ICU Medical Inc

NASDAQ:ICUI

Earnings Call Transcript 2020-Q4

[Operator]

Good afternoon, ladies and gentlemen and welcome to the Fourth Quarter 2020 ICU Medical, Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host Mr. John Mills of ICR, Managing Partner. Thank you. Please go ahead.

[John Mills, Managing Partner-ICR]

Thank you for joining us today to discuss the ICU Medical financial -- for the fourth quarter of 2020. On the call today representing ICU Medical is Vivek Jain, Chief Executive Officer and Chairman; and Brian Bonnell, Chief Financial Officer. We wanted to let everyone know that we have a presentation accompanying today's prepared remarks.

To view the presentation, please go to our Investor page and click on the Events Calendar, and it will be under the Fourth Quarter 2020 Events. Before we start our prepared remarks, I want to touch upon any forward-looking statements made during the call, including beliefs and expectations about the company's future results. Please be aware they are based on the best available information to management and assumptions that are reasonable.

Such statements are not intended to be a full representation of future results and are subject to risks and uncertainties. Future results may differ materially from management's current expectations. We refer all of you to the company's SEC filings for more detailed information on the risks and uncertainties that have a direct bearing on operating results and financial position. Please note that during today's call, we will also discuss non-GAAP financial measures, including results on an adjusted basis.

We believe these financial measures can facilitate a more complete analysis and greater transparency into ICU Medical's ongoing results of operations, particularly when comparing underlying results from period to period. We've also included a reconciliation of these non-GAAP measures in today's release and provided as much detail as possible on any addendums that are added back.

And with that, it is my pleasure to turn the call over to Vivek.

[Vivek Jain, Chief Executive Officer & Chairman]

Thanks, John. Good afternoon, everybody, and we hope you and your families are well. We are happy 2020 is over and we look forward to our hospital customers stabilizing after much volatility and our company continues to adapt well in a challenging environment.

Like everyone in our industry, we want to start first by thanking all of our customers and their frontline workers for trusting us to serve them during these times. And we would like to thank our employees a number of whom had to again deal with weather-related challenges as our largest domestic employee bases are in Texas around our production and distribution sites.

On today's call, we wanted to comment on our Q4 results; explain our view on the full year fiscal 2020 and what drove revenues and impacted earnings and assess our performance in a volatile market; provide our opinions on 2021, the transition to reopening our build and timing for a return to a more normal environment; update on the new effects of the pandemic to ICU Medical; the recent weather disturbances and our normal housekeeping items; outline our near-term 2021 financial expectations; and lastly, articulate how we feel about our positioning in this environment any strategic implications and reflect on the criteria by which we are judging ourselves and our belief that each of our business can continue growing into 2021 and beyond.

The short story on Q4 is as follows; we did see revenue growth in all of our lines of business, which supported 4% total company reported growth year-over-year for the quarter and we again did have variance across the regions, albeit, a bit more muted than Q3.

Specifically in the US market, we had 8% year-over-year growth, which was the net effect of utilization still being down from our view of baseline offset by higher temporary COVID admissions, new customer onboarding, hardware sales and the addition of Pursuit Vascular. Europe and LatAm did saw some with sequential improvement and we did have some declines in selected South Asian markets.

We finished the quarter with $309 million in adjusted revenue, adjusted EBITDA came in at $60 million and adjusted EPS was $1.77. Profit was impacted slightly by our Austin maintenance shutdown being in October and additional costs for sales compensation and bonus accruals.

We had our best quarter of free cash flow generation in the last 2.5 years and added $60 million to our balance sheet as operational improvements have materialized and restructuring and integration costs have dramatically reduced. When we reflect on the full year of 2020, which started out quite solid for us and then experienced turbulence in Q2 and Q3 and found stronger footing again in Q4, we believe at a minimum volumes were down from normal levels at least 10% in Q2 and Q3 in 2020.

Q4 is a bit harder to triangulate as while procedures and admissions were still down, there was an incremental amount of COVID-related admissions in the system. Each of our lines of business is directly dependent on admissions, including the majority of sales in the Infusion Systems segment as dedicated pump sets represent the majority of sales.

And in the face of these dramatic utilization shortfalls, our Consumables and Solutions segments were essentially flat on a year-over-year basis and our Infusion Systems segment was up double-digits for most of the year helped by competitive share wins and expansion orders directly related to COVID. So we feel optimistic that we still grew in the face of this environment and believe in our ability to continue when a normal environment returns.

Profitability was impacted from our original expectations most acutely by our mix, less consumables and utilization of dedicated pump sets contribute more profit than Infusion Systems hardware and currency, while painful earlier in the year, did give some back in the back half on a translational basis.

So let's go through the businesses quickly and then come back to discuss the current environment. Starting as usual with Infusion Consumables, which is our largest business. Infusion Consumables had revenues of $123 million in Q4 2020, which was a 3% increase year-over-year on a constant currency basis and 2% on a reported basis.

We had the strongest quarter in the US region for consumables in a few years and oncology was not the major driver of this in Q4. While we did have sequential improvement in Europe in aggregate the rest of the world lines of businesses were very close to flat to 2019 levels.

Oncology was much stronger in the US in the second half of the year compared to the first, but did not reach double-digit growth for the year. We do not think we had any pandemic stocking in Q4 anywhere in the world.

The story for Q4 was really again about sequential improvements in US volumes, implementations starting to happen and frankly just holding serve and waiting for volumes to increase, while finding more stability internationally. For 2021, we believe this segment gets back to mid-single-digit growth with oncology again being a strong driver.

Moving to Infusion Systems, which is primarily LVP pumps and associated dedicated sets. This segment did $92 million in adjusted revenue, which was growth of 8% on a constant currency and reported basis. As a reminder, this segment captures not only infusion of hardware, but the lock-in key dedicated pump sets. Those pump sets also improved sequentially Q4 versus Q3, and finished the year essentially flat in the face of pretty steep utilization declines as I just mentioned. That math works because we had more pumps active in the marketplace and the overall segment results were aided by not only the competitive wins and installations, but a healthy amount of pandemic orders from governments and add-ons from existing customers.

The other challenge we faced over the last few years since we bought the business has been the declines of our non-LVP products, which are down more than $30 million in aggregate over the last few years. Those items in 2021 should account for 5% or less of the segment now. We believe we have enough demand and expansion to eventually jump over these declines. We're holding the best amount of rollover and competitive signings we've had in many years. The challenge continues to be getting into hospitals and implementing these conversions. We continue to believe we have stabilized a 10-plus year installed base decline. We still know that safety is a critical factor when choosing an infusion pump. We believe our plum LVP technology is positioned well as evidenced by the recent clinical guidelines around IV pumps and winning the class award again for interoperable pumps. We've gotten back to the core marketing message around our plum LVP pump, as these independent and clinical reviews have validated our differentiation.

The Infusion Systems segment delivered 10% growth in 2020. And in 2021, it's difficult to predict the exact installation timelines as our customers are battling with everything from vaccine rollouts to weather-related delays. We think the safest thing to say at the moment is that the business could be up or down a little for the year. As we said last year, we would come back to mention those government and excess orders we received in the spring and summer of 2020 of this -- 2020 time frame. That would be difficult to repeat, but we believe we will have more regular non-COVID surge pumps in the market each day and that we hold enough to ensure sustained growth over time. Most important to us is as vaccinations rollout and the customer base eases on COVID cases in-house, it should allow for improved focus and decision-making on new technology. We do not see capital as a constraint and we still believe relative to our size there is solid competitive opportunity and we're focused on commercial execution here.

Finishing the segment discussion with Infusion Solutions. We had $82 million of revenue -- of adjusted revenue in the quarter or 1% year-over-year growth. We do not believe we had any material customer stocking in the quarter. We continue to believe the quality of our customer book has improved with us holding the best list of sustainable relationships versus the day we bought the business and the entire industry has moved forward into renewals of longer-term contracts. We are healthy on safety stock and our new national distribution center's running in Texas to help improve our supply chain costs longer term and provide enhanced supply chain services to our customers. We hope the recent events have illustrated the value of having a healthy and diverse supply chain in the country.

Regarding the recent weather and its impact on our Texas operations. We have invested nearly $100 million in CapEx into this site, since we took ownership and we saw the benefits of that during the deep freeze. We had no infrastructure damage in either our production or distribution sites. However, due to the impassable road conditions for employees in Austin, we did have a few days of unplanned shutdown until all the roads cleared. We had and have adequate inventory in hand to ensure continued high customer service levels and our facilities and engineering teams worked tirelessly to quickly bring back up operations. We're not going to penalize our employees due to the unforeseen weather and we will have to spend a bit more in overtime over the next few weeks, which makes an impact as that cost rolls through gross margins. But all that CapEx investment did protect our infrastructure and as insured items like the move away from Pfizer Rocky Mount and a more efficient distribution network has happened. No change here into 2021, as we continue to believe this is an $80 million a quarter business.

Okay. Moving on to some general updates. Commercially, we have seen sequential in-person customer calls picking up. Ballpark as of the moment we see about 30% of our calls live and do assume T&E and other discretionary spending will resume at some point this year. Quality there's not much new. We have had some successful smaller notified body audits in the last quarter. We continue to make progress on leading all the new regulation guidelines related to EU MDR. Operationally, the manufacture network logistics and systems of the company are all running well. In Q4, we had solid global fulfillment rates to our customers. We handled the weather challenges. In 2020 for the full year, we invested in employee safety, provided incremental compensation. We have focused on securing our supply of raw materials and components and we'll continue to invest in incremental inventory as a buffer for unforeseen disruptions like the one two weeks ago. As a reminder, our primary manufacturing locations are in Texas, Utah, Costa Rica and Ensenada Mexico.

On the Pfizer discussion related to the calculation of an earnout payment. It is more likely than not we will enter an arbitration process. Pfizer has been a solid partner and we've worked with them to provide additional details pursuant to our agreement. Pfizer was obviously an equity participant here in on our Board of Directors and we've tried to treat them well at every step as we addressed the litany of issues that came with Hospira. We feel very comfortable with our position and are prepared for the matter, but we do assume it will take possibly up to another six months for an arbitration result.

Okay. To give a little bit more color on what we experienced throughout the quarter and even more recently and how it impacts our thinking for 2021. In Q4, we believe that US hospitals had a high level of ICU utilization with COVID patients and we saw that trend continue through January. In Europe, we had sequential growth even in the face of some pretty severe lockdowns and we did not see international markets with the same patient mix. Obviously for the US now with the drops in infections and related hospitalizations there is capacity freeing up in the system. But the hardest item to predict is the timing of when it's replaced with normal recurring volume. We have seen large companies give a wide variety of ranges from very quickly to only in the back half of 2021. But we just don't know the answer right now and what's more important to us is that we can still grow our valuable items of consumables and dedicated sets on a year-over-year basis.

Regarding our Q1 -- regarding Q1 2021 near-term financial results. Even with this uncertainty, we think we will have sequential growth in Consumables. We expect pumps to have a little less hardware be installed and be slightly down. For the year, we have tried again to give general direction on revenues. From an expense perspective, we do expect a 10% or so increase in R&D spending as we have a number of key projects that are reaching filing status in 2021 and we would expect some of the discretionary expenses to return in the back half of the year. The largest driver of profit will again be mixed, depending on how much hardware gets implemented.

We think it's prudent for now to take the view that adjusted EBITDA would be in the $245 million to $265 million range and Brian will walk you down to EPS. This assumes a steady build through the year and some caution that it does take time for hospitals to return to normal levels as the decrease in COVID cases free up capacity. As a reminder, the net effect of the pandemic was neutral to down in earnings for the company in 2020. While we generated margin from excess hardware sales and cost savings and discretionary expenses, the hit in absolute volumes to Consumables was a large negative.

To synthesize all these comments on the business segments, the pandemic how we're trying to judge ourselves, we've stated for a while that we have the ability to improve our position in our most differentiated businesses of IV Consumables and IV Systems and we have proven stability in our less differentiated businesses IV Solutions. While there can be quarter-to-quarter variations and jumping over the excess hardware is tougher earlier in the year, we believe each of the businesses can be bigger over time.

We've talked about the industry structure attractiveness for years, why we fit in the puzzle and that our products are in a good position from a technology, quality and manufacturing perspective. While the pandemic has introduced substantial volatility, strategically we do think the weakness is it is exposed in the health care supply chain add to the argument for all participants to be healthy and stable which has been our commentary since we became a full line supplier.

We make essential items that require significant clinical training, capital expenditures and in general are items that customers do not want to switch unless they have to. We are a U.S. manufacturer that's deeply vertically integrated and has core redundancy on products that we do not produce domestically between Ensenada and Costa Rica. We do believe the market broadly defined does not want a winner-take-all set up in these essential items categories and that's before each category is assessed on its own innovation clinical outcomes et cetera.

In the new normal or COVID-19 world where supply chain resiliency and diversity matters, we believe our essential items logically benefit and our most differentiated items are still differentiated. So we focus on what we can control in these moments: having the best list of support of healthy customers; win important new customers while waiting for volumes to normalize; keeping our employees safe while delivering the best operational stability for our customers; making sure we drive differentiation in the most valuable categories; have the best liquidity we can for a company our size, using all of the above to be prepared for whatever realignments or opportunity arise and focus on our own execution.

Our company has emerged stronger from all the events of the last few years. Thank you to all the employees customers suppliers and frontline health care workers. Our company appreciates the role each of us and each of you has had to play. With that I'll turn it over to Brian.

[Brian Bonnell, Chief Financial Officer]

Thanks Vivek and good afternoon everyone. To begin I'll first walk down the P&L and discuss our results for the fourth quarter including a recap on full year performance for the businesses. I'll then move on to cash flow and the balance sheet before wrapping up the discussion with our guidance for 2021.

So starting with the revenue line. Our fourth quarter 2020 GAAP revenue was $320 million compared to $316 million last year which is up 2% or 1% on a constant currency basis. For your reference, the 2019 and 2020 adjusted revenue figures which exclude contract manufacturing sales to Pfizer can be found on Slide number 3 of the presentation. Our adjusted revenue for the quarter was $309 million compared to $297 million last year which is up 4% or 3% on a constant currency basis.

Infusion Consumables was up 3% or 2% on a constant currency basis. Infusion Systems was up 8% on both a reported and constant currency basis. IV Solutions which we sell primarily in the U.S. was up 1% on both a reported and constant currency basis. And Critical Care was up 6% or 5% on a constant currency basis.

When looking at full year 2020 adjusted revenue on a constant currency basis, the business in total was up 3% compared to 2019 and we grew total adjusted revenue in every quarter during the year. Infusion Consumables which was the business most impacted by lower hospital census, finished the year down only 1% while Infusion Systems was up 10% due to competitive wins in COVID-related expansion.

IV Solutions was flat and Critical Care grew 7% for the year. Overall we were pleased with this level of performance given the volatility and other challenges presented by COVID.

As you can see from Slide number 4 of the presentation for the fourth quarter our adjusted gross margin was in line with our expectations at 39% compared to 40% for the fourth quarter last year. The year-over-year decline of 1 percentage point reflects the timing of the annual scheduled maintenance shutdown of our Austin manufacturing facility that was completed in October, as compared to the summer months in prior years.

Sequentially adjusted gross margins improved by one percentage point compared to 38% in the third quarter as a result of improved mix as our Consumables volumes during the fourth quarter approached more normal levels. SG&A expense of $74 million in Q4 was up 4% year-over-year and reflected a $3 million increase compared to the third quarter, driven by higher commissions expense primarily in our Infusion Systems business along with year-end adjustments to incentive compensation.

R&D expense was $12 million for the quarter, down $1 million year-over-year but up $2 million compared to the third quarter. The changes compared to both prior year and the third quarter are primarily driven by timing of project spend. Restructuring, integration and strategic transaction expenses were $6 million in the fourth quarter versus $11 million last year. The fourth quarter 2020 spending related primarily to the transfer of manufacturing lines for certain products currently produced in Pfizer's Rocky Mount facility as we prepare to exit the MSA along with other onetime restructuring costs.

Adjusted diluted earnings per share for the fourth quarter of 2020 were $1.77 compared to $1.94 last year. This year's Q4 results were favorably impacted by a lower tax rate that contributed approximately $0.15 of benefit to adjusted EPS. The lower tax rate was the result of excess tax benefits related to equity compensation. Diluted shares outstanding for the quarter were 21.6 million. And finally adjusted EBITDA for Q4 decreased 2% to $60 million compared to $61 million last year.

Now moving on to cash flow and the balance sheet. For the quarter free cash flow was $55 million and Q4 was another strong quarter of cash flow generation driven by a combination of solid earnings, declining restructuring and integration spending and further reductions in working capital.

Net working capital at the end of the fourth quarter was down $37 million compared to the end of the third quarter, due mostly to improvements in accounts receivable. The strong Q4 cash flow allowed us to end the year with $424 million of cash and investments on the balance sheet which is well ahead of our $350 million target communicated at the beginning of 2020.

For the full year 2020, the company generated $137 million of free cash flow after investing over $90 million in CapEx and an additional $28 million in restructuring, integration and strategic transaction expenses. We are very pleased with our cash flow results for 2020.

Looking forward, we feel we have now mostly optimized our levels of working capital and don't expect to further benefit from large onetime reductions like those we generated in 2020. But we do continue to believe that annual free cash flow of $100 million or more, exclusive of any acquisition-related payments, is appropriate, based on our current profile.

In the fourth quarter, we spent $30 million on CapEx for general maintenance and capacity expansion at our facilities, as well as placement of revenue-generating infusion pumps with customers outside of the U.S. This was in line with our expectations and brought our total CapEx spending for 2020 to $92 million.

Moving forward to 2021, Vivek already provided some guidance related to our expectations for each of our businesses, so I'll cover the rest of the P&L. For 2021, we expect adjusted gross margins to be in the range of 38% to 39%, which reflects the benefits from improved consumables mix, offset by the impact from higher Infusion Systems hardware revenues, as we implement competitive wins.

In terms of operating expenses, we expect SG&A to increase in the low- to mid-single-digit range, as selling, marketing and travel expenses returned to more normal levels over the course of the year. In 2021, we will prioritize R&D investment, which should increase approximately 10% compared to 2020.

We anticipate further declines in restructuring, integration and strategic transaction spending, which we estimate will be between $15 million and $20 million for the year, mostly related to the Pfizer MSA exit and improvements to our customer-facing systems and processes.

For the full year 2021, we expect adjusted EBITDA to be between $245 million and $265 million and adjusted EPS to be between $6.50 and $7.20 per share. The adjusted EPS guidance assumes a tax rate in the normalized range of 21% to 23%. And for modeling purposes, you can assume average diluted shares outstanding during the year of 21.8 million. And finally, we expect to see our CapEx requirements decline for the third year in a row to around $80 million in 2021.

To emphasize Vivek's earlier comments, similar to revenues, we expect earnings in 2021 to reflect a steady ramp over the course of the year, driven by: one, continued recovery of volumes to pre-COVID levels; two, implementation of Infusion Systems pumps as hospital resources free up; and three, getting beyond some of the incremental costs related to recent weather events.

During our second quarter call, after having reported top line growth in the quarter for the company as a whole, we stated that our near-term goal was to get all four businesses growing at the same time. In Q4, we achieved that goal, which was a nice end to a year full of challenges.

As we start off 2021, this remains our goal. And although quarterly year-over-year growth rates this year will vary due to the impacts of the pandemic, we feel good about our opportunity to continue to drive growth in our most differentiated businesses.

And with that, I'd like to turn the call over for any questions.

[Operator]

[Operator Instructions] Your first question comes from the line of Matthew Mishan with KeyBanc. You may ask your question.

[Matthew Mishan, KeyBanc]

Hey. Good afternoon Vivek, Brian. How you’re doing?

[Vivek Jain, Chief Executive Officer & Chairman]

Hey, Matt.

[Brian Bonnell, Chief Financial Officer]

Hey, Matt.

[Matthew Mishan, KeyBanc]

Hey. So, I think, these two questions actually are -- actually kind of come together. First, can you give us a sense of the backlog of installations you have in systems heading into 2021? And then, secondly, every piece of your guidance makes a lot of sense, but the gross margin. You're coming off a quarter in which Infusion Systems was elevated, coming off a year where Infusion System was elevated.

Next year Consumables are going to be a higher mix of the volume. And I'm assuming there's going to be some kind of margin benefit from moving the manufacturing from Rocky Mount to Austin. So what am I missing as far as the gross margin guidance being flat year-over-year?

[Vivek Jain, Chief Executive Officer & Chairman]

Why don't I do the first one and Brian will do the second one, right? On the systems, I don't think we are in a place where we would quote a backlog number, something like that, I think, we tried to say in the script now, which is we have more competitive wins that we haven't installed yet than we've ever had before.

And I think a year ago, January, we said we thought we had gained a point from our pretty low place we were on LVP and I think we thought we're in a better place than that today, competitively. So that's probably all I want to say on the backlog. And I'll let Brian comment on the margin.

[Brian Bonnell, Chief Financial Officer]

Matt, your question on the margin, it's a good one and it relates actually back to your first question around Infusion Systems hardware and backlog. And really, what we're expecting for 2021 is, margins to be a little bit negatively impacted, as a result of a higher mix of Infusion Systems hardware installations related to competitive captures.

Those tend to be much lower margin initially at the time of the implementation and revenue recognition on the pumps, followed by improving margins from the dedicated disposables that follow afterwards. But there is a timing difference between that initial installation and the subsequent dedicated disposables.

[Matthew Mishan, KeyBanc]

Okay. And then, sort of, last question for me, because I think you explained everything very well. Can you talk through some of the new products that you'll be focusing your attention on in 2021?

[Vivek Jain, Chief Executive Officer & Chairman]

Sure. I mean, I think, we have a number of things getting on the filing docket in 2021, as I said, that's why spend is going up. As you would expect, I mean, the majority of dollars that we've been putting in over a three-year period have been, certainly, since we have the full freedom to do so on the systems side.

And that, obviously, means finishing the software products that we've been talking about and getting those out of kind of the LMR phase and really into the market and then some different ideas on the hardware side that we've been working on.

So as usual, we want to talk about those more when they happen, but I think we've been pretty transparent and it's easy to figure out. Historically, our spend on the consumables-related business is very much what ICU used to spend and the rest has been on the systems side, since we did the acquisition.

[Matthew Mishan, KeyBanc]

All right. Thank you very much.

[Operator]

Your next question comes from the line of Larry Solow with CJS Securities. Your line is open. You may ask your question.

[Vivek Jain, Chief Executive Officer & Chairman]

Hello.

[Peter Lukas]

Yes. Hi. It's Pete Lukas for Larry. So just to clarify, sorry on the margin side, in terms of margins for Solutions, do you see increased volume as being able to help you out with that? Should we think about that as a positive given, Austin and the new distribution plant?

[Vivek Jain, Chief Executive Officer & Chairman]

I think, I would say, it's been a bit of a wash there Pete. We can't -- obviously margins were higher for the company when we were selling more solutions two years ago 2.5 years ago.

The distribution center has added some efficiencies, but we've also extended a number of the contracts et cetera and a lot of activity happened around that in late 2019 and through most of 2020 and it gobbled some of that back up.

So I think for us, it's much safer to say solutions is what it is right now, and it's not going to be driving a lot more incremental margin. It's not going to be getting worse it just kind of exists.

[Pete Lukas, CJS Securities]

Perfect. And you guys covered a lot most of what I had here, just one more just a general question in terms of M&A. Can you discuss just broadly what you're seeing in terms of -- from the sellers in this environment? And they're willingness to engage given all the impacts of COVID?

[Vivek Jain, Chief Executive Officer & Chairman]

Yeah. I mean, I think, it's a balancing act, depending on, where you -- where -- what part of the market you're playing in there. Certainly, folks who have had COVID make an impact on their business or say of operations there is a constructive dialogue.

Otherwise, I mean, I think the market is challenging as everybody's seen on that front. So I'm not sure that I would say COVID has made the M&A environment easier, if that's where you're going.

[Pete Lukas, CJS Securities]

Yeah, very helpful. Thanks. I'll jump back in queue.

[Vivek Jain, Chief Executive Officer & Chairman]

Thank you, Pete.

[Operator]

[Operator Instructions] Your next question comes from the line of Jayson Bedford with Raymond James. You may now ask a question.

[Jayson Bedford, Raymond James]

Good afternoon. Thanks guys. I wanted to get back to the gross margin pump dynamic question. And I appreciate there's a lot of moving parts here. But just I guess simply are you expecting to sell more pumps in 2021, than you did in 2020?

[Vivek Jain, Chief Executive Officer & Chairman]

I think, Jayson it's not only the absolute number of pumps. It's what class of trade are they going into right? Whether it was maybe pandemic surge in some of the international markets versus some of the competitive situations that's, probably a bigger factor than the absolute number of pumps.

In terms of the absolute number, I think we're saying, pumps could be down a little which means we wouldn't sell as many pieces of hardware as we did last year. That there is an outcome where that happens if we can't get all the installations on it and when, still some things we want to win and get in this year.

[Jayson Bedford, Raymond James]

Okay. And just, I guess, just to follow on the pump side, you mentioned the government orders in the spring and summer kind of inferred that you didn't see any kind of government orders in the fourth quarter. One, is that correct? And was there anything exceptional on the pump side here in the fourth quarter?

[Vivek Jain, Chief Executive Officer & Chairman]

That is correct. There was real no material government business really from August, September onward, nothing very unusual in Q4 in the pump business. Uptick probably a bit due to acuity on some of the dedicated sets hard to triangulate exactly and a little bit of maybe accelerated add on expansion at a few customers, but nothing out of the ordinary.

[Jayson Bedford, Raymond James]

Okay. Gross margin in the quarter the 39%, was that negatively impacted by the plant shutdown? I'm just wondering the impact of that.

[Brian Bonnell, Chief Financial Officer]

Yeah. Jayson, that's right. It was negative impact for Q4. And if you compare it to prior years in prior years we -- the shutdown was typically in the summer months.

[Vivek Jain, Chief Executive Officer & Chairman]

We usually did it in June. And it rolled in over the next two or three months of the summer quarter, if you went back on the scripts and with the pandemic kind of in full flight last year we made a call to keep producing and just delayed it until October.

[Jayson Bedford, Raymond James]

Okay. And I don't want to be greedy with the question, but is there a basis point impact to that? Or is there a way quantify it, on the 39%?

[Brian Bonnell, Chief Financial Officer]

Probably around a percentage point, somewhere in that neighborhood.

[Jayson Bedford, Raymond James]

Okay. And then, just a clarification on the commentary around 1Q, I think you mentioned quarter-on-quarter growth in Consumables -- pumps may be slightly down. I was a little unclear whether that's quarter-over-quarter, year-over-year?

[Vivek Jain, Chief Executive Officer & Chairman]

Sequentially, quarter-over-quarter.

[Jayson Bedford, Raymond James]

Okay. Okay. Okay sequentially. And then similar, the other comment I think with respect to 1Q was a 10% increase in R&D. I assume that's, quarter-over-quarter sequential?

[Vivek Jain, Chief Executive Officer & Chairman]

No, I don't actually think -- I don't know if I have the right number -- I don't think it's...

[Brian Bonnell, Chief Financial Officer]

I don't think -- know if there's even a difference.

[Vivek Jain, Chief Executive Officer & Chairman]

Over the balance of the year -- over the balance of the year, most things probably be back half weighted on the spend side this year.

[Jayson Bedford, Raymond James]

Okay. So that was an annual. Okay. Okay. That's it for me. Thank you.

[Brian Bonnell, Chief Financial Officer]

Okay. Thanks, Jayson.

[Operator]

[Operator Instructions] I am showing no further question at this time. I would now like to turn the conference back to Vivek Jain, for any closing remarks.

[Vivek Jain, Chief Executive Officer & Chairman]

Great. Thanks everybody. I appreciate the time you made for us today. We at the company are pulling for all of our employees that had deal with a lot of things in the last couple of weeks. And for everybody on the phone and to the company, we hope you have a great 2021. And we look forward to speaking to you later in the year. Thank you.

[Operator]

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. And have a wonderful day. You may all disconnect.