Johnson & Johnson

NYSE:JNJ

Earnings Call Transcript 2021-Q2

[Operator]

Good morning. Welcome to Johnson & Johnson 's Second Quarter 2021 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. [Operator Instructions]. I would now like to turn the conference call over to Johnson & Johnson. You may begin.

[Chris DelOrefice, Vice President of Investor Relations]

Good morning. This is Chris DelOrefice, Vice President of Investor Relations for Johnson & Johnson. Welcome to our Company's review of business results for the Second Quarter and our updated financial outlook for 2021. Joining me on today's call is Joe Wolk, Executive Vice President, Chief Financial Officer.

Also joining Joe and myself during the Q&A portion of the call will be Jennifer Taubert, Executive Vice President and Worldwide Chair, Pharmaceuticals, Thibaut Mongon, Executive Vice President and Worldwide Chair, Consumer Health, and Ashley McEvoy, Executive Vice President and Worldwide Chair, Medical Devices.

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 and Johnson web site at investor.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 the cautionary statement included in today's presentation, which identifies certain risks and factors that may cause the Company's actual results, to differ materially from those projected.

In particular, there is uncertainty about the duration and contemplated impact of the COVID-19 pandemic. This means the results could change at any time, and the contemplated impact of COVID-19 on the Company's business results and outlook, is a best estimate, based on the information available as of today's date.

A further description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2020 Form 10-K and subsequent Form 10-Qs, along with reconciliations of the non-GAAP financial measures, utilized for today's discussion, to the most comparable GAAP measures are also available at investor.J&J.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. I will review the second quarter sales and P&L results for the corporation and the 3 business segments.

Joe will provide insights about our cash position and capital allocation deployment, and will outline our updated guidance, inclusive of the COVID-19 vaccine for 2021. Then we will begin the Q&A session with each of the segment leaders providing a brief update on their respective businesses.

The remaining time will be available for your questions. We anticipate the webcast will last up to 75 minutes. Now, let's move to the second quarter results. Worldwide sales were $23.3 billion for the second quarter of 2021, an increase of 27.1% versus the second quarter of 2020.

Operational sales growth, which excludes the effect of translational currency, increased 23% as currency had a positive impact of 4.1 points. In the U.S., sales increased 24.9%. In regions outside the U.S., our reported growth was 29.5%.

Operational sales growth outside the U.S. was 20.9%, with currency positively impacting our reported OUS results by 8.6 points. Excluding the net impact of acquisitions and divestitures, adjusted operational sales growth was 23.8% worldwide, 25.1% in the U.S. and 22.4% outside the U.S. Turning now to earnings.

For the quarter, net earnings were $6.3 billion and diluted earnings per share was $2.35, versus diluted earnings per share of $1.36 a year ago. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $6.6 billion, and adjusted diluted earnings per share was $2.48, representing increases of 49% and 48.5% respectively, compared to the second quarter of 2020.

On an operational basis, adjusted diluted earnings per share increased 44.9%. I will now comment on business segment sales performance, 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 second quarter of 2020, and therefore exclude the impact of currency translation. Beginning with Consumer Health. Worldwide Consumer Health sales totaled $3.7 billion and increased 9.2%, with increases in the U.S. of 12.4% and growth of 6.3% outside of the U.S.

Excluding the impact of divestitures, worldwide growth was 10%. Year-to-date adjusted operational growth was 3.3% and is more reflective of performance given the quarterly fluctuations of COVID-19 impacts.

The over-the-counter medicines grew 8.9% globally, driven by strong growth in ZYRTEC, due to both the timing of and increased incidents in the allergy season. Digestive Health grew double-digits driven by U.S. PEPCID, new skew stocking in the Club Channel, coupled with share growth and increased COVID-19 related healthcare professional recommendations for the hydration benefit offering, ORSL, in the Asia Pacific region.

The skin health beauty franchise grew 12.9% globally, with the U.S. increasing 23% and OUS increasing 1.4%. Skin health beauty outside the U.S. was negatively impacted by approximately 300 basis points due to divestitures.

Worldwide growth was driven by market recovery in key markets, increased U.S. stocking for new products, and comparisons to COVID -19 related destocking dynamics. NEUTROGENA and AVEENO delivered strong performance in the U.S., primarily due to market recovery, new product innovation, and higher stocking due to the NEUTROGENA rapid firming product launch, partially offset by competitive pressures. [Indiscernible] growth was driven by share gains and market growth in hair care.

Oral Care grew 2.5% globally due to strong OUS performance for LISTERINE, reflecting accelerated category and increased demand from continued successful promotional campaigns. Divestitures in the quarter, negatively impacted results by 310 basis points.

The Baby Care franchise grew by 5% as a result of market recovery and OUS strength in Johnson's and AVEENO Baby in eCommerce. Wound Care delivered strong growth of 13.4%, driven by U.S. market growth with increased consumer behaviors focused on preparedness and infection prevention, and seasonal stocking versus prior year COVID-19 destocking dynamics.

Moving on to our Pharmaceutical segment. Worldwide Pharmaceutical sales of $12.6 billion grew 13.6%, with strength in both the U.S. increasing by 12.2% and OUS with sales increasing by 15.4%. Excluding the impact of divestitures, worldwide growth was 14.1%. Global sales in the quarter included a $164 million contribution from the COVID-19 vaccine.

Additionally, as a reminder for comparison purposes, Q2 of 2020 was negatively impacted by access-related constraints due to COVID-19, resulting in a decrease of roughly 300 to 350 basis points in total across key brands. Our strong portfolio of products and commercial capabilities continues to enable us to deliver strong adjusted operational growth at above market levels.

Our immunology therapeutic area delivered global sales growth of 17%, driven by strong double-digit performance of STELARA and TREMFYA offset by declines in REMICADE due to biosimilar competition. STELARA continued to show strength in all regions, growing at 30.5% driven by increased market growth and share gains, with U.S. share increasing roughly 4 points in Crohn's disease and nearly 8 points in ulcerative colitis. TREMFYA was up 36.8% with strong double-digit growth worldwide due to share gains, continued global expansion into new markets, and additional penetration into the psoriatic arthritis indication that was approved in 2020.

U.S. share increased over 2 points in psoriasis and nearly 3 points in psoriatic arthritis in the quarter. Our oncology portfolio delivered another strong quarter with growth of 21.5%. DARZALEX continued its exceptional performance trajectory growing 53.8%, driven by share gains and increased penetration of the subcutaneous formulation in the U.S. and EU.

DARZALEX continues to grow share across all lines of therapy, with nearly 4 points of share growth in Line 1 in the U.S. this quarter. ERLEADA also continued its global momentum with growth of 73.7% in the quarter, driven by market share, which increased by nearly 2 points across indications, and penetration gains, especially in the metastatic indication.

IMBRUVICA grew 12.5% globally due to volume gains driven by our market-leading share, but was partially offset by modest share losses in the U.S. to novel oral competition and a market that remains slightly depressed due to temporary COVID-19 impacts on new patient starts.

In neuroscience, our paliperidone long-acting portfolio had strong double-digit growth of 10.6%, driven by market and share growth due to increased new patient starts and strong persistency. Cardiovascular, metabolism, other declined 7.3% this quarter, driven by continued biosimilar competition for PROCRIT and competitive pressures in INVOKANA, which was partially offset by growth of 1.8% in XARELTO due to continued demand strength.

Lastly, our pulmonary hypertension portfolio achieved growth of 8.7% with OPSUMIT growth of 11.9% and UPTRAVI growth of 9.8%, both driven by market penetration and share gains. I'll now turn your attention to the Medical Devices segment.

Worldwide medical devices sales of $7 billion grew 57.2%, with the U.S. increasing 77.2% and OUS increasing 41.9%, primarily due to the recovery of procedures from COVID-19 restrictions that occurred in the second quarter of 2020, coupled with the success of recently launched products and commercial activities across the business.

Selling days had a minor positive impact on growth this quarter. We expect the full-year impact from selling days, excluding the impact of the 53rd week in 2020, to be minimal. Given the extent of the procedure disruption from COVID-19 in 2020, I thought it may be helpful to provide context for our current quarter performance versus the second quarter of 2019.

Worldwide Medical Devices grew about 7% versus Q2 2019, with 8 of our 11 billion-dollar platforms showing growth versus 2019. The pace of market recovery in knees, spine, and vision-surgical, has been slower than the other markets in which we compete as these procedures are perceived to be more deferrable by patients.

Geographically, both the U.S. and Asia-Pacific markets surpassed Q2 2019. While EMEA and Latin America markets have been slower to recover, and Q2 results remained at or below 2019 levels. Looking at results for each of our platforms, Interventional Solutions delivered another strong quarter with worldwide growth of 71.3% and strong double-digit growth versus the second quarter of 2019.

Electrophysiology reinforced our global market share leadership position growing 74.4%, driven by recovery in the market coupled with our market expansion activities, the strength of our broad-based portfolio, and new products.

Worldwide orthopaedics delivered 48.6% growth versus the prior year, driven primarily by market recovery and success of newer product launches. Worldwide trauma delivered growth of 24.8%, reflecting market recovery, strength of our comprehensive portfolio, and success of newer product introductions.

This quarter, we expanded our market-leading portfolio of products with the launch of a next-generation Variable Angle Clavicle Plate System designed to enhance plate to bone fit on a broad range of patients and simplify implant selection for the surgeon.

And we launched an advanced tibial nailing system, designed to provide a more stable implant solution and create efficiency within the healthcare system by streamlining instrumentation across our portfolio.

Worldwide hips grew 68.1% this quarter, driven by market recovery, our continued leadership position in the anterior approach, demand for the ACTIS Stem, aided by our other enabling technologies, such as VELYS Hip Navigation and innovative commercial programs focused on expanding coverage and access for hip fracture patients in parts of Europe and Latin America.

Knees returned to growth this quarter, increasing 94.6% globally, primarily due to market recovery. Results reflect continued COVID-19 challenges and the related impact on procedures in markets like India, Japan, and Australia, and other dynamics, including faster recovery trends in primary knee procedures compared to revisions.

This quarter, we began commercialization of our VELYS Robotic-Assisted Solution for total knee procedures in the U.S. We believe this launch, along with our differentiated VELYS Digital Solutions and ATTUNE knee platform, including the second half 2021 launch of ATTUNE Cementless Fixed Bearing Knee with AFFIXIUM 3D Printed Technology, will enhance our portfolio and competitiveness as procedures continue to recover.

Spine returned to worldwide growth this quarter, increasing 51.7%, reflecting market recovery and positive impact from recently launched products, SYMFONY, CONDUIT and FIBERGRAFT, as well as strategic partnerships which further enhance our offerings, such as the X-Pac Expandable Cage.

Advanced Surgery grew 44.3% versus prior - year. In addition to the positive impact of procedure recovery, Biosurgery delivered sales growth of 48% and positive share momentum driven by new products and commercial strategies to expand market penetration and adoption. Endocutters and Energy both grew around 40% globally, primarily due to procedure recovery, new product introductions, and China Tier 2 and 3 hospital market expansion activities, partially offset by competitive pressure in the U.S.

We also achieved a significant milestone within the quarter with our Monarch robotic platform, surpassing a 100 customers and 8,000 procedures. General surgery grew 67.8% globally, with Wound Closure growing 50.1% globally, driven by recovery in the markets, continued strength of our market-leading suture portfolio, including our Plus sutures and STRATAFIX Barb suture family, and a change in channel inventory levels in the U.S., contributing about 6 points to global growth.

Global General Surgery sales were positively impacted by 23 points due to a prior-year unfavorable pricing adjustment in the U.S., we communicated last year. Worldwide Vision grew 66% this quarter, primarily driven by market recovery. U.S. Contact Lens growth of 73.6% reflects the strength of our market-leading ACUVUE Portfolio.

Commercial initiatives, such as our Prioritize Your Eyes campaign, launched to raise awareness around the importance of routine screenings, new products, including early success from ACUVUE Multifocal, and an inventory build contributing about 5 points. Growth outside the U.S. of 43.1% reflects market recovery and strength of ACUVUE 1-DAY, and recent Asia-Pacific ACUVUE DEFINE FRESH Beauty launch.

Global Surgical Vision delivered growth of a 115.8%, driven by market recovery and positive momentum related to new products like TECNIS Eyhance, TECNIS Synergy, which both launched this year in the U.S. market, and VERITAS, our next-generation phacoemulsification device.

Now regarding our consolidated statement of earnings for the Second Quarter of 2021, please direct your attention to the box section of the schedule. You will see we have provided our earnings adjusted to exclude intangible amortization expense and special items. As reported this morning, our adjusted EPS of $2.48 reflects a reported increase of 48.5% and an operational increase of 44.9%.

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. Cost of products sold improved by 340 basis points, primarily driven by the recovery in Medical Device from prior-year COVID-19 related inventory impacts and fixed cost deleveraging.

Selling, marketing, and administrative margins improved 110 basis points due to the recovery of Medical Device sales from the prior year's negative COVID-19 impact. We continue to invest in Research and Development at competitive levels, investing 14.6% of sales this quarter.

The $3.4 billion investment was a 25% increase versus the prior year due to portfolio progression. The Other Income and Expense Line showed Net income of $488 million in the Second Quarter of 2021 compared to net expense of 24 million in the second quarter of 2020, primarily due to reduced litigation-related items, partially offset by lower unrealized gains on securities.

Regarding taxes in the quarter, on a GAAP basis, our effective tax rate declined from 8% in the second quarter of 2020 to 5.8% in the second quarter of 2021, primarily driven by a one-time tax benefit the Company recognized in the second quarter 2021, resulting from an internal reorganization of certain international subsidiaries. In the second quarter of 2020, the Company recorded additional tax benefits related to the transitional provisions of Swiss tax reform, which benefited the 2020 tax rate.

Excluding special items, the effective tax rate was 14.8% versus 16.7% in the same period last year. I encourage you to review our 10-Q for additional details on specific tax matters. Let's now look at adjusted income before tax by segment.

In the second quarter of 2021, our adjusted income before tax for the enterprise as a percentage of sales increased from 29.1% to 33.4%. The The following are the main drivers of change to the adjusted income before tax by segment.

Medical Devices margin improved from 1.2% to 28.6% driven primarily by overall expense leveraging, resulting from the COVID-19 related sales recovery. Consumer health margins improved by 380 basis points, primarily driven by supply chain efficiencies, including the benefit from our SKU rationalization program, partially offset by increased investments in brand marketing expenses.

Pharmaceutical margins decreased by 450 basis points, primarily driven by increased research and development investment, inclusive of the COVID-19 vaccine net costs, and general portfolio progression. Moving to important developments, here is a slide summarizing notable developments occurring in the second quarter.

I'll highlight a few, starting with our Pharmaceutical business. We continue to make positive progress advancing our strong pipeline of innovative medicines and therapies. As we've shared previously, we are rigorous and focusing on differentiated, transformational medical innovation.

In the quarter, we announced our decision not to continue the collaboration and license agreement for Cusatuzumab, an investigational therapeutic antibody that targets CD70. The decision is based upon Janssen's review of all available data and in consideration of the evolving standard of care for the treatment of AML.

We received EU approval for PONVORY in relapsing multiple sclerosis, and also U.S. approval of RYBREVANT for the treatment of patients with locally-advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 Insertion Mutations.

In addition, we completed our EU filing for Cilta-Cel, a BCMA CAR-T for the treatment of multiple myeloma. We anticipate U.S. approval for our BCMA CAR-T later this year, which will represent a third NME approval this year.

Within our Medical Device portfolio, we continue to make meaningful advancements in our innovation pipeline, launching 17 major first-country launches in the first half of 2021, including 8 products this quarter. As noted earlier, we received FDA approval and launched TECNIS Synergy and TECNIS Synergy Toric II intraocular lenses in the U.S.

These are next-generation presbyopia correcting lenses, and deliver the widest range of continuous vision, and the best near vision among leading PC IOLs. Finally, within the surgery business, the ENSEAL X1 Curved Jaw Tissue S sealer launched in the U.S., expanding the Ethicon advanced bipolar energy portfolio.

That concludes the sales P&L and pipeline highlights for Johnson & Johnson 's Second Quarter. I'm now pleased to turn the call over to Joe Wolk.

[Joseph Wolk]

Thank you, Chris. Good morning. And thanks to all of you for joining us today to discuss our strong first half of 2021, specifically the high growth we experienced in the second quarter, and our updated outlook for the balance of the year. I hope everyone is having a safe, healthy, and enjoyable summer.

As Chris referenced, Johnson & Johnson 's businesses remain leaders, or are better positioned, within the markets in which they compete. While the pandemic makes it difficult to reliably gauge what results will be in any given quarter, you likely noticed that all three segments beat your expectations.

We continue to be poised for further growth and value creation not just in 2021, but more importantly for 2022 and beyond. Over the past 18 months, our people have been a driving force behind our success. And guided by our credo, they have demonstrated resilience and agility while remaining committed to ensuring our life-saving medicines and products reach patients and consumers around the world.

Thanks to the effors of our 136,000 colleagues across the world, Johnson & Johnson continues to make significant strides towards our mission of improving human health and well-being of everyone, everywhere. Foundational to any healthy business is a focus and commitment to broader stakeholder stewardship.

We are proud to share the progress we are making in a transparent and accountable manner. A few weeks ago, we held our annual ESG Investor Update following the publication of our 2020 Health for Humanity report and our 2025 goals. Through these goals, we aim to deliver even greater long-term value to our broad set of stakeholders.

I hope you had the opportunity to view this webcast. If you have not, the replay is still available on the Johnson & Johnson website. Let's get into the results with an update on our cash position. We continue to generate strong free cash flow, with approximately $8 billion year-to-date.

We ended the second quarter with approximately $25 billion of cash in marketable securities and approximately $33 billion of debt, resulting in $8 billion of net debt. Our financial position and balance sheet remains strong. As we enter the back half of the year, we are well-positioned to continue to deploy capital in a strategic, value-creating way that will benefit stakeholders over the long term.

Our dividend remains a key priority. And during the quarter, we distributed $2.8 billion to shareholders. Regarding M&A, we continually evaluate strategic opportunities that have the potential to further enhance our business, while also driving better health outcomes for patients and consumers.

Since Chris covered highlights from our second quarter performance and our worldwide shares will provide sector-specific commentary to open the Q&A session. I will now move directly to providing the update to our full-year 2021 guidance, which reflects our strong year-to-date performance.

For clarity, I will first comment on our core business revenue and then remark on our anticipated COVID-19 vaccine revenue, which is now included in our enterprise guidance. For full-year 2021, we continue to expect our base business defined as excluding our COVID-19 vaccine to remain strong.

Based on this confidence, we are increasing and tightening our adjusted operational sales range to 9.5% to 10.5%. This adjusted operational sales growth is on a constant currency basis, consistent with how we manage our business performance.

We are maintaining our estimate for the net impact of acquisitions and divestitures of approximately 50 basis points, which accounts for previously completed divestitures in Medical Devices, Consumer Health, as well as within other oncology in Pharmaceuticals, resulting in an operational sales range of 9% to 10%, or $90 billion to $90.8 billion for a midpoint of 9.5% or $90.4 billion.

While we don't predict currency movements, utilizing the Euro spot rate relative to the U.S. dollar as of last week at 1.18, and in consideration of other currency movements, there is no change from our previous estimates, resulting in favorable currency impact of $1.3 billion or a year-over-year increase of 150 basis points.

This results in estimated reported sales in the range of $91.3 billion to $92.1 billion, an increase of 10.5% to 11.5%, or 11% at the midpoint versus 2020. Now, a few words on the expected contribution of our COVID-19 vaccine to our updated full-year 2021 guidance.

Our goal has always been to bring forth our scientific capabilities and resources to develop a safe and efficacious vaccine that would complement other measures to end the global pandemic. We are proud to have been part of the unprecedented collaboration in the healthcare industry that has led to a number of authorized vaccines in the marketplace.

Chris shared earlier that we recorded vaccine revenue in the quarter. Specifically, our COVID-19 vaccine contributed a $164 million in revenue in the second quarter, bringing the year-to-date total to $264 million. At this point, revenue from the first half of the year was provisionally recorded at $5 per dose, given that volumes during the pandemic period were uncertain. Currently, we expect the ultimate final not-for-profit price could be as much as $8 per dose.

The final not-for-profit price will fluctuate until the end of the year when we know precisely all the variables that go into the calculation, namely the net cost incurred, as well as, volumes produced during the pandemic period. Given the firm contracts we have in place, pending advanced purchase agreements, we expect to recognize vaccine sales of approximately $2.5 billion in 2021, with more than half of that revenue likely to occur in the fourth quarter.

Regarding vaccine manufacturing, we continue to expand our global network to include 10 manufacturing sites for various stages of production. On July 2nd, the European Medicines Agency's Committee for Medicinal Products for Human Use approved an expansion of our facility in the Netherlands increasing our capacity to produce active drug substance.

The FDA also released 5 batches of drug substance manufactured at the Emergent BioSolution's Bayview facility under the Emergency Use Authorization, and we continue to work with health authorities on the approval of additional drug substance manufactured at Emergent.

Now, I do appreciate that many of you are understandably looking beyond 2021-2022. It is simply too early to provide specific information on a 2022 outlook for our COVID-19 vaccine, given the uncertainty on the need for boosters and new variance. But as recent published clinical data indicates, our vaccine appears to have durability for at least eight months and is effective against the recent Delta variant and other highly prevalent viral variance.

At this time, I'd caution you to wait to include future-year vaccine projections in your models for our business. The COVID-19 vaccine market will continue to evolve, and we look forward to sharing additional details as more data become available, including the role our vaccine will play for you to forecast future years.

Given this and what I already provided on our base business, our new updated guidance expectations are reflected on this slide, reflecting an enterprise total revenue of $94.2 billion at the midpoint. Moving to other items of the P&L. We are now expecting our operating margins to be nearly a 200 basis point improvement over last year, slightly less than our prior guidance as we continue to invest for the long term.

We are increasing our other income estimate to a range of $800 million to $900 million. This increase is primarily attributable to increased investment returns related to our employee benefit programs. As a reminder, pension service costs are recorded in operating expenses, while any investment performance related to our employee benefit programs are recorded in other income net expense.

Moving to interest expense. Based on our year-to-date experience, we are lowering our estimate to a range of 100 million to 200 million. Finally, we are lowering our effective tax rate estimate to a range of 16.0% to 17.0% based on certain one-time benefits realized in the first half of the year. The results of these updates translate to increasing our earnings guidance.

We are also tightening the guidance range. The new adjusted operational per share guidance range is 18.4% to 19.6%, or $9.50 to $9.60, with a midpoint of 19% or $9.55 per share. While not predicting currency movements, but to provide some direction on the impact of currency fluctuations on our reported adjusted EPS, we expect a slight change from what we communicated on the Q1 earnings call.

Currency will now impact EPS by 1.2% or $0.10 per share. Accounting for that, we would be comfortable with your models reflecting reported adjusted EPS ranging from $9.60 to $9.70 or a midpoint of $9.65, increasing 20.2%. Consistent with what we shared before, given the not-for-profit nature of the vaccine, there is no significant EPS contribution in 2021, and therefore, the EPS guidance I provided is inclusive of the vaccine revenue.

I am now pleased and want to thank our worldwide shares, Jennifer Taubert, Thibaut Mongon, and Ashley McEvoy, for their participation in the Q&A portion of our call today. I know this audience values having these leaders on earnings calls from time-to-time.

Before we jump into the Q&A portion of the call, I'd like to ask Jennifer, Thibaut, and Ashley, each to provide a brief business segment update and qualitative outlook for the remainder of 2021. Jennifer, let's start with the Pharmaceutical segment.

[Jennifer Taubert]

Well, thank you, Joe, and hello everyone. It's a pleasure to be here with you today. I'd like to start by thanking my Janssen colleagues around the world for their relentless focus on delivering for patients. As a result, I'm proud to share that our Pharmaceutical sector had another strong quarter of above-market growth.

As you heard from Chris, our Pharmaceuticals business delivered $12.6 billion in worldwide sales in the second quarter, with adjusted operational growth of approximately 14%. Our base business, excluding the COVID-19 vaccine, demonstrated robust growth at 12.6%. This is our third consecutive quarter with sales exceeding $12 billion, and our growth was broadly based across geographic regions and our therapeutic area.

We continue to maximize the value of our industry-leading portfolio, delivering double-digit growth for 9 key brands, including our oncology medicines, DARZALEX, IMBRUVICA, and ERLEADA, our immunology medicines, TREMFYA and STELARA, our pulmonary hypertension medicines, OPSUMIT and UPTRAVI, and INVEGA SUSTENNA and TRINZA in our neuroscience portfolio.

Our leading commercial and market access capabilities enabled increased market penetration and share gains across our key promoted brands. And as we shared in our transparency report this year, our growth continues to come from volume gains and not price.

This is a strong indication that our life-changing medicines are reaching more patients each day worldwide. It's important to note, we continue to be a trough investor in research and development. This investment fuels our pipeline and builds the foundation for our long-term growth.

During the second quarter, we continued to deliver on our pipeline of transformational medicines. I'll highlight just a few of the key milestones and achievements. First, in May, the FDA approved amivantamab now known as RYBREVANT. This is the first by-specific antibody approved for the treatment of non-small cell lung cancer, characterized by EGFR exon 20 insertion mutations.

This is our first approved treatment for lung cancer, which we hope will be an important area for us going forward. This is our second NME approval of this year. PONVORY, or ponesimod, was our first 2021 NME approval, and this was by the FDA in March, for the treatment of adults with relapsing forms of multiple sclerosis. In the second quarter, it was also approved by the European Commission and Health Canada.

We also advanced our BCMA CAR-T cell therapy program, Cilta-Cel, for patients with multiple myeloma. In the second quarter, the U.S. FDA granted our BCMA CAR-T priority review. A marketing authorization was filed with the European Medicines Agency, and submission was made to the Brazilian Health Regulatory Agency.

We anticipate FDA approval of Cilta-Cel as our third NME approval later this year. In addition, our subcutaneous form of DARZALEX continues to benefit an increasing number of patients. In the second quarter, the European Commission approved DARZALEX for 2 additional patient populations; as combination therapy for the treatment of adults with newly diagnosed systemic light chain amyloidosis, which is the first and only approved therapy for this rare and life-threatening blood disorder; and as combination therapy for adults with pretreated multiple myeloma.

Additionally, subsequent to the quarter, the FDA -approved DARZALEX FASPRO in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma after first or subsequent relapse, our sixth indication specific to our subcutaneous form of DARZALEX. I'm proud of our Pharmaceutical results in the second quarter and feel confident in our ability to make 2021 our tenth consecutive year of above-market growth.

Our outlook for the rest of the year remains strong. Before I close, I'd like to invite you to join us for our Pharmaceuticals business review on November 18. We look forward to sharing a comprehensive overview of our business, our robust pipeline, and our long-term growth outlook.

We'll cover our key therapeutic areas, including oncology and immunology, which are always areas of high interest, and we'll delve deeper into some of our newer areas, including our retina and gene therapy pipeline, and the details behind the breadth of our auto antibody program that came through our acquisition of MOMENTA last year.

I hope you'll be able to join us. So again, it's a pleasure to have this opportunity to connect with you today. Thibaut, I will now turn it over to you.

[Thibaut Mongon]

Alright. Thank you, Jennifer. And good morning to all of you on the call. I would like to start by congratulating my Consumer Health colleagues for their continued focus on flawlessly executing against our strategy. Last year we focused on execution across our broad-based portfolio, delivered solid results, growing 3% operationally. And this year, we continue to demonstrate a strong level of perfomance.

The strategy we set a couple of years ago for the Consumer Health segment to be focused on personal health with science-based, professionally endorsed brands, and advancing our digital capabilities, continues to strengthen our ability to meet the needs of our consumers and customers worldwide, resulting in strong quarterly results and solid year-to-date performance.

Our Consumer Health sector grew 9.2% operationally in the quarter and 2.7% on a year-to-date basis. Our adjusted operational growth for Acquisitions and Divestitures was 10% in the quarter and 3.3% on a year-to-date basis.

And as Chris stated in his remarks, these year-to-date results are a better representation of our performance given the fluctuations we've seen in the market due to COVID-19 dynamics and seasonality overall. We saw strong year-to-date performance for brands in our two strongholds such as ZYRTEC, PEPCID, and NICORETTE in OTC, or AVEENO, NEUTROGENA, and OGX in Skin Health.

In our specialty areas, brands like LISTERINE, AVEENO Baby, and BAND-AID also contributed nicely to our year-to-date results. And from a geographic perspective, we are encouraged to see that we grew across all regions in the quarter. Now, if we look into the future, even if we will continue to see variability in categories depending on seasonality and local market conditions, we are confident that our strategy is working.

We have the right portfolio to continue to deliver solid results; well balanced, both in terms of categories we compete in, and in terms of geographic presence. And lastly, we have been able to achieve our solid sales results while simultaneously improving our margin profile. Our efforts on end-to-end profitability improvement, including portfolio optimization and network improvements, have delivered to plan.

Our year-to-date adjusted IBT is approximately 27%, or another 250 basis point improvement over last year. We have made great strides in increasing our profitability to become a leader within our peer set.

And we will continue to look for opportunities to improve our margin profile, while at the same time investing to grow the topline, launching new products, and Chris referenced some of them in his remarks, and managing through anticipated higher commodity and distribution costs in the back half of 2021.

So in a nutshell, Consumer Health delivered a strong quarter and a solid first half. Our strategy is working and we are confident in our ability to continue to deliver profitable growth in line with the categories and market in which we compete. And now, let me hand over to Ashley McEvoy. Ashley?

[Ashley McEvoy]

Thank you. Thank you, Thibaut, and good morning. Thanks for joining. Let me just begin with across JNJ, how privileged we feel to work in healthcare because we recognize that what we do matters, especially now. We're united by our purpose to profoundly change the trajectory of Health for Humanity and we're propelled by our MedTech aspiration to re-imagine the future of health today, in three ways. One is innovating across the continuum of patient care, two is prioritizing and modernizing health, and three is promoting health equity and wellness.

We continue to see strong evidence that our focus and actions to impact human health and improve our competitiveness is working. This quarter, MedTech delivered sales of $7 billion, representing adjusted operational growth of 59% versus 2020 and, as Chris mentioned, up 7% versus 2019, bringing our first half of 2021 revenue performance to just over 5% compared to 2019. Our sales reflect market recovery and our positive competitive momentum.

Eight of our $11 billion MedTech platforms grew versus the second quarter 2019. And quarter one '21 share trends show, that we have maintained or gained share in ten of these platforms. We have an exciting pipeline, and we've achieved some truly amazing results in the first half of this year which position us well to continue our growth momentum. We've launched 17 major products in the first half of 2021. This is the highest number of first-half of the year launches in 5 years for our business.

These include products which will strengthen our core like TECNIS SYNERGY, our most advanced premier intraocular lens in surgical vision; and the ENSEAL X1 Curved Tissue Sealer, a next-generation advanced energy solution in our surgery franchise. We continue to focus on significant global health concerns, including myopia management, where we plan to have a portfolio of solutions for patients.

And we are progressing all things digital with solutions covering the entire paradigm of care, including open and laparoscopic procedures, orthopedics, and illuminal, interventional and vision. Our Monarch platform achieved a significant milestone reaching over 100 customers and enabling over 8000 bronchoscopies, which is life-changing, and potentially life-saving, in the detection and treatment of lung cancer. VELYS, our robotic assisted solution for total knee procedures, launched in the United States and received regulatory approval in Australia this month.

We're extremely pleased with the early customer engagement and feedback confirming the differentiation of this next-generation solution. And Ottava, our soft tissue digital surgery offering, continues to progress its key development milestones. We also recognize that the digitization of healthcare is happening and rapidly accelerating technology like this, making it possible to deliver new ways of care. An example of this is from our innovative team in China to develop the virtual solution powered by artificial intelligence and machine learning to more effectively train and expand the number of highly skilled electrophysiologists and provide broader access to high-quality care. Learning curves went from novice to experts from a year to 4 months.

In the first 4 months of launch, 150 newly trained physicians delivered care to 7500 patients. It's no surprise our Electrophysiology business in China is so strong. And we continue to leverage science to influence industry trends and positively impact patient outcomes and human health. Just this month, the UK modified their NICE guidelines to recommend the use of PLUS SUTURES as a standard of care, giving the evidence supporting their role in reducing surgical site infections and are necessary cost to the healthcare system.

Regarding the pandemic, we are seeing light at the end of COVID-19 tunnel, but this remains, as we all know, a very fluid situation. The pace of continued recovery will depend on multiple factors, including the speed at which global populations are vaccinated, healthcare capacity, and the ability to manage through surges, as well as the rate at which patients seek treatment. In closing, and I'd like to emphasize that our strong quarter 2 results and continuing momentum can be attributed to our purpose-driven, globally diverse team, which embody a winning spirit every day.

Their resilience, agility, and creativity have taken us to the next level in our business, build stronger relationships with our customers and patients, and defined a clear vision of our future. Thank you. And I look forward to your questions.

[Chris DelOrefice, Vice President of Investor Relations]

Great. Thank you, Jennifer, thanks, Thibaut and thanks, Ashley. Let's now move to the Q&A portion of the webcast. Rob, can you please provide instructions for those on the line wishing to ask a question?

[Operator]

Yes. Thank you. [Operator Instruction]. Please limit your questions to one question only. Your first question comes from Louise Chen with Cantor Fitzgerald.

[Louise Chen, Cantor Fitzgerald]

Hi. Congratulations on the strong quarter and thanks for taking my question. My question is about the global surge in COVID. There has been a surge despite high rates of vaccinations in many places in the world. So just curious, how do you think this could impact your business in the second half '21 if it continues to get worse? Thank you.

[Joseph Wolk]

Yes. Thanks for the question, Louise. I think it's probably best maybe that you hear from both Ashley and Jennifer on this specific perspective. Ashley?

[Ashley McEvoy]

Yeah, Louise. I would say -- listen, we're encouraged by, quite frankly, several things. How -- the ability that hospitals can manage through capacity in surges and labor, as well as, obviously, the vaccination efforts around the world. And just the patient, there's a significant backlog of care. If I look at the UK, my goodness, there's like 5,000,000 patients waiting for medical interventions, 400,000 of those folks waiting for surgery for the past 12 months.

But as we know, it's not going to be linear. We do know hospital systems in the United States are starting to delay care right now. I think quarter-to-quarter, it will improve, but it will never be a linear line.

[Jennifer Taubert]

I can add in. On the Pharma side, most of our core categories are pretty much back to the pre-COVID level, the exception on that actually being CLL. But we're really seeing strength coming back, for example, in the United States and in Europe. And we do anticipate some modest ups and downs, but I think our team really did an extraordinary job last year of partnering with healthcare systems, and physicians, and patients to make sure that they could get on and stay on the therapies that they need.

So our outlook for the rest of the year really remains strong for our sector, regardless of what happens with emerging variants and any continued blips as it relates to COVID.

[Joseph Wolk]

I'd also add, Louise, that I think we've got to really tip our cap to the healthcare administrators, health professionals across the globe. We're in a much better position to handle a pandemic than we were of March of last year. And so, certainly, that would have, I would say, a favorable impact on whatever unfavorable events may occur. We really need to recognize just the great resiliency and agility that those individuals have shown as well.

[Chris DelOrefice, Vice President of Investor Relations]

Thibaut, do you want to share a little bit about consumer and the momentum you see there, and maybe some couple of the category dynamics as well?

[Thibaut Mongon]

Now, we see strong momentum across our broad-based portfolio as I told you earlier this morning, Our categories will continue to be impacted by market level conditions, seasonality. Having said that, we have proven, over the past 18 months, is that our broad-based portfolio, in terms of both categories and geographies, allowed us to weather whatever external conditions happen. And we expect continued momentum into the back half of the year.

[Chris DelOrefice, Vice President of Investor Relations]

Great, terrific. Thanks, Louise. I appreciate the question. Rob, next question, please?

[Operator]

The next question comes from the line of Larry Biegelsen with Wells Fargo. Please proceed with your question.

[Larry Biegelsen, Wells Fargo]

Good morning. Thanks for taking the question. Actually, just a finer point on the quarter-over-quarter improvement in device, as you mentioned. Do you expect the continued acceleration relative to 2019 in Q3 and Q4? And Joe, could you just help us think about the operational ex - COVID vaccine sales in EPS cadence in the second half, given the easier comp in Q3 and the extra week in Q4 2020? Thanks for taking the questions.

[Ashley McEvoy]

Sure. Thanks for the question, Larry. I think what you heard is, in quarter 2 we were up about 7% relative to 2019, and that was pretty broad based. I'd say 3 out of 4 of our franchises posted growth versus 2019. Orthopedics was down about a point. We were up in the United States about a point. Down about 3 points in orthopedics in OUS in quarter 2, really due to some of the slower moving countries like Japan and India in opening up in COVID.

When I think about quarter 3 and quarter 4, I do expect continued momentum. You'll recall last year, we were down about 3% in quarter 3 versus 2019, and we were down about 1.5% in quarter 4 2020 versus '19. I do expect continued progress. I expect Orthopedics to go positive. I expect Vision to accelerate, given a lot of the new product launches. As we've discussed, we think the category is going to be high double-digit. We expect to be more in the high single-digit at the end of this year versus 2019.

[Joseph Wolk]

Yeah. And Larry, with respect to your question on guidance overall, I think I'd almost have to mirror a little bit what Ashley had said, the comparables were going to be most pronounced for the second quarter. There will be a little bit of benefit as we look into the third and fourth quarter. As you know, we don't provide guidance by quarter. But I really looking at the underlying strength of each of our businesses, improved share in the markets in which we lead and for those that which we don't lead. In addition to the -- what you heard from all 3 of our segment leaders, just an improved cadence of innovation; new approvals, new offerings that offer better healthcare solutions. That's how we're thinking about it.

From an EPS perspective, we are challenging our teams to continue to invest. We think when we have 10% top-line growth, then EPS growth, that will approach 20%. We think that's very healthy to take it up today on top of what we delivered in January, which surprised to the upside as well. We want to make sure that we don't only deliver strong results in the current quarter or the next 2 quarters, but really in the middle and back half of this decade as well. We think we're very well-positioned to do that.

[Chris DelOrefice, Vice President of Investor Relations]

Great. Thanks, Larry. Appreciate the question. Rob, next question, please.

[Operator]

Your next question comes from the line of Chris Schott with JP Morgan. Please proceed with your question.

[Chris Schott, JP Morgan]

Great. Thanks so much for the questions. I guess my question is just on the core revenue growth guidance. I think you've raised it twice this year. I'm just looking for a little bit more color of what's driving the upside versus your expectation? Is this more device versus pharma or consumer? Is it share gain versus overall market growth? Other geographies there standing out? I'm just trying to get a sense of like really what would've been the real upsides versus your initial expectations?

Having to slip a second quick one in, I think you mentioned the Pharma margins were impacted by increased investments in 2Q. Should we be thinking about that as a one-time event with the COVID vaccine expenses, et cetera, or are we entering kind of a sustained period of R&D ramp here or where we could see with some of those margins under pressure? Thank you.

[Joseph Wolk]

Yes. Chris, let me take a stab at that and maybe, Jennifer, you can chime in with anything that I might have missed. But with respect to the revenue guidance, Chris, I would say, coming into the year, just like every other Company and probably every other industry, we remained a little bit cautious with respect to how the recovery would unfold; would there be new variants?

And so we took a, what I thought was a very responsible and prudent approach to our expectations at the beginning of the year. That being said, I don't want to undermine just the operational performance that each of the teams are executing upon as we go throughout this year. What we did learn, and it really is a credit to the leaders that you've heard from today and their teams, just how important it is reaching out to customers during the last 18 months, not only to find out what the status of COVID-19 was and how it was impacting the businesses, but also how Johnson & Johnson could help them in the recovery.

And I think that is having some, I'll call it a goodwill factor, with respect to how we're approaching our business today. With respect to operating margins in R&D, I would say that the COVID investment for the vaccine specifically is a small part of it. What we're seeing, and really what we all take great pride in is there's not one big outlying expense item or investment item in the quarter or even year-to-date with respect to milestones. It's really just the maturity of the portfolio, again, across all three segments That really positions us well. Last year, you might recall we increased our R&D investment by $800 million above 2019 levels. Even with all the questions and uncertainty, and even though maybe competitors pulled back a little bit, we know the only right answer was to invest for the long term.

We're actually at a pace this year through 6 months, about $1.3 billion above last year's level on a 6 month comparator. So we feel very well-positioned. And again, with how I answered Larry earlier on the EPS accretion, we think we're hitting the mark across all aspects. I don't know, Jennifer, if there's anything else you want to add.

[Jennifer Taubert]

What I'd add in, we really focused on being a transformational medical innovator and we know that we do disproportionately invest in R&D versus the other areas of our business. If you take a look at the strength of our pipeline as well as the continued progression, we are seeing more assets transitioning into those later stages of development that require additional costs. And as Joe had indicated earlier, the beauty right now of the strength that we have for the business is it's allowing us to invest for those future waves of innovation. We feel real good about the level of investment for R&D in the Pharm group.

[Joseph Wolk]

And just so nobody has a takeaway, we're only investing in pharmaceuticals. We're investing in digital surgery capabilities that Ashley mentioned, we're investing in the consumer space, connecting with the consumer in more digital enabled ways. So it's really across the board.

[Chris DelOrefice, Vice President of Investor Relations]

Yeah, Chris, and I would just add. I guess on the Medical Device side, actually alluded to the amount of innovation we've seen in the quarter. So I think some of the strength you're seeing on the top line is clearly the result of the focus on bringing strong innovation to market. We're well-poised over a two-year period to deliver nearly 40, what we will call major new product launches, which is significant increase from where we've been.

I think you're seeing that coupled with the recovery in MD results and then clearly in Pharm. Double-digit growth year-to-date, strong above-market performance. I think those investments are paying off, and focus on innovation will be a core focus of ours. Thanks for the question, Chris. Rob, next question, please?

[Operator]

Your next question comes from the line of Bob Hopkins with Bank of America. Please proceed with your question.

[Bob Hopkins, Bank of America]

Okay. Thank you very much. Just a quick one for me. For MedTech, thank you for giving that 7% number versus 2019. I was just curious, is that a reported number or is that a number that adjusts for currency? And then one other thing I'd love a quick comment on is on the COVID -tied questions. Just curious, especially on the the Device side, Ashley, is there a major geography right now where increasing levels of hospitalization have you particularly concerned or are we not quite at that stage yet?

[Chris DelOrefice, Vice President of Investor Relations]

I guess, first real quick, Bob. The 7% is an adjusted OPS growth number. Just for consistency, so you understand underlying organic.

[Ashley McEvoy]

Yeah. And Bob, just to -- again, thanks for the question. Again, we've had the benefit to learn from how this virus manifests around the world, starting with China. Asia is a region that is above 2019 in terms of procedure volume, clearly really driven by China. We've seen that Japan 's in lockdown. We know that Australia went back to lockdowns recently. We know India is digging out. So some of those other countries are going to be slower to recover.

EMEA, we've been -- which has been at a slower pace than the United States. We actually see a lot of acceleration happening right now in EMEA, with the vast distribution and uptake of vaccinations and quite frankly, the backlog of patients that really need to be cared for. As I mentioned, I share a little bit of the waiting list data in the U.K.. And then U.S. in quarter 2 has had significant recovery versus the first quarter. I look at data like in January, we were down. Medical procedures were down about 6% in January versus 2019.

And in May that went positive to up about 3%. But as I mentioned, it's going to be not a vertical line, given the recent surges that are happening in hospital systems in the U.S., like Florida, like Michigan in the midwest. So, again, I think our systems are unbelievably equipped to manage through this. I have huge respect and admiration for a lot of our customers who are managing COVID as well as non-COVID patients.

[Chris DelOrefice, Vice President of Investor Relations]

Thanks, Bob. I appreciate the question. Rob, next question, please.

[Operator]

The next question is from the line of Josh Jennings with Cowen. Please proceed with your question.

[Josh Jennings, Cowen]

Hi. Good morning. Thanks for taking the questions. Joe, I was hoping to just -- as we're thinking about 2022 and you are encouraging the street to exclude COVID vaccine revenues from our forecast. I was hoping just to better understand the COVID-19 vaccine margin impact in 2021. It seems to be margin dilutive, but how we should be thinking about the core businesses margin for a baseline for a great 2022 forecast.

[Joseph Wolk]

Yeah. Josh, I would say at this point, it's really a minimal, in terms of both the segment, as well as, certainly Johnson & Johnson 's margin profile. Thus far through 6 months, it's been dilutive, again, to a minimal amount. We expect that dilution to reverse itself in the second half of this year. But again, being a not-for-profit, there's no material impact on EPS despite the 2.5 billion revenue estimate that we've provided earlier today.

[Chris DelOrefice, Vice President of Investor Relations]

Thanks, Josh. Appreciate the question. Rob, next question, please?

[Operator]

Next question is from the line of Terrence Flynn with Goldman Sachs. Please proceed with your question.

[Terrence Flynn, Goldman Sachs]

Great. Thanks so much for taking the questions. I guess the first one is just on the duration of protection with the vaccines. Joe, you touched on this a little bit. But maybe just, what's your perspective on how often a booster might be required here, and then can you remind us the timing of your 2-dose Phase 3 trial? And then Jennifer, would love any more details you could provide on the DARZALEX subcu-conversion and the IMBRUVICA competitor dynamics that you mentioned. Thank you.

[Joseph Wolk]

Yes. Terrence, thanks for the questions. I would say in terms of the booster, whether it's needed or not, I think we should really defer to health officials around the world as to what that call will be. We do like the durability of at least 8 months.

For our vaccine, we think that's better than some of the other vaccines that are out there, not to disparage them in any manner whatsoever, but health official still have not made any type of decisions on when or if a booster will be needed, so we'll just defer to them when more data is collected.

[Jennifer Taubert]

Perfect. So then, as it relates to DARZALEX, starting off with DARZALEX, we saw the very strong results that we had in the quarter. Also, the significance of the additional indications that continue to come through, and our 6th indication specifically for the DARZALEX FASPRO application. As we take a look so far across the business, already 60% of our DARZALEX business is in the subcutaneous form, and that's whether we look at the United States or whether we look outside the U.S. And so very, very rapid adoption as well as expanded into additional patient populations for DARZALEX.

We're very, very confident in the uptake and this is really providing significant benefits from patients going from multiple-hour infusions down to a 3-5 minute injection. A lot of good things to come on DARZALEX. As it relates to IMBRUVICA, we're seeing very strong growth for IMBRUVICA outside the United States.

Right now, a 22% growth in the quarter. As we take a look at IMBRUVICA overall, we had double-digit growth, but obviously less than that in the U.S.. In the U.S., we're still a bit impacted. The patient volumes and new patients starts are still down a little bit and CLL due to COVID. For these patient populations there can be more of a watchful waiting period or sometimes treatment with older therapies.

And so we did see a slower growth rate, particularly in the U.S. in the quarter. but we do anticipate that to rebound as we move forward and more people get vaccinated. As it relates to the competitive dynamics, IMBRUVICA remains a number 1 prescribed treatment in CLL, and Relapsed/Refractory MCL, and also Waldenstrom. It's a number one BTKI wherever they are prescribed.

It's also the only agent that's got demonstrated overall survival in first-line CLL, and a safety profile that's supported by over 5 years of follow-up in clinical experience. We believe we've got a great profile that stands up competitively with IMBRUVICA and will continue to be able to deliver great growth for us going forward.

[Joseph Wolk]

And Terrence, with respect to your question on the 2-dose study for the vaccine, we would expect that data to be late Q3, early Q4 at this point.

[Chris DelOrefice, Vice President of Investor Relations]

Thanks, Terence, appreciate the question. Rob, next question, please.

[Operator]

Next question is from the line of Matt Miksic with Credit Suisse. Please proceed with your question.

[Matt Miksic, Credit Suisse]

Hey, thanks so much for taking our question. Just one -- just quick follow-up. I know that there were some questions early on on the tone of the market and COVID and trends for the back half of the year. But just to clarify, specifically for Ashley, the third quarter, for those businesses that are in the past, the Med Device businesses that have been seasonally off, down slightly, flattish from Q2 to Q3.

Is that the pattern when you talk about improving momentum? And is that the pattern we should see a normal seasonal pattern or is the momentum you're describing something that would actually take this -- some of those businesses up sequentially? And I have one follow-up if I could.

[Ashley McEvoy]

Yeah, Matt. I think -- thank you for the question. I would tell you that what we've experienced is maybe some bookends like our Electrophysiology business, our AFib, treating cardiac ablation has recovered very expeditiously. And that team right now is just really working on refilling the patient funnel. At the other bookend, I would say would be cataract surgeries, which are -- procedure volumes are still below 2019. We would expect that one to significantly accelerate on a balance to go. So it really depends by procedure. They really are meeting the bell curve, if you will.

And again, as I kind of come back to what's going to affect the pace. It's really the pace of vaccinations, pace at hospitals being able to match the capacity and keep a highly engaged, healthy workforce and manage through some of the surges that we're seeing right now in the U.S. and other pockets of the world. And then just really patients sentiment. There's been a lot of investment that JNJ has been doing to reassure patients to go seek medical care.

And I think we've seen a lot of the facts, and data, and publications on the impact on non-COVID patients who haven't seek ed care. So we expect that to continue. We don't expect, again, a perfect linear line. I keep saying that because we learn every week, we take four steps forward and maybe a step back. Thank you.

[Matt Miksic, Credit Suisse]

Super. And then just one on Vision if I could. You mentioned the approval of Synergy in the U.S. I know it's been out. This is the presbyopia correcting IOL that's been out for a while in Europe. Just wondering if you can tell us what that has done for the European business, what the response has been, and how you're thinking about that mapping over to the U.S.? Thanks.

[Ashley McEvoy]

Sure. We've seen really strong performance of the TECNIS Synergy in EMEA. We are growing market share in EMEA in vision surgery and that market's had a lot of available premium intraocular lenses. We're pleased to bring that technology to the United States. We just launched in quarter 2, there's been very good pickup. It's also complemented, as Chris was mentioning, with our first innovation in the phacoemulsifier, the VERITAS.

So the combination of those 2 with really our first advancement in Monofocals and the TECNIS Eyhance, which just launched earlier in quarter 1, the combination of those 3 innovations, I expect should improve our current run rate of revenue performance in the U.S. Surgical Vision. And as you heard in quarter 2, we did grow revenue versus 2019 in OUS. And so I expect that that should get -- have the U.S. start to pick up more in the back half of the year.

[Matt Miksic, Credit Suisse]

Thanks, Ashley. Appreciate it.

[Chris DelOrefice, Vice President of Investor Relations]

Matt, thanks for the question. Rob, next question, please?

[Operator]

The next question comes from the line of Joanne Wuensch with Citi. Please proceed with your question.

[Joanne Wuensch, Citi]

Good morning. And thank you for taking the question. Two of them. One, could you sort of give us a little bit of update and color on the ORTHOTAXY adoption. You did provide some statistics on MONARCH, but anything else that you can sort of add in that bucket? And then my second question is, I might be reading the tea leaves a little bit here, but you sounded maybe just a little bit stronger on the idea or concept of M&A. Am I interpreting that correctly?

[Ashley McEvoy]

Thanks, Joanne. I'll start and then I'll turn to my colleagues to talk a bit about M&A and some of the other businesses as well. I would say we were very encouraged. We've had about 750 on-hand demonstrations with our VELYS knee digital surgery offering. We've done about 100 cases to date. What we keep hearing from customers who have been giving us really positive feedback on a couple of things.

The value of the system, smaller footprint, the image's interoperative capabilities, and really the ease of integration for surgeons and OR teams, the workflows, reducing the heavy physical and financial burdens of the currently available marketplace offering. It's new. We just got approval also in Australia, so we're going to start to do cases in Australia. And I would say very, very encouraging. We have several different commercial models that were assessing and we're seeing hospitals take really multiple archetypes, so stay tuned on that.

And then I think you had a second question, Joanne, on M&A. And I would just say for MedTech point of view. You're seeing, we've invested over $10 billion of capital in M&A, really behind getting into iHealth. Getting more significant into digital surgery. And then really starting to invest in, I'll call it standard of care changing technology. It's like new ways in ablation. For liver ablation was the first indication.

Right now we are under clinical trial to partner that technology with our endoluminal Monarch technology for lung cancer, the treatment of tumors -- bleeding tumor cells. We're also in first-in-human in oncolytic viruses and drug delivery using Monarch. As well as starting to get a stronger foothold in the fast-growing area of stroke.

Our stroke business was up over 30% in quarter 2 relative to 2019. Again, a procedure that was less affected in the COVID environment that we continue to build down to. But I'll turn to my colleagues to talk a little bit about M&A.

[Jennifer Taubert]

One of the things that helps us be really successful here is that we're truly agnostic to the source of innovation. So the win is having something that's really transformational and being able to get it to patients. It' not where it originated from. And so as a result, about 50% of our products come internally, 50% externally. So for example, late last year, we brought in [Indiscernible] we made the acquisition of MOMENTA, we brought in TARIS as a drug delivery device for bladder, a gene therapy for geographic atrophy and age-related macular degeneration from Hemera.

And so we really do work very, very assertively to find the best technologies in our key areas of focus. And many times that's coming from our internal labs. Many times it's also coming externally. Our strategy and interest there remains the same and making sure that we've got the best innovation for patients going forward. I feel like we're doing a really good job on that front.

[Thibaut Mongon]

And in Consumer Health, I would say that we have a very strong portfolio of iconic brands that we continue to develop very quickly. Mostly, we continuously scan the market for opportunities to find either new go-to-market models or close gaps in our portfolio. But if you look at the acquisitions we have made over the past couple of years, we are really pleased with their performance. All of them, whether it's in self-care or skin health, are performing well. And that's very encouraging for the future.

[Joseph Wolk]

And, Joanne, I'll just say you're going to force me to review the transcripts in maybe more detail than I usually do. I didn't think our language changed much. We always remain pretty aggressive when it comes to rigorous portfolio management; making sure that we're making the most of the scientific expertise, the commercial capabilities that we have, and we just got to find deals that really fit the financial construct in a disciplined way.

Whether it's in MedTech, Pharmaceuticals, or Consumer, we look across the board really monthly, if not more often, at opportunities that may fit nicely within the Johnson & Johnson business.

[Chris DelOrefice, Vice President of Investor Relations]

Thanks, Joanne. Appreciate the question. Operator, last question, please.

[Operator]

Yes. That question will be coming from the line of Jayson Bedford with Raymond James. Please proceed with your question.

[Jayson Bedford, Raymond James]

Good morning. And thanks for squeezing me in. Two unrelated questions that require, I think, quick answers. I'll ask both upfront. First, on the potential knock-on impact of the vaccine, I appreciate the not-for-profit nature of the product.

But do you expect to see a halo effect, meaning do you think the vaccine will help pull through or benefit other areas of the portfolio? And then my second question, maybe for Thibaut. At 28%, how much further can consumer margins go? And then any further commentary on the inflationary pressures that you alluded to in the commentary? Thanks.

[Jennifer Taubert]

I'll jump in on the vaccine question first. Really, we're really proud of what we've been able to do in bringing forward a COVID vaccine. And we see this as, really, the start of what will become a vibrant vaccine business for Johnson & Johnson. You were talking about the halo effect or a knock-on effect. We believe the good that we're doing in the world, and that we will continue to be doing on the COVID vaccine, is a great start.

And in our pipeline right now, we've got a number of vaccines in development that we hope to have positive results coming from, including an RSV vaccine, an HIV vaccine, one for prevention of sepsis and others that we're looking at. We hope this to be a start of what will become a very vibrant vaccine business for us over time.

[Thibaut Mongon]

Yeah. And to your question on consumer. As I said, we have seen the first half, and we continue to expect into the back half of the year pressure in part of our Portfolio in terms of commodity inflation and distribution costs. We are prepared to absorb those. And in terms of margin improvements, we are committed to continuously improve our margin profile. But as I said, it's going to be a mix of continuing search for efficiencies, but also investment in our business, whether it's brand-building activities or new innovation program.

[Chris DelOrefice, Vice President of Investor Relations]

Great. Thanks, Jayson. Appreciate the question. And thanks to everyone for your questions and your continued interest. Apologies to those we couldn't get to because of time, but don't hesitate to reach out to the Investor Relations team as needed. I'll now turn the call back to Joe for some brief closing remarks.

[Joseph Wolk]

Great. Thank you, Chris. And thank you really, everyone for joining today's call to discuss our second quarter results and updated outlook. We are incredibly proud of the relentless focus each of our JNJ colleagues apply to really meet patient and consumer needs around the globe, resulting in a strong financial performance this quarter across the enterprise while simultaneously investing for a very strong future.

I'm very confident in our outlook for the rest of 2021. Our business is performing even beyond the mathematical year-on-year comps. And hopefully, that's your takeaway today. Thank you for your time and bye for now.

[Operator]

Thank you. This concludes today's Johnson & Johnson Second Quarter 2021 Earnings Conference Call. You may now disconnect.