Mayne Pharma Group Limited

Good morning, everyone, and thank you for joining Maine Pharma's One Age Fiscal 26 results presentation. Today, we will cover the group financial outcome for the half, then take you through each segment, women's health, dermatology, and international, before finishing with our Fiscal 26 focus and outlook. As investors will appreciate, we have already provided a set of our unaudited numbers within our presentation at the company's 2025 Annual General Meeting on 29 January, 2026. Before we begin the formal aspects of today's presentation, as we announced to the market this morning, Main Pharma is undertaking a planned and orderly leadership transition, with Sean Patrick O'Brien stepping down as Chief Executive Officer and Managing Director, and with me having been appointed Chief Executive Officer, both effective from February 21. This transition is part of the board structured succession process and is designed to maintain momentum and execution with continuity of strategy, governance, and financial discipline. Importantly, the business remains stable with a strong, experienced leadership team in place across our key functions and business units. And we are continuing to operate exactly as planned with a focus on performance, outcomes, and disciplined allocation of capital. I want to acknowledge and thank Sean for his contribution and partnership with me through a period of meaningful change. And I'm pleased that he will remain available to the board in an advisory capacity to support an orderly transition for me as CEO. I would now like to turn over to Sean, who was with me on today's call, to make some remarks on the transition.

Thanks, Aaron. It's been a pleasure to work with you over the last three and a half years at Maine Pharma. Investors should note this is a planned succession process, and the board and I have been very deliberate about continuity. Aaron has consistently demonstrated deep knowledge of the business and our industry, and he's been central to the progress we've made together over the last three and a half years. As a team, we've delivered a genuine turnaround. We've transformed Maine from a predominantly generic CDMO profile into a US-branded growth company focused on women's health and dermatology. While also turning around the Salisbury facility and completing its modernization, we've strengthened the fundamentals, people, process, and products, building sharper capabilities, clearer execution discipline, and stronger business cases behind key initiatives, including the expansion of our women's health portfolio, and our recent dermatology acquisitions. Just as importantly, we've built durable relationships with Australian and US investors and fostered a culture where people care and take accountability and stay focused on the outcome for our patients. From my perspective, I'm incredibly proud of what we've achieved economically, culturally, and how we've satisfied our customers. and I'm confident the company is in a strong position to maintain the momentum and improve upon it under Aaron's leadership as I exit the business. I will now turn it back to Aaron.

Thank you, Sean. Looking ahead, Maine Pharma is in a strong position to capitalize on the opportunities in front of us. We have a differentiated portfolio, improving commercial execution, and clear strategic priorities across women's health, dermatology, and international. underpinned by continued focus on operational delivery and cash discipline. The company has also commenced a formal process to appoint a new chief financial officer to replace my role. And in the interim, we will maintain governance and reporting continuity through internal arrangements with ongoing board oversight. We appreciate the continued support of our shareholders, and we remain focused on delivering sustainable growth and improved returns over time. Next slide, please. For slide two, 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. Next slide, please. Turning to the headline numbers for the half, revenue was $212.1 million, broadly flat year-on-year, while gross margin increased to 65.3%. up from 61.4% in the prior corresponding period. Underlying EBITDA was $28.6 million, down 8%, and total direct segment contribution increased to $68.1 million. Adjusted operating cash flow from continuing operations was $16.9 million, and we closed the half with $67.4 million in cash and marketable securities. I will now cover off our group financial performance before turning to our three segments. Turning to slide five, we are separating what we delivered operationally from items that are non-recurring or non-cash so investors can compare period-to-period performance. Reported EBITDA includes a number of one-offs and accounting movements. Our half-year underlying EBITDA excludes a $54.5 million non-cash earn-out reassessment and $21.3 million of diligence, business development, litigation, and restructuring charges. Adjusted operating cash flow from continuing operations was $16.9 million, highlighting that the core business continues to be cash flow positive. The main volatility sits outside underlying operations, driven by discrete legal and transaction costs and earn-out style payments. The takeaway is that the underlying earnings base remained resilient with disciplined margin management and execution across the portfolio. despite the uncertainty and distraction associated with the COSET transaction process. Turning to slide 6, this slide shows how we improved total contribution even with revenue flat for the half. Gross profit improved by 6%, driven primarily by a positive mix effect in dermatology, and that supported a $3.1 million increase in direct contribution, up 5% to $68.1 million. Direct operating expenses increased by 4.6 million, or 7%, reflecting targeted investments, most notably increased women's health promotional activity and higher international sales and marketing expense following the Nextelis Pharmaceutical Benefits Scheme, or PBS, listing in Australia. This increased operating expenses. The key point is that we are being deliberate, investing where returns are attractive, while continuing to lift the quality of gross profit through mix and channel strategy. Turning now to slide seven. On EBITDA, reported results were driven by scheme-related legal costs, including litigation, as well as the non-cash earn-out reassessment in women's health. Underlying EBITDA was down 8% versus PCP, reflecting lower women's health contribution from additional sales investment, offset by higher dermatology direct contribution from strong margin growth. On cash, the business generated positive $16.9 million of underlying cash flow from continuing operations, excluding transaction and litigation costs. Against that, scheme-related transaction and litigation costs were $20.7 million. We also made earn-out payments comprising $7.3 million in royalties and $10.3 million related to the Twinio and Epsile intangible acquisition costs. In addition, discontinued operations cash outflows were $5.1 million and earn-outs from discontinued operations were $3.1 million. Finally, investing and financing movements included capital leases of minus 1.7 million net capex of minus 1.3 million and other items of minus 0.5 million the overall message is that the underlying business remains cash generative with the half impacted by discrete transaction litigation and earn out payments turning now to the specific performance of our segments in further detail slide 9 steps down into segment performance Total direct contribution increased by 3.1 million to 68.1 million in 1H fiscal 26 versus the PCP. The biggest driver was dermatology, up strongly on margin and mix, while women's health delivered solid top-line growth but with higher planned investment. International reflected an investment phase post-PBS approval. In aggregate, what's encouraging is that direct contribution grew despite flat revenue, which speaks to the quality of earnings improving, particularly in dermatology, where mix and channel economics are doing real work. It also reinforces that our strategy is not just about chasing revenue, but also building durable margin and cash conversion. The other point here is balance. Women's health is delivering demand growth and is in an intentional investment phase. Dermatology is delivering margin-led contribution growth, and international is positioned for additional value as we leverage our infrastructure to generate growth and the PBS for approval in Australia for Nextellis. Together, that creates a more resilient group profile across different periods. Turning now to women's health. The first half delivered a solid outcome with continued momentum across the portfolio, translating into sustained demand and share gains. We've improved the cadence and effectiveness of prescriber engagement, and we're benefiting from favorable macro tailwinds in menopause, which supports by Juva and Invexi in particular. Women's Health continues to be a category tailwind business for us, and our focus is translating that into sustained share gains through field effectiveness, targeting and patient access, because those are the controllables that determine whether demand becomes filled prescriptions. Importantly, we are building a franchise with multiple pillars, Nextelis, Invexi, Byjuva, and Anovera, so performance is not reliant on a single product. That supports stability in earnings and gives us more levers to optimize promotional mix and payer strategy. Financially, Women's Health delivered revenue of $96.5 million, up 2% versus the PCP. Within the portfolio, Nextel's continued to build steadily with demand cycles up 16% and net sales up 4% to U.S. $23.4 million. Importantly, we also saw strength across the menopause-driven products. In Vexi, total prescriptions were up 3%, with net sales up 2% to U.S. $15.6 million. and by Juva TRX up 26% with net sales up 23% to U.S. $8.2 million, which reinforces that the momentum is broad-based, not reliant on a single product. On the other hand, Innovera showed a mixed picture. TRX was up 2%, but net sales were down 9% to U.S. $14.4 million. So while prescription demand held up, The net sales outcome reflects net realization dynamics from inventory returns rather than volume weakness. From a profitability perspective, gross profit was 76.2 million, down 1%, and gross margin was 79%, down 3% versus the PCP. That margin movement combined with the planned investment explains the contribution result. Specifically, direct OPEX increased to 40 million or 6% growth on PCP, reflecting our deliberate choice to invest behind the franchise, and direct contribution was 36.2 million, down 8% versus PCP. In summary, for women's health, top line held and demand strengthened, especially in our core menopause products. Gross margin moderated, and we chose to reinvest, which temporarily weighs on direct contribution during the half. Turning now to slide 12 on Nextelis. This chart shows the trajectory in Nextella's demand cycles. The key message is that demand growth remains strong, and we achieved all-time high levels during the half. We're layering in refreshed marketing materials and ongoing Salesforce optimization to sustain and extend that momentum. From here, the focus is to convert demand into the best possible net economics, reducing abandonment, improving prescription stickiness through repeats, and keeping the patient journey smooth through access and affordability programs. That's where we see the next step in durable, repeatable growth. On net sales, growth in Nextelis is being supported by steady net selling price alongside continued volume growth. Importantly, new coverage decisions effective 1 January expanded access adding approximately 25 million additional covered lives in the United States. Access is a major driver of whether demand translates into filled prescriptions, and the step up in covered lives supports that conversion. The addition of those 25 million covered lives reduces friction in the demand to revenue pathway. From a financial standpoint, broader patient access supports lower abandonment rates, improved net revenue per script, and greater predictability in revenue. It also reduces volatility in rebates and contracting dynamics, which helps stabilize gross margin performance. Slide 13 shows demand continuing to build across our menopause-led products. Invexi delivered total prescription growth of 3% on PCP, translating to US $15.6 million in net sales. Bijuva is the standout, with total prescription volumes up 26% for the half versus PCP and U.S. 8.2 million in net sales, reinforcing that momentum is broad-based across the portfolio. For Anovera, demand was steady, up 2% for the half, with U.S. 14.4 million in net sales. The key nuance is that first half net sales were impacted by around U.S. 1.7 million of product returns, so that's more of a period-specific adjustment than a change in underlying demand. However, this product return profile is unsatisfactory, and we are working with our partners to improve the returns profile. Slide 14 shows the future drivers for our women's health segment. Looking forward, our growth levers are clear. Number one, drive market penetration from our low single-digit market share of the competitive sets, share being approximately 1% for Byjuva, 3% for Invexi and Nextelis, and 2% for Anavera. Number two, defend portfolio runways through our long-dated intellectual property. Three, keep sharpening commercial execution through targeting and field effectiveness. And finally, four, continue to improve access through payer contracting and patient programs. Turning now to the performance of our dermatology segment for the half. Slide 16 provides the operating and financial highlights for dermatology. This segment continues to demonstrate the benefits of mix, channel strategy, and execution. We are building a more resilient earnings profile through a higher percentage of branded sales and leverage of our channel to improve patient access and conversion. Dermatology is demonstrating what we mean by quality of revenue. Even when the top line is not accelerating, mix and channel strategy can materially change the profitability outcome, and that is exactly what we are seeing. In the half, dermatology revenue was 78.6 million, down 3% on the PCP, but profitability improved meaningfully. Gross margin expanded to 65%, up 12 percentage points, driving direct contribution up 35% to 29.8 million. That's a strong example of operating leverage and favorable mix, even in the face of top-line pressure. We've shown that profitability can improve materially through mix and improved conversion of our channel. What we are finding exciting is that we're now moving from building the ecosystem to scaling it. Each incremental prescription routed through our disintermediated pathway improves both patient access and the profitability profile of the segment. We will soon be launching the next leg of our disintermediation strategy with that launch planned for Q3 fiscal 26. Slide 17 shows very clearly that dermatology's earnings improvement is being driven by mix. Branded revenue increased to $51.2 million, or 65% of the mix, up from $44.5 million, or 55% of the mix in the PCP. Investors should note the contribution of Twinio and Epsile given their relaunch by Main Pharma was responsible for part of the increase. All other dermatology products we sell reduced to 35% of the mix from 45% in the PCP. That is the core driver of the profitability uplift. This drove the gross margin improvement, and when combined with flat segment OPEX, provided solid operating leverage to contribution, which grew 35% for the half. Returning to slide 18 on future drivers for dermatology, Having delivered continued improvement in margin and contribution, the priorities now are about making those improvements repeatable and scalable. First, we continue to scale the disintermediation and specialty ecosystem because when more scripts move through the pathway we control, this supports better patient access and improved conversion outcomes, which also then leads to higher profitability. Second, we'll continue to expand and refresh the dermatology portfolio through capital-efficient accretive arrangements, specifically targeted business development of new FDA-approved brands and products that broaden addressable segments. Third, we'll keep lifting execution, Salesforce capability upgrades, and refresh marketing. so we rebuild and accelerate demand while protecting the improved gross margin profile created from the mix and channel shift. Turning now to our final segment, International. Operationally, there were three key highlights. First, PBS approval for Nextel is in Australia, and we have commenced promotion post-PBS approval. Second, we inaugurated the completed Salisbury facility upgrade, which was an $18 million investment, including $4.8 million from the Modern Manufacturing Initiative grant. Third, we received external recognition for export performance, which supports partner confidence and demand. Financially, revenue was $36.9 million, minus 1% versus PCP. But importantly, gross profit increased to $11.3 million, plus 7%, and gross margin improved to 30.5%, plus 3%. So unit economics are moving in the right direction. Direct OpEx was 9.2 million plus 32%, reflecting primarily the planned investment phase related to Nextelis. And as a result, direct contribution was 2.1 million minus 42% versus PCP. The message is we're seeing improving margin and gross profit while we invest to build the pipeline for future scale and operating leverage. Slide 21 sets out how we convert that investment into improved performance. The first lever is capacity and reliability from Salisbury post-upgrade, enabling higher output, better service levels, and improved die-thought to support export and partner growth. This is the pathway to better utilization and improved fixed cost absorption. Second, the PBS listing is already showing early traction as access and affordability improve. We have seen 118% growth in three-pack volumes of Nextelis in December 2025, immediately following the PBS decision. That's a meaningful early indicator that promotion plus access can translate into volume growth. The objective now is to compound those leading indicators into repeatable revenue and ultimately improved contribution, alongside expanded supply agreements and partnerships through the network. Turning to our outlook on slide 22. For women's health, we aim to continue our market share growth with dedicated people who are 100% focused on women's health, drive our refreshed marketing and product access solutions, and protect our strong intellectual property for our best-in-class products. We will make targeted investments to drive growth and focus on sustainable cost leverage. For dermatology, we will take the next step in our disintermediation strategy to fully leverage the ecosystem we have built to improve access and patient outcomes for dermatology, and pursue expansion into other therapeutic areas. We look forward to updating investors with our new strategy as well this quarter. For international, we have focused activities to unlock the value created by the investments that have been made in the international business via Nextella's PBS listing, the $18 million CapEx infusion, and growing international supply agreements. We intend to enforce our agreements and reserve all of Maine Pharma's rights and balancing these costs with shareholder value in mind. As you have seen, we have commenced proceedings in the Supreme Court of New South Wales against Cosette and related parties, Avista and David Bergstaller. Maine Pharma is seeking substantial damages on behalf of Maine Pharma shareholders and on its own behalf. Finally, from a capital perspective, we continue to evaluate a variety of capital allocation priorities, including share repurchases, targeted asset acquisitions, and expanding our promotional activities across our segments. That concludes the formal part of today's conference call. I will now turn the call over to the operator for the question and answer session. Please go ahead.

Thank you. If you would like to ask a question, please press star 1 and wait for your name to be announced. If you'd like to cancel your request, please press Start to.

If you are on a speakerphone, please pick up your handset to ask your question. As there are no phone questions at this time, I'll now hand back over to Mr. Gray to address any questions submitted to management.

Thank you. Tom, have we received – I believe we received a couple of questions from investors that this might be a good time to address.

Yes, we have, Aaron. I'll just read them out. First question is, what is the ability of the company to continue to drive revenue growth and Scripps growth in women's health?

Okay, so compared to the PCP, one age fiscal 26, saw solid RX growth, demand growth, but our revenue was relatively flat. That was a function of a couple of things. We were weighed down by the returns on Anovera, which I talked about in the presentation. We also had in the PCP, so in the first half of fiscal 25, we had a number of credits that we recognized due to our conservative GTN methodology. We've continued to refine our GTN methodology basically continuous improvement, improving every period. And so the amount of buffer that we carry has reduced over the periods. Basically, we got a credit in the first half of fiscal 25 that didn't repeat in the first half of fiscal 26. So I would expect once that is normalized out and in the rearview mirror, we should see revenue growth at the same or higher rate that we would see TRX growth looking forward.

Okay, thanks Aaron. Second question, what is the current status of emerging competition for Rofaid in 2026?

So Rofaid, we acquired Rofaid out of a bankruptcy proceeding. This was an extremely good acquisition. It paid for itself in several months. And we've obviously continued to realize revenues and profit and cash from it. Rofaid, when we acquired the asset, we knew that it was not a long-lived asset. the previous owner had reached a settlement on the introduction of competing generic products, which happens at the end of our fiscal year 26. And so we do expect there will be some competitors launching at the end of our fiscal 26. We will also be taking our own steps and taking measures to make sure that we protect and maintain our share of the market there. Thank you, Aaron.

And third question, what is the company's view of the adjustments to underlying EBITDA on a go-forward basis, particularly legal costs and discontinued operations?

So with respect to the discontinued operations, obviously our 1H fiscal 26 was heavily impacted by costs associated with the Cosette transaction. That was a very, that was an extremely extensive effort. we would expect the costs of an appeal to be significantly reduced compared to what we've already we've already expended we would also then expect the cost of pursuing the damages claim that i mentioned to be reduced compared to the initial spend as well as then depending on time frame these costs could spread over a longer period of time That said, we incurred significant legal costs related to defense of some of our intellectual property. That weighed down EBITDA to the tune of more than $2 million in the first half. We are working diligently to put those behind us and to reach some kind of an agreement on those. Can't comment more, but I would expect going forward that we would not see those. There will be a point where we will not see those expenses continue at the same rate. The other item that we had was we had a significant step up in cost related to FDA post-approval studies, which are required for the women's health products. We've stepped up about $2.6 million compared to the prior fiscal first half in those FDA costs, and we expect those to step down to a level that's something below the fiscal year 25 run rate, looking forward into fiscal 27. So those costs will continue across the second half of fiscal 26. However, we expect them to step down beginning in fiscal 27 as those studies have been completed. Right.

I have some other questions here for you, Aaron. One of the investors has asked if you could give a little more granularity and colour around Anadera product returns and how you will wind this back in or wind it back down so the level of inventory returns are not sort of at that same rate moving forward.

So Anovera returns come when we use the big three, the channel, which is we call it the big three, the large three wholesalers. They have a fairly liberal right to return and they do so when it's to their advantage to do so, as you would expect. Anovera is a challenging product from a logistics perspective. It's a multi-month prescription. It's a relatively high-priced product, and it risks seeing higher abandonment. So scripts cannot just be put into the channel assuming they're going to be filled. We need to have a bit more of a targeted, dedicated, handheld process across the access solution to make sure that Anavera gets filled. We also, to the extent we have existing customers, are working to understand why abandonment for that product is higher than we experience on other products. And we are looking at changes to the supply side certain of our customers that are supplied through the big three, we have the option to contract with other wholesalers who do not have quite the same right to return. And so it's basically a multi-pronged approach, throw everything at it to make sure we drive that rate back down to where it should be. Okay, terrific.

And just following up from that in women's sales, was there anything particular which drove Bajudo momentum for the house?

But you've seen just a significant lift based on, I think, general awareness in hormone replacement therapy. There's been other products that have spent the millions of dollars per minute to advertise at the Super Bowl. There's been, you know, much more conversation and discussion around hormone replacement therapy. And, in fact, the U.S. government removed the black box warning from certain hormone replacement therapy products, among them by Juba and Invexi. And so I think that's triggered a conversation around HRT. which hasn't happened, which is changing rather in the United States. So I think attitudes and thoughts around HRT are changing fundamentally. And the black box warning, while the government, the U.S. government made the decision to remove the black box warning, we haven't completed the update of our label yet. That's in process. So we expect to see those attitudes and opinions continue to change.

Perfect. If I could ask the operator to flick to slide 33, which is one of the appendices in the main deck. Aaron, we had a question on this slide in particular, just whether you could expand on how you see the opportunity for dermatology moving forward. It's a macro-derived slide. I'm not sure if you can see that now in front of you.

I can't see it, but I can talk on the opportunity for dermatology. Dermatology dermatological conditions are not being cured. So there's a populace that still has a need for care. There's not an awful lot of new development in small molecule medical derm. And most companies following the traditional pharma model of make money on coverage scripts to lose money on cash scripts, it simply doesn't work because the coverage profile for small molecule medical derm is fairly poor relative to other products. And so that requires a completely different model. Hence, the years that the main pharma team has spent trying to set up this alternative distribution. The opportunity continues to pick up assets in a capital light structure where companies are, because of the traditional model, companies have the inability to remain profitable. the way they do business. Instead, they may benefit from handing the assets over to us in some kind of a structured transaction. So anybody who's in small molecule medical derm, there could be a partnership there that's mutually beneficial. That's what we've seen as we've picked up a number of products in partnership with Galderma. And there are other companies out there that we can also work with on that. So there are further product acquisition opportunities. The coverage is not going to fundamentally change. If anything, the coverage is going to deteriorate on small molecule medical derm products. And our solution, our access solution, provides access for the patient. It provides a frictionless experience for the provider. It provides cost certainty at the time the script is written, whether a patient has insurance or not. And it basically has no switching, no prior authorizations required, and the medicine shows up at the patient's door. So I think the market has not contracted for dermatology. The need is still there. Anybody who's in a position that can meet that access need has the potential to capture significant amounts of share there. All right. Thanks, Aaron. That concludes the questions from investors.

I'll turn back to the operator.