Bioxyne lifts FY26 EBITDA guidance to AUD16.5-19m after record H1 FY2026 with AUD31.3m revenue (+149% YoY); expands capacity, enters UK/Germany/LATAM.

Key points

• Record H1 revenue and substantial EBITDA guidance upgrade.
• Operational milestones achieved: expanded GMP capacity and first Australian-made MDMA capsules.
• International growth strategy advancing with new markets entered and UK facility development.

Bioxyne (ASX: BXN) has significantly upgraded its  EBITDA guidance to AUD16.5-19 million on the back of record H1 FY2026 results, reporting revenue of AUD31.3 million—a substantial 149% increase year-on-year.

The company reported adjusted EBITDA of AUD8.3 million and a net profit after tax (NPAT) of AUD7.3 million.

Bioxyne additionally announced multiple strategic developments including capacity expansions and international market entries.

FY26 revenue guidance remains unchanged, projected to be between AUD65 million and AUD75 million.

The improvements in H1 margins contributed to this revised EBITDA outlook, a factor the company will focus on maintaining.

Expanded Manufacturing Capacity and MDMA Milestone

Bioxyne continued to scale its Good Manufacturing Practice (GMP) capabilities, successfully increasing its GMP clean room capacity by 100% and its storage capacity by 200%.

This expansion supports higher production volumes for its specialised product lines.

A major operational milestone was achieved with the successful production of the first Australian-made GMP-certified MDMA capsules.

This development is critical for Bioxyne’s psychedelic product pipeline.

The company states its total revenue capacity for finished products now exceeds AUD250 million per year, with its Australian facility capable of producing up to 6 million MDMA pastilles per month.

International Expansion Gains Traction

Bioxyne made significant strides in its international market penetration, entering new territories including the UK, Germany, and LATAM.

Initial shipments to Germany alone generated AUD2.7 million in revenue during H1 FY26.

To further bolster its global footprint and enhance access to European capital, the company completed a dual listing on the Frankfurt Stock Exchange (PR8.F) on October 13, 2025.

Furthermore, development of a UK GMP manufacturing facility in the Scottish Borders is underway, with construction starting in February 2026 and completion targeted for June 2026.

This facility is supported by £0.848 million in non-dilutive funding from South of Scotland Enterprise, with licensing for the UK facility targeted for December 2026.

Strong Financial Position and Funding

At the end of H1 FY2026, Bioxyne reported a cash on hand balance of AUD7.6 million.

The company’s net assets stood at AUD20.0 million, with total assets of AUD34.6 million and total liabilities of AUD14.5 million.

To meet anticipated demand, inventories increased to AUD11.7 million, and trade receivables were AUD5.8 million.

This strategic inventory build contributed to a negative operating cash flow of AUD1.29 million during the H1 FY26 period.

The previously mentioned £0.848 million non-dilutive funding for the UK GMP site provides additional financial support for its growth initiatives.

Article by SmallCaps – https://smallcaps.com.au/article/bioxyne-bxn-boosts-fy26-outlook-on-strong-performance-and-international-growth

Medicinal cannabis manufacturer Bioxyne has received its first order of GMP-manufactured psilocybin capsules for investigational use in treatment-resistant depression.

The order will see Bioxyne subsidiary Breathe Life Sciences (BLS) supply 250 doses to authorised prescribers in Queensland and Western Australia to treat approximately 60 patients over the next 12 months.

The capsules will also be used for exploratory research into other mental health conditions including anxiety disorders, substance use disorder and PTSD.

Bioxyne chief executive Sam Watson said BLS was “translating its psychedelic manufacturing capabilities into early commercial results and positive patient outcomes”.

“For Bioxyne, these initial supply agreements reflect disciplined execution at the outset of a multi-billion dollar opportunity with the potential to meaningfully improve quality of life for millions of people,” he said.

Article by Cannabiz – https://www.cannabiz.com.au/news-in-brief-bioxyne-receives-first-psilocybin-order/ 

Bioxyne has plenty of ‘shroom to move after first psilocybin sale.

A first mover in making psychedelic medications, Bioxyne (ASX:BXN) has reported its first local order for its psilocybin capsules.

The company is the only compliant local manufacturer of this substance – a.k.a. ‘magic mushrooms’ – which is being trialed for treatment-resistant depression.

Psilocybin also could be relevant for anxiety, substance abuse and post-traumatic stress disorder.

Bioxyne has supplied the capsules to clinicians in Queensland and WA, who work via the Therapeutic Goods Administration’s Authorised Prescriber Scheme.

The order is for 250 doses: enough to treat around 60 patients for the next 12 months.

“This represents only a small fraction of Australia’s estimated addressable market of approximately 300,000 patients living with treatment-resistant depression,” Bioxyne says.

“The company is prepared to scale manufacturing and supply significantly over the next 12 months to meet anticipated demand across Australia.”

Earlier, Bioxyne shipped its first order for MDMA – ‘Molly’ – which it also manufactures.

For the time being, the company derives most of its revenue from making and selling medical cannabis, both here and in Europe and the UK.

Article by Stockhead – https://stockhead.com.au/health/health-check-csl-loses-16-billion-of-value-in-a-bloody-results-horror-show/

ASX biotechs are serving up champion performances amid the odd fault or two, as reflected in today’s crop of quarterly reports.

• Life science companies are flooding the bourse with quarterly reports
• Many of them are hitting winners with trial updates and revenue upgrades
• Bioxyne served up record revenue with its dual medical cannabis and psychedelics strategy

Bioxyne is on a high

We’ll start with Bioxyne (ASX:BXN), which is hitting some solid aces with its dual medicinal cannabis and psychedelics strategy.

Unlike most of its peers, Bioxyne is solidly revenue-generating and profitable.

Bioxyne reported record December quarter revenue of $17.2 million, 11% higher year on year, with $2.5 million of positive cash flow.

The company reports “sustained growth” for its local Breathe Life Sciences (BLS) arm.

BLS supplies cannabis flower, oils, vapes and pastilles.

If these delivery mechanisms don’t cut it, the company has also launched a third-party inhalation device.

Bioxyne largely is focused on Europe, notably Germany, which “de-narcotised” medical cannabis in 2024.

“Germany is the largest and fastest growing legal cannabis market in Europe, projected to surpass €1 billion ($1.8 billion) in sales in 2026,” the company says.

On the psychedelics side, locally Bioxyne released the first Australian-made MDMA (‘Molly’) capsules. These supply clinical trials and authorised prescribers in Queensland.

The company also supplied pills to Victoria’s Eastern Health, for a treatment-resistant post-traumatic stress disorder trial.

CEO Sam Watson says the company is “firmly on track” to deliver on its current full-year guidance of $65–75 million of revenue and $11.5–13.5m in underlying earnings.

Bioxyne dual listed on the Frankfurt Stock Exchange last October, “enhancing liquidity and access for European investors”.

Article by Stockhead: https://stockhead.com.au/health/health-check-biotech-quarterlies-serve-up-sizzling-aces-and-only-a-few-unforced-errors/

Brisbane manufacturer Bioxyne delivered record quarterly revenue of A$17.2 million in Q2 FY26, a 21% increase on Q1 and a 112% life on the previous corresponding year.

Cash receipts reached a record $18.4m, up 149% on Q2 FY25, while net cash from operating activities was positive at $2.5m.

Article by Cannabiz  – https://www.cannabiz.com.au/bioxyne-hits-record-quarterly-revenue/

The US government under President Donald Trump has changed the federal classification of cannabis. While cannabis is not being legalized under a presidential order, it is being moved from the strictest category (Schedule I), considered especially dangerous, to a less restrictive one. This signals a shift in the federal treatment of cannabis without full national legalization. According to official statements, the new classification reduces the perceived risks of the substance but leaves its legal status unchanged. At the same time, a pilot program was announced that would make CBD products available through Medicare.

For the cannabis sector, this political development represents a potential boost: The debate surrounding the classification has once again sparked increased investor interest and led to volatility in hemp stocks.

Bioxyne Limited: strong position in Central America

Bioxyne Limited (WKN A1JWM6, ISIN AU000000BXN6) is an Australian company focused on the development and manufacture of pharmaceutical products and has recently expanded its activities in the cannabis sector.
Through its subsidiary Breathe Life Sciences, the company has entered into an agreement with the Central American company Remidose LATAM SRL. This secures Bioxyne a primary supplier position in the emerging medical cannabis markets of Costa Rica and Panama. The supply of pharmaceutical cannabis lozenges by Bioxyne is contingent upon the pending TGA export licenses and product registrations, which are currently being expedited. CEO Sam Watson described the agreement as a strategic step towards global expansion and positioning in underserved markets.

The agreement could generate millions in revenue in the long term if successfully implemented, and leverages Bioxyne’s GMP certification for the production of non-flowering cannabis formats. In the context of evolving US regulations, Bioxyne is thus positioned in a market that is transitioning from a fragmented cannabis sector to more heavily regulated pharmaceutical applications.

Village Farms and High Tide: Competitors and Industry Comparison

Following President Donald Trump’s reclassification of cannabis, other publicly traded companies are once again coming into sharper focus for the capital markets. A recent analysis identifies High Tide Inc. and Village Farms International as key players in the North American cannabis sector.

High Tide Inc. (WKN A3CMT9, ISIN CA42981E4013) is classified as a retail company focused on selling cannabis products through its own retail network. Its business model relies heavily on recurring consumer sales. The analysis highlights that High Tide could benefit from potential regulatory relief in the US, as lower legal hurdles would improve the operating environment for retailers. At the same time, the report points out that competition in brick-and-mortar retail remains intense and margins are under pressure.

Village Farms International (WKN A0YJNB, ISIN CA92707Y1088) is described as a producer with an agricultural base. The company originally focused on greenhouse vegetable cultivation and has expanded its business model into the cannabis sector. According to the analysis, Village Farms has a comparatively cost-efficient production structure, which is seen as an advantage in the current market environment. At the same time, it is noted that the dependence on wholesale prices and regulatory frameworks makes the business model susceptible to fluctuations.

Both companies are cited as examples of how differently cannabis business models can react to political impulses. While High Tide is more dependent on consumption trends and legal clarity in the retail sector, Village Farms focuses on the scalability of production.

In contrast, Bioxyne Limited pursues a clearly defined approach. The company focuses on pharmaceutical manufacturing and supply structures outside the US end-consumer market and addresses medical applications in regulated foreign markets. This distinguishes Bioxyne from both High Tide’s trade-driven model and Village Farms’ agrarian production approach.

Article by Small-& Microcap:  https://small-microcap.eu/tilray-innocan-pharma-bioxyne-limited-neue-marktchancen-fuer-medizinisches-cannabis/

Bioxyne CEO and Managing Director Sam Watson talked with Proactive about the company’s major developments across medical psychedelics and cannabis in 2025, highlighting growing domestic and international momentum.

Watson described Bioxyne as a pharmaceutical manufacturer targeting patients with unmet clinical needs. Through its wholly owned subsidiary Breathe Life Sciences, the company produces treatments including medical cannabis, MDMA, and psilocybin for conditions such as PTSD, chronic pain, and depression.

He noted the growing demand and acceptance for these treatments, especially in Australia, where Bioxyne has delivered locally manufactured MDMA batches to a Victorian government hospital. “We were the first and one of the only companies licensed to manufacture those medicines,” he said, adding that products are being supplied across clinical trials, government-backed schemes and private clinics.

Watson also spoke about Bioxyne’s international expansion, including new operations in Costa Rica and Panama. He said there is strong recreational cannabis usage in the region, and the company aims to transition users into the legal medical framework. “The deal we’ve just done in Costa Rica is primarily for our pastilles — THC and CBD gummies,” he said.

In addition, Watson discussed the human impact of Bioxyne’s treatments, from helping PTSD sufferers restore daily function to improving quality of life for cancer patients undergoing chemotherapy. He also pointed to growth opportunities in the UK, Germany, and wider Europe, with financial results due in early 2026 expected to reflect the scale of expansion.

For more biotech updates and executive interviews, visit Proactive’s YouTube channel. Don’t forget to like this video, subscribe to the channel, and enable notifications for future content.

#Bioxyne #MedicalCannabis #MedicalMDMA #Psilocybin #PsychedelicMedicine #BreatheLifeSciences #PharmaceuticalManufacturing #BiotechStocks #MentalHealthTreatment
#AustraliaBiotech #PTSDTreatment #CannabisGummies #GlobalExpansion

Media coverage by Proactive  – https://www.proactiveinvestors.com.au/companies/news/1084635/bioxyne-2025-manufacturing-psychedelics-for-ptsd.html

In February 2024, Ukraine took a historic step. President Volodymyr Zelensky signed into law a bill legalizing the use of medical cannabis, marking a turning point in the country’s healthcare landscape — and perhaps in its collective healing. For a nation still grappling with the deep scars of war, this reform carries a significance far beyond medicine. It’s a gesture of compassion, progress, and resilience.

The new law allows cannabis-based medicines to be prescribed for conditions such as chronic pain, cancer-related symptoms, and post-traumatic stress disorder. In a country where millions live with the physical and psychological toll of conflict, that’s no small matter. The Ukrainian Ministry of Health estimates that as many as six million people may benefit from medical cannabis treatments, many of them veterans and civilians who have experienced unimaginable trauma.

Zelensky’s decision didn’t come out of nowhere. For months, he had been publicly advocating for medical cannabis legalization, urging lawmakers to “apply all the world’s best practices” to help those who suffer. The law was finally approved by parliament in late 2023 and signed at the start of 2024, reflecting both political will and social necessity. In his vision, this wasn’t just a policy change — it was a moral duty.

Implementation will take time, of course. The plan foresees the creation of a controlled network of pharmacies where cannabis-based medicines can be dispensed under prescription. Initial supplies are expected to be imported, while domestic cultivation — crucial for long-term sustainability — will likely take longer to organize. Estimates suggest that around two hundred pharmacies may eventually offer cannabis-based treatments across Ukraine. It’s a small start, but one with enormous symbolic and practical importance.

What makes this move particularly powerful is its timing. The war has left millions struggling with PTSD, anxiety, and chronic pain. Mental health care is stretched to its limits, and traditional treatments often fall short. By legalizing medical cannabis, Ukraine acknowledges both the suffering of its people and the need for new, evidence-based approaches to care. It’s a recognition that healing isn’t only about rebuilding cities — it’s also about mending minds.

Still, challenges lie ahead. Building a safe and effective medical cannabis system from scratch isn’t easy. Authorities must ensure that medicines are properly regulated, that quality is consistent, and that healthcare professionals receive the training they need to prescribe responsibly. The stigma surrounding cannabis use, though slowly fading, remains another barrier to overcome. Changing hearts and minds may prove just as difficult as drafting legislation.

Yet the potential rewards are significant. Beyond the immediate relief it could bring to patients, the new framework might strengthen Ukraine’s healthcare system as a whole. It could open new opportunities for research, pharmaceutical development, and even domestic cultivation — fostering an emerging industry that combines medical science with economic potential. In the long term, Ukraine could become a model for responsible and compassionate medical cannabis regulation in Eastern Europe.

There’s also something profoundly human about this reform. In times of war, societies often focus solely on survival — on defending borders and rebuilding infrastructure. But Ukraine’s decision to legalize medical cannabis suggests something deeper: a refusal to let suffering go untreated, and a determination to care for the invisible wounds that conflict leaves behind. It’s an act of healing at the national level, one that goes beyond politics.

For patients, it’s a long-awaited sign of hope. For doctors and pharmacists, it’s an opportunity to expand their tools for treatment. And for the country as a whole, it’s a step toward a more compassionate and modern healthcare future.

The road ahead will not be easy, but Ukraine’s commitment to improving the lives of those who’ve endured so much deserves recognition. This law is more than a piece of legislation — it’s a promise. A promise that, amid destruction and pain, healing is still possible.