Abbott Laboratories (ABT) — Q2 2022 Earnings Call Transcript

Good morning, and thank you for joining us. With me today are Robert Ford, Chairman and Chief Executive Officer; and Bob Funck, Executive Vice President, Finance and Chief Financial Officer. Robert and Bob will provide opening remarks. Following their comments, we'll take your questions. Before we get started, some statements made today may be forward-looking for purposes of the Private Securities Litigation Reform Act of 1995, including the expected financial results for 2022. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, Risk Factors, to our annual report on Form 10-K for the year ended December 31, 2021. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand Abbott's ongoing business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings news release and regulatory filings from today, which are available on our website at abbott.com. Note that Abbott has not provided the GAAP financial measure for organic sales growth on a forward-looking basis because the company is unable to predict future changes in foreign exchange rates, which could impact reported sales growth. Unless otherwise noted, our commentary on sales growth refers to organic sales growth, which excludes the impact of foreign exchange. With that, I will now turn the call over to Robert.

Thanks, Scott. Good morning, everyone, and thank you for joining us. Today, we reported results of another strong quarter. Earnings per share were $1.43, reflecting more than 20% growth compared to last year. Sales increased nearly 14.5% on an organic basis in the quarter led by growth in Established Pharmaceuticals, Diagnostics and Medical Devices. Based on our performance for the first 6 months, we increased our earnings per share guidance to at least $4.90 for the full year. This speaks to the strength and resilience of our diversified health care model as well as strong execution in this challenging macro environment. We continue to advance our R&D pipeline and strengthen our long-term growth platforms with several new product approvals. Our supply chain has remained resilient, and our financial health remains strong. I'll now summarize our second quarter results in more detail before turning the call over to Bob, and I'll start with Established Pharmaceuticals, or EPD, where sales increased more than 9% in the quarter. Strong performance this quarter was led by double-digit growth across several countries, including China, Brazil, Colombia, Mexico and Vietnam. EPD continues to execute and perform at a very high level in a dynamic environment, achieving double-digit organic sales growth over the past 1.5 years, including more than 11% organic growth for the first half of this year. Moving to Diagnostics, where sales grew over 35% in the quarter. COVID test sales were $2.3 billion in the quarter, more than 95% of which came from rapid tests, including BinaxNOW in the U.S., Panbio internationally and ID NOW globally. As we had predicted some time ago, rapid testing has become widely accepted and has proven to be a very important tool in combating the virus due to its affordability and accessibility, including at-home testing. And while vaccines have been shown to play an important role in reducing severity of outcomes, with the emergence of new variants that escape immunity, rapid tests have become the best tool we have to help people quickly and easily identify new cases and quarantine to help slow and prevent transmission. As you know, forecasting COVID testing demand beyond the near term has been challenging. As such, our forecast for the next few months contemplates a modest approaching endemic-like amount of testing sales. We are in regular discussions with governments around the world, including the U.S., for surveillance testing needs and to ensure capacity is available and ready, if we see another surge this winter. If that were to happen, we have a lot of manufacturing capacity in the U.S. and internationally to help meet testing needs. I'll now turn to Nutrition, where, as you know, we initiated a voluntary recall in February of certain infant formula products manufactured at one of our U.S. facilities. Earlier this month, we resumed partial production at that facility, starting with our specialty formula EleCare and metabolic formulas. We are in the final phases of testing to restart Similac production. As a reminder, once we begin production, it takes several weeks for product to reach store shelves. That said, we will do everything possible to accelerate delivery of product to retailers, so families can have access to the formula they need as soon as possible. We've already started to see some share recovery at retail over the past couple of months, as we leveraged our global manufacturing network to increase supply to the U.S., including importing product from our FDA registered plant in Ireland. We also began importing product from Spain after receiving informed discretion from the FDA that expanded the allowance for imports. As I said in April, it's important to note that the results of the investigation from the FDA, CDC and Abbott concluded no evidence linked our formulas to any infant illnesses or deaths, and there is no new information to suggest otherwise. We take this matter very seriously, and we're making a number of enhancements to our operations at the impacted manufacturing plant. We're also taking steps across our manufacturing network to expand capacity and redundancy. We're committed to set the standard in industry on quality and safety and to re-earn the trust of the families that depend on us. Across our broader Nutrition business, global sales in Adult Nutrition increased 5% in the quarter, including more than 7.5% growth internationally led by our market-leading Ensure and Glucerna brands. And lastly, I'll wrap up with Medical Devices, where sales grew 7.5% in the quarter. In cardiovascular devices, sales growth was led by Structural Heart and Heart Failure. While cardiovascular procedure trends continued to improve, growth in the quarter was somewhat more modest than what we had anticipated back in April due to several factors, most notably health care staffing challenges, COVID surges and lockdowns in China that were implemented as part of their efforts to control the spread of the virus. We expect these dynamics to improve in the second half of the year. In Diabetes Care, sales of FreeStyle Libre grew more than 25% on an organic basis in the quarter, and our user base now exceeds 4 million users globally. During the quarter, we continued to strengthen our Medical Device portfolio with innovative new products, most notably U.S. FDA clearance of our FreeStyle Libre 3 continuous glucose monitoring system, which is the world's smallest and thinnest wearable glucose sensor that provides results with the highest level of accuracy in the industry. And U.S. approval of Aveir, our leadless pacemaker for the management of slow heart rhythms, Aveir was specifically designed to be retrievable if the device ever needs to be removed and expandable to a dual-chamber device, which is currently under development if the therapy needs to evolve over time. So in summary, our diversified health care model continues to prove highly resilient in a dynamic macro environment. We're achieving strong growth across several areas of the portfolio and making good progress restarting our nutrition manufacturing facility. And as a result of our strong performance through the first 6 months, we're raising our EPS guidance for the year. I'll now turn over the call to Bob. Bob?

Thanks, Robert. As Scott mentioned earlier, please note that all references to sales growth rates, unless otherwise noted, are on an organic basis, which excludes the impact of foreign exchange. Turning to our results. Sales for the second quarter increased 14.3% on an organic basis, which was led by strong growth in Diagnostics, Established Pharmaceuticals and Medical Devices, along with global COVID testing-related sales of $2.3 billion in the quarter. During the second quarter, sales were negatively impacted by a voluntary recall and manufacturing shutdown in February of certain infant formula products manufactured at one of our U.S. plants. Excluding COVID testing-related sales and the U.S. sales associated with the recalled products, Abbott sales increased 6.2% on an organic basis in the second quarter. Foreign exchange had an unfavorable year-over-year impact of 4.2% on second quarter sales. During the quarter, we saw the U.S. dollar continue to strengthen versus several currencies, which resulted in a more unfavorable impact on sales compared to exchange rates at the time of our earnings call in April. Regarding other aspects of the P&L, the adjusted gross margin ratio was 56.7% of sales, which reflects the impacts of the recent nutrition recall and incremental inflation we saw in certain manufacturing and distribution costs in the quarter. Adjusted R&D investment was 5.8% of sales, and adjusted SG&A investment was 24.4% of sales in the second quarter. Lastly, our second quarter adjusted tax rate was 14.5%. Turning to our outlook for the full year 2022. We forecast total company organic sales growth, excluding the impact of COVID testing-related sales, to be in the mid- to high single digits. 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 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. We will continue to update our COVID testing-related sales forecast 1 quarter at a time as appropriate. Lastly, based on current rates, we would now expect exchange to have an unfavorable impact of approximately 5% on our full year reported sales. With that, we'll now open the call for questions.

Congrats on a good quarter. Robert, maybe to start — maybe I'll get a little greedy here since we're only sitting in July, and half of '22 is done. But I think the focus for investors is quickly shifting to next year, and there's a lot of moving pieces going on in 2022, a lot of assumptions we have to make in the go forward of 2023. Where is COVID testing? How fast does Nutrition come back? And how steady can the Device business be going forward? So there's a lot of uncertainty out there of where numbers should sit and how to start thinking about the business for next year. Any thoughts you have at this point would be really helpful.

Sure. Well, I think there's a lot of uncertainty for everybody regarding 2023. I think you've kind of highlighted some of the aspects as it relates to our business here. But the macro environment still is pretty challenging, and I don't think it's unique to us. Obviously, there's significant inflation, and seems like there's a pretty significant, call it, a commodity super cycle for us. There's health care staffing challenges, you hear about that. And then, obviously, a strong U.S. dollar. So all those kind of combinations are the challenges that a lot of companies are going to face. And if you look at a lot of the financial and consumer indicators, retail, housing, auto, et cetera, those tend to point towards an increased risk here of recession. So what I would say is, historically, in that macro environment, health care has proven to be pretty resilient. And whether it's the durability of these essential procedures and products, I mean, you can only defer them somewhat. A large portion of the health care spend is government-funded, and we've got a diversified model that's proved itself to be very resilient in this kind of environment. So at a macro level, I think those are the headwinds that we're all facing and we'll all be facing. You mentioned COVID as a factor here. It's interesting. Last year at this time, we were talking about how COVID would — COVID testing would move away, but we've actually shipped just as an amount of tests in the first 6 months of this year compared to all of last year. So I think that we're going to need to see how the cases evolve, Robbie, especially during the winter and fall months over here. And obviously, I don't think it's prudent to forecast a winter surge. But like I said, we've got capacity to be able to deal with that. So those are some of the key factors here that we're looking at. Nutrition that you mentioned, we're recovering pretty nicely, I would say, versus where we originally thought we were going to be back in April. A lot of focus on restarting the manufacturing site. We've recovered already a good portion of the share that we lost. And obviously, we continue to see that moving forward positively. So on the flip side, though, what I would say is that we're not going to just sit still over the next couple of months and wait for these macro kind of factors here to play out, right? We're taking a very proactive approach on the elements that we can control and that we can impact. We're taking price where we can, and we've seen that in our consumer base businesses. These are businesses, because of the strength of our brands, that we've been able to do that and pass it on. We're also looking at other areas that we can — or that historically, we haven't necessarily looked at in terms of price. We're looking at our cost structure. I talked about this in previous calls, too, and we've got a program in place now where we're looking at our cost structure. The hurdles in terms of investment have obviously increased given this macro environment. We're not going to put any risk to our long-term growth platforms, but we're definitely looking at our cost structure and see where we can improve. And the inventory is important, as we move into this inflationary period here. So we're ensuring that we've got the right amount of inventory. So I put all that together, Robbie. We've got macro headwinds that everybody else has. Regarding Nutrition, I think our performance is well aligned to where we planned and where I see us ending up end of the year is ultimately where our forecast — the forecast that we laid out. COVID testing is one that, to simply assume, that there won't be any COVID testing next year. We've never believed that. The question is just your ability to forecast beyond 3 to 6 months, that's the challenge. So fundamentally, I think our business remains very strong. We've got leading positions in attractive long-term growth markets, strong pipeline, and I'm sure we'll talk about some of that today also. We've got a lot of ongoing, upcoming launch activity and a strong balance sheet that provides us a lot of strategic and financial flexibility. So it's difficult to pin a number on it right now, Robbie. But at a high level, those are the elements that we're working with and, ultimately, like to see some of these elements play out over the next couple of months here.

Great. Maybe just as a follow-up to that, Robert. You were talking about the cost structure at Abbott, and this is something we're hearing from basically everyone, that inflation, supply chain, et cetera. You're in this enviable position where you've probably grown operating margins more than anyone else in medtech since the start of COVID. A lot of that has been from the benefit of COVID testing sales, which are at healthy margins and still healthy reinvestment against that. So as we think about your operating margins going forward and you reevaluating your cost base here, I just — it's a difficult question and it's been a while for medtech investors to see anything but just margins going straight up. So how do you want investors to start thinking about where your base operating margin is maybe potentially of COVID testing sales slowdown in the future?

Yes. I always appreciate you like to get at the next year's number in a couple of different ways, Robbie. I guess, I would say on the cost structure piece, I don't necessarily fully agree with you, the way you characterized it in terms of COVID being the ultimate driver here. I think we made a lot of progress on our gross margins historically, whether it was in Devices and in Nutrition. So as the Device business continues to grow, that profile of that business is accretive, and you've seen our growth rates in that business over these last couple of years. So that helps the margin. Our biggest challenge, I would say, from a gross margin perspective is really on the inflation side. Yes, we're seeing input cost go up probably more on the commodity side, so impacting EPD, impacting Nutrition, less so, I would say, in Devices and Diagnostics. Yes, there's some noise that happens here with one supplier — another supplier, and we deal with it. But the real challenge we've had, I would say, over the last kind of 6 months here has been on the Nutrition side. And part of that is — some of it is commodities. 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. 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. 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. And we put some money towards brand recovery. And I think that, that was an investment that's necessary to get our share back in position that we need as we go into next year. So that being said, as I said, we're going to look at our cost structure. We're going to look at areas that have a higher hurdle now for passing an investment hypothesis or thesis, and we're going to — we'll take action where we need to take action. So that's how I'd characterize our margin.

I was hoping to start with a follow-up on the raise of the 2022 EPS guidance floor and just better understand the puts and takes. I think there are some questions around the $0.30 beat in 2Q and the $0.20 increase, again, realizing that it is a floor. But it seems like a lot of that kind of guess $0.10 delta is driven by the move in the U.S. dollar in July. But just wanted to better understand the puts and takes and how you guys arrived at the increase that you did. I have one follow-up.

Sure. Yes. I think you'll see — I mean, we've seen a lot of companies kind of beat their Q2 and either maintain their guidance for the full year or actually reduce it. And we looked at our numbers very carefully, and we basically looked at the strength of our base business. 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. So between the strength of the base business and the COVID sales, we then felt that we had enough power here to navigate and push through some of these macro headwinds that are pretty significant, right? Inflation is a big element there. We had some costs. When we gave initial guidance in January, we increased that in our April call. And we've assumed another couple of hundred million dollars of inflation since that number that we provided in April. So that's one element that we're absorbing, I guess. The, what I would call, health care staffing challenges, COVID cancellations, the lockdown issues that we saw in Q2, especially, I'd say, on our Core Lab business and EP in China, for example, those are being absorbed also. And then currency, as you referenced, pretty dramatic strengthening here of the U.S. dollar. So we've assumed all of that. And as I said also to Robbie, we've had to factor in some additional costs on the nutrition side, whether it's the WIC rebate, the freight and distribution, some of the investments we're making to support share recovery. So you put those 2 together — those 2 elements together on the macro on nutrition side and then you offset that with our base business and COVID sales, and those — that's really the element there, Josh. And as you said, since the beginning of the pandemic, we've gotten to at least floor-like guidance here, and that's what $4.90 is. It's a floor right now. Could that be better? Yes, it could. There could be elements that could make that number be better. But on top of absorbing all these incremental headwinds here, inflation, currency, making some of the investments we need on nutrition, we're still able to raise our full year guidance.

Vijay, this is Bob, I'll take that call — question. I think it's — I think using an implied kind of fourth quarter exit rate as an indicator kind of how we're thinking about '23 probably wouldn't be prudent at this point. There's obviously a lot going on in the macro environment that warrants further monitoring and assessment. And on top of that, there are a couple of swing factors that are specific to us. Strength of our COVID testing business, that's provided us an awful lot of flexibility to reinvest back into our P&L over the last couple of years. And so as part of our — and as Robert kind of talked about, we'll see kind of how COVID testing plays out. We continue to see very strong demand. And so there's some element of that, that we fully expect to stick around. And it's just difficult to pinpoint what that level is at this point in the year. But as part of our budgeting process for next year, we'll take a close look at the overall cost structure, which Robert touched on, and our investment priorities. And as you know, we're also working through the nutrition recall and making good progress, incrementally investing, and Robert talked about the fact that some of those investments will modulate over time or even go away. And so that, combined with recapturing share, we'll see the earnings power of that business ramp up over time. So — and then finally, our pipeline has been highly productive and especially in devices. And as we drive that growth, that's accretive growth overall to the corporation. So those are big moving parts. And as we start to think about 2023, we'll incorporate all those elements and especially in devices. And as we drive that growth, that's accretive growth overall to the corporation. So those are big moving parts. And as we start to think about 2023, we'll incorporate all those elements in our forecast next year.

Robert, can you hear me okay?

Yes, I can, Larry.

You'd cut out a little bit. So 2 for me, I wanted to start with Libre. Robert, just a multipart question here on Libre. Another nice quarter. Any — how should we think about the Libre 3 launch in the U.S.? Should we expect it to be kind of a gradual rollout like we saw with Libre 2? And how are you feeling about resolving the vitamin C interaction issue? It sounds like you guys have made some good progress there. And just lastly, international was a little softer than we expected. Is this just kind of a law of large numbers? Or is this just a timing issue in terms of the full rollout of Libre 3? And I did have one follow-up.

Sure. I think Libre 3, we're very excited. We've had very good success in Germany in terms of upgrading the base and then with the benefits of Libre 3 actually seeing some conversions from competitive systems. So the U.S. launch is going to be exciting for the U.S. team. It will be the only CGM with a sub-8% MARD. And that launch process is underway, but it is a little bit more gradual. So we're going to work to get on to pharmacy contracts, PBM contracts, managed care contracts, et cetera. So we're building inventory. We're familiarizing the physicians with the product. But given what I've seen in Europe, I think this is a great opportunity for our U.S. business, which, by the way, did really well this quarter, right, even without Libre 3. We grew 53% in the second quarter, and I actually think that we can maintain that 30% to 40% growth rate in the U.S. even without Libre 3. 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. I do think, Larry, that CGM is a little different. I mean, we have it in devices, but the model, at least in the U.S., is very pharma-like and — where patient out-of-pocket, coinsurance, co-pays, contracts, et cetera, they play a big role in understanding those, and the interdependencies of those are very important. I think in an environment where employers and consumers are going to be looking more closely at managing their expenses, I think the value proposition of Libre is going to be even stronger. Regarding your question on vitamin C, fixed, yes. We have done the work to be able to address that. We've made very good progress. I'm going to provide further updates over time. But obviously, this relates only to the U.S. We're actually going to be launching an AID system in Europe with our partners in Europe in Q4 with Libre 2. So — but you'll get more updates on that. I think that the exciting piece on the pump connectivity, though, is what we announced in June at the ADA with a dual sensor, a glucose-ketone sensor that's under development, that's received breakthrough designation from the FDA. The scientific advisers that I've spoken to, both in the U.S. and international, believe that this is going to become the go-to sensor for pump connectivity and — just because of the ability to bring in the ketone measurement and perfect even more of those algorithms. So I think this is going to be an ideal sensor for existing pump companies and even for new pump manufacturers. Regarding your question on international, there's a little bit of timing there, I would say. Well, it's 2 parts, a little bit of timing from — in Germany as we convert to Libre 3 and the mechanism is in place there. And then there was some FX headwind that impacted a lot of our international businesses. So did that cover all for you, Larry? Well, listen, we've always kind of had a balanced approach for deploying our cash. We're mindful of our cash on hand. We're investing in the dividend, and we've been growing that dividend, and that's an important part of it. We're investing in the capacity expansions in several of our areas, Libre, Electrophysiology, MitraClip, Nutrition. And we bought back shares in the first half of the year and something that we'll continue to assess as we go through the second half year. So the approach towards our capital allocation is pretty balanced, and we're committed to the dividend. Done some share buybacks in the first half. We'll continue to assess in the second half. And there's great opportunities for us to continue to invest organically to be able to drive the organic part of the business.

I'm going to put them all upfront. Some questions regarding your Structural Heart franchise. Could you give us sort of a state of the union or update on where you are on some key products, MitraClip, Portico and Amulet? And then just as a follow-up to the previous question, could you remind us where you are on share repurchases and your view towards if you're not using the cash for M&A, what you will be using the cash for?

Sure. On the Structural Heart side, I talked about how this is such an important division for us and the focus that we've had there. So I'd say on Amulet, we've had a very good quarter in Amulet aligned to the trends that we were hoping for. We've got an expansion of the amount of accounts that are using the product and also an expansion on the amount of implanters that are completing and performing this procedure. One of the challenges we had in the beginning was just really to get the implanters trained. We needed proctors. And as you remember, in November, December, January and February, there was a lot of challenge with travel. So that's actually looking really nice in terms of the ramp there. What I'm very encouraged about is the traction we're seeing from the early adopters. So some of those that began the training and implanting in Q4 of last year, their utilization is more than double that of the average user. So we're seeing both things in terms of driving the sales there, the increase of new accounts and then the increase in productivity and utilization of the existing implanters. On the Portico side or on the TAVR side, sales have been strong, especially in Europe where we've introduced Navitor, which is our next-generation TAVR system. It's a competitive device from a clinical profile in high-risk patients. I estimate right now — we estimate right now that we're about a high single digit. But when we look at the centers that are using Navitor, and Navitor is probably in about 40%, 45% of the centers in Europe, shares in the mid-teens. And that's very encouraging also because Navitor being our second product has really been an improvement for Portico. And as you know, we filed that in the U.S. in October of last year at the PMA. I expect that to be the case. I expect to see an approval and an opportunity for us to launch into the TAVR market here in the U.S. And on MitraClip, this was a tough comp for us this quarter. Last quarter — last year, it was the highest quarter we've ever had in terms of procedures, in terms of sales. So there's no doubt that this one here is probably a little bit more impacted by COVID and some of the health care staffing challenges and the rescheduling of the procedures. So I expect these dynamics to steadily improve over time. And as I said previously, I don't think we fully benefited yet from the indication expansion that we received for the functional MR. So the market still remains pretty underpenetrated, and there's a lot of opportunity for growth there. 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. Sure. Well, as I said, we restarted in July 1, and we began production of the specialty formulas. 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're very close there, and we obviously have a team that's ready to go and to ramp up. We know that we're going to have to work hard to shorten the time between manufacturer and on-shelf availability. So there's a team that's specifically dedicated to working on accelerated that time frame also. So I like where we're at. And we'll continue to use our global network to be able to augment those efforts of share recapture.

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. I think the debate on '23 is predominantly market share and then there might be a little bit of market also in terms of understanding how much of the growth in today's market is inventory build. We have seen an increase in birth rates, so that's another opportunity also for — to maybe to offset that. So — but yes, I think it's mostly about market share, market share recovery. And like I said, I think in the previous question, I think we've done pretty well about using our network to be able to regain the market share that we had lost in those first couple of months. So yes, it's really about looking at our share and share recovery, which is why, as I said, we've made some investments during — over the next 3, 4, 5 months here to be able to put us in, in that right position in 2023.

Thank you, operator, and thank you for all of your questions. This now concludes Abbott's conference call. A webcast replay of this call will be available after 11:00 a.m. Central time today on Abbott's Investor Relations website at abbottinvestor.com. Thank you for joining us today.