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

Thank you for standing by, and welcome to the Mayne Pharma Group Limited Half Year 2023 Results Briefing. [Operator Instructions] I will now hand the conference over to Mr. Shawn Patrick O'Brien, CEO. Please go ahead.

Thank you. And apologies, everyone, for the technical difficulties. We had to try 3 different ways to get connected here. So sorry for the delay. Good day, and welcome to the Mayne Pharma half year results conference call. At this time, I'm taking over the conference call with myself, CEO and Managing Director of Mayne Pharma; and my colleague here, Aaron Gray, our Chief Financial Officer. Based on the feedback from our investors, this presentation has a lot more information included than normal. We will not be covering the details of every slide, but wanted you to have a comprehensive depth for your reference going forward. The next slide, please, is our disclaimer slide, and I'll leave that for you to review. And Slide 3, as announced yesterday, we are very pleased with the definitive agreement to sell the U.S. retail generics business to Dr. Reddy's Laboratories for USD 50 million (sic) [ USD 90 million ] upfront and expected receipt for working capital in the $20 million to $30 million range for the inventory and contingency payments of up to $15 million for years 1 and 2. Slide 4. In Australian currency, that is $134 million upfront, $22 million in contingencies and $29 million to $44 million in net working capital expected. This deal is subject to HSR approval by the FTC and is expected to close by the end of fiscal year '23 as there is very little overlap in our product line. In addition, we are pleased with the signed 10-year supply agreement for our Salisbury facility in Adelaide to continue to provide products to Dr. Reddy's Laboratories. This is a very important step in our strategic execution to divest noncore assets, simplify the business and cost structure. It provides improved financial flexibility for us to drive profitable growth and restore shareholder value. Going forward, we have our 3 business units to drive growth. We're in health, dermatology and our international business. Slide 5. The past 5 months have been a period of significant change as Mayne's new management team began the process of transforming the company into an agile specialty pharma organization delivering commercial and operational excellence. Today, Mayne Pharma is a commercial company operating in 2 main U.S. verticals: women's health and dermatology and our international business. Slide 6. Since the beginning of fiscal year, we've taken several steps to refocus the company around these areas and ensure we have the financial strength to execute on our goals, as outlined on Slide 6. In order to strengthen our balance sheet and free up working capital to grow our core business, we divested 2 noncore assets. First, in October '22, we sold Metrics Contract Services, or MCS, for USD 475 million. Yesterday, we announced the sale of our retail generics business to Dr. Reddy's for USD 90 million upfront plus net working capital and contingencies up to $15 million. To expand our position in the U.S. women's health market and strengthen our distribution chain, we've acquired exclusive commercialization rights for 3 branded, IP-protected women's health products and a portfolio of prenatal vitamins from TherapeuticsMD. The transaction closed in December '22 for total cash consideration of USD 140 million plus milestone payments and royalties. The transaction will be immediately accretive to net profit after tax. Together, these actions create a leaner, less complex business and will help establish the financial flexibility required to support internal growth and support business development opportunities aligned with our mission of becoming a top branded business in the United States for women's health and dermatology. We have strengthened our leadership team to ensure we can deliver on commercial and operational [ execution ]. Slide 8. Looking in detail, the Branded Products Division is up over 100% sequentially. NEXTSTELLIS momentum continues with refreshed sales leadership and marketing strategies to help deliver month-on-month growth. We've seen a 50% increase in monthly cycle count from 13,000 to over 20,000 in December, and the monthly prescriptions have increased to almost 12,000 in December. We've seen strong traffic on nextstellis.com, over 175,000 visits in the last couple of months. If this growth rate continues, we expect to achieve profitable run rate by the end of the year for NEXTSTELLIS, fiscal year '23 into '24. Looking at our Portfolio Products Division, dermatology. Obviously, continued poor result that we flagged at the AGM back in November is attributable to a long wind down of the channel inventories built up in June and the launch of new products to gain market share. First half fiscal '23 is characterized by competitive price pressures at Epiduo Forte, significant price pressures there; one-off gross to net impacts on key products as well as onetime adjustments. We have implemented a methodology change on estimating co-pay accrual to address the timing issues on earnings recognition. In retail generics, the business performance has been challenged by the industry volatility and the headwinds. Looking at the international business, we've seen flat results, but we expect to improve the performance of our manufacturing operations in Salisbury going forward. And we're really pleased with our NEXTSTELLIS performance so far in Australia as it's tracking to plan. Looking at Slide 9. As we shared at the AGM, I focus on ensuring we have the right people, effective and efficient processes and products to serve our customers profitably. We have reduced the number of direct reports to me, improved accountability, introduced new processes and strengthened our portfolio, all designed to improve our ability to deliver profitable growth and strong free cash flow to rebuild value for our shareholders. Slide 10. Looking forward, we are off to a great start in the second half fiscal '23. In women's health, we've seen week on week records for NEXTSTELLIS prescriptions through February. Sales force expansion that occurred when we selected unique TXMD hires with updated targeting and refreshed messaging, and we've optimized our channel. Sales of ANNOVERA, BIJUVA and IMVEXXY are in line with our plan. And in fact, IMVEXXY was our largest-selling product in the month of January, and this is despite that we didn't start trading the product until January 12 in the marketplace. So the portfolio is expected to deliver positive earnings and cash in second half fiscal '23. In dermatology, the launch of DORYX MPC 60 and our recent announcement of generic ORACEA improved our product mix quality dramatically. The generic launches of diltiazem and HALOETTE, also known as generic NUVARING, [ are off ] and moving forward and achieving ahead of expectations. In international, we're pleased with the progress of NEXTSTELLIS, as I mentioned previously, and actions of our new leader, [ Grant Sport ], has taken to make our Salisbury facility world-class. Over to Aaron to provide more financial details on the business. Aaron?

Next slide, please, Craig. Everybody has seen and heard about our restatement announcement. We announced February 15 that we were restating 2022 results. This restatement comes as a result of the issues that Shawn highlighted in the dermatology business. Effectively, we launched new products in the latter part of fiscal year '22, and those new products quickly gained market share, driving some of those products to be the leading product in the market. This strong drive for sales resulted in our -- a significant amount of inventory being built up in the channel. This is what led to the restatement. The inventory in the channel, we have a historically audited and approved method that we use to estimate how much liability the company has related to inventory in the channel. That estimate was wrong. That estimate was -- worked fine in the past. It simply didn't take into account more volatile trading patterns that were driven by a quick uptake in the new product. We have gone through extensive reviews with our external auditor, with our management and within the team itself to look at different ways how this information can be managed going forward. We have derived the new methodology, which is actively in use now. So in addition to looking at monthly results for these [ 3 ] different accounts, we also follow a different methodology to determine the liability that should be set aside going forward. Next slide, please, Craig. Going on to the restatement. The effect of the restatement was an overall impact to the group, reduction of $23.9 million, with a gross margin effect of $17.9 million. The difference between the 2 -- this was a timing adjustment, timing of revenue recognition and an accounting adjustment. The difference between the revenue and the gross profit impact comes because of the profit share within the dermatology business. This restatement was isolated 100% to the dermatology business, and we believe it is fully behind us having come through the first half. Next slide. We should be on Slide 15 now. Looking at the group financial overview. We do see a disappointing performance in revenue. These figures, by the way, are comparable, excluding MCS. So we've seen overall a 33% decline in reported revenue, and this is as a result of a continued decline in the retail generics business with discontinuation of products, also as a result of the dermatology topic. The dermatology restatement addressed the co-pay accrual related to those products sitting in the inventory channel at the end of fiscal '22. However, that inventory also resulted in lower sales across the first half of fiscal year '23. We also had some significant charges related to discontinued products on the retail generics business. We evaluate the economics of individual products and decide whether to continue supplying the product or not. When we discontinue a product, it's often because the economics of the product have changed, meaning that there are others in the marketplace who supply for cheaper, which can result in a large volume of returns, which is what we have seen across the first half. The returns that we've seen are primarily retail generics. We had some small amount related to dermatology on LEXETTE, not related to an economics issue, but more related to a supply issue. We also did have an FX impact of about AUD 13 million. The FX impact is an actual loss. This was the result of a currency hedge that we placed against the receipt of U.S. dollars for the MCS transaction. So while we do reflect an FX loss of $13 million, we do have a gain on the sale that was much in excess of that number between the date that we signed and the date that we actually closed based on the movement between the 2 rates. Next slide, please. Looking at the full group financial overview, Slide 16, looking at the amounts reported attributable to members compared to the underlying results. The major items on here are: the restructuring item at $9.3 million; discontinued products at $31.3 million, which I've just spoken about; and then an impairment leading down to PBIT. The restructuring is primarily personnel costs related to some of the adjustments that Shawn has spoken about. The impairment was undertaken through the half as we had triggering events caused by the divestment of MCS. So the impairment really is a function of moving some of the corporate costs around to the different cash-generating units. Next slide, please. This slide is the reconciliation of reported to underlying EBITDA. This basically just adds a little more detail to the previous slide, which was taken from the statutory accounts. Walking from that minus $99.2 million to the minus $53.1 million, you can see we have certain noncash movements taken here in the accounts. We have the restructuring that I mentioned, the discontinued products, and then we have ongoing litigation associated with a number of topics. On the INTI entity, the company has disposed of INTI, and so this is no longer part of our results. We have recognized a noncash loss on INTI as we have deconsolidated that entity. We continue to report the underlying earnings, excluding NEXTSTELLIS, as we are still coming through the launch period for NEXTSTELLIS. Hence, we moved from a minus $53.1 million to a minus $25.9 million. Next slide, please. Walking from that $99.2 million attributable to members EBITDA down to the cash flow, you will see that there's a number of large movements here, the largest movements being: the payments for the intangible assets associated with TXMD; the working capital that we acquired from TXMD at $18.1 million, which was made up of receivables, payables and certain other assets, primarily inventory; and then the proceeds from the MCS business. So what we have basically is a free cash flow before financing activities of $424.9 million. This was at December 31. The company has repaid the syndicated facility in full. And so the company's debt position now reflects only the receivable facility and the convertible note, which was taken out to help finance the purchase of the license of the TXMD assets. Next slide. Group consolidated balance sheet. The big movements here, reduction in PP&E, which is related to the sale of MCS. We have a payables increase of $45 million, which is a function of the payables acquired by -- in the TXMD transaction primarily. We have the repayment of the loan, which was the liquidation of the syndicated facility. And then we have, of course, the recognition of the intangibles and other items associated with the TXMD transaction. So total assets have moved to $1,493.6 billion. Total liabilities have declined to $695.4 million. Next slide, please. Looking at our cost base. This is something that Shawn and I have spent a fair amount of time focusing on. We are not simply looking to cut the cost base. We are looking to invest the cost in the right areas for growth. So the key points here, we are adjusting the overhead costs, and in fact, we have initiated an overhead reduction program geared at taking between 10% and 15% out of the overhead cost. We have currently realized on a full year basis approximately USD 3 million coming out of that program, and we have some more work to do there. This doesn't just touch OpEx. It touches multiple different areas where we consume cash. We continue to invest in NEXTSTELLIS, and what you will see through the second half is that we've added some OpEx related to TXMD. So the key here really is to pare back in the businesses where it makes sense to do so and where we can drive productivity and be efficient, but also then continue to invest in the businesses where we have the growth opportunity. Next slide to the segmental performance. Looking at the Branded Products division. This should be Slide 22. You'll note that NEXTSTELLIS revenues are up significantly, up 122% compared to the prior half. This is a function of the growth that we've been seeing. The growth is a function of new Rx but also repeat RX, and so growth will grow at an increasing rate. This is the key thing that we have to drive and the key focus area of the organization. Looking back to first half fiscal '22, NEXTSTELLIS net revenues are up 545%, coming from a low base, of course. So it sounds great, but it's -- we're still getting there. NEXTSTELLIS operating expenses are up. We've talked about this in the past, but we continue to invest in NEXTSTELLIS, primarily in fiscal year '23 with the DTC, the direct-to-consumer campaign. This is geared at driving consumer awareness and overcoming some of the hurdles associated with launching the brand. For TOLSURA and SOLTAMOX, we continue to see these products delivering growth, delivering positive revenues and profit contribution in spite of a very lean cost profile. Next slide. PPD really, as Shawn mentioned, is where we've seen the challenges. This division has been challenged across the board. We have the dermatology challenges which come from the inventory situation at the end of fiscal year '22, which has been exacerbated by certain price pressures across the first half of fiscal year '23. We also have then the retail generics business continuing to decline as we discontinue products. So this is the challenged division. This is where we had put focus, and this is why we've got significant investment going into some new products in retail generics and why the company was focused on the sale of the retail generics business. Next slide, please. This slide looks a little bit further at PPD and talks about dermatology. What you can see on the left-hand side is that independently of a restatement, the dermatology business has come under pressure. Our top products, making up approximately 90% of the revenues, have come under price pressure. And we see, as a result, about 12% gross price reduction between the second half of fiscal '22 and the first half of fiscal '23. This contributed to the gross margin decline that we've seen. In addition to the price pressures, we've also had certain onetime effects related to gross-to-net adjustments that we were forced to take based upon some of the competitive pressures and competitive entrants on the products. On the right-hand side of the chart that you see is unit sales going all the way back to July 2020. You can see the strong peak that is visible at June of 2022 and then, of course, the sharp drop immediately in July of '22. We are now focused on returning this business to a growth base. We are focused on reducing some of the volatility out of this business and making sure that we are driving the right earnings and cash profile here. The new product launches, we believe, will help to not only drive growth but also to drive accretive profitable growth, and we are also then looking at the cost base of this business as well. Next slide. This slide is similar to one that was shown at the AGM. This slide shows gross sales as the solid darker line; net sales, so post gross-to-net adjustments, as the solid lighter-colored line; and then the gross-to-net percentage as the dashed line. The effect of the restatement you can see by the difference between the peak in the dashed line and the peak in the other 2 lines. What you can also see from this slide is that through January of 2023, the gross-to-net profile is normalizing. So we -- the volatility is behind us. We have a stable amount and a visibility onto the amount of inventory in the channel, and the gross-to-net percentages are following a normalized pattern now. Next slide, please. Looking at international. The international business has benefited from some growth. The business has been able to grow in multiple different areas; of course, continues to remain focused on the launch of NEXTSTELLIS. The business has been challenged with some challenges on the operational side primarily related to the manufacturing performance, but continues to deliver a positive direct contribution. The focus for the international business, of course, will be to deliver on those products that we've already started the launch for and then really to improve the operational excellence of that facility going forward. And with that, I believe I turn it back over to Shawn for the business overview and strategy.

Thank you, Aaron. And let's look at Slide 27 -- so slide 28. Let's discuss our businesses in more detail. This slide summarizes the Mayne Pharma organization following the sale of our noncore businesses that we've completed and announced recently with the sale of U.S. generics. As mentioned earlier, our 2 primary verticals are in the U.S. women's health and dermatology. We also have our international division, which provides products to the U.S., Australian and international markets, as shown here. Slide 29. In women's health in the U.S. and dermatology, historically, they've been challenging markets with several pain points as outlined in this slide. The problems in U.S. pharma affect all parties involved, from the consumer to the health care providers, to payers, to the wholesalers and to retailers. Costs and administrative hassles are rising. Access and quality coverage are declining. And doctors need to find a way to minimize the abandonment rate of when they write a prescription, i.e., they write a prescription and they don't get what they asked for, for the patient. The supply chain needs well-priced, safe products that are accessible, and Mayne Pharma is uniquely positioned to do this. Through our unique ecosystem, we have an ability to offer effective drug sourcing in order to find the right drug at the best price; a stable and trusted provider network; real-time information on coverage; a smooth, user-friendly, one-stop experience; and quick fulfillment and refills. On the next slide, 30, shows the ecosystem in greater detail. First, we have a strong portfolio of products, covering 1/3 of dermatology prescriptions written today in the United States. And following the TXMD transaction, we can cover quite a few of the contraceptive prescriptions with our current generic portfolio. We have an extensive drug sourcing capabilities with access to 13,000 health care professionals throughout the dermatology and women's health care platforms. Our pharmacy network is robust with over 400 specialty pharmacy locations throughout the U.S. And through our collaboration with GoodRx, we have access to 6 million monthly active consumers and over 800,000 health care providers, including a significant number of obstetrician and gynecologists. Our reach is also vast. We have over 130 territory representatives, covering 60% of prescribing activity, and the team we have in place understands how to commercialize products and go to the market. Slide 31. GoodRx is a leading direct-to-consumer digital platform in the United States and reaches over 6 million customers each month. Mayne Pharma and GoodRx is working together to deliver enhanced NEXTSTELLIS DTC campaign to drive awareness and accelerate the growth in adoption of the product. In addition, GoodRx women's health hub provides patient education, telehealth, treatment advice and product costing. This helps raise awareness [ of available ] birth control methods and improves access and affordability of birth control, including NEXTSTELLIS. On Slide 32, we're going to look at now the women's health market in a little more detail. We see the women's health market is becoming more attractive. As consolidations happen and [ exits out ] of the business, it's giving opportunities for companies like ours to become a leader in the marketplace. The U.S. contraceptive market is valued roughly at $8 billion and the menopausal market at $2 billion. We see a great opportunity as we increase our commercial footprint to become a leading provider in women's health in the United States. We have a portfolio of differentiated products that are IP-protected and over 100 reps in the field, 91 reps and 9 sales managers in the field, to drive awareness of our product. And as I highlighted before, we believe we have a solution that allows our patients to get the medications they need through our disintermediation strategy. And secondly, we have the ability to leverage the opportunity the Affordable Care Act is providing with new guidance on no co-pay for contraceptive products that do not have a generic equivalent. Looking in detail at the TXMD assets that we acquired. ANNOVERA, patient-inserted ring, used monthly, that lasts for up to 1 year. The patients can use this in the early stages of contraceptive and in the late phases of contraceptive. It is a unique product and is now starting to regrow in the marketplace. We support that with our prenatal vitamins that are available. And then in the menopausal area, we have BIJUVA and IMVEXXY, BIJUVA looking at vasomotor symptoms and IMVEXXY looking at vaginal dryness and atrophy. We are really excited about the -- [ taking ] these assets. And as we said earlier, IMVEXXY was our strongest product in the first month of this half, and the rest of the products are going to plan. So we're really pleased with these assets and how we can bring them together, as shown in Slide 35, and how they complement NEXTSTELLIS, which we believe is the best birth control pill in the market. In summary, we have the infrastructure in place, a team of over 100 reps able to reach our targeted customers. We're taking all actions to reduce the barriers to ensure patients get the medications with our unique approach. And we're able to leverage fully the changes of the Affordable Care Act that are being implemented, not only at the payer level -- on the private payer level, but also at the state level starting April 1 with Medicaid patients. We've improved our marketing mix to drive awareness, and we're accelerating our direct-to-consumer campaign through the traditional media campaign. And also now, we are pleased, on Slide 36, announced in February, we have a video streaming campaign to complement our Facebook, Instagram and other social media. We expect to launch BIJUVA low-dose capsule in the first half of fiscal year '24 and continue to take advantage of the ACA guideline changes not only for NEXTSTELLIS, but ANNOVERA as well. If you look at Slide 37, we're going to pivot to dermatology. Looking at Slide 38, we see this as an attractive market. However, we've been susceptible to price pressures and market changes by having products that had generic influences, such as Epiduo Forte and ACZONE. However, when we compare that with our market penetration with ABSORICA, which achieved over 46% market share in the 12-month period, and it's sustaining its growth and we're seeing rapid growth in the first few months of the calendar year '23. So we continue to see dermatology as an attractive market. The average patient walks out of the dermatologist's office with over 4 scripts. As mentioned previously, we have the ability to get -- capture 1/3 of all scripts written for dermatology. So we're continuing to enhance our portfolio and improve the quality of the products that we bring to market. And our recent announcements of DORYX MPC 60, and our deal with our friends that -- to bring generic ORACEA to the market is improving the quality of the products that we have in the market and to be able to tap into the rosacea market for DORYX -- or sorry, ORACEA. So looking at our international -- or sorry, I just wanted on Slide 39, look at our product portfolio and our partners, and we'll continue to work with Galderma and others to bring in high-value products. Our goal here is to improve the quality of the products and bring products into this channel that do not have threats from generic competition. Looking at our international business, Slide 40. And now switching to 41. We have the ability to take products from concept to commercialization with our CDMO and the full-scale FDA-certified plant, TGA and [ MHA ] approved. Australia is a favorable regulatory environment and has quality regulatory guidelines that are in line with the FDA, and we have significant experience in tech transfer program in the team. So we expect to improve the margin and our productivity of the business through existing IP into new markets but also increase the capacity and efficiency of our business by the completion of the MMI Grant Program that's going to allow us to put in new equipment into the business. Nextstellis growth is continuing in Australia, and we expect it to add other products to our business. Looking at Slide 42. Overall, we've seen a nice historical growth into our international business, but that flattened out in our first reporting half of fiscal year '23 and what we need to do on that. Well, I'll come to that in a second. I just want to highlight on Slide 43 that Nextstellis is on track. We've had over 10,000 interactions with healthcare providers since the launch in August, and we've had over 15,000 samples in the market. Our capital improvements to the facility are complemented with a $4.8 million grant from the government. So we have a High Speed Encapsulator coming in, High Speed Blister Packaging, in addition to high-speed bottling line that has serialization capacity and capabilities with them. We will continue to drive double-digit growth for our CDMO business. And ensure that we can drive business from our CDMO that are Phase II, Phase III and then finally, commercial opportunities for production. When you look at the key international actions that we're taking on Slide 44, and really pleased with the appointment of our new General Manager, Grant Swart. He's a turn-around expert as an operational leader. We expect continued growth in Australian-based specialty pharmaceutical business with Nextstellis and other new products to be launched, such as ACTIKERALL for dermatology and to continue to grow the CDMO business. We aggressively are pursuing and developing new business opportunities and have new commercial infrastructure aligned to the existing capabilities while we identify future state opportunities for the business. And overall, we're excited about what we can do with our facility here and return it to a world-class facility and continue to drive domestic growth for the business. So that's the highlight of our 3 business units. And now looking at on Slide 26 is really looking at the business and restating the business as a go-forward business. So this is looking at fiscal year '22 adjusted for structural changes, the restatement and how the business would look with TXMD results in there. This is all in Australian dollars. So if I can remind you that in fiscal year '22, we reported profit or EBITDA -- underlying EBITDA of AUD 45.8 million, of which $42.2 million was MCS. Since then, we indicated we are increasing our investment in Nextstellis by $20 million in the U.S. and Australia to drive that growth forward. And so we look at a restatement in the bold line without the [ RGx ] would have a negative contribution or underlying EBITDA of $29.3 million. Adding that TXMD based on what we expect for the cost structure that we've put in place, the royalty streams we put in place, that brings our EBITDA back to $43.5 million. So this reflects on that our maneuvers for the business keeps the possible EBITDA at the same level that we had back in '22 going forward but has the company in a position of growth with patent protected products in women's health and moving forward in dermatology. So in summary, on Slide 47, this is our 5 strategic pillars priorities for fiscal year '23 and '24 to drive shareholder value. Number 1 priority is drive Nextstellis is U.S. and Australia to breakeven as soon as possible. Number 2 priority is to deliver positive EBITDA in our women's health franchise. With ANNOVERA, BIJUVA, IMVEXXY and Nextstellis with the prenatal items in the United States. Number 3 is to improve our margin and access to medication using our U.S. disintermediation platform both in dermatology and women's health and improve the access that patients have to medications and reduce the hassle. Number 4 is actually to bring in, as I highlighted before, better derm assets into the portfolio so we can leverage our commercial infrastructure. And we also believe we have an opportunity to continue to grow our women's health franchise and do a roll-up in women's health in United States as we see a lot of valuable assets that are available going forward. And lastly, but not least, we need to continue to accelerate the growth of Australia, improving productivity in our facility in Salisbury, driving our specialty sales with Nextstellis and new brands in the Australian market and accelerating the profitability of our CDMO business. I'd like to thank everybody for their attention. And now I'll turn it back for questions going forward.

[Operator Instructions] Your first phone question comes from Melissa Benson from Wilson.

The first one was just around Nextstellis, you mentioned that you're kind of targeting that to be profitable by the end of this fiscal year. And previously, I think it's been guided to kind of a cycle this sensation of I think it was 5x FY '22, which I think implied about 350,000 cycles. Can you kind of -- is that still a relevant guidance to think about -- or are you thinking about that now differently?

So again, Melissa, thanks for your question. And let me clarify what we communicated here today was driving to a run rate profitability so that we exit June for the next 12 months, if it was flat, that we'd have a profitable product with Nextstellis in the U.S. market based on our new cost base. Only 60% of the sales force is being allocated to Nextstellis. The drive here, as you saw, the scripts were pretty flat, July, August, September time frame, we took some significant changes when I came on board in November and December to what I would call enhance the access to the product by improving the co-pay by bringing the product into our disintermediation strategy and leveraging our relationship with GoodRx so those are what I would call light switch approaches, instant changes and you could see how that enhanced the scripts from November, December, January and right up to date, and seeing now roughly 5% growth on a weekly rate over the last few weeks. So we expect now with actions such as increasing our sales team from 78 to 91 reps and 9 managers in the field and getting white space covered that we had in the Western area. We picked up the top sales leader from TXMD and 4 out of his 10 reps were the top reps of the company at TXMD. So that kind of activity to [ redifining ] and the retargeting of our physician population in addition to our re-messaging for Nextstellis are slower but continuous build, and that's what we're starting to see now and our prescription volume growing from those activities of targeting improvement and message improvement. And then the enthusiasm the team have now that they're fully trained on all products in women's health. So the goal here is to ensure that we accelerate the growth as we continue to do going north of 5% every week and then driving the exit rate, so that the run rate is a profitable rate as we end fiscal year '23. So we're not focused on $350,000. We will focus on the steepness of the exit [ plan ] for the business coming out in June.

Okay. That's helpful. So a bit of a change is how we think about that. Second question was just around the divestment of the U.S. generics that you announced yesterday. How should we think about the impact to that more so you already spoke about an OpEx reduction program generally across corporate costs. But I guess -- just some color around how much of the working capital and I guess the corporate overheads will be kind of eased, if you like, with that divestment? Is it quite material like what kind of impact will that have?

It's quite material. If we were to calculate like working capital as of Sunday on the inventory, it is USD 29.8 million. So that's a significant amount on the chain. It is a big part of our working capital when you look at generics inventory, and that includes API, not just product and inventory. And so between now and the close with our partnership with DRL, that could increase or decrease. We expect it to decrease over time. But that's the net number as it stands. They would -- if the deal closed on Sunday, the net working capital, that would have been the number. So that's a big number. And we have generated roughly a $5 million run rate of cost without any transaction changes relative to the generics business. And obviously, there's some headcount and people and resources associated running with the generics besides the inventory and the working capital, and that is quite significant. So Aaron, do you want to add any color to that?

No. The transaction that was announced last night, Melissa, includes the inventory. It does not include the full net working capital. Liabilities that are main responsibility related to the existing channel will remain main responsibility and we have reserves set aside for these. The receivables will also remain with main as we have basically factored those receivables under our receivable facility.

Okay. That's helpful. Perhaps I'll get back in the queue.

[Operator Instructions] Your next phone question comes from [ Roytol to from MST ].

Actually, it's Andrew Goodfield here. Sorry, I think we've registered across the two. I was just going to ask, obviously, a lot of numbers, which is great and a lot of movement in the numbers. Just trying to get a sense of where the cost run rate is now just to understand sort of where you've got to at this point, whether you just talk about the half or the monthly or...

Yes. So the -- when we talk about cost run rate, we have to -- we typically differentiate direct OpEx versus indirect OpEx. The indirect OpEx is down. And when you look into the notes of the financial statements, Note 3 specifically addresses certain costs. What I would recommend to do is have a look at that note in the financials, it notes a reduction in salaries and wages, which is really coming from these OpEx reductions that is kind of peppered throughout the first half. So as Shawn and I have been looking at it, we have cash basis, approximately USD 3 million reduced compared to the fiscal year '22 actuals. That $3 million would be the full year run rate, and that's where we have a little more work to do. In terms of the go forward, really the driver of our OpEx is sales costs and marketing costs. And so the main choice there is going to be depending on how the growth performs, what adjustments, if any, do we need to make up or down to those respective costs. And so this being the launch year, I would expect that the marketing costs are rather heavy. The sales cost, I would not expect to see a major change at least for the near term. Does that answer the question, okay?

Yes. Yes. I guess we can try and sort of back solve but obviously, the direct OpEx, we're going to see that parallel sales and marketing, I guess, so and maybe just coming to Nextstellis. You talked about an additional $20 million investment there. So I guess this does sort of start to talk to the direct OpEx. Just trying to understand maybe when you talk about being run rate breakeven at the end of the financial year, again sort of where that sort of cost base is going to get to, I guess, in rough terms, to sort of understand how that matches up?

One moment, please. So I'm trying to refer back to the slide to make sure I don't talk about something that we haven't put forth. So the OpEx through the first half of fiscal '23 for the Branded Products division was AUD 36.7 million. We would see that roughly 2x, I think, would be a reasonable assumption for the entire fiscal. We would then have to obviously -- we would be looking at that cost profile going forward to see how -- do we need to continue to spend at that rate? Or is that rate also then something that we're able to reduce as the product pushes through its NRx curve and we get the lift from the renewal prescriptions. So I would think of it as 36.7% x 2 is basically where we are today. And we wouldn't see a need to do too much OpEx addition at least for the next 18 months.

Okay. Got it. Just a quick question on the litigation issues, just if there's any legacy issues that are ongoing?

Is there a question there? Or just do you want a general comment on those?

Just a general comment. Obviously, it's a pretty small piece of the cost line now, but just any sort of ongoing litigation issues that we should be thinking about in the outlook.

Okay. I have Kim Parker here. She's our GC, and she can highlight, I guess, 3 areas of that's going on, on the litigation front?

Yes. So there is ongoing litigation, nothing new. The litigation matters are the same that we've disclosed and were in our annual report. We have the DOJ investigation that led to certain multi-district litigation in the U.S. that is ongoing, and we continue to have a normal amount of spend on that. But the case has not progressed further against Mayne Pharma. We also have an investigation that is ongoing, and we are cooperating with the government in that respect. And then we have the related -- to the first matter we have the related [ class action ] shareholder case, and we are still in the discovery phase in that matter, and that is ongoing.

Your next question is a follow-up question from Melissa Benson from Wilsons.

So 2 more questions from me. Firstly, just an easy one on the restatement. You noted that that's isolated to the dermatology segment. But should we think about that is isolated just to the second half of fiscal '22? Or is there because you've obviously just given full year numbers, so is it complying to that second half period? I guess I'm just wondering if it affects the PCP that we're looking at today.

So the -- does it -- the restatement is on the second half of fiscal year '22 for the dermatology business only. And it reflects -- we've changed our methodology when we saw the results that we reported or prepared to report and reported at the AGM. We changed our methodology and took actions to understand what was the driver of negative net sales. So there were issues on gross to net, there was amount of volume that was being absorbed that was put into the chain back in May and June of '22. We have taken some policies on how we maintain our inventory and number of weeks in the market that we have. and we try to reflect that based on the products we have in our portfolio. So when we have products that are new to launch, we want to make sure that there -- the supply chain has enough product to ensure that when we create demand, it's not lost through abandonment because the script is not available to fill because the product is not in the pharmacy. So everything is focused on fiscal year '22 back half. So from a prior same period, if not -- it wouldn't reflect on the first half of '22.

Yes. Okay. That's helpful. And final question also on dermatology. You mentioned that, that segment these products are coming under pricing pressure. I think you mentioned about 12%. I mean, is that kind of -- that's obviously a trend we had seen for some time in the U.S. retail generics business. I mean, is it the same kind of pressures affecting dermatology? Or is there a reason why you have different strategies to combat that as opposed to that increasing pricing pressure that continue to prevail across retail generics.

So the 2 products that really suffered on the pricing pressure in the reported period here are dapsone and Epiduo Forte and Epiduo Forte went from $365 to $25 a product in a matter of 6 weeks. That's significant. As we've reported previously, we were able to strike significant market share for both those products and also with generic Absorica. So the model is demonstrating we can drive it, and it's not all about having coverage, as you do in generics. There's a lot of cash business that goes through our models. And so they're more resilient to I would say, what you've seen in generic markets. But as I said in our conversation today, we are striving to improve the quality of the products that we put in the dermatology platform, products that have improved IP and longevity and not -- can be susceptible to pricing pressures that we experienced with Dapsone and Epiduo Forte. And we'll continue to do what we call capital-light profit-sharing deals in dermatology as we just did for [ our ratio ].

Okay. So examples of that could be like authorized generics or bringing some more kind of branded products into the derm portfolio, because that is a mix of ... ?

Yes. Authorized generics that don't have other products in the market, i.e., only the brand and the authorized generic and no generics because there's a period of protection and then also branded products with IP or haven't lost exclusivity yet. Does that answer your question, Melissa?

Yes.

There any other audio questions at this time. I will now hand over for webcast questions.

Okay. I do have one webcast question. I'll read the question. You provided pro forma fiscal year '22 EBITDA of AUD 43.4 million. MCS was responsible for quite a lot of historic depreciation. Can you give a sense of go-forward depreciation and then also noncash amortization? What's the outlook for tax going forward? This is a very good question. In general, we do have a pretty light depreciation going forward. Depreciation on fixed assets, on real assets is coming exclusively going forward from -- that's on PP&E is coming exclusively from Salisbury and the run rate is something around AUD 5 million annual. I don't have the amortization, the noncash amortization on the other products at my fingertips. However, I will try and tease it out of the result. And I think we have a -- I'll follow up with the person that asked the question specifically to address that question. There's another question that's come through that says the direct OpEx, Slide 46 for baseline fiscal year '22 is 38% of revenue. What is the guidance for direct OpEx under normalized operations going forward. We actually have not set any guidance. We're in the process rather of resetting the guidance for what we believe a proper targeted direct OpEx is. Part of the disintermediation strategy is driving the business volumes into different channels, and that has a different, i.e., lower OpEx profile. So I'd have to follow-up with that question separately. But in general, what we would expect to see since we have a large chunk of fixed cost sitting with the Nextstellis during the [ ramp ] period we will get a pretty good fixed cost digression or OpEx digression as we get the growth in Nextstellis to the peak sales number. Are there any other webcast questions? Okay. Operator, I believe that's all the questions that we've had, both from phone questions and on the web. And if there are any other questions, don't hesitate to e-mail investors, [email protected]. Go ahead.

That does conclude our conference for today. Thank you for participating. You may now disconnect. Thank you.