Mayne Pharma Group Limited (MYX) Earnings Call Transcript & Summary

Thank you, and thank you all for joining. My name is Shawn Patrick O'Brien, and I am the CEO and Managing Director of Mayne Pharma. Today, we're here to present our financial results for the 12 months ended 30th of June 2025, namely FY '25. Joining me on the call this morning is Mayne Pharma's CFO, Aaron Gray. Today, our focus will be on presenting our FY financial results. We will also briefly update on the scheme of arrangement with Cosette Pharmaceuticals under which Cosette agreed to acquire 100% of shares of Mayne Pharma for $7.40 cash per share. There will be no Q&A at the end of today's presentation. Looking at Slide 2 is our standard disclaimer. Today's presentation contains forward-looking statements and non-IFRS financial measures, all of which should be considered in light of the assumptions and risk factors outlined here. Unless otherwise stated, all dollar figures are in Australian dollars. Looking at Slide 3, which summarizes our financial highlights. FY '25 was another year of disciplined execution and tangible progress against our strategic priorities. We delivered revenue of $408.1 million, a 5% increase on a prior corresponding period, or PCP. This growth was driven primarily by strong performances in Women's Health, partially offset by a more challenging year for our Dermatology franchise. However, our overall result was underpinned by cost discipline across the group and more favorable product margins. Q3 was negatively impacted by a number of factors including anticipated deductible resets and a lagging effect of the Women's Health sales force reset, while Q4 was strong in revenue and EBITDA growth. Our gross margin expanded to 60.6%, up from 56.3% in FY '24. This improvement reflects a higher contribution from Women's Health where segment margins exceeded 80% and a stronger product mix in Dermatology, supported by targeted pricing strategies and improvement in the product cost. Underlying EBITDA more than double, up 105% to $47 million compared to $22.9 million in FY '24. Importantly, this result was achieved within the guidance range we issued earlier in the year and demonstrated that our focus on EBITDA growth is delivering. Operating cash flow from continuing operations was $45.4 million, up 460% on the prior period of $8.1 million, driven by higher profitability and careful working capital management. This figure includes the cash consumed by the implementation and defense of the scheme arrangement. We closed the year with $100.4 million in cash and marketable securities, down from $149.3 million last year. After discontinued ops and the class action settlement, we funded a strategic acquisition, made earnout payments and invested in our manufacturing capability. This leaves us well positioned to fund future growth initiatives. Slide 4 outlines the key operational achievements for the year. In Women's Health, demand cycles for NEXTSTELLIS grew 30% year-on-year, reflecting both new patient starts and repeat prescription growth. Our licensed portfolio of ANNOVERA, IMVEXXY and BIJUVA delivered 17% total prescription growth, with ANNOVERA volumes up 6%. ANNOVERA also benefited from a label change that extended shelf life by 1/3 now to 24 months. In Dermatology, we did see our revenues impacted by at-risk competitive launches of generic ORACEA and lower revenue for RHOFADE on reduced payer coverage. We have successfully renegotiated the cost of our supply for our authorized generic ORACEA, reducing unit costs substantially, which will significantly improve its profitability despite the generic launches noted moving forward. Our Dermatology disintermediation strategy continues to provide meaningful financial benefits to the company with greater than 70% of all Mayne products now outside of the traditional distribution channel of the big 3. Sales by Mayne's own pharmacy, Adelaide Apothecary, now account for 5% of the total prescription volumes representing a 57% increase on FY '24. During the year, we completed the acquisition of TWYNEO and EPSOLAY from Sol-Gel Technologies for USD 10 million upfront and an additional USD 6 million in FY '26. Together, these products generated over USD 40 million in 2024 IQVIA sales. And we'll expand our present both at acne and rosacea. Mayne Pharma successfully launched these products just last week and expects these products to contribute favorably to the Dermatology gross margin profile improvement. Internationally, we completed the multiyear major modernization upgrade at our Salisbury's manufacturing facility, improving production capability and efficiency. We also expanded our agreement with our partner in Canada to include a new 200-milligram format of KADIAN and broadened the indications beyond paying 2 opioid substitution therapy. Our DIFOT also improved to 96.5% versus 91% at the first half of FY '25. Overall, our FY '25 results reflects balanced near-term performance with a build of long-term capability. I will now hand over to Aaron to take you through the group financial performance on Slide 5. Aaron?

Thank you, Shawn. We'll now walk the investors through the financial performance over the next few slides. On Slide 6, group revenue for fiscal year '25 was $408.1 million, up $19.7 million or 5% on the PCP. This was driven by volume growth across the Women's Health portfolio, particularly NEXTSTELLIS, IMVEXXY and BIJUVA. Although Dermatology revenues did decline, we saw a significantly improved profitability in Dermatology from better pricing, renegotiated supply terms and improvements in the overall product mix. Underlying EBITDA came in at $47 million, an increase of $24.1 million over the prior year. This was underpinned by gross margin expansion with tight control of operating expenses, despite increased promotional investment in Women's Health. As Shawn mentioned, we saw a strong improvement in our operating cash flow from continuing operations during the year versus the prior period. All 3 segments provided a positive direct contribution to EBITDA, demonstrating the strength of the portfolio and our cost discipline. Slide 7, please. Slide 7 highlights some of the operating cost development in the business. Gross margin increased to 60.6% from 56.3% in the PCP, driven by a higher share of revenue from Women's Health, where segment margins are above 80%; and an improved Dermatology mix with the Dermatology gross margin increasing from 48% to approximately 54%. Direct operating expenses increased by 6%, in line with revenue growth, holding steady as a percentage of sales at around 1/3. The increase in direct operating costs were associated with full headcount for Women's Health, as we had significant vacancies in fiscal '24. In addition, we incurred higher promotional cost for Women's Health and for our disintermediation strategy. Slide 8, please. Group cash and marketable securities. Slide 8 shows a waterfall reconciliation between the company's cash and marketable securities position as at 30 June 2025 from 30 June 2024. From continuing operations, we generated the mentioned $45.4 million in cash before taking into account inflow from the IRS tax refund, outflows related to earn-out payments and the class action settlement. The IRS refund was $13.2 million. Earnout payments for the year totaled $39.8 million, consisting of a milestone payment of $20 million to the Population Council for ANNOVERA, and royalty payments relating to acquisitions that we've made, existing obligations of $19.8 million. The class action settlement resulted in a one-off net cash outflow of $33.2 million. 16% of the cash used was used in the continued wind down of discontinued operations at $7.9 million with approximately $4 million of remaining outflows at 30 June 2025. In terms of investing cash flows, we invested $16.5 million in product acquisitions and $11.1 million in capital expenditures to complete the Salisbury modernization. At year-end, we held $100.4 million in cash and marketable securities, providing some flexibility for future strategic investments. I will now hand it back to Shawn to run through the segments.

Thanks, Aaron. I will now discuss the FY '25 performance of our 3 segments, namely Women's Health, Dermatology and International; and Aaron will be commenting on the financials for each of the 3 segments over the next few slides. On Slide 10 shows that in aggregate, the 3 segments delivered positive year-on-year growth in direct contribution with total group direct contribution up 24% to $109.7 million. Women's Health was the strongest performer, increasing direct contribution by $26.8 million, or 76%, to $62 million, driven by higher sales and improved operating leverage. Dermatology declined by 9% to $40.2 million, driven by competitive pressures for ORACEA and a shift in the DORYX market from branded to generic offerings. International contribution declined 17%, or $1.6 million, reflecting some product mix changes and OpEx increases, driven by investment in machine downtime. While performance across the business units varied, all contributed and demonstrated the resilience of our operating model. Over to you, Aaron.

Thank you. Turning to Slide 11. This slide summarizes the financial performance of the segments versus the prior full year and the prior year has. I won't dwell long on the detail of this slide, as Shawn has already walked through many of the key drivers. But it is worth highlighting some of the trends across the business. We continue to deliver strong double-digit revenue growth with our branded Women's Health portfolio standing out as a major contributor to direct contribution for the year. The 5% growth in overall revenue has been underpinned by margin improvement, which, in the case of Dermatology, nearly negated the impact of a 12% decline in revenues for the year. Cost management across 3 segments and a deliberate shift towards a more targeted sales and marketing strategy ensures resources are deployed where they will have the greatest impact. Execution of the group strategy is ongoing and is underpinned by the group's segment contribution rising to $109.7 million in fiscal '25 from $88.5 million in the PCP. This improvement reflects increased sales volumes and stronger gross margins, both sustainable and profitable. H2 Women's Health was impacted by a lag effect from the sales force refresh, creating slower growth in Q3, which rebounded in Q4. H2 was also impacted by multiple generic competitor launches on authorized generic ORACEA, which impacted prices and volumes. Our channel strategy, combined with some renegotiated contract terms, are expected to improve performance of that product in fiscal year '26. Back to you, Shawn.

Thanks, Aaron. I'd now like to turn to our focus to Women's Health and the financial performance of this segment. On Slide 13, which summarizes the Women's Health segment half year highlights. Revenue increased 23% to USD 115.5 million, led by NEXTSTELLIS, up 41%; BIJUVA, up 31%; IMVEXXY, up 43%. All products were impacted to some extent by the previously mentioned sales force refresh and that growth has rebounded. IMVEXXY, given counter some temporary supply constraints in Q2 and Q3 of FY '25 due to a production-related matter, but this issue has since been resolved, while ANNOVERA revenue declined by 4% due to demand softness associated with sales force refresh. Gross profit for the segment rose 24% to USD 92.5 million and gross margins improved to 80.1%. Direct contribution increased by 74% to USD 40.2 million due to the tight OpEx control and sales growth. We continue to invest in building product awareness through our medical science liaison team and engagement with our key opinion leaders, ensuring our brands are well supported in the clinical discussions and at the prescriber level. These activities are designed to drive utilization by highlighting the clinical benefits and differentiating features of our portfolio. During FY '25, we conducted additional market research to ensure the relevance and impact and to harmonize messaging across our entire Women's Health portfolio. Messaging was aligned across all channels, and we transitioned to a digital core visual aid format, enabling more engaging and interactive discussions with health care professionals, both in person and through virtual platforms. In July 2025, an FDA expert advisory panel recommended the removal of the black box warning from menopausal hormone therapies, particularly low-dose vaginal or local estrogen products, a label element that has historically deterred some prescribers and patients from initiating treatment. This regulatory development represents a potential catalyst for increased adoption in the years ahead for our menopausal patients. I will now turn the call over to Aaron, who will provide further details of our volumes and sales for our Women's Health portfolio. Please go ahead, Aaron.

Thank you. Referring to Slide 14. Slide 14 focuses on the performance of NEXTSTELLIS. As investors will recall, NEXTSTELLIS remains the first and only FDA-approved contraceptive pill that contains E4, which is plant-derived and identical to human estrogen that is found naturally in the body during pregnancy. Mayne Pharma has a 20-year exclusive license and supply agreement in the U.S. and Australia for NEXTSTELLIS. NEXTSTELLIS continues to be, for the group, a key growth engine. Demand cycles increased 30% year-on-year with net sales up 41% to USD 42.5 million. The net selling price remained stable, with anticipated seasonal fluctuation due to U.S. health plan deductible resets between H1 and H2. Those resets place a higher burden for a period of time on patients and sellers of products beginning each January until out-of-pocket contribution limits are met. The trends for new and repeat prescriptions have been favorable for fiscal year '25 with NEXTSTELLIS repeat prescriptions up 31% over fiscal year '24, and the ratio of repeat prescriptions per total prescriptions up 5.4% in fiscal year '25 over '24. This reflects increased prescriber and patient confidence in the product. We showed a strong Q4 result with demand cycles up 8.4% versus Q3 and up 34% on the PCP, and we're able to strengthen our intellectual property position securing a new U.S. patent for NEXTSTELLIS valid to February 2023. Slide 15, please. On Slide 15, this chart outlines the demand performance of our license portfolio from TherapeuticsMD, which includes ANNOVERA, IMVEXXY and BIJUVA. Across the portfolio, prescription demand trends remain solid in fiscal '25 with IMVEXXY total prescriptions growing 12% and BIJUVA up 31% on the PCP. In the second half, a production issue, which Shawn mentioned, caused a temporary sample supply constraints for IMVEXXY leading to demand softness, which was resolved in Q4 fiscal '25. ANNOVERA volumes increased by 6%, benefiting from improved sales execution. Volumes grew, however, growth was constrained by the lagging effects from the sales force vacancies and focus, in particular, on ANNOVERA. The Women's Health results reflect the strength of our commercial execution and the continuing growth in awareness and adoption of our products in both the contraception and menopause categories. From the perspective of market dynamics, the menopause category continues to benefit from greater prescriber engagement and patient openness about treatment options for symptom management. This, combined with our targeted sales and marketing initiatives, is helping to drive uptake. Our sales force refresh completed during the year is improving quality and coverage of our sales execution, which we expect will deliver further gains over the medium term. Importantly, net sales for IMVEXXY and BIJUVA reached USD 27.2 million and USD 12.5 million, respectively, with strong year-on-year growth, translating into improved segment profitability. Overall, the license portfolio remains a critical component of our Women's Health strategy, complementing the growth of NEXTSTELLIS and helping us build a broader, more durable presence in attractive therapeutic segments. With continued focus on execution, refreshed marketing materials and a more capable sales organization, we believe that there is a clear path to sustained growth for these brands in fiscal '26 and beyond. I will now hand back to Shawn to discuss Dermatology.

Thanks, Aaron. Now to the performance of our Dermatology segment, which delivered a 12% decline in revenues overall. With improved mix and benefits of our channel strategy, we were able to buffer the impact of the revenue decline on the contribution level of 9% decline versus FY '24. Looking at Slide 17. This slide highlights the performance of our Dermatology business in FY '25 for a sharper product mix and the ongoing implementation of our disintermediation strategy underpinned earnings. While total segment revenue declined 13% to USD 99.8 million due to generic ORACEA competition, as mentioned previously, gross margin improved to 53.8%, up from 48% in the prior comparable period, reflecting unfavorable sales mix weighted towards higher-margin branded products. RHOFADE, in particular, sales grew 28% to USD 37.8 million, benefiting from a full 12-month contribution. The launch of our branded Retin-A microsphere 0.08% topical gel in December added to our acne portfolio and positions us well for further penetration in this segment. Our disintermediation strategy, which removes traditional wholesalers, i.e., the big 3, and supplies directly to specialist pharmacies, has delivered greater pricing transparency, improved visibility over volumes and stronger customer relationships. Our Adelaide Apothecary mail order pharmacy achieved sales growth of 67% versus the PCP and reached EBITDA breakeven in June. This structural change in how we go to market is proving effective in helping to offset competitive headwinds and supporting a more sustainable earnings base in Dermatology. Looking ahead, the launches of TWYNEO and EPSOLAY in first quarter FY '26 has added 2 differentiated brands to the portfolio. The agreement with Sol-Gel Technologies included a USD 10 million upfront payment and a second payment of USD 6 million in FY '26. More detail on Slide 18 on the 2 FDA IP-protected dermatology brand for the rest market, TWYNEO, for acne; EPSOLAY for rosacea. With combined 2024 IQVIA sales of USD 40.4 million, we're excited about last week's launch. Both products are supported by FDA Orange Book listed patents to May 2041 and feature proprietary microencapsulation technology aligning well with our branded dermatology focus and channel strategy. From a product standpoint, EPSOLAY is a benzoyl peroxide 5% cream approved for inflammatory lesions of rosacea in adults, which demonstrated USD 16.2 million sales in IQVIA -- by IQVIA for the 12 months to 31 December 2024. TWYNEO combines tretinoin 0.1% and benzoyl peroxide 3% approved for acne in adults and patients 9 years of age and older. They recorded USD 24.2 million over the same period according to IQVIA. The microencapsulation platform is very meaningful point of differentiation in tolerability and delivery and should resonate with high writing specialists already in our network. Strategically, these assets broaden our acne and rosacea footprint and are a natural fit for our Dermatology business platform, supporting better pricing control, pull-through and margin quality. With our launch last week, we're focused on seamless integration, targeted prescriber activation and leveraging our existing field footprint to accelerate the uptake and contribution. To date, we've seen better-than-expected coverage of these products and volumes are tracking to expectations. Aaron will now summarize the Dermatology financials.

Slide 19, please. Turning to Slide 19. As Shawn indicated, revenue declined USD 14.8 million year-on-year to USD 99.8 million with gross margin down USD 1.3 million to USD 53.7 million. The revenue decline reflects competitive launches against ORACEA, loss of some portion of RHOFADE insurance coverage and increased competitive market competition for branded oral antibiotics, mainly DORYX. Despite generics, AG ORACEA has retained approximately 50% share versus the 70% that it had at its peak, underscoring the strength of the dermatology channel. In addition, a renegotiated ORACEA, AG ORACEA supply agreement should enhance profitability of this product from fiscal year '26. As we integrate the newly acquired Sol-Gel products and continue to leverage our disintermediation model, we expect further gains and a stronger competitive position in both the acne and rosacea treatment categories. This will ensure the dermatology business remains resilient and strategically important contributor to the group's overall growth trajectory in fiscal '26 and beyond. Back to you, Shawn.

Thanks Aaron. I will now briefly outline the performance of our International segment. On Slide 21, our International segment delivered a good performance in FY '25, with revenue increasing 7% to $75.6 million, up from $70.7 million in the PCP. Gross profit also improved by 1% to $21.5 million, reflecting the continued strength of our partnerships and the resilience of our product portfolio across key markets. During the year, we entered in an expanded exclusive distribution agreement with our distribution partner covering the 200-milligram strength of KADIAN in Canada. This agreement also introduces a new profit share arrangement on net sales of both the 100-milligram and 200-milligram strength of KADIAN as well as expanded rights into the opioid substitution therapy alongside with moderate-to-severe pain indication. A fixed price now applies to all dosage forms. The upgrade of our Salisbury manufacturing facility reached completion during the year. We have a world-class FDA and TGA compliant site, representing a total investment of $17.8 million, including both the MMI grant and direct investments by Mayne. This facility strengthens our supply chain resilience and supports our growth. In addition, delivery in full, on time, known as DIFOT, performance for FY '25 improved to 96.5%, reflecting operational discipline and efficiency gains. Direct contribution declined from $9 million in FY '24 to $7.4 million in FY '25, reflecting a number of deliberate investments we made to strengthen the business for long-term growth. Now turning to Slide 22 to update on the scheme with Cosette Pharmaceuticals. Proceedings remain ongoing with the court hearing commencing on the 22nd of September and expected to run for several weeks. While the second court date to approve the scheme has not yet been rescheduled from the original date by the court, we anticipate this will be held in mid to late October. Mayne Pharma shareholders showed strong support for the scheme with 99.06% of the votes cast in favor and 89.64% of shareholders voting back the proposal. The Board of Mayne Pharma continues to unanimously recommend the scheme in the absence of a superior proposal and subject to the independent expert maintaining its conclusion that the scheme is in the best interest of all Mayne Pharma shareholders. We will keep shareholders informed through our ASX announcement of any material developments related to the scheme. Looking to Slide 23. Turning to our outlook. At the segment level, in Women's Health, we are focused on unlocking the profit potential of our Women's Health portfolio by driving sales execution, leverage refreshed marketing materials and selectively investing in sales and marketing to maximize long-term value. We are also building scientific awareness through the engagement with our MSLs and our key opinion leaders. For Dermatology, we're differentiating our channel strategy to create a preferred solution for patients, prescribers and our partners. This includes pursuing capital-efficient accretive business arrangements to drive revenue and margin growth while leveraging access and reduce friction to our patients to strengthen partner engagement. Finally, for the International business, we expect to improve profitability by leveraging recent capital investments to expand export revenues and integrate selective processes such as packaging. In Australia, we continue to grow our specialty and generic sales through our strengthened sales force and differentiated product portfolio. Thanks once more for joining us this morning. If you have any follow-up questions or comments, please feel free to contact our Global Investor Relations, Dr. Thomas Duthy. Thanks again, and goodbye.