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David Bailey, Macquarie Research - Research Analyst [27]
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Okay. And then if I can just sneak one more quick one in just in relation to Doryx, just any impacts from Seysara since its launch earlier this year [that explain parts of -- partial reasons] for some of the slowing volume trends that we can observe.
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [28]
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Yes. Look, Seysara has had some impact. I mean we watch Seysara very carefully. I -- our view of Seysara is that, just like any new launch in the space, it's -- it certainly captures share of voice. The company that's marketing Seysara is obviously trying to do everything they can. They've paid a lot of money for this asset.
It's worth noting that their growth has slowed considerably, and we feel very good about the position of Doryx here. In fact, we're seeing Doryx begin to turn in some of our key areas. So look, I'm confident Doryx is going to weather the Seysara storm, if you like. And this is not a highly differentiated product. It's a new tetracycline, yes, but I mean I don't think it's a product that's going to materially disrupt Doryx going forward.
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Operator [29]
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And next, we will go to John Deakin-Bell from Citi.
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John Deakin-Bell, Citigroup Inc, Research Division - Director & Head of Healthcare in Australia and New Zealand [30]
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I just had a couple of questions to try and understand what was happening in the generics side a bit more. Maybe Nick can help me, but in that Slide 5 you've got the gross profit. So the generic sales fell $65 million, but the gross profit fell $13 million. The gross margin on the decline or the sales that you've lost is only 20%. And then on Slide 19, you're saying that most of the sales -- the decline was in dofetilide. Is that -- am I reading that correct? Is that exactly what's happening, that dofetilide's margins were that low?
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Nick Freeman, Mayne Pharma Group Limited - Group CFO & Company Secretary [31]
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Yes -- no. Look, the exchange is -- this is Slide 5, is in Aussie dollars, and obviously the exchange had the strong beneficial impact going the other way. So if you go to Slide 19 and sort of have a look in the U.S. dollar area. So I think sort of this all was back, where generic margins have dropped, 57% to 44%. And that's really probably the best metric to look at. And the drop in those is, as Scott has alluded to, the shift in the sales mix, with dofetilide and lio being the key kind of ones, which were positive in the first half and they've come off. And to a degree, some of the sales have been replaced by lower-margin sales in the second half. Plus we've got those failure to supply, shelf stock adjustments, et cetera, that we called out in the May trading update.
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John Deakin-Bell, Citigroup Inc, Research Division - Director & Head of Healthcare in Australia and New Zealand [32]
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Understood. And I think previously you've talked about Women's Health being maybe 25% of the -- on the generic portfolio. Is that still -- and it's probably a little bit more now, given the decline in some of the other products? Is that right?
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Nick Freeman, Mayne Pharma Group Limited - Group CFO & Company Secretary [33]
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Yes, that's about right, yes. That's about right.
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John Deakin-Bell, Citigroup Inc, Research Division - Director & Head of Healthcare in Australia and New Zealand [34]
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It's because I note -- right. And I haven't had time to go through, so apologies, but on Page 49 of your Annual Report, where you go through that [note in end] and go through the write-downs, I see that you -- it doesn't look like you've written down any of the carrying value of the Women's Health. All of the write-down is in the Other. Is that -- am I reading that correctly?
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Nick Freeman, Mayne Pharma Group Limited - Group CFO & Company Secretary [35]
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Yes, you're reading that exactly correctly. The Women's Health actually has had an improvement over the last year or so. So yes, you are reading correctly.
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Operator [36]
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And next, we will go to John Hester from Bell Potter.
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John Hester, Bell Potter Securities Limited, Research Division - Senior Healthcare Equities Analyst [37]
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I just want to come back to your comments on Tolsura and its prospective growth. So 24 networks in the U.S. reviewing this product. You've quoted an addressable market of $300 million, and you expect to get 25% of that by 2022. Doing the math sort of puts that at around a USD 66 million product within 3 years.
So can you just maybe talk about that a little further? And in particular what you expect to see from that in this current fiscal FY '20? And so yes, if you could address that one, please.
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [38]
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Yes, sure, John. I mean I'm not going to give you an exact number for fiscal '20. And I mean clearly the product is in its launch phase still because of the nature of the hospital or institutional market and the fact that you need to get listed on these formularies first. And I mean I can tell you that we haven't had one example yet of a hospital formulary not being encouraged or excited about the potential of Tolsura on their formulary. In fact, as I said earlier, we've already won, and this was last month, the listing of Tolsura at the biggest single hospital network in the United States. It represents 10% of the market for itraconazole in the systemic market. So that was a great first win. So -- and we've got obviously a lot to come, not of that concentration, though.
So look, I expect to see -- in fiscal '20, I expect to see a bit of a tale of 2 halves. I mean the expectation is this product will start contributing meaningfully into calendar '20, into the second half of this financial year. And if it does and it exits the way that I hope it will based on these formulary wins and patient [directives that I think --], then I think we're on a trajectory that is -- yes. I think we're on a trajectory that's very consistent with the headline comments around 25% of a $300 million addressable market.
I mean, exactly how that trajectory will play out, we will have to wait and see. It could be faster. It might be a bit slower, but the next 6 months will be critical to giving, I suppose, a better prognosis of that.
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John Hester, Bell Potter Securities Limited, Research Division - Senior Healthcare Equities Analyst [39]
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Just a follow-up question. It's got a couple of indications. That estimate around $300 million, is that assuming reasonably significant off-label and -- use as well? Or is that just the need for the indications you've got currently?
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [40]
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No, it's not.
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John Hester, Bell Potter Securities Limited, Research Division - Senior Healthcare Equities Analyst [41]
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Okay. Okay...
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [42]
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It's for the indications we...
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John Hester, Bell Potter Securities Limited, Research Division - Senior Healthcare Equities Analyst [43]
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And so is there any expectation of broad off-label use for this product? I mean it's got -- certainly got plenty of potential.
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [44]
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Well, obviously it's hard for me to comment on that. I mean there clearly is off-label use of various drugs in various markets. We can't promote to that, John, as you know. So we'll just have to wait, clearly.
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John Hester, Bell Potter Securities Limited, Research Division - Senior Healthcare Equities Analyst [45]
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Just have a follow-up question on the NuvaRing product as well. It's reasonably well known that, around about 12 months ago, your European partner developer had a complete response letter from the FDA. Have they completed the responses to that now? And otherwise, what other update can you tell us about the NuvaRing generic?
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [46]
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Yes. So look. I mean it's, I mean, the time frame for us is consistent with what I said, I think, for the first time this time last year, which is that we've received a complete response letter. We're working through that with our partner very, very closely. That work is still in process and it's on track. Nothing's changed. And we expect to respond later this calendar year. So obviously we're in late August now, so it's not far away. And it is -- and it still remains a calendar year '20 launch opportunity.
The other interesting thing, of course, is there's a lot of information out there from some of our competitors around the status of their programs. And you may have read with interest that there have been some delays that some of our competitors have also suffered. And they're probably dealing with some of the issues that we're dealing with that the FDA have put up in front of us. So that's why I made the comment earlier that I think Mayne Pharma is going to be close to the mark. We'll have to wait and see, but certainly I feel better about our order entry position into this market today than I did even 3 months ago, let alone 6 months ago.
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Operator [47]
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(Operator Instructions) We'll take our next question from Simon Conn from Investors Mutual.
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Simon Conn, Investors Mutual Limited - Senior Portfolio Manager [48]
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Scott, quick question. Can you just -- given you're -- I think you're still on the board of the Generics council in the U.S. Can you just talk to the political and regulatory environment in the U.S. in response to the investigative journalist piece that was published in that book, Bottle of Lies? Because obviously it's a hot topic in the U.S., in the unlevel playing field that U.S. companies play versus developing country manufacturers. I mean theft of IP is obviously the issue, but can you just talk in terms of what the regulatory and political response has been in light of the allegations made in that book and how you're being [that effective on the cupboard of] people who don't play by the same rules as U.S. manufacturers?
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [49]
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Yes. And well, look, the Generic industry association in the U.S. that I'm on the board of -- and probably 50% or more of its membership are Generic companies that are based in the subcontinent. So -- but they have significant U.S. forward operations, so that makes very interesting discussion vis a vis that book which has got a lot of press and coverage.
The regulatory response, the FDA has been quite silent, to date, around this. It's rooted in the issue of the degree of oversight that FDA gives from a compliance standpoint, good manufacturing practice standpoint, to domestic U.S. manufacturers versus foreign manufacturers; and the fact there is not a level playing field, i.e., U.S. manufacturers are under far more scrutiny and pressure than foreign manufacturers, albeit probably 50% of all generic medicines that are consumed in the U.S. today are coming from outside of the U.S. So therein lies the political dimension.
There is some -- there is growing political pressure on this topic. Certainly, Trump's agenda around supporting domestic manufacturing also plays into this, and to that extent, Mayne Pharma is well positioned given the investments we've made in Greenville. So look, we'll just have to wait and see. I mean, at the end of the day, it'd be fair to say that the conundrum here is that such a vast significant percentage of pills sold in the U.S. today are coming from India and other jurisdictions, that doing anything dramatic around that supply chain would result in drug shortages. So there's a balance between, if you like, regulatory action and obviously the pragmatic side of drug shortages and the like. So I don't think we've seen the end of this. I think we're pretty well positioned for it at a very macro level because of our -- where we make product. So we'll just have to wait and see.
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Simon Conn, Investors Mutual Limited - Senior Portfolio Manager [50]
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All right. And just a follow-up question then. Scott, just in terms of your portfolio of businesses, if we're thinking of [fall] prices and whether their current mix is correct. Or if -- is this something you think could be more valuable to someone else? Or if this current structure makes sense with the 3 businesses together.
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [51]
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Yes, sure. Well, I mean, clearly I'd like to have -- I don't -- we haven't fallen out of love with the generic business. I mean I think, at the end of the day, the generic industry in the U.S. has been a spectacularly successful segment, notwithstanding obviously some of the recent challenges that the manufacturers are facing.
And of course, the degree of our exposure to the generic business is still too high. It's obviously moving in the right direction. I'd like it to move faster. So there's only 2 ways of doing that really. One is to do something structurally with your generic business, if you like. And the other way is to supercharge or transform your other growth businesses. And obviously outside of our generic business, I think we're well positioned for growth everywhere else. And we're well positioned for inorganic growth in these other areas, provided we see the synergies on specific transactions and provided, of course, we have a suitable mechanism to transact and fund them, given our current context.
I mean one thing is for sure. As I said earlier, this market is -- there's a lot of disruption out there at the product level, at the enterprise level, and there's a lot of opportunity as a result. You've just got to be careful about what moves you make. And one thing I'm not going to do even despite obviously some of the pressure in our generic business, we're not panicking. We're not going to throw ourselves at something to maybe go from the frying pan and into the fire. We've got to be disciplined around that, and we continue to look at everything and even more than look. And so nothing's changed.
I mean the dermatology business, the Women's Health business, the contract services businesses are in good shape. Tolsura is going to be in good shape. And leveraging those assets, leveraging that infrastructure, leveraging what we've done at Greenville organically and inorganically is our core focus, together with obviously doing everything we can through new product launches, cost savings and the like and cost optimization to stabilize the generic business through that journey.
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Operator [52]
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And at this time, we have no further questions. I'd like to turn it back to Scott Richards for closing remarks.
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Scott Anthony Richards, Mayne Pharma Group Limited - MD, CEO & Executive Director [53]
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Okay. Thanks, everybody. And I'm sure I'll see some of you over the course of the next few days. Have a good day. Bye-bye.
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Operator [54]
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And that concludes our call for today. Thank you for your participation. You may now disconnect.