Johnson & Johnson

Good morning. Welcome to Johnson & Johnson's third quarter 2019 earnings conference call. All participants will be in listen only mode until the question and answer session of the conference. This call is being recorded. If anyone has any objections, you may disconnect at this time. If you experience technical difficulties during the conference, you may press star zero to reach the operator. I would now like to turn the conference call over to Johnson & Johnson. You may begin.

Good morning. This is Chris Delorfus, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for the third quarter of 2019. Joining me on today's call is Joe Wolk, Executive Vice President, Chief Financial Officer. Additionally, during our Q&A session, Joe and I are pleased to be joined by Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices. Thibaut Mangon, Executive Vice President, Worldwide Chairman, Consumer. And Jennifer Talbert, Executive Vice President, Worldwide Chairman, Pharmaceuticals. A few logistics before we get into the details. This review is being made available via webcast, accessible through the Investor Relations section of the Johnson & Johnson website at .jnj.com, where you can also find additional materials, including today's presentation and associated schedules. Please note that today's presentation includes forward-looking statements. We encourage you to review this cautionary statement regarding such statements included in today's presentation, as well as the company's Form 10-K, which identifies certain factors that may cause the company's actual results to differ materially from those projected. Our SEC filings, including our 2018 Form 10-K and our most recent 10-Q, along with reconciliations of the non-GAAP financial measures utilized for today's discussion to the most comparable GAAP measures, are also available at .jnj.com. Several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide acknowledges those relationships. Moving to today's agenda, Joe will first provide some perspective on our overall results for the third quarter. I will then review the sales and P&L results for the corporation and the three business segments. Joe will conclude by providing insights about our cash position, capital allocation deployment, and our updated guidance for 2019, along with some considerations for the balance of this year and initial high-level thoughts for next year. The remaining time will be available for your questions. We anticipate the webcast will last about 75 minutes. I'm now pleased to turn the call over to Joe

Wolk. Great, Chris. Good morning, everyone. Thank you for your interest in Johnson & Johnson. As you might suspect, we're very pleased to discuss our strong third quarter results. Our performance positions us well to exceed the 2019 outlook we provided at the start of the year, providing us with a solid foundation for the future. During the quarter, we delivered strong revenue and earnings growth, while also making investments that advance our innovative pipeline across all three segments. We remain committed to advancing solutions that enhance the lives of patients, consumers, employees, and communities, while also delivering value to our shareholders. In a moment, Chris will provide details on our results, but before he does, let me offer some general observations and context about the performance in the third quarter. While there are many headlines surrounding our company as well as the industry, we continue to deliver life-saving and life-enhancing products to patients and consumers, which translates into solid financial performance. We must recognize that businesses in the U.S. are working in a very litigious environment, but the fundamentals of Johnson & Johnson's business are strong. We remain confident in our ability to navigate challenges and deliver results focused on our mission, as we have done for 133 years. For the quarter, our pharmaceutical business, even in the face of significant generic and biosimilar competition, once again delivered above-market performance across a broad base of therapeutic areas, led by double-digit growth in 10 key products. We are particularly pleased by the progress in the quarter of regulatory approvals and submissions, notably the FDA's approval of Erleada for the treatment of metastatic castration-sensitive prostate cancer based on the Titan data, and the approval of Stellara and ulcerative colitis in the EU, additional indications for both of those products. In our consumer health business, third quarter performance reflects continued strength in areas we prioritized earlier this year, beauty and -the-counter medicines. These businesses are fueled by new product innovations and recent acquisitions in large markets experiencing higher growth, which positions the consumer business to grow competitively with the market while also improving the profitability of this segment. Our medical device business continues to accelerate growth. We had some tailwinds that Chris will outline, but the adjusted operational sales growth was the best quarterly growth we posted since 2015. Interventional solutions delivered yet another quarter of double-digit growth, surgery improved, and orthopedics progress continues. We successfully executed multiple launches in the quarter, and we believe we are well positioned to continue the momentum. Let me turn the discussion back to Chris for details on the third quarter sales drivers and notable line items in our P&L. I will return prior to the Q&A to provide comments on our cash position and guidance. Thank

you, Joe. Worldwide sales were $20.7 billion for the third quarter of 2019, an increase of .9% versus the third quarter of 2018. Operational sales growth, which excludes the effect of translational currency, increased .2% as currency had a negative impact of 1.3 points. In the U.S., sales increased 1.2%. In regions outside the U.S., our reported growth was 2.6%. Operational sales growth outside the U.S. was 5.4%, with currency negatively impacting our reported OUS results by 2.8 points. Excluding the net impact of acquisitions and divestitures, adjusted operational sales growth was .2% worldwide, .4% in the U.S. and .3% outside the U.S. Turning now to earnings, for the quarter, net earnings were $4.8 billion, and diluted earnings per share was $1.81 versus diluted earnings per share of $1.44 a year ago. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $5.7 billion, and adjusted diluted earnings per share was $2.12, representing increases of .5% and .4% respectively, compared to the third quarter of 2018. On an operational basis, adjusted diluted earnings per share grew 5.9%. Beginning with consumer health, I will now comment on business segment sales performance for the third quarter, highlighting items that build upon the slides you have in front of you. Unless otherwise stated, percentages quoted represent the operational sales change in comparison to the third quarter of 2018, and therefore exclude the impact of currency translation. In 2018, worldwide consumer segment sales totaled $3.5 billion, growing at 3.3%. Excluding the net impact of acquisitions and investitures, adjusted operational sales growth was 1.3%, with strong growth in the U.S. of 2.4%, due primarily to strong performance in our beauty and OTC franchises. Growth outside of the U.S. was 0.6%. On a -to-date basis, consumer grew double digits across all regions in the e-commerce channel. The beauty franchise grew .1% or 2% adjusted to exclude the impact of the acquisition of Dr. Sulabo and the Rock divestiture. Our priority brands, Neutrogena and Aveeno, delivered strong performance results due to share growth, combined with timing of promotions in our club channel in the U.S. Share growth in Neutrogena was realized in the facial moisturizing treatment, cleansing, and sun protection categories, and Aveeno share gains were due to the hair product line relaunch. -the-counter medicines grew .5% globally, or just over 5% when adjusted to exclude the impact of the Zarbees acquisition, which continues to perform well. In the U.S., OTC adjusted operational sales growth was just over 5% and is growing share. Adult Tylenol was the core contributor to sales growth and continues to drive significant share growth driven by rapid-release gel and Tylenol arthritis products. Zyrtec continued to grow market share. However, sales declined due to lapping 2018 retail stocking due to a competitor supply disruption. Concluding the consumer segment, baby care declined .8% globally, or negative 8% when adjusted to exclude the impact of the baby-centered divestiture. This decline was primarily due to lapping retail stocking associated with the Johnson's Baby relaunch, most notably in the U.S. Excluding the relaunch comparisons, U.S. baby was flat. Moving on to our pharmaceutical segment, worldwide pharmaceutical sales of $10.9 billion grew 6.4%, enabled by double-digit growth in 10 key products. Sales grew in the U.S. by 4% and increased outside the U.S. by 10%. Generic competition for Zytiga negatively impacted our worldwide and U.S. growth by about 350 and 560 basis points respectively. Our strong portfolio of products and commercial capabilities has enabled us to deliver global growth at above market levels despite significant biosimilar and generic headwinds. Our immunology portfolio delivered global sales growth of just over 10%, driven by strong double-digit performance in Stellara, Trimthia, and Symfony, Symfony-Aria. Sales growth was partially offset by continued erosion of Remicade of almost 17%, due to increased discounts and modest share loss in the U.S. to alternative mechanisms of action and biosimilars. Stellara growth of almost 31% was primarily from the Crohn's disease indication, where market share has increased by over six points in the U.S. compared to the third quarter of 2018. Trimthia grew over 70% and achieved an .1% share of the psoriasis market in the U.S., which is up about 2.5 points from the third quarter 2018. Additionally, we filed an application to the U.S. FDA seeking approval of Trimthia for treatment of adults with active psoriatic arthritis. Our oncology therapeutic area delivered another strong quarter with worldwide growth of almost 9%. Darzalex continued its strong performance, growing about 57% globally or about 42% when adjusting for the impact of a favorable comparison to the prior year one-time reimbursement adjustment outside the U.S. The U.S. grew just over 26% and continues to benefit from strong market growth and about a 3.5 point increase in U.S. market share across all lines of therapy. The continued strong growth outside the U.S. is driven by increased penetration and share gains across the 41 Amea countries where it is commercially available, as well as Latin America and the Asia Pacific region. Of note, we received regulatory approval for Darzalex combination regimen for newly diagnosed transplant eligible patients with multiple myeloma in the U.S. Imbruvica grew .5% globally, driven largely by market share gains and strong market growth primarily in the CLL indication in the U.S. along with strong uptake outside the U.S. in the European, Asia Pacific, and Latin America markets. In the U.S., based on second quarter data across all indications and lines of therapy, Imbruvica gained approximately 2.5 points of market share and continues to be the new patient and total patient share leader in chronic lymphocytic leukemia, which gained above 8.5 points of market share in line one therapy. Worldwide Zytiga growth declined by about 21%, with declines of almost 56% in the U.S. due to generic competition, which was partially offset by continued strong growth of about 21% outside the U.S. In non-metastatic castration resistant prostate cancer, we continue to be pleased with the launch progress of Erleada, which gained almost 3 points of market share in the U.S. As Joe highlighted, during the quarter we received approval in the U.S. for treatment of patients with metastatic castration sensitive prostate cancer. We are also pleased with the launch progress in EMEA, where Erleada is now available in eight countries. In neuroscience, our Palo Peridone long-acting portfolio performed well, growing 15%, with higher market share driven by increased new patient starts and strong persistency. In addition, we continue to progress the launch of Spravato. Patient demand is strong, and the unmet need remains very high. To date, over 2,000 sites have been certified in the REMS program to become a Spravato treatment center, and more than 500 of these are actively treating patients with treatment resistant depression. We are encouraged by the continued progression of treatment centers being certified and treating patients. During the quarter, we filed an SNDA in the U.S. for a second indication for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent. In infectious diseases, our portfolio grew 3.6%, led by strong growth of Simtusa and Jaluca for HIV, partially offset by cannibalization and increased generic competition in other products. In our cardiovascular, metabolism, and other product portfolio, we did experience declining sales of 4.8%, primarily driven by declines in Invocana and biosimilar competition for Procred. Xarelto was flat with volume increases offset by rebates, primarily due to increase in the legislative rate for the donut hole from 50% to 70%, along with higher Medicare and donut hole utilization. And just yesterday, we were pleased to announce the U.S. approval of an additional indication for Xarelto for the treatment of VTE in the medically ill population. Our total pulmonary hypertension portfolio grew by 0.5%, with strong performance in both Upsummit and Uptravy growing by about 13% and 24% respectively on a global basis. Both benefited from further market penetration and increased share. This growth was offset by Traclear, which was negatively impacted by the recent generic entry in the U.S., as well as continued generic competition outside of the U.S. I'll now turn your attention to the medical devices segment. Worldwide medical devices sales were $6.4 billion, declining 2%, excluding the net impact of acquisitions and divestitures, primarily the divestitures of LifeScan and ASP, adjusted operational sales growth was .3% worldwide. Growth in the quarter was aided by one-time items contributing about 80 basis points to growth, largely related to forward buying ahead of the consumption tax change in Japan, primarily impacting our vision business. We expect the majority of this to sell through in Q4, with the remainder occurring in Q1 2020. Interventional solutions grew over 14% globally, led by continued strength in our electrophysiology business, achieving about 15% growth worldwide, continuing its trend of double-digit growth. Growth was strong in all regions, driven by our newer product offerings in Ablation and Advanced Catheters, contributing to atrial fibrillation procedure market growth. During the quarter, we were pleased to share the results of the atrial fibrillation progression trial, known as a test, which showed that patients treated with catheter ablation were almost 10 times less likely to develop persistent atrial fibrillation than patients on standard anti-arrhythmic drugs at three years after study initiation. Additionally, our Sarenovus business delivered a fifth straight quarter of double-digit growth, driven by new product innovation, including EmboTrap, for the treatment of ischemic stroke, as well as strong market growth. Vision growth of .1% was driven by contact lenses, which grew .6% globally, led by daily disposables in the Oasis family. As I mentioned earlier, total vision sales were aided by a forward buy in Japan in advance of a consumption tax increase worth approximately 300 basis points globally. In surgical vision, we launched our TecNAS Synergy intraocular lens, a continuous range of vision intraocular lens. Orthopedics growth continues to improve, with significant acceleration in the quarter, delivering growth of 2.3%, its largest quarterly growth since 2016. This progress reflects the continued execution of our innovation and commercial strategies aimed to improve performance. Hips grew 2.9%, driven by our leadership position in the anterior approach, continued strong demand for our primary STEM actus, and the concise surgical automated system. Trauma growth of .7% globally was driven by market growth, supported by strong adoption of newer innovation, such as our ephemeral neck system and recon nails. Sales growth was also aided by a one-time rebate reserve adjustment in the U.S. worth almost 90 basis points globally. Adjusting for this item, as the market leader in trauma, we are driving growth and expect our performance to represent growth in line with the overall global market. Spine decline less than 3%, with the U.S. being the primary driver of decline. While we continue to see stabilization of performance, driven by new products, such as the VIPER Prime system for minimally invasive surgery, and our newly launched Conduit inner body platform with EIT cellular titanium 3D printed technology to treat degenerative spine disease, we lost share in the quarter. Knee's growth was .3% in the quarter, with declines in the U.S., offset by strong double-digit growth of .8% outside the U.S. OUS results are expected to represent above-market performance, led by new innovation, including attune revision and S+. The U.S. market continues to realize positive uptake from the attune revision system, and this quarter we launched the attune cementless knee in the U.S. and other select markets around the world. Pricing pressure continued to impact all categories in orthopedics, but did show modest improvement compared to Q2. However, U.S. pure price was negative across all platforms for the quarter. Spine, hips, and trauma all declined approximately 2%, with knees declining about 1%. Moving to the results for the surgery business, advanced surgery delivered global growth of over 5%, led by strong performance in energy of 8%, primarily driven by share gains and new products in the Asia Pacific region. Biosurgery grew approximately 5% with growth in all regions, particularly the Asia Pacific region. We were pleased to have brought surger flow back to the market in the U.S. at the end of July. With that one month of being off the market in the quarter impacting global growth by about 100 basis points. Wound closure grew almost 5% driven by share gains in conventional and barb sutures and continued strong market growth in China. Timing of purchases in the veterinary channel favorably impacted global growth by almost 100 basis points. Additionally, we launched the industry's first powered circular stapler for colorectal, gastric, and thoracic surgery, a key innovation for us in our general surgery franchise. As expected, selling days had a minor positive impact on our global growth rates in the third quarter, and we do not expect a significant impact in Q4. I will now provide some commentary on our earnings for the quarter. Regarding our consolidated statement of earnings for the third quarter of 2019, please direct your attention to the box section of the schedule. As referenced in the table of non-GAAP measures, the 2019 third quarter net earnings are adjusted to exclude intangible asset amortization expense and special items of $0.8 billion on an after-tax basis, primarily driven by intangible amortization of $1 billion. Excluding the impact of those items, our adjusted earnings per share is $2.12, an increase of .4% versus the third quarter 2018. Adjusted EPS on a constant currency basis was $2.17, up .9% versus third quarter 2018. I'd like to now highlight a few noteworthy items that have changed on the statement of earnings compared to the same quarter last year. Costs of products sold de-leveraged slightly, primarily driven by negative impact of currency in the pharmaceuticals business. Selling, marketing, and administrative margins for the quarter improved as a result of favorable segment mix, planned prioritization in the consumer and medical devices businesses, as well as expense leveraging in the pharmaceuticals business. We continue to invest in R&D at competitive levels, and our investment in research and development this quarter as a percent to sales was 12.5%, which is higher than the third quarter 2018 by 20 basis points. This increase was primarily driven by higher investment in our medical devices business related to robotics, digital programs, and key growth platforms. The change recorded in the other income and expense line was primarily driven by a contingent liability reversal in the third quarter of 2018. Net interest expense was lower by $109 million, primarily driven by the positive effect of net investment hedging arrangements and lower interest expense due to a lower average debt balance. Regarding taxes in the quarter, our effective tax rate was .4% compared to the third quarter of 2018 tax rate of 11.1%. As a reminder, regarding the third quarter of 2018, the company recorded a favorable financial impact of approximately 9% related to U.S. tax reform. The current quarter includes an estimated tax benefit for the transition provisions of Swiss tax reform, partially offset by an adjustment to existing tax reserve positions negatively impacting the effective tax rate. We encourage you to reference our 10Q for further details on this and other specific tax matters. Excluding special items, the effective tax rate was .3% compared to .6% in the same period last year. The increase was driven by the adjustment to tax reserve positions previously noted. Now looking at adjusted income before tax. In the third quarter of 2019, our adjusted income before tax for the enterprise as a percent of sales increased from .3% to .3% in 2019, primarily driven by improvement in selling, marketing, and administrative margins for the quarter as previously noted. The following are the main drivers of adjusted income before tax by segment. The decrease in pharmaceutical margins by 180 basis points was primarily driven by the negative impact of currency in cost of goods sold. Consumer margins improved by 450 basis points primarily due to planned optimization of selling and marketing expenses. Medical devices improved by 220 basis points due to investment optimization in selling, marketing, and administrative expenses, and other income items which were partially offset by R&D investment in robotics and digital surgery solutions. That concludes the sales and P&L highlights for Johnson & Johnson's third quarter 2019. For your reference, here is a slide summarizing notable developments occurring in the third quarter, some of which were mentioned in my comments. I will now turn the call back to Joe.

Thanks, Chris. With respect to cash, at the end of the third quarter, we had approximately $11 billion of net debt, consisting of approximately $18 billion of cash and marketable securities, and approximately $29 billion of debt. We estimate our -to-date free cash flow to be approximately $14.5 billion. We acted upon all four tenets of our capital allocation strategy, which are designed to and continue to drive shareholder value. Some of the highlights include investing $2.6 billion in research and development in the quarter. Investing in our business to deliver transformative healthcare solutions remains a top priority at Johnson & Johnson. As in previous years, we expect to experience even higher levels of investment during the fourth quarter. Some tangible examples of where this investment will be directed will be progressing our future digital surgery offerings, and R&D activity related to CAR-T, Cousatuzumab, Darzalex subcutaneous formulation, and line extensions within the immunology portfolio, such as Stellar and Lupus. At the same time, we continue to evaluate strategic transactions that will further enhance our broad-based business and drive value creation, having invested nearly $6 billion this year. We also used cash in the quarter to complete the authorized $5 billion share repurchase program announced just last December, deploying $1.2 billion in the third quarter. I will now provide updates to our guidance for 2019. We continue to see strong results across our enterprise. As such, we are increasing sales guidance and are now comfortable with your models reflecting operational sales growth of .5% to .0% for the year. This growth would result in sales for 2019 on a constant currency basis of approximately $83.7 billion to $84.2 billion. We expect that operational sales growth excluding the impact of acquisitions and divestitures will be between .5% and .0% for the year. Both metrics are up over 200 basis points at the respective midpoints from the original guidance we provided in January and over 100 basis points from the guidance we provided last July. Although we are not predicting the impact of currency movements utilizing the euro spot rate relative to the US dollar as of last week at 1.10, the negative impact of foreign currency translation is slightly worse than our last guide by 20 basis points and is estimated to negatively impact reported sales by approximately 2.3 points. Under this scenario, we expect reported sales growth in the range of .2% to .7% or approximately $81.8 billion to $82.3 billion. Moving to items impacting earnings, net interest expense is now expected to be net interest income of $50 to $100 million. For other income and expenses, we are tightening the range to $2.75 billion to $2.85 billion. As a reminder, this is the account where we record royalty income as well as gains and losses arising from such items as litigation, investments by our development corporation, divestitures, assets sales, and write-offs. Our effective tax rate guidance for 2019 is now estimated to be approximately .0% to 18.5%, reflecting the higher end and a tightening of the previous guidance range. Given those updates, we are now comfortable with the adjusted EPS guidance in a range of $8.84 to $8.89 per share on a constant currency basis. This reflects operational or constant currency growth of approximately .1% to 8.7%, which is higher than our prior guidance and reflective of our solid performance this year. Again, we are not predicting the impact of currency movements, but to give you an idea of potential impact on EPS, using recent exchange rates, a reported adjusted EPS would be negatively impacted by approximately 22 cents per share versus prior guidance of negative 20 cents. Accounting for that, our reported adjusted EPS would range from $8.62 to $8.67 per share, reflecting growth of approximately .7% at the midpoint, which is also higher than our previous guidance. While we do not provide quarterly guidance and are not providing guidance for next year just yet, I will provide a few comments for you to consider looking ahead, both for the fourth quarter as well as for 2020, to better inform your modeling. One notable item for the fourth quarter of this year, you may recall that in the fourth quarter of 2018, we had an elevated level of adjusted other income of approximately $800 million, primarily due to the light scan divestiture. There is nothing similarly planned for the fourth quarter of this year. Looking beyond the fourth quarter, we are still in the process of finalizing our 2020 plans, but allow me to provide some context from line items where we have some preliminary insights. Qualitatively for sales, we expect our pharmaceutical business to continue to deliver growth above market. Our medical device business is anticipated to continue sales momentum, and we remain focused on optimizing our consumer portfolio for competitive growth while improving profitability. In terms of items on the P&L, again, robust plans are still being developed by our leaders, but we will continue to balance improved operating efficiency with investing for sustainable long-term success. For other income and expense at this early stage, we expect at this time to record approximately half the level of income just provided in our current 2019 guidance range. We continue to prefer investment in R&D to progress our robust pipeline of assets. This includes continued investment in our digital surgery portfolio, which was bolstered by the acquisition of AORUS that we completed in the second quarter of 2019. For the effective tax rate, based on current legislation, we anticipate the range being relatively similar to the 2019 full-year tax guidance I provided earlier, .0% to 18.5%. And while we don't forecast currency fluctuations based on current exchange rates, we expect currency to continue to be a headwind, although less than this year's impact. That concludes our financial summary. I am pleased to be joined on today's call by Ashley, Thiebaud, and Jennifer to help me address your questions. Before we open up the call for Q&A, I would like to thank our Johnson & Johnson Associates around the world for their continued hard work and dedication. We celebrated the 75th anniversary of our initial public offering at the New York Stock Exchange in September, a significant milestone made possible by their tremendous efforts and those who preceded them. I will now turn the call back over to Chris to begin the Q&A portion.

Thank you, Joe. We will now move to the Q&A portion of the webcast. As a reminder, I would encourage you to take advantage of Ashley, Thiebaud, and Jennifer being on today's call by directing questions to them about their areas of expertise. Operator, can you please provide instructions for those on the line wishing to ask a question?

Ladies and gentlemen, if you would like to ask a question at this time, please press star then one on your telephone keypad. If you would like to withdraw your question, press star then two. Please send me your questions to one question and one follow-up. Your first question comes from David Lewis with Morgan Stanley.

Good morning and thanks for the questions. Maybe just, Joe, one for you and then one for Ashley. Joe, this is a greater level of financial disclosure we typically get heading into 2020, so thank you in advance. Just doing some quick math here, it does sound like you're basically suggesting for 2020 outlook, or you're not providing official guidance. Top line should accelerate into next year, and you're pretty comfortable with that kind of relative type of leverage J&J has done historically, which is sort of an earnings growth rate kind of in the one and a half ratio in earnings relative to sales. Is that a decent way of thinking about 2020? Yes,

David, thanks for the comments. Certainly glad that you find some of the outlook commentary helpful to you. I do want to emphasize, though, what I said in the prepared remarks in that our teams are still working through their plans for 2020. We want to see the momentum that we've seen through this year carry on through. With respect to top line, I would say if you recall back in January, we were a little bit more conservative with this year's outlook given some of the ability to hold on to brands that were facing exclusivity risk. You know, Zytego, Pro, Creature, Clear, we performed a little bit better. So we do expect to be above market, but just not as pronounced as we would have thought in the beginning of this year for 2020. But we're feeling very good about the momentum. With respect to the income ratio to sales growth ratio, I'd say that's a little bit early to comment on. I would expect to see some moderating more back towards around sales growth. This year, if you look at it, let's just take adjust it to adjust it. So accounting for divestitures and acquisitions impact, it's a 1.8 ratio. That's a little bit higher than we typically run at. And then obviously we're going to digest a pretty significant hit on the other income line. So again, the team's working through the plans. We do have ambitious goals for next year. And what I would say is stay tuned. It's probably the best direction I could give you at this point in time.

Okay, maybe just two quick follow-ups. Joe, the first is for you on the repo. You completed the repo this quarter. So just given the operational performance of J&J and the company's historical discount, what are you thinking now with the share repo completed going forward? And then actually just real quickly, can you just talk a little bit about U.S. market dynamics with Envision, two specific dynamics? You talked about pressure in the surgical business. To what extent is that IOL dynamics in the marketplace versus the Lasik franchise? That'd be super helpful. Thanks so much.

So David, with respect to the share repurchase, we are pleased to have the $5 billion board authorized program completed. It continues to be one of the four pillars within our capital allocation strategy. I would say in terms of pecking order, as you know, haven't covered us for years, it's probably the least of our preferred options, although it's still an option, simply because it doesn't provide us capabilities going forward. But we'll continue to evaluate that along with the dividend increase, the investment in R&D, as well as opportunistic acquisitions that make sense from a value creation standpoint, but also a really good strategic fits that expand our portfolio.

And thank you, David, for the question on Envision. But before I get to that, I have to first acknowledge kind of the strong quarter for medical device in quarter three, growing 5.3%. And as Chris had mentioned, you know, we did experience some forward buying in the Japan consumption, so if you take that out, we're looking at around .5% growth, which is the strongest that we've had in four years. So as you know, we've been on this journey since 2017 to really enhance our performance year over year. And when we look at 17, we exited .5% growth on revenue. In 18, we exited 2.6%. And in 2019 to date, we're tracking to a little bit north of 4%. So as I always say, I don't think our growth is going to be linear, but I do think that we've turned the corner. And that really is due to predominantly in the near term the strategic choices that we're making to strengthen our competitiveness. And it's really about this very strong seasoned leadership team. He's got five quarters underneath them and a very, very strong focus on execution. So I think this is starting to have an effect. So to your question on vision, you know, vision had a good quarter, I would say. Contact Lens in particular had a very healthy quarter, really driven by very strong growth in the United States of around 6%. In surgery, we had very strong outside of U.S. performance, double digit. The U.S. surgical business is challenged really due to two fronts. Number one, some competitive inroads, and we are working to strengthen our commercial execution in U.S. We strengthened that leadership team, revisited our programs, and we're also accelerating some innovations. We expect to have three meaningful innovations in premium IOLs and monofocal IOLs over the next 18 months. And to your earlier point, yes, we do believe that we've seen some softening in the LASIK market in the United States. Thanks for the question, David.

Great. Thank you, David. Appreciate the question. Rob, next question, please.

Your next question is from Chris Schott with JP Morgan.

Great. Thanks very much. Just two questions here. Maybe first, can you talk about Tremphya Dynamics, particularly relative to Skyrizy, the product obviously, Tremphya obviously ramping nicely. I know there's some investor concern, though, that that ramp could be impacted by a strong launch from your competitor. So just how do you think about price and volume for that business going forward? The second question was on liabilities. It seems like kind of these liabilities have somewhat dominated the narrative for the change in story this year. What do you think the company can do to address that overhang? And what's the company's approach towards settlement? Because it seems like right now the mix of opioids, talc, and some others have overshadowed what seems to be very strong underlying fundamentals of the company. Thank you.

So, Jennifer, why don't you address Chris's question around Tremphya? Maybe you can give him some pharmaceutical perspective, and then I'll take up the litigation matters.

Hi, Chris, and good morning, everyone. First off, it was a really strong quarter for the pharmaceutical group, and I just wanted to highlight a couple of key points, the first being, you know, sales of $10.9 billion, .5% operational growth. This was our sixth consecutive quarter with sales above $10 billion. And if you take a look at our growth excluding Zytiga, it was 10%, and also with very strong contribution from the U.S. and the international markets, where actually we had 10% growth outside of the U.S. as well. Our growth was broadly based with 10 of our key brands growing at double-digit rates, which more than offset the erosion due to biosimilars and generics. Overall, our immunology business was up 10%, our oncology business up 9%, and neuroscience up 8%. A few notable call-outs, Stellara had 31% growth, Darzalex had 57%, Imbruvica, 33% growth, Trumfya, which I'll come back to, 70% growth, in Vegas, a 10 of 15%, and Erleada, 95% growth. So very strong performance across our base of business and across our key growth drivers. Additionally, it was a really nice quarter for the progression of our pipeline, and we had a number of significant approvals as well as filings that are worth calling out. Most recently, as of last Friday, we got approval for Zirelto to help prevent VTE in acutely, medically ill patients. We got approval for Invokana for the treatment of diabetic kidney disease. Darzalex, we got approval for the combination regimen in newly diagnosed transplant eligible patients. And for Erleada, we got approval for treatment of metastatic castration-sensitive prostate cancer, which expands our opportunity for that product so that it's not only in the non-metastatic space but into the metastatic space as well. We also had a number of regulatory submissions and two breakthrough designations that were granted. So strong performance for our key growth drivers and good reasons for optimism on our pipeline progression as well. In terms of Tremphia, our Tremphia business grew 70% versus the third quarter, and in addition, we filed an application for use in active psoriatic arthritis in August. And so to date, we're really pleased with the launch progress and the trajectory. Based on the strength of the profile of the product that we've got coupled with the very strong longevity data that we have, we believe that we've got a really competitive offering, that IL-23 is the right mechanism for psoriasis and other areas that we're exploring and also that we've got a very, very strong package to drive continued growth. I think in these settings before, we've discussed the strength of the package that we have with superiority data versus three separate mechanisms. So approval versus, in our label, superiority data versus Humira as an anti-TNF versus Stellar and non-responders, IL-1223 mechanism, and then our most recent data versus Cosentex, which is an IL-17 and POSI-90 at week 48. And now we actually have four years of data that further demonstrates the therapeutic longevity of the asset. That's going to be presented next week. So when you take a look at it, we believe we've got a real competitive profile versus the IL-17s. We've also got a competitive profile versus the other IL-23s. And we don't see that they're bringing anything to the market that is any different. In fact, based on the strength of our data plus now our four-year data and the strength of the access that we have in the market, we think that we're going to continue to compete very, very well in what will arguably be a very competitive space.

Thanks, Jennifer. Chris, with respect to your second question and litigation more broadly and what can the company do, so I think it's important without going into too deep of a litany about the cases that are out there, there's three I'd say headline grabbers that folks have taken notice of. It is important for me to just give a brief summary of the position on each because they are unique in their own right. With respect to the risk-adult judgment that you heard last week, you know, first of all, let's make sure people understand the benefits of risk-adult, what it provides for psychosis. It's for decades now been on WHO's list of most preferred medicines. And the judgment itself, based on U.S. Supreme Court precedent, would suggest it's very egregious. So we don't expect that to stand. We will appeal certainly the amount, and you can expect that to come down should the precedent hold. With respect to opioids, you've seen two divergent paths there for us. So in Oklahoma, we thought that based on the theory of law in which it was brought under in public nuisance, as well as the facts that underlie that case, where even the attorney general of the states had many times during the court proceedings, this is not about Johnson and Johnson. It's about that there's an opioid crisis where we had less than 1 percent market share. That's not just for the state of Oklahoma, but across the country. Where those facts were ignored and we couldn't find a reasonable settlement approach, we decided to pursue with that case, and we are currently appealing that case and have made motions to do that. In Ohio, you saw something different. We saw a reasonable amount in proportion to other companies that were involved as defendants. We were particularly pleased to see that the funds were going to victims of opioid addiction. And so for many reasons there, we thought the best path for all stakeholders was settlement. And that's something that we will always kind of take into account in terms of what is the best solution for all stakeholders, including investors who obviously want certainty. Lastly, with TALC, this to me is probably the poster child for how big business plaintiff's attorneys have made this type of approach. If you think about the outstanding cases, product liability cases in the U.S. court system today, about 50 percent are related to life sciences or are against life science companies when products have never been safer and have never been more effective. The plaintiff's bar in total has spent over $400 million this year alone in advertising on TV, trying to drum up the numbers in class action suits. It's become a $36 billion industry. And what you may not realize, you'll see the headlines certainly when verdicts are ruled against us. And I will remind everyone that there's currently not any case that's been fully adjudicated that stands in judgment against us. But last week alone, there were three decisions that were in favor of the company. And you don't see headlines on that. So in that case, we're going to continue to defend a product that we know to be safe, that we know does not cause cancer. And that's not just the opinions of Johnson & Johnson scientists. That's the opinion of respected institutions like the National Cancer Institute, the FDA, and numerous prestigious universities. So we'll continue to evaluate each situation for its unique merits. But what I can't underscore enough is we've got a small, great legal team working on this matter. As today's results hopefully demonstrate to all of you on the phone and anybody who's reading the press release, is that we continue to be focused as an organization of 135,000 associates trying to bring better solutions, better innovation to healthcare. That will eventually win out. We're very strong in our conviction around that. It has for 133 years. We know how to navigate these matters. And we're going to stay focused at the task at hand. With that last point, you know, it may be good, sometimes we get a question, especially as it relates to talk, if there's been any overhang on the business. And for that, I'd like to turn it over to Thibault maybe just to give some quick commentary with respect to the consumer business and whether he's seeing any impact from it.

Sure. Good morning, everyone. The short answer is no. We do not see any significant effect across the consumer business. As Joe just referenced, our employees around the world in the consumer sector are hyper-focused on delivering personal health in a very differentiated way with very strong brands that are rooted in science and endorsed by professionals. In Q3, as Chris highlighted earlier, we delivered solid growth in our key priority areas that we declared at the beginning of the year. You had about .2% growth in OTC, 2% in beauty, strong performance by brands like Tylenol, Neutrogena, Aveeno. From a full perspective and to ground you, the baby franchise represents only 12% approximately of our revenues and approximately 80% of those sales are outside the United States where there is less of an impact from the U.S. events. So you see the performance of the business in the U.S. We continue to gain share in beauty and OTC. We are outperforming the market. We are well positioned in segments that are growing to .5% in the markets and segments where we compete. You also saw that we increase our adjusted IBT significantly this year, 210 basis points so far a year today at 22.4%. So we are focused on executing our strategy.

Great. Thanks, Thibaut. Chris, thanks for the question. Rob, next question,

please.

The next question is from Larry

Beegle. This is from Wells Fargo. Good morning. Thanks for taking the question. One for China, one on China and one on MedTech for Ashley. So first on China, Joe, any color on what you're seeing across divisions there and your expectations going forward? Obviously there's been some concern about the environment in China. And just remind us of how much China accounts for as a percent of total JJ sales. And I just had one follow-up for Ashley.

Yeah, sure, Larry. Good to speak with you. So China continues to perform extremely well for us. So if you look, if I strip out significant divestitures of life, life skin and ASP, our overall growth was about 15%. I would say medical devices, which we know is the number one company for medical devices in China. We were up around 19%, 14% in pharmaceuticals and about 5% in consumers. So very healthy across the board. We have not seen any impacts on tariffs. And we don't know of any that are pending around healthcare. So we've been fortunate in that way. We continue to monitor it. The business overall was $1 billion for the quarter. So that's, I think, a high-water mark for that business as it continues to go fairly strong in terms of growth levels.

That's very helpful, Joe. And Ashley, your advanced surgery business has been growing outside the U.S. nicely, but has been soft in the U.S. So my question is, what turns that around in the U.S.? And will these recent trends continue until you launch your surgical robot? Thanks for taking the question.

Thanks, Larry. I mean, before I kind of get specifically into kind of the surgery business, I do think it's helpful to share. You know, I had talked at the last quarter some of our hot spots and how do we address some of those. And then when we look at some of the areas that are really on fire, as Joe mentioned, in China, like our Asia business continues to perform double digit. And we actually performed high single digit, if not double digit, in all of our franchises in orthopedics and surgery, as well as in interventional. And as I talked last time, really, you know, the U.S. is our largest market. How do we continue to accelerate growth there? So I am pleased to see that year to date that business is up around 2.2%. And this time last year that number was a little bit south of 1%. And then when I look at our global orthopedics business where we do command the world leading position in orthopedics, we've accelerated that revenue in 2019. So year to date that business is up around 1%, really fueled by a very strong quarter in quarter three, up of around 2.3%, which is our strongest quarter since 2016, which is a growth acceleration versus a year ago where that number was about down 1%. So if I turn my attention to surgery, I would say, you know, our energy business has a very strong performance, really double digit growth, OUS. In the U.S., we will be challenged until we get our digital surgery offerings out there. And then similarly for endocutters, endocutters globally had a softer quarter versus the second quarter, really due to some phasing between quarter two and quarter three, and due to a very healthy comp last year where we grew 10% in endocutters. Similarly, we're seeing very strong performance outside of the United States, high single digit, but we are challenged versus the robotic penetration happening in the United States.

Thank you. Great. Thank you, Larry. Appreciate the question. Rob, next

question, please. Next question is from Danielle Entalfi with SVB Lyric.

Hey, good morning, guys. Thanks so much for taking the question. I appreciate all the commentary on medical devices. Love to see the growth this quarter. Ashley, just a quick question for you. As we think about that .5% growth you talked about, XM1 timers, how should we think about the sustainability of this? I know there's probably going to be volatility quarter to quarter, but just want to make sure this level of growth isn't going to fall off for any sort of reason. So I'm wondering if you could talk about, if we look out over the next four to six quarters, the sustainability of that 4% to 5% growth level, or are there any headwinds in any particular quarter coming out that we should be thinking about?

So thanks for the question, Danielle. And, you know, listen, it's really good to see a number four, you know, and we're pleased with quarter three, and we're pleased with really kind of the year over the year enhancement. So I feel confident in that continued year over year progression. I don't anticipate us having a perfect linear line every quarter to quarter. You know, the market is just, we'll have to adapt to the market. But I really think that we're going to accomplish that. What you're seeing is really the benefit of strengthened commercial execution. But I would say what I'm equally bullish on is really the innovation agenda. And when I look at 2019, I think we benefited from some really novel innovations in our circular, powered circular staple for complex oncology cases. We had a first in contact lens with a light adaptive lens. We are launching our cementless, which is a high growing segment in knees, in quarter three. In quarter four, we'll have some news in spine related to our symphony launch for our complex posterior cervical and deformity. So I really think that those are going to have an effect. But equally important is really what I look at the innovations coming out over the next, let's say, 18 months. And we're going to have a first in kind smart micro catheter in our electrophysiology business under QDOT, which is going to deliver about two to three times the amount of energy and take the procedure from four hours to two hours. We're going to have another novel innovation in vision related to the first ever drug eluting contact lens for allergy, more premium intraocular lens coming. And we're going to have some digital surgery robots in our orthopedic business really beginning with the filing in 2020, let alone all the digital surgery offerings that we have with Monarch and the future with the Verve and iPlatform. So thanks for the question.

Thanks, Danielle. Appreciate the question. Rob, next question, please.

Next question

is from Terrence Flynn with Goldman Sachs. Hi. Thanks for taking the question. Just as we think about margins, obviously posted a really strong quarter. It looks like consumer and med tech were the key drivers of the improvement. Just wondering if that level is sustainable here or if there's room for further improvement in each of these segments as we look into 2020. And then on DARZELEC's looking ahead into 2020, is it reasonable to assume that year over year growth in the U.S. should inflect positively next year given the frontline label? Thanks.

Maybe Thibaut and Ashley, if you'd like to address your levels of investment with respect to your businesses. And then, Jennifer, you can handle the DARZELEC question.

Sure. I can start with consumer, Terrence. As you saw, we are very focused on improving our profitability level. I just talked about the sequential improvement we are seeing this year. As I look at 2020, we expect to see moderate acceleration in the top line with market growing around 3 percent. And we remain focused on driving our productivity agenda. So that's the agenda for 2020.

Yeah. I think the best way to characterize it relative to this year, Terrence, is that this year was the bigger lift in terms of profit improvement, profitability margins improving for the consumer unit. So you will still see continued improvement, as Thibaut mentioned, but not to the same degree you probably saw in 2019.

And just to build, Terrence, this is Ashley, on the kind of the investments and what the expectations are. I think we're seeing very strong performance in Asia. We've made continued investment in Asia and continued investment in China. We continue. We command a leadership position in China, and we command leadership position in emerging markets. And it's really nice to see emerging markets up 10 percent and China up 19 percent. And we will continue to make those very, very select investments. And then in areas like commercial infrastructure around having a world-class sales force and world-class professional education, I think we're seeing the investments that we made, particularly in new deployment models in the United States, having an effect. And then clearly in innovation, both in digital surgery through the RS acquisition and what we're continuing to do with our verb and orthotaxi and some robotic programs in spine. And as you know, we've invested about $12 billion in M&A since 2017 in medical devices to make sure that we're playing in the most attractive spaces.

And to be fair, Terrence, it's a little bit of a tough question for our business leaders to answer at this point in time. As I mentioned at the outset, we're still developing our plans for 2020. And for us, when we go through those plannings, we're really looking at what investment opportunities are available to us in terms of fortifying not just the short term, but the long term. What's going to make us truly competitively advantaged two, three, five years down the road? So that's why it's a little bit difficult to answer. But we're always looking to make sure that we've got, you know, over sustained periods of time, sales growth that exceeds the market in the respective segments. And then profit a little bit better growth than sales growth.

Hi, Terrence. Our oncology business had another strong quarter, and Darzalex was really one of the key drivers of that with 57% growth versus the third quarter of last year. As you noted, we've got a great opportunity to make strides in the front line setting. Right now, Darzalex is a leader in line two plus. However, at the end of June, we gained approval in the front line setting for transplant ineligible patients in combination with Revlimid. And at the end of the third quarter, we gained approval in front line for the transplant eligible patients in combination with Velcade and Phthalidomide based on our Cassiopeia data. And so we're really looking to continue to expand Darzalex across the various lines of therapy and in various combinations to really be a backbone of therapy. Importantly for us, and I believe a key growth driver for the future, we filed our sub-q formulation, which is going to take us from a several hour infusion on this product down to under five minutes. And so we think that's going to be an important catalyst for growth, particularly in the outpatient settings, the more community settings. And we're also importantly studying Darzalex and amyloidosis, smoldering myeloma. So we think that there's both near-term, short-term growth as well as continued long-term growth potential on this asset. So based on the strength of the performance to date, the additional data that we're seeing and the opportunities that we have in the front line setting and growth potential coupled with the sub-q formulation that's coming up, we believe that there's very good reasons for very strong continued growth for Darzalex going forward.

Great. Thanks, Terrence. Appreciate the question. Rob, next question, please. Your next question

is from Kristen Stewart with Barclays.

Hey, everyone. Thanks for taking the question. I just wanted to, I guess, clarify just some of the timing around the digital surgery platforms. I think Ashley mentioned filing for orthotaxi in 2020. Just wanted to get some clarification there and then also any updates on progress with Monarch and then timing around for... And I think you might have a medical device day next year. Just wondering what we should expect with that and just kind of urban thoughts with Medtronic, I guess, showcasing their platform too.

Thank you, Kristen, for the question. So listen, I couldn't be more bullish around how J&J is going to create value in this space. And really kind of the goal that we're trying to achieve is really to make medical interventions smarter, less invasive, more personalized, quite frankly, to change the standard of care, not just for the next 10 years, but the 20 years and 30 years. So it really starts with, as you know, our very strong footprint that we actually have today as a world leader in open surgery and a world leader in minimally invasive laparoscopic surgery. I'm very pleased to share that Monarch is off to a great start as a -end-illuminal surgery. We've conducted over a thousand bronchoscopes using the Monarch system. You'll see in the chest at the end of October we will be sharing our post-market surveillance data. And so stay tuned for that. We have a very healthy pipeline with Monarch for not just lung biopsies, but potentially lung treatment via ablation and potential treatment via oncologic viruses. So that program is well on its way. We also are looking at applications of Monarch in endourology for the treatment of kidney stones. And we also are assessing the potential application of Monarch in GI endoscopies. So very encouraged with Monarch, equally encouraged with the acquisition of RRS as well as VIRB. We brought in a new leader to head our VIRB program, Kurt Azurbane, who's got over 30 years' experience in minimally invasive surgery and robotics. It's pretty fun to watch Kurt and the community of Dr. Fred Moll, again one of the founders of Intuitive, Peter Shen, who's grown up on Ethicon instrumentation, and then Andy Conrad from Verily kind of put those thought leaders together with over 30 different key opinion leaders from around the world who have been really assessing how we can create value with all of these assets over the next several years. So I am encouraged to say both programs have conducted, and I mean both programs, both the RSI platform and VIRB have conducted -to-end procedures in multiple different indications in general surgery. We've gotten very good feedback from over 30-plus surgeons, and we're going to take the absolute best of all of those as we in parallel advance both of those programs. Equally pleased to see Dr. Fred Moll engage with our orthopedics team. We plan to file our orthopedics program for filing middle of 2020. And so when I take a step back, I really see us having a healthy cadence of news starting last year with the launch of Monarch every single year having meaningful news. We are completing our assessment. Kristen, as you had mentioned, around the iPlatform and VIRB and how do we create the most amount of value. Right now we're not changing any timelines until that assessment is complete, so stay tuned.

Great. Thanks, Ashley. And maybe just another update to Ashley's point on the progress of the Monarch platform. While it's early and limited revenue today, we're very pleased with the progress of the placement of systems, two times the amount -to-date versus where we were in 2018. So that continues to progress well from an adoption standpoint in the marketplace. Thanks, Kristen. Rob, next question, please. Your next question is from Josh Jennings with Cal

Winding Company. Hi. Good morning. Congratulations on a strong quarter. I was hoping to start off around on the farm of business. Just wanted an update on the generic slash bio-assembler, Headwind. You guys have just called out a kind of $3 billion number for 2019. And just any way you can help us think about where that Headwind will sit as we head into 2020. And then the second question, another farmer question, just on Xeralto. Congrats on the line extension. Any help there just in terms of how you will proceed launching into this new indication? Are there any pricing considerations you need to undertake? And can Xeralto return to grow that has been a blockbuster, that's been a relatively anchor over the last number of quarters? Thanks a lot.

Hi, Josh. It's Jennifer. So as we take a look at this year, first on your question regarding sort of biosimilar and generic impact, we think we're seeing about $2 billion of incremental impact from biosims and generics. This is a little bit less than what we'd anticipated this year. However, the number of generic approvals and the erosion rates are starting to catch up. And so we think as we enter into next year, we'll work through the rest of that. So part of it, a little bit of it is going to carry over into 2020. And then we'll be working through and be done with that. As it relates to Xeralto, we're very excited about the new indication. This is actually the eighth indication for Xeralto. And that product really remains unmatched in the oral space in terms of the number of indications. So the asset has indications in AFib, VTE prevention and treatment, and then also in CAD, PAD. So how to think about the acute medically ill indication? First of all, it broadens Xeralto's base of indications across these three areas. And it's really unmatched. And so that can help from a formulary and from a payer perspective. And then within the market, there's over 7 million Americans that are hospitalized each year with acute medical illnesses. And so these patients are at increased risk of clots for up to three months post discharge. So currently they're treated in hospital with a product like Lovenox. But because of the complications and the difficulties with injections, they typically go untreated once they leave the hospital. What we now know from our studies and our data is that it's much better for these patients to actually be treated for about 31 to 39 days following their medical illness. And so this is a – we believe that patients will start on Xeralto in hospital when they're there with the acute medical illness. And then our goal is a transition out of hospital with a script and continue on oral medication for that 31 to 39 days. Now you may have the question, you know, how do we go about doing this? The good news is Xeralto 10-milligram, which is the right dose for this indication, is already available on hospital formularies. That's the dose that we've had in the market now for a number of years for post knee and hip surgery. So we do have very broad availability in hospitals, formulary access, and also payer access for this. We've also got teams that are already deployed to hospitals across the other range of indication sets. So in our – as in our typical way, we do next day launches, so the team's already out in the markets getting ready and working on this indication, as well as continuing to drive uptake in the paradigm-changing CAD-PAD indication and fighting out for competitive share in both AFib as well as the other VTE treatment and prevention indications. So we feel very good that we reached flat this year. That's obviously not where we want to be, but we're moving, you know, moving forward and getting past some of the doughnut hole and rebate issues, and we do believe there's an opportunity for growth for this asset as we take a look at completing the year and going forward.

Great. Thanks, Josh. Appreciate the question. Rob, next question, please. Next question is from Matt Mixick with Current Suisse.

Hi. Thanks for taking the question. So just two follow-ups, if I could. One on the digital surgery side. Ashley, appreciate the color on the strategy across the major business lines. The one that I wanted to ask about was your spine. You have a partnership with BrainLab, and that continues to progress. You have a pretty solid set of new products that you mentioned are going to drive improving growth in spine. But just if you could, what amount of the competitive pressure there is coming from this sort of increase in robots in that space, and how do you think about that strategically? And I just want to follow up for Joe, if I could.

Sure. Thank you, Matt. So spine, we're number two in the world in spine. We have been challenged. Our revenue performance has been challenged. And really what we've been working on is, one, to give very dedicated focus to, if I'll call it, like the top six markets in spine that are really going to be the growth contributors in stabilizing those from a leadership point of view, from a commercial execution point of view, from a clinical acumen of how we engage with spine surgeons, and then rebuilding the spine portfolio. And so I think we're starting to see the fruit of that on stabilization. And we mentioned some of – Chris had mentioned some of the innovations around VIPER Prime, around conduit and inner-body cages, around symphony, which is going out in quarter four. And so clearly digital surgery is also going to be important that we launch that. To date, that has had a very minimal effect. As you know and you referenced, we do have a strategic partnership with BrainLab, which is offering us an -to-end navigation solution. And we actually, in quarter three, entered into a co-marketing distribution and R&D agreement with Tanavi, who is the market leader in orthopedics robotics in China. And actually it's the only arm-based robotic technology approved for spine in China. So clearly we feel like we have to have a digital surgery offering as well in spine.

Well, that's helpful. And the question for Joe, if I could, just I understand from your comments on the call that you're working through the plan for next year, and it's still not a full outlook for next year. But just if you could help us understand perhaps the puts and takes and how you think about spending, as you mentioned, balancing near-term to long-term against some of the -over-year challenges you may have elsewhere in the P&L, that would be super helpful just to maybe walk us through R&D and SG&A and any potential flex or opportunities you have in gross margin just at a high level, Joe, that would be super helpful.

Yeah. So I appreciate the question, Matt. I think I'm going to be respectful to the teams on letting them finalize their plans. What I would say in terms of puts and takes, I feel very good about the top-line growth. We need to see where the net of all the incremental, generic, and biosimilar erosions will eventually land as we go through the fourth quarter here. That will give us a pretty good insight. As you saw with medical devices, we expect to be around the market, so 4 to 5 percent is where we see that market overall. As you know, some of that is influenced by some of the higher segments where we yet don't have a, I'd say, a pronounced presence, but working our way towards that. But again, Ashley and the team have their line of sight in continued acceleration there. Maybe as a step back for the overall farmer market, we see about 4 percent growth for next year. And then in consumer, you know, you've heard from TiBo that we expect to be competitive with the market, which we anticipate will be around 3 percent, but the focus there has been on prioritization to skin health and self-care and improving the profitability profile. We're going to continue to invest in R&D. That's been a bias of ours for a number of years. You can see that when we issue our P&Ls that there's a disproportionate share, and that's where we grow as a percent to sales more often than not. And we're going to continue to look for those opportunities to advance the pipeline. I was really thrilled with the press release today, not simply because of the financial results, although I was very pleased with those. I would say it was the 15 items that were listed across our businesses of notable advancements in our pipeline. And that really just bodes well for the future. So, Matt, I appreciate the question. I apologize I can't give you a little bit more detailed guidance today, but stay tuned for our report out in January, and we'll be pretty specific then.

Great. Thanks, Matt. Appreciate it. Rob, next question,

please. And the next question is from Bob Hopkins with Bank of America.

Oh, thanks very much for taking the question. Just two really quick ones, given the strength in medical devices. I was wondering if you could comment on two quick things. One, you had very strong growth in hips and knees outside the United States. I was wondering if you could just elaborate on what drove that incremental growth. You know, was it market share? Was it market strength? And then just one last one on VIRB. I was just wondering when you think you'll be able to be in a position to provide us with a more detailed update on the timelines for filing and approval. And I ask in part because of your comments on the new cutters and in part because one of the other large competitors has now provided pretty specific timelines. So just those two quick device questions. Thank you.

Sure. Thanks, Bob. I think I'm pleased with the performance that we've had in hips, around 3%. You know, we have a strong portfolio in hips, and we're really leading the way on the anterior approach. We actually just completed a new acquisition of JointPoint, which is going to help us with kind of an interoperative software program to enable a more digitally oriented procedure in hips. I'd say hips is pretty balanced between OUS and U.S. You know, knees, I am encouraged. This is the first quarter in several quarters that we actually posted growth in knees of around 2%, really fueled by OUS performance. The U.S., I'll come back to that. Attune is performing well in the U.S. We've seen a pivot and start in primary and revision in Attune. We're working off some legacy transition in some of our legacy knee brands in Sigma. Really what's enabling knees is just a couple things. One, strength in commercial execution and our top six markets. It's also about innovation. We have a very strong foundation in our Attune knee platform that we've invested over 10 years in bringing to market. It's performing very well from an efficacy and safety point of view. We now have a full portfolio in the Attune revision, both fixed bearing and rotating platform. And we've also launched our cement list in quarter three. And then you can add to that, Bob. As you can see in next year when we'll have cement list and fixed bearing, we'll have our digital surgery offering in knees, I feel pretty confident that our joint platform will start to get back to the market performance. As it relates to VIRB, we have been progressing VIRB and all of the milestones to bring this to market. We have been preparing for kind of validation studies. We've been in active discussions with all regulatory authorities, both in the United States as well as in Europe. As I mentioned, we brought in a new CEO of VIRB, Kurt Azarbein, about 60 days ago. So we've been letting him get underneath the hood of what needs more focus, what we need acceleration. Very pleased with, again, the customer feedback from VIRB. What we've done is we've brought in the combination of AORUS, their leaders with Dr. Fred Moll and Kurt and Verily, our partner in Verily, of creating kind of this connected OR of the future. And we're in the middle of assessing how do we really optimize all of these assets to make a difference in healthcare systems. So we're still in the middle of that, and I expect to have that completed before the end of the year. Right now we're holding to the timelines, but I expect probably in quarter one with some updates we'll keep you posted. Thanks for the question, Bob.

Great. Thanks, Ashley. Rob, we have time for one last question, and then after that I'll turn it over to Joe Wolk for just some closing remarks.

Thank you. Your next question comes from Jason Bedford with Raven James.

Hi. Good morning. I'll keep it to one question, and thanks for squeezing me in. Just maybe for TiBo, and I apologize if I missed this earlier, but your international consumer business seems to have lagged -to-date about 1% growth. Can you give us a little detail on why the international growth has been a little slower, and then you alluded to a bit of a pickup in market growth next year in consumer. What are the big factors driving that better growth? Thanks.

Yeah, thank you for the question. Regarding, as you said, we had a very strong quarter in the U.S., a bit softer outside of the U.S. There are a number of factors, internal and external. Externally, we see some softness in some emerging markets, Latin America especially, and we are rolling out our baby, our new Johnson's Baby brand around the world. The rollout will be completed by the end of this year, and this has an impact on our shipments outside of the U.S. We have already completed this rollout last year, as we just talked about. Regarding next year, we anticipate a modest acceleration in the markets and geographies in which we compete from 2% to .5% this year to 3% next year. And as Joe just mentioned, we are finalizing our plans to grow competitively in these markets while continuing to work on our profitability agenda so we can improve our profitability and at the same time invest behind the growth opportunities we see in our priority areas.

Great. Thank you, Jason. Appreciate the question. Joe, final comments from

you? Sure. Well, first let me thank all of you on the webcast today for your time and your continued interest in Johnson & Johnson. Ashley, Thibault, Jennifer, Chris and I were certainly proud to discuss the quarterly results and also engaged in discussing the overall health of our business. What you hopefully saw from today's press release and the discussion that we're about to conclude is that you have a focused organization here on delivering transformational innovation for the betterment of health care and much broader society. We manage through any challenges that we face to deliver those results, not just over one year or five years, but many, many years, many, many decades, and hopefully you saw that on display today. So again, thank you for your time and we look forward to the next encounter.

Thank you. This concludes today's Johnson & Johnson's Third Quarter 2019 earnings conference call. You may now disconnect.