Q4 2026 Mayne Pharma Group Ltd Earnings Call
Operator 1: Thank you for standing by, and welcome to the Mayne Pharma Group Limited Full Year 2026 results. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. If you would like to ask a question via the phone, you will need to press the star key followed by the number one on your telephone keypad. If you would like to ask a question via the webcast, please enter it into the Ask a Question box and click Submit. I would now like to hand the conference over to Mr. Aaron Gray, CEO. Please go ahead.
Operator: Thank you for standing by, and welcome to the Mayne Pharma Group Limited Full Year 2026 results. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. If you would like to ask a question via the phone, you will need to press the star key followed by the number one on your telephone keypad. If you would like to ask a question via the webcast, please enter it into the Ask a Question box and click Submit. I would now like to hand the conference over to Mr. Aaron Gray, CEO. Please go ahead.
Speaker #1: There will be a presentation followed by a question-and-answer session. If you would like to ask a question via the phone, you will need to press the star key followed by the number 1 on your telephone keypad.
Speaker #1: If you would like to ask a question via the webcast, please enter it into the Ask a Question box and click Submit. I am now pleased to hand the conference over to Mr. Aaron Gray.
Speaker #1: CEO. Please go ahead.
Speaker #2: Thank you, operator. Good morning, everyone, and thank you for joining Mayne Pharma's fiscal year '26 full-year results presentation. I'm Aaron Gray, Chief Executive Officer.
Aaron Gray: Thank you, operator. Good morning, everyone, and thank you for joining Mayne Pharma's Fiscal Year 2026 full year results presentation. I am Aaron Gray, Chief Executive Officer, and I am joined today by Griffin Buchanan, our Chief Financial Officer, who was appointed in August. Today, I will begin with our Fiscal 2026 corporate highlights and global footprint. Griffin will then take you through the group financial performance before I return to walk through each of the three segments, Women's Health, Dermatology and DistributRx, and International. We will then close with our future growth drivers and Fiscal Year 2027 focus and outlook. Then we will open the line for questions. Please take a moment to read the disclaimer regarding forward-looking statements and the use of non-IFRS measures. Today's comments should be read in conjunction with our audited financial statements and ASX disclosures. Excuse me.
Aaron Gray: Thank you, operator. Good morning, everyone, and thank you for joining Mayne Pharma's Fiscal Year 2026 full year results presentation. I am Aaron Gray, Chief Executive Officer, and I am joined today by Griffin Buchanan, our Chief Financial Officer, who was appointed in August. Today, I will begin with our Fiscal 2026 corporate highlights and global footprint. Griffin will then take you through the group financial performance before I return to walk through each of the three segments, Women's Health, Dermatology and DistributRx, and International. We will then close with our future growth drivers and Fiscal Year 2027 focus and outlook. Then we will open the line for questions. Please take a moment to read the disclaimer regarding forward-looking statements and the use of non-IFRS measures. Today's comments should be read in conjunction with our audited financial statements and ASX disclosures. Excuse me.
Speaker #2: And I'm joined today by Griffin Buchanan, our Chief Financial Officer, who was appointed in August. Today, I'll begin with our fiscal '26 corporate highlights and global footprint.
Speaker #2: Griffin will then take you through the group financial performance, before I return to walk through each of the three segments: Women's Health, Dermatology and Distributed Rx, and International.
Speaker #2: And we'll then close with our future growth drivers and fiscal year 2027 focus and outlook. Then we will open the line for questions. Please take a moment to read the disclaimer regarding forward-looking statements and the use of non-IFRS measures.
Speaker #2: Today's comments should be read in conjunction with our audited financial statements and ASX disclosures. Excuse me. Turning to slide 3 and our fiscal year 2026 corporate highlights.
Aaron Gray: Turning to slide 3 and our Fiscal Year 2026 corporate highlights. Fiscal Year 2026 was a year of resilience and focus against a backdrop of considerable distraction and disruption. First, as part of our realignment of the Women's Health sales force, we refreshed our sales and marketing materials to better support the team in the field. We also introduced dedicated menopause and contraception field representation, which will allow us to drive deeper, more meaningful engagement with our high-value prescribers. In particular, we are increasing our focus on menopause given the strong structural tailwinds behind it, which includes favorable regulatory changes, rising awareness, and robust market growth. Second, we launched DistributRx in March, a landmark step in our disintermediation strategy.
Aaron Gray: Turning to slide 3 and our Fiscal Year 2026 corporate highlights. Fiscal Year 2026 was a year of resilience and focus against a backdrop of considerable distraction and disruption. First, as part of our realignment of the Women's Health sales force, we refreshed our sales and marketing materials to better support the team in the field. We also introduced dedicated menopause and contraception field representation, which will allow us to drive deeper, more meaningful engagement with our high-value prescribers. In particular, we are increasing our focus on menopause given the strong structural tailwinds behind it, which includes favorable regulatory changes, rising awareness, and robust market growth. Second, we launched DistributRx in March, a landmark step in our disintermediation strategy.
Speaker #2: Fiscal year '26 was a year of resilience and focus against a backdrop of considerable distraction and disruption. First, as part of our realignment of the Women's Health salesforce, we refreshed our sales and marketing materials to better support the team in the field.
Speaker #2: We also introduced dedicated menopause and contraception field representation, which will allow us to drive deeper, more meaningful engagement with our high-value prescribers. In particular, we are increasing our focus on menopause, given the strong structural tailwinds behind it.
Speaker #2: Which includes favorable regulatory changes, rising awareness, and robust market growth. Second, we launched Distributed Rx in March—a landmark step in our disintermediation strategy.
Speaker #2: Distributed Rx is a healthcare solutions business that partners with manufacturers to streamline prescription distribution and expand patient access. It has exceeded expectations thus far.
Aaron Gray: DistributRx is a healthcare solutions business that partners with manufacturers to streamline prescription distribution and expand patient access, and it has exceeded expectations thus far, necessitating expansion to a new facility, which will include capital equipment that enables continued growth at scale. The new facility is expected to enable a sevenfold increase in capacity over two phases. Finally, the Cosette transaction process and subsequent legal matters placed considerable demands on management focus and organizational bandwidth. We received USD 14.4 million from Cosette in satisfaction of court-ordered legal costs and interest. The outcome of Cosette's appeal remains pending, and our damages claim against Cosette continues. We have also seen changes to the executive team and board. I was appointed CEO in February, having previously served as CFO, and Griffin joined as CFO in August.
Aaron Gray: DistributRx is a healthcare solutions business that partners with manufacturers to streamline prescription distribution and expand patient access, and it has exceeded expectations thus far, necessitating expansion to a new facility, which will include capital equipment that enables continued growth at scale. The new facility is expected to enable a sevenfold increase in capacity over two phases. Finally, the Cosette transaction process and subsequent legal matters placed considerable demands on management focus and organizational bandwidth. We received USD 14.4 million from Cosette in satisfaction of court-ordered legal costs and interest. The outcome of Cosette's appeal remains pending, and our damages claim against Cosette continues. We have also seen changes to the executive team and board. I was appointed CEO in February, having previously served as CFO, and Griffin joined as CFO in August.
Speaker #2: Necessitating expansion to a new facility, which will include capital equipment that enables continued growth at scale. The new facility is expected to enable a sevenfold increase in capacity over two phases.
Speaker #2: Finally, the Cosette transaction process and subsequent legal matters placed considerable demands on management focus and organizational bandwidth. We received $14.4 million from Cosette in satisfaction of court-ordered legal costs and interest.
Speaker #2: The outcome of Cosette's appeal remains pending, and our damages claim against Cosette continues. We've also seen changes to the executive team and board; I was appointed CEO in February, having previously served as CFO.
Speaker #2: And Griffin joined as CFO in August. Professor Bruce Robinson was appointed Chair, and we welcomed two new non-executive directors following three retirements from the Board.
Aaron Gray: Professor Bruce Robinson was appointed Chair, and we welcomed two new non-executive directors following three retirements from the board, strengthening the experience around the table. I am confident we have the right team to deliver in FY '27 and am excited by what the future holds for Mayne Pharma. This next slide sets out our global footprint. At 30 June 2026, the company employed a total of 470 people, 227 in the United States and 243 in Australia. The majority of our US headcount is focused on sales, with our women's health sales force at 102 employees across 91 territories and our DistributRx sales force at 28 employees across 23 territories. We operate in territories across the US with dedicated company locations in Lexington, Kentucky, and in Raleigh, North Carolina.
Aaron Gray: Professor Bruce Robinson was appointed Chair, and we welcomed two new non-executive directors following three retirements from the board, strengthening the experience around the table. I am confident we have the right team to deliver in FY '27 and am excited by what the future holds for Mayne Pharma. This next slide sets out our global footprint. At 30 June 2026, the company employed a total of 470 people, 227 in the United States and 243 in Australia. The majority of our US headcount is focused on sales, with our women's health sales force at 102 employees across 91 territories and our DistributRx sales force at 28 employees across 23 territories. We operate in territories across the US with dedicated company locations in Lexington, Kentucky, and in Raleigh, North Carolina.
Speaker #2: Strengthening the experience around the table, I am confident we have the right team to deliver in fiscal year 2027, and I am excited by what the future holds for Mayne Pharma.
Speaker #2: This next slide sets out our global footprint. At 30 June 2026, the company employed a total of 470 people—227 in the United States and 243 in Australia.
Speaker #2: The majority of our U.S. headcount is focused on sales, with our Women's Health Salesforce at 102 employees across 91 territories, and our Distributed Rx Salesforce at 28 employees across 23 territories.
Speaker #2: We operate in territories across the US, with dedicated company locations in Lexington, Kentucky, and in Raleigh, North Carolina. Our Australian employees are primarily supporting production at our facility in Salisbury, South Australia, developing and manufacturing products for sale into markets outside the US, including Canada, Europe, Asia, Australia, and New Zealand.
Aaron Gray: Our Australian employees are primarily supporting production at our facility in Salisbury, South Australia, developing and manufacturing products for sale into markets outside the US, including Canada, Europe, Asia, Australia, and New Zealand. Turning to our FY '26 financial highlights on slide 5. Group revenue was AUD 383.7 million, down 6% in Australian dollars on the prior year and significantly impacted by foreign exchange translation. Encouragingly, gross margin expanded to 64.7%, up 411 basis points, reflecting disciplined pricing, mix, and channel execution. Gross profit was essentially flat at AUD 248.1 million despite the lower revenue. Total direct segment contribution was AUD 107.1 million, down 2%. Underlying EBITDA was AUD 34.2 million, down 27% on the AUD 47 million delivered in FY '25.
Aaron Gray: Our Australian employees are primarily supporting production at our facility in Salisbury, South Australia, developing and manufacturing products for sale into markets outside the US, including Canada, Europe, Asia, Australia, and New Zealand. Turning to our FY '26 financial highlights on slide 5. Group revenue was AUD 383.7 million, down 6% in Australian dollars on the prior year and significantly impacted by foreign exchange translation. Encouragingly, gross margin expanded to 64.7%, up 411 basis points, reflecting disciplined pricing, mix, and channel execution. Gross profit was essentially flat at AUD 248.1 million despite the lower revenue. Total direct segment contribution was AUD 107.1 million, down 2%. Underlying EBITDA was AUD 34.2 million, down 27% on the AUD 47 million delivered in FY '25.
Speaker #2: Turning to our fiscal year '26 financial highlights on slide 5: Group revenue was $383.7 million, down 6% in Australian dollars on the prior year, and significantly impacted by foreign exchange translation.
Speaker #2: Encouragingly, gross margin expanded to 64.7%, up 411 basis points, reflecting disciplined pricing, mix, and channel execution. Gross profit was essentially flat at $248.1 million, despite the lower revenue.
Speaker #2: Total direct segment contribution was $107.1 million, down 2%. Underlying EBITDA was $34.2 million, down 27% on the $47 million delivered in fiscal year '25.
Speaker #2: I do want to briefly address the increase of $2.5 million to our underlying EBITDA between the announcement made on 31 July, when the company anticipated fiscal year 2026 underlying EBITDA of $31.7 million, to today's number of $34.2 million.
Aaron Gray: I do want to briefly address the increase of AUD 2.5 million to our underlying EBITDA between the announcement made on 31 July, when the company anticipated FY '26 underlying EBITDA of AUD 31.7 million to today's number of AUD 34.2 million. The 7.9% increase in underlying EBITDA announced today is driven by the company electing to treat the portion of share-based expense, which is attributable to retention as part of the continuing operations adjustments, given the one-off nature of this expense. We closed the year with cash and marketable securities of AUD 80 million. I will now turn the call over to Griffin to run investors through our numbers at the group level and the segment level. Please go ahead, Griffin.
Aaron Gray: I do want to briefly address the increase of AUD 2.5 million to our underlying EBITDA between the announcement made on 31 July, when the company anticipated FY '26 underlying EBITDA of AUD 31.7 million to today's number of AUD 34.2 million. The 7.9% increase in underlying EBITDA announced today is driven by the company electing to treat the portion of share-based expense, which is attributable to retention as part of the continuing operations adjustments, given the one-off nature of this expense. We closed the year with cash and marketable securities of AUD 80 million. I will now turn the call over to Griffin to run investors through our numbers at the group level and the segment level. Please go ahead, Griffin.
Speaker #2: The 7.9% increase in underlying EBITDA announced today is driven by the company electing to treat the portion of share-based expense which is attributable to retention as part of the continuing operations adjustments, given the one-off nature of this expense.
Speaker #2: We closed the year with cash and marketable securities of $80 million. I will now turn the call over to Griffin to run investors through our numbers at the group level and the segment level.
Speaker #2: Please go ahead, Griffin.
Speaker #3: Thank you, Aaron. I will cover our group performance before turning to our three segments. Turning to our continuing operations for FY26, reported revenue came in at $383.7 million.
Griffin Buchanan: Thank you, Aaron. I will cover our group performance before turning to our three segments. Turning to our continuing operations for FY '26, reported revenue came in at AUD 383.7 million, down 6% on FY '25's AUD 408.1 million. That decline was driven by three factors: appreciation of the Australian dollar against the US dollar, a decline in dermatology from the loss of certain insurance coverage, competitive erosion on some brands, and a decline in the international, as we transitioned our portfolio mix from lower to higher margin products and exited certain lines. Gross profit held essentially flat at AUD 248.1 million.
Griffin Buchanan: Thank you, Aaron. I will cover our group performance before turning to our three segments. Turning to our continuing operations for FY '26, reported revenue came in at AUD 383.7 million, down 6% on FY '25's AUD 408.1 million. That decline was driven by three factors: appreciation of the Australian dollar against the US dollar, a decline in dermatology from the loss of certain insurance coverage, competitive erosion on some brands, and a decline in the international, as we transitioned our portfolio mix from lower to higher margin products and exited certain lines. Gross profit held essentially flat at AUD 248.1 million.
Speaker #3: Down 6% on FY25's $408.1 million. That decline was driven by three factors: appreciation of the Australian dollar against the US dollar, a decline in dermatology from the loss of certain—.
Speaker #3: Insurance coverage, competitive erosion on some brands, and a decline in the international segment as we transitioned our portfolio mix from lower- to higher-margin products and exited certain lines.
Speaker #3: Gross profit held essentially flat at $248.1 million. Reported direct contribution was $107.1 million, down 2% on the prior year, reflecting higher sales and marketing investment in Women's Health, continued investment behind Nextellus PBS listing in Australia, and an increase in OPEX dermatology tied to higher volumes through Adelaide Apothecary, partially offset by an 11% increase in dermatology's own contribution.
Griffin Buchanan: Reported direct contribution was AUD 107.1 million, down 2% on the prior year, reflecting higher sales and marketing investment in women's health, continued investment behind NEXTSTELLIS PBS listing in Australia, and an increased OpEx dermatology tied to higher volumes through Adelaide Apothecary, partially offset by an 11% increase in dermatology's own contribution. Reported EBITDA was AUD 141.4 million, well above FY '25's AUD 18.4 million. Though that comparison is affected by one-offs, litigation, and restructuring charges, derivative fair value adjustment, and the largest impact coming from the lease of earn-out liabilities from a reduction in future revenue forecast of certain licensed products. On an underlying basis, EBITDA was AUD 34.2 million, down 27% year-on-year. Operating cash flows from continuing operations was broadly stable at AUD 24.9 million, while adjusted operating cash flow was AUD 34.5 million, down 24%, reflecting the timing and scale of these one-offs. Slide 8 bridges reported EBITDA to underlying EBITDA.
Griffin Buchanan: Reported direct contribution was AUD 107.1 million, down 2% on the prior year, reflecting higher sales and marketing investment in women's health, continued investment behind NEXTSTELLIS PBS listing in Australia, and an increased OpEx dermatology tied to higher volumes through Adelaide Apothecary, partially offset by an 11% increase in dermatology's own contribution. Reported EBITDA was AUD 141.4 million, well above FY '25's AUD 18.4 million. Though that comparison is affected by one-offs, litigation, and restructuring charges, derivative fair value adjustment, and the largest impact coming from the lease of earn-out liabilities from a reduction in future revenue forecast of certain licensed products.
Speaker #3: Reported EBITDA was $141.4 million, well above FY25's $18.4 million. Though that comparison is affected by one-offs, litigation and restructuring charges, derivative fair value adjustment, and the largest impact coming from the release of earn-out liabilities from a reduction in future revenue forecast of certain licensed products.
Speaker #3: On an underlying basis, EBITDA was $34.2 million, down 27% year on year. Operating cash flows from continuing operations were broadly stable at $24.9 million, while adjusted operating cash flow was $34.5 million, down 24%.
Griffin Buchanan: On an underlying basis, EBITDA was AUD 34.2 million, down 27% year-on-year. Operating cash flows from continuing operations was broadly stable at AUD 24.9 million, while adjusted operating cash flow was AUD 34.5 million, down 24%, reflecting the timing and scale of these one-offs. Slide 8 bridges reported EBITDA to underlying EBITDA.
Speaker #3: Reflecting the timing and scale of these one-offs, slide 8 bridges reported EBITDA to underlying EBITDA. Reported EBITDA was affected by significant scheme-related legal fees, including litigation, restructuring charges, and non-cash earn-out reassessment of the Women's Health portfolio.
Griffin Buchanan: Reported EBITDA was affected by significant scheme-related legal fees, including litigation, restructuring charges, and non-cash earn-out reassessment of the women's health portfolio. The earn-out reassessment is reflective of a reduction to future forecasted revenues, specifically for ANNOVERA. I have mentioned the reasons of the AUD 2.5 million increase in underlying EBITDA from the expectation we provided to the market on 31 July, reflecting the company's decision to treat the portion of share-based expense attributable to retention as part of the continuing operations adjustment, given the one-off nature of this expense. In addition, an underlying basis, the year-on-year decline reflects the general business disruption caused by the Cosette transaction, our deliberate step up in women's health sales and marketing, together with the higher mandatory post-approval study cost.
Griffin Buchanan: Reported EBITDA was affected by significant scheme-related legal fees, including litigation, restructuring charges, and non-cash earn-out reassessment of the women's health portfolio. The earn-out reassessment is reflective of a reduction to future forecasted revenues, specifically for ANNOVERA. I have mentioned the reasons of the AUD 2.5 million increase in underlying EBITDA from the expectation we provided to the market on 31 July, reflecting the company's decision to treat the portion of share-based expense attributable to retention as part of the continuing operations adjustment, given the one-off nature of this expense. In addition, an underlying basis, the year-on-year decline reflects the general business disruption caused by the Cosette transaction, our deliberate step up in women's health sales and marketing, together with the higher mandatory post-approval study cost.
Speaker #3: The earn-out reassessment is reflective of a reduction to future forecasted revenues, specifically for Anavera. I have mentioned the reasons for the $2.5 million increase in underlying EBITDA from the expectation we provided to the market on the 31st of July, reflecting the company's decision to treat the portion of share-based expense attributable to retention as part of the continuing operations adjustment, given the one-off nature of the expense.
Speaker #3: In addition, on an underlying basis, the year-on-year decline reflects the general business disruption caused by the Cosette transaction, our deliberate step-up in women's health sales and marketing, together with the higher mandatory post-approval study costs.
Speaker #3: Unfavorable foreign exchange of approximately $1.9 million as the Australian dollar appreciated. Short-term incentives of approximately $7.1 million are expected to be recognized in FY26 versus none in FY25.
Griffin Buchanan: Unfavorable foreign exchange of approximately 1.9 as the Australian dollar appreciated short-term incentives of approximately 7.1 expected to be recognized in FY '26 versus none in FY '25. In the absence of prior period managed care true-up benefits of approximately $5.6 million recognized in FY '25. Underlying EBITDA is a non-IFRS measure and is unaudited. Slide 9 walks you through the movement in cash and marketable securities from AUD 100.4 million at 30 June 2025 to AUD 80 million at 30 June 2026. The continuing business generated positive operating cash of approximately AUD 34.5 million, excluding the Cosette litigation and transactional cost of AUD 12.6 million, and we made payments of approximately AUD 12.5 million in royalties and an AUD 10.3 million earn-out payment for the TWYNEO and EPSOLAY acquisitions. The key message is the underlying business remains cash generative with the year's movement driven largely by discrete earn-out and litigation items.
Griffin Buchanan: Unfavorable foreign exchange of approximately 1.9 as the Australian dollar appreciated short-term incentives of approximately 7.1 expected to be recognized in FY '26 versus none in FY '25. In the absence of prior period managed care true-up benefits of approximately $5.6 million recognized in FY '25. Underlying EBITDA is a non-IFRS measure and is unaudited. Slide 9 walks you through the movement in cash and marketable securities from AUD 100.4 million at 30 June 2025 to AUD 80 million at 30 June 2026.
Speaker #3: In the absence of prior period managed care true-up benefits of approximately $5.6 million, recognized in FY25, underlying EBITDA is a non-IFRS measure and is unaudited.
Speaker #3: Slide 9 walks you through the movement in cash and marketable securities from $100.4 million at 30 June 2025 to $80 million at 30 June 2026.
Speaker #3: The continuing business generated positive operating cash of approximately $34.5 million, excluding the Cosette litigation and transactional costs of $12.6 million. We made payments of approximately $12.5 million in royalties and a $10.3 million earn-out payment for the 20 Obagi acquisitions.
Griffin Buchanan: The continuing business generated positive operating cash of approximately AUD 34.5 million, excluding the Cosette litigation and transactional cost of AUD 12.6 million, and we made payments of approximately AUD 12.5 million in royalties and an AUD 10.3 million earn-out payment for the TWYNEO and EPSOLAY acquisitions. The key message is the underlying business remains cash generative with the year's movement driven largely by discrete earn-out and litigation items.
Speaker #3: The key message is the underlying business remains cash generative, with this year's movement driven largely by discrete earn-out and litigation items. Now, turning to the segment performance.
Griffin Buchanan: Now turning to the segment performance. Slide 11 shows the FY '26 revenue and contribution split across three segments. Women's Health contributed revenue of AUD 174.3 million, Dermatology AUD 138.7 million, and International AUD 70.7 million. On total direct contribution of AUD 100.7 million, Women's Health delivered AUD 57.9 million, Dermatology AUD 44.5 million, and International AUD 4.6 million, underlying Women's Health and Dermatology as Mayne Pharma Group's primary earning engines. Slide 12 summarizes the operating highlights across the three segments. In Women's Health, the FDA removed the black box warning on BIJUVA in February of 2026. We made a targeted investment in sales, marketing, and patient access. We completed a sales force optimization for the menopause and contraception specialist in key metro markets, and we advanced the FDA-required post-marketing studies for ANNOVERA and IMVEXXY. In Dermatology, we launched TWYNEO and EPSOLAY, successfully launched DistributeRx in March, secured a major two-phase expansion at Adelaide Apothecary, and broadened the DistributeRx platform.
Griffin Buchanan: Now turning to the segment performance. Slide 11 shows the FY '26 revenue and contribution split across three segments. Women's Health contributed revenue of AUD 174.3 million, Dermatology AUD 138.7 million, and International AUD 70.7 million. On total direct contribution of AUD 100.7 million, Women's Health delivered AUD 57.9 million, Dermatology AUD 44.5 million, and International AUD 4.6 million, underlying Women's Health and Dermatology as Mayne Pharma Group's primary earning engines. Slide 12 summarizes the operating highlights across the three segments. In Women's Health, the FDA removed the black box warning on BIJUVA in February of 2026. We made a targeted investment in sales, marketing, and patient access.
Speaker #3: Slide 11 shows the FY26 revenue and contributions split across three segments. Women's Health contributed revenue of $174.3 million, Dermatology $138.7 million, and International $70.7 million.
Speaker #3: In total, direct contribution was $100.7 million. Women's health delivered $57.9 million, dermatology $44.5 million, and international $4.6 million, underlying women's health and dermatology as the group's primary earning engines.
Speaker #3: Slide 12 summarizes the operating highlights across the three segments. In Women's Health, the FDA removed the black box warning on Bhajuva in February of 2026.
Speaker #3: We made a targeted investment in sales, marketing, and patient access. We completed a Salesforce optimization for the menopause and contraception specialist and key metro markets, and we advanced the FDA-required post-marketing studies for Anavera and Invexi.
Griffin Buchanan: We completed a sales force optimization for the menopause and contraception specialist in key metro markets, and we advanced the FDA-required post-marketing studies for ANNOVERA and IMVEXXY. In Dermatology, we launched TWYNEO and EPSOLAY, successfully launched DistributeRx in March, secured a major two-phase expansion at Adelaide Apothecary, and broadened the DistributeRx platform.
Speaker #3: In dermatology, we launched 20, and Epsilon successfully launched distributed Rx in March. We secured a major two-phase expansion at Apocaly and broadened the distributed Rx platform.
Speaker #3: Signing the first third-party partner, we furthered manufacturing agreements and negotiations. Internationally, we inaugurated an $18 million upgrade at the Salisbury facility, which was recognized in export and business awards, and importantly, secured PBS approval for Nextellus.
Griffin Buchanan: Signing the first third-party partner, we further manufacture agreement in negotiation. In International, we inaugurated AUD 18 million in the Salisbury facility upgraded, which was recognized in export and business awards, and importantly, secured the PBS approval for NEXTSTELLIS in Australia, driving strong prescription growth, expanded KADIAN distribution in Canada, and improved Delivered in Full, On Time to 97.4%. Turning to the segment performance on slide 13, Women's Health is where the FX impact is most pronounced. Revenue was actually up 2% in US dollar terms at $118.2 million, but down 2% once translated to the Australian dollar at AUD 174.3 million. On an underlying consistent currency basis, the segment grew. That is reflected across the brand portfolio too. NEXTSTELLIS grew 6% in US dollars to $45.2 million, and BIJUVA grew 20% to $15 million US dollars, and direct contribution came in at AUD 57.9, down 7% on a reported basis.
Griffin Buchanan: Signing the first third-party partner, we further manufacture agreement in negotiation. In International, we inaugurated AUD 18 million in the Salisbury facility upgraded, which was recognized in export and business awards, and importantly, secured the PBS approval for NEXTSTELLIS in Australia, driving strong prescription growth, expanded KADIAN distribution in Canada, and improved Delivered in Full, On Time to 97.4%. Turning to the segment performance on slide 13, Women's Health is where the FX impact is most pronounced. Revenue was actually up 2% in US dollar terms at $118.2 million, but down 2% once translated to the Australian dollar at AUD 174.3 million.
Speaker #3: In Australia, we are driving strong prescription growth, expanding Cadian distribution in Canada, and improving delivered-in-full on-time to 97.4%. Turning to the segment performance on slide 13, women's health is where the FX impact is most pronounced.
Speaker #3: Revenue was actually up 2% in US dollar terms at $118.2 million, but down 2% once translated to the Australian dollar at $174.3 million. So, on an underlying, constant currency basis, the segment grew.
Griffin Buchanan: On an underlying consistent currency basis, the segment grew. That is reflected across the brand portfolio too. NEXTSTELLIS grew 6% in US dollars to $45.2 million, and BIJUVA grew 20% to $15 million US dollars, and direct contribution came in at AUD 57.9, down 7% on a reported basis.
Speaker #3: That's reflected across the brand portfolio too. Nextellus grew 6% in US dollars to $45.2 million, and Bhajuva grew 20% to $15 million US dollars, and direct contribution came in at $57.9 million, down 7% on a reported basis.
Speaker #3: For dermatology, revenue was $94.1 million, down 6% on a US dollar basis, but once translated into Australian dollars, that becomes $138.7 million, down 10%.
Griffin Buchanan: For Dermatology, revenue was $94.1 million, down 6% on the US dollar basis, but once translated into US dollars, that becomes $138.7 million, down 10%. Direct OpEx was up 4% to AUD 44.2 million. Gross profit rose 7% to AUD 88.7 million on a 63.9% margin, and a direct contribution grew 11% to AUD 44.5 million. International delivered revenue of AUD 70.7 million, down 7%, with direct OpEx up 18% to AUD 16.7 million, and direct contribution down 38% to AUD 4.6 million. These figures are reported in Australian dollars without a material US dollar cross-currency effect. I will now hand the call back to Aaron to walk through the particular segment highlights. Please go ahead, Aaron.
Griffin Buchanan: For Dermatology, revenue was $94.1 million, down 6% on the US dollar basis, but once translated into US dollars, that becomes $138.7 million, down 10%. Direct OpEx was up 4% to AUD 44.2 million. Gross profit rose 7% to AUD 88.7 million on a 63.9% margin, and a direct contribution grew 11% to AUD 44.5 million. International delivered revenue of AUD 70.7 million, down 7%, with direct OpEx up 18% to AUD 16.7 million, and direct contribution down 38% to AUD 4.6 million. These figures are reported in Australian dollars without a material US dollar cross-currency effect. I will now hand the call back to Aaron to walk through the particular segment highlights. Please go ahead, Aaron.
Speaker #3: Direct OPEX was up 4% to $44.2 million. Gross profit rose 7% to $88.7 million, on a 63.9% margin, and direct contribution grew 11% to $44.5 million.
Speaker #3: International delivered revenue of $70.7 million, down 7%, with direct opex up 18% to $16.7 million, and direct contribution down 38% to $4.6 million. These figures are reported in Australian dollars without a material US dollar cross-currency effect.
Speaker #3: I will now hand the call back to Aaron to walk through the particular segment highlights. Please go ahead, Aaron.
Speaker #1: Thanks, Griffin. Now, going into some further detail on women's health—slide 15 frames the menopause opportunity, which underpins Bhajuva and Invexi. The category is being de-risked by regulatory changes with the FDA's removal of the black box warning for certain hormone replacement therapies, including Bhajuva.
Aaron Gray: Thanks, Griffin. Now going into some further detail on Women's Health. Slide 15 frames the menopause opportunity, which underpins BIJUVA and IMVEXXY. The category is being de-risked by regulation changes with the FDA's removal of the black box warning for certain hormone replacement therapies, including BIJUVA. There is a powerful demographic tailwind with around 75 million women in the United States now in peri or post-menopause and a further 1.3 million entering each year. A market that remains significantly underserved. Celebrity-led destigmatization is converting awareness into clinical demand. Payer coverage is expanding, and independent estimates see the menopause market growing from around US $10 to $15 billion in 2026 to US $15 to $25 billion by 2030, or an estimated 60% growth. We invested in a specialist menopause sales force in the second half, given the category's potential.
Aaron Gray: Thanks, Griffin. Now going into some further detail on Women's Health. Slide 15 frames the menopause opportunity, which underpins BIJUVA and IMVEXXY. The category is being de-risked by regulation changes with the FDA's removal of the black box warning for certain hormone replacement therapies, including BIJUVA. There is a powerful demographic tailwind with around 75 million women in the United States now in peri or post-menopause and a further 1.3 million entering each year. A market that remains significantly underserved. Celebrity-led destigmatization is converting awareness into clinical demand. Payer coverage is expanding, and independent estimates see the menopause market growing from around US $10 to $15 billion in 2026 to US $15 to $25 billion by 2030, or an estimated 60% growth. We invested in a specialist menopause sales force in the second half, given the category's potential.
Speaker #1: There is a powerful demographic tailwind, with around 75 million women in the United States now in peri- or post-menopause, and a further 1.3 million entering each year.
Speaker #1: A market that remains significantly underserved. Celebrity-led destigmatization is converting awareness into clinical demand. Payer coverage is expanding, and independent estimates see the menopause market growing from around $10 to $15 billion in 2026 to $15 to $25 billion by 2030, or an estimated 60% growth.
Speaker #1: We invested in a specialist menopause salesforce in the second half, given the category's potential. Bhajuva delivered total prescription growth of 26% and net sales up 20% to $15 million.
Aaron Gray: BIJUVA delivered total prescription growth of 26% and net sales up 20% to US $15 million. IMVEXXY grew prescription 6%, with net sales up 8% to US $29.3 million. Slide 16 covers contraception and NEXTSTELLIS. Key drivers include expanding payer willingness to cover open, affordable contraceptive access under the Affordable Care Act, growing digital and direct-to-patient access through telehealth and online pharmacies, and improved payer coverage that drove a significant step-up in volumes in Q4. We added approximately 15 million additional covered lives in FY '26. NEXTSTELLIS delivered demand cycles up 15% and net sales up 6% to US $45.2 million. ANNOVERA saw prescriptions up 2%, though net sales were down 13% to US $25.7 million, reflecting persistent product returns, which we are actively working to address. Turning now to dermatology and DistributeRx on slide 17.
Aaron Gray: BIJUVA delivered total prescription growth of 26% and net sales up 20% to US $15 million. IMVEXXY grew prescription 6%, with net sales up 8% to US $29.3 million. Slide 16 covers contraception and NEXTSTELLIS. Key drivers include expanding payer willingness to cover open, affordable contraceptive access under the Affordable Care Act, growing digital and direct-to-patient access through telehealth and online pharmacies, and improved payer coverage that drove a significant step-up in volumes in Q4. We added approximately 15 million additional covered lives in FY '26. NEXTSTELLIS delivered demand cycles up 15% and net sales up 6% to US $45.2 million. ANNOVERA saw prescriptions up 2%, though net sales were down 13% to US $25.7 million, reflecting persistent product returns, which we are actively working to address. Turning now to dermatology and DistributeRx on slide 17.
Speaker #1: Invexi grew prescriptions 6%, with net sales up 8% to US$29.3 million. Slide 16 covers contraception and Nextellus. Key drivers include expanding payer willingness to cover open, affordable contraceptive access under the Affordable Care Act, growing digital and direct-to-patient access through telehealth and online pharmacies, and improved payer coverage that drove a significant step up in volumes in the fourth quarter.
Speaker #1: We added approximately 15 million additional covered lives in fiscal year '26. Nextellus delivered demand cycles up 15%, and net sales up 6%, to US $45.2 million.
Speaker #1: Anovera saw prescriptions up 2%, though net sales were down 13% to $25.7 million, reflecting persistent product returns, which we are actively working to address.
Speaker #1: Turning now to dermatology and distributed RX. On slide 17. Slide 18 shows how a shift in our dermatology product mix is driving margin and contribution growth.
Aaron Gray: Slide 18 shows how a shift in our dermatology product mix is driving margin and contribution growth. Branded products increased as a share of the portfolio from around 54% in FY '25 to 58% in FY '26. That shift, combined with continued channel optimization, drove gross margin and contribution growth even against a lower revenue base. Slide 19 sets out our dermatology portfolio, a mix of branded and generic products. Six branded products and 25 generic and authorized generic products for 31 total Mayne Pharma dermatology products with long-dated patent protection extending in some cases to 2041. I should note that a generic RHOFADE launched in July 2026 as expected. Slide 20 explains our disintermediation strategy. Removing intermediaries between Mayne Pharma as manufacturer and between the patient.
Aaron Gray: Slide 18 shows how a shift in our dermatology product mix is driving margin and contribution growth. Branded products increased as a share of the portfolio from around 54% in FY '25 to 58% in FY '26. That shift, combined with continued channel optimization, drove gross margin and contribution growth even against a lower revenue base. Slide 19 sets out our dermatology portfolio, a mix of branded and generic products. Six branded products and 25 generic and authorized generic products for 31 total Mayne Pharma dermatology products with long-dated patent protection extending in some cases to 2041. I should note that a generic RHOFADE launched in July 2026 as expected. Slide 20 explains our disintermediation strategy. Removing intermediaries between Mayne Pharma as manufacturer and between the patient.
Speaker #1: Branded products increased as a share of the portfolio, from around 54% in fiscal year '25 to 58% in fiscal '26. That shift, combined with continued channel optimization, drove gross margin and contribution growth even against a lower revenue base.
Speaker #1: Slide 19 sets out our dermatology portfolio—a mix of branded and generic products. We have six branded products and 25 generic and authorized generic products, for a total of 31 main pharma dermatology products.
Speaker #1: With long-dated patent protection extending, in some cases, to 2041. I should note that a generic Rofade launched in July 2026, as expected. Slide 20 explains our disintermediation strategy—removing intermediaries between Mayne Pharma as manufacturer and the patient.
Speaker #1: The US pharmacy distribution system creates real friction. Handoffs, stage gates, opaque financial incentives, and obstructions that increase cost to patients and manufacturers through rebates and fees increase unfilled prescriptions from barriers and outright abandonment, and create significant additional effort for patients and HCPs to attempt to get the prescribed medication into the hands of the patient.
Aaron Gray: The US pharmacy distribution system creates real friction, handoffs, stage gates, opaque financial incentives, and obstructions that increase cost to patients and manufacturers through rebates and fees, increase unfilled prescriptions from barriers and outright abandonment, and create significant additional effort to patients and HCPs to attempt to get the prescribed medication into the hands of the patient. DistributeRx with Adelaide Apothecary as our licensed cash pay pharmacy arm addresses that friction. Mayne has been focused on these problems for five-plus years, and as a result, FY '26 saw approximately 60% of our US women's health and dermatology volumes move through those non-traditional channels. Slide 21. DistributeRx is a wholly owned subsidiary of Mayne Pharma, focused on partnership with manufacturers, providers, and pharmacies to improve patient access and offer predictable prices. We compete in the e-pharmacy market space. This market is expected to reach around US $252 billion by 2030.
Aaron Gray: The US pharmacy distribution system creates real friction, handoffs, stage gates, opaque financial incentives, and obstructions that increase cost to patients and manufacturers through rebates and fees, increase unfilled prescriptions from barriers and outright abandonment, and create significant additional effort to patients and HCPs to attempt to get the prescribed medication into the hands of the patient. DistributeRx with Adelaide Apothecary as our licensed cash pay pharmacy arm addresses that friction. Mayne has been focused on these problems for five-plus years, and as a result, FY '26 saw approximately 60% of our US women's health and dermatology volumes move through those non-traditional channels. Slide 21. DistributeRx is a wholly owned subsidiary of Mayne Pharma, focused on partnership with manufacturers, providers, and pharmacies to improve patient access and offer predictable prices. We compete in the e-pharmacy market space. This market is expected to reach around US $252 billion by 2030.
Speaker #1: Distributed RX, with Adelaide Apothecary as our licensed cash-pay pharmacy arm, addresses that friction. Mayne has been focused on these problems for five-plus years, and as a result, fiscal year '26 saw approximately 60% of our U.S. women's health and dermatology volumes move through those non-traditional channels.
Speaker #1: Slide 21. Distributed RX is a wholly owned subsidiary of Mayne Pharma focused on partnership with manufacturers, providers, and pharmacies to improve patient access and offer predictable prices.
Speaker #1: We compete in the e-pharmacy market space. This market is expected to reach around $252 billion by 2030. The launch of distributed RX materially exceeded expectations.
Aaron Gray: The launch of DistributeRx materially exceeded expectations, delivering strong prescription growth ahead of forecast and the prior corresponding period, with around 5,000 new prescribers added since launch. In May, we announced a major expansion of Adelaide Apothecary in Lexington, Kentucky, lifting capacity to up to 2.5 million prescriptions per annum across two phases, with around US $4 million invested for capital equipment and automation. Slide 22 shows the total DistributeRx portfolio, including the Mayne Pharma and non-Mayne products. At present, the channel carries the previously mentioned 31 Mayne Pharma dermatology products alongside a further 208 third-party products with a pipeline of additional products across several new manufacturers, including our first third-party partnership with Resilia Pharmaceuticals, announced 1 June 2026. Turning now to our final segment, international. NEXTSTELLIS was added to the PBS on 1 October 2025.
Aaron Gray: The launch of DistributeRx materially exceeded expectations, delivering strong prescription growth ahead of forecast and the prior corresponding period, with around 5,000 new prescribers added since launch. In May, we announced a major expansion of Adelaide Apothecary in Lexington, Kentucky, lifting capacity to up to 2.5 million prescriptions per annum across two phases, with around US $4 million invested for capital equipment and automation. Slide 22 shows the total DistributeRx portfolio, including the Mayne Pharma and non-Mayne products. At present, the channel carries the previously mentioned 31 Mayne Pharma dermatology products alongside a further 208 third-party products with a pipeline of additional products across several new manufacturers, including our first third-party partnership with Resilia Pharmaceuticals, announced 1 June 2026. Turning now to our final segment, international. NEXTSTELLIS was added to the PBS on 1 October 2025.
Speaker #1: Delivering strong prescription growth ahead of forecast and the prior corresponding period, with around 5,000 new prescribers added since launch. In May, we announced a major expansion of Adelaide Apothecary in Lexington, Kentucky, lifting capacity to up to 2.5 million prescriptions per annum across two phases.
Speaker #1: With around US$4 million invested for capital equipment and automation, Slide 22 shows the total distributed RX portfolio, including the main pharma and non-main products.
Speaker #1: At present, the channel carries the previously mentioned 31 main pharma dermatology products, alongside a further 208 third-party products, with a pipeline of additional products across several new manufacturers, including our first third-party partnership with Resilia Pharmaceuticals, announced on June 1, 2026.
Speaker #1: Turning now to our final segment, International. Nextellus was added to the PBS on the 1st of October 2025, with around 1.7 million Australian women using contraception each year. Following our investment in sales and marketing post-listing, we've generated strong prescription growth, with Australian demand cycles rising materially through the second half and reaching record levels. Slide 25 sets out our future growth drivers.
Aaron Gray: With around 1.7 million Australian women using contraception each year and following our investment in sales and marketing post-listing, we have generated strong prescription growth, with Australian demand cycles rising materially through the H2 and reaching record. Slide 25 sets out our future growth drivers. In women's health, our strong intellectual property and current market share provides ample headroom to continue to grow all products. We have a significant market opportunity in the hormone replacement therapy space with the promotion, sales execution, and access all in the right position at the right time to pursue this opportunity. In dermatology, the Mayne products can address as many as one in three derm conditions, and there is an acute and growing need for improved patient access, price transparency, and process efficiency. The DistributeRx solution has been purpose-built, tested, and launched to address these needs.
Aaron Gray: With around 1.7 million Australian women using contraception each year and following our investment in sales and marketing post-listing, we have generated strong prescription growth, with Australian demand cycles rising materially through the H2 and reaching record. Slide 25 sets out our future growth drivers. In women's health, our strong intellectual property and current market share provides ample headroom to continue to grow all products. We have a significant market opportunity in the hormone replacement therapy space with the promotion, sales execution, and access all in the right position at the right time to pursue this opportunity. In dermatology, the Mayne products can address as many as one in three derm conditions, and there is an acute and growing need for improved patient access, price transparency, and process efficiency. The DistributeRx solution has been purpose-built, tested, and launched to address these needs.
Speaker #1: In women's health, our strong intellectual property and current market share provide ample headroom to continue to grow all products. We have a significant market opportunity in the hormone replacement therapy space, with promotion, sales execution, and access all in the right position at the right time to pursue this opportunity.
Speaker #1: In dermatology, the main products can address as many as one in three derm conditions, and there is an acute and growing need for improved patient access, price transparency, and process efficiency.
Speaker #1: The distributed Rx solution has been purpose-built, tested, and launched to address these needs. We do see opportunities to continue to expand our asset portfolio with a focus on profitability and capital efficiency, and, as mentioned, have a number of promising manufacturing partnerships in the works.
Aaron Gray: We do see opportunities to continue to expand our asset portfolio with a focus on profitability and capital efficiency and, as mentioned, have a number of promising manufacturing partnerships in work. In international, NEXTSTELLIS growth has accelerated following the PBS tailwind and the Salisbury capacity upgrade together with significant business development efforts will add partnerships to grow exports and add products. Slide 26 summarizes our FY '27 focus. In women's health, we will leverage the current commercial structure to grow where the opportunities are greatest. Improved coverage on NEXTSTELLIS, removal of the black box warning on BIJUVA, and general increase in awareness on hormone replacement therapies to treat menopause creates significant opportunity. We will further optimize how our products move through distribution channels to improve patient and manufacturer outcomes.
Aaron Gray: We do see opportunities to continue to expand our asset portfolio with a focus on profitability and capital efficiency and, as mentioned, have a number of promising manufacturing partnerships in work. In international, NEXTSTELLIS growth has accelerated following the PBS tailwind and the Salisbury capacity upgrade together with significant business development efforts will add partnerships to grow exports and add products. Slide 26 summarizes our FY '27 focus. In women's health, we will leverage the current commercial structure to grow where the opportunities are greatest. Improved coverage on NEXTSTELLIS, removal of the black box warning on BIJUVA, and general increase in awareness on hormone replacement therapies to treat menopause creates significant opportunity. We will further optimize how our products move through distribution channels to improve patient and manufacturer outcomes.
Speaker #1: In International, Nextellus growth has accelerated following the PBS tailwind, and the Salisbury capacity upgrade, together with significant business development efforts, will add partnerships to grow exports and add products.
Speaker #1: Slide 26 summarizes our fiscal year '27 focus. In women's health, we will leverage the current commercial structure to grow where the opportunities are greatest.
Speaker #1: Improved coverage on Nextellus, removal of the black box warning on Bajuva, and the general increase in awareness of hormone replacement therapies to treat menopause create significant opportunity.
Speaker #1: We will further optimize how our products move through distribution channels to improve patient and manufacturer outcomes. In dermatology, we will grow the portfolio and optimize supply and pricing in the face of some anticipated loss of insurance coverage on Twenio and generic entry against Rofade.
Aaron Gray: In dermatology, we will grow the portfolio and optimize supply and pricing in the face of some anticipated loss of insurance coverage on TWYNEO and generic entry against RHOFADE. DistributeRx will be focused on prescription growth with addition of territories, products, and partnerships driving growth in new and repeat writers. In international, we will build on NEXTSTELLIS growth and leverage the Salisbury investment for export and contract manufacturing growth. At a corporate level, we will continue to evaluate capital efficient, synergistic acquisitions alongside disciplined capital management. In closing, FY '26 was a year in which we strengthened the foundations of the business, and we enter FY '27 with clear commercial momentum and a disciplined plan to convert it into durable, profitable growth. I would like to thank all of the Mayne Pharma employees who all contributed to make that happen. That concludes our formal presentation.
Aaron Gray: In dermatology, we will grow the portfolio and optimize supply and pricing in the face of some anticipated loss of insurance coverage on TWYNEO and generic entry against RHOFADE. DistributeRx will be focused on prescription growth with addition of territories, products, and partnerships driving growth in new and repeat writers. In international, we will build on NEXTSTELLIS growth and leverage the Salisbury investment for export and contract manufacturing growth. At a corporate level, we will continue to evaluate capital efficient, synergistic acquisitions alongside disciplined capital management. In closing, FY '26 was a year in which we strengthened the foundations of the business, and we enter FY '27 with clear commercial momentum and a disciplined plan to convert it into durable, profitable growth. I would like to thank all of the Mayne Pharma employees who all contributed to make that happen. That concludes our formal presentation.
Speaker #1: Distributed RX will be focused on prescription growth, with the addition of territories, products, and partnerships driving growth in new and repeat writers. In international, we will build on Nextellus growth and leverage the Salisbury investment for export and contract manufacturing growth.
Speaker #1: And at a corporate level, we will continue to evaluate capital-efficient, synergistic acquisitions alongside disciplined capital management. In closing, fiscal year '26 was a year in which we strengthened the foundations of the business, and we enter fiscal year '27 with clear commercial momentum and a disciplined plan to convert it into durable, profitable growth. I would like to thank all of the Mayne Pharma employees, who all contributed to make that happen.
Speaker #1: That concludes our formal presentation. Griffin and I would now be happy to take your questions. Our investor relations contact details are on screen.
Aaron Gray: Griffin and I would now be happy to take your questions. Our investor relations contact details are on screen.
Aaron Gray: Griffin and I would now be happy to take your questions. Our investor relations contact details are on screen.
Speaker #2: Thank you. If you would like to ask a question via the phone, you'll need to press the star key followed by the number one on your telephone keypad.
Operator 2: Thank you. If you would like to ask a question via the phone, you will need to press the star key followed by the number 1 on your telephone keypad. If you would like to ask a question via the webcast, please type your question into the Ask a Question box and click Submit. I would first like to hand over to Mr. Tom Duthy to address any pre-submitted questions.
Operator: Thank you. If you would like to ask a question via the phone, you will need to press the star key followed by the number 1 on your telephone keypad. If you would like to ask a question via the webcast, please type your question into the Ask a Question box and click Submit. I would first like to hand over to Mr. Tom Duthy to address any pre-submitted questions.
Speaker #2: If you'd like to ask a question via the webcast, please type your question into the 'Ask a Question' box and click submit. I'd first like to hand over to Mr. Tom Doothy to address any pre-submitted questions.
Speaker #3: Thank you very much, Darcy. We've had a couple of questions relating to the distributed RX manufacturing pipeline, or manufacturer pipeline. So, Aaron, this is a consolidated question.
Tom Duthy: Thank you very much, Darcy. We have had a couple of questions relating to the DistributeRx manufacturing pipeline or manufacturer pipeline. Aaron, this is a consolidated question. One DistributeRx manufacturer, Resilia Pharmaceuticals, is signed, and 7 more are in negotiation covering 13 pipeline products. What revenue uplift should the market expect as those progressively convert? On what timeline do we anticipate these to be converted? Thank you.
Tom Duthy: Thank you very much, Darcy. We have had a couple of questions relating to the DistributeRx manufacturing pipeline or manufacturer pipeline. Aaron, this is a consolidated question. One DistributeRx manufacturer, Resilia Pharmaceuticals, is signed, and 7 more are in negotiation covering 13 pipeline products. What revenue uplift should the market expect as those progressively convert? On what timeline do we anticipate these to be converted? Thank you.
Speaker #3: One distributed Rx manufacturer, Resilia Pharma, is signed, and seven more are in negotiation, covering 13 pipeline products. What revenue uplift should the market expect as those progressively convert, and on what timeline do we anticipate these to be converted?
Speaker #3: Thank you.
Speaker #1: Thanks, Tom, and thanks for the question. The expansion of these arrangements is driven by manufacturers seeing what Mayne Pharma sees—namely, that distributed Rx is a value-added channel for their products.
Aaron Gray: Thanks, Tom, and thanks for the question. The expansion for these arrangements is driven by manufacturers seeing what Mayne Pharma sees. Namely, that DistributeRx is a value-added channel for their products. As mentioned, we have 7 additional manufacturers in negotiation covering 13 different products. We would expect to convert a significant percentage of those manufacturers in the near term. We do not specifically provide revenue guidance for DistributeRx, but do expect to be able to provide the market with some numbers at the H1 of FY '27. We do anticipate extending beyond dermatology as well, so some of those products that we would add may expand beyond the dermatology therapeutic area.
Aaron Gray: Thanks, Tom, and thanks for the question. The expansion for these arrangements is driven by manufacturers seeing what Mayne Pharma sees. Namely, that DistributeRx is a value-added channel for their products. As mentioned, we have 7 additional manufacturers in negotiation covering 13 different products. We would expect to convert a significant percentage of those manufacturers in the near term. We do not specifically provide revenue guidance for DistributeRx, but do expect to be able to provide the market with some numbers at the H1 of FY '27. We do anticipate extending beyond dermatology as well, so some of those products that we would add may expand beyond the dermatology therapeutic area.
Speaker #1: As mentioned, we have seven additional manufacturers in negotiation, covering 13 different products. We would expect to convert a significant percentage of those manufacturers in the near term.
Speaker #1: We don't specifically provide revenue guidance for distributed RX, but we do expect to be able to provide the market with some numbers in the first half of fiscal year 2027.
Speaker #1: We do anticipate extending beyond dermatology as well. So, some of those products that we would add may expand beyond the dermatology therapeutic area.
Speaker #3: Thank you, Aaron. The next question relates to menopause. Menopause is clearly central to your growth story for Bajuva and Invexy, and the FDA black box warning removal.
Tom Duthy: Thank you, Aaron. The next question relates to menopause. Menopause is clearly central to your growth story, BIJUVA and IMVEXXY, and the FDA black box warning removal. With Mayne Pharma as currently indicated to the market, holding a very low single-digit share of these markets. The question is, why are you so confident menopause is a growth driver for this business? What needs to be true for Mayne to capture a disproportionate share of that expansion?
Tom Duthy: Thank you, Aaron. The next question relates to menopause. Menopause is clearly central to your growth story, BIJUVA and IMVEXXY, and the FDA black box warning removal. With Mayne Pharma as currently indicated to the market, holding a very low single-digit share of these markets. The question is, why are you so confident menopause is a growth driver for this business? What needs to be true for Mayne to capture a disproportionate share of that expansion?
Speaker #3: With Mayne Pharma, as currently indicated to the market, holding a very low single-digit share of these markets, the question is: why are you so confident menopause is a growth driver for this business, and what needs to be true for Mayne to capture a disproportionate share of that expansion?
Speaker #1: Thanks for that question. Menopause has been an area that was, especially in the US, severely impacted by a study that was performed in 2002.
Aaron Gray: Thanks for that question. Menopause has been an area that was, especially in the US, severely impacted by a study that was performed in 2002. In the year 2000, as many as 27% of women in the United States used hormone replacement therapy for menopause symptoms. Following the WHI study that I mentioned in 2002, that usage declined to around 4% to 6% of women. The use declined from 27% to something around 5%. Consumer behavior, knowledge of healthcare providers, and regulators signaling an increased acceptance with black box warning removal have all spurred significant growth. This market, expect to grow as much as 60% by 2030. A reasonable proxy is Europe, where today approximately 16% of women use hormone replacement therapy for menopause symptoms. The products that we have are best-in-class products.
Aaron Gray: Thanks for that question. Menopause has been an area that was, especially in the US, severely impacted by a study that was performed in 2002. In the year 2000, as many as 27% of women in the United States used hormone replacement therapy for menopause symptoms. Following the WHI study that I mentioned in 2002, that usage declined to around 4% to 6% of women. The use declined from 27% to something around 5%. Consumer behavior, knowledge of healthcare providers, and regulators signaling an increased acceptance with black box warning removal have all spurred significant growth. This market, expect to grow as much as 60% by 2030. A reasonable proxy is Europe, where today approximately 16% of women use hormone replacement therapy for menopause symptoms. The products that we have are best-in-class products.
Speaker #1: In the year 2000, as many as 27% of women in the United States used hormone replacement therapy for menopause symptoms. Following the WHI study that I mentioned in 2002, that usage declined to around 4% to 6% of women.
Speaker #1: So the use declined from 27% to something around 5%. Consumer behavior, knowledge of healthcare providers, and regulators signaling an increased acceptance with black box warning removal have all spurred significant growth.
Speaker #1: With this market expected to grow as much as 60% by 2030. A reasonable proxy is Europe, where today approximately 16% of women use hormone replacement therapy for menopause symptoms.
Speaker #1: The products that we have are best-in-class products—they have an accretive cash profile versus some of our other products. And they've been at the center of some of the investments that we've made to increase digital and in-person promotion of menopause products, and the growth that we've seen to date actually predates those investments.
Aaron Gray: They have an accretive cash profile versus some of our other products, and they've been at the center of some of the investments that we've made to increase digital and in-person promotion of menopause products. The growth that we've seen to date actually predates those investments. We've made targeted investments. We've made those investments with very grounded assessments of what those investments will be worth, and we are already seeing the positive results of those investments.
Aaron Gray: They have an accretive cash profile versus some of our other products, and they've been at the center of some of the investments that we've made to increase digital and in-person promotion of menopause products. The growth that we've seen to date actually predates those investments. We've made targeted investments. We've made those investments with very grounded assessments of what those investments will be worth, and we are already seeing the positive results of those investments.
Speaker #1: So we've made targeted investments. We've made those investments with very grounded assessments of what those investments will be worth, and we are already seeing the positive results of those investments.
Speaker #3: Thank you. We have a question relating to the gross margin in Women's Health. There was a decline in FY26. The question is, can you comment on the direction of the Women's Health gross margin going into FY27?
Tom Duthy: Thank you. We have a question relating to the gross margin in women's health. There was a decline in FY 2026. The question is, can you comment on the direction of the women's health gross margin into FY 2027?
Tom Duthy: Thank you. We have a question relating to the gross margin in women's health. There was a decline in FY 2026. The question is, can you comment on the direction of the women's health gross margin into FY 2027?
Speaker #1: We would generally expect the gross margins to improve between fiscal year '26 and fiscal year '27. We continue to see growth in the women's health products. Fiscal year '25 was buoyed by a managed care adjustment of about $5.6 million, which was non-recurring in fiscal year '26.
Aaron Gray: We would generally expect the gross margins to improve between fiscal year '26 and fiscal year '27. We continue to see growth in the women's health products. Fiscal year '25 was buoyed by a managed care adjustment of about $5.6 million, which was non-recurring in fiscal year '26. It was an inflation on fiscal year '25 that we didn't see again in fiscal '26. That was a function of some of the conservativism that I as CFO held in the gross-to-net estimation as we overhauled all of our processes, all of our data, et cetera, over a multi-year period. We continue to refine our approach there, but our approach has proven to be quite accurate. Hence, we didn't need to hold the same level of conservativism.
Aaron Gray: We would generally expect the gross margins to improve between fiscal year '26 and fiscal year '27. We continue to see growth in the women's health products. Fiscal year '25 was buoyed by a managed care adjustment of about $5.6 million, which was non-recurring in fiscal year '26. It was an inflation on fiscal year '25 that we didn't see again in fiscal '26. That was a function of some of the conservativism that I as CFO held in the gross-to-net estimation as we overhauled all of our processes, all of our data, et cetera, over a multi-year period. We continue to refine our approach there, but our approach has proven to be quite accurate. Hence, we didn't need to hold the same level of conservativism.
Speaker #1: And so that was a it was an inflation on fiscal year 25 that we didn't see again in fiscal 26. That was a function of some of the conservativism that that I as CFO held in in the gross to net estimation as we overhauled all of our processes, all of our data, etc.
Speaker #1: over a multi-year period. And so we've continued to refine our approach there, but our approach has proven to be quite accurate; hence, we didn't need to hold the same level of conservatism.
Speaker #1: We also saw that fiscal year '26 was heavily weighed down with over $11 million of product returns on Anovera, and that's $11 million negative revenue, or a debit to revenue—a reduction of revenue.
Aaron Gray: We also saw that FY '26 was heavily weighed down with over USD 11 million of product returns on ANNOVERA, and that is USD 11 million negative revenue or debit to revenue, reduction of revenue, with a straight hit to profit. We are working on changing the way that product is handled and treating that product more as a specialty product than as a standard pharmacy product that runs through a more traditional channel. The size of the opportunity there as well is USD 11 million. In addition to that, the increase in NEXTSTELLIS coverage that I mentioned with the expansion of covered lives gives us a higher mix of covered transactions compared to cash transactions. We would expect some volume of cash transactions to move to covered, and overall, that mix effect would be expected to be accretive to the FY '26 margin profile.
Aaron Gray: We also saw that FY '26 was heavily weighed down with over USD 11 million of product returns on ANNOVERA, and that is USD 11 million negative revenue or debit to revenue, reduction of revenue, with a straight hit to profit. We are working on changing the way that product is handled and treating that product more as a specialty product than as a standard pharmacy product that runs through a more traditional channel. The size of the opportunity there as well is USD 11 million. In addition to that, the increase in NEXTSTELLIS coverage that I mentioned with the expansion of covered lives gives us a higher mix of covered transactions compared to cash transactions. We would expect some volume of cash transactions to move to covered, and overall, that mix effect would be expected to be accretive to the FY '26 margin profile.
Speaker #1: With a straight hit to profit. And so we're working on changing the way that product is handled and treating that product more as a specialty product than as a standard pharmacy product that runs through a more traditional channel.
Speaker #1: So, the size of the opportunity there as well is $11 million. In addition to that, the increase in Nextellus coverage that I mentioned, with the expansion of covered lives, gives us a higher mix of covered transactions compared to cash transactions.
Speaker #1: So we would expect some volume of cash transactions to move to covered, and overall that mix effect would be expected to be accretive to the fiscal year '26 margin profile.
Speaker #3: Thank you, Aaron. Just while we're on women's health, and the women's health product, this relates to the international business Nextellus. Australian demand is up strongly since the PBS listing.
Tom Duthy: Thank you, Aaron. Just while we are on women's health and the women's health product, this relates to the international business. NEXTSTELLIS Australian demand is up strongly since PBS listing. Is this a function of the PBS cost effect for patients or the sales and marketing push?
Tom Duthy: Thank you, Aaron. Just while we are on women's health and the women's health product, this relates to the international business. NEXTSTELLIS Australian demand is up strongly since PBS listing. Is this a function of the PBS cost effect for patients or the sales and marketing push?
Speaker #3: Is this a function of the PBS cost effect for patients, or the sales and marketing push?
Speaker #1: That is a function of both. A three-month supply of Nextellus now costs a patient in Australia $25, which is one factor, putting us on equal footing with other oral contraceptives.
Aaron Gray: That is a function of both. A three-month supply of NEXTSTELLIS now costs a patient in Australia AUD 25, which is one factor, putting us on equal footing with other oral contraceptives. Another factor is that the unique profile of the product, which has been central to being able to drive increased sales. We have promoted the product. The product is a differentiated superior product, and it is now on equal footing with other oral contraceptives that are on the PBS. We have a solid runway there, and we expect to see continued growth for this product in Australia.
Aaron Gray: That is a function of both. A three-month supply of NEXTSTELLIS now costs a patient in Australia AUD 25, which is one factor, putting us on equal footing with other oral contraceptives. Another factor is that the unique profile of the product, which has been central to being able to drive increased sales. We have promoted the product. The product is a differentiated superior product, and it is now on equal footing with other oral contraceptives that are on the PBS. We have a solid runway there, and we expect to see continued growth for this product in Australia.
Speaker #1: But another factor is the unique profile of the product, which has been central to being able to drive increased sales. So we've promoted the product.
Speaker #1: The product is a differentiated, superior product, and it's now on equal footing with other oral contraceptives that are on the PBS. We have a solid runway there.
Speaker #1: And we expect to see continued growth for this product in Australia.
Speaker #3: Thank you, Aaron. This question relates to guidance. Is there any guidance for one-off costs moving forward, and can you provide any updates on the legal scheme costs moving forward?
Tom Duthy: Thank you, Aaron. This question relates to guidance. Is there any guidance for one-off costs moving forward, and can you provide any updates on the legal scheme costs moving forward?
Tom Duthy: Thank you, Aaron. This question relates to guidance. Is there any guidance for one-off costs moving forward, and can you provide any updates on the legal scheme costs moving forward?
Speaker #1: So, we don't provide guidance on one-off costs; by their nature, they're relatively difficult to guide upon or predict. We've significantly reduced the one-off costs, having exited the generics business and run down a large portion of the surprises that come there.
Aaron Gray: We do not provide guidance on one-off costs. By their nature, they are relatively difficult to guide upon or predict. We have significantly reduced the one-off costs to having exited the generics business and running down a large portion of the surprises that come there, as a function of either Inflation Reduction Act topics, product returns, or legacy matters, that were part of the core thesis for us to exit the generics business. We have significantly run that down. I would expect that to be lower year-on-year than what we have experienced. With respect to other one-off costs, scheme costs, there are no further costs for the scheme with Cosette. We only would have litigation costs, which we do not provide guidance information to the market, but we would not expect the litigation cost to be outsized relative to other matters that are similar.
Aaron Gray: We do not provide guidance on one-off costs. By their nature, they are relatively difficult to guide upon or predict. We have significantly reduced the one-off costs to having exited the generics business and running down a large portion of the surprises that come there, as a function of either Inflation Reduction Act topics, product returns, or legacy matters, that were part of the core thesis for us to exit the generics business. We have significantly run that down. I would expect that to be lower year-on-year than what we have experienced. With respect to other one-off costs, scheme costs, there are no further costs for the scheme with Cosette. We only would have litigation costs, which we do not provide guidance information to the market, but we would not expect the litigation cost to be outsized relative to other matters that are similar.
Speaker #1: As a function of either Inflation Reduction Act topics, product returns, you know, legacy matters—those were part of the core thesis for us to exit the generics business.
Speaker #1: So we've significantly run that down. I would expect that to be lower year on year than what we've experienced. With respect to other one-off scheme costs, there are no further costs for the scheme with Cosette.
Speaker #1: We would only have litigation costs, which we don't provide guidance information to the market on, but we would not expect the litigation costs to be outsized relative to other matters that are similar.
Speaker #1: The the litigation forward-looking is runs on a more normal time frame and a more normal scale compared to what we what we worked through in the in the determination of the of the scheme.
Aaron Gray: The litigation forward-looking runs on a more normal timeframe and a more normal scale compared to what we worked through in the termination of the scheme.
Aaron Gray: The litigation forward-looking runs on a more normal timeframe and a more normal scale compared to what we worked through in the termination of the scheme.
Speaker #3: Thank you. This just relates to the growth opportunity for e-pharmacy and distributed Rx generally. You mentioned on the call today that the e-pharmacy market is forecast to reach $252 billion US by 2030.
Tom Duthy: Thank you. This just relates to the growth opportunity for ePharmacy and DistributeRx generally. You have mentioned on the call today that the ePharmacy market is forecast to reach USD 252 billion by 2030. The question is, what structural shift in US pharmacy distribution makes now the right time for DistributeRx, and how is Mayne positioned to grow this business unit strongly over time?
Tom Duthy: Thank you. This just relates to the growth opportunity for ePharmacy and DistributeRx generally. You have mentioned on the call today that the ePharmacy market is forecast to reach USD 252 billion by 2030. The question is, what structural shift in US pharmacy distribution makes now the right time for DistributeRx, and how is Mayne positioned to grow this business unit strongly over time?
Speaker #3: The question is, what structural shift in U.S. pharmacy distribution makes now the right time for distributed Rx, and how is Mayne positioned to grow this business unit strongly over time?
Speaker #1: The US healthcare system and consumer awareness are reaching a point—being a participant in the US healthcare system and a consumer—where patients see diminishing, and maybe little or no, value in having insurance.
Aaron Gray: The US healthcare system and consumer awareness are reaching a point being a participant in the US healthcare system and a consumer, where patients see diminishing and maybe little or no value in having insurance. In many cases, paying cash for a product is less costly to the patient than using their insurance, and that does not even include the cost of having the insurance. In many cases, the sum of the fees paid across the standard value flow for a pharmaceutical product exceed the net realized price of the product by multiples of 2 to 4 times. Product availability can be a challenge. We have seen vertical integration and financial incentives between large payers, pharmacy benefit managers, and pharmacies, which have the effect to limit patient and provider choice. This is really something that Mayne has been battling for the past 5-plus years.
Aaron Gray: The US healthcare system and consumer awareness are reaching a point being a participant in the US healthcare system and a consumer, where patients see diminishing and maybe little or no value in having insurance. In many cases, paying cash for a product is less costly to the patient than using their insurance, and that does not even include the cost of having the insurance. In many cases, the sum of the fees paid across the standard value flow for a pharmaceutical product exceed the net realized price of the product by multiples of 2 to 4 times. Product availability can be a challenge. We have seen vertical integration and financial incentives between large payers, pharmacy benefit managers, and pharmacies, which have the effect to limit patient and provider choice. This is really something that Mayne has been battling for the past 5-plus years.
Speaker #1: And in many cases, paying cash for a product is less costly to the patient than using their insurance, and that doesn't even include the cost of having the insurance.
Speaker #1: In many cases, the sum of the fees paid across the standard value flow for a pharmaceutical product exceeds the net realized price of the product by multiples of two to four times.
Speaker #1: Product availability can be a challenge. We've seen vertical integration and financial incentives between large payers, pharmacy benefit managers, and pharmacies, which have the effect of limiting patient and provider choice.
Speaker #1: And this is really something that Mayne's been battling for the past five-plus years. Mayne is an early mover in this space, and our solutions have been designed and tested pretty significantly.
Aaron Gray: Mayne is an early mover in this space, and our solutions have been designed and tested pretty significantly. Our solution is embedded in workflow in the office, which makes using our solution much more convenient for the provider and the patient. It works. Our solution is one of the only solutions, maybe the only solution, that works with insured and cash patients and provides them with transparency to make the choice themselves. This solution also only provides pharmacy options that actually dispense the drug the HCP has prescribed. It is not a script that gets sent to your neighborhood pharmacy, which if it happens to be one of the vertically integrated pharmacies, who shall remain nameless on the call, could result in switching due to some of the aforementioned financial incentives or some of the barriers that are put in place.
Aaron Gray: Mayne is an early mover in this space, and our solutions have been designed and tested pretty significantly. Our solution is embedded in workflow in the office, which makes using our solution much more convenient for the provider and the patient. It works. Our solution is one of the only solutions, maybe the only solution, that works with insured and cash patients and provides them with transparency to make the choice themselves. This solution also only provides pharmacy options that actually dispense the drug the HCP has prescribed. It is not a script that gets sent to your neighborhood pharmacy, which if it happens to be one of the vertically integrated pharmacies, who shall remain nameless on the call, could result in switching due to some of the aforementioned financial incentives or some of the barriers that are put in place.
Speaker #1: Our solution is embedded in workflow in the office, which makes using our solution much more convenient for the provider and the patient. It works. Our solution is one of the only solutions—maybe the only solution—that works with insured and cash patients and provides them with transparency to make the choice themselves.
Speaker #1: This solution also only provides pharmacy options that actually dispense the drug the HCP has prescribed. It's not a script that gets sent to your neighborhood pharmacy, which, if it happens to be one of the vertically integrated pharmacies—you shall remain nameless on the call.
Speaker #1: This could result in switching due to some of the aforementioned financial incentives or some of the barriers that are put in place. Since launch, since we've launched this in March, we've significantly scaled the business and are actually operating at or above full capacity at Adelaide Apothecary.
Aaron Gray: Since we have launched this in March, we have significantly scaled the business and are actually operating at or above full capacity at Adelaide Apothecary. Shout out to that team, and thanks to Jill and the full team. Hence the relocation and investment in a new facility. The growth we have realized to date is driven by dermatology products, but the solution also works quite well for any non-acute prescription that has poor or low insurance coverage. That creates the potential to expand to other therapeutic areas, other products, and the need is real, because of all these structural matters, for products well beyond dermatology.
Aaron Gray: Since we have launched this in March, we have significantly scaled the business and are actually operating at or above full capacity at Adelaide Apothecary. Shout out to that team, and thanks to Jill and the full team. Hence the relocation and investment in a new facility. The growth we have realized to date is driven by dermatology products, but the solution also works quite well for any non-acute prescription that has poor or low insurance coverage. That creates the potential to expand to other therapeutic areas, other products, and the need is real, because of all these structural matters, for products well beyond dermatology.
Speaker #1: Shout out to that team, and thanks to Jill and the full team. Hence the relocation and investment in a new facility. The growth we've realized to date is driven by dermatology products, but the solution also works quite well for any non-acute prescription that has poor or low insurance coverage.
Speaker #1: And that creates the potential to expand to other therapeutic areas, other products, and the need is real because of all the structural matters for products well beyond dermatology.
Speaker #3: All right. Thank you, Aaron. The next question relates to some of the media speculation regarding Mayne Pharma over the preceding weeks. How widespread is the shareholder disquiet that has been expressed publicly, and what is Mayne's response?
Tom Duthy: Right. Thank you, Aaron. The next question relates to some of the media speculation regarding Mayne Pharma over the preceding weeks. How widespread is the shareholder disquiet that has been expressed publicly, and what is Mayne's response?
Tom Duthy: Right. Thank you, Aaron. The next question relates to some of the media speculation regarding Mayne Pharma over the preceding weeks. How widespread is the shareholder disquiet that has been expressed publicly, and what is Mayne's response?
Speaker #1: We don't comment on market speculation. We will, of course, comply with our continuous disclosure obligations if a matter requiring disclosure arises. But I would just say that we do not comment on market speculation.
Aaron Gray: We do not comment on market speculation. We will, of course, comply with our continuous disclosure obligations if a matter requiring disclosure arises. I would just say that we do not comment on market speculation.
Aaron Gray: We do not comment on market speculation. We will, of course, comply with our continuous disclosure obligations if a matter requiring disclosure arises. I would just say that we do not comment on market speculation.
Speaker #3: Thank you, Aaron. I would like to turn the call back over to Darcy for a phone question. Over to you, Darcy.
Tom Duthy: Thank you, Aaron. I would like to turn the call back over to Darcy for a phone question. Over to you, Darcy.
Tom Duthy: Thank you, Aaron. I would like to turn the call back over to Darcy for a phone question. Over to you, Darcy.
Speaker #4: Thank you. Once again, if you would like to ask a question, please press star one on your telephone and wait for your name to be announced.
Operator 2: Thank you. Once again, if you would like to ask a question, please press star one on your telephone and wait for your name to be announced. Your first question from the phone comes from Andrew Goodsall from MST Marquee. Please go ahead.
Operator: Thank you. Once again, if you would like to ask a question, please press star one on your telephone and wait for your name to be announced. Your first question from the phone comes from Andrew Goodsall from MST Marquee. Please go ahead.
Speaker #4: Your first question from the phone comes from Andrew Goodsall from MST Marquee. Please go ahead.
Speaker #5: Oh, good morning. Thanks for taking my question. Just trying to understand the direction of travel for the gross profit margins. Just looking at sort of first half, second half, '26 comparisons.
Andrew Goodsall: Oh, good morning. Thanks for taking my question. Just trying to understand direction of travel for the gross profit margins. Just looking at H1, H2 2026 comparisons and starting with women's health, it doesn't look like there's been a big turnaround, but I guess you might have better visibility on direction of travel with those margins, just particularly with maybe the last quarter.
Andrew Goodsall: Oh, good morning. Thanks for taking my question. Just trying to understand direction of travel for the gross profit margins. Just looking at H1, H2 2026 comparisons and starting with women's health, it doesn't look like there's been a big turnaround, but I guess you might have better visibility on direction of travel with those margins, just particularly with maybe the last quarter.
Speaker #5: And starting with Women's Health, it doesn't look like there's been a sort of big turnaround, but I guess you might have better visibility on sort of direction of travel with those margins.
Speaker #5: Just, just particularly with maybe the last quarter.
Speaker #1: Yeah. One of the things to remember, Andrew, and thanks for the question. One of the things to remember is that our second half experiences significant seasonality, following the copay resets in the US healthcare system that happen at the beginning of January.
Aaron Gray: Well, one of the things to remember, Andrew, and thanks for the question. One of the things to remember is that our H2 experiences significant seasonality.
Aaron Gray: Well, one of the things to remember, Andrew, and thanks for the question. One of the things to remember is that our H2 experiences significant seasonality.
Aaron Gray: following the copay resets in the U.S. healthcare system that happened at the beginning of January. We typically see a significant reduction in covered scripts and a significant increase in cash scripts during the H1. We also continued to suffer the returns topic that I mentioned on ANNOVERA across the H2, and that hit us to a discrepant portion. The seasonality will continue. That is just an artifact of the system that we are in to the extent that we continue to derive a significant portion of our margins from covered business. However, we are actively working to address the ANNOVERA returns. It is not an overnight thing that we can do, but as I mentioned, that was an USD 11 million impact in FY '26.
Aaron Gray: following the copay resets in the U.S. healthcare system that happened at the beginning of January. We typically see a significant reduction in covered scripts and a significant increase in cash scripts during the H1. We also continued to suffer the returns topic that I mentioned on ANNOVERA across the H2, and that hit us to a discrepant portion. The seasonality will continue. That is just an artifact of the system that we are in to the extent that we continue to derive a significant portion of our margins from covered business. However, we are actively working to address the ANNOVERA returns. It is not an overnight thing that we can do, but as I mentioned, that was an USD 11 million impact in FY '26.
Speaker #1: And so we typically see a significant reduction in covered scripts and a significant increase in cash scripts during the first half. We also continue to suffer the returns topic that I mentioned on Enovera across the second half, and that hit us to a discrepant portion.
Speaker #1: So, those are the seasonalities that will continue. That's just an artifact of the system that we're in, to the extent that we continue to derive a significant portion of our margins from covered business.
Speaker #1: However, we are actively working to address the Enovera returns. It's not an overnight thing that we can do, but as I mentioned, that was an $11 million USD impact in fiscal year 2026.
Speaker #5: And I I guess just in terms of direction you know with with adding to the portfolio and so on you know is your expectation or ambition to get those margins up or?
Andrew Goodsall: I guess just in terms of direction with adding to the portfolio and so on, is your expectation or ambition to get those margins up?
Andrew Goodsall: I guess just in terms of direction with adding to the portfolio and so on, is your expectation or ambition to get those margins up?
Speaker #1: Yeah. I mean, so generally we would expect that those margins would increase as we increase the mix of covered scripts—that is, the weighted average skews towards more coverage on Nextellus with the additional covered lives that I've mentioned.
Aaron Gray: Well, generally, we would expect that those margins would increase. As we increase the mix of covered scripts that the weighted average skews towards more coverage on NEXTSTELLIS with the additional covered lives that I have mentioned. We will have fewer cash scripts at a lower profit margin. We have implemented a number of things to try and improve our overall margins, continuing to refine copay monitoring and different pharmacy partnerships and how we manage those partnerships. Obviously, we will address the ANNOVERA returns as well. We do not see barriers to be able to continue to drive some of those margins. We also continue to have the option of price increases. There can be some cost inflation, but generally speaking, we would expect the margins to hold and slightly accrete.
Aaron Gray: Well, generally, we would expect that those margins would increase. As we increase the mix of covered scripts that the weighted average skews towards more coverage on NEXTSTELLIS with the additional covered lives that I have mentioned. We will have fewer cash scripts at a lower profit margin. We have implemented a number of things to try and improve our overall margins, continuing to refine copay monitoring and different pharmacy partnerships and how we manage those partnerships. Obviously, we will address the ANNOVERA returns as well. We do not see barriers to be able to continue to drive some of those margins. We also continue to have the option of price increases. There can be some cost inflation, but generally speaking, we would expect the margins to hold and slightly accrete.
Speaker #1: We'll have fewer cash scripts at a lower profit margin. We've implemented a number of things to try and improve our overall margins, continuing to refine copay monitoring and different pharmacy partnerships, and how we manage those partnerships.
Speaker #1: And obviously, we'll address the Enovera returns as well. So, we don't see barriers to being able to continue to drive some of those margins.
Speaker #1: We also continue to have the option of price increases. So there can be some cost inflation, but generally speaking, we would expect the margins to hold and slightly accrete.
Speaker #5: Okay. And no, it certainly does. But just on the launch of 20O and Ypsilon, is there any sort of reaction to how they're tracking?
Andrew Goodsall: Okay. I know it is early days, but just the launch of TWYNEO and EPSOLAY, just any sort of reaction to how they are tracking?
Andrew Goodsall: Okay. I know it is early days, but just the launch of TWYNEO and EPSOLAY, just any sort of reaction to how they are tracking?
Speaker #1: Andrew, you're breaking up pretty badly. I think there's interference on the line.
Aaron Gray: Andrew, you are breaking up pretty bad. I think there is an interference on the line.
Aaron Gray: Andrew, you are breaking up pretty bad. I think there is an interference on the line.
Speaker #5: Yeah, I could hear you. Just Ypsilon and 20O, just how they're tracking.
Andrew Goodsall: Yeah.
Andrew Goodsall: Yeah.
Aaron Gray: I think your phone is closed.
Aaron Gray: I think your phone is closed.
Andrew Goodsall: Just EPSOLAY and TWYNEO, just how they are tracking.
Andrew Goodsall: Just EPSOLAY and TWYNEO, just how they are tracking.
Speaker #1: Oh, 200 and Ypsilon have been tracking basically on plan for us. They've significantly lifted the overall gross margin of the dermatology portfolio, which is what you can see with the gross margin development.
Aaron Gray: TWYNEO and EPSOLAY have been tracking basically on plan for us. They have significantly lifted the overall gross margin of the dermatology portfolio, which is what you can see with the gross margin development. That development year-on-year, the increase in the gross margin is a function of having added TWYNEO and EPSOLAY to the portfolio. They are tracking reasonably well. They are solid products with really long patent lives, and so we expect to be able to continue to derive margin from them. I did note in the presentation that we lost some amount of coverage on TWYNEO, so we would expect that there is some amount of price impact throughout FY '27. But the product continues to be a really good product for us. We are very happy with it.
Aaron Gray: TWYNEO and EPSOLAY have been tracking basically on plan for us. They have significantly lifted the overall gross margin of the dermatology portfolio, which is what you can see with the gross margin development. That development year-on-year, the increase in the gross margin is a function of having added TWYNEO and EPSOLAY to the portfolio. They are tracking reasonably well. They are solid products with really long patent lives, and so we expect to be able to continue to derive margin from them. I did note in the presentation that we lost some amount of coverage on TWYNEO, so we would expect that there is some amount of price impact throughout FY '27. But the product continues to be a really good product for us. We are very happy with it.
Speaker #1: That development—year on year, the increase in the gross margin is a function of having added 200 and Ypsilon to the portfolio. So they're tracking reasonably well.
Speaker #1: They are solid products with really long patent lives, and so we expect to be able to continue to derive margin from them.
Speaker #1: I did note in the presentation that we lost some amount of coverage on 20O, so we would expect that there is some amount of price impact throughout fiscal year '27.
Speaker #1: But the product continues to be a really good product for us. We're very happy with it.
Speaker #4: Thank you. As a runner for the final questions, I'll now hand back to Mr. Aaron Gray for any closing remarks.
Operator 2: Thank you. As there are no further phone questions, I will now hand back to Mr. Aaron Gray for any closing remarks.
Operator: Thank you. As there are no further phone questions, I will now hand back to Mr. Aaron Gray for any closing remarks.
Speaker #1: Thank you very much, operator. Appreciate it. Thanks, everybody, for joining. Again, fiscal year '26 was a tough year for the company because the SET transaction ended in December, and so it's been a relatively short time that we've been turning things around and getting people back engaged.
Aaron Gray: Thank you very much, operator. Appreciate it. Thanks everybody for joining. Again, FY '26 was a tough year for the company because that transaction ended in December, so it has been a relatively short time that we have been turning things around, getting people back engaged. I would just like to repeat what I said earlier, which was thanking all of the employees of the company for sticking with us and for helping to bring us to this stage. We are well-positioned for FY '27 with all of the work that has been done.
Aaron Gray: Thank you very much, operator. Appreciate it. Thanks everybody for joining. Again, FY '26 was a tough year for the company because that transaction ended in December, so it has been a relatively short time that we have been turning things around, getting people back engaged. I would just like to repeat what I said earlier, which was thanking all of the employees of the company for sticking with us and for helping to bring us to this stage. We are well-positioned for FY '27 with all of the work that has been done.
Speaker #1: And I would just like to repeat what I said earlier, which was thanking all of the employees of the company for sticking with us and for helping to bring us to this stage.
Speaker #1: We're well positioned for fiscal year '27 with all of the work that's been done.
Operator 2: That does conclude our conference for today. Thank you for participating. You may now disconnect.
Operator: That does conclude our conference for today. Thank you for participating. You may now disconnect.
