Mayne Pharma Group Posts $31M FY26 Net Profit as Women’s Health Volumes Climb

FY26 results headline: Women’s Health momentum builds as Mayne Pharma returns to net profit

Mayne Pharma Group (ASX: MYX) reported its FY26 financial results for the 12 months ended 30 June 2026, recording revenue of $383.7 million (down 6% on the prior corresponding period) and underlying EBITDA of $34.2 million (down 27%).

The specialty pharmaceutical company delivered a reported net profit after tax of $31.2 million, a swing from the $90.1 million loss posted in FY25. That return to profit was driven largely by a $125.6 million non-cash earn-out liability re-assessment gain, not by operating outperformance.

Management framed FY26 as a year of foundation-building: increased investment behind the Women’s Health portfolio, the launch of the DistributeRx direct-to-patient distribution platform, and disruption arising from the Cosette transaction process. The results were reported across three operating segments — Women’s Health, Dermatology/DistributeRx, and International.

Q&A on the numbers: FY26 group financial results

The standout positive within the group financials was gross margin, which expanded 410 basis points to 64.7% despite lower revenue, reflecting disciplined pricing, portfolio mix and channel execution.

The 27% decline in underlying EBITDA reflected several structural drivers. These included a deliberate step-up in Women’s Health sales and marketing during the second half, unfavourable foreign exchange movements of approximately $1.9 million, roughly $7.1 million in short-term incentives recognised in FY26 (with nil paid in FY25), and a $5.6 million prior-period true-up benefit recognised in FY25 that was not repeated.

Cash and marketable securities closed at $80.0 million, down from $100.4 million a year earlier. The $20.4 million reduction was attributable to:

• $25.7 million in earn-out payments across royalties and the TWYNEO®/EPSOLAY® acquisition

• $12.6 million in Cosette transaction and litigation costs (net of $14.4 million recovered from Cosette)

• $8.1 million in discontinued operations outflows

• $8.4 million in capital leases, net capex and other items

CEO Commentary

“FY26 was a year in which we strengthened the foundations of the business and positioned the business for long term growth. While the Cosette transaction process and subsequent legal matters placed real demands on management focus and caused general disruption, we used the year to invest with conviction by increasing our Women’s Health sales and promotional capability to capture the strong momentum we are seeing across the portfolio, particularly in menopause,” said Aaron Gray, Chief Executive Officer.

Segment performance: Women’s Health leads the growth story

Women’s Health momentum

The Women’s Health segment recorded revenue of $174.3 million (down 2%), though underlying volume signals were more encouraging. BIJUVA® total prescriptions (TRx) rose 26%, IMVEXXY® TRx increased 6%, NEXTSTELLIS® demand cycles grew 15%, and ANNOVERA® TRx was up 2%.

A key tailwind was the removal of the FDA black box warning for BIJUVA®, announced in February 2026, which the company noted continues to support practitioner confidence and prescribing.

IMVEXXY safety data from a post-marketing study covering 9.5 million postmenopausal women found no increased risk of endometrial cancer from very-low-dose vaginal estrogen, a finding consistent with the FDA’s decision to remove box warnings from both IMVEXXY and BIJUVA prescribing information.

Not all metrics moved in the same direction. ANNOVERA® net sales fell 13% due to persistent product returns, prompting the company to shift to alternate sales channels with a more favourable returns profile and improved product economics.

Dermatology and DistributeRx traction

Dermatology revenue declined 10% to $138.7 million, yet the segment’s economics improved markedly. Gross margin expanded to 64% (up 19%) and direct contribution grew 11% to $44.5 million, reflecting the disintermediation strategy reshaping segment economics.

In its first full quarter, DistributeRx (including Adelaide Apothecary scripts) generated 62,000 total prescriptions, up 63% on the prior corresponding period. New prescriptions rose to 42,000, an increase of 104%, across 5,042 unique prescribers.

As at 30 June 2026, DistributeRx was in active discussions with seven pharmaceutical companies seeking to onboard their products, collectively representing approximately 13 products (around 11 dermatology and two non-dermatology).

International rebuild

International revenue eased 7% to $70.7 million as the segment transitioned toward higher margin products. NEXTSTELLIS® received Pharmaceutical Benefits Scheme (PBS) approval effective 1 October 2025, driving FY26 demand cycle growth of 127% versus the prior year. The $18 million Salisbury facility upgrade was inaugurated during the year, and delivered in full on time (DIFOT) performance improved to 97.4%.

Understanding disintermediation: why DistributeRx matters

The US pharmaceutical distribution system carries significant friction. High copayments, complex prior authorisations, formulary exclusions and intermediary fees can drive prescription abandonment and erode economics, while patients increasingly seek lower cost alternatives outside traditional insurance channels.

A direct-to-patient distribution platform aims to address these pain points. By using Adelaide Apothecary as its licensed pharmacy arm, DistributeRx is positioned to capture more margin and improve patient access by streamlining the route from prescriber to patient.

For investors, this represents Mayne Pharma’s structural bet on owning distribution economics rather than ceding margin to intermediaries. The planned seven-fold capacity expansion signals management conviction in the strategy.

Building capacity: the new automated facility and FY27 outlook

On 18 May 2026, the company announced that Adelaide Apothecary will relocate and expand to a new automated facility in Lexington, Kentucky. The build-out is expected to lift capacity approximately seven-fold to over 2.5 million prescriptions per annum across two phases, with up to US$2 million to complete Phase 1 and operations expected to commence in early 2027.

The Adelaide Apothecary expansion announcement in May 2026 provided fuller context on the demand conditions driving the investment, including a 73% surge in prescription volumes following the DistributeRx launch that significantly exceeded management expectations.

Management outlined FY27 priorities by segment:

1. Women’s Health — accelerate portfolio growth through a focused salesforce, refreshed marketing and improved prescriber access, underpinned by the removal of the HRT black box warning, particularly for BIJUVA®.

2. Dermatology/DistributeRx — scale the platform across additional products, while anticipating some loss of insurance coverage for TWYNEO® and generic RHOFADE® entry (launched July 2026).

3. International — build on NEXTSTELLIS® PBS growth and leverage the Salisbury investment to deliver export growth and contract manufacturing revenues.

4. Corporate — continue to evaluate capital-efficient, synergistic acquisitions alongside disciplined capital management.

Management framed FY27 as the year to convert commercial momentum into durable business performance, pointing to a refreshed leadership team and Board, and the $80.0 million cash and marketable securities position as backing for the plan.

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