Interesting Risk/Reward, But Management Has to Prove It

Penthrox the Green Whistle is a genuinely good product with a complicated past. Methoxyflurane was used as a surgical anaesthetic in the 60s and 70s, caused kidney toxicity at those high repeated doses, and got pulled. The reputation stuck for decades, even though Penthrox delivers it at a fraction of that dose via a handheld inhaler for a few minutes of acute pain relief. The TGA, EMA, MHRA, and 30+ European regulators have all reviewed it and approved it. Australia has used it in ambulances and EDs for 30+ years with no nephrotoxicity signals at population scale. The FDA still hasn't approved it, that legacy baggage is the main reason the US remains locked out, but everywhere else the safety story is well established.

The product works. The adoption problem was largely regulatory history, not the product itself.

The Last Five Years Were Ugly

Five consecutive years of losses. $63M in accumulated losses on $115M of contributed equity. A $40M goodwill impairment in FY24 from a failed prior strategy. Shares on issue grew ~10% per year, not from acquisitions, just capital raises to keep the lights on.

FY25 was the first profitable year. Net profit: $94k on $39M revenue. Barely registers, but the direction changed, No equity raises since mid-FY25. Cash sits at $16.9M with no real debt.

The ship hasn't turned yet, but it's stopped sinking.

Red Flags

• Management ownership effectively zero — no skin in the game
• $63M in accumulated losses — long history of capital destruction
• Dilution has been brutal ~10%/yr for five years, though this should slow materially now
• FY25 "profit" = $94k, one bad quarter erases it entirely
• Respiratory segment declining, down 10% in H1 FY26, US tariffs adding pressure, no clear fix
• No substantial shareholders on record, no anchor institutional conviction
• US approval is years away and expensive, the biggest market remains locked out

Green Flags

• Penthrox is genuinely differentiated, no real substitute in pre-hospital inhaled analgesia
• $16.9M cash, no debt, can absorb a bad year without another raise
• Australian hospital segment compounding fast  up 43% in FY25, up 26% in H1 FY26
• European paediatric label expected by August 2026 — a real near-term catalyst in an already-approved market
• Capital-light pivot underway — partner distribution in France and Switzerland now operational
• Dilution should drop to ~1–2%/yr going forward

The Risk/Reward

The downside looks limited. With $16.9M cash against a ~$47M market cap, you're not paying much for the business itself. You're unlikely to lose 80% from here. But if hospital penetration stalls, Respiratory keeps falling, and management can't convert momentum into real earnings, you're looking at a slow grind sideways with ongoing minor dilution.

The upside is real if they execute. A base case of 12% revenue CAGR gets you to ~$69M revenue by FY30. At an 8% net margin and 20–25x PE, that's a $1.00–$1.30 stock — roughly 3x from here. The bull case with 20% CAGR and operating leverage gets you to $3.50+.

The asymmetry is reasonable, lose a little, make a lot but only if management actually executes, which they haven't proven over a full cycle yet.

Watchlist for me until two consecutive quarters of meaningful NPAT. Another equity raise or Respiratory deteriorating past 15% decline would be the exits.

Recent Buying

Russell Basser

30 October 2025

Buying On Market 40,000 shares at average price $0.7056 ($28,227)

Mark Fladrich 

30 September 2025

Buying on Market 62,858 shares at average price $0.7099 ($44,629)

Paul Townsend

22 September 2025

Buyiing on Market 25,000 shares at average price $0.6714 (16,785.31)

Management Bio’s

Mark Fladrich - Chair

Mark is an experienced leader with over 30 years of experience in the pharmaceutical industry, specialising in commercial, strategic, and operational roles across a broad range of therapeutic areas, including pain management.

Most recently, Mark served as Chief Commercial Officer at Grunenthal, a privately owned German company with a strong presence in Europe and Latin America. During his time at the company, he expanded Grunenthal’s commercial presence into the US in parallel with the relaunch of a non-opioid chronic pain management treatment.

Prior to this, Mark spent 23 years at AstraZeneca, holding various senior roles, including Vice President of Global Strategic Marketing, Country President roles in Germany, Australia and New Zealand and Regional Head of Southern and Western Europe.

Mark has also held leadership roles at Allergan and Faulding Pharmaceuticals in Australia.

Currently, Mark is the Chair of QBiotics, an Australian life sciences company, the Chair of the Strategic Advisory Board for Atacana, a global pharmaceutical and biotech industry consulting firm and serves as a Board Observer and Strategic Advisor at HealthMatch, a Sydney based digital startup who have developed a patient centric platform for clinical trial recruitment.

Leon Hoare - Non-Executive Director

Leon is an accomplished commercial leader with expertise across multiple Life Science sectors. He is currently the Managing Director of Lohmann & Rauscher, Australia & New Zealand (ANZ), a private EU based medical device company.

Previously, Leon was Managing Director of Smith & Nephew (S&N) ANZ, one of S&N’s largest global subsidiaries outside the USA. He served as President of S&N’s Asia Pacific Advanced Wound Management (AWM) business for 5 years and was a member of the Global Executive Management for the AWM Division (as one of three Regional Presidents).

In his 24 years with S&N, he also held roles in marketing, divisional and general management.

Leon’s career has also included a senior role at Bristol-Myers Squibb, and as Vice-Chair of the board of Australia’s peak medical device industry body, Medical Technology Association of Australia. Leon is also the Chair of MDI’s Human Resources Committee.

Public company directorships in the past 3 years:

Polynovo Limited since 27 January 2016

Christine Emmanuel-Donnelly Non-Executive Director

Christine is an experienced IP and business development professional having 35 years’ experience locally and internationally.

Christine is a former Executive Manager of Business Development and Commercial at the CSIRO, where she led the management of CSIRO’s IP team and IP portfolio for 14 years and managed the CSIRO equity portfolio for over 5 years.

Prior to this role, Christine was in-house IP Counsel for Unilever in the UK and practised as a patent and trademark attorney for Wilson Gunn (UK), Davies Collison Cave and Griffith Hack in Melbourne.

Christine is also currently chairwoman of Impedimed Ltd and non-executive director of Polynovo Ltd, Pikcha Holdings Ltd, trading as Seminal. She was previously on the Board of the Institute of Patent & Trademarks Attorneys of Australia for 13 years.

Public company directorships in the past 3 years:

Polynovo Limited since 13 May 2020

Impedimed Limited since 2023

Russell Basser Non-Executive Director

Russell is a qualified physician, with over 30 years of international medical and biopharmaceutical experience. He has worked as a medical oncologist in Melbourne prior to joining CSL in 2001.

During his 21 years at CSL, Russell held multiple global executive roles, including Head of Global Clinical Development, Chief Medical Officer and Senior VP of Research and Development for CSL Seqirus. He has substantial expertise in international drug and vaccine development and spent several years based in the USA.

Russell currently serves as a non-executive director on the Boards of Starpharma Holdings Limited and Doherty Clinical Trials. He has previously served on the Board of the ANZ Breast Cancer Trials Group and the Hadassah Australia Medical Research Collaboration.

Paul Townsend - Non-Executive Director

Paul is an experienced global finance executive with a strong commercial focus and reputation of delivering results across diverse industries, including manufacturing, resources, consumer products and academia.

Paul has substantial ASX CFO experience at organisations including Nufarm, Asaleo Care, and Pacific Hydro, as well as Monash University, bringing a wealth of knowledge to MDI.

His extensive track record includes business turnarounds, new venture start-ups, mergers and acquisitions across local and global markets, navigating equity and debt capital markets and implementing changes necessary to deliver strong earnings growth, robust cash flow, and balance sheet optimisation.

Paul’s strategic mindset and leadership have consistently enabled successful business outcomes and the generation of long-term value. Paul has a Bachelor of Business (Accounting), FCA and GAICD.

Brent MacGregor - Chief Executive Officer

Brent joined MDI as Chief Executive Officer in November 2020.

Previously, Brent was the Senior VP Commercial Operations for Seqirus, from its inception in 2015 until 2020. He has also held roles as Head of North America for Novartis Vaccines and Diagnostics and Managing Director ANZ, Managing Director Japan, VP Global Marketing, and Global Head Strategic Planning for Sanofi Pasteur.

Brent is also a board member of Dynavax, a Hepatitis B vaccine company.

Brent has a BA in Political Science/Economics from Carleton University, Ottawa Canada, MA in Political Economy from Reading University, UK and an MBA from Kellogg – Northwestern University, Evanston IL USA.

Anita James - Chief Financial Officer

Anita joined MDI in May 2022 as Chief Financial Officer, bringing extensive senior finance and commercial experience in ASX listed environments.

Prior to joining MDI Anita worked at Pact Group Holdings Ltd, as General Manager Finance and Investor Relations, and other ASX listed companies in the mining and resources sector, including 12 years with the multi-national mining services Company Orica Ltd.

Capital Raising (Last 10 years)

In last 10 year raised approx $101.24m, today market cap is $42.8m at today price $0.38

·      July 2024 Raised $10m, $5.5m placements and $4.5m entitlement offer at issue price of $0.38 per share. https://announcements.asx.com.au/asxpdf/20240726/pdf/065ymvh74jhzf0.pdf

·      August 2022 completed the placement and institutional entitlement raising $30m at a price $2.00 per new share. https://announcements.asx.com.au/asxpdf/20220808/pdf/45cmpm852scgx5.pdf

·      December 2020 SPP Raised $11.768m at a issue price of $6.50 per share. https://announcements.asx.com.au/asxpdf/20210121/pdf/44rx7xg0fgl8kb.pdf

·      December 2020 completes $25m placement at price of $6.50 per share to a number of institutions and sophisticated and professional investors. https://announcements.asx.com.au/asxpdf/20201214/pdf/44qxj14w5l9qzb.pdf

·      August 2018 SPP Raised $7.475m at a price of $4.00 per share. https://announcements.asx.com.au/asxpdf/20180919/pdf/43yg2hm0lpgylz.pdf

·      August 2018 Raised $17m at a price of $4.00 per share from number of sophisticated and wholesale investors. https://announcements.asx.com.au/asxpdf/20180808/pdf/43x5bbhzqw57r5.pdf

Acquisitions

·      December 2015 MVP acquire Avita Medical’s Australian Respiratroy Business. Includes the Breath-A-Tech branded range of products. Total Consideration is circa $2.64m. https://announcements.asx.com.au/asxpdf/20151224/pdf/4341t3dfsv178p.pdf