Johnson & Johnson (NYSE:JNJ) Q4 2022 Earnings Call Transcript January 24, 2023

Operator: Good morning and welcome to Johnson & Johnson's Fourth Quarter 2022 Earnings Conference Call. All participants will be in a 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. I would now like to turn the conference call over to Johnson & Johnson. You may begin.

Jessica Moore: Good morning. This is Jessica Moore, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of business results for the fourth quarter and full year of 2022 and our financial outlook for 2023. Joining me on today's call are Joaquin Duato, Chairman of the Board and Chief Executive Officer; and Joe Wolk, Executive Vice President, Chief Financial Officer. A few logistics before we get into the details. As a reminder, you can find additional materials, including today's presentation and associated schedules on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com. Please note that today's meeting may include forward-looking statements related to, among other things, the Company's future financial performance, product development, market position, and business strategy and the anticipated separation of the Company's Consumer Health business.

You're cautioned not to rely on these statements, which are based on current expectations of future events, using the information available as of today's date, and are subject to certain risks and uncertainties that may cause the Company's actual results to differ materially from those projected. In particular, there is significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic. A further description of these risks, uncertainties, and other factors can be found in our SEC filings, including our 2021 Form 10-K, which is available at investor.jnj.com and on the SEC's website. Additionally, 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 agenda, Joaquin will open with the comments highlighting his first year as CEO and his priorities for 2023. I will then review the fourth quarter sales and P&L results for the corporation and highlights related to the three segments as well as full year 2022 results for the enterprise. Joe will then close with additional business commentary before sharing an overview of our cash position, our capital allocation priorities and our guidance for 2023. The remaining time will be available for your questions. We anticipate the webcast will last approximately 75 minutes. I'm now pleased to turn the call over to Joaquin.

Joaquin Duato: Thanks, Jess. Good morning, everyone. I'm pleased to be here today to review our 2022 results and highlight my priorities for the business. I'm excited for the future of Johnson & Johnson. For over 135 years, people have counted on Johnson & Johnson to be at the forefront of healthcare innovation. This remains as true today as the day we were founded. And I'm honored to continue this legacy. In 2022, despite macroeconomic challenges, we delivered full year operational growth of over 6%. This is the result of the dedication and focus of our employees around the world, as well as the breadth and diversification of our business. There were many business achievements last year. Let me share some highlights. Our Pharmaceutical team achieved its 11th consecutive year of above market adjusted operational sales growth, excluding the COVID-19 vaccine, delivering nearly 7% growth as we continue to advance our innovation pipeline.

I'm particularly excited about the progress made across our multiple myeloma portfolio. This includes the launches of CARVYKTI, our first cell therapy; and TECVAYLI, our BCMA CD3 bispecific antibody, along with the recent filing of Talquetamab, our GPRC5D CD3 bispecific. In MedTech, we generated above 6% full year operational growth, anticipating our second consecutive year outperforming our competitive composite. In terms of innovation, we accelerated the cadence of new product launches and significantly enhanced the quality of our MedTech pipeline, including more than doubling the number of programs with over $100 million of net present value potential. Notably, we completed the acquisition of Abiomed, which positions us as the global leader in heart recovery and immediately enhances MedTech revenue growth.

This transaction will become accretive to earnings in 2024. Finally, we made significant progress towards the separation of Kenvue. We have begun operating our consumer business as a company within a company, and we filed our Form S-1 with the SEC, giving us the option to pursue an IPO as a potential step in the separation. Looking ahead, while we expect some of the headwinds that impacted 2022 to continue, we have proven that Johnson & Johnson is resilient in times of macroeconomic challenges. In this environment, our approach to 2023 can be best described as prudent, and our priorities for the year are clear and remain consistent. First, we are finalizing our plans for Johnson & Johnson to operate as a two-sector company, dedicated to competitive performance, both in Pharmaceutical and MedTech.

This change will enable us to become simpler, faster and more focused. In Pharmaceutical, we will continue delivering top line growth annually, while driving towards $60 billion in revenue by 2025. We believe we will be able to achieve our market growth in 2023 for the 12th consecutive year, even in the face of the STELARA loss of exclusivity and macroeconomic challenges. Growth will be driven primarily by our existing portfolio, including DARZALEX, TREMFYA, ERLEADA, INVEGA SUSTENNA and UPTRAVI, and also continued uptake from new launches, including SPRAVATO, CARVYKTI and TECVAYLI. In MedTech, with the acquisition of Abiomed, we now have 12 platforms with over $1 billion in annual sales. We expect to continue to build on 2022's momentum. We will do this by maximizing the commercial opportunity for recently launched innovations, continuing to advance the Abiomed pipeline and prioritizing investment in higher growth segments of our markets.

This will be a transformational year for Johnson & Johnson, which brings me to my next priority, completing the successful creation of our new Consumer Health Company, Kenvue. We remain on track to complete the separation in 2023 as indicated in our initial announcement in November of 2021. As we look forward, our track record gives us the confidence that we can grow ahead of our peers and cement the foundation for long-term success. Following 2021, a year where we substantially increased R&D investment, we continue our commitment to organic innovation. We invested nearly $15 billion in R&D during 2022. Also, we increased our dividend for the 60th consecutive year. We instituted a share repurchase and we deployed over $17 billion in M&A, including the acquisition of Abiomed.

Very few companies have the capability and the balance sheet to take such significant actions concurrently, especially in a year like 2022. I'm confident that we are well positioned for 2023 and beyond. In closing, I am energized about what is to come. As the largest and most diversified health care products company in the world, we will continue to use our scale and breadth to drive innovations, deliver for patients and shape the future of health care around the world. Now, let me turn it back to Jess.

Jessica Moore: Thanks, Joaquin. Starting with Q4 2022 sales results. Worldwide sales were $23.7 billion for the fourth quarter of 2022, a decrease of 4.4% versus the fourth quarter of 2021. Operational sales growth, which excludes the effect of translational currency, increased 0.9% as currency had a negative impact of 5.3 points. In the U.S., sales increased 2.9%. In regions outside the U.S., our reported sales declined 11.5%. Operational sales outside the U.S. declined 1.1%, with currency negatively impacting our reported OUS results by 10.4 points. Excluding sales from the COVID-19 vaccine, operational sales growth was 4.6% worldwide, 4.7% in the U.S. and 4.4% outside the U.S. As you will find in our supplemental sales schedule, acquisitions and divestitures had an immaterial impact on our results in the quarter.

Turning now to earnings. For the quarter, net earnings were $3.5 billion and diluted earnings per share was $1.33 versus diluted earnings per share of $1.77 one year ago. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $6.2 billion, and adjusted diluted earnings per share was $2.35, representing increases of 9.5% and 10.3%, respectively, compared to the fourth quarter of 2021. On an operational basis, adjusted diluted earnings per share increased 15.5%. For the full year 2022, consolidated sales were $94.9 billion, an increase of 1.3% compared to the full year of 2021. Operationally, full year sales grew 6.1%, with currency having a negative impact of 4.8 points.

Sales growth in the U.S. was 3%. In regions outside the U.S., our reported year-over-year sales declined 0.6%. Operational sales growth outside the U.S. grew by 9.1%, with currency negatively impacting our reported OUS results by 9.7 points. As you will find in our supplemental sales schedules, acquisition and divestitures as well as sales from our COVID-19 vaccine had an immaterial impact on our results for the full year. Net earnings for the full year 2022 were $17.9 billion and diluted earnings per share was $6.73 versus diluted earnings per share of $7.81 a year ago. 2022 adjusted net earnings were $27 billion and adjusted diluted earnings per share was $10.15, representing increases of 3.2% and 3.6%, respectively, versus full year 2021.

On an operational basis, adjusted diluted earnings per share increased by 9.2%. While not part of our prepared remarks for today's call, we have provided additional information and backup for our full year 2022 sales by segment, consolidated statement of earnings and adjusted income before tax by segment, which can be downloaded from our website. I will now comment on business segment sales performance highlights for the quarter. Unless otherwise stated, percentages quoted represent the operational sales change in comparison to the fourth quarter of 2021 and therefore, exclude the impact of currency translation. Beginning with Consumer Health. Worldwide Consumer Health sales of $3.8 billion increased 1%, with an increase of 10.9% in the U.S. and a decline of 5.8% outside the U.S. Excluding translational currency, worldwide operational sales growth increased 6.4% and outside the U.S., operational sales growth increased 3.2%.

Results were primarily driven by strategic price increases, growth in OTC due to a strong cough, cold and flu season, and growth in NEUTROGENA as well as strong new product introductions in Asia Pacific and Latin America. NEUTROGENA growth contributed to the second consecutive quarter of 5% operational growth for Skin Health/Beauty. Growth across the portfolio was partially offset by continued, although reduced supply constraints in the U.S. COVID-19 impacts in China, portfolio simplification and the suspension of personal care product sales in Russia. Moving on to our Pharmaceutical segment. Worldwide Pharmaceutical sales of $13.2 billion decreased 7.4% with declines of 0.6% in the U.S. and 14.9% outside of the U.S. Excluding translational currency, worldwide operational sales declined 2.5%, and outside the U.S., operational sales declined 4.5%.

Excluding the COVID-19 vaccine sales, worldwide operational sales growth increased 3.9%, U.S. operational sales growth increased 2.4%, and outside the U.S., operational sales growth increased 6%. Pharmaceutical growth, excluding the COVID-19 vaccine, was driven by our key brands and continued uptake in our recently launched products, enabling us to continue to deliver above-market adjusted operational sales growth for the 11th consecutive year, including 7 assets with double-digit growth. Growth was driven by DARZALEX, ERLEADA, STELARA and TREMFYA, and was partially offset by REMICADE and ZYTIGA, due to loss of exclusivity along with a decrease in IMBRUVICA sales. Within our oncology business, DARZALEX and ERLEADA continued to drive strong sales growth, with increases of 33.9% and 48.6%, respectively.

ZYTIGA sales declined 43.6% worldwide, predominantly due to loss of exclusivity in Europe in September. IMBRUVICA sales declined 12.3% worldwide due to competitive pressures and a suppressed CLL market due to COVID-19. Despite competitive pressures, IMBRUVICA maintains its market leadership position worldwide. In our immunology business, STELARA grew 6.2%, driven by market growth and share gains in Crohn's disease and ulcerative colitis, with gains of 4 points and 5.4 points in the U.S., respectively, as well as a favorable prior period adjustment impacting worldwide results by approximately 460 basis points. Results in the quarter were partially offset by unfavorable patient mix and rebating in the U.S. as well as austerity measures in Europe and shipment timing in Asia Pacific.

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TREMFYA grew 12.5%, driven by share gains in psoriasis and psoriatic arthritis, with gains of 1.4 points and 2.9 points in the U.S., respectively, along with market growth. Q4 growth was partially offset by a net unfavorable prior period adjustment impacting worldwide results by approximately 1,150 basis points, unfavorable patient mix and a challenging prior year comparison. Beginning in Q1 2023, we anticipate that CARVYKTI, currently reported in other oncology, and SPRAVATO, currently reported in other neuroscience, will meet the threshold to be separately disclosed. I'll now turn your attention to the MedTech segment. Worldwide MedTech sales of $6.8 billion decreased by 1.2%, with growth of 7.1% in the U.S. and a decline of 8.6% outside of the U.S. Excluding translational currency, worldwide operational sales growth increased 4.9%, and outside the U.S. operational sales growth increased 2.9%.

Excluding the impact of acquisition and divestitures, worldwide adjusted operational sales growth was 4.4%. Q4 growth was driven by commercial execution, strong new product introduction performance as well as COVID-19 procedure recovery in many parts of the world. Partially offsetting growth in the quarter was the impact of value-based procurement, COVID resurgence in China as well as supply constraints predominantly envision. Strong growth continued in the U.S., with dollar sales sequentially improving each quarter throughout 2022. OUS performance was adversely impacted by dynamics related to COVID-19, especially given our strong position in China. The Interventional Solutions franchise delivered another quarter of worldwide double-digit growth at 15.1%, driven primarily by strong new product introductions performance, commercial execution and continued market growth in electrophysiology.

Abiomed sales are also reported in Interventional Solutions, and financial results were reflected as of December 22nd, the date the acquisition closed. Contact lens global growth of 7.7% reflects strong performance of our ACUVUE OASYS 1-Day family of products, including the recent launch of ACUVUE OASYS MAX 1-Day, strong commercial execution and market appropriate price actions. Growth was tempered by continued supply challenges. In the orthopedics franchise, digital and enabling technologies reported in spine, sports and other continued to accelerate and drive pull-through sales in areas like hips and knees. For additional context, selling days had approximately a 60 basis points positive impact on results in the quarter. Now turning to our consolidated statement of earnings for the fourth quarter of 2022.

I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of products sold deleveraged by 70 basis points, primarily driven by onetime COVID-19 vaccine manufacturing-related costs, unfavorable currency impact in the Pharmaceutical business, inflationary pressures as well as unfavorable mix with the enterprise, with a lower portion of sales coming from the Pharmaceutical business. Selling, marketing and administrative margins leveraged by 150 basis points. This represents a 9% reduction versus the prior year, driven by phasing with higher spend earlier in the year as well as proactive management of costs given the current inflationary environment. We continued to invest strategically in research and development at competitive levels, investing 16.2% of sales this quarter.

The $3.8 billion invested was an 18.6% reduction versus the prior year, driven primarily by phasing with higher spend earlier in the year. Interest income was favorable to prior year by just over $100 million, driven by higher rates of interest earned on cash balances. The other income and expense line was an expense of $1.2 billion in the fourth quarter of 2022 compared to an expense of $9 million in the fourth quarter of 2021. This was primarily driven by onetime COVID-19 vaccine manufacturing-related exit costs, higher Consumer Health separation-related costs, higher costs related to the Abiomed acquisition and lower gains on securities. As we announced in Q2 2022, we continue to have commitments and obligations related to the COVID-19 vaccine, including external manufacturing network exit cost and required clinical trial expenses, associated with the Company's modification of its COVID-19 vaccine research program and manufacturing capacity to levels that meet all remaining customer contractual requirements.

Regarding taxes in the quarter, our effective tax rate was 16.2% versus 2.1% in the same period last year. The increase was primarily driven by more income in higher tax jurisdictions versus the prior year. Additionally, the Company benefited from onetime tax items in the fourth quarter of 2021 that did not repeat in the current year. Excluding special items, the effective tax rate was 16.2% versus 10.4% in the same period last year. I encourage you to review our upcoming 2022 10-K filing for additional details on specific tax matters. Lastly, I'll direct your attention to the box section of the slide, where we have also provided our income before tax, net earnings and earnings per share adjusted to exclude the impact of intangible amortization expense and special items.

Now, let's look at adjusted income before tax by segment. In the fourth quarter of 2022, our adjusted income before tax for the enterprise as a percentage of sales increased from 25.6% to 31.3%. Pharmaceutical margins improved from 33.9% to 38.2%, primarily driven by SG&A and R&D phasing, with higher spend earlier in the year, partially offset by the negative impact of currency and cost of products sold. MedTech margins improved from 18.1% to 25.3%, primarily driven by SG&A and R&D phasing, with higher spend earlier in the year, favorable portfolio mix and supply chain efficiencies, partially offset by inflationary pressures. Finally, Consumer Health margins improved from 18.6% to 22%, driven by brand marketing phasing with higher spend earlier in the year and supply chain efficiencies, partially offset by inflationary pressures.

This concludes the sales and earnings portion of the Johnson & Johnson fourth quarter and full year 2022 results. I'm now pleased to turn the call over to Joe Wolk. Joe?

Joe Wolk: Thank you, Jess, and thanks, everyone, for joining us today. As Jess shared, we reported solid results with competitive growth across our business segments in 2022. While macroeconomic challenges and lingering COVID-19-related impacts tempered our fourth quarter sales growth, we prioritized our top investments, while managing costs to yield slightly better margin performance than guided in October to meet our earnings expectations. The business is resilient, and we should be positioned well entering 2023. We are particularly proud of the advancements in our pipeline and portfolio to solidify the long-term, including the launch of TECVAYLI, the filing of Talquetamab in the U.S. and Europe, FDA clearance for our TELIGEN digital supply solution, the closing of the Abiomed acquisition and the tremendous progress made on separating our Consumer Health business.

Let's delve into the financials, beginning with our 2022 year-end cash position and execution against our capital allocation priorities. We generated free cash flow for the year of approximately $17 billion. And at the end of 2022, we had approximately $24 billion of cash and marketable securities and approximately $40 billion of debt for a net debt position of $16 billion. Despite macroeconomic uncertainty, we had a strong year deploying capital against all of our capital allocation priorities. These priorities remain unchanged. This past year, we invested more than 15% of sales for a total of nearly $15 billion in research and development. This investment has enabled the advancement of important programs, including strengthening our MedTech pipeline and progression of our multiple myeloma portfolio, which Joaquin referenced.

Investment in R&D remains a top priority to support long-term growth and value creation. Our second priority is our commitment to dividends. 2022 marked the 60th consecutive year in which we increased our annual dividend. We know investors value our dividend. And as a part of the Consumer Health separation, we intend, at a minimum, to maintain that dividend. As you can appreciate, we will need more clarity on the type of separation to determine how that is best achieved. Our third priority is strategic acquisitions, which is intended to complement our organic activities. In 2022, we closed the acquisition of Abiomed, strengthening MedTech's presence in higher growth segments, as well as more than 100 smaller early-stage acquisitions, licensing deals and partnerships.

Finally, our Board authorized a $5 billion share repurchase program in the third quarter. And as of the end of the year, we've completed approximately 50% of that program. In combination with our dividend, we returned over $14 billion to shareholders in 2022. I'll now provide our full year 2023 guidance. As we are still in the process of the Kenvue separation, our guidance represents the current Johnson & Johnson businesses, inclusive of Pharmaceuticals, MedTech and Consumer Health segments. We expect operational sales growth for the full year 2023 in the range of 4.5% to 5.5% or $96.9 billion to $97.9 billion. This guidance is provided on a constant currency basis, reflecting how we manage business performance. We estimate a favorable impact from net acquisitions and divestitures associated primarily with the Abiomed acquisition, and thus, are comfortable with your models reflecting adjusted operational sales growth in the range of 3.5% to 4.5%.

Our sales guidance continues to exclude contribution from the COVID-19 vaccine, which, as your models already correctly anticipate, will decline in 2023. As you know, we don't speculate on future currency movements, but utilizing the euro spot rate relative to the U.S. dollar as of last week at 1.08 as well as other currencies, we estimate there would be no impact from foreign currency translation on reported sales for the year. Regarding other items on our P&L, we expect 2023 adjusted pretax operating margin to be flat driven by continued inflationary pressures and cost of goods sold, offset by continued operating expense leverage. Regarding other income and expense, the line on the P&L where we record royalty income, the return on assets and actuarial costs associated with certain employee benefit programs as well as gains and losses related to items such as investments by Johnson & Johnson Development Corp., litigation and balance sheet write-offs.

On an adjusted basis, we expect this to be $1.9 billion, $2.1 billion for 2023. The majority of this income is associated with our employee benefits programs aligned with accounting disclosure requirements, rising interest rates, return on assets and program actions the team has implemented to derisk the plans have lowered our projected future benefit obligations. And based on current trends, we expect this benefit to continue through the next couple of years. We are comfortable with you modeling net interest expense between $250 million and $350 million. These figures include increased financing charges versus 2022 associated with the Abiomed acquisition. Finally, we are projecting an effective tax rate for 2023 in the range of 15.5% to 16.5% based on current tax laws and anticipated geographic income mix across our businesses.

Considering all these factors, we are guiding adjusted earnings per share in the range of $10.40 to $10.60 on a constant currency basis, reflecting operational or constant currency growth of approximately 2.5% to 4.5% or 3.5% at the midpoint. While not predicting the impact of currency movements, assuming recent exchange rates I previously referenced, our reported adjusted operational earnings per share for the year would be favorably impacted by approximately $0.05 per share, resulting in adjusted reported earnings per share in a range of $10.45 to $10.65 or $10.55 at the midpoint, growth of 4% versus the prior year. While we do not provide guidance by segment or on a quarterly basis, I'd like to provide some qualitative considerations for your modeling.

Some segment remarks, starting with Pharmaceuticals. We expect to again deliver above-market growth in 2023, driven by key assets such as DARZALEX, ERLEADA, TREMFYA, INVEGA SUSTENNA and UPTRAVI as well as continued uptake of recently launched products, such as CARVYKTI, SPRAVATO and TECVAYLI. This growth is despite lower Pharmaceutical market growth than experienced in recent years and considers the STELARA loss of exclusivity, which we anticipate occurring in late 2023 in the U.S. While we continue to expect volume growth for STELARA in the U.S. up to the LOE date, we expect this growth to be offset by pricing pressure. Further, we continue to expect a 2023 impact from other post-LOE products as well as potential increased austerity measures across Europe.

In MedTech, we expect continued competitive growth fueled by market recovery and continued commercial uptake of recently launched products. We anticipate a relatively stable recovery in procedure volumes with health care staffing constraints remaining the most significant limitation on the pace of recovery. Specific to China, we anticipate continued pressure into 2023 related to the easing of the zero COVID policies as well as impacts from volume-based procurement. As we've said, we're excited about the Abiomed acquisition, which accelerates our sales growth in 2023. In Consumer Health, we anticipate continued growth in line with the markets that we compete in. We also expect to continue to utilize strategic price increases across the portfolio to minimize the impact of ongoing inflationary pressures within the supply chain.

Regarding quarterly phasing, it's best summed up with a general theme that we expect the second half to be stronger than the first half and likely the second quarter is stronger than the first quarter. We are assuming the following to support these statements. In Pharmaceuticals, the first half of the year will be impacted by continued declines from LOE products in Europe that impacted Q4 2022 results, namely ZYTIGA and INVEGA SUSTENNA as well as continued pricing pressure. Also, we expect the ramp of new product launches will occur more prominently in the second half of the year. In MedTech, we expect second half operational sales growth to be higher than the first half of the year as we anticipate ongoing procedure recovery to improve as the year progresses.

We also believe that some of the COVID impact felt in China in Q4 will carry over into early 2023. And similar to Pharmaceuticals, uptake of new product launches is assumed to be more pronounced in the second half. Given we are in the registration process, regulations limit what we can currently discuss around the planned Consumer Health Company. On the P&L, we also anticipate operating margin to be better in the second half than the first half. This is attributable to inventory built in 2022 at higher costs driven by inflation that will flow through the P&L in the first half of 2023 and a second half that accounts for cost leverage driven by mitigation efforts and higher sales reflected in the comments I just made. And finally, while we don't speculate on future currency movements, utilizing the euro spot rate relative to the U.S. dollar as of last week at 1.08 as well as other currencies, foreign exchange would have a negative impact on our results in the first half of the year, but potentially a favorable impact in the second half.

Turning to key events in 2023. As mentioned, we are limited in the information we can provide around the planned Consumer Health separation. We publicly filed a Form S-1 on January 4th with the Securities and Exchange Commission, giving us the option to pursue an initial public offering as a potential first step in the planned separation, and we have started to operate Kenvue as a company within a company. Consistent with our initial announcement in November of 2021, we continue to expect to complete the separation in 2023. And we expect that any interim steps, such as an IPO, would be consistent with that timing, subject to market conditions. We are estimating $1.8 billion to $2.1 billion in after-tax Kenvue standup costs, with $1.2 billion having already been incurred through the end of 2022.

These estimates are in line with industry average for transactions such as this one, given Johnson & Johnson's market cap. In terms of dissynergies to be incurred following the completion of the separation, we are estimating between $500 million and $750 million of annual after-tax impact. We are already executing on plans to address these dissynergies and expect to have them fully mitigated by the end of 2024. As we separate new Johnson & Johnson, we'll also continue to reevaluate the level of ongoing financial information provided based on discussions with investors. While our financials will become simpler as we move from a three-segment company to a two-segment company, we will continue to look for ways to enhance our disclosures, such as providing quarterly R&D by segment and a patent expiry table in our Form 10-K.

We also expect 2023 to be an important year of scientific innovations and readouts across our segments. In our Pharmaceutical business, some examples include the potential approval of Talquetamab, our GPRC5D CD3 bispecific antibody in relapsed/refractory multiple myeloma. Potential clinical data from CARTITUDE-4, a trial studying CARVYKTI, our BCMA CAR-T in patients with 1 to 3 lines of prior therapy. The potential for an interim analysis of the MARIPOSA study of RYBREVANT plus lazertinib in frontline non-small cell lung cancer with EGFR mutations versus Tagrisso as well as potential clinical data from the PAPILLON study in frontline non-small cell lung cancer in combination with chemotherapy. Early clinical data from the Phase 2 SunRISe-1 study of TAR-200, our drug eluting device in non-muscle invasive bladder cancer.

Starting Phase 3 clinical program for milvexian, a Factor XI anticoagulant in partnership with Bristol-Myers Squibb. Potential Phase 2 clinical data from nipocalimab, our FcRn antagonist in rheumatoid arthritis and hemolytic disease of the fetus and newborn, potential Phase 3 clinical data from TREMFYA in Crohn's disease and ulcerative colitis. And finally, TREMFYA, our IL-23 inhibitor, was recently added to the National Reimbursement Drug List in China, which will take effect later this year. In MedTech, we look forward to providing information on significant innovation programs across the business, including expansion of our digital solutions in orthopedics, our digital robotic solution, Ottava, our pulsed field ablation solutions for cardiac ablation and advancements in our pipeline and clinical studies for heart recovery associated with Abiomed.

Overall, our approach to 2023 financial guidance should be viewed as responsibly cautious given the many external uncertainties. We are focused on delivering competitive growth for new Johnson & Johnson, while also completing a successful Consumer Health separation. We are confident that our current plans position us for long-term growth and value creation for shareholders. That concludes our prepared remarks. I am now pleased to open the line for your questions. Kevin, will you please provide the listeners with instructions if they'd like to ask a question.

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