Mayne Pharma’s unaudited first-quarter revenue fell 2% to A$95.7 million, while underlying EBITDA dropped 52% as generic competition hit Dermatology. Strong prescription growth in Women’s Health and DistributeRx offered a partial counterweight, alongside progress on key legal disputes.
- Underlying EBITDA fell 52% to A$5.3 million
- Women’s Health prescriptions rose across BIJUVA, IMVEXXY and NEXTSTELLIS
- Generic RHOFADE entry drove lower Dermatology sales and margins
- DistributeRx prescriptions increased 120% to 84,000
- IMVEXXY patent disputes and Cosette appeal proceedings advanced
Generic competition cuts first-quarter earnings
Mayne Pharma Group Limited (ASX:MYX) is trying to replace mature Dermatology earnings with faster-growing Women’s Health and direct-prescription channels. The transition was visible in its September quarter: revenue slipped 2% to A$95.7 million, but underlying EBITDA fell 52% to A$5.3 million.
The sharper earnings decline reflected the launch of a generic RHOFADE product in the United States during July, alongside lost payer coverage for TWYNEO. Gross profit fell 8% to A$60.3 million and direct contribution declined 23% to A$23.3 million. Reported EBITDA was a A$1.6 million loss after A$6.9 million in excluded legal and restructuring costs.
Mayne said the quarter also included planned investment in Women’s Health commercial capabilities. Adjusted operating cash flow from continuing operations was an outflow of A$2.1 million, primarily because rebates and chargebacks from earlier sales were paid during the quarter. Cash and marketable securities stood at A$67.3 million at 30 September.
Women’s Health demand continues to build
The brighter part of the portfolio remained Women’s Health. BIJUVA total prescriptions rose 25% year on year, IMVEXXY prescriptions increased 13%, and NEXTSTELLIS demand cycles climbed 27%. Segment revenue reached US$34.4 million, up 9%, with direct contribution rising 4% to US$12.8 million.
IMVEXXY net sales increased 39% to US$8.5 million, while BIJUVA sales rose 8% to US$4.5 million. NEXTSTELLIS sales grew 17% to US$14.7 million after expanded coverage increased commercial and Medicaid access to approximately 128 million US lives. ANNOVERA remained the weak point, with sales down 27% to US$5.9 million after Mayne reduced channel inventory to address elevated returns.
The company has now completed its post-marketing study requirements for IMVEXXY following confirmation from the US Food and Drug Administration. Its patent position also became clearer after the IMVEXXY patent settlements with Sun Pharma and Teva, which set potential generic entry dates in October and September 2032 respectively, subject to earlier-entry provisions.
DistributeRx scales ahead of Lexington expansion
DistributeRx delivered 84,000 prescriptions in the quarter, up 120% from the previous corresponding period and 35% from the June quarter. New prescriptions rose 198% year on year to 61,000, generated by 6,059 unique prescribers.
The direct-to-patient channel is intended to soften the impact of payer decisions and generic substitution in Dermatology. Its automated Adelaide Apothecary fulfilment facility in Lexington, Kentucky remains on track to begin operations in early 2027, with capacity planned to rise to more than 2.5 million prescriptions a year across two phases. Mayne said it was discussing the addition of about 11 products from other pharmaceutical companies.
The platform is growing from a low base, and its commercial contribution has not yet offset the broader Dermatology decline. Dermatology and DistributeRx revenue fell 16% to US$18.9 million, gross profit dropped 28% to US$10.7 million and direct contribution fell 61% to US$3.1 million.
Legal exposure narrows, but damages claim remains
The NSW Court of Appeal upheld the Supreme Court judgment in Mayne’s favour in the Cosette proceedings and awarded costs. The court rejected Cosette’s claim that it could terminate the Scheme Implementation Deed, while Mayne’s damages claim against Cosette, its related entities and individuals continues. The company had already recovered A$14.4 million in legal costs in June, following the Cosette legal costs ruling.
Separately, Mayne paid US$0.65 million to settle a US civil action brought by attorneys general from 49 states and territories concerning alleged anticompetitive conduct in generic pharmaceuticals. The settlement contains no admission of liability or wrongdoing and remains subject to court approval.
Mayne’s International segment provided another modest offset, with revenue up 13% to A$20.2 million. NEXTSTELLIS demand cycles in Australia rose 306% year on year after its PBS listing, while a five-year Australian licence for BLISSEL is scheduled to add another menopause product in FY28.
Bottom Line?
The next quarter should show whether Women’s Health and DistributeRx can grow quickly enough to absorb the continuing Dermatology earnings reset.
Questions in the middle?
- How much of the RHOFADE revenue and margin decline will remain after the authorised generic gains scale?
- Can the Lexington facility convert DistributeRx prescription growth into sustained contribution and cash generation?
- Will the Cosette damages claim produce a material recovery, or continue to consume legal resources?