Gary Ellis
Analyst · Matthew Dodds
Thanks, Omar. First quarter revenue of $4,049,000,000 increased 7.3% as reported or 2.4% on a constant-currency basis after adjusting for a $186 million of favorable effect of foreign currency. Breaking this out geographically, revenue in the U.S. of $2,206,000,000 declined 1%, while international sales of $1,843,000,000 increased 19% as reported or 7% on a constant-currency basis. Q1 international revenue results by region were as follows: Latin America grew 30%; growth in greater China was 28%, Middle East and Africa grew 17%; growth in Other Asia was 8%; Canada grew 4%; growth in Japan was 2%; and Europe and Central Asia growth slowed to 3%, which includes revenue deferral of $7 million in Greece due to the current economic environment and payment uncertainty. Q1 GAAP earnings and diluted earnings per share were $821 million and $0.77, a decrease of 1% and an increase of 1%, respectively. After adjusting for acquisition-related items, as well as the noncash charge for convertible debt interest expense, first quarter earnings and diluted earnings per share on a non-GAAP basis were $845 million and $0.79, a decrease of 3% and 1%, respectively. It is worth noting that after adjusting for the onetime tax benefit we received in Q1 last year as well as the RDN dilution, our non-GAAP diluted earnings per share increased 3%. In our Cardiac and Vascular Group, revenue of $2,206,000,000 grew 3%. Results were driven by double-digit growth in Structural Heart, Endovascular, AF Solutions and Physio-Control, as well as growth in coronary and pacing, offset by declines in ICDs. CRDM revenue of $1,253,000,000 declined 3%. Worldwide ICD revenue of $697 million declined 8%, and we estimate that the worldwide ICD market declined in the mid-single digits. Our U.S. ICD business declined 12%, and we estimate that the market declined in the high-single digits. As Omar noted, the U.S. ICD market continues to feel the impact of a number of factors that are affecting procedural volumes and pricing. Despite the market slowdown, we are pleased with the impact our recently approved Protecta high power devices are having on share and pricing. We estimate our U.S. high-power share was up over 100 basis points sequentially. Protecta's SmartShock Technology is commanding mid-single digit price increases, which is helping to improve the mid-single digit pricing declines we have seen in U.S. ICDs. With Protecta's launch still ramping, our U.S. high-power pricing was relatively stable sequentially. Our international ICD business declined 1% while the market was flat. In Europe, we continued to gain share on the strength of Protecta, as well as our value-segment products, Cardia and Egida. In Japan, we lost some share in Q1, but are confident that our DF-4 connector devices, which are expected to launch in Q2 should help to reverse this trend. Pacing revenue of $508 million grew 1% as the market continued to decline in the low-single digits. U.S. pacing grew 1%, and we gained 250 basis points of shares sequentially, driven by the Revo MRI SureScan pacemaker. In addition, Revo's solid double-digit percentage price uplift has offset the pricing pressure we experienced in pacing over the past several years. Our international pacing business grew 1% while we estimate the international pacing market was flat. Our AF Solutions business grew in excess of 40%, driven by the ongoing successful launch in the U.S. and the continued adoption in Europe of our Arctic Front cryoballoon. We are taking share in this important market and continue to expect this business to grow 30% to 40%. Our CardioVascular businesses posted another strong quarter with revenue of $850 million growing 11%, with 10% growth in the U.S. and 11% growth in the international markets. Coronary revenue of $389 million grew 6%, including $6 million of revenue from Ardian. It is worth noting that our Peripheral business is now part of Endovascular. Worldwide drug-eluting stent revenue in the quarter was $193 million, including $43 million in the U.S. This quarter, we received approval for Resolute Integrity DES in Australia, and we continue to expect a late FY '12 approval of Resolute in the U.S., which we believe will be a meaningful driver of revenue growth. To put some perspective on this U.S. opportunity, in Europe, where we have more competitors than the U.S., our DES share is merely double our share in the U.S. In fact, in markets where we have regulatory approval for our Resolute Integrity drug-eluting stent and Integrity bare-metal stent, Medtronic holds the market leading coronary stent share position. Turning to Ardian, this multi-billion dollar opportunity in hypertension is progressing well. On the commercial front, customer excitement around Ardian is building as we expand into new centers in Europe and Latin America. In July, we received U.S. IDE approval for our SYMPLICITY HTN-3 pivotal study. We are in the final stages of selecting our 60 sites, and we expect the first procedure to occur shortly. We believe Ardian represents one of the most significant product advances in medtech, and we intend to maximize its potential. Structural Heart revenue of $275 million increased 15%, which included $20 million of revenue from ACS. Our CoreValve transcatheter valve business continues to drive growth with a TCV market now annualizing at over $625 million and growing over 50%. We continue to split the market with our competitor and are seeing strong, early adoption of our 31-millimeter CoreValve, which receives CE Mark approval in July. We continued to expect CE Mark approval for our 23-millimeter CoreValve on the 16 French delivery system in the second half of FY '12. In the U.S., we are pleased with the progress of our CoreValve pivotal trial. Enrollment is well underway, and all 40 sites are active. In surgical valves, we grew 20% on the strength of ATS. ATS revenue grew 6% sequentially, including double-digit growth in mechanical valves. Turning to our Endovascular and Peripheral. Revenue of $186 million grew 16%. In the U.S., revenue growth of 27% was driven by the continued success of the Endurant Abdominal Stent Graft. In peripheral, we continue to see strong market acceptance for our drug-eluting balloon in international markets, which had outstanding double-digit growth. Physio-Control revenue of $103 million increased 17%. This business had strong growth in the pre-hospital segment as the LIFEPAK 15 and LUCAS chest compression system continue to take share. This business also gained share in the AED market on the strength of our LIFEPAK CR Plus and LIFEPAK EXPRESS. We continue with our efforts to divest Physio-Control. Now turning to our Restorative Therapies Group. Revenue of $1,843,000,000 grew 2%. Growth was driven by another quarter of solid performance in Diabetes and Surgical Technologies, as well as growth in Neuromodulation, offset by challenges in Spinal. Spinal revenue of $825 million declined 3%. This quarter, global spine market growth of approximately 1%, and U.S. market decline of at 1% were both modestly slower than last quarter. Although the market continues to be challenged, our Spinal business grew 7% in international markets on the strength of new products. In Core Spinal, which includes Core Metal Constructs, IPDs and BKP products, revenue of $610 million declined 5%, as this business continues to feel the impact of its exposure to VCF and IPD markets. Core Metal Construct products declined 3%. Although new product lines, including Solera, VERTEX SELECT and ATLANTIS VISION ELITE cervical plates, are generating growth with their ongoing launches. They are still ramping up and account for only a small percentage of our U.S. core spinal revenue mix today. In Kyphon, revenue declined 13%. We launched the Xpander II balloon late in the quarter and looking ahead, believe that new products, the Japan expansion and the increasing awareness of our growing body of positive clinical evidence will stabilize Kyphon. Biologics revenue of $215 million grew 2%, driven by Osteotech, which added $23 million in revenue. Sales of INFUSE declined 8% for the quarter, but declined in the upper teens in the period following the publication of The Spine Journal articles in late June. Turning to Neuromodulation. Revenue of $397 million increased 4%. Results were driven by double-digit growth in InterStim, as the sales force additions and market development investments made in the second half of the last fiscal year are starting to pay off. In pain, the RestoreSensor spinal cord stimulator with our proprietary AdaptiveStim technology continues to perform well in Europe, and we expect to launch this breakthrough technology in the U.S. later this fiscal year. In DBS, we had solid growth in the U.S. and continue to see very little impact from competition in international markets. In Uro/Gastro, we are focusing on training U.S. colorectal surgeons on the U.S. of InterStim Therapy for bowel control as we ramp this launch. Diabetes revenue of $355 million grew 9%, driven by strong double-digit growth in CGM. Our CGM business continues to hold the vast majority of market share, driven by sales of our soft sensor in the U.S. and our recently launched Enlite Sensor in international markets. Enlite is one of the most important advances in CGM technology in many years as it is more comfortable, accurate and easier to use than previous sensors. We continue to invest heavily in a broad range of diabetes technologies, including those leading to a closed-loop system. For example, we are working toward IDE approval of our U.S. study for our Veo insulin pump with its low glucose suspend technology. Surgical Technologies revenue of $266 million grew 9%, with strong performance in international markets and balanced growth across our core platforms in the EMT, spine and cranial markets. We were pleased to announce our intent to acquire Salient Surgical and PEAK Surgical in July. These strategic acquisitions are expected to leverage our existing strength in Surgical Technologies, as well as access substantial adjacent therapy opportunities. Integration planning is underway and on schedule and we expect to close these acquisitions in Q2. Now turning to the rest of the income statement. The gross margin was 75.2%. The gross margin was negatively affected this quarter by 30 basis points from 3 nonrecurring items, including a scrap charge related to our manufacturing issue at our facility producing Resolute Integrity. It is worth noting that while we have resolved the Resolute Integrity production issue, we are still ramping up inventory to supply the resulting back order in the European market. We continue to believe our gross margin for the remainder of the fiscal year should be in the range of 75% to 75.5% on an operational basis, as we continue to offset pricing pressure through our $1 billion cost of goods sold reduction program. First quarter R&D spending of $371 million was 9.2% of revenue. We remain committed to invest in new technologies to drive future growth and continue to expect R&D spending in the range of 9% to 9.5%. First quarter SG&A expenditures of $1,408,000,000 represented 34.8% of sales, a 60 basis point improvement from the first quarter last year. We continue to focus on several initiatives to leverage our expenses while at the same time investing in new product launches and adding to our sales force in faster growing businesses and geographies. In FY '12, we expect SG&A spending to be in the range of 33.5% to 34%. In an effort to improve disclosure to investors, we are breaking out the noncash amortization expense as a separate line item from net other expense on our income statement this quarter and going forward. Amortization expense for the quarter was $88 million compared to $82 million in the first quarter of last year. For FY '12, we would expect amortization expense in the range of $80 million to $85 million per quarter. Net other expense for the quarter was $109 million compared to $35 million in income in the prior year. The year-over-year increase in expense is primarily a result of the losses from our hedging programs, which were $64 million during the quarter compared to $54 million in gains in the comparable period last year. As you know, we hedged much of our operating results to reduce volatility in our earnings. However, the FX impact was more negative than we had expected since the currencies we do not hedge were very volatile, especially the strengthening Swiss franc. We estimate that this reduced our results by about $0.01 from what we had originally expected. Net other expense this quarter also includes $29 million in expense from the Puerto Rico excise tax, which is almost entirely offset by a corresponding tax benefit I will discuss in a moment. Looking ahead, based on current FX rates, we anticipate Q2 net other expense will be in the range of $125 million to $145 million, including hedging losses in the range of $70 million to $80 million. For FY '12, we expect net other expense will be in the range of $460 million to $520 million, which includes hedging losses in the range of $250 million to $300 million based on current exchange rates. Net interest expense for the quarter was $32 million compared to $74 million in the prior year period. Excluding the $21 million noncash charge for convertible debt interest expense, non-GAAP net interest expense was $11 million. At the end of Q1, we had approximately $9.2 billion of cash and cash investments and $10 billion of debt. Let's now turn to our tax rate. Our effective tax rate in the first quarter was 19.7%. Excluding the impact of onetime charges, our adjusted non-GAAP nominal tax rate in Q1 was 20%. Included in this rate is the $24 million tax benefit associated with the U.S. foreign tax credit from the Puerto Rico excise tax, which -- was mostly offsets the charge recorded in other expense. For FY '12, we expect an adjusted non-GAAP nominal tax rate in the range of 19% to 19.5%, which includes the tax credit associated with the Puerto Rico excise tax and assumes the R&D tax credit will be extended beyond December 31. In Q1, we generated $1 billion of free cash flow, defined as operating free cash flow minus capital expenditures. We expect to generate $4 billion in free cash flow on FY '12 and remain committed to returning 40% to 50% of our free cash flow to shareholders. During Q1, we repurchased $400 million of our common stock. In June, our Board of Directors increased our share repurchase plan authorization by an additional 75 million shares. As of the end of Q1, we had a remaining authorization to repurchase approximately 86 million shares. First quarter weighted average shares outstanding on a diluted basis were 1,070,000,000 shares. In June, our Board of Directors also increased our cash dividend for FY '12 by 8%, which now equates to an annual dividend of $0.97 per share. As of yesterday's close, our dividend yield was over 3%. Our dividend has more than doubled over the past 5 years, and this is our 34th consecutive year of increased dividend payments. Let me conclude by commenting on our fiscal year 2012 revenue outlook and earnings per share guidance. We believe that constant currency revenue growth of 1% to 3% continues to be reasonable for FY '12. While we cannot predict the impact of currency movements, to give you a sense of the FX impact if exchange rates were to remain similar to yesterday for the remainder of the fiscal year, then our FY '12 revenue would be possibly affected by approximately $500 million to $540 million, including a positive $140 million to $160 million impact in Q2. Our FY '12 revenue outlook now assumes our CRDM and Spinal businesses continue to decline in the low-single digits on a constant-currency basis. Our outlook continues to assume the rest of our businesses continue to grow in the mid to high-single digits on a constant-currency basis. Turning to guidance on the bottom line. Based on the expected constant-currency revenue growth of 1% to 3%, we believe it is reasonable to continue to expect earnings per share in the range of $3.43 to $3.50, which includes approximately $0.04 to $0.06 of dilution from the Ardian acquisition. After adjusting for the Ardian dilution and the $0.10 of onetime tax benefits we received in FY '11, our guidance implies FY '12 earnings per share growth of 6% to 9%. As in the past, my comments on guidance do not include any unusual charges or gains that might occur during the fiscal year, nor do they include the impact of a noncash charge for convertible debt interest expense. With that, Omar and I would now like to open up the phone lines for Q&A. In the interest of getting to as many questions as possible, we respectively request that each caller limit themselves to only 1 question and only 1 follow-up. Operator, first question please.