Thank you for standing by, and welcome to the Mayne Pharma Group Limited Half Year 2024 Results Call. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. If you wish to ask a question via the phones, 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 enter it into the ask a question box and click submit. I would now like to hand the conference over to Mr. Shawn Patrick O’Brien, CEO. Please go ahead.
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, but as stated on the disclaimer slide, I want to emphasize that the information provided today is general 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, and all numbers reported here are in Australian dollars, unless otherwise noted in US 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 2024 results. 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 AUD 18.1 million each and international at AUD 4.4 million in direct contribution. We expect this performance to continue, continue in the second half and deliver a full-year positive direct contribution from all business units. Secondly, we're excited that we reached positive underlying EBITDA of AUD 8 million during the half, a significant improvement over the second half of FY 2023, underlying loss of AUD 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 reductions already achieved in the first half of FY 2024 against our operating budget, which did not include new product launches such as RHOFADE. 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 AUD 188 million, up 43% from the second half of FY 2023, results of AUD 131 million at that time, and slightly ahead of our full 2023 year results of AUD 185 million. This strong growth performance reflects the growth of the U.S. dermatology and Women's Health business units. Overall, we achieved AUD 40.6 million in direct contribution from all three business units.
As shared previously, our underlying EBITDA of AUD 8 million is a big swing from a loss of AUD 25.9 million in the second half of 2023, driven by revenue growth and cost optimization. Closing cash of AUD 146.8 million represents a cash outflow of AUD 73.3 million during the period. Half of that outflow related to debt repayment, our RHOFADE acquisition, and our on-market share buyback, and a further AUD 13.8 million was related to planned discontinued operations closeout. In addition, we saw AUD 19.2 million outflow from continuing operations and AUD 3.9 million of burnout 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 unit's 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, and during the half, we secured the Orange Book listing for the NEXTSTELLIS patent. We're also continuing to see improved metrics with the assets we licensed in. Both ANNOVERA and IMVEXXY are growing, and with the launch of our low-strength BIJUVA in January, we expect a 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 Oracea and RHOFADE are driving growth. In fact, our U.S. $8 million purchase of RHOFADE 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're able to roll it out nationally this past January.
While international revenue was down in the second half of FY 2023, direct contribution was actually up as a result of 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 rollouts as an opioid substitution therapy continues the progress in Canada, EU, and Asia. For the first time in years, we've invested AUD 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?
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, that's been requested by different investors. So 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 and 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 AUD 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. $10 million cost out program that's been discussed previously and cost discipline across the business. Direct costs in the half were AUD 65.2 million versus AUD 64.6 million in the comparable period.
Underlying EBITDA of AUD 8 million reflects adjustments from statutory EBITDA of AUD -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's 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 AUD 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. I think that's me. Maybe we got a little bit sideways here, so come back, if you would. Thank you. Okay. The purpose of this slide, 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 this slide. So 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, 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 equivalence balance stands now at AUD 146.8 million, down from AUD 220.1 million at June 30. We reported that cash was AUD 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 -AUD 28.7 million. Adjusting for cash used for discontinued operations of AUD 9.5 million, continuing operations consumed AUD 19.2 million in operating cash in the period.
To provide some more detail on operating cash use, we invested or built AUD 25.7 million in working capital during the half. We invested AUD 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 AUD 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 AUD 3.9 million and AUD 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 $111 million. We have significantly improved trade terms and collections, and so that, that facility has become redundant. The successful product acquisition of RHOFADE, 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 have 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 net working capital investments. The item that is growth, CapEx, and asset acquisition includes the capital spend that Sean mentioned at the Salisbury site, as well as the acquisition of RHOFADE. Next slide. Slide 11 shows our balance sheet.
Key call-outs here are that you can see the improvement in working capital, particularly against the revenue. Our liabilities for gross to net stands at approximately AUD 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 AUD 15 million, which reflects good progress as part of the closeout.
You will also note that marketable securities of AUD 36.7 million is included in other assets, so the cash balance plus that 36.7 ties back to the AUD 146.8 million cash that we discussed. Next slide, please. Moving on to the segment performance. Slide 13, or 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. US dollar for Women's Health and Dermatology, and Australian dollars for international. We've replicated the Women's Health and Dermatology slide in Australian dollars in the Appendix, to make it easier for those who want to see a single currency.
Sean 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 and 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, 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 AUD 11.8 million positive. As we showed at our 1Q update, we have tried to show a cash, cash proxy at segment level by adding back depreciation, which is included in direct OpEx. This relates specifically to the, the sales, sales leases on cars. And we have also reflected the estimated earn-out liability of AUD 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 timing difference 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 breakeven in December. This view includes demand cycles through January 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. So we expect, going forward, that to translate to a clearer correlation between volume, price, and revenue reported. 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. That, 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. Slide, please. Oh, I'm sorry. Back to derm, I'm sorry. I had a little bit more. We launched RHOFADE during the first half, as Sean 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 stated previously, tends to be driven and continues to be driven primarily by capital-light transactions, i.e., profit share included as part of cost of goods sold. Now, I'll hand it over to Shawn for the next slide.
Thank you, Aaron. Appreciate that. So we've been talking about disintermediation for quite a period of time, and we've had great success recently with these 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, 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 costs 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 US 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 second half of 2023 due to production timing, partially offset by stock revaluation benefit.
The international segment still had strong gross margins and a positive direct contribution of AUD 4.4 million and cash contribution of AUD 6.3 million. We are making some progress in building the pipeline, and we see opportunity to grow the and leverage capacity of this facility being created with operational improvements in Salisbury. You can see that gross profit improves. This is a mixed dependent. OpEx remains in line, and there's good work across the various efficiency initiatives, so from supply chain through procurement and scheduling. Moving forward to the overall outlook for our business. Here's our outlook for the remainder of FY 2024. We are reiterating prior guidance and expect all three business units to deliver positive contribution margin in FY 2024, 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 a 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 the President, the out-of-pocket expenses for birth control should be zero for patients, and at least 30 states and 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 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, especially in generic product sales locally in Australia, including the drive of NEXTSTELLIS in Australia. We will continue to invest in a targeted manner in the Salisbury facility and expect to invest $8+ million this half to improve productivity and capabilities over the long term. The previously announced cost reductions of approximately $10 million will extend in the second half and are expected to deliver benefits FY 2025 and beyond.
We will continue to execute other accretive uses of our capital. You've heard today it's been a great start to FY 2024, and we're excited to keep that momentum going into the second half of the year. With that, I'd like to turn it over to the operator for questions.
Thank you. If you wish to ask a question via the phones, 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.
Well, 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 RHOFADE and Oracea, but not much to DORYX. So just looking for some color on what was happening to DORYX in the period. And 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?
Okay. Thanks, Andrew. So the question I heard was, good performance on Oracea and RHOFADE. Didn't hear much on DORYX , and is there any seasonality with the other products? On the DORYX, we're pleased that DORYX now, with the launch of DORYX MPC, we've become the market leader at a prescription level for that product. So 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. It's-
Yeah.
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. So 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 co-pay increases for patients because of a reset of their health plan, and we didn't see that happen almost straight across the board, both in women's health and dermatology. So we're pleased with the kickoff that we have in the results we've seen in January. So we expect the dermatology business on the acne to grow.
Now that we have both Accutane and isotretinoin, both in ABSORICA formulation and, and the original Accutane, we, we have opportunity to get a lot of that market. Is that helpful?
Yeah, I was just trying to understand, particularly with some of the product ads, whether you'll dampen some of the sort of seasonality when you get to the summer.
Yeah. We don't- Go ahead.
Oh, sorry. Oh, you go. Sorry.
No, go ahead, Andrew.
Just on Women's Health, obviously 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.
So we have 85 territories in the market right now. We just took on a new sales leader under Lynn, Lynn who took over Women's Health at the beginning of the year. We have a new sales leader in place, and really 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 opporunity 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. Lynn's taken over the focus on women's health. So it's really a move reflecting on our confidence of both those business units growing rapidly.
Okay. Thank you.
Thank you. Your next question comes from Melissa Benson, from Wilsons Advisory. Please go ahead.
Good morning, Shawn and Aaron. Thanks for taking my questions. The 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... You know, 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?
So, on that, we have always allocated, I think we've communicated this previously, that 60% of a commercial footprint is allocated to NEXTSTELLIS and the other 40% to the remaining portfolio on Women's Health, on the cost base. So that's how we... Does that answer the question there?
Yes, no, it does. That's helpful. And thinking about that cost out, that $10 million cost out, and a 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 base, or a lot of that was delivered in this first half?
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. And the $2 million in cost of goods won't be, wasn't seen at all in the first half. That's gonna 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're down $5 million, roughly, directly in women's health. And the cost out, the majority, like 80% of the cost out, was focused on NEXTSTELLIS. Actually, 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's been many Women's Health companies who have failed in this marketplace, overinvesting and not getting the return. Going forward, we're gonna continue to look at not just NEXTSTELLIS, but ANNOVERA and IMVEXXY and BIJUVA, how we want to invest and drive growth. And now with the new patent in place, it gives a level of confidence in the opportunity that we didn't have previously.
That's helpful. On the international business, you know, you called out it was a little bit softer at the top line, and that was kind of customer mix impacts there, but you saw some efficiencies in the business. I mean, how should we think about revenue growth in that business? Or, or rather a little bit more color on customer mix, and I guess if some of those operating efficiencies now have been reached, if we think that, you know, pending top-line growth, the cost base is fairly stable from here.
I would look at the second half of the- And right now, it's gonna be roughly flat growth.
Mm-hmm.
On the cost side, you know, we just secured a new contract on procuring our API, which is gonna give us an AUD 500,000 annual saving over previously for one of our products. So that's 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.
A quick clarification: Does any NEXTSTELLIS sales from the international business, is that captured in Women's Health or that's separate?
No, it's captured in the international business. It's part of-
Yes. Okay.
Australian Pharmaceutical, M PA.
Yeah.
Mayne Pharma Australia.
Yep. And, final question for me was just around at the J.P. Morgan conference in January. I think, Shawn, you were speaking to revenue, you know, run rates and the potential for this business to do, you know, 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?
Well, if you look at the run rate we have right now, $188 million x2, it puts you into the $375+ range, $377. And then, if you look at our, you know, 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 gonna be north of that $375 million level.
Thanks very much.
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 my 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?
The only pricing—I think we've done a very good job using Ryzerx to make sure that our co-pay cards are used efficiently and as intended, and reducing the abuse. So that's given us productivity. But, and then all the other activities we've done in place. So we've, you know, 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. But 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+ signatures from senators and congressmen about this particular issue and sent to the payers' community for asking them to abide by the law. So 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. So the law is intended to ensure that anybody getting a birth control method, whether it's a pill, IUD, or et cetera, has no out-of-pocket expense for products that are, do not have a substitutable product.
Great, thanks. And then, just in terms of Derm, you know, historically, you've kind of talked to potentially making as many as 10 new product launches there. Is that, is that still something that, that you're kind of on track to do? And, and in terms of, like, revenue and earnings capacity, how are you framing those product launches?
So yes, we're on track to do that. We've launched RHOFADE, SOOLANTRA, WYNZORA, ACCUTANE, so far, and we have five more launches in front of us. And so we're pleased with that. Obviously, RHOFADE has been a great win for the company. We are, you know, realizing a better net selling price than we expected, than the business plan. And so that's really why we've been able to drive that margin into the business in the first quarter. But overall, it's really... If you have to not just look at the product offering, but how this disintermediation strategy is working.
And 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. So it's a reflection of volume and margin mix that is driving the growth in dermatology, and the volume coming from new product launches. And penetration. As I said, we're number one now in DORYX in prescription volume, and now that we have both ACCUTANE and ABSORICA formulations of isotretinoin, we have an opportunity to gain market shares in that sector.
Great. Thank you.
Thank you. There are no further phone questions at this time. I'll now hand over for webcast questions.
So there are-
We have a question from Mark Whitaker. Thanks, Mark. First question is, are you pleased with the run rate for NEXTSTELLIS? Breakeven is a good result, but how do you accelerate sales?
It's a good, good question, Mark. So if you look at the exit rate of the number of... Take the script data and look at the exit rate of number cycles, we did achieve that break even, even rate in December. That would provide, with no extra growth, a 36% increase in cycles in the second half, and 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 has carried through, and, so we're expecting that.
As I said previously, Lynn brought on Tony into the business, and it's really about making sure we execute on our plan that we have for NEXTSTELLIS, ANNOVERA, and IMVEXXY, and BIJUVA. And we weren't fully on plan on our execution, and I guarantee you that's gonna change. So really right now, the focus for NEXTSTELLIS and Women's Health is all about our sales and marketing execution and delivering the growth expectations. So we think we can move it forward faster with greater discipline in place.
Pleased but not satisfied, I would say.
That's how, yeah, I'm a continuous improvement person, so let's, we gotta always do things better.
Next question, also from 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? 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, et cetera. 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 RHOFADE, 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 obviously channel inventory issues, which we, as I communicated, we've changed processes, had our results validated by third parties, et cetera. So 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. 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.
And so I would believe that we'll see growth in the second half over the first half, as a function of all those, all those factors.
From a headwind standpoint, there's pressures on Dapsone. In addition, you know, we communicated previously that we are getting a better selling price for RHOFADE than expected on plan, so there could be some headwinds against that net selling price.
Yeah, compared to the first half. That's right. So it'll be additional month of revenue, potentially a slightly lower net selling price on RHOFADE. Good one. Thank you. Next question from Michael Mills 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? You know, it's part of our plan, but there's no immediate action here on that. It's, you know, just a reflection of where our business is, where 80%+ of our revenue is out of the U.S., and it's a way to attract healthcare-focused investors of the future.