Shulkin the Tree: Former US Secretary Joins Emyria (ASX: EMD)

Good morning, Armchair Army,

Welcome to today's edition of The Armchair Analyst, a 5-minute daily update on the ASX life-sciences sector.

Pop quiz…

What do $2.6 billion 4D Medical (ASX: 4DX) and $40 million Emyria (ASX: EMD) have in common?

The same direct line into Washington.

Today, Emyria (ASX: EMD) announced that former US Secretary of Veterans Affairs Dr David Shulkin is joining as a Strategic Advisor.

… he is also the US strategic advisor to 4D Medical.

Under Obama, Shulkin ran the US veterans’ healthcare system as the Under Secretary of Health.

Under Trump, Shulkin ran the whole department as Secretary of Veterans Affairs.

350,000 employees. 

1,400 facilities.

…and servicing over 9 million U.S. veterans.

He has been named among the “100 most influential people in healthcare”.

Now he is with Emyria.

In 2023, he joined 4DX as an advisor.

Two months ago, 4DX's technology ended up at the centre of a bipartisan bill for Congress.

Worth US$5 million per year to 4DX as a pilot program.

Shulkin was central to getting this deal across the line.

Deep ties into Washington.

Deep ties into the US healthcare system.

An existing track record of helping another ASX-listed company navigate the same market.

There are no two ways about this… this is a coup for Emyria.

Shulkin will support Emyria with:

Emyria’s US strategy to deliver psychedelic-assisted therapies is finally taking shape.

… it has a 3-year head start over the rest of the world.

This is just the beginning.

But first...

Telix Pharmaceuticals (ASX: TLX) announces a merger with ITM for US$1.65 billion in cash, US$1.25 billion in shares, and up to US$700 million in milestone payments. (TLX)

🪑 This is a baller move by TLX. 

ITM is the world's leading manufacturer of radioisotopes. 

Big consolidation is happening in the radiotherapeutics industry, and TLX didn’t miss its chance.

Paradigm Biopharmaceuticals (ASX: PAR) requests a trading halt pending the release of interim analysis results for its Phase 3 clinical trial. (PAR)

🪑 Good luck!

Emyria (ASX: EMD) appoints former U.S. Secretary of Veterans Affairs Dr David Shulkin as a Strategic Advisor. (EMD, held, Armchair Pick)

🪑Welcome Dr Shulkin.

Neurotech International (ASX: NTI) doses the first patient in its pivotal Phase 3 study, targeting Autism Spectrum Disorder. Australia only, 200 patients. (NTI, held)

🪑 And we’re off…

I’m looking forward to this one. Very good results in Phase 2… let’s see if it can translate to a bigger cohort.

Orthocell (ASX: OCC) achieves first sales of Remplir™ in Thailand, partnering with exclusive distributor MediTime. (OCC)

🪑 Very nice

EBR Systems (ASX: EBR) announces an increase in Medicare inpatient reimbursement for WiSE System procedures. First category, up from US$23K to US$36K and second category, up from US$13K to US$25K. (EBR)

🪑 Good uplift, pure margin increase for EBR.

The New South Wales government has passed new cannabis driving laws. (NSW)

🪑 This is big for the Australian cannabis industry. The biggest beneficiaries are likely to be Breathe Life Sciences (ASX: BLS) and Little Green Farmer (ASX: LGP).

AFT Pharma's (ASX: AFP) CEO sent me this flick of him and Mark Cuban after signing a deal with costplusdrugs.com. Love it!

Clinuvel Pharmaceuticals (ASX: CUV) sets the date for its AGM. Friday, November 6th. (CUV)

🪑  Big watch on this one. CUV have had the rem report struck down three years in a row. A fourth would trigger a second board spill resolution in four years.

Nyrada Inc. (ASX: NYR) raised A$12 million at $0.62 per share with 3-for-4 options (with a piggyback). Planned SPP targeting an additional A$2 million. (NYR)

Prescient Therapeutics (ASX: PTX) has entered a trading halt pending a capital raise. (PTX)

Last week, Emyria (ASX: EMD) was invited to present in front of the US FDA in one of the most important hearings on psychedelic drug delivery:

This week, it brings on board one of the most credentialed US healthcare advisors.

For most Aussie companies, the US is the dream destination.

… but it’s also a graveyard.

Expensive sales teams, slow progress, and extreme competition.

The biggest market. Biggest opportunity.

But it's also extremely risky if you don't know what you're doing.

That's why you get help.

For the last three years, Emyria has been scaling and growing psychedelic-assisted therapy clinics in Australia.

They've been able to do this because, in 2023, Australia down-scheduled psilocybin and MDMA from Schedule 9 to Schedule 8.

Unprecedented.

But it also gave Emyria a huge head start.

Emyria is now shaping its US strategy, with the first psychedelic drug looking likely to be approved over the next 6 months.

The problem?

… these drug developers (Compass, Lilly, Definium) will have no way to deliver it.

The US is a huge opportunity for Emyria... 

But without the proper guidance and support, it could become a very expensive venture.

They don't want to blow this lead.

Enter Dr David Shulkin.

Shulkin is first and foremost a doctor.

He ran hospitals for two decades, including Beth Israel in New York and Morristown in New Jersey.

Then Obama put him in charge of the VA hospital system.

1,400-odd care sites.

9 million veterans.

It's the largest integrated health system in the United States.

Then Trump promoted him to run the department.

Confirmed 100 to 0 by the Senate in February 2017.

The only Trump cabinet nominee to get a unanimous vote.

While he had the job, the VA expanded urgent mental health access to former service members with other-than-honourable discharges. 

About 500,000 people who had been shut out of the system.

He also got same-day urgent primary and mental health services running across all 1,000-plus VA facilities.

Since he left the Trump administration, he's built a second career advising selective, high-potential healthcare businesses.

Brightside Health, a US virtual mental health provider, brought him on to help expand care for patients at elevated suicide risk.

Paradigm Health, to help open up clinical trial access in rural and community settings.

… and 4D Medical.

It's a fairly specific set of partners…

Mental health delivery. Trial access. Veteran Affairs.

No surprises that Emyria was next… as these are the EXACT pillars of its US playbook.

Emyria has said before…

“Clinical delivery capacity, not drug development, is the primary constraint to a global rollout of physical-assisted therapy.”

As psychedelic drugs get approved, US companies will start developing the clinical care model from scratch.

Emyria is not.

In the last 12 months, since signing a deal with Australia's largest private health insurance company, Medibank, Emyria has grown from 1 clinic in Perth to 5 clinics all around Australia.

Over 150 trained therapists.

Over 20 authorised prescribers.

Hundreds of patients treated.

Successfully rolling out a drug like psychedelics, where the therapy is part of the treatment, requires a deliberate delivery strategy.

It’s not just a pill you pick up at the pharmacy.

The infrastructure is hard.

Just look at what happened with Johnson & Johnson's ketamine nasal spray.

They didn't even report sales for the first 3 years because... there weren't really any.

Only in year 4 did they figure out the care model, and that's when sales started to grow.

That ketamine nasal spray does US$2.3 billion each year.

The care model unlocked the drug…

… not the other way around.

Emyria has had multiple years to work out this care model.

Delivery protocols, staff training, scale up services, and, most importantly, gather real-world patient data for use in any reimbursement application.

This is EMD’s “playbook”.

… and Shulkin is the first step to help EMD actually get this playbook into the US.

Here are the four vectors for EMD in the US:

I see Shulkin working across all four areas of this opportunity.

Opening the right doors and getting Emyria in front of the right people. 

Last week, the FDA had a hearing on psychedelic medicine.

Yes... 

I watched the whole thing.

All 4 hours.

One thing that stood out was just the sheer number of U.S. veterans who either had experience with psychedelic medicine or were supportive of it.

To be honest, veterans were most of the hearing.

Emyria was also invited to speak; here is the Chairman, Greg Hutchinson:

Earlier this year, the US Department of Veterans Affairs and the U.S. Health and Human Services signed a memorandum of understanding all about psychedelics.

It covers clinician training, participation in trials, and collecting safety, effectiveness and cost data.

Essentially, it's a list of everything Emyria has done in Australia over the past three years.

The VA is also putting its own money in.

In December 2024, it funded the first VA study of psychedelic-assisted therapy since the 1960s, ~US$1.5 million over five years for MDMA-assisted therapy in veterans with PTSD and alcohol use disorder.

Access to veterans' groups is central to the demand pipeline for any US business in this field.​​

This is where Shulkin has the best networks.

… and he has already shown he can execute with 4D Medical.

4DX appointed Shulkin as an advisor in April 2023.

His role? 

Execute a top-down strategy of lobbying government and senior VA officials.

Here is where that led…

On that last one…

Two members of the House Veterans' Affairs Committee introduced a bill directing the VA to run a five-year pilot using FDA-approved four-dimensional functional lung imaging software.

Republican Juan Ciscomani and Democrat Chris Pappas.

US$5 million a year, FY2027 through FY2031.

Shulkin isn't just someone who’s there for a paycheck and a photo.

He has delivered multiple deals to 4D Medical over his three-year term.

Emyria has spent three years building the psychedelic care model.

The clinics.

The therapists.

The patient data.

Now it needs someone who can get that playbook in front of the right people in the largest healthcare market in the world.

The US.

… just when they are about to commercialise psychedelic-assisted therapy.

Shulkin has the network, the experience, and a track record with 4D Medical.

The next milestone?

A US partnership.

Clinical trials, data licensing, care-model licensing, or a veterans’ program.

… any one of those would transform this appointment into a genuine commercial opportunity.

Emyria has the playbook.

Shulkin has the relationships.

Now we shake the tree…

… and see what falls out.

See you all tomorrow,

The Armchair Analyst

What is an Armchair Pick?

An Armchair Pick is an invite-only spot I reserve for my highest-conviction investment ideas.

It's a paid arrangement, but to align myself, I only take my fee in shares - half escrowed for 6 months, half for 12.

It is general commentary only, not personal financial advice or a recommendation to buy, sell, or hold. Always see the disclosure at the top of the article and do your own research.