Simon Jonathan Lowth
Analyst
Well, thank you, Pascal, and good morning, afternoon to everyone on the call. I'll focus on 5 topics. First, I'm going to summarize the headline numbers. I'll then go on and cover the revenue performance by region and for some selected brands. I'll then turn to the core operating performance and I'll -- with an emphasis on the key drivers of operating profit and margin. I'll briefly touch on cash distributions to shareholders and then finally, I'll close with our thoughts on guidance for the full year. So on to the headline results. Total company revenue was $6.7 billion in the quarter. That's a 15% decline in constant currency terms. Revenue declined by 19% on an actual basis as a result of the negative impact of exchange rate movements. The dominant feature of our revenue profile in the third quarter, as indeed it has been for the year-to-date, is the loss of exclusivity on several brands. Seroquel IR alone was down more than $850 million, and the disposals of Astra Tech and Aptium accounted for 1.8 percentage points of the revenue decline. I'll discuss the regional and brand revenue performances shortly, but let's just now continue with the headline numbers. Core operating profit in the quarter was down 14% in constant currency to $2.6 billion. The decline is broadly in line with the revenue, but to be fair, core operating profit did benefit from the $250 million proceeds from the sale of Nexium OTC rights. Benefits from restructuring and disciplined management of operating costs are also playing their part in helping to mitigate the impact of revenue declines on earnings. Core earnings per share in the quarter were $1.51 compared with $1.71 last year. That's an 8% decrease in constant currency terms, with the benefit from net share repurchases providing the uplift compared to the core operating profit trend. Reported EPS were $1.22. That's down 50% at constant currency compared with $2.56 last year, which, of course, included the $1.08 per share from the sale of Astra Tech. So those are the headlines for the third quarter. It's a broadly similar picture for the 9 months in constant currency terms with revenue down 15%, core EPS down 11% and reported EPS down 36% versus last year. Now returning to the third quarter revenue performance, and when I refer to growth rates, they will be on a constant currency basis. Revenue in the U.S. was down 19% compared with the third quarter last year, driven by loss of exclusivity for Seroquel IR. Excluding Seroquel IR, the rest of the portfolio increased by 6% in the quarter. Third quarter revenue includes $44 million related to our share of sales of the Amylin diabetes portfolio following completion of the alliance expansion in August. Revenue in Western Europe was down 20% in the quarter. Loss of exclusivity on 4 products, Seroquel IR, Atacand, Nexium and Merrem, accounted for 70% of the revenue decline. And in addition, we faced continued headwinds from government interventions. Revenue in Established Rest of World was down 18%, largely due to a 43% decline in Canada as a result of generic competition to Crestor and Atacand. Revenue in Emerging Markets was up 6% in the quarter. Revenue increased by 23% in both China and Russia. Brazil returned to modest growth as the impact from the loss of exclusivity for Crestor and Seroquel IR is now behind us. A weak performance in Mexico in the face of challenging market conditions continues to negatively impact our performance, reducing revenue growth in Emerging Markets by more than 2 percentage points. We hope to see some stabilizing the trend in Mexico once we pass the 12-month anniversary of the at-risk launch of generics for Crestor. This slide provides a snapshot of revenue for our key brands. As you see, we grew revenues for the key brands that retain market exclusivity in most of our major markets, except for Crestor, where we've had generic competition in Canada since April. Excluding Canada, worldwide sales of Crestor were up 7%. Crestor -- sorry, Symbicort had a good quarter on strong growth in the U.S. Seroquel XR was up 8%. We had another strong quarter for our oncology products, IRESSA and FASLODEX. Saw a good performance for ONGLYZA and slow but steady progress on Brilinta. But as you can see at the bottom of the slide, loss of exclusivity continues to take its toll on Seroquel IR, Atacand and Merrem. Nexium has generic competition in Western Europe, but we also had a decline this quarter in Japan where sales in the third quarter last year was launch stocking, whereas demand so far this year has been significantly constrained by the riotanke [ph]. Riotanke [ph], recall, is the regulation that restricts prescriptions to products in their first year on the market into Japan to just a 2-week supply, and that has ended the launch uptake. Riotanke [ph] was lifted at the beginning of October, and we are now seeing a significant ramp-up in daily sales. We look forward to a solid performance for Nexium in Japan going forward. There are detailed commentaries on brand performance in the press release, but I'd like to provide some additional color on 3 products: Crestor, an update on the Brilinta launch and the performance of the diabetes franchise. So first, Crestor. Crestor sales were $1.5 billion in the quarter, and that's down 3% due to generic competition in Canada. As I mentioned earlier, if you exclude Canada, global sales are up 7%. Crestor sales in the U.S. were up 11% to $833 million. Total prescriptions for Crestor in the third quarter were down a bit more than 3% compared to just under 1% growth in the statin market. Now I'm going to turn to a slide that we've used in the past to look below the surface of total prescriptions and look at the dynamic components to illustrate the trends. If we look at the yellow hash line, which is net dynamic volume, you'll note the strong uplift beginning in June of last year following the label change for simvastatin. So part of the slight downturn this quarter is due to the strength of the prior-year period. Now Lipitor first went generic at the end of November 2011 and then multisource generics arrived at the end of May, and you can see that the dynamic trend is quite resilient before and after May 2012. I'd like to now take the same data and look at it by payer channel in order to illustrate the second driver to the quarter's TRx performance. On the left is the same dynamic data we showed earlier but isolating the majority of retail business. That's commercial managed care and Medicare Part D, and it shows the same trend as before, got a bump from the simvastatin label change last year and then relative stability spanning the 2 Lipitor loss of exclusivity dates. On the right is the same data for Medicaid fee-for-service channel. The half-year results, you may recall Tony Zook mentioned, that we were no longer pursuing this low-margin business going forward, and you can see the volume erosion beginning in July. So I hope that gives you some greater insight into the volume trends for Crestor, relative stability in the face of multisource generic atorvastatin, but a weakness against a strong third quarter a year ago that was driven by the simvastatin label change and a small decline in the current quarter as a result of our decision to not chase low margin Medicaid business. So against the low single-digit decline in total prescriptions, how did we generate 11% revenue growth in the quarter? Well, there was a little bit of inventory movement year-on-year, but mostly this growth is driven by price. So far this year, we've been able to achieve an increase in net realized prices for Crestor, but we also said that this would come under pressure once we had to contend with multiple generic atorvastatins, and this is proving to be the case as we complete the contracting cycle for 2013. We look to be in a good position for formulary access in 2013 and broadly similar to the high access we currently enjoy, but this is coming at the expense of price. I don't want to get too far ahead of our financial guidance for next year, but I think it's prudent to be thinking of net price declines for Crestor in the U.S. next year. In the Rest of World, I already mentioned the big driver and that is loss of exclusivity for Crestor in Canada. Now turning to Brilinta. Sales were $24 million in the quarter, with $15 million from Western Europe and $7 million in the U.S. In the U.S., we continue to make progress on the key launch metrics. In particular, I would note the increase in trial rates amongst interventional cardiologists as well as the nice uptick in unrestricted access in Medicare Part D. We have recently prioritized driving trial and utilization where we're already on formulary and protocol, and that is helping drive prescriptions. You can see here from the latest data that total prescriptions in the third quarter are 55% higher than in quarter 2. So progress to be sure, but much, much more to do. In Europe, the picture is a continuation of the growth trends that we saw in the second quarter as you can see here in Germany. Bear with us. So in Germany and in the Nordics, so there's Germany. Let's move on to the next slide in the Nordic region and in Italy. We launched in France in July, so it is still very early days, but initial indications are that we're having a launch trajectory on par with other successful launches in Europe. Finally, the diabetes franchise. Revenue for ONGLYZA was up 42% to $84 million in the quarter. Much of this is still in the U.S. where alliance revenue was $62 million. Total prescriptions for DPP4s in the U.S. are still growing strongly, up 21% in the quarter. Our franchise share was 17.7% in September, and that's up 1.2 percentage points since December with ONGLYZA holding steady while KOMBIGLYZE XR market share is up. We're now in a position to begin launching KOMBOGLYZE, that's the combination of ONGLYZA and metformin immediate release, in Europe over the next several months. So I'll now turn to the third quarter P&L. I'll focus here on core margins and profits. The press release does, of course, contain the strategy numbers and a detailed reconciliation to the core measures. As with sales, when I refer to growth rates, they will be on a constant currency basis. Core gross margin in the quarter was 81.1% of sales. That's down 10 basis points compared with the third quarter last year. Now there are some moving parts below this broadly flat surface. But an unfavorable product mix and higher royalties as a percentage of revenue were broadly offset by benefits from the absence of Astra Tech and a lower net expense related to the Merck arrangements. Core SG&A expense was down 12% compared with the third quarter last year. Restructuring benefits, the absence of Astra Tech costs and continued discipline in managing costs were partially offset by new sales and marketing spend associated with the Amylin diabetes portfolio as well as amortization of the related intangible assets. I expect the run rate for SG&A in the fourth quarter to be higher than this quarter. Core other income more than doubled in the quarter based on the proceeds from the sale of OTC rights for Nexium to Pfizer. And for the year-to-date, the movement of the U.S. commercial contribution for Zomig from sales to other income is also affecting the comparison to last year. So that leads to a core pre-R&D operating margin of 55.7% of revenue. That's above the top of our 48% to 54% panning range and 2.2 percentage points higher than last year, and that's largely on the Nexium OTC benefits to core other income. As I said earlier, restructuring and spending discipline is doing its part on mitigating the revenue decline but of itself will be insufficient. Core R&D investment in the quarter was $1.1 billion. That's a 3% decrease versus last year. Benefits from the restructuring program in R&D has enabled us to show a decrease in R&D spend while absorbing the partial year effect of bringing on board the new projects from business development such as Amgen, Ardea and Amylin, which otherwise would've exerted an upward pressure on R&D spend. Core operating profit was $2.6 billion in the quarter. That's 14% lower than last year. Core operating margin was 39.4% of revenue, 30 basis points higher than last year. Turning to our productivity program. For the 9 months, we've incurred $1.2 billion of costs associated with the third phase, and that was combined with the $8.3 billion charge in the fourth quarter of 2011. So we're on pace to take most of the $2.1 billion in program costs by the end of this year, and we remain on track for delivering the estimated $1.6 billion in annual benefits by the end of 2014. Cash generated from operating activities was $4.1 billion for the 9 months compared with $4.8 billion in the same period last year. Lower tax payments and net improvements in working capital only partially offset the lower operating profit. For the 9 months, cash outflows on externalization activities reached $4.8 billion driven by the acquisition of Ardea and the intangible assets associated with our collaboration with Bristol-Myers Squibb on Amylin. Net cash distribution for shareholders for the 9 months was $5.9 billion through net share repurchases of $2.3 billion and dividends of $3.7 billion, being the combination of the second interim from 2011 and the first interim in 2012. We announced the suspension of further share repurchases on the 1st of October. So finally, turning to guidance. As we expected, our financial performance for the first 9 months largely reflects the ongoing impact from the loss of exclusivity for several brands in key markets, particularly Seroquel IR, but also for Atacand, Merrem, Crestor in Canada and Nexium in Europe. And the disposals of Astra Tech and Aptium obviously also weigh on the year-on-year comparisons. In addition, we continue to face the same challenges that the whole sector's facing: government interventions, payer pressures and the headwinds of a sluggish recovery in the global economy. Benefits from our restructuring programs and continued discipline in operating expenses have provided headroom for reinvestment in the business, while also partially mitigating the impact of declining revenue on core operating profit and margin. As I mentioned in our first quarter results call, despite continued pressures on revenues and margins, the company will continue to invest to drive future growth and value in sales and marketing to support our new products in growth markets and in research and development to progress value-creating assets within our portfolio and through further business development. Based on the performance to date and the outlook for the remainder of the year, the company continues to anticipate that the revenue for the full year will decline in the range of the low to mid teens in constant currency terms. The company's core EPS target for the full year also remains unchanged in the range of $6 to $6.30. For the 9 months of 2012, recall that core operating profit and EPS includes one-off items totaling $0.35 per share. That's $0.19 from the tax settlement in the second quarter and then $0.16 from the sale of OTC rights for Nexium in this quarter. Currency was neutral to core EPS versus our guidance rates for the first 9 months, but I would remind you that the forward look is based on the January 2012 average exchange rates upon which our guidance was based. It takes no account for the likelihood that average exchange rates for the remainder of the year may differ materially from the January 2012 average. So let's now move on to the Q&A session. [Operator Instructions] So with that, can we have the first question, please, operator?