Mayne Pharma Group Limited (ASX:MYX)
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Apr 24, 2026, 4:11 PM AEST
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Earnings Call: H1 2025

Feb 25, 2025

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

Thank you, Operator. Hello, everyone, and thank you for joining us as we discuss the first half of fiscal year 2024 results. This provides us an opportunity to share the Mayne transformation story to a higher-margin growth business that operates on a lower level of net working capital than previously. With me on the call today is Aaron Gray, our CFO of Mayne Pharma Group. On our next slide, the disclaimer slide, we're excited to share the results with you today. As stated on the disclaimer slide, I want to emphasize that the information provided today is general in nature and in summary form only. It should be read in conjunction with the company's financial statements, which have been reviewed and signed off by BDO, and our market disclosures. We report on an Australian IFRS basis and not a GAAP basis.

All numbers reported here are in Australian dollars unless otherwise noted in U.S. dollars. The historic numbers represent the ongoing business. This presentation may also contain forward-looking statements that involve subjective judgment and analysis that are subject to significant uncertainties, risks, and contingencies, many of which are outside of our control and unknown to the company. With that, let's turn to our first half of 2024 results. When we started FY 2023 results back, when we reported our FY 2023 results back in August and at the AGM, I highlighted several goals we hope to reach by the end of fiscal year 2024.

They were: all three business units delivering positive direct contribution; two, return the company to positive underlying EBITDA; three, optimize our cost base with deductions of greater than $10 million; four, achieve a run rate break-even for NEXTSTELLIS; and five, return the company to positive operating cash generation in fiscal year 2024. Four of these were year-end goals, and I'm pleased to say that as of mid-year, we've achieved four of these five milestones. All three business units are delivering positive contribution, with Women's Health and Dermatology delivering $18.1 million each and International at $4.4 million in direct contribution. We expect this performance to continue in the second half and deliver a full-year positive direct contribution from all business units.

Secondly, we're excited that we reached $8 million in positive underlying EBITDA during the half, a significant improvement over the second half of FY 2023, underlying loss of $25.9 million. We are on track to deliver positive underlying EBITDA for the second half of FY 2024 and the full year. Third, we executed reductions on our cost base to improve our cost leverage to drive growth, with $10 million identified and $5 million in reductions already achieved in the first half of FY 2024 against our operating budget, which did not include new product launches such as NEXTSTELLIS. On our fourth goal, I'm pleased that in December we reached a run rate break-even for NEXTSTELLIS through a combination of growth, net selling price, and cost reductions, while we delivered 33% cycle growth over the second half of FY 2023.

On our fifth goal, we've made significant progress on generating positive cash in FY 2024, with most of our outflow of cash during FY 2024 related to investing, financing, and discontinued operations. Aaron will provide more details during the financial overview on the flow of cash in the first half. However, we do expect to reach positive operating cash in the second half and for the full year. I'm proud of the team for working together to deliver these exceptional results. Let me highlight the business performance in the next two slides. With strong revenue in the first half of $188 million, up 43% from the second half of FY 2023, results of $131 million at that time, and slightly ahead of our full 2023 year results of $185 million. This strong growth performance reflects the growth of the U.S. dermatology and women's health business units.

Overall, we achieved $40.6 million in direct contribution from all three business units. As shared previously, our underlying EBITDA of $8 million is a big swing from a loss of $25.9 million in the second half of 2023, driven by revenue growth and cost optimization. Closing cash of $146.8 million represents a cash outflow of $73.3 million during the period. Half of that outflow related to debt repayment, our road RHOFADE acquisition, and our on-market share buyback. A further $13.8 million was related to planned discontinued operations closing. In addition, we saw a $19.2 million outflow from continuing operations and $3.9 million of earn-out payments. Aaron will provide more detail on this and how we're tracking to be a positive in operating cash by the year-end.

With a more simplified business combined with operating and financial discipline, we're striving for operational and commercial excellence, which drives sustainable, improved financial results. Let's look at the business units' individual performance in the first half. We're excited about the potential for Nextstellis with the addition of the Orange Book patent, which expires June of 2036. Starting with our women's health business, it was a strong first half with $18.1 million in direct contribution, a $20 million improvement over the prior six months. Nextstellis' growth cycle was up 33% in the first half compared to the prior six months. During the half, we secured the Orange Book listing for Nextstellis patent. We're also continuing to see improved metrics with the assets we licensed in. Both Annovera and Vyleesi are growing.

With the launch of our low strength BIJUVA in January, we expect BIJUVA growth to further accelerate. In dermatology, we delivered $18.1 million in direct contribution, up from $16.7 million in the second half of FY 2023. This is driven by stronger operating discipline, channel strategies, and the benefits of new product launches. Authorized generic Aviane and Roflumilast are driving growth. In fact, our $8 million purchase of Roflumilast allowed us to deliver over $8 million in revenue in the period and $7.3 million in margin in the first three months of our ownership. Our distribution service pilot was successful, confirming the value and need for the solution, so we were able to roll it out nationally this past January.

While international revenue was down from the second half of FY 2023, direct contribution was actually up, as a result driving efficiencies to improve operating metrics at the site. We're pleased that our new two-year Betadine supply agreement is profitable, first time in five years. The Kadian and Kapanol roll-out as an opioid substitution therapy continues the progress in Canada, EU, and Asia. For the first time in years, we've invested $3.2 million in the period for capital and system projects to make the business more efficient on the long term. At the group level, as we transition the company from a capital-intensive to a working capital-efficient business growth, we maintain our focus on ROI so we can drive operational and commercial excellence. I'm excited about the progress we've made in the first half and look forward to continuing the momentum in the rest of the year.

Now, we'll turn it over to Aaron to discuss our financial results in more detail. Aaron?

Aaron Gray
CFO, Mayne Pharma

Thank you, Shawn. Before I go through the individual financial slides, I would at this point like to note that we've prepared a number of additional slides in the appendix to provide some of the information that's been requested by different investors. I'll talk through a number of slides, but there are some additional slides in the appendix. Next slide, please. As noted previously, we are focusing on the comparison of the first half, fiscal 2024, to second half, fiscal 2023, as that is the first period we had sales from the licensed assets, Annovera, IMVEXXY, BIJUVA, and the prenatal vitamins. For reported revenue, I will go through the detail in the segment discussion, but broadly, we are pleased with the progress made on women's health and derm.

Gross profit of $105.8 million represents a margin of 56% versus 52%, reflecting higher margin in dermatology from new products, in addition to some operational improvements and growth in the higher margin women's health portfolio. Direct contribution of $40.6 million is a strong turnaround, taking into account growth, and I'm pleased that direct expenses are only up 1% compared to the prior half, including expenses for growth and new products, which is a good effort reflecting some results from the U.S. dollar $10 million cost-out program that's been discussed previously and cost discipline across the business. Direct costs in the half were $65.2 million versus $64.6 million in the comparable period.

Underlying EBITDA of $8 million reflects adjustments from statutory EBITDA of $21.9 million to remove non-cash expenses relating to an increase in earn-out liability for Nextstellis, which is driven by the new patent, and the non-cash mark-to-market on the convertible note, which is a function of the movement in our share price. It also adjusts for litigation and some small restructuring charges. We have worked very hard to simplify the business, and this can be seen in the reduced number of adjustments to underlying from our statutory numbers. There is more to do, but we think we have made real progress in presenting our financial performance and cash flow that is clearly reconcilable to our actual operating performance. The $8 million of underlying EBITDA is a significant improvement on the comparable period and sets us up well to deliver on our goal of returning the business to consistent profitability.

Next slide, please. Thank you. Maybe we got a little bit sideways here, so jump back if you would. Thank you. Okay. The purpose of the slides, this was originally put together to help reconcile between our statutory accounts and a number of figures used throughout this presentation. In this view and in statutory accounts, depreciation is included in COGS, direct opex, and indirect opex. We have footnoted the respective amounts on the slide. This is put together to help reconcile to the stat accounts and provide a clear bridge between some of the numbers we'll speak about in the stat accounts. Now, next slide, please. Cash and working capital management are top priorities, as is closeout and management of discontinued operations. This slide includes cash and marketable securities. Please note that the cash figure as presented in the statutory accounts excludes marketable securities.

The sum of those two figures should be thought of as our cash balance. Our cash and equivalents balance stands now at $146.8 million, down from $220.1 million at 30 June. We reported that cash was $163 million at our 1Q balance date, so cash outflow has slowed in the second quarter. Cash from operations, as per the statutory accounts, is minus $28.7 million, adjusting for cash used for discontinued operations of $9.5 million, continuing operations consumed $19.2 million in operating cash in the period. To provide some more detail on operating cash use, we invested or built $25.7 million in working capital during the half. We invested $14.6 million in inventory to support new product growth and to mitigate some supply chain risks to ensure we have product available to maintain and grow the revenues.

Our receivables balance also built by $9.7 million during the period, reflective of the substantially higher revenues. We have significantly improved the discipline on cash collection, and you should think of this build as being largely in line with our increased sales performance during the period, especially towards period end when sales were lifted by the new product launches. You can see that we spent $3.9 million and $4.3 million in earn-out payments for continuing and discontinued operations, respectively. We have made real progress on closing out liabilities for discontinued operations, with a range of $10 million-$20 million net remainder to be concluded. We are focusing on closing out this as appropriately as possible, balanced by closing it out as quickly as possible. You can also see that we have used 50% of the cash consumed during the period on investing and financing activities.

We closed out the receivables financing facility at $11 million. We have significantly improved trade terms and collections, and so that facility has become redundant. The successful product acquisition of Roflumilast, which we completed late in September and launched in October, cost us $13 million. Finally, we spent $10.9 million on our share buyback program. Our intention is to continue that program in some form once we get released our results. Next slide, please. This slide presents a different view of cash, separating cash to maintain the business from cash invested to grow the business for continuing operations only. We have invested in net working capital related to continuing ops, primarily in inventory, prepaids, and deposits related to future business and some business changes. Exclusive of investment, we estimate we converted underlying EBITDA to cash at a rate of 78% for this slice of the view.

Moving down the slide, I spoke to the networking—sorry, jump back, please. Moving down the slide, I spoke to the networking capital investments. The item that is growth, CapEx, and asset acquisition includes the capital spend that Shawn mentioned at the Salisbury site, as well as the acquisition of RHOFADE . Next slide. Slide 11 shows our balance sheet. Key callouts here are that you can see the improvement in working capital, particularly against the revenue. Our liabilities for gross to net stand at approximately $168 million, which is included in our payables balance. We've done extensive work around this topic to ensure that we are appropriately recognizing liabilities across each product and each channel. We have significantly changed our processes and tools, and we have leveraged industry experts to validate our approach.

Comparing to the past as a consequence of some of these changes and these efforts, we expect to see significantly less volatility in management of these liabilities. We expect to build receivables going forward in line with growth and have made progress improving payment terms. The receivables relating to discontinued operations reduced by $15 million, which reflects good progress as part of the closeout. You will also note that marketable securities of $36.7 million is included in other assets. The cash balance plus that $36.7 million ties back to the $146.8 million cash that we discussed. Next slide, please. Moving on to the segment performance. Slide 13 of this next slide is our segment note from our statutory accounts in Australian dollars. It shows the progression from revenue through gross profit, direct OpEx, and direct contribution across the three segments and for the group.

We presented segment reporting on a local currency basis going forward in the next subsequent slides, U.S. dollar for women's health and dermatology and Australian dollars for international. We have replicated the women's health and dermatology slides in Australian dollars in the appendix to make it easier for those who want to see a single currency. Shawn has dealt with the operating highlights of each segment, so I will focus on the financial aspects of each segment. Slide please. For women's health, women's health, again stated in U.S. dollars, shows growth of 45%, which includes a 96% increase in Nextstellis revenue and 29% increase for Annovera, Imvexxy, and Bijuva compared to the prior half, which I should note was impacted by accounting adjustments as discussed at year-end.

Gross margin of 81% reflects stable net selling prices, and we believe is a good representation of the go-forward margin profile for this business, subject to some movements in mix. You can see that direct OpEx has reduced over the second half of fiscal year 2023, which reflects roughly $5 million of costs taken out in headcount and marketing costs. We have delivered a strong turnaround in direct contribution to $11.8 million positive. As we showed at our Q1 update, we have tried to show a cash proxy at segment level by adding back depreciation, which is included in direct OpEx. This relates specifically to the sales leases on cars. We have also reflected the estimated earn-out liability of $3.4 million, which, as before, as shown prior, is the amount of earn-out liability matched to the revenue for the period.

This number is not easily reconcilable to the accounts due to the way that our accounts have historically dealt with product acquisitions and licensing, and there are some tiny differences to cash flow. However, we do believe this provides a reasonable proxy and provides some additional transparency on performance of the business. Next slide. You can see the development of the Nextstellis cycles for the first half, up 33% on the prior period. As you know, as we've stated previously, net selling price was restored and improved across the half. The growth, combined with improved net selling price and lower costs, have allowed us to achieve a break-even in December. This view includes demand cycles through January of 2024. In January, Nextstellis reached 44,453 cycles.

We are pleased with the continued growth of Nextstellis, particularly in context that January tends to be a soft month with a reset in patient out-of-pocket costs, with admittedly more work to do. Going forward, we do not plan to make comment on individual product profitability as we manage the portfolio across contraception and menopause products to maximize the overall business sales while managing the operating costs and productivity across product and segment. The chart to the right reflects the half-on-half sales development by product, and we believe represents a clean view in the sense that we now have our accrual liability processes in place. We expect going forward that to translate to a clearer correlation between volume, price, and revenue reported. Next slide, please. Moving to dermatology, you can see growth in revenue as the core portfolio in dermatology has continued to deliver solid results.

We have strong discipline in place related to channel liabilities. New product launches have delivered a meaningful contribution as well. You will recall that at the year-end, we spoke about the initial disappointment in the fiscal 2023 Oracea launch as volumes from the previous licensee were worked out of the channel. During the first half, that has fully resolved, and we have high expectations for Oracea realized in the first half and continuing in the second half, including a favorable COGS position that we've been able to secure. We did have some catch-up provisioning in the second quarter on Oracea, which is reflected in the flat performance in Q2. Oh, I'm sorry. Back to general. I'm sorry. I had a little bit more. We launched Roflumilast during the first half, as Shawn has mentioned, and it's performed very well for us.

Strong sales and higher coverage than we had expected have led to a solid contribution to gross profit. Gross profit does reflect improved core performance and a shift in mix to a higher margin product. As Shawn said, we have a number of bolt-on NPLs in the second half. Broadly, I expect margin rates to remain in the range of what we have seen in the first half. Direct opex has increased against the comparable period, reflecting costs associated primarily with the new product launches and the pilot of our disintermediation strategy. Overall, our derm headcount is flat, but we do believe this demonstrates the model and the leverage that our strategy can deliver as we layer in more products.

You can see that adjustments to the cash contribution are much lower than in women's health, as this business, as we've stated previously, tends to be driven and continues to be driven primarily by capital-light transactions, i.e., profit share included as a part of cost of goods sold. Now, I'll hand it over to Shawn for the next slide.

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

Thank you, Aaron. Appreciate that. We have been talking about disintermediation for quite a period of time, and we've had great success recently with the services pilot program that we did initiate in the first half.

Due to Mayne's drug sourcing ability, extensive pharmacy network of over 400 pharmacies across the U.S., and our own mail-order pharmacy, Adelaide Apothecary, which is licensed in all 50 states, plus an extensive provider and customer coverage, we have an opportunity to disintermediate the very inefficient pharmaceutical value chain and create a comprehensive, frictionless, transparent, and cost-effective experience for providers and patients. Dermatology was the ideal place to launch our pilot with GoodRx and the AssistRx platform, so providers and patients are able to see the product at the best available price and the lowest out-of-pocket cost based on that patient's insurance program. If the patient's insurance plan does not cover the product, patients are offered the option to use Adelaide Apothecary to acquire the product at a cash price.

The result is this channel strategy provides patients and providers with a seamless prescription at lower cost and improved margin per prescription for us. We plan to transition this program into women's health division very soon. Now, turning to our international segment. Our international segment consists of three units: Mayne Pharma Australia, our international product sales, and our CDMO, which produces products for companies globally, including our own U.S. business. We've been making progress in the international with increased efficiency and improved operational performance for the business. For this segment, first half net sales were down slightly compared to the second half of 2023 due to production time partially offset by stock revaluation benefits. The international segment still had strong gross margins and a positive direct contribution of $4.4 million and cash contribution of $6.3 million.

We are making some progress in building the pipeline, and we see opportunity to grow and leverage the capacity of this facility being created with operational improvements in Salisbury. You can see that gross profit improved. This is a mix dependent. OpEx remains in line, and there's good work across the various efficiency initiatives from supply chain through procurement and scheduling. Moving forward to the overall outlook for our business. Here's our outlook for the remainder of FY2024. We are reiterating prior guidance and expect all three business units to deliver positive contribution margin in FY2024 with positive EBITDA and operating cash flow for the group. We continue to execute on our women's health portfolio, driving the growth of Nextstellis through the second half of the year. I'm pleased that Lynn Sullivan has joined Mayne Pharma to lead our women's health division.

Previously, she was the pioneer at Novo Nordisk who created the weight loss business. We plan to deliver growth across all our women's health brands, leveraging our sales force scale and effectiveness and the operational improvements we have made. We'll also take advantage of changes in the ACA law. Under the executive order signed by President Biden, out-of-pocket expenses for birth control, the patient should be zero, and at least 30 states in the District of Columbia have started to implement this. This represents a significant upside for the potential improved access for both Nextstellis and Annovera. We'll drive net revenue growth and margin expansion in the dermatology division by active portfolio management, increasing volumes for branded products and launching additional products. By the end of the year, we expect to transition our unique prescriber patient fulfillment process from the pilot to a fully scaled operation.

On the international side, the company is pursuing targeted investment in new manufacturing revenue streams. We will continue to drive specialty and generic product sales locally in Australia, including drive Nextstellis in Australia. We will continue to invest in a target manufacturing Salisbury facility and expect to invest $8 million-plus this half to improve productivity and capabilities over the long term. The previously announced cost reductions of approximately $10 million U.S. will extend in the second half and are expected to deliver benefits in FY2025 and beyond. We will continue to execute other accretive uses of our capital. You have heard today, it has been a great start to FY2024, and we are excited to keep that momentum going into the second half of the year. With that, I would like to turn it over to the operator for questions.

Operator

Thank you.

If you wish to ask a question via the phone, you'll need to press the star key followed by the number one on your telephone keypad. If you wish to ask a question via the webcast, please type your question into the Ask a Question box. Your first question comes from Andrew Goodsall from MST. Please go ahead.

Andrew Goodsall
Analyst, MST Financial

Thanks very much for taking my questions and congrats on the turnaround of the EBITDA. Just a quick one to start with on dermatology. Talked to Roflumilast and Oracea, but not much to Doryx. Just looking for some color on what was happening to Doryx in the period. I guess the second part of that question is, with the growth of the other drugs, how does that change the seasonality of that derm segment?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

Thanks, Andrew. The question I heard was good performance on Oracea and Roflumilast.

Didn't hear much on Doryx. Is there any seasonality with the other products? On the Doryx, we're pleased that Doryx now, with the launch of MPC 60, we've become the market leader at a prescription level for that product. There's still growth happening there in a significant way. Relative to the seasonality, we're now in the U.S., what I would call the acne season. You'll see Accutane tends to grow in volume use between January and April of each year, and we're right in the middle of that. There's generally a softening of the use of isotretinoin through either technology in the summer months, and then it seems to pick up. What we're really pleased with, Andrew, is normally the business sees a softening of prescription volumes in January due to copay increases for patients because of a reset of their health plan.

We did not see that happen almost straight across the board, both in women's health and dermatology. We are pleased with the kickoff that we have in the results we have seen in January. We expect the dermatology business on the acne to grow. Now that we have both Accutane and isotretinoin, both in Absorica formulation and the original Accutane, we have opportunity to get a lot of that market. Is that helpful?

Andrew Goodsall
Analyst, MST Financial

Yeah. I was just trying to understand, particularly with some of the product ads, whether you will dampen some of the sort of seasonality when you get to the summer.

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

Yeah. We do not. Go ahead.

Andrew Goodsall
Analyst, MST Financial

Oh, sorry. Oh, you go. Sorry.

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

Go ahead, Andrew.

Andrew Goodsall
Analyst, MST Financial

Just on women's health, obviously a great trend with Nextstellis, just trying to understand what the headcount's looking like in the sales force to support that growth, whether you've got more to spend or you're getting towards the end of that build-out.

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

We have 85 territories in the market right now. We just took on a new sales leader under Lynn, who took over women's health at the beginning of the year. We have a new sales leader in place. Right now, it's about building the execution back to where we had it and when we showed significant growth this time last year when we changed the curve. We had data where we weren't executing the way we wanted to, and that's why we made the change in the sales leadership.

Relative to making the leadership change and taking Daniel's job and having it, it's really a reflection of the progression of the business. We have a big opportunity in women's health, and we have a big opportunity in dermatology and a big opportunity in our disintermediation strategy. Daniel will continue to lead our dermatology and disintermediation strategy going forward, and Lynn's taken over the focus on women's health. It is really a move reflecting on our confidence of both those business units growing rapidly.

Andrew Goodsall
Analyst, MST Financial

Okay. Thank you.

Operator

Thank you. Your next question comes from Melissa Benson from Wilsons Advisory. Please go ahead.

Melissa Benson
Healthcare Analyst, Wilsons Advisory

Good morning, Shawn and Aaron. Thanks for taking my questions. First one, just on Nextstellis, and I think you've guided us now in December. You hit that break-even run rate for that product as you were aiming to.

Just a little bit of color on how we should think about the, when we see the direct OpEx for the women's health business, but how much are you kind of attributing of that to Nextstellis to kind of calculate that break-even run rate, if you like?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

On that, we have always allocated, I think we've communicated this previously, that 60% of the commercial footprint is allocated to Nextstellis and the other 40% to the remaining portfolio of women's health on the cost base. That's how it was done. Does that answer the question there?

Melissa Benson
Healthcare Analyst, Wilsons Advisory

Yes, it does. That's helpful.

Thinking about that cost out, that $10 million cost out, and the portion of that being the Nextstellis marketing force, I mean, is there more of that to come in the second half in terms of efficiencies in that OpEx space, or a lot of that was delivered in this first half?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

We delivered $5 million in the first half of the identified $10 million. $8 million was women's health that was identified, and $2 million was cost of goods that we identified in the first half. The $2 million in cost of goods was not seen at all in the first half. That is going to be seen in the second half. The $5 million really was driven, as you saw, by our numbers. In the segment data, it shows you we are down $5 million roughly directly in women's health.

The cost out, the majority, like 80% of the cost out, was focused on Nextstellis. It was important for us to get the brand to a level that we had confidence to invest properly in the brand. As you know, there have been many women's health companies who have failed in this marketplace, overinvesting and not getting the return. Going forward, we're going to continue to look at not just Nextstellis, but Annovera, Vyleesi, and Bijuva, how we want to invest and drive growth. Now, with the new patent in place, it gives a level of confidence in the opportunity that we did not have previously.

Melissa Benson
Healthcare Analyst, Wilsons Advisory

That's helpful. On the international business, you called out it was a little bit softer at the top line, and that was kind of customer mix impacts there, but you've got some efficiencies in the business.

I mean, how should we think about revenue growth in that business, or rather a little bit more color on customer mix? I guess if some of those operating efficiencies now have been reached, if we think that pending top-line growth, the cost basis is fairly stable from here.

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

I would look at the second half of right now, it's going to be roughly flat growth on the cost side. We just secured a new contract on procuring our API, which is going to give us a $500,000 annual saving over previously for one of our products. That is a significant change that will go into the bottom line there. We are diligent right now on some opportunities, but most of those opportunities will not give revenue to the business in the near term.

Melissa Benson
Healthcare Analyst, Wilsons Advisory

A quick clarification.

Does any Nextstellis sales from the international business, is that captured in women's health, or that's separate?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

It's captured in the international business. It's part of Dragon Pharmaceutical, MPA, Mayne Pharma Australia.

Melissa Benson
Healthcare Analyst, Wilsons Advisory

Yep. Final question for me was just around at the JP Morgan conference in January. I think, Shawn, you were speaking to revenue run rates and the potential for this business to do over $400 million this year at the top line. I mean, is that still how you're thinking you're tracking? Is that still an achievable goal for us to be thinking about?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

If you look at the run rate we have right now, $188 million times two, it puts you into the $375 million-plus range, $370 million.

If you look at the scripts that we just showed you in January for NEXTSTELLIS, the run rate we're getting on RHOFADE and the run rates we're getting on ORACEA, obviously, we think we're going to be north of that $375 million level.

Melissa Benson
Healthcare Analyst, Wilsons Advisory

Thanks very much.

Operator

Thank you. Once again, if you wish 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 wish to ask a question via the webcast, please type your question into the ask a question box. Your next question comes from Elyse Shapiro from Canaccord. Please go ahead.

Hi, guys. Thanks for taking the question. Quickly on NEXTSTELLIS, it looks like we've seen some improvements in terms of pricing.

How much more room do you think we have to go there in terms of pricing power?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

The only pricing, I think we've done a very good job using RisRx to make sure that our copay cards are used efficiently and as intended and reducing the abuse. That's given us productivity. All the other activities are done in place. We've more than restored the price to what we had on average this time last year. However, the real opportunity for price expansion or margin expansion on the net selling price will come out of ACA, and that will result in volume and price opportunities. Until that solidifies, we're not giving any guidance on the exact impact ACA could have. That's the Affordable Care Act. It is the law, and it's really about getting the payers to follow the law.

Recently, the Congress had, what, 130-plus signatures from senators and congressmen about this particular issue and sent to the payers' community asking them to abide by the law. Hopefully, we'll see some traction on that in the near term. As I mentioned previously, the state of Vermont is suing payers and the government of not using this law as intended. The law is intended to ensure that anybody getting a birth control method, whether it's a pill, IUD, etc., has no out-of-pocket expense for products that do not have a substitutable product.

Elyse Shapiro
Healthcare Analyst, Canaccord Genuity

Great. Thanks. In terms of derm, historically, you've kind of talked to potentially making as many as 10 new product launches there. Is that still something that you're kind of on track to do? In terms of revenue and earnings capacity, how are you framing those product launches?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

Yes, we're on track to do that. We've launched Roflumilast, Soolantra, Wynzora, Accutane so far, and we have five more launches in front of us. We're pleased with that. Obviously, Roflumilast has been a great win for the company. We are realizing a better net selling price than we expected than the business plan. That's really why we've been able to drive that margin into the business in the first quarter. Overall, you have to not just look at the product offering, but how this disintermediation strategy is working. As I communicated previously, this is resulting in us getting a higher margin per prescription and being able to sell product into patients who are not covered under their plan at a cash price that drives profit for us at the same time.

It's a reflection of volume and margin mix that is driving the growth in dermatology and the volume coming from new product launches. Penetration, as I said, we're number one now in Doryx in prescription volume. Now that we have both Accutane and Absorica formulations of isotretinoin, we have an opportunity to gain market shares in that sector.

Elyse Shapiro
Healthcare Analyst, Canaccord Genuity

Great. Thank you.

Operator

Thank you. There are no further phone questions at this time. I'll now hand over for webcast questions.

We have a question from Mark Whitaker. Thanks, Mark. First question is, are you pleased with the run rate for Nextstellis? Break-even is a good result, but how do you accelerate sales?

Shawn O'Brien
CEO and Managing Director, Mayne Pharma

It's a good question, Mark.

If you look at the exit rate of a number of take the script data and look at the exit rate of number cycles, we did achieve that break-even rate in December. That would provide, with no extra growth, a 36% increase in cycles in the second half. We did 33% in the first half growth over the prior period. However, you can see that with the monthly scripts that we just shared with you today at 44,453, that momentum that we achieved at the back end of December is carried through. We are expecting that. As I said previously, Lynn brought on Tony into the business, and it is really about making sure we execute on our plan that we have for NEXTSTELLIS, Annovera, Vyleesi, and BIJUVA. We were not fully on plan on our execution, and I can guarantee you that is going to change.

Really, right now, the focus for Nextstellis and women's health is all about our sales and marketing execution and delivering the growth expectations. We think we can move it faster with greater discipline in place. Pleased but not satisfied, I would say. That's all. Yeah. I'm a continuous improvement person, so we got to always do things better.

Operator

Next question, also for Mark, excuse me, is the dermatology revenue level. The question is, what should we think about for the full year given the strong 1H performance?

Aaron Gray
CFO, Mayne Pharma

I'll take that one. From my perspective, the first half benefited obviously from some turnaround activities that we've engaged, improvement in pricing, launch of new products, copay monitoring, etc. What I would say for the second half is that we would expect the new products to give some level of lift.

We would expect the additional months of the Roflumilast, which we launched during the first half, and obviously, we'll have for the full six months of the second half. We would expect that to give some level of lift. I'm optimistic that a national launch of the disintermediation strategy provides us a good hedge against potential price erosion, which we might have seen in the past. In the past, we had channel inventory issues, which, as I communicated, we've changed processes that are results validated by third parties, etc. We don't believe we'll see a repeat of that. We also suffered because of the mix and the pricing pressure on some of the different assets. If we look at Epiduo Forte as a case study, the price pressure that came into the marketplace really impacted Mayne at the end of fiscal 2022.

We don't have the same profile of products. We've got better products with better protection, better IP protection, and less competitive pressure. I would believe that we'll see growth in the second half over the first half as a function of all those factors. From a headwind standpoint, there's pressures on DAP zone. In addition, we communicated previously that we are getting a better selling price for Roflumilast than expected on plan. There could be some headwinds against that net selling price for Roflumilast, compared to the first half. That's right. It will be additional months of revenue, potentially a slightly lower net selling price on Roflumilast .

Operator

Thank you. Next question from Michael Milne is, you have previously spoken about a possible U.S. listing pending further improvement in financial performance. What does that look like? What does a U.S. listing look like?

Aaron Gray
CFO, Mayne Pharma

It's part of our plan, but there's no immediate action here on that. It's just a reflection of where our business is. We're 80+% of our revenues out of the U.S., and it's a way to attract healthcare-focused investors at the future.

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