Thank you for standing by, and welcome to the Mayne Pharma Group Limited full year 2023 results. 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 webcast, please enter it into the Ask a Question box and click Submit. On today's call, we have Mr. Shawn Patrick O'Brien, CEO, and Mr. Aaron Gray, CFO. I would now like to hand the conference over to Mr. Shawn Patrick O'Brien. Please go ahead.
Thank you, operator, and good morning in Australia and good evening in the US, everybody. Thank you for joining us to discuss Mayne Pharma's fiscal year 2023 results. Also joining me on the call is Aaron Gray, our Chief Financial Officer. On slide two, our disclaimer slide is there for you to review, but I would like to bring to your attention that these results are preliminary final report and thus are unaudited results. We fully expect that our audited results will be ready very shortly and will not materially be different from the results we are sharing with you today.
We're excited to share these results as they demonstrate that we are progressing with our transformation journey for Mayne, yet we have lots of work in front of us to realize the full potential of our three business units.
All numbers today are reported in Australian dollars, unless otherwise noted, in US currency. So, looking at slide three, fiscal year 2023 has been a transformative year for Mayne. We began the year with a new management team and a clear set of objectives, and I'm proud to say the team has executed on multiple fronts. First, we set out to reduce the complexity of the business, refocusing on three core segments: women's health, dermatology, and international.
To this end, we sold our Metrics Contract Services and our US retail generics businesses for a combined total of $565 million and expanded our position in the US women's health market by acquiring the exclusive commercialization rights for three branded products, ANNOVERA, IMVEXXY, BIJUVA, and a portfolio of prenatal vitamins.
Mayne Pharma is now one of the top two women's health companies in the US from a commercial footprint view and our ability to reach the OBGYN customers. We transformed our balance sheet and enabled an end of the year with a net cash position of AUD 172.6 million, compared to a net debt position of AUD 317 million at the end of fiscal year 2022. This represents a AUD 480 million plus improvement in our net cash position.
While we continue to maintain a conservative capital management, we were able to provide a AUD 46.7 million special dividend and initiate an on-market share buyback program up to 10%, of which we have purchased 6.2 million by 30 June 2023.
Another major objective was to ensure the successful commercialization of our flagship product, NEXTSTELLIS, an oral contraceptive pill with a unique estrogen. Under new leadership and a refreshed marketing plan, we relaunched the product in the second half of fiscal year 2023 to strong results. For the full year, NEXTSTELLIS revenue was up 267% compared to 2022. The momentum is building, with cycles increasing 80% from the first to the second half of fiscal year 2023.
The strength of NEXTSTELLIS launch, combined with the successful integration of the products acquired from TXMD, resulted in a 484% year-over-year increase in revenue in our women's health division. Our goal is to grow the top line and improve the contribution margin of all three business units.
Our Australian-based specialty pharmaceutical and CDMO business saw a 19% year-over-year increase in revenue due to improvement in manufacturing performance and commercial execution. As reported in our last call, the dermatology business has faced challenges due to co-pay charges, pricing pressure. But I am pleased to report that we saw a significant rebound in the second half, with a 314% increase in revenue over the first half.
Our final fiscal 2023 objective was to set Mayne on a path towards generating operating cash and returning the business to profitability in the near future. Our revenue growth in the second half fiscal year of 2023 was across all three segments to AUD 131.3 million versus 52 million in the first half.
Moving over to the next slide, fiscal 2023 was an important year for Mayne, and this momentum has carried into fiscal year 2024 nicely. We are pleased with the trends we are seeing already in July and August for the entire business. We still have a lot of work to complete the integration of our three major transactions that occurred in fiscal year 2023.
We are focused on execution and delivering on commercial and operational excellence... We expect that all three business units to generate positive contribution margin, which will help return Mayne to a positive EBITDA and cash generation in fiscal year 2024. In our women's health or BPD division, we will complete the integration of the licensed women's health portfolio in fiscal year 2024, with an improved focus on net selling prices.
For NEXTSTELLIS, we're targeting a break-even run rate in the first half, with continued growth throughout fiscal year 2024. We also plan to launch low-strength BIJUVA in menopausal symptoms, leveraging our sales force scale and effectiveness. For dermatology, we continue to seek capital-light, accretive business opportunities while driving commercial excellence. We are further refining our channel strategy to better leverage our ability to drive market share to expand partnerships. Improved profitability is a clear objective for this side of the business.
Finally, in our international segment, we'll pursue targeted investments and new manufacturing revenue streams, which reflects our investment to drive growth going forward in all three segments. Let's look at how each of the units is performing overall. Slide seven.
We wanna focus on the movements here from the first half to the second half of fiscal year 2023 in all three segments. All three segments, women's health, derm, and international, showed improvement in revenue, gross profits, and direct contribution, while our costs went up as planned only in women's health, as we invested in NEXTSTELLIS and our portfolio of new products, ANNOVERA, IMVEXXY, BIJUVA, and our prenatal vitamins. Overall, we delivered about $1 million in contribution in the second half, versus a negative contribution in the first half of $42.7 million.
Sometimes I get questions, "Why don't you sell the international business?" But as you can see here, fiscal year 2023, international represents 35% of our revenue, only 9.7% of our OpEx, 22.6% of the gross profit, and delivered the only positive contribution with AUD 6.9 million. This helps us invest in other higher growth segments, such as women's health and in dermatology. I'd like to hand it over to Aaron Gray, our CFO, to provide more financial details. Aaron?
Thank you, Sean. There we go. Thank you. This slide is a group overview showing the consolidated group comparable between fiscal 2023 and fiscal year 2022. These figures have been converted to be shown on a comparable basis, meaning that we have carved out all activity from both fiscal years, from the MCS business and from the retail generics business, that was divested. What you can see looking at these results is that the reported revenue is up year-on-year. We'll go a little further into the halves and what the halves look like.
The company sees about a 17% growth, driven by the women's health portfolio and the international business. These businesses have actually over-driven revenue, offsetting some of the declines that we've seen in the dermatology business, which links back to the channel inventory topic that led to the restatement in the first half. Gross margin has risen in absolute terms, has risen year-on-year.
However, the margin percentage has declined year-on-year, driven by some movements and some challenges facing the dermatology and the international business. We'll go a little bit more into those. Underlying EBITDA, comparing the results for fiscal year 2023 compared to what may have been seen in the past, is reflecting far fewer adjustments as a result of the sale of the retail generics business and the cessation of the discontinued products phenomena that was affecting that business. Would you please jump to the next slide, please? Thank you.
Looking at this slide, you'll see significant differences between the first half and the second half. This slide basically is revenue from each individual segment, operating margin from each segment, then back to the top on the other side, therefore, group profit. Basically, subtracting group profit minus OpEx equals direct contribution. Between the two halves, you've got the first half, which was heavily burdened by dermatology and the excess channel inventory topic, which again led to the restatement in the first half.
The second half includes not only a higher run rate of NEXTSTELLIS cycles, but also the integration of the TherapeuticsMD assets. The women's health assets are driving revenue growth year on year and half on half.
I think it's important also, though, to note that we are continuing to work through a number of integration topics on the women's health expansion, which are the products that we licensed from TherapeuticsMD. Dermatology revenues have recovered, as Shawn mentioned. Roughly 81% of the total revenues for the fiscal year in dermatology came in the second half. However, some of the margins have lagged on higher charges against revenue.
We've maintained a conservative footing with respect to this topic, and we continue to refine our approach on analytics and other levers to be able to improve the overall dermatology performance. Overall, the group has returned to positive contribution in the second half. Slide, please. Thank you.
This is a table which reconciles from the reported result to the underlying result across revenue, gross profit, EBITDA, and PBIT. One thing that one would note compared to historical results is that the adjustments, while some of the headings are the same, some of the quantum is the same, the volume of adjustments from discontinued products has drastically reduced as a function of the divestment of the retail generics business.
The largest movement that we see here is really related to the depreciation and amortization, which in majority is coming from depreciation of intangible assets. Next slide, please. Slide nine. Thank you. This is a view that gives a little bit more detail and gives me a chance to talk in a little more detail about some of these specific movements.
Similar to the prior slide, it walks on the EBITDA only from the reported number to the underlying number. Reported EBITDA of 102 loss. We then had an earn-out assessment. The earn-out assessment change was basically a non-cash movement, which comes from a change in the fair value of earn-out liabilities. Basically, this is the payments that we owe to the licensed partners that we have licensed the assets from. We are increasing the earn-out liabilities overall, which is reflective of a change in the forecast for NEXTSTELLIS, and a change, some amount of change in the forecast for TXMD as well.
The NEXTSTELLIS change really is driven by the revised strategy, which is also being seen in some of the growth rates and some of the other topics that Shawn mentioned. The next item is restructuring. We have taken on considerable restructuring to transform the group. Some of this geared at reducing stranded costs, which, are present because of as a result of the Metrics divestment, some to reduce stranded costs as a result of the retail generics divestment, and some to reduce overall our cost profile. The next item down, doubtful debt.
This is one specific item. We have a large receivable, which is still outstanding. We have fully reserved for this receivable, based on difficulty trying to collect this for the past 15 months. Next item down, supply chain disruption. This refers to LEXETTE. LEXETTE is the product, it's a dermatology product that was discontinued in fiscal year 2022. We're in the process of relaunching that product based on, our ability, the fact that we've been able to find an alternate supplier.
So the activity through fiscal year 2023 was treated as part of discontinued operations, as that we were selling through inventory until such time as we were able to find another supplier. Insurance recovery is a one-time topic, a windfall gain that comes out of a business interruption insurance claim for the Salisbury plant. We've booked this entry even though we've become aware of the recovery. The claim's been approved effectively after the fiscal year ended, and so the cash has not come in yet on this.
The derivative FVA topic is basically a mark to market on the convertible note that the company took out in support of the TXMD transaction. It's a non-cash movement. The INTI settlement is basically our loss on disposal as we exit that partnership and exit that agreement.
Another non-cash movement, there was a loss on the INTI disposal overall, and there were payments due on INTI. However, this was paid by the insurance company. Litigation. We've had an increase overall in litigation, specifically related to drug pricing and healthcare investigations, the US Department of Justice, and a couple of other topics. So, where we land, we move from AUD 102 to negative AUD 102 to negative AUD 95.3 on an underlying basis. Next slide, please. Slide 10. Thank you. Group financial overview, looking basically at... Okay.
Group financial overview, looking at a walk from that AUD 95.3 million number that I just, that I just showed, down to what the total change in cash is. A lot of detail on here, but a few things to note. First of all, the company generated positive cash flow in the second half of fiscal year 2023, positive operating cash flow. This is driven really by improved business performance and by a large item that you can see in the operating cash flow line, which is total working capital movements.
The working capital movements come as a function of some efforts to reduce overall our cash conversion cycle, but it's really driven in large part by the divestment of primarily the retail generics business. The other big topics here, the transaction costs, are related to costs that we've incurred to divest those businesses. Any costs related to TXMD would not... I'm sorry, this is the cash. So, and would include also cost to acquire TXMD.
The other topics that we have, so if we look at cash used in operating activities, it's a negative AUD 42.7 million for the year, but a positive AUD 14.1 million for the second half. So, significant improvement there. Continuing down, I'm sorry, we did have a very active year with respect to both cash flows from investing activities and cash flows from financing activities. Cash flows from investing activities totaled AUD 473.5 million. Cash flows from financing activities totaled negative AUD 431.5 million. And so overall, where we land is an overall change in cash of negative AUD 1 million.
One thing that should be noted on this view is that we carry a deposit in the United States, an overnight deposit in short-term marketable securities. That item specifically is reflected as a movement of cash out. This is actually an accounting classification, not really related to our inability to access those funds. If that's added back, the total cash change would actually be a net positive number.
Next slide, please. Looking at the consolidated balance sheet, it's been a year of change. We have massive changes across the business. I mentioned already the cash and cash equivalents topic. This is linked to the marketable securities, which are included below in other assets.
The major changes that we have here are the PP&E, which comes from the divestment of the MCS business, the inventory and receivables topics, which are those of the divestments of the net working capital. Our income tax receivable is still classified as a current asset, as we do expect to be able to collect that in the near future.
Other items of note on this page are the payables. Payables will have been reduced as a function of the divestments that we've made, but we've also increased our gross to net reserves substantially, both on a conservative footing as we integrate the TherapeuticsMD assets, but also as a function of some accounting method changes that we've made, that we'll talk a little bit more about further on.
At the bottom, you'll see the points that Shawn referred to, which is the net cash and net debt, from negative 317 to 172.6, so a reversion of almost AUD 490 million. Next slide, please. Slide 12. Thank you. We've talked in the past quite a bit about cost, and we've talked about cost reduction programs that we've been working on. The company undertook to make a number of investments and a number of process changes in fiscal year 2023, that basically were going to increase cost, and some of these things did increase cost.
What we have undertaken, though, is a program that's geared at trying to find money for investment. So, where we need to invest, what reductions can we make in order to fund that investment? What you see on this slide really is a fiscal year 2022 OpEx base of $143.1 million, along with then some changes, walking down to what would have been the fiscal year 2023 OpEx base at $195.2 million.
Where we land ultimately is $189.9 million on the lower box, which is a net savings of about $5.8 million. This really comes from reductions in headcount. It comes from divest from, basically restructuring the retail generics business and reducing costs there. There are other measures that we are focused on. The headline says, "More work to do." There is more work to do. And so with that, next slide, please, number 13. Thank you.
So what this slide attempts to do is to talk about reductions in process, reductions made, and investments pending. In fiscal year 2023, we targeted to make a number of investments, investing a total of AUD 39.4 million, and that was primarily the NEXTSTELLIS DTC, the Australian NEXTSTELLIS launch, but then also the additions of cost for TherapeuticsMD, on a half year basis when we acquired those assets. We invested some money into disintermediation.
We had a number of topics: inflation, software changes, et cetera, et cetera, that impacted us. But in fiscal year 2023, we were able to save about $5.8 million. What we're targeting for fiscal year 2024 is AUD 10.5 million. Some of that is, it's basically all in execution and budgeted.
Some of it is a flow over from fiscal year 2023, actions taken in 2023, that now add to the total fiscal year cost number. Some of it is new actions that are going to be taken. On top of that, we still have some additional costs that we have targeted for reduction. We just haven't quite gotten to it yet, and that totals a further $3.5 million.
One point in the far right-hand side, we are making investments, and we continue to invest where it makes sense. In the past, we've said we'll save where we can and invest where we need to. And so that is really where the focus lies for the future. I think with that, I turn it back over to Shawn.
Thank you, Aaron, and let me just briefly go through some of our sections. Then the first section is our branded portfolio section, which is women's health. So looking at slide 15, out of the 17% growth that our group saw to bring in revenues up to AUD 183 million in fiscal year 2023, we saw the women's health growth go from AUD 10 million to actually AUD 62 million or a third of the business in fiscal year 2023.
So, number one driver is women's health, driven by NEXTSTELLIS, and also which is a result of our refreshed marketing strategy. NEXTSTELLIS revenue was AUD 14.1 million, with both the first half and second half in line with each other. We had some one-off i mpact on the profitability, but we're still seeing our path to profitability, i.e., a breakeven run rate in the first half of 2024. And I'll show you with some of the growth that we're seeing in the cycles.
So, if we look at the expansion portfolio of products, the revenues were $24.5 million, roughly, in the second half, and the volume demands there, and I'll share those curves for you. There was a one-time accounting charge of $5.7 million, so this revenue would actually been $30 million in the second half of 2023. If you look at our contraceptive products, NEXTSTELLIS and ANNOVERA actually represent 63% of the women's health revenue, followed by IMVEXXY for menopausal dryness at 20%.
So we're excited about where the women's health business is heading, and we're maintaining a very vigilant cost management to support the growth of our sales team and the marketing efforts to drive profitable growth for these products. So let's look at slide 16, and we can see what our refreshed marketing strategy has done to the number of cycles on a monthly basis for NEXTSTELLIS. It's been steady, up 80% the second half over the first half, since we've been targeting Yaz and Yasmin with selective selectivity messaging, and a reach in frequency.
We've improved, as I communicated before, the number of samples, the number of calls, and the calls that we're getting signatures from our customers. We are seeing about 2.2% weekly growth, and to date, we're on track to the expected trend, so that will allow us to deliver a break-even run rate for NEXTSTELLIS. So let's quickly look over at the expanded portfolio products, IMVEXXY is on the left.
These are unit sales of IMVEXXY, followed by ANNOVERA to the right. ANNOVERA has some of the non-reporting pharmacies that are reflected here. We're seeing growth in the product. And then BIJUVA units are on a consistent slope upward over the significant period to period there. So there are no change to the business case of the acquisition of TherapeuticsMD as they're delivering to expectations. So moving over to dermatology on slide number 19, I believe it is. Next slide. Sorry.
Second half 2023, you know, dermatology is in a turnaround situation since the first half poor performance, and the second half improved the sales dramatically. The inventories have normalized, and the pricing is more stable, and you can see the unit growth slightly going up over time, and you're not seeing the spikes in the buying patterns. So we're taking a conservative approach to the copay methodology, and we're excited about the successful launch of MPC DORYX MPC 60, and our generic or authorized generic Arazlo.
While it's underperformed due to unplanned channel inventories, we think this will wash out from the prior distributor of this product, and we'll see significant growth in the first part of fiscal year 2024. So we're excited about the dermatology turnaround.
There's a lot of work to be done, and we'll continue to drive that forward. So briefly, let's look at our business, and how we're looking at the pain points that patients and customers have in the pharmaceutical value chain. We call this disintermediation. There's, you know, you got your manufacturers, your plan sponsors, the wholesalers, providers of the prescription, and then the patient. And with increasing out-of-pocket expenses for patients, they're getting selectivity, and that affects adherence to medications.
Dermatology is one of the areas where adherence is poor and patients shop around to get their prescriptions. So, our goal is really to help patients receive quality drugs quickly, at the best possible price, while increasing prescriber efficiency and effectiveness.
Physicians do not want to spend times on the phone getting prescriptions changed back and forth. So looking on slide 21, looking at, you know, why we're focused on this initially in dermatology, this is an area that's undergone a lot of pricing pressure in the past, on the topicals and on the orals in dermatology. And, you know, it's a repeat business. There's a lot of long cycle times for the treatment, chronic therapy for many conditions such as psoriasis and acne. So it's value, but the insurance coverage is very poor and seems to be getting worse in some areas.
So, we have ability to fulfill roughly 33% of all retail prescriptions that are written by the number of products we have for psoriasis, acne, atopic dermatitis, et cetera, in our bag. We have established relationships with manufacturers for generic and branded products. So, we have a pharmacy network, and we're working with GoodRx to expand this. We have Adelaide Apothecary that's now licensed to operate in 50 states, and we have over 400 specialty pharmacies contracted with us to ensure that patients get the product that the physician ordered.
We have an ability to drive the market with a combined sales team of over 145 reps between our dermatology and women's health franchise. So, we can reach over 50,000 prescribers and drive that. So this is allowing, you know, the various companies with dermatological agents to come our way, Galderma, Sandoz, Upsher-Smith, to name a few, are coming our way, and they see our ability to drive market share through our unique model.
And working with AssistRx and GoodRx, we expect to expand on this model significantly in fiscal year 2024. So let's look at our international business briefly. We've invested in a new leadership team here, solid progress. You saw on a segment basis, we had nice revenue, uptick in the second half versus the first half. This is the only business that provided contribution in fiscal year 2023, at AUD 6.9 million. The operating costs were maintained flat at AUD 16 million in the two halves, while we drove increased revenue coming forward.
So we have a AUD 12 million investment in partnership with the Australian government, who provided a AUD 4.8 million grant on the MMI grant or Modern Manufacturing Initiative. And this is gonna allow us to improve the capabilities and effectiveness, and efficiency in the Salisbury facility. We'll continue to drive growth, in our, our Australian domestic business, driven by NEXTSTELLIS and other products in, in the market. We continue to, expand our international business, especially with Kapanol and the opioid substitution therapy opportunity in Europe.
And we continue to invest in the growth of NEXTSTELLIS, in, in the Australian market. So, we're delighted on the solid growth that we're seeing out of the international business going forward. So, if you look at slide 24, I've talked about, you know, there's people, process, and, and products.
We've, you know, made some people changes. We're improving processes. We've learned a lot more about Gross to Net and how to manage that more directly in the company. We've offered new products, and these three elements, with our people, products, and the processes that we put in place, are all here to serve the patients and drive profitable growth. So we're excited at what we're doing in women's health, dermatology, and international. We'll continue to broaden our women's health and dermatology franchises with accretive assets.
We'll continue to create access for our patients through disintermediation in our relationship with GoodRx and AssistRx. And we're gonna continue to drive improved profitability with dermatology and also with our international business.
So, looking at the outlook for fiscal year 2024, the company expects to complete the integration of the licensed women's health assets, focus on growth for those products and improve the net selling prices of all those brands. We're gonna continue our growth and investment strategy for NEXTSTELLIS. In addition, we have a half-strength BIJUVA launch expected in January of calendar year 2024. And we're gonna continue to leverage our sales force and our efforts for NEXTSTELLIS.
So that break even run rate of first half of 2024 is on target, and we're gonna continue to drive growth for NEXTSTELLIS beyond that. For dermatology, we continue to plan to enter in the capital-light accretive business agreements and drive commercial excellence throughout fiscal year 2024.
We are gonna continue, as I said, to develop our channel strategy and create access for patients and improve profitability, is a clear objective for the dermatology franchise. So in international, it's targeted investment and new manufacturing revenue streams, investing in our local domestic business and especially in NEXTSTELLIS, and then looking targeted investments in Salisbury's facility to improve that productivity and capabilities, with the capital improvements we talked there. So when we look in, in fiscal year 2024, we'll see all three business units contributing positive contribution margin.
The company then expects that we'll return to positive EBITDA in 2024, with the contribution margin coming out of all three units, and generate up operating cash flow. So we now can turn to the Q&A and answer questions that you may have on our business.
Thank you.
Operator?
If you wish to ask a question through 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 type your question into the Ask a Question box. Your first question comes from Melissa Benson with Wilsons. Please go ahead.
Good morning. Thank you for taking my questions. Perhaps the first one on NEXTSTELLIS. Just around the status update on payer coverage and kind of tiers of reimbursement, where that's sitting?
So not much has changed on the payer coverage with NEXTSTELLIS in the last six months. We still do not have United coverage because their approach to it is too punitive for us to go ahead with them. There is... The ACA is still working its way through the American Care Act, Affordable Care Act.
Mm-hmm.
And the requirement that no patients have out-of-pocket expense. As you know, President Biden did write an executive order, and most of the agencies are working through that, and we expect some positive outcomes of that effort by the president in the next six months. But you know, one of the things we did early on, Melissa, was improve our co-pay cards and the cost to the patient that's driving business.
And another thing that we're doing is making sure there's not abuse of our co-pay cards in the marketplace and working with AssistRx, and we've already seen on a per unit basis, a 7% improvement on a per unit basis there. The overall network for us on reimbursement hasn't changed in the last six months, but we're improving how we manage each prescription for NEXTSTELLIS.
Just staying with NEXTSTELLIS, on the gross margin front, has that layout largely kind of remained stable for that product?
Yes. Gross margin, yes.
Okay. Yes. And then if we're thinking about women's health division, you know, we've seen that the OpEx is around $45 million in the second half. So, is it right to think that that $90 million is kind of at a, on an annual basis, that's a good run rate, and that's kind of, you've completed the expansion there, and so it's just leverage now with that being the full cost base for women's health?
Yeah. Actually, you know, the run rate of the second half, if you were to take that and multiply it by 2, it's slightly lower than that going into fiscal year 2024.
Okay. And then how much of that cost base, you know, should we think is attributable to the TXMD assets? Or is it, is it a case that, you know, that's a women's health force and they're selling NEXTSTELLIS as well as the other, so they- that's the combined, you can't really separate?
Tell me about that. Yeah. So fair question. So, we had 72 reps, and we went through roughly 93 reps. And we've had some rep changes who were not productive throughout the year and improved that. So, when we took on the TXMD assets, we, we indicated that we thought we'd be running an incremental investment of roughly $20 million, and that includes...
Mm-hmm.
salesforce and, direct to consumer advertising and marketing. That wasn't a light switch turn on, and we certainly are not at $20 million run rate yet for those, those brands. But we have since April, increased our DTC advertising, on social media for ANNOVERA and IMVEXXY, and, and BIJUVA.
Okay.
We're seeing that, you know, increased activity at the website for all three of the brands. But DTC is an area that we are, you know, cautious about because we're not seeing the ROI, and we've seen several other companies in the women's health area overinvest in DTC and create negative results for themselves.
Mm-hmm.
So we're measuring that effort quite significantly going forward. But overall, we allocate roughly 60% of our sales force allocation to NEXTSTELLIS and the rest to the acquired assets.
Okay. One final one. Just around the AUD 5 and a bit million TXMD, that one-off accounting charge. Just what was that?
Yeah, hey, Melissa, this is Aaron. I'm happy to, happy to explain that.
Okay.
Basically, what we've done... One of the topics that a company has to deal with, when you deal with Gross to Net charges against revenue, is how much inventory is sitting in the channel. This is the same topic that came up on dermatology in the past, albeit a little different.
Mm-hmm.
What we've done basically is rather than expense managed care charges, which are typically charges that come when somebody who has a covered script. It's a charge that comes from the pharmacy benefit manager.
Mm-hmm.
Rather than expense those managed care charges as they come in, what we've done is use the inventory channel estimates to set aside monies on the managed care charges.
Okay.
It's a one-time adjustment, where in effect...
Yes.
W hat we've done is incurred an additional period of charges that won't happen in the future.
Okay, so that is a one-off. We can then just look at, say, the AUD 30 million as kind of the exit run rate?
Uh... [crosstalk]
On a revenue basis.
Yeah.
Sorry.
I mean, we, we can talk a little bit. Yeah, yeah, correct. Correct.
Okay, excellent.
We... Yep.
Thank you. And then just a final one, the restructuring costs for AUD 12 million you have as an adjustment to EBITDA, should we think, is there any further kind of restructuring or now we're moving into 2024 as kind of clean slate?
We expect minimal additional restructuring. There could be some...
Okay.
S ome nominal charges here and there, but I would say, Melissa, on quantum, we're probably talking AUD 2 million or less.
Okay, great. Thank you very much.
Once again, if you wish to ask a question, please press star one on your telephone or type your question into the Ask a Question box. Your next question comes from Elyse Shapiro with Canaccord. Please go ahead.
Hi, guys. Thanks for taking the question. Looking at Derm, you know, you're kind of talking to a positive contribution in 2024. When we look at the year-to-date performance, is that running positive through August?
So actually, Elise, we haven't closed August yet. And we've been so heavily consumed with the results. I can't answer your question. It's a great question, but I'm not in a position...
Okay.
T o answer it at this time. What we do expect is, based on some of the new product launches that we have and based upon some of the levers that we've been able to pull with respect to the channel, we do expect the positive contribution to be a, it's not a to-do, it's a largely done, and we now monitor the result.
Yeah.
Got it.
As I said earlier, I did mention that Arazlo, because of Prasco, had more inventory than we expected of the authorized generic. That is still coming through, and that should be pretty well flushed through by now. And those are patients that we're actually going to have better margin on. And we've also negotiated a cost of goods reduction of 12% for that. So, we'll be able to move the margin up for Arazlo and drive increased volume at the same time.
Got it. Do you anticipate having any negative impact from the IRA discussions that are going on?
Not as yet. I think those are hitting the bigger branded companies than ourselves. As you know, many of the large pharma companies are in a suit against the Inflation Reduction Act. But where we're positioned, we'd rather let them lead the path and we'll exploit the opportunity.
Got it. And then just on sales force with women's health, are you seeing really positive cross-selling coming through yet, for you know, the TherapeuticsMD team selling NEXTSTELLIS and vice versa? Or do you think there's a bit more to come in terms of the benefit there?
I would say, honestly, yeah, there's more to come. We had our national sales meeting a couple weeks ago in Miami. I was there with the team, and you know, part of the exercise was to you know, demonstrate the ability to detail NEXTSTELLIS and then pivot to ANNOVERA. There's not 100%, crossover between the menopausal prescribers and the contraceptive prescribers in the OBGYN market, maybe less than about 70% overlap.
And so, there are customers where, you know, the focus is BIJUVA and IMVEXXY. And then the common denominator include prenatal vitamins seem to be enjoyed by both segment. So, the cross-selling is a big effort that we're putting forward, going now.
We had effective training on this exercise at the recent national sales meeting.
Great. Thanks for taking the questions.
No problem.
Next question comes from Andrew Goodsall with MST. Please go ahead.
Well, good morning, and thanks very much for taking my question. Just looking at slide 16 and the growth in NEXTSTELLIS, just wondered where we're at in terms of that July number, and in terms of your reach with the number of prescribers and how many prescribers you'd ultimately like to be reaching.
So, Andrew, sorry, I did... [crosstalk]
Oh, yes.
I didn't understand the back half of the question.
Oh, just trying to understand where you are in terms of signing on with prescribers or your reach with prescribers. Are you sort of 50% the way there or, you know, 100%, just, just in terms of that exit rate?
Sure, sure. So, yeah, we ended up with roughly 31,000 cycles in June, up to 33,000 plus in July. You know, as we said, our target is to get to a break-even growth run rate. And so when we mean a break-even run rate, that means the number of cycles times our revenue is at, you know, on an annualized basis, taking that weekly result and analyzing it, would equal the cost that we're putting in or the investment we're putting in, the sales force, marketing, et cetera. And we see visibility of that happening in the first half of this year. And what's the major driver?
We've shared previously, and I don't have that slide here with us, but we've had a dramatic uptick in our commercial reach and thrust into the marketplace. It softened a little bit in July and August. We had the reps out at the sales meeting for a week. We had vacations, et cetera. But we're seeing a dramatic uptick in our reps' reach and frequency.
So the number one thing that we're you know communicating with the reps your sales potential is really driven by your knowledge, and that is your knowledge of your customer in the market and the competition, and your brand relative to the competition, your skills at looking at your target list. So we have our target list, which really folks focus on Yaz because they have the same progesterone and the better estrogen here.
You know, skills that they have at closing the customer and building their business plan and going to the right customer at the right time with the message and being able to close. Then it's the activity, and I've talked about the activity, you know, the number of calls. We've got some solid data that shows you can't oversample in the birth control market, and we're taking advantage of that and driving that forward.
One of the deficits we've had in the past, not just on the commercial side, but is our medical education, and we've hired six new medical science liaisons and a new leader in medical affairs, who is a card-carrying OBGYN, who's a leader in menopausal therapies and contraceptives.
So we're expanding our, you know, our reach of not just the reps, but also the scientific meetings and the various speaker programs that are running. We have a whole new speaker kit that's out there driving new speaker programs. And the customers are very enthusiastic about how they share the data with NEXTSTELLIS and clearly see why potentially it could be seen by their patients as the best estrogen in the marketplace and the best oral contraceptive.
We're hitting our targets, you know, not 100% in every territory, and we're keeping active maintenance with the leadership in the field to ensure that the activity rates are there. And then lastly, the passion. So, you know, it's KSAP, it's knowledge, skills, activity, and passion that's gonna drive the results. And all the managers and the leaders in the field are focused on making sure we're 100% on all of those. Does that answer your question?
That's very comprehensive. Thank you. I appreciate it. I was just gonna follow up with a question around some of the PBM reform proposals that are before the Congress, just whether there's any implications for your business, in a positive way coming out of those?
Well, the positive trend for us is really the Affordable Care Act and the implementation of the executive order that President Biden put through and driving that through to implementation or that nobody pays anything out of pocket. And that obviously will be a significant driver for a product like ANNOVERA, where you get a month's therapy ... a year's therapy, sorry, on each prescription, over $1,000 revenue. And then ensuring that, you know, repeat scripts happen with NEXTSTELLIS.
That's the, you know, most important thing in a launch is, when you're launching new brands, is not getting a one-off for NEXTSTELLIS, but getting the repeat script and making sure that the patient and the physician are seeing the benefits for them going forward. On the payer front, the biggest driver we see happening that'll benefit us is successful implementation of the laws of the ACA with the PBMs.
Terrific. And I think some of the reforms with the PBM are also pushing to help reduce patient out-of-pocket costs. So, I'm assuming that that's directionally positive for you?
Absolutely.
Yep. Thank you very much.
Thank you, Andrew.
There are no further phone questions at this time. I'll now hand the conference back over to address any webcast questions.
So, there aren't any more questions on the web. So, if there's any ... It's still, sorry. I'm trying to read what's here.
If there aren't any more questions, there are some web questions asking for specifics regarding profit, gross margin, operating costs for certain products and businesses. Since we do not provide guidance, we would like to refer the participants to the outlook statement for some high-level indicators of what we're expecting for fiscal year 2024.
Yeah, and thank you for that, Kimberly. And I just want to reflect, you know, some investors who've been in the Mayne game for a long time, you know, we're shifting this business from a low-margin business to a higher-margin business. Selling the US generic business, it was part of that generic journey. MCS, we were very happy with the level of sale that we got for that business.
I don't think we would attract that level of price today based on how the market's changed, but that was a capital-intense business and a slower growth business. So, you know, all our investment is driving higher margin products and higher growth products in both women's health and dermatology.
So that's a major shift that everybody should be thinking about, you know, the gross margin of this business is totally different than it was a year ago. Any other questions? Well, thank you, everybody, for joining us tonight and, or today, this morning in Australia, and we look forward to next time the opportunity to share the Mayne story. Operator, we're complete here.
Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect.