Abbott Laboratories (ABT)

“For the third quarter, we forecast adjusted earnings per share of $1.38 to $1.46”

“Which includes our expectation for exchange to have a negative impact of approximately 1% on third quarter sales.”

“we expect to transition from limited market to a full market release in the third quarter.”

“My confidence remains high in that second half acceleration.”

“our deal model, that we put together to support the acquisition, for 2026 had mid-teens. I feel confident that we will achieve that.”

“but when it does happen, it is gonna definitely accelerate our sales.”

“So we feel good about that second-half acceleration.”

“Our continued focus on gross margin expansion gives us confidence in raising our full year EPS guidance.”

“We have momentum building across the portfolio and have a clear line of sight to the key drivers of sales growth acceleration that are forecasted in the second half.”

“Remain confident in our outlook for the second half of the year, including our expectations to begin outperforming the market and recapturing share.”

“These structural tailwinds combined with our broad portfolio expanding pipeline of biosimilars and strong brand equity position EPD to sustainably deliver high single digit sales growth.”

“raising our EPS guidance range to $5.45 to $5.60”

“Considering our second quarter results, and updated outlook for the remainder of the year, we are reaffirming our full year guidance for comparable sales growth of 6.5% to 7.5% and raising our EPS guidance range to $5.45 to $5.60”

“Our cash generation and cash flow management are likely gonna put us ahead of our January forecast for the year, and that is gonna just allow greater flexibility here for capital return.”

“I think Q3 will probably be the most, I would say, cleanest quarter. Obviously, Q4 will have a pretty big comp issue. Right? Which is why I am if you look at the exit rate, we are gonna be in that 2.5%, 3% if you take it on a 2 year CAGR.”

“But I think by the end of the year, I think you will start to see that start to change.”

“Yeah. Listen. I expect structural heart by the end of the year to be in that kind of mid- to high-single-digit single digit growth rate back to where we were before.”

“And med tech, you know, we view as kind of an 8% to 10% grower.”

“Our diagnostics portfolio with the with the addition of Exact, the VBP impact in China subsiding a little bit is now a 7% to 8% kind of range that we think about.”

“nutrition, you know, has been a 2% to 4% grower, and I think that is probably, as we think about it going forward, that is probably the right range to be thinking about.”

“I previously referenced 7% as a as a very kind of sustainable growth rate. I believe 7% is still the right target.”

“And then with that, we will have strong momentum going into next year with both rollout of Tactiflex Duo in The US continued acceleration of Bolt in the US, launching our next generation LAA device also. So I see that momentum continue into next year.”

“And I expect that momentum that we are building this year to carry through to next year.”

“I think we are entering this phase here where we will start to outperform marketing capture share.”

“I think where I will leave it right now is, we do expect to grow faster than the market.”

“You know, the model called for second half being higher than first half”

“We are probably in the final stages here of, planning for a fifth manufacturing facility... it will probably be a billion dollar investment”

“You know, that is a 100 million sensor facility. We are probably gonna be bumping up against capacity at that facility probably in the next couple of years.”

“We are still forecasting a decline in the China business, but much, much lower, mid single digits”

“Based on current rates, we expect exchange to have a positive impact of 1% on full year sales.”

“And we have several new products that we anticipate launching at a steady cadence over the next 12 months.”

“We will begin the international rollout of Libre Duo in the fall and we look forward to bringing this innovative new technology to the United States market After we obtain FDA approval.”

“We continue to expect cancer diagnostics growth in the second half of the year to be higher than the first half of the year to be higher than the first half supported by increasing volumes from care gap programs, recently launched tests, and continued international adoption.”

“We also remain on track to begin patient enrollment in the fourth quarter for several important clinical trials that will support a steady cadence of future product launches.”

“We anticipate launching these 3 new products. Along with our Tactiflex Duo PFA catheter in the US at a steady cadence over the next 12 months.”

“I can see if I can see a potential to be able to get this approved by year end.”

“This could be a multibillion dollar opportunity, and it could happen in the fall.”

“I remain very confident in our expectation for an acceleration in growth in the second half.”

“We are now moving to broaden the launches, which gives us confidence that growth will accelerate, including growing faster than the market by the exit of this year.”

“I cannot tell you the exact month, but I know it is going to happen, and it is going to add close to 10 million people that do not have coverage now and will be able to have coverage, which will accelerate commercial coverage too.”

“What I have seen over the last six months really gives me confidence that we are very much on track, or slightly ahead, of that recovery in Diagnostics and that growth trajectory change.”

“If I go back to how I described our year and the year progression, there are a couple of key blocks that really drive our growth throughout the year. The first block is sustaining the growth of our MedTech business and our pharma business—MedTech business low double digits, our pharma business above 7%.”

“We remain confident in our expectations for an acceleration in growth in the second half of the year, and we have clear visibility to the key drivers of that acceleration and are highly focused on executing on them.”

“they have strategies to do better than that, with the second half higher than the first, consistent with what we have historically done.”

“I expect full-year Core Lab growth to be mid-single digits.”

“we have China modeled at a single-digit decline for the year.”

“We think the market will be mid- to high-teens, and we are aiming to do better than that.”

“I continue to expect our Structural Heart growth to be high single digits for the full year.”

“On innovation as another catalyst, we are still committed to and expect approval of our dual-analyte system.”

“but we are seeing really good indications that the actions we took, combined with the new product launches, are going to drive that recovery.”

“Based on current rates, we expect exchange to have a favorable impact of approximately 1% on full-year reported sales.”

“our full-year 2026 sales growth outlook of 6.5% to 7.5% is now on a comparable basis as well.”

“As we broaden the launch of both catheters, we expect growth in our Electrophysiology business to accelerate.”

“We continue to expect that these pricing actions, combined with the launch of several new products, will result in growth improving over the course of the year.”

“Sales of Core Lab diagnostic tests, which exclude capital equipment and digital health solutions, increased on both a year-over-year and sequential basis, and this is a trend that we expect to continue and drive higher growth in the second half of the year compared to the first half.”

“we forecast the addition of Exact Sciences to add approximately $3 billion of incremental sales in 2026 and accelerate Abbott Laboratories' long-term sales growth rate.”

“I am confident that what we're going to be able to do here is reignite volume growth, and you'll see that business get back to growth.”

“This year, we'll have the launch of Volt here in The US and Tactiflex Duo internationally.”

“I think there's a lot to like here. I think there's a lot of growth here. And while we know we've got some work to do in nutrition, I can guarantee you that we're not distracted by that from all the great opportunities that we have here. So like I said, I think we've got a good setup for 2026. A lot of accelerating growth as we progress through the year.”

“We expect our next-generation amulet. Expect to be launching that beginning of next year.”

“And then we're also going to start our IDE trial for our trans-mitral valve replacement program too, which I think is going to be best-in-class.”

“We're going to go into trial, into our IDE trial with our balloon TAVR in the second half of this year.”

“But I'm going to rely heavily on a team that has shown that they can actually do that and do that in pretty difficult circumstances already. And continue to be able to drive the business in that, you know, seven, eight, 9% range here.”

“So I don't like doing that, Matt, because, you know, China is part of our business. But you'll see an acceleration even with China just because it's a little bit more stable versus where it was last year.”

“I'd say the outlook of that business is we will be, I'd say, single-digit growth this year versus kind of where we were in 2025. And if you remove China, again, this is a full-year view. If you remove China, then you're in those you're in that kind of 7 to 8% kind of range.”

“I think that if you look at across all three, all three patient groups... math will work out to what you just kind of highlighted there. In the kind of low teens.”

“I think from a capital allocation perspective, you know, I've always been pretty consistent with our approach... I think post-close, our gross debt to EBITDA ratio will be around 2.7 times.”

“Expect to do more of the same, focus on the things that are strategically aligned and adhere to where we continue to look at a 50 to 70 basis point improvement in operating margins every year, and that's kind of what we've got built into this and fully expect we'll do that through both gross margin expansion as we've done, but continue to gain leverage in the P&L where appropriate.”

“Our forecast for COVID is, you know, around that same number, around $200 million.”

“I expect that we should grow at least in line with the market, David, which I expect I think it seems like the forecast here is mid to high teens.”

“So we'll have a couple of quarters here where growth in nutrition is going to be challenged. And then in the second half, we'll return to positive growth.”

“And we forecast our adjusted tax rate to be in the range of 15 to 16%.”

“Based on current rates, we expect exchange to have a favorable impact of around 1% on full-year reported sales, which includes an expected favorable impact of around 3% on first-quarter reported sales.”

“With the expected approval of our coronary IVL device next year, we expect growth in vascular to follow a similar pattern of acceleration that we've seen in rhythm management.”

“We expect performance in nutrition to remain challenged in the first half of the year with a return to growth in the second half.”

“Following the launch of two new versions of Ensure late last year, we expect to launch at least eight new products over the course of the next twelve months.”

“We expect 2026 to be another year powered by innovation, operational excellence, and strategic execution. As we announced this morning, we forecast the midpoint of our 2026 organic sales growth range to be 7% and the midpoint of our adjusted earnings per share range to reflect 10% growth.”

“We recently won two new WIC contracts The combination of those two contracts actually are higher than the one that we lost, but those go into into effect Q1 and Q2 Of Next Year.”

“And I think we are kind of on track with year to date 60 basis points of gross margin expansion and comfortable that that pattern will continue here and and kind of maintain that sort of 57% outlook in the profile going forward.”

“I think most importantly we remain on track with the original U. S. Full year growth assumption of over 20%.”

“And we remain on track to deliver high single-digit organic sales growth and double-digit EPS growth.”

“I expect some of these, some of these share losses here that we've seen in The U. S. To impact our growth rate here. And The US pediatric for the next couple of quarters.”

“So we'll be filing you know, we've to do the follow-up and then we'll be filing in the first half of the next year.”

“We'll start to see a little bit of that headwind kind of that comp start to be minimized in Q4 This Year In China.”

“So I feel good about that part of our med tech portfolio and be able to sustain that double digit growth going forward.”

“My expectation is is very sustainable We're in these very high growth markets.”

“So you put you put that combination together, David, of passing the headwinds of the VBP in China, and continue acceleration in the on all the other geographies. I I think diagnostics is set up for a nice for a nice recovery year next year.”

“Second half was going be better than the first half. And 26 will be better than 25.”

“So we'll be able to deliver that high single digit top line growth double digit EPS growth, while at the same time, I'm gonna remain unwavering here in the commitment to invest in the pipeline and drive growth organically.”

“I'm very comfortable with consensus.”

“So our organic r and d engine continues to be highly, highly productive. And I expect that we'll be able to sustain this performance, this growth as we as we carry into 2026 and beyond.”

“We've got $3 billion of debt, to pay down next year. And I think I'd prefer to pay that down when it comes due, but we'll we'll wait see what what interest rates look like.”

“We've got a read out of our trial, against NOAC. That'll be in 2027.”

“I expect this to continue. I expect this type of performance to continue for the next two years.”

“I think a growth rate of mid-single digits, at least how we're planning for, is how we built our how we're looking at our 2026.”

“that's going to be the other dynamic here to be able to move our diagnostic business from being you know, kind of low single digit growth, to now kind of mid single mid to high single digit growth next year.”

“So I expect EP to do much better in '26 than what it did this year, and I think this year has done pretty well too.”

“To your question on, you know, kinda next year, yeah, I expect to see another real strong year of growth in in The US with additional demand coming from the from the new, from the new sensor the new dual analyte sensor.”

“Looking ahead, we expect increasing contributions from new products across the portfolio with a balanced mix of iterative and transformative innovation.”

“So we'll see if, if this is a, if this is a 2026 launch or if it's more of 2027 launch.”

“And on top of that, we've reaffirmed our guidance despite some of these headwinds and the impact of tariffs.”

“Still we're committed to high single-digit growth and double-digit EPS growth.”

“The second half sales growth guidance is derisked to account for some of these items here that I consider to be a little bit more transitory that are specific in the diagnostic space, and we're going to be lapping these next year. That still leaves $1-plus billion revenue -- quarterly revenue growing high single digits throughout the rest of the year.”

“By the end of this year, we'll have doubled it versus last year. And there's a normal ramp-up in terms of rep productivity that we know in this space. So all the people that we've been adding, I expect that to now start to really have a nice impact as we go into 2026.”

“Our sales have doubled over the past 2 years. The big driver of that, I would say, over these past 2 years has been international has really been the driving factor here of success, and I expect that to continue.”

“But you put all that together, it's -- together with the -- with the funding for HIV testing, that's over $1 billion of I guess, a headwind. And even with that $1 billion, we're still forecasting high single-digit growth and absorbing the impact of tariffs, which we now expect to be just $200 million of impact.”

“We had expected a market volume recovery to start happening in quite frankly, starting in Q2. We haven't seen that. So we've moved that out into [ Q4 ].”

“And then as you look into 2026, those headwinds aren't going to be there.”

“we're developing this conduction system pacing product here, which we're targeting to start up pivotal call in 2026.”

“And following the successful outcome of this study, we are targeting to start the pivotal trial next year.”

“We plan to start the pivotal trial next year and look forward to creating a new solution to help treat the world's most common heart valve disease, which impacts the lives of millions of people around the world.”

“We are on track to deliver on the financial commitments we set at the beginning of the year.”

“We've had a good start to the year, and I anticipate that that momentum is going to continue.”

“So I think the teams have done a really good job at establishing that foundation... I think this will probably exit the year at about half a billion dollars.”

“So all in all, I think the structural heart business is going to continue to be in these teen growth rates.”

“I expect that to hit midyear, and that's another great opportunity.”

“So I expect this to annualize at around a quarter of a billion dollars but really gaining a lot of momentum as we exit the year for a couple of things.”

“And, you know, as we accelerate the launch of Volt into international markets in the second half of the year, I think I said in the beginning of this year, I think the second half of the year will be better than the first half.”

“So the point here is we believe this is going to fundamentally change... our goal is to start the pivotal trial for this product in 2026.”

“We're going to have a next-generation version come out we're working on that's going to increase the battery life by about 25%.”

“So looking forward for that business to continue to be a contributor in the next few years.”

“I think it's going to be a meaningful growth driver here for our vascular business, which we've already started to see an improvement on the growth rate.”

“We expect to complete enrollment in this trial next year and file for FDA approval shortly thereafter.”

“We do have some debt to pay down this year, which we will.”

“I expect that intensity to increase when it comes to the ablation catheters. But I'm confident that we can maintain a strong position in the mapping segment and everything that comes with all the consumables that come with that.”

“We believe that we can achieve another 80 basis points of improvement in 2025, and that's what's embedded in that guide is continuous improvement on the gross margin in the tune of 80 basis points, will be driven by continued focus on gross margin improvement programs and then mix as some of the higher gross margin products continue to grow ahead of the company average, you get that mix effect.”

“I think we can continue to extend that with the strategy that we're doing, which is to really lead in this area.”

“We've got a scenario here where we believe that with our portfolio, we'll see some pretty stable pricing.”

“That's going to be with us in 2025 as they're rolling out new panels of testing that's going to go through that.”

“And maybe you've got a tail of two halves, where the second half is going to grow faster than the first half as Volt comes on board. But I'd say, for the full year, high single-digits seems like a good place to start, call that our base case.”

“You mentioned bridging to PFA in 2026. It's more like 2025 on PFA, at least internationally.”

“I think you'll see throughout this year several announcements on connectivity in different geographies, and that's gives us the opportunity to penetrate, albeit a smaller segment, but be able to penetrate that segment and take share.”

“So Libre 3 supply with two manufacturing sites up and running and I think you'll start to see throughout the next one or two quarters a change here and a little bit on the NBRxs on the TRxs.”

“We forecast our adjusted tax rate to be in the range of 16% to 17%, which reflects an increase compared to last year related to the adoption of the Pillar 2 tax framework.”

“We forecast our full year 2025 adjusted operating margin profile to be in the range of 23.5% to 24% of sales, which reflects an improvement of 150 basis points versus the prior year at the midpoint of range.”

“We expect our full year 2025 adjusted gross margin profile to be around 57% of sales, which reflects an improvement of around 80 basis points versus the prior year.”

“For the year, we forecast organic sales growth to be in the range of 7.5% to 8.5%.”

“We made great progress expanding our gross margin profile, and we expect that progress to continue into 2025.”

“As we announced this morning, we forecast organic sales growth to be in the range of 7.5% to 8.5% and adjusted earnings per share to be in the range of $5.05 to $5.25, which reflects double-digit growth at the midpoint.”

“It's not a matter of if, but when we get back to the legacy and historical gross margin profiles.”

“I don't anticipate rates coming down to the point that we might want to look at refinancing that. So we'll pay off that debt. It's about $1.5 billion this year.”

“I think now that we understand what it takes to be able drive adoption with this completely different consumer segment that we'll probably be expanding this and expanding this more nationally here in the U.S. and potentially looking at other areas internationally due to bring this.”

“We're on track to finish the year at the high end of the initial guidance that we provided back in January.”

“Not seeing the bottleneck, not forecasting bottleneck, not concerned about the capacity here.”

“So, I think we'll have a very good year with a good strong close in Q4.”

“And yes, revenue at that 9.5% to 10% still feel very good about that.”

“I think this is a great quarter now as we're into Q4 and there's less COVID comps, we'll see our EPS grow double digits back to the growth model that we had during pre-COVID.”

“And as you look forward to Q4, yes, we do have still very high confidence in the businesses, if I was at all concerned about it, I wouldn't have raised our guidance now for the third time this year.”

“We continue to make good progress expanding our gross margin profile and remain on track to improve our profile by 75 basis points on a full year basis compared to last year.”

“And then the team has been working on Amulet 2.0. And I expect that we will be beginning or entering the trial in that business with that product towards the end of this year.”

“The first of these biosimilars is on track to launch in emerging markets in late 2025.”

“after we complete the required patient follow-up phase, we expect to file for FDA approval next year.”

“So, I think the combination of that will allow us to have that op margin expansion.”

“Recently launched products this year are going to contribute about $1 billion of revenue this year, and that's double to what it was in 2023. And I expect that to be the case again next year, right?”

“We'll add $1 billion of revenue this year, add 1 million users.”

“So I expect to see international pediatric and overall nutrition growth step up in the quarter.”

“We forecast adjusted earnings per share guidance of $1.31 to $1.37, and based on current rates, we expect exchange to have an unfavorable impact of less than 1% on fourth quarter reported sales.”

“When we put out the $10 billion target, Larry, we talked about a compound annual growth rate of 15%. So, we're ahead of that, and we're going to work hard to make sure that we stay ahead of that, and we continue to gain share.”

“I'd say, yes, similar to last year, I look at the analyst estimates going into 2025, high single-digit growth, 10% EPS. And like I said last year, that feels like a very reasonable starting point.”

“The combination of all of those contributes to the confidence here and continuing to drive the top tier sales performance, but also expand margins throughout the year.”

“So yes, we feel good about our ability... do I think that we can continue to deliver this top tier performance throughout this year and into next year? Yes, I absolutely do, because of, one, what we’ve built, and then just the evidence and the proof points that we’ve been able to reliably and sustainably deliver that.”

“Yes, I mean, ultimately I think this whole leadless is going to change the growth trajectory of our CRM business.”

“So structural heart, the growth rate has accelerated from Q1, doing very well, and I’d say it’s really across a full portfolio approach versus just really trying to single out one product or one technology... and I continue to see that that’s going to be definitely for the rest of this year and going into next year.”

“We're well positioned to deliver strong results for the remainder of the year.”

“Based on our performance in the quarter and confidence in our outlook for the remainder of the year, we raised our guidance and now forecast full year organic sales growth, excluding COVID testing sales, to be 9.5% to 10% and adjusted earnings per share in a range of $4.61 to $4.71.”

“I think one of the questions there about showing our EPS exiting the year in high single digits, double-digit kind of range and getting back to our formula, that's what we're interested in, and we've got a lot of positive momentum here heading into the second half of the year.”

“We’re seeing freight and distribution profiles normalize and start to be more a tailwind as opposed to headwind, and we’re also seen in commodity markets as well things not only stabilizing, but coming down and also contributing to tailwinds to gross margin, and anticipate that to persist here as well.”

“With respect to margin expansion and gross margin in particular, the guidance for the year is around 75 basis points as you highlight some progress here, and more to go, but the trajectory is there.”

“Based on current rates, we expect exchange to have an unfavorable impact of more than 2.5% on full-year reported sales, which includes an expected unfavorable impact of approximately 3% on third quarter reported sales.”

“Turning to our outlook for the full year, we now forecast full-year adjusted earnings per share of $4.61 to $4.71, which represents an increase compared to the guidance range we provided in April.”

“With several recent large account wins expected to increasingly contribute to growth in the second half of the year.”

“As you think about the ramp-up of what we’ve got in the pipeline, we’ll start launching in 2025, but you look at some of the big molecules that will come up for us ’26,’27, that’s I think when some of these very large oncology opportunities that we have will play a huge role for us and accelerate the growth there.”

“Sure. Like I said in my opening comments, we completed the trial. There's a six month follow-up, Larry. That means that, we will be on target here to file for CE mark by the end of this year.”

“We are very well-positioned to continue to deliver strong results for the remainder of the year”

“We continue to make great progress toward bringing our innovative PFA catheter, Volt to market. In March, we completed enrollment in our CE Mark clinical study, putting us on-track to file for international approval before the end of the year.”

“I've talked about this not being a question of if, just a question of when, so I think that's not a bad cadence.”

“But probably the biggest the biggest opportunity we have here Travis, is just to expand the gross margin through portfolio mix.”

“I think as the year progresses, we'll see connectivity occur whether it's with Libre 2 Plus our streaming product or whether it's with Libre 3.”

“And like I said, I think you will see as the year progresses, whether it's in medical events or just as the year progresses, I think you'll see more coverage decisions.”

“Let's go first to your question on the guidance, yeah, you're right... we consider top tier to be high single-digit double-digit EPS growth.”

“Excited about entry into the IVL market sometime in 2027, coronary DCB, we're working on kind of new TAVR systems also that allow us to branch out into other segments.”

“And I'm forecasting here top-tier growth in 2024.”

“But I expect over time, we'll get back to our pre-pandemic gross margin profile. It's -- for me, it's not a question of if -- it's just a question of when we could target 50, 75, I mean it's never going to be as linear as we always would want, but that kind of expansion for us, I think, really provides a good opportunity to drive earnings growth over the next couple of years.”

“As I've said, I think that we can be at the higher end of that range once everything kind of settles down.”

“Given the strength of the portfolio of team and what we went through and the actions that we've taken, I'd actually expect us to actually surpass our pre-recall share. I don't know exactly when, but that will be my expectation on that.”

“They'll grow 50%, at least we're forecasting a 50% growth next year and they will contribute about 1 point of growth to the overall company.”

“I expect that to increase in 2024 to about 1 point of growth, total Abbott contribution.”

“So I look at the basal, I look at the pump, it's probably good drivers for us in '24, '25, but we've got multiple growth verticals here on this platform like I've said.”

“Some of the headwinds that we faced, I'd say, over the last couple of years are starting to turn a little bit into tailwinds. So whether it's commodity costs, freight and distribution, all those elements seem to be, let's say, right now and given our visibility for the year as we stand here today, turning into tailwinds, so that helps.”

“We forecast nonoperating income of approximately $130 million and an adjusted tax rate of 15%.”

“Based on current rates, we would expect exchange to have an unfavorable impact of a little more than 1% on our reported full year sales, which includes an unfavorable impact of approximately 2% on our first quarter reported sales.”

“So I'd say that's probably an opportunity for us to maybe break out of that higher end 6% range going forward.”

“It's clear that we're seeing broad-based growth across the entire company. As I said in my comments, we've now delivered double-digit organic sales growth here for the past 3 quarters and forecasting that type of growth again this next quarter EPS contributions and the growth in the base business has increased every quarter, and we've exceeded the expectations we set for the initial guidance of the year.”

“Again, I feel good about our high single-digit growth forecast. I feel good about our double-digit EPS growth.”

“So I feel good about delivering that in 2024.”

“But I'd say it's really about reiterating and reinforcing our growth model, our growth framework, which is high single-digit revenue growth, double-digit bottom line growth, margin expansion, strong free cash flow generation and a balanced capital allocation strategy.”

“The Street models double-digit EPS on the base business right now, and I feel real good about our ability to deliver that.”

“And I believe that momentum is going to sustain and continue as we go into 2024.”

“Based on our performance through the first 9 months of the year, we raised the midpoint of our full year adjusted earnings per share guidance and narrowed the range to $4.42 to $4.46.”

“Jayson, relative to 2023 COVID testing sales forecast full year is about $1.5 billion here.”

“So yes, we understand that gross margin is key to be able to deliver on that double-digit bottom line EPS growth. And we're -- this is something that we work on every year. And I think we've got a little bit more of a better environment for our teams to work on.”

“Sure. Yes, there's visibility. I mean, the visibility is in the first half of 2024, then I'd say no, but we do have a plan to be able to kind of drive gross margin and gross margin expansion.”

“Yes, it's my understanding here that we'll see a launch sometime by the end of this year with Tandem.”

“I've been public about our intention to file Lingo here in the U.S. by the end of the year.”

“I'm excited about a full-on launch in the U.K. starting next year.”

“So I think that this is going to probably start, I'd say, late Q1 and into Q2.”

“I think the process will start sometime in the first half of next year.”

“That process started earlier this year in April, I'd say about 80% of the market has now been implemented and expect the remainder of that to be implemented by year-end.”

“So we're forecasting other step up in the fourth quarter.”

“The base business has grown double digits, 3 quarters in a row, and I expect to be doing that again in Q4.”

“For the fourth quarter, we forecast total underlying base business organic sales growth, excluding COVID testing sales to be in the low double digits and exchange to have an unfavorable impact of a little more than 1% on fourth quarter reported sales.”

“For the full year, we now forecast ongoing earnings per share of $4.42 to $4.46, which is comprised of our year-to-date results plus ongoing earnings per share guidance of $1.17 to $1.21 for the fourth quarter.”

“And that's a key growth driver here of this target, we have to reach $10 billion by 2028.”

“Right now, the expectation of that panel is I said the date that we think we have right now is January but we'll have to see how that occurs.”

“We've raised the organic sales growth and the EPS guidance on the base business. And the EPS guidance on the base business is now forecast, as I said in the beginning, to be about $0.15 higher than our original guidance back in January. So momentum is building. We're well positioned for the second half of the year and heading into next year.”

“So team's working really hard at this, and I'm not changing that target.”

“No, I kind of made my team, and I also kind of said publicly that our target here is to get back to 100% of our market share by the end of the year.”

“I don't expect big contribution right now from a financial perspective early on. Maybe my team will surprise me, but I absolutely expect this to be a significant contributor over time for us.”

“So as commodities come down and we start to look at our contracts for next year, I think that will be a great opportunity for us as we go through it.”

“So growth is doing very well... and I expect to see this continuing throughout this year.”

“And as -- so as we work into 2024, we would expect to see some improvement overall in our gross margins.”

“And I think for the balance of the year, we would expect to see gross margins roughly in the range of 56%, and then we would look for steady improvement after that.”

“I intend to file in the U.S. at the end of the year.”

“And the team is on target here to start and initiate our glucose-ketone dual-sensor trial sometime in Q4 here.”

“So we'll be launching our 15-day sensor here in the U.S. second half -- in the second half of this year.”

“If you look at our integration with pumps, it's my understanding here that sometime in this second half, we'll see Tandem integration with our CGM system here in the U.S., and that will be exciting.”

“I expect to do better than that in the year as the next quarters progress.”

“So if I put this all into account, I think we're achieving a lot of growth, top and bottom line, the new product contributions, strong pipeline and then the opportunity that we'll have for gross margin expansion.”

“EPD has sustained, I'd say, high single-digit, low double-digit growth the last 2 years, and I think that continues.”

“Lastly, our full year adjusted earnings per share guidance of $4.30 to $4.50 remains unchanged, but reflects a lower earnings contribution from COVID testing sales compared to expectations in April, offset by raising our underlying base business earnings forecast by approximately $0.05 based on our strong performance and outlook.”

“Based on current rates, we expect exchange to have an unfavorable impact of a little more than 1.5% on full year reported sales.”

“For the third quarter, we forecast COVID testing sales of around $100 million.”

“And I think that's what you're seeing right now play out in these last couple of quarters and what we think is going to continue to play out throughout the rest of the year and going into 2024.”

“Your point on endpoint costs are true. We are seeing certain input costs come down, certain commodities come down. And if we see that continue throughout -- going into next year, I think we'll have a great opportunity there.”

“So Joanne, in terms of kind of net interest expense for the year, we're forecasting a few hundred million dollars there.”

“I've talked about -- we've talked about this business being between 4% to 6% in terms of the target growth range, maybe towards the upper end of that range.”

“But I think that provides a nice tailwind of growth over the next couple of years for this franchise.”

“This is not a -- I don't think this is a quick fix, but it's definitely an area that we're going to see steady improvement over the next couple of years here in terms of improvement.”

“So we keep that strong top line. There's obviously work that we got to continue to do on margin and margin expansion, and that's a big area of focus for us.”

“Lastly, our full year adjusted earnings per share guidance of $4.30 to $4.50 remains unchanged, but now reflects a lower earnings contribution from COVID testing sales compared to expectations in January, offset by raising our underlying base business earnings forecast by a little more than $0.10 based on our strong performance and outlook.”

“Based on current rates, we expect exchange to have an unfavorable impact of a little more than 1% on full year reported sales, which includes an expected unfavorable impact of a little more than 2% on second quarter reported sales.”

“For the second quarter, we forecast COVID testing sales of around $200 million.”

“We're now forecasting COVID testing-related sales of around $1.5 billion, which is below the full year forecast of approximately $2 billion we provided in January due to current testing dynamics we're seeing in the market.”

“I've talked about Libre being a $10 billion product by 2028 that implies a 15% annual growth rate. We'll do better than that this year.”

“Can we see a path for another 20% growth in 2023? Yes, I can.”

“I expect those 5 products to kind of have maybe not 100%, but pretty high growth rate in next -- in this year.”

“In terms of inflation, we are going to see a carryover impact from last year, still pretty meaningful. But we've been able to mitigate a good portion of that through both our gross margin improvement programs that we have across our businesses as well as taking some price where we can.”

“But as we continue to see an acceleration from a mix standpoint and continue to work at some of our costs, we'd expect over time to see that gross margin to continue to improve.”

“On the positive side, I'd say the recovery we're forecasting in the U.S. infant nutrition business will contribute positively.”

“I'd say the other kind of key use here for us this year is going to be debt. We have some debt towers coming up, and we're not going to be renegotiating those just given interest rates. We want to move those off.”

“I'd say in terms of buybacks going forward, we'll be contemplating them and they'll be largely focused on offsetting any kind of dilution that we have this year.”

“I'd like to see our market share get back to pre-pandemic levels by the end of the year.”

“we want to roll this out in a way that allows us to be sustainable in that strategy of being able to be a double-digit share gain over the next couple of years.”

“We had a significant improvement in that situation in Q4. I expect 1 or 2 more months of until we can completely resolve that, but a significant improvement over there on our international performance.”

“At current rates, as I said in my opening remarks, exchange is approximately a 1% headwind on sales. EPS, it's a little bit more than $0.30 headwind for us in 2023.”

“For China, Robbie, I'd say we've assumed a softer start in Q1 given some of the dynamics there at the start of this year, but we anticipate that will improve over the course of the year.”

“COVID, we forecast about $2 billion next year, and I think that's the right number right now.”

“If you look at our device portfolio, we'll be looking at high single-digit growth rate, low double-digit growth rate, a combination of both kind of recovery, the steady recovery procedures that we're seeing combined with all these product launches that we've got lined up that will ultimately have a full year impact”

“if you take that comp out on the recall product side this year as we return to market, and look at the base business, obviously, without the COVID testings, we're going to be growing high single digits, probably at a higher end of that pre-pandemic rate, probably 8-plus percent.”

“We forecast net interest expense of around $300 million, nonoperating income of around $450 million and a full year adjusted tax rate of approximately 14% for the year.”

“Also for the year, we forecast R&D investment of around $2.5 billion and SG&A investment of around $11 billion, which reflects investments to support several ongoing and upcoming new product launches and strategic growth initiatives.”

“We forecast an adjusted gross margin ratio for the full year of approximately 56% of sales.”

“We forecast COVID testing-related sales of around $2 billion with around $750 million forecasted in the first quarter.”

“For the year, we forecast organic sales growth excluding the impact of COVID testing-related sales to be in the high single digits.”

“we forecast around $2 billion of COVID testing sales for the full year 2023.”

“We forecast organic sales growth, excluding COVID testing sales in the high single digits, and we forecast around $2 billion of COVID testing sales for the full year 2023.”

“In Europe, I'd say the first one will probably be in the first half of this year and the second one in the second half.”

“But what I would say is that as soon as that gets approved, then we'll start to see the product with a couple of quarters connect to ID pump systems.”

“But even if you take all that into consideration, the opportunity starts with a $1 billion and it can range depending on the speed and the uptake of that.”

“No, I don't feel that I need to do M&A to be able to sustain that high single-digit growth that we've been posting pretty consistently on devices.”

“Kind of given the way that inflation has hit us over the course of this year, the inventory that we purchased and manufacture this year at these higher costs will definitely negatively impact us next year when that inventory is sold even if inflationary pressures start to come down kind of as we get into next year.”

“These products combined are an annual run rate of about $0.5 billion, growing 50% and those will also receive the kind of investments to be able to kind of drive their growth since I think they're, again, in the early innings of growth for us.”

“And at the top line, the way it's kind of laid out comes through and the leverage falls through, you're going to see that sales growth falling through at, I'd say, pretty healthy margins.”

“It is going to be a little bit of a headwind. You can think about it as either currency and VBP. We've gone through this in some other parts of our business. So we do expect this value-based procurement or pricing here to play out.”

“We do have it factored in into next year probably launching in the beginning of the year and then building from there. But we'll be launching, like I said, in a challenging environment, but I still think it's the right thing to do from a long-term perspective.”

“We've incorporated about another $100 million impact to gross margin in our current guidance. So that's about $1 billion for the year, so call it, maybe 240 -- probably a little more than 240 basis points on the gross margin.”

“But again, it is going to be a significant headwind for us next year.”

“So if you look at our Q4 number, our Q4 number that we're forecasting is really what I would call an endemic state, right? So about $0.5 billion across the world, across all of our platforms, in a winter season without necessarily forecasting the kind of surge that we saw last year.”

“So we'll start to see the share recovery build month-over-month.”

“It's going to expand CGM coverage by about 1.5 million patients on CMS.”

“And so while there are certainly other moving parts, that fourth quarter impact should give you a pretty good feel for the magnitude of headwind that's flowing into next year, particularly in the first 2 to 3 quarters of the year.”

“I think that as we look -- I want to see how the next few months look like. I think Bob made a comment in terms of our forecast for Q4. We haven't really planned for a big win to surge. It's more of an endemic-like forecast for Q4. And I think that's the kind of endemic forecast that we'll see going into 2023.”

“I expect the same kind of growth rate that we're seeing in EPD.”

“And I'd say the currency headwinds are very much kind of in play here for next year, right?”

“We forecast COVID testing-related sales of approximately $500 million, which does not assume a COVID testing surge in the fourth quarter.”

“Excluding U.S. sales impacted by the temporary manufacturing disruption, we forecast fourth quarter organic sales growth to be in the mid-to-high single digits for the remainder of our combined businesses, which includes Medical Devices, Established Pharmaceuticals, Diagnostics, excluding COVID testing-related sales, and areas of nutrition, not impacted by the disruption.”

“Lastly, our third quarter adjusted tax rate was 18.1%, which reflects an adjustment to align our year-to-date tax rate with our revised full year effective tax rate forecast of 15.5%.”

“We're moving forward with plans for a $0.5 billion investment in a new U.S. nutrition facility for specialty and metabolic infant formulas.”

“In September, we began production of several Similac products, which we expect will begin to reach retail store shelves over the coming weeks.”

“We believe that we've got pathway between 15 million and 20 million users on this product.”

“We believe this is a $10 billion franchise by 2028.”

“I wouldn't necessarily take that $0.10 impact in the fourth quarter and extrapolate that for the full year of next year.”

“So this is probably going to be in terms of the timing of public comments and amount of time it's going to take for CMS to make the decision and then the implementation date, et cetera. So this is probably more of a second half 2023 item, I would say, but it's pretty significant.”

“But I think it's -- right now, it's looking like COVID test sales are stickier than most have assumed.”

“The production of the Similac, which we call our more base formula, I mean, we're very close to that, Jayson, is what I would say. I don't want to necessarily kind of put an exact date here, but we're not talking months, we're not talking weeks.”

“So we feel confident in that floor number. And we believe that there's opportunities here for upside to that.”

“COVID testing is one that, to simply assume, that there won't be any COVID testing next year. We've never believed that.”

“So Robert, when we look at '23 for USP, is it -- the debate just around market share, and I'm assuming from a manufacturing standpoint, you should be clean in '23. Yes. That's our expectation.”

“Vijay, I would just say, as Bob said in his prepared remarks, excluding Nutrition, we expect high single digits for the kind of remainder of the businesses to your point.”

“So a lot of activity in our Structural Heart business, a lot of good performance. And I just expect that to get better over the next couple of quarters.”

“So I expect these dynamics to steadily improve over time.”

“We're actually going to be launching an AID system in Europe with our partners in Europe in Q4 with Libre 2.”

“So I think that's going to be an important growth driver for us towards the end of the year and as we go into 2023.”

“So in terms of when you receive the materials to build the product, now we are building inventory, and I don't anticipate that to be the case going forward in the second half.”

“So those are really our fact -- those are really the facts that had our Device business a little bit more modest than what we predicted in April. I think those get better.”

“So if you exclude AN, our nutrition -- the parts of the Nutrition business that was recalled, we're growing high single digits, and we continue to see that kind of growth rate going forward.”

“I made statements in my opening comments about bringing product in from overseas. We brought a lot of formula from overseas, and that's all airfreight. And you know the story on freight and distribution. So once that facility starts up and running, I don't anticipate to see those same kind of freight expenses from overseas shipments.”

“But the other part of the Nutrition is, I would say, cost that I don't anticipate to be there next year. So for example, we're paying WIC rebates for competitive products since April -- actually, since March when we initiated the recall. And as we restart production in the facility, I don't assume that, that will continue.”

“We forecast COVID testing-related sales of $6.1 billion, which includes year-to-date sales through June of $5.6 billion and projected sales of approximately $500 million over the next few months.”

“It is important to note, excluding products impacted by the nutrition recall, we forecast total organic sales growth in the high single digits for the remainder of our combined businesses, which includes Medical Devices, Established Pharmaceuticals, Diagnostics, excluding COVID testing-related sales and areas of nutrition not impacted by the recall.”

“We forecast total company organic sales growth, excluding the impact of COVID testing-related sales, to be in the mid- to high single digits.”

“We expect these dynamics to improve in the second half of the year.”

“As such, our forecast for the next few months contemplates a modest approaching endemic-like amount of testing sales.”

“That said, at a high level, based upon kind of where we're at today, a decent portion of the impact we're seeing this year will carry into next year.”

“So we're going to have to see how those look like over the next kind of couple of months, seeing some slowing down of some commodities, but that's the biggest kind of driver there.”

“So that's now moved into high gear, not only in Germany, but for the rest of the year.”