Gary Ellis
Analyst · David Lewis
Thanks Omar. Third quarter revenue of $4.318 million increased 3.7% as reported or 7.5% on a constant currency basis after adjusting for our $158 million unfavorable impact from foreign currency. On an organic basis, revenue growth was 7% after adjusting for the impact of acquisitions and divestitures. Q3 revenue results on a geographic basis were as follows; growth in the U.S. was 8% and represented 57% of our overall sales; non-U.S. developed markets grew 5% and represented 30% of our overall sales. And growth in emerging markets was 12% and represented 13% of our overall sales. Q3 diluted earnings per share on a non-GAAP basis were $1.01, an increase of 11%. Q3 GAAP diluted earnings per share were $0.98, an increase of 31%. This quarter’s GAAP to non-GAAP adjustments on an after tax basis included; a $66 million charge for acquisition related items, primarily associated with transaction cost in connection with the Covidien acquisition; a $25 million gain on the micro divestiture within our Surgical Technologies Division; a $62 million gain on the sale of our remaining equity investment in Weigao which is earmarked to fund the Medtronic foundation and a payment that occurred back in Q2 and a $49 million in interest expense related to debt issued in advance to finance the Covidien transaction. It is worth noting that on a non-GAAP cash basis, Q3 dilutive earnings per share were $1.07, an increase of 10%. In our Cardiac and Vascular group revenue of $2.224 billion, grew 10%. Results were driven by strong double-digit growth on Low Power, Structural Heart, and AF & Other, along with mid-single digit growth in High Power and Aortic & Peripheral Vascular, partially offset by a modest decline in Coronary. In the Cardiac Rhythm & Heart Failure division revenue of $1.269 billion grew 12%, High Power revenue of $650 million, grew 4%. We estimate the global High Power market is growing modestly with low single-digit growth in international market offsetting low single digit declines in the U.S. In the U.S., we estimate we have several percentage points of High Power share since launching our Attain Performa quadripolar CRTD system. Our CRTD implant volumes which were flat prior to this launch grew nearly 20% in Q3 as the U.S. market continued to show strong preference with a combination of our AdaptivCRT algorithm and next generation quadripolar technology, which includes steroid on every electrode to reduce capture thresholds, short middle electrode spacing to reduce peripheral nerve simulation and fast vector express programming. In the quarter, the FDA approved two additional versions of our quadripolar leads the Straight and S-shape giving even more options to electro physiologists. U.S. High Power growth also benefitted from accelerating adoption of the TYRX anti-envelop technology for use in high risk implant procedures. We assigned our first TYRX risks sharing agreement and have a strong pipeline of U.S. hospitals interested in partnering in this innovative business model. In January, we started enrolment in our 7,000 patient rapid trial which is assessing the clinical and economic defectiveness of TYRX. We expect results from this trial in FY18. In Japan, we launched Evera MRI SureScan ICD in the quarter. Evera MRI, which allows the full body MRI scan is garnering strong adoption of the Japanese market resulting an 13 percentage points of ICD share gain in Japan this quarter. Low Power revenue of $489 million grew 17%, driven by continued strong global launch of Reveal LINQ. We continue to see strong adoption of this innovative diagnostic with daily implant growth up in the high single-digit sequentially. Looking at the U.S. pacing market, we were pleased to see improvements in both initial implant volumes and our overall market-share driven by the continued mix shift toward Advisa MRI and growing pay sneaker pull through from the expanded use of Reveal LINQ in patients with unexplained sympathy. In Japan, we continue to see good traction of our Advisa MRI pace maker, while our share remains over 250 basis points above prelaunch levels despite competitive entrance. Looking ahead, we have completed the enrolment basis of our U.S. and CE Mark clinical trials for our micro transcatheter patient system and expect CE Mark by the end of this quarter with U.S. approval to follow in FY17. AF Solutions grew over 30%, globally driven by continued robust growth of our Arctic Front Advance CryoAblation System. Leveraging the increasing body of clinical and economic evidence on safety, efficacy and procedural efficiency of Arctic Front, we continue to take AF ablation share growing nearly twice as fast as the overall AF market, despite new competitor product introductions. Turning to our Coronary & Structural Heart division, revenue of $737 million grew 8%, our Coronary business declined 2% with our global drug-eluting stent revenue share declining slightly as we began to enter our next new product introduction cycle. The international launch of our Resolute Onyx DES occurred late in Q3 and is off to a good start. Resolute Onyx builds on a superior deliverability and proven clinical performance of Resolute integrity, with finished drugs to improve deliverability even further. It is the first stent to feature our core wire technology, which markedly enhances visibility. In our broader Coronary product portfolio, Q3 saw the continued rollout of our new NC Euphora Noncompliant PTCA Balloon family, as well as strong sequential growth in U.S. revenues from our FFR co-promotion alliance with Acist Medical Systems. In renal denervation, we remain confident in our leadership in this field. Since the results of HTN-3 we have analysed compounding factors of that trial performed, ground rating preclinical research and engaged numerous expert physicians to stakeholders. In the coming days, we plan to formerly submit the U.S. IDE to our global clinical program and we look forward to providing further details in the future. Our Structural Heart business grew 22% driven by another strong quarter in transcatheter valves which grew over 60%. Our U.S. launch of CoreValve continues to drives growth and we estimate this resulted in U.S. sequential share gains. In addition, hospital customers are reacting positively to the new TAVR DRGs which were established in October and in general resulted in improved reimbursement and hospital economics for institutions looking to establish TAVR programs. Enrolment in our CoreValve Evolut R U.S study is well underway and we continue to plan for U.S launch in mid FY16. Evolut R is our next-generation recapturable system, with a differentiated 14 French equivalent delivery system. In international markets we receive CE Mark for the Evolut R 26 and 29 millimetre valves broadening our size offerings for this innovative platform into the largest segments of the market. Looking ahead we expect the global TAVR market to grow on the 20% or 25% range over the next year. In our aortic and peripheral vascular division revenue of $218 million grew 5% aortic revenue grew 3% led by strong growth and in thoracic. In AAA the launch of the Endurant IIs a unique three piece version of our market leading Endurant platform is off to a good start. Revenue for our Peripheral business grew 16% in Q3. During the quarter we received U.S FDA approval for our IN.PACT Admiral drug-coated balloon for use in the upper lay. While this did not contribute revenue in Q3 as first commercial U.S implants occurred earlier this month. In addition 12 months results of the landmark IN.PACT Admiral DCB study were published online in the journal circulation in December showing the highest rate of primary patency and lowest rate of clinically driven TLR ever reported from a study of interventional treatments for peripheral artery disease in the upper lay. We expect our IN.PACT Admiral DCB to drive growth in peripheral in the coming quarters and we plan to broaden the launch and have our Covidien peripheral sales force start selling the product later this month. Now turning to our Restorative Therapies Group, revenue of $1.645 billion grew 5% with all three divisions contributing to growth. Results were driven by double digit growth in Surgical Technologies, mid-single growth in Neuromodulation and low single digit in Spine. Spine revenue of 740 million grew 2% both the global and U.S Spine markets grew at the low single digits, the third quarter in a row of modest sequential improvement. Our core Spine business grew 1% in Q3. We are seeing good option of our recently launched Pure Titanium Coating inter body fusion devices, the PRESTIGE LP artificial cervical disc, and our new Divergence Anterior Cervical Fusion System. We recently received have FDA approval for our divergence standalone system and [Zibo] anterior fixation system. FY15 is an important for product and launches in our core spine business and as we have noted all year we expect this to support a return to modest growth for our overall spine business in FY15. In addition to working with surgeons to develop leading differentiated technologies in spine our business continues to focus on procedural innovation. Sales and product to perform our OLF25 procedure grew nearly 30%, this innovative minimally invasive procedure utilizes an oblique trajectory to avoid nerve bundles psoas muscle providing an alternative to lateral approaches that are depended on nerve monitoring. We also continue to evolve and deploy our differentiated surgical synergy program which integrates our enabling technologies, surgical tools spinal implants and expertise to improve surgical outcomes and efficiencies, we now estimate that 16% of our thoracolumbar procedures use our proprietary PowerEase system, of power surgical instruments and over 20% use our StealthStation surgical and navigation technology. Interventional Spine, which primarily consists of our balloon kyphoplasty product line, had stable sales in Q3. The business had low single digit growth in U.S and mid-teens growth in Japan offset by declines in Europe where the business experienced pricing pressure in Germany. BMP sales of $122 million grew 9% with stable underlying demand we do believe we have turn the corner end but expect BMP sales growth to be slightly positive going forward. Turning to Surgical Technologies, revenue of $418 million grew 11% Surgical Technologies had solid balanced growth contribution from all three of its businesses Neurosurgery, ENT and Advanced Energy. Neurosurgery had double digit growth with strong sales of Midas Rex power equipment and O-arm Surgical Imaging System. ENT grew in the upper single digits driven by the recent launches of a StraightShot M5 Microdebrider in the NuVent sinus balloon. In Advance Energy strong adaption of our proprietary Aquamantys tissue sealing, and PEAK PlasmaBlade technologies drove solid mid-teens growth. In Neuromodulation revenue of $487 million increased 5% led by upper single digit growth in our Gastro to Uro and DBS businesses. Gatro or Uro had a strong quarter InterStim sales worldwide. In DBS our global focus on neurologist referral programs and the strength of the early stim data in international markets continues to drive solid growth. In Pain stim we estimate the U.S market is declining in the mid-single digits as slower travelling activity is effecting new implant growth. However we estimate we gained modest U.S market share and maintained our global share on the strength of our RestoreSensor SureScan MRI spinal cord stimulation system with its proprietary AdaptiveStim automatic stimulation adjustment feature and access to MRI scans anywhere in the body. In our diabetes group revenue of $449 million grew 6%. However, after adjusting for the $23 million in deferred revenue that was recognized in Q3 last year, the group grew 12%. Diabetes had a strong quarter in international growing 12% including growth of 36% in emerging markets. In the U.S. we continued to see strong adoption of our MiniMed 530G System with Enlite CGM sensor. We recently announced the results of a retrospective analysis from over 20,000 MiniMed 530G users in the Journal of Diabetes Technology and Therapeutics which found that the pump's Threshold Suspend feature reduced hypoglycemia by 69% with even greater benefit at night without significantly increasing hypoglycemia. We were also pleased that the U.S. FDA lifted the warning letter on our diabetes business in late December. In international, we began the limited launch in select markets of our next generation MiniMed 640G System with the Enhanced Enlite CGM sensor. In addition to incorporating a brand new insulin pump design and user interface, the MiniMed 640G System features SmartGuard technology, which automatically suspends insulin delivery when sensor glucose levels are predicted to approach a low limit and then resumes insulin delivery once levels recover. We continue to make progress in bringing this technology to the U.S. and plan to submit the PMA to the system later this calendar year. The predictive low glucose management clinical study associated with this PMA is underway which is studying our next generation insulin pump and fourth generation CGM sensor. This sensor has new intelligent diagnostics that are expected to result in enhanced accuracy and it is 80% smaller than the Enlite sensor currently sold in the U.S. Turning to the rest of the income statement, in addition to commenting on our Q3 results I will also make some forward-looking comments which are based upon the combination of both Medtronic and Covidien P&Ls and also reflect a number of reclassifications that we have made to the Covidien P&L in order to be consistent. Information on each re-classes is available on the footnote section of the combined historical Covidien Medtronic financial statement presentation on our investor Web site. The Q3 gross margin was 73.9% and included 20 basis points of negative impact from foreign currency. The gross margin continues to include significant spending related to resources diverted to address quality issues in neuromodulation. The Q3 gross margin was also negative impacted by product mix shift toward diagnostic and AF products in CRHF and the acquisition of NGC Medical. NGC Medical which was acquired in Q2 has a gross margin which is similar to our existing cath lab managing services business and is significantly below our corporate average. However, NGC and cath lab managing service have operating margins that are closer to corporate average due to the lower spending on SG&A and R&D. Looking ahead for the newly combined company after taking into account the Covidien reclassifications I mentioned earlier we would expect gross margins to be more in the 69% to 71% range on an operational basis. This outlook does not include the impact of the Covidien inventory step up arising from the purchase accounting rules. Third quarter R&D spending of $373 million was 8.6% of revenue. We are pleased that are past R&D investments are resulting in faster organic revenue growth and we continue to invest in new technologies as well generating clinical and economic evidence to drive future growth. When you combine Medtronic and Covidien we would expect R&D expense to be more in the range of 7% and 7.5%. Third quarter SG&A expenditures of $1.487 million represented 34.4% of sales. Q3 SG&A on a constant currency basis was 34.3%. Looking ahead in addition to the reclassifications this is the line item that will reflect most of the benefits from our cost synergy initiatives. Taking this into account as well as the pre-existing leverage initiatives of both Medtronic and Covidien combined SG&A in the range of 32% to 33% on an operational basis seems reasonable in Q4. Amortization expense for the quarter was $89 million. For Q4 we would expect the combined company amortization expense to be in the range of $450 million to $600 million reflecting the impact of the Covidien acquisition. This is a wide range as the preliminary purchase accounting and related amortization of intangibles have not yet been determined and likely won’t be until the end of the quarter. It is worth noting that we will be shifting in Q4 to cash earnings per share and thus will exclude this expense from our non-GAAP earnings. Net other expense for the quarter was $24 million including net gains from our hedging programs of $54 million. We hedged the majority of our operating results in developed market currencies to reduce volatility in our earnings from foreign exchange. However a growing portion of our profits are un-hedged especially emerging market currencies which can create some modest volatility in our earnings. As I will talk about in a moment the mix of our earnings that are un-hedged will increase further with the addition of Covidien. Based on the current exchange rates as well as the reclassifications of the combined company net other expense in the fourth quarter for the combined company is expected to be in the range of 35 to 60. Q3 net interest expense on a non-GAAP basis was $4 million, after adjusting for the $77 million incremental net interest expense related to our December 2014, $17 billion bond offering used to fund the Covidien acquisition. While we excluded this incremental interest expense from our non-GAAP earnings this quarter because of the difference in timing between the debt issuance and the closing on the acquisition, we will include the incremental interest expense on our non-GAAP earnings going forward. At the end of Q3, we had approximately $31.1 billion in cash investments and $28.8 billion in debt, subsequent to Q3 there are number of items that will affect our year-end cash and debt balances including revision of our $3 billion term loan, the approximately $16 billion cash consideration paid for Covidien, the addition of approximately $5.5 billion in previously held Covidien debt at fair value and $2 billion in cash and the $1.2 billion in debt maturing in March which will entire using existing cash. Based on current rates, we would expect Q4 net interest expense for the combined company to be in the range of $195 million to $250 million. Our non-GAAP, our tax rate in Q3 was 17.1%, included in our -- this quarter tax rate is a $29 million benefit associated with the extension of the U.S. R&D tax credit. It is worth noting that on a combined company basis, the non-GAAP normal tax rate excluding amortization has been running in the range of 18% to 19%. And as we have noted in the past, the combined tax rate going forward could be approximately 2 percentage points better. In Q3, we generated $1.7 billion in free cash flow. We remain committed to returning 50% of our free cash flow to shareholders. In Q3, we paid $300 million in dividends and there were no share repurchases giving restrictions related to the Covidien acquisition. As of the end of Q3, we had remaining authorization to repurchase approximately 34 million shares and we intent to restart our share repurchase program later in Q4 pending Irish core administrative approval which we expected in early March. Third quarter average shares outstanding on our dilutive basis were 996 million shares. It is important to note that we expect the cash where you see from stock option redemptions which was a $165 million from Q3 will also continue to be use 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 Q4 we would expect diluted weighted average shares outstanding to be approximately 1.440 billion shares reflecting the shares issued in the Covidien acquisition. Next I would like to comment on our revenue outlook for the fourth quarter, which will be our first quarter reporting combine Medtronic-Covidien results. For the fourth quarter, we believe constant currency revenue growth of 46% on a combined pro forma basis is reasonable and we expect to be in the upper part of the range. While we cannot predict the impact of currency movements to give you a sense of the FX impact if the exchange rates were to remain similar to yesterday for the remainder of the fiscal year, our Q4 revenue will be negatively affected by approximately $420 million to $480 million which will result in reported revenue on an actual FX basis of approximately $7 billion to $7.1 billion. Taking into account our revenue and P&L comments that I have already covered, it would not be surprising to see models from our Q4 cash earnings per share somewhere in the broad range of a $1.08 to $1.13. Next I would like to provide some high level framing comments on fiscal year 2016. While we intent to give our revenue outlook and earnings per share guidance for our normal practise in our Q4 call, given the changes result in from the addition of Covidien here are some items to keep in mind as we think about our next fiscal year. First on revenue growth, while we are not formerly providing our FY16 revenue outlook, we believe it is reasonable to think about our revenue growth in the mid-single-digit range on a constant currency basis consistent with our baseline expectations. Next keep in mind that we will have an extra selling week from the first quarter of FY6, which we would estimate to have an impact of approximately 100 basis points to 150 basis points of incremental revenue growth for the full fiscal year or approximately 400 basis points to 600 basis points in Q1. This gives us increase confidence that we could be in the upper half of the mid-single-digit revenue growth baseline expectation in FY16. Regarding foreign exchange, the significant strengthening of U.S. dollar represents a strong potential headwind in FY16, even though our legacy Medtronic businesses continue to realize the benefit of our hedging program on major developed market currencies, it is not possible to completely hedge FY16 and FY15 rates given to-date exchange rates. This would result in our legacy Medtronic businesses to experience a negative impact from foreign currency albeit somewhat mitigated by the benefit of our hedging program. At the same time the legacy Covidien business does not have the same benefit today. Taken together if exchange rates were to remain similar to yesterday's broad FY16, our combined FY16 revenue will be negatively affected by approximately $1.2 billion to $1.4 billion. On a bottom-line based on today’s rates, this could translate into our $0.30 to $0.40 negative impact to earnings per share. Turning to our focus on cost synergies as Omar had mentioned cost synergy activities are underway and we are in the process of finalizing our FY '16 targets. We are targeting over $850 million in cost synergies to FY '18, in terms of timing it is reasonable to straight line these statements over the three years and our organization will be working hard to exceed this goal. Also looking ahead I will like to note that we anticipate holding our Q4 earnings call before market opens on June 2nd. This is two weeks later than our normal timing as this will the first quarter where Covidien results will be combined in our financial reports. However we do believe we will have an earlier view on our revenue results and we will plan to pre-release revenue on May 19. I will now turn the call back over to Omar.