Ladies and gentlemen, thank you for standing by. I am Katie, your PGI call operator. Welcome, and thank you for joining QIAGEN's Q2 2023 Earnings Conference Call Webcast. [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..

Thank you, operator, and welcome to all of you, and thank you as well for joining this call. We appreciate your interest in QIAGEN. Our speakers today are Thierry Bernard, our Chief Executive Officer; and Roland Sackers, our Chief Financial Officer. We also have Phoebe Loh from the Investor Relations team here with us.

This call is being webcast live and will be archived on the Investors section of our website at www.qiagen.com. You can also find a copy of the quarterly results press release and presentation on our website. We'll begin as usual with remarks from Thierry and Roland and then have a Q&A session.

Before we start, let's briefly go over our safe harbor statement. The views expressed during this conference call and the responses to your questions represent the perspectives of management as of today, August 9, 2023.

We will be making statements and providing responses to your questions that convey our intentions, beliefs, expectations or predictions for the future. These forward-looking statements fall under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

They involve risks and uncertainties, and actual results may differ materially from those suggested by these forward-looking statements. Factors that could influence results are mentioned in our filings with the U.S. Securities and Exchange Commission. These filings are also available on the SEC's website and also our own website.

QIAGEN disclaims any intention or obligations to update any forward-looking statements. Additionally, we will be referring to certain financial measures not prepared following generally accepted accounting principles or GAAP. All references to EPS refer to diluted EPS.

You can find the reconciliation of these non-GAAP financial measures to the most directly comparable GAAP measures in our press release and the presentation. I'd like to now hand over the call to Thierry..

Thank you, John, and hello, good morning, good afternoon or good evening, depending on where you are in the world to all of you, and thank you for joining us. We are very pleased to report today our very solid results for the second quarter of 2023.

As you have already heard from other companies this quarter, we are operating in an uncertain macro environment. Therefore, we are especially pleased with how our teams have remained focused and dedicated to executing on our goals.

Our results are another confirmation of the strength and resilience of our business, the depth of experience and knowledge in our teams and our agility in navigating through a dynamic environment. Now let me go to the top messages for today.

First, we achieved our outlook for net sales growth and adjusted EPS for the second quarter, driven by strong sales in the base business. Net sales were $497 million at constant exchange rates and exceeded our outlook for at least $490 million. We saw some softness in capital spending for instrumentation.

However, remember that our business is heavily weighted towards highly recurring consumables revenues. Over 85% of QIAGEN sales are coming from high-margin consumables and related revenues. We saw 10% CER growth in non-COVID consumable sales with resilient broad-based demand across both customer classes, life science and clinical diagnostics.

In terms of profitability, adjusted earnings per share was $0.52 CER, which was above the outlook for at least $0.50 CER. Second key message, our key pillars of growth progressed well in driving our base business. To call out just a few.

Our market-leading QuantiFERON latent TB test delivered another outstanding quarter, generating 27% CER growth and crossing a significant milestone with quarterly sales rising above $100 million for the first time. We continue to see a very healthy conversion trends from the tuberculin skin test.

This has clearly accelerated since the pandemic due to the benefits of QuantiFERON requiring only 1 visit with a simple blood draw as opposed to 2 visits to a medical professional with a traditional skin test. The QIAstat syndromic testing platforms also did very well this quarter with a solid increase in consumable sales for non-COVID applications.

Our team did a great job in achieving a higher number of new placements over the second quarter of 2022. Another example is the QIAcuity digital PCR system, which continued to benefit from increasing demand in the life science market with significant sales growth in the second quarter.

This was driven by both the growing demand for consumables and an ongoing high level of instrument placement. Third message, we saw a solid operating margin improvement in the second quarter while continuing to make important investments. Our adjusted operating income margin in the second quarter was 27.4%.

We achieved this level while investing around 10% of sales into research and development, which is important, obviously, to create new relays of growth and support our midterm ambitions.

And finally, fourth message, we are revising our full year outlook for 2023 to reflect the significant drop-off in COVID testing and the volatility in our OEM business, which is driven by large-scale bulk orders. This is against the backdrop of a challenging macro environment.

Our new outlook for net sales is for at least $1.970 billion CER while the outlook for adjusted earnings per share is now set to at least $2.07 CER again. Roland a bit later will provide more color and perspectives in his remarks. Before I hand over to Roland, I would also like to discuss a change in our leadership team.

QIAGEN is very pleased to welcome Nitin Sood, who will join QIAGEN in October as Senior Vice President, Head of our Life Science business area and member of the Executive Committee.

Nitin joins us with over 20 years of experience in diagnostic and in life science in companies like PerkinElmer, Agilent and most recently, was serving as Chief Commercial Officer at Adaptive Biotechnologies. We are very much looking forward to his fresh perspectives and key contribution in driving forward our Life Science business.

Nitin is taking over this role from Thomas Schweins, who has decided to step down as part of his plan to retire in 2024. Thomas will be working closely, obviously, with Nitin to support the transition.

We are extremely grateful to Thomas for many contribution during his nearly 20 years at QIAGEN in many roles, in particular, the development of the QIAGEN brand, and we wish him all the best in his future endeavors. Now I'd like to hand over to Roland to review our results in greater detail..

Hello, everyone. First of all, I would also like to thank Thomas for his significant contributions over his long and impactful career at QIAGEN. I will first discuss our results for the second quarter and first half of the year and then share some views on our outlook.

As you saw in our press release, net sales for the second quarter of 2023 were USD 495 million at actual rates and USD 497 million at constant exchange rates. Given that there was little impact from currency movements, sales declined 4% compared to the year ago period, which had a substantial COVID-19 revenues.

Non-COVID product groups experienced strong growth with sales up 9% CER to $457 million and representing well over 90% of total sales in the second quarter. In fact, this non-COVID sales were up 10% CER for the first half of the year.

Instrument sales declined at a low single-digit CER rate as academic and biotech customers continue to be conservative in capital spending. However, we continue to see good placement trends for reagent rental agreements that are linked to our multiyear consumable contracts among molecular diagnostic customers.

These agreements are a normal part of our business and helps secure future consumable commitments. Among our 4 product groups, let's start with sample technologies, which represents about 1/3 of total sales. We saw a healthy 6% CER growth in non-COVID products, and this represented well over 85% of sales within this product group.

This group continue to have a very tough comparison against the drop-off in COVID-19 testing demand, which led to the overall decline. Diagnostic solutions, our second product group, also represents about 1/3 of sales.

As we mentioned earlier, the QuantiFERON latent TB test was the main driver with all regions delivering sales growth above 20% CER amidst the ongoing strong conversion from the traditional skin test.

In light of the performance in the first half of 2023, we now expect full year sales north of USD 380 million from the prior expectations of USD 360 million. This group also includes the QIAstat-Dx system for syndromic testing. This sales rose over 40% CER on dynamic growth in non-COVID applications.

This is especially due to the increased non-COVID utilization in Europe. In the first half on a global basis, we have seen significant double-digit growth in these non-COVID revenues.

NeuMoDx, our integrated clinical PCR testing platform again saw a sales decline in the second quarter due to headwinds against the high level of COVID testing revenues in the second quarter 2022.

While we saw double-digit CER growth in non-COVID sales and new placements, we have taken a more cautious view on NeuMoDx sales for this year due to the rapid and more significant decline in COVID testing. As a result, our new target for sales in '23 is for over USD 40 million. Moving on to the PCR/Nucleic acid amplification product group.

Sales in the second quarter were down 29% CER. This was due to the sharp drop-off in sales to our OEM third-party customers. This was also a factor contributing to the revised full year outlook. At the same time, QIAcuity digital PCR sales are tracking well towards the 2023 goal for at least USD 70 million.

Here, we saw dynamic growth for the quarter, driven particularly by increasing consumables pull-through from biopharma placements. The last product group is Genomics NGS, which includes platform-agnostic products used for next-generation sequencing and our QIAGEN Digital Insights bioinformatics business.

The QDI business had an outstanding performance, delivering growth above 20% CER in the second quarter and a double-digit CER growth rate for the first half of the year.

Also supporting growth in this product group were incremental sales from our expansion into NGS-based applications for forensics and human identification through the acquisition of Verogen at the start of this year. Moving to sales on a geographic basis. The Americas grew 4% CER and were led by the U.S.

Among the key drivers were the QuantiFERON-TB test and solid biopharma demand for the QIAcuity digital PCR systems. This more than offsets the drop-off in COVID-19 sales in this region. In the Europe, Middle East, Africa region, sales rose at a double-digit CER rate for non-COVID product groups.

But here, we saw the pandemic headwinds led to overall sales declined 7% CER compared to Q2 '22. Among the top-performing countries were the United Kingdom and France. Results for the Asia Pacific/Japan region showed a 17% CER decline in overall sales but sales for the non-COVID products grew at a mid-single digit CER pace.

In China, which currently accounts for about 6% of sales, non-COVID sales declined slightly from the second quarter of '22, while overall sales declined about 30% CER due to the COVID-related revenues in the second quarter of '22. Let's now go through the rest of the income statement.

Adjusted operating income was down 7% to USD 136 million from the same period of '22, reflecting the impact of the lower sales base due to the drop-off in COVID-19 revenues. The adjusted operating income margin showed a sequential improvement from the first quarter and was 27.4% of sales.

The adjusted gross margin was 66.9% of sales in the second quarter of '23 and down about 0.5 percentage points from the '22 period. This reflected the overall lower sales levels and the related lower manufacturing capacity utilization. We expect adjusted gross margin to continue at the same level for the rest of the year.

R&D investments continued at a high pace as we invested organically into the business, rising to 10.1% of sales in the second quarter '23 from about 9.7% in the year ago period. We see these investments trending into a 9% to 10% range for the full year.

Sales and marketing expenses were slightly higher than in Q2 '22, rising to 23.5% of sales from 23.1% in the year ago period as we seek to gain more impact and effectiveness from customer engagement, especially through digital channels, which now account for the majority of sales.

General and administrative expenses were slightly lower than in Q2 '22 and represented 5.9% of sales. Here, we continue to see benefits of the shared service teams we have built at our key hubs in Poland and the Philippines, while also reallocating resources to step up investments into IT systems and cybersecurity.

To close out our income statement, adjusted EPS for the second quarter was $0.52 at constant exchange rates and above the outlook for at least $0.50 CER. The adjusted tax rate was 18% and the share count at 231 million shares, and these were in line with our outlook. Turning to cash flow.

Results for the first half of '23 reflect the lower sales and profit levels from the same period of '22. Operating cash flow for the first half of '23 was USD 183 million and free cash flow was USD 121 million. As we mentioned in the call for the first quarter, the cash flow results for '23 include higher working capital requirements.

This is due to our decision to increase inventories to ensure adequate product availability and the current macro environment. This is seen as well as the balance sheet in terms of the increase in inventories.

Continuing with the balance sheet, our total consolidated net debt stood at USD 556 million as of June 30 compared to USD 443 million at the end of '22. Our liquidity position remained at about $1.3 billion at the end of the second quarter compared to USD 1.4 billion at the end of December '22.

This means that our leverage ratio was about 0.8x net debt to adjusted EBITDA compared to about 0.5x at the end of '22. In terms of using cash proceeds, we have approximately $400 million of debt reaching maturity in the third quarter of this year and will use a portion of these proceeds for the repayment.

Even with this repayment, we continue to have a healthy balance sheet to support our business expansion and a disciplined capital allocation policies. I would now like to hand back to Thierry..

Many thanks, Roland. And at this point, please allow me to take a few minutes to review key aspects of our portfolio and our strategy based on balance in serving customers across the Life Sciences and Molecular Diagnostics and to focus on targeted highly attractive growth opportunities.

This is the basis for our ability to generate above-market growth and meaningful midterm returns. Let me walk through a key couple points that shore up our business. First of all, remember that the foundation of QIAGEN rest on highly recurring revenues. We consistently see over 85% of our total sales coming from high-margin consumables.

Our closed automation system drive the use of a broad portfolio of consumables. But keep in mind that some of our sample prep kits are used also manually, so there is a wide range of opportunities for expansion. Those sales are well balanced across Life Sciences and Molecular Diagnostics, where our products carry a healthy, healthy gross margin.

And despite some of the more challenging topics in the current environment, both of these markets have a real solid longer-term outlook.

For example, in the Life Sciences, we continue to see good research funding levels and an ability to target attractive areas in translational medicine, oncology research and hot topics like liquid biopsy, minimum residual disease, cell and gene therapy or microbiome where QIAGEN is already positioned and ready to capture more opportunities.

Many of those key advances make their way across the continuum into clinical health care. And here, we can support customers as we target the areas of immune response, infectious diseases and oncology. In fact, since the pandemic, molecular testing is clearly being utilized more than ever to increase the quality of patient care.

It is clear that more and more molecular applications are a keystone for future growth in both life science, research and clinical diagnostic, and QIAGEN is a clear leader in molecular technologies. In our growth pillars, we are leveraging strong leadership position as well as products in early commercialization stages with significant potential.

First example, obviously, sample technologies, the foundation of QIAGEN which continues to lead the market in sample preparation kits, which are used in the front of almost every molecular workflow in both research and clinical labs.

This robust, comprehensive portfolio leverages core gold standard kits while continually evolving to capture emerging applications such as liquid biopsy, microbiome once again or CRISPR. Sample technologies have delivered sales growth well above-market CAGR in the last few years as we implement instrument upgrade in the automation portfolio.

And we have no reason to expect less than solid low- to mid-single-digit growth in our midterm perspective. Our second pillar with very strong leadership is the QuantiFERON franchise. The QuantiFERON latent TB has been delivering double-digit growth on a sizable base for good reason.

Now on the fourth generation and with enhanced automation through our partnership with DiaSorin, but also with Hamilton and Tecan, it has generated more than $2 billion of cumulative sales for QIAGEN since the acquisition of Cellestis. Well over 100 million people have been screened to date using the QuantiFERON test.

Our specialized commercial teams have built critical relationships with national entities in the ongoing effort to transition latent TB screening to this modern blood test from the antiquated old skin test. Moving to our 3 pillars in early commercialization stage.

Our infectious disease platform, QIAstat and NeuMoDx, certainly received a boost from the pandemic. And while those systems were in high utilization during COVID as they are excellent for respiratory testing, their value to customers lies in a much broader context as we continue to expand the menu for those platform.

QIAstat has quickly taken a top position among system used for syndromic testing based on some key differentiators. Some recent analysis on the market have already positioned it as the #2 on the market.

It is very easy to operate with no upfront sample preparation, and its capability to provide PCR-based quantitative results brings added clinical value for more targeted treatment decision. NeuMoDx core testing platform offer next-level technology with true random-access sample loading and unmatched capabilities for running laboratory-developed test.

In Europe and other markets which are accepting the CE mark, we have one already of the most broadest testing menu available. At the same time, in the U.S., we have seen some delays in developing the test menu as a consequence of the priority to support the pandemic response. And for our last pillar of growth, QIAcuity digital PCR platform.

Those platforms are especially important in democratizing digital PCR to wider customer base. QIAGEN launched the line of instruments with novel integrated technology, bringing the time to result down under 2 hours.

Those systems address the scaling needs of customers from the low-volume users in academia, all the way up to biopharma labs processing high volume of samples. And we are rapidly expanding the menu with internally developed assays as well as partnering with companies in emerging applications for digital PCR.

Looking forward, a key milestone will be the FDA submission to enter the clinical market in 2024. Our business is targeted on high-growth areas. And while we have a sharp focus on our growth pillars, they are anchored by core portfolios where QIAGEN has leading position.

As an example, we are a top 3 provider for human identification solutions, which have included sample preparation and PCR kits.

We are now leveraging this position as we expand into next-generation sequencing-based application with the recent acquisition of Verogen early 2023, which is offering new ways to solve cases and bring resolution to those affected.

QIAGEN is also considered as a top provider of consumable and bioinformatics solution for use with any next-generation sequencer. In those businesses, especially QIAGEN Digital Insight for bioinformatics, we have taken significant market share and delivered strong growth in the most recent years. Another example is Precision Medicine.

QIAGEN has over 30 partnerships with pharma and biotech companies for companion diagnostic to help guide treatment decisions. And we are probably the only company able to offer quantitative PCR, digital PCR and next-generation sequencing modalities to pharma company.

So this brief summary helps you to see that we are well positioned in diverse markets with attractive growth potential. And while this year may be a bit more challenging than expected, our teams are committed to capitalizing on opportunities by leveraging this portfolio and delivering attractive midterm growth.

And now back to Roland to give you more details on our outlook for 2023..

the dynamic drop-off of COVID testing as well as significant volatility in large bulk orders coming from our OEM customers. In terms of COVID-19 test sales for 2023, we have reduced our initial assessment for about USD 200 million to USD 210 million to a new level of about USD 165 million.

Remember that in 2019, we had USD 143 million of sales from products that were redeployed for use during the pandemic, and these were mainly sample technologies for use in obtaining RNA. So it is important to understand that we are approaching the pre-pandemic baseline for these products.

In regards to our OEM business, as we have seen in the past, this is an area that can be volatile. We are certainly seeing that volatility this year in terms of customer order patterns against our initial plans. This business involves large-scale customer bulk orders, which impacts both COVID and non-COVID sales results.

In terms of regions, we are keeping an eye on trends in China and how this develops during the year. The sequential improvement of the market that was expected is taking more time in light of the Chinese economy. So for the second half of the year, we are taking a more cautious view than at the start of '23.

We are now expecting China non-COVID sales to remain flat over H2 2022. At the same time, we see the strength of our base business with sales growth expectations higher than many of our peers. We now expect healthy sales growth in the non-COVID product groups of at least 8% CER.

This is driven by resilient demand for our industry-leading portfolio of consumables. We are also anticipating a healthy level of instrument placements for the remainder of the year.

In terms of profitability, we have taken the reduced sales contribution into consideration with the revised outlook for adjusted EPS of at least $2.07 at constant exchange rates. We have been taking a very disciplined approach to balancing cost while investing in the business.

This remains a top priority during the second half of the year when we also expect to see benefits from having accelerated certain activities such as R&D investments into the first half. Moving to the third quarter. Our outlook is for net sales of at least $465 million CER.

Adjusted earnings per share are expected to be at least $0.48 per share also at CER. As for the currency movements and based on rates as of August 1, we expect a neutral impact on both net sales and adjusted EPS for the full year 2023.

For the third quarter, we expect tailwinds of up to 1 percentage points on net sales and a neutral impact on adjusted EPS. I would like to now hand back to Thierry..

Thierry, if you're muted, if you could check your mute function. We're not hearing you..

one, the significant drop of in COVID-19 testing; and two, the volatility in ordering among our OEM customers. Against this backdrop, we are currently delivering one of the highest base business growth profile in the industry.

We remain confident in the midterm growth potential of our portfolio and believe that our company, QIAGEN, is well positioned to deliver on the goals that we have set. Our track record of executing on our goals, combined with the dedication of our teams will help us to successfully navigate through the current macro environment.

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

[Operator Instructions]. Our first question comes from Patrick Donnelly with Citi..

This is on for Patrick. So in the quarter, I saw you saw a 9% CER decline in life science customers in the quarter.

What are you seeing from a biopharma funding perspective? And is there anything to kind of parse out between emerging biotech and large pharma trends?.

Thanks,. First of all, we consider that for life science, especially the overall environment for funding, remains extremely healthy. We have not seen cuts into the budget, for example, of CDC or other major organizations. Second, we are probably less exposed than many other companies to pharma or biopharma over-inventory.

We have seen a softening of some demand sometime in biotech for our bioinformatic QDI activities. But overall, we are not that much affected by those trends at the moment..

We'll take our next question from Odysseas Manesiotis..

So I want to ask one on QuantiFERON. In this scenario, one of your largest peers on the immunoassay side launched a similar test to yours on TB.

What makes you comfortable that you'll be better able to maintain your market position compared to HPV a few years back?.

This is a very good question, Odysseas. But I would say, first of all, we have prepared this and it's probably a very good example of a company with leadership position, planning the future and the potential increase of competition. And this was the rationale behind our partnership with DiaSorin for back-end automation of our tests.

In addition to this partnership, we built front-end automation partnership with Hamilton or Tecan. As a result, as of today, we have the most automated workflow for latent TB on the market. Second, we are talking about 20 years of medical education, publication around QuantiFERON. This is a real brand name on the market.

Dedicated people on the sales, on the marketing side, on the medical education side with QIAGEN for many years, extremely close relation with all the organization dedicated to the fight against TB, WHO's and so many others.

So we are not belittling of course the potential arrival on the market from competitors, but we see it rather positively because it will probably help raising the awareness around the necessary testing for latent TB in the fight against tuberculosis..

We'll take our next question from Derik De Bruin with Bank of America..

This is Peter on for Derik. Just at a high level, have things generally remained stable here at this point in the third quarter? Just could you kind of discuss how things have evolved since exiting 2Q, whether it be by customer class, product or geography? And I guess anything incremental would be helpful..

Thanks, Peter. I think Roland gave already some colors. I believe that geographically at the moment, there is nothing to highlight when we move into Q3. You know that we need to take Q3 also with a grain of salt. Part of the world, especially in Europe, a strong holidays, either in July for Germany or in August for the rest of Europe.

Third, we don't see any sequential improvement, as Roland highlighted, on the Chinese market. So I don't think that there is no specific highlight at the moment with either product-wise or geography-wise. What I would just highlight is that for us, Q3 is an interesting quarter, especially for QuantiFERON. Why? Because especially in the U.S.

with so many students going back to school, it's an important testing time. So I don't know if we are going to achieve the same performance as Q2 with $100 million generated in 1 quarter, but we shouldn't be that far away from that..

We'll go next to Dan Brennan with TD Cowen..

Congrats on the quarter, guys. I just wanted to unpack the guide a little bit, if you don't mind.

So the OEM business, Roland and Thierry, can you just help size how big that business is? What are the decline? Or what does it do in Q2? And it sounds like of your cut for the year, $80 million or so, a chunk from COVID, how much of the remaining $40 million is from the OEM business versus the China? I'm just trying to get a sense of like now, what are you assuming for the OEM business for the full year? Because I know you said 8% ex COVID CER growth for the year.

I'm just trying to understand what the OEM business -- how the OEM business impacts that..

Yes. Thanks, Dan. Thanks for the question. Again, I do not want to introduce another layer of numbers. But if we would take OEM out of our, call it, non-COVID numbers, actually, the growth rate would be north of 10% for the year. So you clearly can see that it is actually the OEM volatility, which is affecting our business for 2023.

Just to help you a bit to pack it as I said before, the OEM business is a very different business than our typical, call it, blue box consumable business, whether with few customers, whether it's orders -- significant 7 digits and even above and that being very volatile typically either enzymes and oligo business for us.

And it clearly had a very strong last year. As we said before, it is a combination of COVID and non-COVID-related business. Last year, it was around about $170 million in revenues. For this year, we expect it rather to be around USD 90 million. We clearly anticipated a drop already from last year when we have given initial guidance.

But unfortunately, we have to see now that given the overall macro environment, seeing that particularly the larger pharma and diagnostic companies, also reviewing the inventories and things like that, that, that created additional volatility.

We saw it is the right time now to more or less sell it on a new base because the volatility probably remains for the rest of this year. And I don't think it's worthwhile that has overshadows our existing performance in the overall consumable business..

We'll take our next question from Dan Arias with Stifel..

Roland or Thierry, can you just expand on the non-COVID China performance down slightly year-over-year, I believe? What did the Diagnostics versus Life Sciences business look like there if you have it? And then how do you see clinical demand finishing out for the year there? It sounds like it's a healthier environment than in the research setting.

And then if I could stick on a follow-up question to Dan's question on OEM destocking. Roland, if I'm not mistaken, that is a lower margin part of the portfolio.

So is what's happening there on the destocking actually having a positive impact on profitability, just boosting the margins a bit on mix? Or is that not material enough?.

Thanks, Dan. What I propose is we'll follow up immediately on the question on destocking with Roland, and then I'll take on China just after..

Yes. On OEM, again, as I said, it's only a few customers. I don't want to talk too much about margin in general. But I do think it's fair to say that we do expect more or less a year finishing in terms of margin performance above 27% in EBIT margin as well. So you can do the math by yourself. Again, this is a business that's very much deal driven.

Nevertheless, you know that our overall consumable business has actually an overall very strong margins. So I think it's hard to put things in perspective..

Thank you, Roland. And regarding China, I believe it's fair to say that the current situation doesn't change our vision for this market and the vision that we have been explaining to the market for at least the last 2 years.

First of all, it is a significant market, both for life science and clinical diagnostics, it's the second market in the world just after the American market. Second, it is a very, very specific market with a significant trend towards nationalization of the health care, not only diagnostic, but also pharma in China.

In other words, the Chinese authority are trying to favor local champions against foreign competitors. To cope with that situation, it is paramount in China to be able to localize manufacturing and research development. We can do that at QIAGEN with our manufacturing and research development site that we have in Shenzhen.

This is rather typical and other companies do the same.

QIAGEN is probably a bit specific because in addition to that, we have also a second brand in China, a company which is independent operationally from our sales and marketing activities in China, which is selling Chinese-originated product mainly to Chinese company, but is fully owned by QIAGEN and fully consolidated in our results and revenues.

And I think this will be a key differentiation and help for the coming years.

However, I repeated many times that if you would have asked me before the pandemic, what would or what should be the growth expected from China in QIAGEN sales year after year, I would have told you double digit, probably low double digit, around 10% to 12% per year post pandemic.

And due to the different factors that I just explained, our expectation in a normalized situation would be a growth coming from China of 5% to 6% per year.

Probably more coming from life science than clinical diagnostic for one key reason, the competition from Chinese company will probably be much more intense in clinical diagnostic than in life science.

Last, I would say that luckily, QIAGEN is positioned in molecular technologies where probably there is less Chinese competition at the moment than in other businesses, such as immunoassays or clinical chemistry..

We'll go next to Matt Sykes with Goldman Sachs..

Maybe just two quick ones, I'll ask them both upfront. But just on the OEM business, given it sounds like it's destocking and it's generally volatile and not very many customers, what is the type of visibility you have on those customers in terms of sort of the duration of these issues, if any? Maybe help us out with that.

And then just secondly, on sort of the menu -- reporting the menu into the U.S. and a number of the diagnostic platforms you have, I understand that there's sort of a lot that's out of your control in terms of the approval process.

But is there anything that you can do to try to accelerate that or reprioritize different types of tests on the menu in order to realize your goals in the U.S.

in terms of menu expansion?.

Matt, those are two good questions. OEM first, and Roland, if you want, feel free to chime in as well. We have, obviously, as you can imagine, a very close discussion with those few customers. And Roland highlighted in his presentation that what we are selling to them is rather basically compulsory in their process. We are talking oligos or enzymes.

So we work on having forecast or improve forecast accuracy. However, I think they are faced at the moment with also softness in demand on their side, and this is why it has been more difficult this year.

We strongly believe that at least on the base business that we have, this $90 million that Roland highlighted a few minutes ago, we have a good visibility and good reason to continue that business in the coming years. On the menu for the U.S., it's a good question. It's problematic of portfolio allocation.

What is happening is that at this moment, we are in very intense discussion with the FDA to try to push our GI panel, which would be our second panel for QIAstat in the U.S. On NeuMoDx, the situation is slightly different. In NeuMoDx, we had to make a significant choice at the point. It was giving the priority to answering the pandemic volume.

And therefore, we had to postpone some menu submission in the U.S. We are starting again this year. For example, we have submitted CT/NG. We will continue in 2024 and '25. But I repeat, for NeuMoDx, we probably have taken 1 year to 1.5-year delays compared to initial plan for early submission.

But this was because we had to answer the pandemic increase or the pandemic situation..

We'll take our next question from Aisyah Noor with Morgan Stanley..

I had a broader question around the guidance given you've now lowered your expectations for non-COVID growth to over 8%. As you look at the state of your portfolio today in the panel launches you have lined up for the next, call it, 6 to 12 months and then you balance that with here now. lower visibility on the OEM business.

How are you feeling about your ability to drive double-digit non-COVID growth in 2024? And which segments or product lines do you think will be the biggest contributors to that? And then I have a follow-up after that, if that's okay..

Thanks a lot, Aisyah, for your question. First of all, we need to be very clear. We never took a commitment on double-digit growth in 2024 for the base business, what you refer to as the non-COVID. What we always said and we stick to that statement, QIAGEN has a portfolio to grow above market growth, and this is what we will deliver.

There is no reason to see a brutal decrease lower than double digit, for example, for our QuantiFERON sales, at least for 2024. As we said in the presentation today, we stick to what we gave you back in December 8, 2021, when we say our sample tech portfolio has clearly a low- to mid-single-digit growth potential. We confirm that.

In that same day in December '21, we said we believe that QIAcuity and QIAstat definitely have a double-digit growth profile. We confirm this. NeuMoDx is fighting against the weight, obviously, of COVID. So as long as we do not stabilize this, it will be growing in Europe in the base business and will be affected in the U.S. because of COVID.

But all those elements, plus the fact that we have serious double-digit growth, for example, in NGS and QDI, that our companion diagnostic portfolio is constantly enriched by new launches, you have seen our recent press release this year as well. We think that really, we are positioned to exceed market growth for the coming years, not only in 2024..

Great. That's helpful. And then just a quick follow-up on the share buyback program and when you expect to get approval for this..

I think before we go there, I think it's probably also important to add, I think if you aggregate together what we just said, you clearly can see that, that is something that adds up nicely to what we said before, above-market growth rate in midterm, which again is mid- to high single digit.

But I think it's also important to say that we also, again, as I said before, we have a 27% plus EBIT margin for this year. We do not see any reason why we shouldn't see an improvement in margins also mid or long term. I think we have a good record of doing so.

And I think that trend probably also remains quite stable, and nothing has changed about both actually with the announcement as of yesterday, I think it's important to realize that as well. In terms of share buyback, the good news is we got the approval on the shareholder meeting.

So we are technically more or less approved for a synthetic share buyback.

As I said in my remarks, we are clearly open to continue what we did more or less quite successful since 2012, which is 3 different ways of capital allocation, investing into the business, both on M&A activities as we did blood and as we did Verogen and of course, share buyback activities.

Right now, as you know, we are in the middle also in unsettling some of our financing instruments going to a repayment that has some technical topics where we have to work through. Once we are done with that, it's quite obvious that we have full flexibility..

We'll take our next question from Hugo Solvet with BNP Paribas..

Just on QuantiFERON TB. Maybe, Thierry, can you talk to the strength of the business in the U.S. in Tier 1 accounts and maybe smaller Tier 2 accounts? And given you're tracking well of the full year guide or should we think about phasing of growth and sales for Q3, Q4? And I will have one follow-up after that..

Thank you, Hugo. And as you're probably aware, for QuantiFERON, North America is our main market. We are not referring to Tier 1 and Tier 2, but we are dividing the market between what we call national accounts, typically laboratories like Quest, LabCorp, ARUP, for example, and nonnational accounts.

And both are developing extremely well at a comparable growth rate. In addition, we have been able to not only extract value from the automation with DiaSorin, in other words, any time we automate a customer from QuantiFERON fourth generation to DiaSorin, we do it at a premium price.

But we also, on top of that, passed price increase, not only last year, but also at the beginning of the year. Nonetheless, I would like to insist that the growth in the U.S., like in the rest of the world for QuantiFERON is driven mainly by volume before than price.

What makes us optimistic and confident for QuantiFERON, especially in North America, is that we continue to open new opportunities. For example, diabetes patient is becoming a significant opportunity for us. Second, immigration is starting again at a higher pace compared to the previous administration or the pandemic period.

Anytime there is immigration, especially from emerging countries, there is testing for QuantiFERON. And last but not least, we now have, after a significant investment in marketing, a much more precise knowledge of where the skin tests are in North America. And what is interesting is that the U.S.

is one of the country where the price of a skin test is very comparable to the price of a QuantiFERON. Therefore, conversion is at least a bit easier. I believe it answered your question, but I think you had a second question, Hugo..

Yes. Just a follow-up on the previous question as you think about 2024. Thank you for answering the -- on the non-COVID portfolio.

But on the COVID, should we assume sales going back to pre-COVID baseline of about USD 143 million? Or should we assume a low single-digit growth of that baseline theoretically over the 2020, 2023 period just to have a better sense of what the landing point will be?.

No. I think assuming some of the growth in the underlying portfolio, I would say the revenues for next year in that area stay probably at least $160 million plus, might be $165 million plus a few percentage points. Again, I think that is more or less a baseline..

We'll go next to Falko Friedrichs with Deutsche Bank..

My question is in line with the -- Thierry, can you just remind us on the non-COVID -- what makes you confident that this will continue to be a winner in the market? I mean QIAstat and QIAcuity seem to be doing very well.

So what makes you confident that NeuMoDx will be sort of one of the drivers that might be lagging a bit behind?.

Thanks. It's a good question, Falko, but it's -- first of all, when we look at an instrument or an investment like NeuMoDx, we cannot judge on a quarter or a year, obviously.

What makes us first confident in the system is that in something like 2 years, 2.5 years in number of placements, QIAGEN has already taken more than 10% of the market share of the current #1 in that market. And as you know, it's a competitive market. Obviously, we are very late because of what I explained in the U.S., and we are not happy with that.

But the system, the platform is extremely differentiated. In this business, where there are big competitors, none of them have seriously upgraded their solution over the last 10 years or very slightly. NeuMoDx is completely differentiated, better automation, easier to use.

You take a DNA result with NeuMoDx in 60 to 70 minutes against 3 hours for our main competitors. True random access, the first platform on the market and the only to this date, where a laboratory can do, at the same time, any kind of sample, any kind of assays and either laboratory-developed test or regulated assays.

So there is no doubt that the platform is differentiated. Obviously, obviously, we need to continue to develop the menu. But remember, in Europe and CE marking countries, we already have one of the largest menu available, more than 16 assays for infectious diseases. So we have all the tools to fight.

At the same time, we need to constantly review what's the best strategy, what's the best capital allocation per geographies to push that solution to the market..

Our last question will come from Casey Woodring with JPMorgan..

And so apologies if you guys have touched on this but jumped on late. Just maybe one for Roland on '24. So the Street is at 7% top line growth. It sounds like your exit rate in 4Q will be in that high single-digit growth range on the non-COVID side. And similarly, the Street is at 100 basis points margin expansion for next year.

So can you maybe just walk through the swing factors for '24 on those numbers if pharma demand continues to kind of be soft from OEM and maybe puts and takes in China and instrument demand? Kind of just maybe kind of level set expectations for '24. That would be helpful..

Yes. Thanks, Casey, for asking that question because again, you should do my job as well because exactly what I see right now as well. So I think that fits quite well. Overall, I think as you said before, that what you just stated doesn't make us uncomfortable at all. I think that is all very reasonable. But of course, there is volatility in the market.

There is clearly a market environment which might change in either direction. There is still an ongoing war, in particular in Europe. So I do think there's a lot of uncertainty in the market, which right now is hard to get our hands around.

Nevertheless, the good news for us is that 85% of our business is a very resilient consumable business, and we haven't seen any reason to believe that it's going to change either in '23 or in '24.

So overall, we are growing with good comfort into next year, particularly our pillars of growth, as we just said before, overall are all very well underway. There's clearly some even shining more than others. But overall, I would say, a good performance. At the same time, there is a couple of areas where there's upside opportunities.

As you just said, we do believe midterm, there is a good reason to believe that our pharma and diagnostic clients and OEM side come back to normal and that it becomes another high single, even a double-digit grower, very helpful.

We all hope not only in our industry but in general, that China becomes business-wise a more stable environment, that might be helpful as well. So I think there's a lot of reasons where also we could expect and seize upside opportunities. Is it too early to call them out? Absolutely.

At the same time, we shouldn't forget that as ongoing menu expansion in many areas at QIAGEN, so we're driving our R&D activities. I talked about that, that we actually accelerated a lot of things.

And again, there is also something what was very helpful for us in the last 3 years, we shouldn't forget that we had now many consecutive quarters with a healthy double-digit growth rate. And again, also here, finishing that year with an 8% all in non-COVID ex OEM, 10-plus growth rate, I think, is still a very healthy performance..

Okay. With that, Roland and Thierry, I'd like to end the call here. Thank you very much for your participation today. If you have any questions, comments or suggestions, please do not hesitate to reach out to Phoebe and me. We're always available to support you on topics. Thank you very much. Bye-bye..

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