John B. Thomas
Analyst · Leerink Swann
Thanks, Tom. This morning, I'll review the fourth quarter performance for 2011 and the 2012 outlook for our major business categories. I'll also provide a brief overview of our pipeline and the major milestones we expect this year. I'll describe our fourth quarter and full year 2011 results on a reported basis, that is, including the impact of foreign exchange. For our 2012 division outlook, when I get there and given recent FX trends, I'll provide both operational and reported expectations. So let me start with our Proprietary Pharmaceuticals business, where our worldwide reported sales in the fourth quarter increased nearly 7%. For the full year 2011, worldwide reported sales in pharmaceuticals increased 11%. Global demand for HUMIRA continues to outpace the market with reported sales up nearly 16% in the fourth quarter. Performance was driven by strong U.S. sales growth, consistent with underlying trends in the quarter. We continue to see steady market growth globally, including strong performance for HUMIRA in the gastroenterology and dermatology segments. International HUMIRA growth in the quarter was impacted by our previous change to calendar year reporting for our international operations. Therefore, adjusting for results on a calendar year basis, HUMIRA international sales would have increased approximately 15% in the fourth quarter on a reported basis. Full year 2011 recorded sales for HUMIRA increased 21% globally, ahead of our original outlook at this time last year, which was low teens growth. As we look ahead to 2012, we expect low double-digit reported sales growth for HUMIRA worldwide, which includes the negative expected impact of foreign exchange. Global reported sales of CREON in the quarter were approximately $175 million, up approximately 13%. Full year 2011 global reported sales were approximately $630 million, and that was up 45%. CREON maintains market leadership in the pancreatic enzyme market. And over the past year, we've captured the vast majority of new prescription starts in this category. U.S. sales of Lupron in the quarter were up 7%. Full year global Lupron sales were $810 million, and that was ahead of our expectations. Our recently approved 6-month formulation of Lupron Depot continues to perform well, driving share gains and further expanding our category leadership. And U.S. sales of Synthroid were approximately $135 million in the quarter. Full year sales were approximately $520 million, and that was up more than 15%. For 2012, we expect U.S. Synthroid sales of more than $500 million. Moving on to AndroGel, where U.S. sales in the fourth quarter were approximately $260 million, up nearly 20%. Full year 2011 sales were approximately $875 million, an increase of nearly 35%. AndroGel holds the #1 share position in the testosterone replacement market, where growth is being driven by increasing diagnostics and treatment of low testosterone. Our new low-volume formulation is the fastest growing therapy in the market and has quickly gained market share. So for 2012, we expect continued double-digit growth for AndroGel. Moving on to our more mature lipid franchise, where sales of Niospan were $258 million in the quarter, down 10%, with prescription growth slowing following the discontinuation of the AIM-HIGH trial in May as we previously discussed. Global TRILIPIX/TriCor reported sales in the quarter were down approximately 4%, reflecting ongoing impact from the ACCORD study and continued softness in the overall cholesterol market. In terms of our 2012 outlook for our Proprietary Pharmaceuticals business, we contemplated the current dynamics of the total cholesterol market, prescription trends for our range of lipid products, including TriCor, TRILIPIX and Niaspan and the entry of generic TriCor in the second half of the year. As a result, we expect low single-digit reported sales growth for the global Proprietary Pharmaceuticals business, including roughly flat performance in the U.S. and low single-digit reported growth in the international business. On an operational or performance basis, excluding the impact on the foreign exchange, we expect international Proprietary Pharmaceutical sales growth of mid to high single digits. Moving onto our Established Pharmaceuticals division, or EPD, which includes international sales of our branded generics portfolio. Fourth quarter reported global sales were nearly $1.4 billion. Excluding the impact of timing related to a significant tender for vaccine sales that occurred in the third quarter of 2011 rather than the fourth quarter, sales in our Established Pharmaceuticals business increased approximately 3% in the fourth quarter. In 2011, we received approximately 250 product approvals across numerous countries. And over the next several years, we expect more than 1,000 product launches in EPD, including registrations across multiple geographies to help drive continued durable performance in this business. So for 2012, we expect mid single-digit operational sales growth in our Established Pharmaceuticals division, including continued double-digit growth in key emerging markets with strong bottom line growth. However, since this business consists entirely of international sales, we expect reported sales growth to be roughly flat, including a mid single-digit negative sales impact from foreign exchange. Turning to our worldwide Nutritionals business, where global reported sales increased approximately 8.5% in the fourth quarter, driven by mi -single-digit sales growth in the U.S. and double-digit growth internationally. Full year 2011 global sales were more than $6 billion in this division, an increase of more than 8%. Over the course of the past year, we've advanced several strategic objectives in our Nutritionals business. In the United States, Abbott Nutrition continues to maintain its strong market position in both infant formula, as well as adult nutritionals. In addition to regaining significant U.S. infant formula market share in 2011, as Miles mentioned, we drove double-digit growth in Pediasure, our toddler brand, and Ensure, our top-selling adult nutritional product. Internationally in our Nutritional business, we successfully completed approximately 50 new product launches in key countries around the world. And also as Miles mention, we continued to deliver strong double-digit growth for our Nutrition business in emerging markets, as well as drive meaningful operating margin expansion. As we look ahead to the full year 2012 in our global Nutritionals business, we're forecasting high single-digit reported sales growth including mid single-digit growth in our U.S. business and low double-digit reported growth for our international business, which includes an estimated negative impact from foreign exchange of approximately 1%. In our global Diabetes Care business, worldwide reported sales increased 4% in the quarter. U.S. sales were up more than 7% as we continue to grow our retail prescription share through expanded consumer outreach and patient education. In 2011, we launched our new FreeStyle InsuLinx blood glucose monitor in Canada, as well as several European countries and expect to launch it in additional markets this year. In addition, in 2011, we significantly improved the profitability of our diabetes business, increasing operating margin by more than 300 basis points as a result of favorable product mix and operating cost reductions. And we expect continued margin improvement throughout 2012. So as we look ahead to 2012 in our global diabetes business, we expect flat to low single-digit reported revenue growth, including an estimated impact from foreign exchange of approximately 2.5%. In our Core Laboratory Diagnostics business, which includes immunoassay, blood screening and hematology, global reported sales in the quarter increased nearly 6% with U.S. sales up 10%, driven by continued strong growth of our ARCHITECT and PRISM systems. Full year sales were nearly $3.4 billion, and we continue to deliver strong margin improvement. In our Point of Care business, reported global sales in the fourth quarter increased nearly 8%. Full year global sales were up more than 10% in 2011, driven by strong growth of our bedside cardiac tests and continued expansion in emerging markets such as China. And in Molecular Diagnostics, reported global sales increased more than 10% in the fourth quarter, driven by double-digit sales growth in both the U.S. and international markets. Full year global sales were up nearly 15% in 2011, including more than 20% reported international sales growth. We've seen strong uptake of our ALK companion diagnostic to a new non-small cell lung cancer medicine. And we continue to place new systems and expand the menu of tests offered on the PLEX-ID System. So as we look ahead for the full year 2012, we expect our worldwide Diagnostics business, and that includes our Core Laboratory, Point of Care and Molecular businesses to generate mid single-digit reported sales growth, including an estimated negative impact of foreign exchange of approximately 2.5%. Moving onto our Vision Care business, where worldwide reported sales in the fourth quarter increased approximately 2% and more than 4% for the full year 2011. Internationally, we've seen good uptake of our new TECNIS Toric IOL in Europe and strong double-digit growth in emerging markets such as China and India. For 2012, we expect low to mid single-digit reported sales growth in our Vision Care business, including an estimated negative impact from foreign exchange of approximately 2%. And finally, in our Vascular business, worldwide sales in the fourth quarter were $826 million. Sales were roughly flat on a reported basis. However, excluding noncommercial revenues, sales increased mid single digits for the fourth quarter. As a reminder, the third-party distributor of PROMUS is now transitioning away from this product as we approach the end of our distribution agreement with them this year. International Vascular sales, which now comprise more than half of our total Vascular business, increased 7% in the quarter. In emerging markets, which comprised nearly 20% of this business, increased more than 14% in the quarter. In our coronary stent business, the U.S. launches last year of XIENCE nano in May, followed by XIENCE PRIME in November, contributed to DES franchise revenues of approximately $480 million in the fourth quarter. XIENCE sales increased nearly 10% globally, offset by a double-digit decline in PROMUS revenues as expected. With the recent U.S. launches of nano and PRIME and continued strong performance in Japan, China and other key international markets, XIENCE has solidified its position as the #1 drug-eluting stent family globally. XIENCE PRIME is the only everolimus drug-eluting stent available in long lengths in the U.S., which is helping us to continue to gain share at a higher price point. Our endovascular, other coronary and structural heart businesses comprised 40% of Vascular sales, and they increased mid single digits in the fourth quarter, led by continued strong growth of MitraClip, which posted sales in the fourth quarter of more than $25 million. Also, it was driven by growth in coronary balloons, with the launch of TREK, as well as growth in endovascular, driven by our new Armada line of peripheral balloons, and our renal stent, Herculink Elite. So as we look ahead to 2012 for Abbott Vascular, we expect roughly flat global reported sales growth, including our assumptions for PROMUS and nearly 2% of negative foreign exchange, offset by continued strong performance from our underlying business. The PROMUS transition will be nearly completed by the end of 2012, positioning 2013 for a stronger reported growth rate. And now turning to our pipeline. Since Miles spent time this morning discussing a number of compounds and technologies in our portfolio, let me spend a few moments outlining some of the milestones we expect that will occur this year in 2012. We've taken significant strategic actions to strengthen and advance our pipeline, and we expect a good deal of activity throughout this year, including new regulatory filings and product approvals, clinical trial advancement and data presentations. Starting with Diagnostics. We expect regulatory filings and approvals for a number of new assays for our ARCHITECT platform. We also expect the worldwide launch of a Web-based informatics platform called OneLab, designed to connect all of the labs’ information into one easy-to-use system. OneLab was released in Europe and Australia this month and is expected to launch in the U.S. and Canada later this year. In Molecular Diagnostics, we expect CE Mark for a number of infectious disease tests for our m2000 system. In addition, we'll launch our ALK companion diagnostic in more than 50 additional countries, following U.S. approval last year. In our Nutrition business, we expect nearly 70 innovations globally in our adult and pediatric business lines in 2012. In our Vascular business, the productivity of our pipeline is resulting in multiple new coronary and endovascular product launches across every major geography this year. Some of these include: our continued rollout of XIENCE PRIME, including geographic expansion into Japan and China in the first half of 2012; the launch of XIENCE XPEDITION in Europe, which offers a new catheter for enhanced deliverability, as well as a broader-size matrix; 2 stents for iliac indications in the U.S., Absolute Pro and Omnilink Elite; and a full commercial launch by the end of this year in Europe and a number of other countries around the world of ABSORB, our bioresorbable vascular scaffold. We're finalizing the ABSORB U.S. trial design and expect to begin enrollment in the first half of this year, with our Japan registration trial beginning in the second half of this year. We also continue our ongoing dialogue with the FDA on the U.S. review of MitraClip. In AMO, we expect European launches for a number of products, and we plan to submit our U.S. PMA for the TECNIS Toric intraocular lens. And then finally, in Propriety Pharmaceuticals, 2012 promises to be a pretty significant year for our HCV program, with results from our initial interferon-free trials presented at a spring conference and preliminary data from several Phase IIb studies in the fall. We have a high level of confidence that our HCV compounds in development can dramatically change the treatment landscape. We plan to present additional data analysis from our Phase IIb study of bardoxolone this year as well for the treatment of chronic kidney disease. The Phase III program is enrolling very well, and we continue to expect results from that trial later next year. Also in development for CKD is atrasentan. We expect to complete our ongoing Phase IIb study in diabetic patients this year and plan to initiate the Phase III program next year in 2013. We expect to present Phase II data from ABT-126, our NNR in development for Alzheimer's and other conditions this year as well, likely at a medical meeting this summer. We're working with regulatory authorities to finalize the Phase III study on elagolix for endometriosis and expect to initiate the global trial in the coming months. We plan to present Phase III pivotal data for Duodopa, an intestinal gel for advanced Parkinson's disease at an upcoming medical meeting. We expect to submit our U.S. regulatory application for Duodopa later this year as well. And finally, certainly the most important milestone for 2012 will be the separation into 2 companies. As Miles mentioned, we expect significant activity leading up to the separation as we disclose additional detail and meet with existing and potential new investors throughout the coming year. So in summary, in 2011, Abbott demonstrated strength through its sales and earnings growth and reported financial results generating total shareholder return, as Miles mentioned, of approximately 22%. We delivered gross margin expansion and significant profitability improvements in many of our major business segments, as well as another record year of cash flow and dividends. As we move into 2012, we look forward to delivering another year of strong growth as we prepare to separate into 2 leading healthcare companies with unique investment identities. With that now, Hélène, we will take questions from the analysts.