CSL and Mayne Pharma Navigate US Tariff Challenges
CSL and Mayne Pharma are confident of escaping the impact of Donald Trump’s 100% pharma tariff. The company’s decision to invest heavily in expanding its US manufacturing presence seems to be paying off, with the company likely to avoid the proposed tariffs.
The US President flagged the pharma tariff via a proclamation under Section 232 of the Trade Expansion Act. This allows the leader of the free world to adjust duties on imported goods if they threaten US national security. However, the US Supreme Court torpedoed Trump’s initial attempt to impose sweeping tariffs.
“CSL is working through the details of the proclamation, but the initial view is that most of CSL’s US product sales will not be subject to tariffs,” the company said. CSL was pleased the Administration had “recognised the unique nature of plasma-derived therapies under the proclamation”.
This was “consistent with the longstanding approach of special policy accommodations to ensure patient access to these life-saving therapies”. CSL’s plasma therapies sold in the US are derived entirely from US-sourced product. In other words, blood donations from dinky-di Americans and – er – Mexicans.
The company recently said it would spend US$1.5 billion to expand its plasma manufacturing capabilities in Illinois. Meanwhile, the company’s Seqirus flu division mainly sells its Fluad vaccine (covering four flu strains) in the US. CSL makes Fluad in the UK. As such, the vaccine currently is subject to a 10% tariff but “current expectations are that this tariff will reduce to zero”.
The company expects “any new tariff impacts” to be effective from September 29 this year. According to the trade website Thompson Hine, medical products outside the scope of the new tariff include nuclear medicines, fertility treatments, animal health drugs and, yes, plasma-derived therapies.
CSL shares this morning edged up 1.4%. Australian Super reportedly has sold down its CSL stake to the tune of $500 million, leaving a $450 million allocation.
Mayne Pharma’s Perspective
Another company that could do with some good news, specialty druggist Mayne Pharma says the proposed US tariffs should have “no material impact” on its 2026-27 financial year results. The company expects its dermatology generics portfolio to be exempt altogether. This business chipped in 16% of Mayne’s December half revenue.
“Several of the company’s branded dermatology products may be subject to the new tariffs,” the company said. “However at this time, Mayne does not believe the application of these tariffs will result in a material impact to the dermatology segment contribution.”
Management also expects “no material impact” on its women’s health portfolio. Mayne last year attracted a takeover offer from US dermatology group Cosette but was later spurned. It’s a long story. Mayne shares spurted 4.7% higher this morning.
Amplia’s Pancreatic Cancer Trial Setback
Tearaway Amplia has had a clinical trial setback, sending the stock tumbling as much as 30%. Amplia has halted recruitment of its pancreatic cancer combination study, Amplicity, after three of the eight patients experienced “dose limiting toxicities”.
The company said the problems related to the chemotherapy regimen, rather than Amplia’s drug candidate, narmafotinib. The patients already on the trial would remain on the study, the company said. The study used the chemotherapy agent Folfirinox.
“Folfirinox has been one of the main chemotherapy regimens used to treat pancreatic cancer patients who are generally fitter and have a higher performance status,” the company said. “It is recognised as being more aggressive and less well tolerated by patients compared to gemcitabine and Abraxane.”
Amplia is using these two agents in its ongoing study, called Accent. Amplia shares last month soared after the company reported four more complete responses, taking the total number of ‘cures’ to five. With deadly pancreatic cancer, this is virtually unheard of.
“The dose limiting toxicities are very disappointing for the patients and their families,” Amplia CEO Dr Chris Burns said. “However, toxicity with Folfirinox chemotherapy is well documented. Given these effects … we will continue to build on our promising Accent trial data, as well as plan for additional studies with new targeted agents being developed for pancreatic cancer.”
ImpediMed Announces New CEO
In the latest CEO change at the smaller end of the market, device play ImpediMed has replaced its head honcho under an “orderly transition”. Current CEO Dr Parmjot Bains departs on June 30, to be replaced by current director Erik Anderson (who joined the board six weeks ago). Bains will advise Anderson, who takes on the new role immediately.
ImpediMed has commercialised its Sozo devices, which measure breast cancer-related lymphoedema far more accurately than the standard of care (a tape measure). The board said while Sozo sales had “gained momentum”, the company’s next phase “required a step change in commercial execution, particularly in the US”.
Anderson most recently was divisional president of Hologic’s breast and skeletal health business. “He has deep expertise in US health care delivery, including hospital procurement, clinical adoption and reimbursement,” the company says. During the reign of Bains, the company launched two new Sozo indications. Sozo’s reimbursement also extended to 93% of covered lives in the US.
However, ImpediMed shares have plunged 62% over the last year – and we guess that’s the acid test of performance. Meanwhile the struggling Genetic Signatures and medical cannabis platform Vitura Health have also anointed new CEOs.
AFT Affirms Earnings and Revenue Guidance
Trans-Tasman niche drug outfit AFT Corporation is on track to hit its revenue target of NZ$300 million for the 2026-27 year. The company today said it would post record sales for the year to March 2026, with operating earnings of NZ$20-24 million (in line with guidance).
AFT is due to report on May 21. While management did not specify 2025-26 revenue, it said that growth was in the double digits across all markets. “We have seen broad-based growth across all our operations and continuing strong demand,” AFT founder and CEO Dr Hartley Atkinson said. “We had already significantly lifted inventory levels, which will help us to manage the uncertainties and ensure a continued supply to our customers.”
Atkinson said the company expected to file registration applications for at least 70 new products this year. The company is preparing to launch a pivotal study of its novel injectable iron treatment, after “successful engagement” with the US Food and Drug Administration.
Completed last year, an earlier study showed the medicine had fewer side effects, with lower toxicity compared to traditional oral iron and intravenous therapies. Addressing a potential market of US$7.4 billion, the drug is one of the “most exciting” in AFT’s pipeline.
Aft and co-funder Hyloris expect the follow-on study to enroll 1360 patients at sites in New Zealand, India, China, Japan, Armenia, Europe and the US. Cuban deal gets the cigar. AFT said it would sell its Maxigesic tablet (marketed as Combogesic Rapid) via the US Cost Plus Pharmacy Chain. The group is backed by billionaire, former Dallas Mavericks majority owner and Shark Tank star Mark Cuban.
Cost Plus stocks more than 2300 commonly prescribed medicines, distributing them at a set 15% mark up. AFT also said it had successfully integrated the South African hospital business of Pharma Dynamics, acquired in December. This business should contribute “strongly” to the 2026-27 results.
The company’s business strategy revolves around developing and selling proprietary and in-licenced drugs. These are for indications overlooked by big pharma. AFT’s products are available in 125 countries. Meanwhile, Telix Pharmaceuticals shares soared 8% on a strong March quarter update.
