Sovereign sterile manufacturing · Adelaide

Securing Australia's supply of hospital-critical injectables.

Elemental IV is building an automation-led GMP manufacturing platform for the ready-to-use injectable medicines Australia's hospitals can no longer afford to import-depend on — a complementary domestic source of supply for the products most exposed to shortage.

The thesis

Australia imports ~90% of its prescription medicines. When global supply breaks, hospitals ration. We're building the missing domestic capability — capital-efficient, automated, and policy-aligned.

Storme PaesFounder & Managing Director
0%
of prescription medicines used in Australia are imported.
~0
active medicine shortages managed by the TGA at any one time.
0%+
of those active shortages are injectable medicines.
Why now

A structural gap, an open policy window.

The 2024 IV-fluid crisis exposed how concentrated Australia's sterile-medicine supply has become. The acute crisis passed — but the vulnerability across electrolytes, antibiotics and ICU infusions remains. For the first time in a decade, the policy and capital environment is aligned to fix it.

Import dependence

Only one large-scale domestic IV-fluid manufacturer operates at meaningful scale. The rest of the sterile formulary is met through imports, manual hospital compounding, or Section 19A approvals priced 2–5× above domestic equivalents.

Policy tailwind

Sovereign manufacturing is now active federal policy. The National Reconstruction Fund (A$15B) names Medical Science a priority sector, alongside Modern Manufacturing grants and South Australian co-investment programs.

Mature automation

Automated sterile fill-finish is now standard internationally — yet most Australian sterile compounding remains manual. We pair validated automation with disciplined Australian GMP execution, at scale.

We're not competing with the large fluid manufacturers or compounders. We're the missing piece — a reliable domestic source for the ready-to-use injectables that imports leave hospitals most exposed on.
The market

Non-discretionary demand, recurring by design.

Hospital demand for sterile injectables is recurrent, growing with an ageing population, and procured on reliability and quality rather than price alone. Our serviceable entry point is sized bottom-up from acute hospital admissions.

TAM
A$1.5–2.0B
Australian sterile injectable & IV market
Across public & private hospitals, Defence, emergency services and aged care.
SAM
A$80–180M
Targeted RTU electrolyte & acute-care segment
The shortage-prone, import-exposed products we're built to supply.
SOM
A$10–25M
Annual revenue by Year 5
At low single-digit penetration of the serviceable segment.
Our approach

Capital-efficient, automation-led, built to license fast.

A modular GMP facility in Adelaide, anchored by an equipment and technical partnership with global sterile-consumables manufacturer Epic Medical — engineered for speed-to-licensure and scalable output.

01

Modular GMP platform

ISO 7/8 cleanrooms and TGA-aligned quality systems in a refit facility, sized for staged expansion rather than a single oversized capital outlay.

02

Epic Medical partnership

Automated SmartFill filling technology contributed by Epic Medical, plus technical integration support and a preferred-supplier arrangement for sterile consumables.

03

Automation over manual

Higher sterility assurance, consistent quality and the throughput that point-of-use manual compounding can't deliver — the core efficiency advantage.

04

Staged execution

Phase 1 high-frequency products fund and de-risk the platform before expanding into higher-value shortage-list injectables on the same GMP licence.

Product portfolio

Start with frequency. Expand into scarcity.

A disciplined SKU strategy: anchor on the highest-frequency hospital injectables, then move into the specific products on the TGA's active shortage list where margins and supply security are strongest.

Phase 1 · Anchor volume

High-frequency electrolytes & acute care

Consistent, ready-to-use supply that replaces labour-intensive manual preparation.

0.9% Saline Hartmann's solution Potassium chloride Balanced electrolytes Water for Injection
Phase 2 · High value

Shortage-list injectables

Products currently in recurring shortage — the highest-margin, highest-resilience opportunity.

Benzathine penicillin Lidocaine injection Metronidazole Cefotaxime Adrenaline pre-filled syringe
Financial trajectory

A manufacturing growth curve, not a moonshot.

$1.40M
FY28
41% gross margin
$4.42M
FY29
45% gross margin
$9.69M
FY30
54% gross margin

Operating leverage from a fixed cost base.

FY28 is a validation year. As shifts extend and the higher-value Phase 2 mix comes online, revenue compounds while fixed costs grow modestly — lifting gross margin and turning EBITDA positive.

  • Revenue: A$1.4M → A$9.7M across FY28–FY30 (base case).
  • Gross margin: expands from 41% to 54% on Phase 2 product mix.
  • EBITDA: positive from FY29, reaching ~A$3.4M by FY30.

Base case. Full integrated financial model and use-of-funds detail available to qualified investors under NDA.

The investment

Healthcare infrastructure — not a venture-shaped bet.

Asset-backed, with recurring institutional demand and a manufacturing-style return profile. Suited to healthcare specialists, family offices, co-investment funds and strategic partners.

Recurring, non-discretionary demand

Hospital injectables are consumed continuously and procured on reliability — not discretionary spend.

High regulatory barriers to entry

GMP licensing, validation and TGA registration create a defensible moat once cleared.

Non-dilutive capital available

NRF, Modern Manufacturing and SA state programs are designed for exactly this profile — pursued in parallel with equity.

Clear exit horizon

Year 4–7 via strategic acquisition, partnership, or an operating-yield platform.

Currently raising

Staged capital strategy

A sequenced raise that capitalises validated milestones rather than promises.

Stage 1 — Seed (open now)Milestone close
Stage 2 — Series ABuild & scale
Non-dilutive (parallel)NRF / MMI / SA
Use of fundsOn request
Request the full deck
Get in touch

Let's talk about securing sovereign supply.

We're speaking with healthcare-focused investors, family offices and strategic partners. Request the full business plan and integrated financial model.

Based at
Stone & Chalk, Adelaide
South Australia
Phone