The board contends that while the trial fell over because of missing data from US clinical sites, unblinded results from other patients showed the drug candidate Zilosul as effective.

Paradigm shares have been suspended since the results.

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