Qiagen NV

NYSE:QGEN

Earnings Call Transcript 2020-Q4

[Operator]

Ladies and gentlemen, thank you for standing by. I am Cecilia your PGi call operator. Welcome and thank you for joining QIAGEN's Q4 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. Please be advised that this call is being recorded at QIAGEN's request and will be made available on their Internet site. The presentation will be followed by a question-and-answer session. [Operator Instructions]

At this time, I would like to introduce your host, John Gilardi, Vice President, Head of Corporate Communications and Investor Relations at QIAGEN. Please, go ahead, sir.

[John Gilardi]

Thank you very much and welcome to all of you to our conference call today. The speakers we have for you are Thierry Bernard, the CEO of QIAGEN; and Roland Sackers, our Chief Financial Officer. Also joining us is Phoebe Loh, Director of Investor Relations.

Please note that this call is being webcast live and will be archived on the Investors section of our website at www.qiagen.com. A copy of the press release is also available in the same section.

Before we begin, let me cover our safe harbor statement. The discussions and responses to your questions on this call reflect management's views as of today February 10, 2021. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations or predictions of the future. These constitute forward-looking statements for the purpose of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected.

QIAGEN disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the U.S. Securities and Exchange Commission. These are also available on our website.

We will also be referring to certain financial measures not prepared in accordance with Generally Accepted Accounting Principles. You can find a reconciliation of these figures to GAAP in the press release and the presentation for this call.

I'd like to now turn the call over to Thierry.

[Thierry Bernard, Chief Executive Officer]

Thank you very much, John, and good evening, good afternoon, good morning to all of you. Let me please begin by welcoming all of you to our conference call today. And as a first remark on behalf of our QIAGEN team and myself, I would like again to wish you and your families very good health and all the best during those unprecedented times.

Without question 2020 was a year of significant changes and developments for all of us. For QIAGEN, obviously, it significantly shifted the way we work, the demand for our products and the dynamics in the market we serve.

Throughout the year, our teams continued to adapt and position QIAGEN to serve the rapidly changing phases of the pandemic. They are also doing an excellent job of managing our non-COVID business and therefore positioning our company for future growth. I'd like to thank all of our employees for this tremendous performance. It is indeed a humbling experience to be able to lead such a dedicated team.

Let me go through our four key messages of today. First, our teams exceeded the outlook for sales growth and adjusted EPS in the fourth quarter. As you have seen, we continue to deliver on our commitments. Sales grew 36% at constant exchange rates to $571.2 million. And this was well above the outlook set for at least 32% CER growth. Adjusted earnings per share were $0.68 at constant exchange rates and this was well above our outlook range for $0.64 to $0.65 CER.

Second, the performance in the fourth quarter leads to a second good performance for the full year sales result and adjusted EPS for 2020. This also exceeded our outlook. Sales of $1.87 billion in 2020 represented 23% CER growth over 2019. This was above our outlook for 22% CER increase. Adjusted earnings per shares were $2.17 at constant exchange rates. This was once again above the high end of our outlook by $0.03.

The third key message today relates to the ongoing impact of the pandemic in the fourth quarter. We experienced dynamic growth for product groups used in COVID-19 testing, while, as well seeing further improvements in non-COVID areas. The fourth quarter represented indeed the strongest year-on-year growth in sales during 2020 and also a very strong sequential improvement from the second and third quarters of the year. Those results underpin once again that QIAGEN is COVID-19 relevant, but QIAGEN is not COVID-19 dependent.

We are actively managing our business both sales and expenses to navigate through the pandemic, but also to make sure we are best positioned to continue our business expansion in the future and create therefore long-term value for our shareholders. This is why we are putting a relentless and I insist on this relentless focus on the five pillars of growth, which we outlined to you at our recent Virtual Deep Dive Event on December 8 of last year. If you remember, those pillars include: first, our leading position in sample technologies; second, the QuantiFERON franchise anchored by our tuberculosis test; third, the QIAcuity digital PCR series of platform that we recently launched; fourth, the new MolDx integrated PCR system for clinical diagnostic; and fifth, the QIAstat diagnostic syndromic testing platform.

As a final key message for today, we are reaffirming our full year 2021 outlook announced in December 2020. We are confident to deliver an ongoing high level of sales growth and further improvements in adjusted EPS for 2021. For the full year, we are expecting sales growth of about 18% to 20% CER growth over the same period in 2020. This is based on expectation for ongoing strong demand for COVID-19 product sales during at least the first half of 2021 along with continued improvements in other areas of our portfolio. For adjusted EPS, we continue to expect about $2.42 to $2.46 at CER again. This reflects our plans to invest in our five pillars of growth to strengthen our competitive profile.

And I would like now to hand over to Roland.

[Roland Sackers, Chief Financial Officer]

Thank you, Thierry. Hello and thank you as well from me for joining us on this conference call. Our sales results for the fourth quarter of 2020 were the strongest of the year. Sales growth was 36% CER and currency movements had a positive impact of two percentage points on results. This was driven by both COVID-related sales and sales of non-COVID product groups. These results represented a continuation from the third quarter for improving sales trends in non-COVID products. I will give you more details on our sales performance in the upcoming slides.

Moving down the income statement. The adjusted gross margin declined about two percentage points to 69.3% of sales in the fourth quarter. This was due to a continued higher share of instrument sales and increased production expenses. This included the addition of more than 400 new employees in production at the end of 2020 compared to the end of 2019 as we ramp up our expansion plans. For the full year, the adjusted gross margin was 69.6% compared to 71% in 2019. This remains at a strong level and reflects trends seen in the fourth quarter and during the course of 2020.

The adjusted operating income for the fourth quarter was 34.4% of sales and improved over the same period in 2019 due to lower expenses as a percentage of sales for R&D sales and marketing and administration. Areas of savings included the drop-off in travel and marketing expenses during the year. An additional factor is the savings from the decision we announced in October 2019 to change the orientation of our NGS strategy and implement targeted efficiency programs. At the same time, we made investments into our five pillars of growth during the second half of 2020 and results also included the first time costs associated with the full acquisition of NeuMoDx in September 2020.

Moving to EPS. Adjusted EPS rose 42% CER to $0.68 per share for the fourth quarter and was up 52% to $2.17 at CER for the full year. Results for the fourth quarter and full year 2020 include an after-tax benefit of about $0.34 per share for ArcherDX. This benefit relates to the pre-tax net capital gain of US$113.4 million related to the sale of QIAGEN's stake in ArcherDX, which was recently acquired.

In addition to upfront cash consideration, we also received shares in Invitae, a publicly traded company. These shares are reported at fair market value with gains and loss recorded in earnings. This change in value during the fourth quarter is included in the pre-tax capital gain but this entire capital gain is excluded from adjusted results.

As for cash flow, we saw a 38% increase in operating cash flow to US$457.8 million in 2020 from $330.8 million in 2019. The development in operating cash flow reflects the higher sales and collection during the year as evidenced by the relatively similar levels of account receivables at the end of 2020, compared to 2019, even considering the 23% increase in sales during the year.

Also keep in mind that we had about $126 million of payments in 2020 for the discontinued tender offer and also about $52 million of cash payout in 2020 for the restructuring measures initiated in October 2019. We also saw a significant surge in cash flow during the fourth quarter to nearly US$270 million. This compares to operating cash flow for the first quarter of 2020 of only about US$16 million. For free cash flow we saw a 53% increase compared to the prior year.

Purchase of property, plant and equipment during 2020 reflect our investments in expanded production lines to meet both the current demand for products as well as expanding capacity as we invest in new products focusing on our five pillars of future growth.

Moving to the balance sheet. Our leverage ratio stood at 1.5 times net debt to adjusted EBITDA at the end of 2020. This was slightly lower than the 1.6 turns at the end of 2019. At the same time, our net debt increased to $1.2 billion at the end of 2020 from US$953 million at the end of 2019.

Late in the fourth quarter of 2020, we redeemed the 2021 convertible notes for US$177 million and terminated the related warrants for about US$175 million. This removed about 3.5 million potential dilutive shares from our share count so in essence has the same effect as the share repurchase.

In tandem, we issued $500 million of new zero-coupon convertible notes that mature in 2027. This new 2027 notes have an initial conversion price of $80.72 or representing 6.2 million underlying shares.

During the fourth quarter of 2020, we also completed about $64 million of $100 million tranche before it expired. These programs are running independently by banks and the reduced repurchase amount came as a QIAGEN share price was rising during the period.

I would now like to provide additional perspective on sales with our new reporting by product groups. We have added this perspective, as announced at our Virtual Deep Dive Day in December. These groups provide insights into our business portfolio and will now accompany the sales data we typically provide by product type, customer class and geographic regions.

Sample technologies, one of our five pillars of growth is the first product category and includes products involved in the first step in any molecular lab process. During the fourth quarter of 2020, sales of sample technologies grew 55% CER to US$236 million. This category was driven by ongoing strong demand for RNA extraction kits used in COVID testing and research, increasing demand for DNA kits and the recent launch of QIAprep& as a solution to help scale COVID testing.

Diagnostic solutions include our molecular testing platforms and products covering three of our pillars of growth, which are QuantiFERON, QIAstat-Dx and NeuMoDx as well as precision medicine and companion diagnostic co-development revenues. Sales grew 36% CER and were supported by COVID testing solutions and first-time sales contributions from the NeuMoDx acquisition related to newly acquired US sales.

QuantiFERON sales improved over the course of 2020, finishing strongest in the fourth quarter with solid growth in the US compared to declines for this region in the first three quarters of the year. This was offset by an increasing decline in South Korea throughout 2020. This meant for QuantiFERON, a decline of 3% CER for the fourth quarter of 2020 compared to 2019. And this was a sequential improvement from 46% CER decline in the second quarter and 20% CER decline in the third quarter of 2020.

PCR nucleic acid amplification involves our research and up -- slight PCR solutions and components. This category includes another of our growth pillars with the recent launch of QIAcuity digital PCR platforms. The first orders were received in the fourth quarter well ahead of our internal plans. This helped to drive dynamic growth in both instruments and consumables. Another driver in this category was the demand for our OEM solutions and enzymes used in third-party diagnostic kits for COVID-19 testing.

Genomics NGS includes our universal NGS solutions as well as the full QIAGEN digital insight portfolio. This product group has faced slower customer demand during the pandemic, but we saw improving trends against the second and third quarters of 2020, especially in overall sequencing and clinical oncology applications.

I would like to now give you an update on sales results by product type and customer class. In terms of the two product groups, during the fourth quarter sales of consumables and related revenues rose 33% CER, the highest quarterly rate on a comparative basis in 2020.

Instrument sales continued its 2020 growth momentum in the fourth quarter. These sales were up 52% CER and reached US$77 million in the fourth quarter of 2020 as we experienced record level placement rates across multiple product categories including sample preparation platforms as well as general and integrated PCR equipment and platforms.

Molecular Diagnostic sales were supported by an improved spend in trends in non-COVID applications where testing such as oncology and non-COVID-related infectious diseases began to resume. Additionally, these sales continued to be driven by COVID tailwinds in the fourth quarter of 2020.

Fourth quarter sales in Life Sciences saw the highest growth of the year at 28% CER over the same period of 2019. This growth was driven by viral and vaccine research with demand for RNA extraction, general PCR reagents and enzymes as well as universal NGS solutions which offset lower sales in QIAGEN Digital Insights and for human identification forensics products.

Moving to our geographic results the Europe, Middle East and Africa region led fourth quarter and full year 2020 in growth. Fourth quarter sales were driven by double-digit CER growth in France, the United Kingdom and Italy across both customer classes and single-digit CER growth in Germany. The Americas regions experienced its highest level of 2020 sales growth during the fourth quarter. A key driver was the return to double-digit CER growth in QuantiFERON-TB test sales.

Brazil and Mexico also continued to deliver growth at a high level where sales in Molecular Diagnostics more than doubled compared to the fourth quarter of 2019 in both countries. In the fourth quarter, the Asia-Pacific/Japan region was supported by China growing above 15% CER from strong QIAstat-Dx instrument sales.

Molecular Diagnostics revenues in China saw high single-digit gains in the fourth quarter against declines in the previous quarters of 2020. Sales were also higher in Japan and Australia and this is more than offset weaker trends in India and South Korea.

On the next slide, we have included an overview on the COVID-19 impact to our performance. This provides clarity and understanding of our business performance as we look to manage our growth after the COVID tailwinds. Our non-COVID product groups showed an improving quarterly trend. This totaled US$371 million or about 65% of total sales. We still had a modest decline of 2% CER in the fourth quarter compared to the same quarter of 2019. But this contrasts the sharp drop of 23% in the second quarter of 2020 improving to minus 8% CER in the third quarter of 2020. COVID-19-related product groups continued to experience significant growth in the fourth quarter. This sales growth about 388% CER from the same quarter in 2019 to US$200 million or about 35% of total sales.

I would like to now hand back to Thierry.

[Thierry Bernard, Chief Executive Officer]

Thank you, Roland. We are now moving to the slide number 10 of your presentation. And this gives me the opportunity to review some of our more recent development and show you that indeed QIAGEN is emerging from 2020 as one independent, two stronger, and three more focused company for the coming years ready to execute on growth post pandemic.

First of all, aligning our strategy on five pillars of growth ensures we are focusing on our largest and most attractive growth opportunities. In 2020, we made considerable increases in our output of key consumable products such as sample technology kits, QIAstat diagnostic, or again NeuMoDx cartridges.

Throughout the year, we continue to innovate in anticipation of the changing testing demand and overcome challenges in the market as the pandemic evolved. Moving as rapidly as possible, our teams developed over 10 new solutions for use in the pandemic. And I insist again, all those new solutions have applications beyond the pandemic as well.

Also, serving both COVID and non-COVID application our installed base of instruments shown accelerated growth. In fact, we made over 3,300 new placements in 2020. To solidify, our position in the core testing market PCR. We completed the full acquisition of NeuMoDx in September. We acquired the remaining 80.1% stake and this also gave us rights to commercialization in the US market.

Another key success was the launch of QIAcuity digital PCR platform in September. Our team delivered over 200 orders in 2020, and about 75% of those orders were placed in labs before the end of the year.

On the next slide, I would now like to give you an overview of the QIAGEN products being used in COVID-19 testing and the most recent development. Looking at the split of our fourth quarter sales for COVID-related product groups, the proportion of sales from sample techs shrank slightly due to an increase in sales for testing solutions have we made – as we made progress in increasing our production capacity in PCR testing consumables.

The demand for RNA sample tech continued to trend towards automated extraction as expected and we have made further progress in increasing manufacturing output for those automated consumables. Many of our customers have had great success in implementing our new QIAprep& solution, to help them increase efficiency of their testing workflows and overcome plastic supply constraints.

PCR testing solutions see ongoing high demand for Singleplex, but also Multiplex and syndromic testing. QIAstat Diagnostic and NeuMoDx both experienced a continued boost in market penetration. This is indeed setting up a strong foundation for midterm growth as we are far ahead of the timelines we had only two years ago as we entered the market with those two new systems.

Furthermore, NeuMoDx has expanded its COVID testing options with an FDA approval for the use of saliva samples with our singleplex test. And the construction project to further build the production capacity are progressing well for QIAstat diagnostic in our sites in Germany and Spain.

As communicated a couple of weeks ago, we plan to resubmit the QIAreach antigen test this quarter to the FDA. We have resolved a chemistry issue and are now working on new data sets for the resubmission. The decision to withdraw the submission was made on our side to proactively withdraw -- to proactively address the issue that we found and further improve the performance of the test.

Beyond the solution that you are now familiar with QIAGEN has been developing solutions to fit the needs of every cycle of the pandemic. As an example, recently, we have all seen the onset of more frequent sequencing where QIAseq SARS-CoV-2 panels are being used to monitor the prevalence of viral mutations.

Another example, we have also seen the emergence of new applications such as wastewater testing where our new QIAcuity digital PCR viral kits is being employed to quantify pathogen load in order to calculate population infection rates. And this has been recently a clear driver for placement. Likely today more than 10% of our QIAcuity orders are for COVID wastewater testing.

And finally, last but not least, OEM components where our reagents and enzymes are sold to third-party suppliers and those experienced significant demand in 2020 and this continued in the fourth quarter.

Now moving on to 2021, we expect COVID will continue to place high demands on our portfolio, especially in the first half of the year. As vaccines are rolled out, we anticipate continued strong demand for PCR and antigen testing solution. But we expect as well that this could recede during the second half of 2021 depending of course on the impact of the new viral variants.

In order to provide for those testing trends, we are continuing to invest in the upscales of our production lines. We are dedicated to helping customers get set up with our newly launched technologies such as QIAprep& or the QuantiFERON T-cell test, the QIAcuity platforms and to further employ those solutions in the fight against COVID. And we are focusing again on gaining FDA and then CE-IVD status for our antigen test.

On the other hand, we are also managing increasing demand for non-COVID categories and planning for a steady progressive increase of those sales as clinical testing volume return for oncology and infectious diseases.

As we described on December 8th, during our Deep Dive Day, we have extensive plans for menu expansion in our five pillars of growth. For QIAstat diagnostic for example, we are planning submission for the meningitis panel in Europe and the gastro panel in the US.

For NeuMoDx, we have plans to add four more CE-IVD test and two additional tests to the US menu. So indeed we expect those systems to continue seeing solid growth trends after the pandemic testing subsides. We are also planning for upcoming launches in the QuantiFERON franchise.

QIAreach TB will expand modern TB testing into high burden, low-resource areas and this is based on the same e-hub platform as our QIAreach antigen and antibody test for COVID-19 testing.

The QuantiFERON line test is also planned for CE-IVD launch with our partner DiaSorin on their LIAISON platform, just as we did with the QuantiFERON-TB test. Our menu expansion plan also includes research application, such as specialty areas of sample preparation and further content for supporting QIAcuity digital PCR market penetration.

Moving to Slide 13, and looking specifically at our five pillars of growth. Here you can see our expectation and the key drivers for 2021. Sample technology as Roland explained had a strong year in 2020 and will again show solid performance in 2021 with more than $750 million in sales. As we explained already, we expect accelerated placement levels to continue through the first half of the year with our flagship system the QIAsymphony continuing with at least 200 placements in 2021.

QIAcuity platform are expected to deliver over $45 million in sales with a rapidly growing installed base ending the year with around 600 new placement in 2021. QIAstat diagnostic should continue to deliver rapidly growing sales at over $120 million in 2021 and we will expand the installed base by more than 800 incremental placements during the year.

For NeuMoDx, we are expecting sales of over $140 million driven by a growing installed base with a goal to more than double the current number of placements. And for QuantiFERON you have seen with Roland we have seen a sequential improvement of performance since Q2 2020. We expect to see the sales in this franchise to return to 2019 level and deliver around $230 million of sales.

Here, we feel confident in our ability to expand market shares despite competitor activity in the TB testing space. As we have said before, a key point of our differentiation is QuantiFERON automation capabilities, which we have built along with our partner DiaSorin, but also for the front-end automation Tecan and Hamilton. And we are expanding our capability to reach completely newer areas of this market in emerging countries with the upcoming QIAreach TB launch.

Moving to Slide 14 an important news. I would like to introduce you to our new Supervisory Board member. Dr. Toralf Haag has joined the Board and will be nominated for election at our next Annual General Meeting. As noted in the announcement in January, Toralf was chosen as part of an expansion process launched by the Supervisory Board to further complement and enhance the Board's already extensive experience in Life Science and Diagnostics. The addition of Toralf Haag now brings the number of current supervisory board members to seven.

And I'd like to hand back over to Roland now.

[Roland Sackers, Chief Financial Officer]

Thank you Thierry. As noted earlier, we are reaffirming the full year outlook previously announced in December 2020 for net sales to about 18% to 20% CER growth. For adjusted EPS, we expect $2.42 to $2.46 CER and based on full year weighted average of about 234 million shares outstanding. For the first quarter, we anticipate ongoing very elevated sales growth of at least 45% CER driven by continued improvements in non-COVID-related products coupled with dynamic gains from COVID testing solutions. Adjusted diluted EPS are expected to be about $0.60 to $0.62 CER and this is based on 233 million shares outstanding. This includes significant planned investments in our five pillars of growth during 2021.

As for currencies, based on rates as of February 4, 2021 on a full year basis, we expect a currency tailwind of about two percentage points on sales results at actual rates. For adjusted EPS, for the full year, we expect a currency tailwind of about $0.04 per share. For the first quarter, we expect a tailwind of net sales of about four percentage points and a tailwind of about $0.02 per share.

With that, I would like to hand back to Thierry.

[Thierry Bernard, Chief Executive Officer]

Thank you again Roland. And just as a summary. First, we have shown excellent results for the fourth quarter and the full year 2020 as we exceeded the outlook for sales growth and adjusted EPS in both periods. This really shows that QIAGEN, during an extremely demanding year, has stepped up to the challenge.

Second, we are encouraged for the future as we see continued improvement in other areas of our portfolio, the non-COVID areas, but also a continued dynamic growth in COVID-related product. Third, we are focused on investment in our five pillars of growth to fuel our success beyond the pandemic and create long-term shareholder value.

And as a last point, we are reaffirming our 2021 outlook for both sales growth and adjusted EPS. We are confident for 2021 and our ability to achieve full year sales growth of about 18% to 20% CER and adjusted EPS of $2.42 to $2.46.

With that, I'd like to thank you a lot and hand back to John and the operator for the Q&A session.

[Operator]

Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] We will now take our first question from Jack Meehan from Nephron Research. Please go ahead.

[Jack Meehan, Nephron Research]

Thank you. Good morning. Thierry I was hoping you could elaborate a little bit more on the testing offering for COVID with the new variants. Some of your peers have talked about developing PCR test which can differentiate amongst the variants. Is that a focus for you with NeuMoDx and QIAstat? And just maybe more broadly how do the variants influence your thinking about the testing offering?

[Thierry Bernard, Chief Executive Officer]

Thanks a lot Jack for this key question. Obviously, as you noted there are new needs with this pandemic because there are for example new variants and therefore, there are needs for epidemiology testing.

The first answer of QIAGEN is what we call our QIAseq testing, which is based on NGS technologies and we are ramping manufacturing output because we see an increased demand. The second action that QIAGEN took but not just since 2021, we started Jack in 2020 exactly in May of last year. Every two weeks we continue to monitor our PCR test efficiency on testing and make sure that we pick up all those variants and so far, it's proving extremely successful.

Third indeed, we are looking at the momentum the potential to develop a genotyping PCR solution. We are currently talking with customers and governments to see if there is a real need for this. So, it's in the making in our plans.

[Operator]

We will now take our next question from Daniel Wendorff from Commerzbank. Please go ahead.

[Daniel Wendorff, Commerzbank]

Yes, good afternoon and thanks for taking my question. And my question is on your key pillars of growth basically. Is there anything which has changed your view here since your Deep Dive Day in December?

I'm thinking, in particular, about the new platform launches and the performance of your new platforms, which has been actually quite strong in my view in the last quarter. So, anything which has changed there maybe since early December? Any color there would be much appreciated. Thank you.

[Thierry Bernard, Chief Executive Officer]

Thank you, Daniel. I wouldn't speak about change, but reinforced conviction first of all that those are the key five pillars of growth for QIAGEN. And the good ones. You remember in December we explained that out of a total of 11 billion, total market addressable by QIAGEN solution, those five pillars only cover at least six billion of those 11 billion, first point.

Second, we saw a significant acceleration of market penetration for at least two of the solutions, QIAstat and NeuMoDx. And so, this is where I insist that COVID-19 is basically triggering acceleration of already existing business cases for QIAGEN. But as you know, post-pandemic, we have other menus on those two platforms to make sure that we can continue to grow in a healthy way.

For QIAcuity, we are extremely satisfied with a very, very good first three months of launch. We achieved as we said 200 purchase orders, of which 75% have already been placed at customers. And we have very strong ambition, at least as we said before 600 for this year.

So in a nutshell, COVID tailwind Sample tech, QIAstat, NeuMoDx, are absolutely non-COVID-dependent, because initially digital PCR was launched for life science. We are already -- we are now implementing this wastewater solution. But initially digital PCR was really a life science non-COVID-related. We see strong performance and we see this continuing around 2021. We don't see this deceleration and we see increasing rate of placement.

[Operator]

We will now take our next question from Brian Weinstein from William Blair. Please go ahead.

[Brian Weinstein, William Blair]

Hey, guys. Thanks for taking the question. I wanted to ask about NeuMoDx a little bit here and trying to understand the placements. I think you have over 130. And I'm curious as to a little bit more detail as to where those placements are going now? Are they sitting alongside competitor products? And if so, in those labs what kind of confidence do you have that you will be able to see utilization in a post-COVID-19 world? And as part of that, I'm also wondering just how you think about utilization per box post COVID-19 for NeuMoDx. Thanks.

[Thierry Bernard, Chief Executive Officer]

So indeed, Brian thanks for this question on NeuMoDx. We are extremely pleased by the performance in 2020, as you have said more than 130 placements. We see that trend continuing as we are entering 2021. The placement configuration really depends by geographies and by also customer configuration.

We have sites where we are placing the NeuMoDx alongside other solutions with them, Hologic or Roche, for example. We have configurations where we have won tenders against those competitors based not only on the solution we were offering for COVID, but also on the menu.

Remember Brian, already 13 assays non-COVID available CE mark in Europe. And we have also that tremendous benefit of being able on that platform to run alongside, both LDTs and regulated assays.

So, for example in the US, where we are at the moment less menu registered to the FDA we have demand also and sites using our NeuMoDx, not only for COVID but also for the LDT capabilities. So these are the configuration of our placement.

Second part of your question on the evolution post-pandemic this is where we say that for NeuMoDx like by the way for QIAstat, it's a menu play. This is why we are confident in the placement reason, because we have those 13 assays already approved in Europe that we are now bringing as fast as we can to the US in 2021, 2022 and 2023. We are not commenting on actual pull-through per system post-pandemic because we are basically still addressing at the moment mainly the pandemic needs.

But what I can tell you Brian is that any time we place a NeuMoDx or we sell it, we do it in a site where we have fully explained the menu and where we are convinced that the site is not just thinking pandemic needs, but upcoming menu as well. And this is why we have explained in 2020 that as often as we can, we try to place those system with three-year annual contract two years, three years. So that we make sure that we have some customer loyalty here.

[Operator]

We will now take our next question from Scott Bardo from Berenberg. Please go ahead.

[Scott Bardo, Berenberg]

Yeah, thanks very much for taking questions. Actually just following on from Brian's question please. Clearly testing solutions NeuMoDx and QIAstat forming part of the COVID revenues that you've described in this quarter. Thierry, I think you mentioned then that you expect to continue to grow these franchises. I guess given that revenues are so COVID dependent at the moment is your comments to be interpreted that you expect both QIAstat and NeuMoDx to grow in 2022 despite 2021 projected levels? So if you could comment there further please?

And a follow-up please for Roland, I think if I understand correctly, the revenue line for QIAGEN is now anticipated to be greater than what you previously outlined in December given that you've closed this year stronger than expected and maintained your growth expectation, yet your earnings guidance is the same. Is that because you're investing more than you thought? If you could perhaps just give a little bit of color around that please? Thanks.

[Thierry Bernard, Chief Executive Officer]

So Scott to the first part of your question on the growth profile of QIAstat and NeuMoDx. First of all, I'd like to remind those business cases were embedded in QIAGEN way before the pandemic. So the pandemic has boosted the placement of those two solutions, QIAstat or NeuMoDx. And the way you should see that with the pandemic we have gained potentially one or two years of market growth as regard to instrument placement, first point.

Second, the pandemic doesn't change our strategy. We never launched those instruments because of a pandemic. We always said, it's a menu play. For QIAstat it means that we need to continue to bring at least between one and two new applications per year in 2021 but also in 2022 and then the years after. And for NeuMoDx, it means first as we have said that we need to bring the menu available in Europe to U.S. and then beyond U.S., China and other markets for example, and also to continue menu expansion.

So on the growth profile in 2022, it's a bit difficult to answer precisely to the question Scott, because nobody knows really what is the post-pandemic is it 2021, is it 2022. What we are doing at QIAGEN and what you should try to model is that, we are preparing the two solutions QIAstat and NeuMoDx to continue to grow regardless of the pandemic with the menu that we are developing and making sure that they are approved in the different countries. That's the way we should -- that is the way you should see it. Roland?

[Roland Sackers, Chief Financial Officer]

Yeah. And, Scott, for your question. I think you're right it's now since a year took over, we reported first quarter and every of this quarter we've beaten revenues and we've beaten earnings. So I think it's nice track record, which we also want to continue. And I think it's right that we again do believe that actually in terms of both, in terms of revenues, also in terms of profitability we're looking into a strong year 2021. But I don't think we have at the same time updating our guidance on a monthly basis, right? If we did it more or less in December, and looking forward what happens over the course of the year.

[Operator]

We will now take our next question from Doug Schenkel. Your line is open. Please go ahead.

[Doug Schenkel, Cowen]

Hey, good morning and good afternoon everybody and thank you for taking my questions. So, just a couple on the instrument front and then kind of a related -- well maybe it's an unrelated just guidance question. So first, you're forecasting very strong instrument placements across QIAcuity, digital PCR, QIAstat-Dx and NeuMoDx in 2021. I'm just wondering, if you could share essentially how many of these placements are already ordered or in backlog. My guess is given where you're sitting today that, if you were to put error bars around, what you shared in terms of guidance assumptions on each of those platforms that you have pretty good visibility and that the error bar is actually skewed to the upside there, but I just want to make sure that's the case. So that's the first question.

The second related to that is, regarding QIAstat-Dx and NeuMoDx, are -- what are the key drivers for demand? And essentially what I'm trying to get at is, are you seeing increased motivation that goes beyond COVID-19 testing, or at this point, is the primary motivator still COVID-19?

And then my last one is, just kind of another guidance question. It sounds like, you're assuming that COVID-19 revenue becomes a little bit of a headwind as you move into the second half, just based on uncertainty as we look ahead right now, but that also leaves room for potential upside. I just want to make sure that's the case. Thank you, very much.

[Thierry Bernard, Chief Executive Officer]

Thank you, Doug. And I hope that I captured the three components. I won't give you a percentage on what is already based on purchase order for either QIAcuity, QIAstat or NeuMoDx. What I can tell you is that, just from a simple math, we told you that at the end of 2020, we had 200 purchase orders for QIAcuity of which 75% were placed at customers. So it gives you already basically the carryover, I would say that we have to install immediately in the first days of January, but this continued.

What I can tell you is that, the demand for QIAstat in three months and for NeuMoDx and for QIAcuity, especially now that we are also launching digital PCR wastewater solution for QIAcuity continues to be very strong. And the way you should see it, I see -- I think is that, on QIAstat and NeuMoDx because of the volume needed in COVID-19 testing, we will be below market demand during the duration of the pandemic, which means that every instrument, every consumable that is going to the market is sold. So that's one way to build your model.

The second question on the key drivers. First, let's not forget and we insisted a lot on this. When we launched those two solutions Doug, they are clearly differentiated. There is no equivalent of simplicity of sample preparation for QIAstat for example, none on the market at this stage. This is extremely convincing for many customers. And the fact that we can offer not only a syndromic answer to COVID-19, but also other menus in Europe and soon in the US is also another convincing factor for our customers.

NeuMoDx, the same significantly differentiated faster than any competition ability to run at the same time. LDTs that are very still prevalent in the US or even in some markets in Europe and the regulated assets, all this is seriously convincing for customers, and the fact that on NeuMoDx not only you bring a Singleplex solution, but also a four-Plex solution for COVID. And that they know that together with this, at this moment in Europe again, you have 13 other assays available and our US customers know that we are now bringing those assays in the U.S. This is also obviously helping them to make the decision.

Of course a lot of those decisions of purchase have been also accelerated by the COVID-19 crisis for both QIAstat and NeuMoDx. But again it proves well that those two instruments are COVID relevant, but they are not COVID-dependent. Their success story will not stop when the pandemic subsides.

Now the third part of your question regarding potential headwinds, it is very, very difficult to answer precisely. You have seen Doug in less than a month. Everybody tended to say in December of 2020 sustained demand for COVID for the first year -- the first half of the year and potentially receding a bit in the second half.

Now moving in January more and more analysts, colleagues of yours, companies, customers saying given the speed of vaccination or the lack of in some countries vaccination it might be the case that demand for testing will continue strong beyond. So we continue to adjust, we continue to listen to our customers we continue to read and listen to also your analysis. And so far we are just saying that we are confirming and reaffirming the guidance we gave in December. But Roland you might want to complete this one as well?

[Roland Sackers, Chief Financial Officer]

Yes. No I would agree to what I said before which is again we just gave a guidance in early December. Since then we have seen a couple of news as you were laying out and they probably again displayed the volatility which is in the market and the uncertainties in the market. I would agree right now, it's probably much more good news in terms of testing requirements. But unfortunately I haven't found the crystal ball also, again I think a little bit more time are helpful for us in the industry.

[Operator]

We will now take our next question from Steve Beuchaw from Wolfe Research. Please go ahead.

[Steve Beuchaw, Wolfe Research]

Good afternoon and thank you for time here. I thought I might mix things up a little bit and talk about a non-COVID topic. Roland, one of the things that people are going to struggle with a little bit, given all the moving parts in the model is, how to think about the progression of operating margins from 2021 to '22 and beyond. We have a framework from you guys about how to think about margins long term.

One of the variables that I think would be really helpful to hear about from you would be actually, how much incremental spend there is in 2021 that may be non-repeating as the company works hard to scale things up? And if you could expound upon that to talk about any other sort of swing factors you would suggest we think about between margins in 2021 and 2022 that would be really helpful to hear? Sorry for the very long-winded question. Thanks again.0

[Roland Sackers, Chief Financial Officer]

Yes important question and thanks for it. Yes of course very much as always it is somewhat revenue depending on how we see again the overall development of the revenue situation moving over the next 24 months. Despite that, I do believe a couple of things are important to note further well on the gross margin side. I do believe over the course -- over the next 24 months we will see incremental improvements with a better utilization of equipment.

And also again for us getting new production sites and production lines are online getting out of this incremental cost over the course of 2021 will be incrementally helpful for the overall gross margin side. Second, I think we talked quite significantly about incremental R&D costs particularly in developing our U.S. menu for NeuMoDx. That is something what probably again is a phased approach over the next 12, to 18 months. And therefore I believe also moving now into 2022 into 2023 that should be again getting us similarly on that perspective.

The sales and marketing side, it's quite obvious that there's significant changes in customer behavior ongoing right now. Again if you think through we have north of 60% of our revenues coming via digital channels. So again, overall the leverage you get here in terms of sales and marketing activities. I think also the way for example marketing will be done going forward will change. So I think it will be somewhat leaner, again compared to what we had pre COVID. If you bind that together with also a healthy revenue situation, I believe, quite strongly that we leave the overall COVID situation with a better EBIT margin, then we more or less move into that.

[Operator]

We will now take our next question from Derik De Bruin from Bank of America. Please go ahead.

[Derik De Bruin, Bank of America]

Hi. Good morning. Two questions and Steve just took my margin question, so I'll have to ask something else real quick, I guess the first question is, it's more about one is about long-term strategy. I mean, there's been some press reports recently about potentially some incremental M&A talk.

I'm just wondering if you have any general comments on, that since we're getting a lot of the questions from investors. And I guess, can we talk a little bit about the QuantiFERON product rollouts? And sort of what your expectations are? And what's embedded into the model for the Lyme disease, in particular? Thank you.

[Thierry Bernard, Chief Executive Officer]

Hi. Derik, I'm sorry, I didn't hear the last part of your sentence for QuantiFERON. I do apologize for this.

[Derik De Bruin, Bank of America]

Sure. It's the Lyme disease, Yeah, the Lyme disease, expectation.

[Thierry Bernard, Chief Executive Officer]

The Lyme one.

[Derik De Bruin, Bank of America]

Yeah.

[Thierry Bernard, Chief Executive Officer]

The Lyme disease, Okay. Okay. I will start with your first question, on the potential M&A. I mean, as you know Derik, and we have discussed that extensively, during our Deep Dive Event in December 8th. QIAGEN is really pursuing a strategy to execute on opportunities driven by our five pillars of growth. And we believe that those organic growth opportunities have attractive growth potentials and also large market potential.

And so we also believe that, with those five pillars we position QIAGEN for growth beyond the pandemic. And this will already generate and deliver shareholder value. Now, in terms of capital deployment, we will continue, obviously to consider any kind of potential bolt-on acquisitions that could, as we said in December support and strengthen our portfolio. And specifically the five pillars of growth.

Remember in December, we said, if it's a game to dilute our activities, no. If it's to reinforce, notably the five pillars of growth, yes. And obviously, capital deployment for QIAGEN is also constantly thinking, about increasing returns to our shareholders. And we have used in the past. We could use that again, as share repurchase program, as an example. So that's, to address, the first part of your question.

Lyme disease, as we presented it, when we disclosed this new partnership with DiaSorin, we see, it first, as an extension of the interferon gamma technology, which is behind the QuantiFERON success. Second, it creates a partnership with the company DiaSorin which is already extremely present in the Lyme disease market with their IgG, IgM solutions. So it's going to complement and leverage that market position.

2021 will be the CE marking. We want to launch the product by the summer, which is the key season for Lyme. But we both know that the key year is one year after in 2022 with the FDA launch in the US, where we believe that we will have the stronger impact in terms of numbers. So what is important for us is, through the medical case in 2021 together with our CE mark, we don't expect a significant meaningful contribution to the top line. We will have only a limited number of months of growth. The key moment will be 2022.

[Operator]

The last question comes from Dan Brennan from UBS. Please go ahead.

[Dan Brennan, UBS]

Great. Thank you. Thanks for taking the question. I kind of joined in late. I had a two-part question. First, I was just wondering, could you provide any customer color on NeuMoDx? I know that's expected to be a big driver of growth in 2021 amongst the other new platforms that you have. But I'm just wondering, what customer feedback is like. I know you just had the Investor Day, but you're competing with some big players there with differentiated technology. So I'm just wondering.

And then the second question would be, just as we think about the significant capacity expansion being planned by some of the all-in-one box PCR players like Roche, I think which is expected to quadruple capacity in the first six months of the year. Like is that, factored into your guidance as you think about like your extraction revenue outlook to the extent that these all-in-one players that I don't think rely on your extraction kits potentially take share in 2021? Thank you.

[Thierry Bernard, Chief Executive Officer]

So, thank you, Derik. And obviously, Roland feel free to chime in also at a point. For me the profile of the customers for – first half of your question Derik – Dan I'm sorry is the profile of our customers, mainly hospitals extremely active in infectious diseases. As we said in the previous answers, sometimes we win against competition. Sometimes we are placing or selling the NeuMoDx alongside existing competition, why? Because to your question Dan, it's not the competition which is differentiated, it's the NeuMoDx system which is differentiated. And again, we explained when we acquired the company and started the collaboration with NeuMoDx first, much faster than any competition. Second this tremendous flexibility of running at the same time, laboratory developed tests all regulated assays. This is what the customers are finding extremely interesting. And if we are able to execute on the menu development remember once again already 13 assays are available CE mark in Europe.

Now we bring that to the US and beyond Europe, and the US, if we are able to execute on the development on this menu. On the success of this menu in regulatory approval in the US, I see no competition. To your question yes, like QIAGEN competition is increasing manufacturing capacity because we all have to because the demand is still significant. But if you just want to focus on the market related to NeuMoDx, it's a big market Dan. We are talking about a $3 billion market at least growing at a healthy rate of let's say high single-digit to sometimes double-digit in some geographies. So there is room especially well – or when you have differentiation. And I don't think that anybody among our competitors would have expect that we would put 130 NeuMoDx systems in this market in a bit more than a year.

[John Gilardi]

So thank you, Thierry, and thank you to all of you for your participation. If you have any questions or comments, please don't hesitate to reach out to Phoebe and me. With this, I'd like to end the call. Thank you very much.

[Operator]

Ladies and gentlemen, this concludes the conference call. Thank you for joining. Have a pleasant day. Goodbye.