Gary Ellis
Analyst · JP Morgan
Thanks, Omar. Second quarter revenue of $4.366 billion increased 4% as reported, or 5% on a constant currency basis after adjusting for a $38 million unfavorable impact from foreign currency. Q2 revenue results on a geographic basis were as follows. Growth in the emerging markets was 12%, and represented 13% of our overall sales. The U.S. grew 5% and represented 56% of our overall sales, and growth in non-U.S. developed markets was 2% and represented 31% of our overall sales. Q2 diluted earnings per share on a non-GAAP basis were $0.96, an increase of 5%. Q2 GAAP diluted earnings per share were $0.83, a decrease of 7%. This quarter’s GAAP to non-GAAP adjustments on an after-tax basis included a $64 million multi-year donation to the Medtronic Foundation and a $60 million charge for acquisition-related items, primarily associated with transaction costs in connection with the pending Covidien acquisition. It is worth noting that on a cash basis, Q2 diluted earnings per share were $1.02, an increase of 5%. In our Cardiac and Vascular Group, revenue of $2.286 billion grew 5%. Results were driven by growth in Low Power, Structural Heart and AF & Other, partially offset by declines in Coronary and High Power. In Cardiac Rhythm & Heart Failure, revenue of $1.320 billion grew 5% and included $18 million of combined revenue from our acquisitions of NGC Medical, Corventis and TYRX. High Power revenue of $670 million declined 5% after difficult prior year comparison but sequentially grew 7%, as reported on the strength of the U.S. mid-quarter launch of our Attain Performa quadripolar CRT-D system. Our daily CRT-D implant volumes were flat prior to the launch but jumped to mid-teens growth post launch. In fact despite having Attain Performa available for only part of the quarter, our Q2 in total represented our highest level of average daily CRT-D implants in over three and a half years. As we have noted over the last several quarters, we believe the best way to view the High and Lower Power markets is on a rolling two quarter basis, given the variability in quarter-to-quarter dynamics. We estimate that global High Power market growth is flat to slightly down with low single-digit growth in international markets, offsetting low single digits declines in the United States. Last week, we announced the launch of our Revo MRI SureScan ICDs in Japan. We expect Revo MRI, which allows for full body MRI access to be well received by the Japanese market, given their preference for MRI technology. Low Power revenue of $524 million grew 11%, driven by the strong global launch of Reveal LINQ. In June, data from the CRYSTAL AF trial were published in the New England Journal, showing that in patients with recent cryptogenic strokes, our Reveal monitor detected AF better when compared to standard care. We continued to make progress on our global clinical trial for Micra and expect CE Mark by the end of this fiscal year, with U.S. approval in FY ’17. AF solutions grew over 30%, as we continue to take share and grow the AF market. Results were driven by robust growth of the Arctic Front Advance CryoAblation system which grew over 30%, as well as strong double-digit growth from the international launch of our PVAC Gold phased RF system. We continue to make progress in bringing our phased RF technologies to the U.S. market, as we are enrolling our VICTORY AF pivotal study for patients with persistent AF. In our Coronary & Structural Heart business, revenue of $743 million grew 6%. Coronary declined 2% percent, although our drug-eluting stent share remains stable in the United States and was up slightly in international markets. The business executed on a strong global launch of our NC Euphora Balloon, which gained market share in an area where share is usually very sticky. Our agreement with ACIST, where we co-promote their FFR technology in the United States also continues to go very well. We also just received CE Mark for our Resolute Onyx DES and are preparing to broadly launch in Q3. Resolute Onyx builds on a superior deliverability, improving clinical performance of Resolute Integrity, with thinner struts to improve deliverability even further and is the first stent to feature our core wire technology, which markedly enhances visibility. Structural Heart grew 19%, on a continued strength of our U.S. CoreValve launch. Our global transcatheter valve revenue in the quarter was $131 million, representing growth of over 60%. We estimate that the global transcatheter valve market is now annualizing at over $1.5 billion. Our team is aggressively adding new centers, with a presence now in over 200 U.S. centers. We are executing to the launch as plan, with focus on training and strong procedural results. Our share was stable and our experience accounts. In international, the launch of CoreValve Evolut R 23 millimeter valve is well underway with very strong customer reception to the platform. We are expecting to broaden this platform with the approval of our 26 and 29 millimeter valves in early calendar year ’15. Evolut R is our next-generation recapturable system, with a differentiated 14 French equivalent delivery system. In addition, our U.S. IDE study for Evolut R, our 250 patient single-arm study with 30-day follow-up is now enrolling. In our Aortic & Peripheral Vascular business, revenue of $223 million grew 3%, or 5% after adjusting for the divestiture of our Pioneer Plus product line and the voluntary product recall of the below-the-knee DCB. This is the last quarter we faced the negative effect of these two discontinued product lines, which should lead to improved reported growth in this business going forward. Aortic revenue grew 3%, driven by double-digit growth in thoracic with Valiant Captivia stent grafts achieving strong share gains. In AAA, we received CE Mark and FDA approval for our Endurant IIs in the last week of Q2. Endurant IIs, a unique three-piece version of our market leading Endurant platform, will launch in Q3. Revenues for our Peripheral business grew 4% in Q2. However, after adjusting for the discontinued product lines just mentioned, our Peripheral business grew in the mid-teens, with strong double-digit growth in SFA DCB products. Looking ahead, in the first calendar quarter of 2015, we are expecting U.S. approval for our IN.PACT Admiral drug-coated balloon as well as the major medical journal publication of IN.PACT SFA one year results. We expect our IN.PACT Admiral DCB to drive growth in Peripheral in the coming quarters. Now turning to our Restorative Therapies Group, revenue of $1.650 billion grew 4%. Results were driven by growth in Surgical Technologies, Neuromodulation and BMP. Spine revenue of $746 million grew 1%. Core Spine growth was flat year-over-year, a modest improvement from last quarter. We are encouraged that both the global and U.S. Core Spine markets continue to stabilize and are beginning to show bias towards low-single-digit growth. Our Core Spine business is launched in a number of new products this fiscal year, which are expected to return our overall spine business to modest growth in FY '15. In addition to working with surgeons develop the leading technology in spine, our business continues to focus on procedural innovation and our surgical synergy program, which integrates enabling technologies, surgical tools, spinal implants and our expertise. Interventional Spine, which primarily consists of our balloon kyphoplasty product line, declined 5%. While we saw good underlying procedural volumes, we were affected by a product supply issue related to our Cement Delivery System. BMP sales of a $120 million grew 9%, with stable underlying demand. Whiles sales of BMP bounced round a bit, we do believe we have turned the corner and would expect BMP sales growth to be slightly positive going forward. Turning to Surgical Technologies, revenue of $410 million grew 10% and included $3 million of revenue from our acquisition in the quarter of Visualase. Surgical Technologies had balanced growth across Neurosurgery, ENT and Advanced Energy. Neurosurgery grew in the upper-single digits, driven by growth in Midas Rex power equipment, capital equipment service revenue, as well as revenue from Visualase. ENT also grew in the upper-single digits, driven by solid results in ENT power systems due to the recent launch of the M5 Microdebrider and monitoring disposables. The recent launch of our NuVent sinus balloon also drove growth in ENT. In Advanced Energy, strong adoption of our proprietary Aquamantys tissue sealing and PEAK PlasmaBlade technologies drove solid double-digit growth. In Neuromodulation, revenue of $494 million increased 4%, led by upper-single digit growth in Gastro/Uro and DBS businesses. Gastro/Uro results were driven in part by the success of our Care Pathway program, resulting in solid new InterStim implant growth in the United States. We also received the FDA approval and launched the Verify Evaluation System, which is used to provide advanced filing of our InterStim system. In DBS, our global focus on neurologist referral programs and the strength of the early stim data in international markets, which shows DBS provides superior benefits for patients with early motor complications from Parkinson's disease, continues to drive solid new growth. Our DBS business also acquired Sapiens in Q2, a developer of advanced DBS lead technology that features 40 individually programmable stimulation points that can more easily -- can more precisely stimulate the intended target in the brain. We expect to finalize development and initiate clinical studies to bring this technology to market. In Pain Stim, recent reimbursement changes have softened the U.S. market. However, we gained modest share globally on the strength of our SureScan MRI spinal cord stimulation system, with its proprietary adaptive stim automatic stimulation adjustment. In our Diabetes Group, revenue of $430 million grew 10%, driven by the ongoing U.S. launch of the MiniMed 530G system, which includes the Enlite CGM sensor, a smaller, more comfortable, and more accurate sensor. Globally insulin pumps grew in the mid-single digits and CGM grew over 40%. Looking ahead, we are planning a limited launch of our next-generation MiniMed 640G system, with predictive low glucose management in international markets in Q3, followed by a broader Q4 launch. Likewise, our MiniMed 620G, the first integrated system optimized for the Japanese market has begun its limited rollout and will also broadly launch in Q4. In addition, we are making good progress on our sensor pipeline as we advance towards a close loop system. Last month we announced the first enrollment in our U.S. pivotal study of our predictive low glucose management technology, which includes the study of our new insulin pump design in fourth-generation CGM sensor. This sensor has new intelligent diagnostics that are expected to result in enhanced accuracy and is 80% smaller than the Enlite sensor currently sold in the United States. Looking ahead, it is worth noting that in Q3 diabetes will play to difficult comparison due to the $23 million in deferred revenue that was recognized in Q3 last year. Turning to rest of the income statement, please note that all of my forward-looking outlook and guidance comments do not contemplate the effect from the expected closings and related financing of the Covidien transaction. The Q2 gross margin was 73.8%. This was below our expectations due to several factors, including a product mix shift in CVG, the outperformance in BMP sales and our acquisition of NGC Medical. As we have noted in the past, BMP is one of our lowest gross margin products due to the profit sharing arrangement with Pfizer. NGC Medical, which we acquired in the quarter, also have a gross margin that is significantly below our corporate average. However, both BMP and NGC have operating margins that are similar to the corporate average due to lower spend in SG&A and R&D. The gross margin also continues to include significant spending related to resources to address quality issues in neuromodulation and diabetes, which negatively affected the Q2 gross margin by approximately 40 basis points. Looking ahead, we would expect our gross margin to improve sequentially on an operational basis, driven in part by positive manufacturing variances that have already occurred flowing through in the back half of the fiscal year as well as continuing execution on our cost of goods sold reduction program, resulting in gross margins around 74.5% on an operational basis in the second half of FY '15. However, based on current exchange rates, we would expect to have a negative 50 to 60 basis foreign exchange impact in Q3 and Q4, which would result in reported gross margins that are similar to our Q2 reported gross margin. Second quarter R&D spending of $374 million was 8.6% of revenue. We continue to invest in new technologies as well as to generate clinical and economic evidence to drive future growth. We expect R&D expense in FY '15 to around 8.5%. Second quarter SG&A expenditures of $1.507 billion represented 34.5% of sales, both on as reported and operational basis and in line with outlook we provided. We continue to expect FY '15 SG&A to be in the range of 33.7% to 33.9%, implying leverage of 50 to 70 basis points on an operational basis. Amortization expense for the quarter was $89 million. In FY ‘15 we continued to expect amortization expense to remain around $90 million per quarter. Net other expense for the quarter was $63 million. This result was favorable to our prior expectations due in large part to changes in FX, which resulted in $12 million gain in Q2 from our FX hedging program. We continue to hedge the majority of our operating results in developed market currencies to reduce volatility in our earnings from foreign exchange. However, it’s worth noting that there is a growing portion of our profits that is unhedged, especially emerging market currencies, which can create some volatility in our earnings. Based on current exchange rates, we expect FY ‘15 net other expense to be in the range of $180 million to $210 million, which includes an expected $120 million impact from the U.S. Medical Device Tax, as well as increased royalty expense from the Edwards agreement. In Q3, we expect net other expense to be in the range of $30 million to $40 million based on current exchange rates. Net interest expense for the quarter was $8 million. At the end of Q2, we had approximately $14.5 billion in cash and investments and $13.7 billion in debt. Based on current rates, we would expect Q3, net interest expense to be in the range of $5 million to $10 million. This forecast does not include any potential impact from the planned financing of the Covidien acquisition, which we would expect to exclude in our Q3 non-GAAP net interest expense. Our non-GAAP nominal tax rate in Q2 was 19.5%. For FY ‘15, we expect an adjusted non-GAAP nominal tax rate to be in the range of 18% to 20% and we expect to be at the higher end of this range until the presently expired U.S. R&D tax credit is reinstated. In Q2, we generated $951 million in free cash flow after adjusting for the Medtronic foundation, donation and certain litigation payments. We remain committed to returning 50% of our free cash flow, excluding one-time items to shareholders. In Q2, we paid $298 million in dividends and repurchased $555 million of our common stock. As of the end of Q2, we had remaining authorization to repurchase approximately 34 million shares. Second quarter average shares outstanding on a diluted basis were 993 million shares. It is important to note that we expect that the cash we received from stock option redemptions, which was $158 million in Q2 will also continue to be used to repurchase shares on the open market to partially offset the dilutive impact. These share repurchases are incremental to our commitment to return 50% of our free cash flow to shareholders. For FY ‘15, we would expect diluted weighted average shares outstanding to be approximately 998 million shares, including approximately 995 million shares in Q3. Let me conclude by providing our fiscal year 2015 revenue outlook and earnings per share guidance. We are tightening our constant currency revenue growth outlook to 4% to 5% for FY ‘15. And based upon our current forecast for the back half of the fiscal year, we would not be surprised to be at the upper end of this range. 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 ‘15 revenue would be negatively affected by approximately $280 million to $320 million, including a negative $130 million to $150 million impact in Q3. Turning to guidance on the bottomline, we continue to expect FY ‘15 non-GAAP diluted earnings per share in the range of $4 to $4.10. Based on current exchange rates, this implies earnings per share growth in the range of 7% to 10% on a constant currency basis after taking into account the currently expected $0.08 to $0.09 of negative foreign currency impact to earnings. While we don’t provide quarterly guidance, we would point out that Q3 typically had modestly lower revenue and similar earnings per share to Q2. Given this and the fact that the U.S. R&D tax credit has not yet been reinstated, we would not be surprised to see some model shift to few pennies of earnings per share for the Q3 to Q4. As in the past, my comments and guidance do not include any unusual charges or gains that might occur during the fiscal year. In addition, as I’ve mentioned earlier, our outlook and guidance do not contemplate the impact of the expected Covidien transaction. Before turning the call back to Omar, I would like to remind you that we will have an extra selling week in FY ’16, which will occur in the first quarter. This means that Q1 will have a total of 14 weeks, an anomaly due to the way our fiscal years are structured with this catch-up week occurring every six years. Omar?