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AstraZeneca PLC (AZN)

Q2 2015 Earnings Call· Thu, Jul 30, 2015

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Transcript

James D. Gordon - JPMorgan Securities Plc

Management

Hello. Thanks for taking my questions. I had a few Oncology questions and one on the base business as well. On the Oncology business, one was I saw that the biosimilar Avastin program. My question on that was, when do you think you could start combo studies with Avastin with your immuno-oncology agents? And also would you initiate it with Avastin? Or would you do the initial trials with the biosimilar immediately? Another question was just clarifying that for PD-L1 plus chemo for the combo studies, when do you think you could start the Phase III program? And the third Oncology question was just on the NEPTUNE study. So that's a version of MYSTIC, but with an overall survival endpoint in first line. Is a crossing over going to be an issue? Or will you stop patients from crossing over to the PD-L1 therapy if they're in the placebo arm? And then – and so one base business question, which was just contracting for next year, do you think pricing and mix is going to be any better for Diabetes and Respiratory next year, based on the discussions you've had so far? Or should we assume similar pressures? Pascal Soriot - Chief Executive Officer & Executive Director: Thanks, James. So quite a number of questions. Maybe I could allocate the questions. I think we have Rob on the line, and Rob will cover the NEPTUNE question. The PD-L1 combo, Mondher, do you want to cover that one? Mondher Mahjoubi - Head of Oncology, Global Product & Portfolio Strategy: Yeah. Pascal Soriot - Chief Executive Officer & Executive Director: And, Luke, if you want to address the contracting question, would that be okay with you? And maybe, Mondher, you could also comment on the Avastin program? Just a very quick comment…

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Hello. Could you... Pascal Soriot - Chief Executive Officer & Executive Director: Yeah, go ahead.

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Hello. Can you hear me? Pascal Soriot - Chief Executive Officer & Executive Director: Yeah.

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Hi. Sorry about that. Three questions please. Firstly there has been significant discussion about the cost burden for Medicare and alternate payment models. Given we're going into a Presidential election year and Astra is becoming increasingly geared towards Oncology, any thoughts on both noise and ultimate evolution and timeline for changes in Medicare reimbursement will be interesting. Second, Luke, perhaps if you could comment on the outlook in China in terms of pricing? Several of your competitors have outlined increasing pressure on pricing in that market. And then finally, given your legacy presence with Crestor and more recently with Epanova, perhaps you can talk about your interest in CETP inhibition as an interesting modality to continue to extend your cardiometabolic franchise? Thank you. Pascal Soriot - Chief Executive Officer & Executive Director: So, Luke, do you want to cover the last two? Luke Miels - Executive Vice President Global Product and Portfolio Strategy (GPPS) & Corporate Affairs: Sure. Pascal Soriot - Chief Executive Officer & Executive Director: And, Mondher, would you – will you cover the first one later? Or... Luke Miels - Executive Vice President Global Product and Portfolio Strategy (GPPS) & Corporate Affairs: Yeah. Sure. So on CETP we wouldn't speculate. If we look at China I think it's fair to say that there is a structural slowing in the market, which I don't think is a surprise to anyone who's following the overall economy in China. That being said where our focus is, I mean clearly we have a strong position in the large Eastern provinces. But as we go to lower tier cities in the West, we have a concentrated expansion program there. Also our mix of products right now, there is a lot of volume reflex. Of course if you do see pricing pressure with…

Sachin Jain - Bank of America Merrill Lynch

Management

Hi. Thanks for the questions, a couple of financial and a couple of product. Firstly on SG&A, a couple of slides talking about it declining as a percentage of revenues. That's obviously influenced by lumpy externalization. I think it's roughly flat year-on-year in percentage of sales and a 1% decline CER. So given that, which doesn't seem a particularly aggressive decline, could you just sort of give some color on what CER declines you're looking at for the rest of this year? And then more importantly into 2016, as you think about offsetting the Crestor patent expiry and the various one-off incomes that you've had this year that probably won't repeat next year. Secondly, a question on slide 38, which you talked about, Pascal, where you listed the various product launches. I think when you first gave the full year 2017 guidance, the commentary was limited pipeline contribution within that. Given the various pipeline launches you're now listing, I wondered whether the pipeline contribution to maintain 2017 flat has increased, given various pressures you're seeing in the base business. A couple of product questions on the Onglyza/Farxiga fixed-dose combination, just wondering what your perspective on the potential heart failure safety label is, as you head into the PDUFA? And if you do have that safety label, how do you think you position relative to Januvia monotherapy, which might not have that, or the competitor fixed-dose combination, which also might not have that? And then a final question just on the IO lung positioning post-ASCO, now that you've had more opportunity to take feedback from KOLs. Just wondering, you could give us an updated perspective of your IO IO in lung relative to chemo combination, firstly. And then secondly, relative to Bristol where some feedback remains that Bristol's first mover advantage…

Sachin Jain - Bank of America Merrill Lynch

Management

That's as a percentage of revenues, which includes externalization I think, but I may be wrong. Excluding externalization it's flat and 1% CER decline. Pascal Soriot - Chief Executive Officer & Executive Director: I see, yeah. Marc Dunoyer - Chief Financial Officer & Executive Director: So just to cover this, so I think we need to see this as a time series. If you look at quarter four of last year, quarter one of this year, where the SG&A, we're still increasing at plus 10%. I think you will see that the reduction of the SG&A on the second quarter was quite impressive. And we are nowhere near the end of our effort. We need to redouble our effort to be in line with what we provided early in the year, which is we will have an SG&A which is under the level of 2014, and also the ratio will be under the ratio of 2014. So we need to – and we are determined to continue our effort in that direction. Pascal Soriot - Chief Executive Officer & Executive Director: Elisabeth, do you want to cover this, the Onglyza label question? Margareta Elisabeth Björk - Interim Chief Medical Officer: Yes. (57:16) and I'm very happy to do that. We are still in discussions with the FDA around what the exact label update will be for Onglyza based on the (57:26 – 57:32). I can't comment exactly on what that outcome is going to be. What I can say is for the combination of saxa/dapa, we are ignoring the potential to do more mechanistic work, to see really the impact of the two-for-two parts there, reminding everybody of the fact that also dapa has a small diametric impact effect that very well could counterbalance whatever is seen with saxa. So…

Alexandra M. Hauber-Schuele - UBS AG

Broker

Thank you very much. Two questions left. Two on 9291. You said you're going to submit in Japan this quarter. Unfortunately I don't know the Japanese regulatory situation very well. Is there any way for accelerated approval there. Or when is the earliest time you can actually not file but get approval for it? Also on 9291 you said the filing is the second line in patients with the T79 (sic) [T790M] (1:14:12) mutations? Various commentaries from KOL whether we really need that mutation as an – in the indication. Do you expect that to be a – that that is actually required or be used in practice? Or is it just going to be anyone who progresses from sort of first-generation EGFR inhibitors? Moving on to Lynparza, a really great progress here. But when is the first – the earliest time you can get a label expansion in ovarian cancer? It appears that all the SOLO studies are still recruiting. So are those readouts being pushed out? And then final question on, I still call it MEDI 4736, the new studies which were those described in the press release today but also at ASCO in the new indications, are they going to still stop this year or this quarter? Or is this coming at some point in the future? Thank you. Pascal Soriot - Chief Executive Officer & Executive Director: Thanks, Alexandra. A lot of great questions. By the way the medi is called durvalumab now, and like dura, like durable. Durable and valuable. So the first question is about Japan. We'll ask our Japanese expert resident Marc to address that question. Marc Dunoyer - Chief Financial Officer & Executive Director: Thank you. So it's not exactly an accelerated approval. The Japanese call it a priority review. But at…

Alexandra M. Hauber-Schuele - UBS AG

Broker

Exactly, yeah. Mondher Mahjoubi - Head of Oncology, Global Product & Portfolio Strategy: Yeah. Yeah.

Alexandra M. Hauber-Schuele - UBS AG

Broker

Yeah. The other combination. And just I think you said database lock on SOLO2 before year end. According to ClinicalTrials that's still recruiting. So I shouldn't worry about that, it's really going to finish, complete this year. Mondher Mahjoubi - Head of Oncology, Global Product & Portfolio Strategy: Yeah. So we have a very, very concrete example. The head and neck trial for instance, there were two trial, the Hoke and the CONDOR-1 is the PD-L1-positive and the other one is in the PD-L1-negative. The Hoke trial clearly benefit from the fact that now we are opening the CONDOR trial, because patient in – at one point in time when they are organizing the site they have more than one option, whereas still now they didn't have the option but to be PD-L1 positive. So we are accelerating the activation of the sites in the head and neck trial in order to have – do the recruitment finished on time. So there is no change in the timeline when it comes to the accrual for the PD-L1 treme combo in head and neck but also in the other tumor type that we already announced, which are pancreatic cancer, gastric cancer, and bladder cancer, in addition to the lung cancer program. Pascal Soriot - Chief Executive Officer & Executive Director: Thanks, Mondher. So shall we move on to Kerry Holford? Kerry at Exane. Kerry, go ahead.

Kerry Holford - Exane Ltd.

Management

Thank you. Three questions please. Firstly on respiratory. Sorry. Given the difficulties that are being faced by one of your peers in moving from LAMA monotherapy to LAMA/LABA combinations. I'd be interested in your experience, your early experience with Duaklir. And also just your general thought on the treatment paradigms in COPD. Secondly, on 9291 can you just remind me how you believe that product is differentiated versus the competitor from Clovis, which I think is running along at a very similar regulatory timeline? And then thirdly, just to clarify in your guidance being raised for the year in terms of total revenues, does that purely reflect the additional externalization revenues? Or is there also an uplift to the underlying basic tenets? Thank you. Pascal Soriot - Chief Executive Officer & Executive Director: Thank you so much, Kerry. So three questions here. One, 9291 for Mondher. The revenue guidance, Marc, maybe you want to cover this one? And LABA/LAMA, in a nut shell really the experience we have was directly on Europe so far, because we've only launched it in Europe in some market, both in the U.K. and Germany, so far is a very good experience. Now it's very clear that it is a market that we need indication to grow and develop. And there's no doubt about it. But so far with Duaklir we are very satisfied with the progress we are making. Luke, anything you want to add there? Luke Miels - Executive Vice President Global Product and Portfolio Strategy (GPPS) & Corporate Affairs: Yeah, I think it's a promising start. We've got $24 million in revenue. Around 3.5% market share. And if you add in our partner of course it's around 8%. We've had some good results in Germany. Days of treatment, if you look at…

Jeffrey Holford - Jefferies LLC

Management

Hi. Thanks for taking my questions. I wonder if you could just give us your updated thoughts on business development? Are you still hopeful at all of a bridging deal for AstraZeneca? Or is time marching on, the progress in your pipeline? Or perhaps are you seeing little value out there at current market prices, inhibiting any potential of that happening prior to 2017? And then secondly to really appreciate if there's any early color on the Celgene collaboration? And when we'll get to hear more updates on the trials coming up for that partnership? Thank you. Pascal Soriot - Chief Executive Officer & Executive Director: So, Mondher, I'll ask you to comment on the Celgene collaboration. What I'm hearing from our teams and from Celgene themselves is that it's going extremely well. And the teams are working very, very well together. Everyone is rather enthusiastic, and we're moving very expeditiously. Mondher, maybe in a minute you can comment. On the deal actually question, Jeff, the – we're constantly looking at options of course, as you would imagine, like everybody else is doing. We do realize that certainly acquisition that would be accretive would help us bridge to 2017 faster. There's no doubt we are well aware of this. But at the end of the day our core focus is implementing our strategy and delivering our pipeline. And if we were to find a deal, it would have to be a deal at the right price. And you highlighted yourself that prices these days are pretty hefty. And you can be accretive with many things. The issue is also do you have an appropriate rate of return on your investment? That's really also what we are looking at. So we continue looking. But I can't say that it is really…

Richard J. Parkes - Deutsche Bank AG

Broker UK

Hi, yeah. Thanks for taking my questions, they focus on Diabetes actually. Just on Farxiga I've noticed that the new NRx in the U.S., the growth there has been slowing. And also in the context that if you look at your prescriptions, sales per prescription, and compare it to what J&J reports, it looks like you are already heavily rebating there. I think you're at around two-thirds of the level for Invokana. So wondered if you've got any room there to react to that pressure on your NRx? Then secondly Onglyza is clearly suffering from the lack of promotional support and whether – I'm wondering whether there's any thoughts around adjusting how the two products are marketed together? Whether there's any second thoughts about having the same sales force selling those two products? And then finally on Bydureon, the suspension product is obviously key to continuing to drive growth there. I wondered if you could give us any more detail around that device? And what it brings? And whether you've been able to improve the needle gauge? Thanks. Pascal Soriot - Chief Executive Officer & Executive Director: So thank you very much, Richard, for those questions. Luke, most of those are for you. Maybe quickly on the sales per script, let me just say that the difference is not only a rebate, it's also payers – not payers, patients assistance, sorry. When we pay – when we help with copays and we have free coupons for copays. And rebates, typically when you give rebates, it's hard to take them back. But certainly patients assistance coupons to support copays you can flex that up or down of course. And that's certainly something that we have the ability to flex a little bit. But we also – we'll consider this in the…