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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q4
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Christian Hogg

disease control rate, 75%; median progression-free survival, 6.2 months as savolitinib on its own in those MET-driven patients. At the bottom, you can see pembrolizumab, Keytruda, monotherapy in non-clear cell renal cell carcinoma, so the three blocks. And you can see a disease control rate of about 40% and a median PFS of around four months.

Savolitinib is a highly effective therapy in MET-driven disease across pretty much all solid tumor types, including papillary renal cell carcinoma.

The question is, is combining savolitinib with a PD-L1 antibody going to give you a synergistic efficacy? So we see with the savolitinib-Imfinzi combination, you can see response rates in the sort of the high 20s, low 30s. And you see that all the rest of the data there is basically immature.

So the CALYPSO data that was presented a month or 2 ago or a month ago at ASCO GU is encouraging to us, but it's very premature. And it's going to take time for that data to mature. Our hope is that there is a synergistic effect of the MET inhibitor and the PD-L1.

And if that's the case, that has potential not just in papillary renal cell carcinoma but across many solid tumor types. So encouraging, but early is the point. But I hope now you can understand why we said, "Okay, let's stop the savolitinib monotherapy." Because in our mind, the potential for the combination with the PD-L1 is great.

But we need to watch that Phase II study data mature more before we decide what we're going to do with it. In hematological malignancies, on the Syk inhibitor, we're moving rapidly. We have an expansion study in Australia and China now. It's almost 200-patient dose expansions.

So as I said earlier, our plan is to initiate China registration studies on the Syk inhibitor by the end of this year in potentially several indolent non-Hodgkin's lymphoma subtypes. And then finally, the chart that we've been showing on PD-1 VEGFR inhibitor combinations in clear cell renal cell carcinoma.

You see the axitinib/pembrolizumab data that's recently been published. There's definitely a lot of synergy with VEGFR inhibitor and the PD-1s. So that's why we partnered up with 4 PD-1 players in China. The two local companies, Innovent and Junshi, that both have just received approval on their PD-1 antibodies in China.

And so now we're working on expanding development of fruquintinib and surufatinib in combination with those PD-1s. So we're quite excited about this. So that's the highlights on the innovation side. On the commercial business, it's a big platform. Many of you have seen these charts.

In 2018, we sold almost 5 billion doses of medicine in China through our Commercial Platform. It's a big operation, 2,400 medical reps and market-leading products. You can see the commercial success that we've seen in the last few years has been terrific.

On Page 42, you can see the sales in 2018 were $664 million of our subsidiaries and our unconsolidated JVs. On the profit side, the $41.4 million we made in 2018, it's been a long and regimented progression towards increasing profitability on that business.

And you can see total net income from our operations in China over the last -- since 2005 is almost $600 million. So we've generated a lot of cash from these commercial businesses is to help fund our long-term investment in innovation. Page 43 is the commercial organization as it's laid out.

You can see it's primarily focused on Eastern China, Northeast and South China, which is where all the population is, where we cover over 320 cities and towns. You can see on our third-party products, we've done very well. So it's not just on the products we manufacture and sell ourselves.

But taking on third-party products like Seroquel and Concor, you can see we've done very well through the years on these programs and are generating a lot of service fees from those activities. So on the existing business, it's continued organic growth. It's building out synergies on the China oncology operations.

Looking at M&A potentially, both in terms of acquisitions or potentially selling off non-core assets and focusing on cash generation. So finally, talking of cash.

We sit here today or at the end of last year with around $420 million in cash and available resources, $301 million in cash and short-term investments, another $119 million in unutilized banking facilities and only about $27 million in debt.

And if you look at the guidance going forward, we've streamlined our guidance for this year just because we wanted to focus in on what are really the most important metrics for guidance for Chi-Med. And we see those 2 metrics as research and development expenses.

We are -- we've just gone through telling you that we are moving aggressively globally with 5 of our core assets. And when you start developing multiple assets outside of China, it does tend to get quite expensive.

So we feel it's important to give guidance on research and development expenses, which we feel are going to be somewhere in the region of $160 million to $200 million in 2019. And the impact that, that has on essentially cash burn, this metric we have adjusted non-GAAP group net cash flows excluding financing activities.

So this is the pure sort of the cash burn of our operations and our activities, somewhere in the region of $120 million to $150 million, the difference being the cash that we're generating from our Commercial Platform, potentially from some of our multinational partners and offset, to some extent, by our administrative costs, et cetera.

But essentially, those are the 2 metrics that we feel are most disruptive for our business at this stage. So I think on the innovation side, this year, we'll see Elunate ramping up quickly. It'll be a gradual start in 2019. But I think it'll ramp up very quickly over the next couple of years.

And obviously, we'll see an increased investment as we expand in the U.S. and Europe. And then on the Commercial Platform, I think the growth this year will be -- historically, we've seen growth on our Commercial Platform double-digit growth pretty much every year. I think this year in '19, we'll see it a bit more narrow than that.

It'll be in the single digits.

Reason for that, and we go into a lot of detail on this in our announcement, around the restructuring of our logistics and distribution platform under SHPL, our prescription drug business in China, where the Two-Invoice policy has required us to go from a system that used to have 200 primary distributors and 1,600 secondary distributors to a single tier of 800 primary distributors.

We've had to make that change over the last year. And it took us 16 years to get to that 200 and 1,600 structure. And because of Two-Invoice policy, we had to change it. So I'd say that the restructuring has gone really well. Business is doing well. We're actually very optimistic for the full year on SHPL.

But I think that will leave this year to probably single-digit growth as opposed to double-digit growth. And the U.S. dollar is sort of moving in the wrong direction. Our U.S. dollar in the first half of this year was 5% stronger than the RMB versus a year ago.

So we're basically -- we're seeing Donald Trump and all of these China trade tensions leading to a slightly weaker RMB, which is where all of our profits are in China. That said, a weaker RMB actually helps us when it comes to investing in the innovation side. So obviously, we are converting U.S.

dollars into RMB to fund a lot of investments in development in China. So it's kind of give-and-take basically. As far as news flow and targets for 2019, we've got a year of quite a lot of news flow. You can see the starred boxes are the ones, I think, are most important. I've mentioned them already. The savolitinib/Tagrisso -- this is Page 48.

The savolitinib/Tagrisso data at AACR late this month will be very important. The savolitinib monotherapy in exon 14 deletion patients at AACR will also be very important. The next starred item would be surufatinib Phase III interim analysis on extrapancreatic neuroendocrine tumors sometime in the middle of the year. Looking at the top here.

Savolitinib and Taxotere or savolitinib in gastric cancer in the VIKTORY study, that data should be getting presented sort of mid-third quarter of this year. That will be very important data. And then the last star there is the surufatinib, the second Phase III interim in pancreatic NET. So there's a lot of news that's coming this year.

And it's an important year for Chi-Med. I think we've had a very busy year in 2018, a lot of positives and a few disappointments on FALUCA, for example. But we continue on and we have great momentum. We've got all the resources we need. We've got great assets. And I think our view for the future is very, very positive, very optimistic. So that's it.

I'll leave it for some questions now, anybody has any questions. And we have a microphone you have to use.

Mike?.

Michael Mitchell

Mike Mitchell from Panmure Gordon. The Two-Invoice System, just wondering how the restructuring or if we should think about any further restructuring during 2019.

Or was that now completed? And on the QCE bidding process, has that -- how do you think about that mapping on to the Commercial Platform as it stands at present and over the coming years?.

Christian Hogg

So the Two-Invoice policy has basically played out. I think you might see a little bit of impact in 2019 but not much. On the 7+4 QCE policy that's come out, it's essentially a policy that's designed to squeeze pricing in the generic drug industry.

I actually see that -- it will hit the Hutchison Sinopharm business a little bit in terms of revenues just because we do sell some third-party generic products under this Hutchison Sinopharm JV. But they're very low margin. It won't affect our profitability at all.

But I think, in general, that 4+7 QCE policy is going to be really positive for Chi-Med over the next few years because ultimately the whole point of it is to bring price down on generic drugs to open up more headroom for reimbursement of innovative drugs, which will be where we will be bringing our oncology assets.

So yes, I think in the short term, you might see these commercial reforms impacting Hutchison Sinopharm sales a little bit, won't impact our profit by much. And in the long term, mid- to long term, it will really help us as a company..

Cinney Zhang

Cinney Zhang from Bloomberg Intelligence. You're pushing to get fruquintinib on the National Drug Reimbursement List.

When exactly do you expect that to happen? Also do you expect the final reimbursement price to be significantly lower than your retail price?.

Christian Hogg

Thank you, Cinney. I'm hearing that there's going to be an update on the National Drug Reimbursement List sometime in September, October this year. I don't know whether that's certain. But they're trying to get it done this year is what I'm hearing. Whenever you bring a new drug into the National Drug Reimbursement List, it's a negotiation on the price.

And that's a negotiation that is set to happen. It hasn't happened yet. So it's difficult for me to really comment on what the price will be. I haven't seen any drug go into the national reimbursement list with a premium. So it will be a discount. But the extent of that discount will have to be determined through negotiations basically..

Susie Jana

Susie Jana, Edison.

Could you just talk us through the hirings in the U.S., 30 more people this year, what sort of profile you're looking for? And how rapidly are you going to expand in 2020 and 2021, given the amount of assets going into global development?.

Christian Hogg

Thanks, Susie. Yes, the team in the U.S., I mean, it's wonderful to be able to attract high-quality clinical regulatory talent into our U.S. organization. We've recruited in a Chief Medical Officer in the U.S. from Eli Lilly.

And he has set about building a fully functional clinical regulatory organization, clinical operations, clinical science, everything. So we are just in a great position having -- I think what's able -- what allows us to really attract high-quality talent is our assets and our appetite to develop those assets in the U.S. and Europe.

So I would imagine, as I say on this presentation, by the end of this year, our target is to be up to about 30 people. I would imagine that would grow quite rapidly after that because we'll be running multiple programs in parallel and we'll need the resources to manage that. But particularly, it's not just the U.S., it's Europe as well.

Because in a lot of these global studies, you need European sites and you need those European sites to be functioning properly. So you need people on the ground over here as well. I don't know whether that answers your question. But it's a full-fledged building of a big multifunctional organization in this space..

Unidentified Analyst

And just picking up on the -- you mentioned the ASCO GU data, kind of the KEYNOTE-426, you've seen some impressive stuff there.

Are you thinking yourself about maybe a PD-1 fruquintinib combination in kidney cancer? Or is it -- are they too far ahead, those kind of your Merck's world?.

Christian Hogg

So it's a bit -- clearly, fruquintinib or surufatinib in combination with a PD-1 in kidney cancer is attractive to us. It's very competitive. There are a lot of players that are already in that space. But we're looking at a lot of things. I won't go into details of what we're looking at. But we're looking at a lot of things.

And I think there is certainly clear proof of concept in there that both of those assets, surufatinib and fruquintinib, could do well in RCC. But I think you can't just be following what everybody else is doing. You've got to think about it in a slightly different way. And that's what Weiguo and the team are looking into..

Christian Hogg

Any more questions? Okay. Do we have any? Okay. So if that's it, thank you all very much for coming, and appreciate your attendance and look forward to a good year. Thank you..

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