Bio-Techne Corp

NASDAQ:TECH

Earnings Call Transcript 2021-Q4

[Operator]

Good morning, and welcome to the Bio-Techne Earnings Conference Call for the Fourth Quarter of Fiscal Year 2021. [Operator Instructions] I would now like to turn the call over to David Clair, Bio-Techne's Senior Director, Investor Relations and Corporate Development. Please go ahead, sir.

[David Clair, executive]

Good morning, and thank you for joining us. On the call with me this morning are Chuck Kummeth, Chief Executive Officer; and Jim Hippel, Chief Financial Officer of Bio-Techne. Before we begin, let me briefly cover our safe harbor statement. Some of the comments made during this conference call may be considered forward-looking statements, including beliefs and expectations about the company's future results as well as the potential impact of the COVID-19 pandemic on our operations and financial results. The company's 10-K for fiscal year 2020 identifies certain factors that could cause the company's actual results to differ materially from those projected in the forward-looking statements made during this call.

The company does not undertake to update any forward-looking statements as a result of any new information or future events or developments. The 10-K as well as the company's other SEC filings are available on the company's website within its Investor Relations section. During the call, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. Tables reconciling these measures to most comparable GAAP measures are available in the company's press release issued earlier this morning on the Bio-Techne Corporation website at www.bio-techne.com. I will now turn the call over to Chuck.

[Charles Kummeth, executive]

Thanks, Dave, and good morning, everyone. Thank you for joining us for our fourth quarter conference call. With 39% organic growth in the quarter, the fourth quarter closed out a record year for Bio-Techne, where we achieved 22% organic growth for the full 2021 fiscal year. What a difference a year makes. We ended fiscal 2020 on a much different note, as lockdowns and disruptions to our academic and biopharma customers took hold and changed the way research was being conducted.

In the quarter following the initial COVID pandemic spread, there has been a record level of interest in Bio-Techne's portfolio of reagents, analytical tools and services that enable researchers to make discoveries and push science forward. With robust research demand from biopharma end markets and expectations for a favorable government research funding environment, we believe a multiyear research tsunami is upon us. Bio-Techne is incredibly well-positioned to ride this wave. For the second quarter in a row, the Q4 growth rate was the best organic growth the company has delivered over 25 years, both on a year-over-year and over a 2-year CAGR basis. The accelerated Q4 growth was broad-based across our end markets and geographies, although most of our customers experienced the worst of the pandemic-induced lockdowns during our fiscal Q4 last year. The growth within our product category was also broad-based and continue to be led by our analytical instrument platforms, cell and gene therapy solutions and genomics tissue spatial analysis tools.

EMEA had a strong finish to a record year with 25% organic growth for the full fiscal year. Given that our main distribution hub for Europe is in the U.K., Brexit was quite a distraction with multiple supply chain and logistics surprises to conquer between the U.K. and Mainland Europe. The team did an excellent job navigating through this and ensuring the strong demand from our European customers was delivered.

China is a similar story. As you may recall, China was the first to lockdown due to COVID and the first to come out. But China for us is essentially back to business by our fiscal Q4 of last year. So the year-over-year comps for China were tough this year compared to the U.S. and EMEA. Yet China delivered 30% growth for the quarter and the full fiscal year. We are very close to seeing $100 million of annual revenue in China. If not this coming fiscal year, most certainly the year after. Across the company, we delivered this record quarter with a continued focus on profitability as our operating margin expanded by over 740 basis points year-over-year. And during the quarter, we made progress investing in the human capital necessary to position the company for its next leg of growth, although demand for talent in the life science industry remains very high.

Encouragingly, some of the business practices we took for granted in the pre-pandemic world, including business travel, are slowly returning, but remain below normal levels. Consistent with our results throughout fiscal 2021, the deferral of these investments accelerated our profitability. Now let's discuss the performance of our growth platform, starting with the Protein Sciences segment, where organic growth accelerated to 46% in the quarter and 24% for the full fiscal year. During the year, we made great progress with our cell and gene therapy initiatives. We opened our GMP protein facility and signed several large customers. Going forward, we will continue to broaden our GMP portfolio with the planned introduction of GMP-grade recombinant antibodies, cell and expansion media and other critical reagents. The demand for GMP proteins is likely to expand beyond T cell-based therapies to include gene-edited natural killer cells and progenitor cells that fill the regenerative medicine therapies workflow. All of these areas are gaining momentum and increasingly relying on our products.

As evidence of this growing interest, Catamaran Bio and Bio-Techne recently broadened the scope of their collaboration to include the development of novel cell expansion technologies for use in the manufacture CAR-NK cell therapy products. Additionally, Catamaran secured a broad worldwide license for TcBuster, our gene editing platform, and has integrated the technology into its tailwind platform for CAR-NK cell therapies. Importantly, our cell and gene therapy relationships, such as this example, are having a broader impact throughout the company, driving adoption of our media, assays, instrumentation, antibodies and other offerings in our portfolio. We are leveraging our digital marketing capabilities to build awareness and the customer funnel for our expanding portfolio of cell and gene therapy workflow solutions.

During the quarter, we made enhancements to our website, including promotional videos and additional images to more effectively showcase our complete offering. I would encourage all of you to visit the cell and gene Therapy section of Bio-Techne's website to view a video providing a virtual tour of our state-of-the-art GMP protein facility. Now let's discuss the analytical instruments we sell within the Protein Sciences segment. If you would have asked me in the past, if we could grow our 3 main platforms, Simple Western, Jess, Simple Plex, Ella and Biologics Maurice by 30% to 80% all year long, I would have said impossible. What happened this past year, a number of things. First, these instruments are great tools for productivity. If labs redesign themselves around working partially from home, it became more important to increase output while in the lab. Our tools are perfect for this and add a great value. Second, proteomics-based applications are on fire. Research in this area is strong, and our tools are not only the best in class, and in some cases, the only type of tool you can purchase that conducts a specific analysis. For example, Simple Western is the only fully automated Western blot solution on the market. The productivity enabled by our Simple Western instrument combined with our growing installed base has led to a significant increase in market awareness for this product. In fact, we believe this awareness has reached a critical tipping point as almost 90% of the Simple Western instruments sold in the quarter did not require a demo.

Simple Plex continued its streak amazing results in Q4 and with our automated multiplexing platform, Ella, delivering over 65% growth in the quarter as demand for neurology, immunotherapy and cell and gene therapy research applications drove instruments placements and utilization within the installed base. This result is even more impressive considering the particularly challenging year-over-year comp Ella faced when high demand for the system for COVID-related applications drove an almost 100% increase in the same quarter last year. We took several steps to meet ongoing demand for this platform, including additional shifts and are in the initial stages of adding incremental manufacturing capacity to meet forecasted demand.

During this quarter, we announced a collaboration with India-based ophthalmic health care provider, Narayana Nethralaya, for the evaluation of Ella as a diagnostic tool for to analyze LASIK vision correction patients for post surgery complications. This is another example of the untapped potential of Ella as a clinical diagnostic platform. We also recently announced a collaboration with ProGen for the launch of the Simple Plex adeno-associated virus or AAV2, viral titer assay on our Ella platform. AAV2 is commonly used in gene transaction due to its ability to infect a variety of cell types. During the viral vector production process, a series of robust analytical measurements are required to determine the viral titer. Combining the efficiency and the reproducibility of the established AAV2 [indiscernible] from the ProGen with the convenient workflow and robust performance of the Ella platform creates an assay with a broad dynamic range along with hands-free automation to accelerate cell and gene therapy quality control process.

Our biologics portfolio also had a very strong showing with growth over 30% for the quarter and the year. We are excited about the recently announced collaboration with 908 Devices, where our Maurice Biologics platform provides reproducible quantitative analysis of identity, purity and heterogeneity profiles for therapeutic proteins will be paired with the 908 Devices ZipChip. For the collaboration, Maurice will enable the measurement of molecules that have a similar charge or isoform and collect tractions of these isoforms for purification and the preparation on the ZipChip prior to being introduced to a mass spectrometer creating a seamless sample prep workflow.

Finally, our core portfolio of proteomic research reagents increased over 50% for the quarter and nearly 20% for the fiscal year. During the fiscal year, we expanded our market-leading portfolio of research reagents, including the addition of over 300 new research proteins to our expanding catalog of over 6,000 proteins. For antibodies, biopharma is increasingly recognizing our capabilities in immuno-oncology targets and immune cell labeling.

Now let's discuss our Genomics and Diagnostics segment, where the team delivered 22% organic growth in the quarter and 18% for the full fiscal year. Our spatial genomics and tissue pathology business branded ACD, remained extremely strong with the team delivering over 60% growth in the quarter. Growth was broad-based within the portfolio and across geographies with RNA scope remaining strong. And the emerging high-plex BaseScope and microRNA products all gaining traction as new marketing campaigns and deeper account penetration benefited the business. We fortified our RNA scope offering with the introduction of the latest version of our multiplexing spatial genomic technology, HiPlex v2. This latest iteration of HiPlex adds the ability to visualize that the 12 targets simultaneously in our formalin-fixed paraffin embedded or FFPE samples and continues to offer the flexing of up to 48 targets in fresh or freshly frozen tissue samples available in the legacy version of the assay. FFPE is an important sample type for human samples, especially for studying diseases. And we anticipate demand for HiPlex v2 as a tool for cancer and neuroscience applications as well as immuno-oncology studies.

Next, our diagnostic reagents business faced large headwinds this past year with the pandemic dramatically reducing doctor visits and in turn, diagnostic controls to OEM customers. However, this business successfully overcame these headwinds by supplying COVID-related antibodies to COVID-related test and vaccine manufacturing, realizing 8 consecutive quarters of positive growth. With people returning to see their doctor again in a post-vaccinated world, future is bright for our diagnostic reagents business with a strong product and OEM pipeline. Our Exosome Diagnostics business unit continues to make progress despite a very soft urology market. During COVID, patients were not leaving the home to do annual checkups or seeing their urologists. This dramatically reduced their level of PSA test. The tool used by urologists to identify a need to prescribe an ExoDx test for prostate cancer risk analysis and possible biopsy. The market is now recovering. We have staffed up our commercial sales force and our growth is accelerating.

We also made progress on the EPI reimbursement front during the quarter, following our request for reconsideration, our Medicare administrative contractor, National Government Services or NGS, issued an updated ExoDx prostate local coverage decision, or LCD. This updated LCD removed many of the ExoDx prostate restrictions included in the original LCD including limitations for test utilization among certain necessities, excluding patients with first degree relative with prostate cancer as well as removing the restrictions for patients with a persistently elevated PSA score. The reconsidered LCD became effective on August 1st. Following the removal of these EPI usage restrictions, the LCD better reflects the NCCN guidelines and positions the test for improved utilization among the Medicare population.

In addition to the ExoDx prostate test, we continue to advance our pipeline of innovative exosome-based diagnostic tests including our noninvasive kidney transplant rejection assay, ExoTRU. As a reminder, our initial ExoTRU data was published earlier this year in the Journal of the American Society of Nephrology, showing a negative predictive value of 93.3% and a positive predictive value of 86.2%, which we view as best-in-class performance versus the competition. We remain on track to launch this noninvasive urine-based assay later in calendar 2021 and have held preliminary discussions with our MAC on the pathway for Medicare reimbursement.

Finally, I'd like to highlight the acquisition of Asuragen we made this past quarter, a 15-year-old diagnostics company with strong competencies, great leadership and domain knowledge and diagnostic regulations. They also bring kitting expertise, molecular oncology diagnostic kits as well as a strong portfolio of carrier screening diagnostics like Fragile X the world's best-in-class test for identifying prenatal intellectual disabilities. During the quarter, Asuragen published the results of a multi-site evaluation study known as AmplideX, PCR SMA Plus kit in the Journal of Molecular Diagnostics, validating its performance in delivering accurate, reliable information to support carrier identification for the diagnosis of spinal and muscular atrophy or SMA. Asuragen's kit simplifies existing methods for identifying relevant variance in the SMN1 and SMN2 genes by identifying all variants in a single reaction. I want to be clear on our direction for diagnostics. It is not our goal to be simply a CLIA lab service model. We prefer to sell kitted products, primarily in the oncology, neuroscience and prenatal markets. These markets have strong growth due to strong needs as well as good margins and better-than-average reimbursement levels. Since closing the acquisition on April 6, we have made significant progress with the integration efforts with Asuragen and are in the initial stages of building out the commercial team to increase penetration in the largely untapped EMEA market.

We have also begun a coordinated R&D and marketing strategy to identify synergistic projects across the company, especially with Exosome Diagnostics as we position our entire diagnostic offering to penetrate high-value markets with kitted and LDT assays.

Lastly, I'd like to give an update on the impact of our COVID-19 initiatives. Since the start of the pandemic, Bio-Techne's reagents and instruments have facilitated studies that allow a better understanding of the virus, including ACD probe's detected virus and tissue, sales of bulk diagnostic reagent [indiscernible] and COVID testing applications as well as pathogen-specific antibodies and proteins to known variants of the COVID virus. COVID was an estimated 3% tailwind to our business in Q4 and approximately 4% tailwind for the year, including revenue from sales of the Kantaro IgG antibody serology kit. Encouragingly, there is growing interest in niche markets forming around our COVID serology assay offering, specifically as a tool to identify immunocompromised individuals that may not have the antibody response following vaccination to neutralize the virus. We expect the COVID research and diagnostics will be around for many years, particularly as new viral strains continue to emerge, making this tailwind a sustainable new layer of our product portfolio going forward.

Wrapping up. We have reached the tipping point in several of our high-growth businesses, including the ACD Spatial Genomics business and our ProteinSimple branded portfolio of proteomic analytical tools and remain in the early innings of penetrating the nascent Cell and Gene Therapy and liquid biopsy markets that are in the front of the company. Layered on to this is a strong funding environment for our market-leading catalog of research proteins and antibodies and the scientific know-how that has been built around them for over the last 40 years, and I believe we are incredibly well positioned to remain one of the most innovative, high-growth, highly profitable life science tools and diagnostic companies going forward. We are closing in on an important milestone crossing $1 billion in annual revenue. And with our existing portfolio, see a pathway to double that in the years to come. On that note, I want to remind everyone that Bio-Techne will be hosting an Investor Day event on September 10 in New York City. At the meeting, we plan to dive deeper into all our growth drivers and provide an update on our long-term aspirations. We hope to see everyone there.

With that, I'll hand over to Jim.

[James Hippel, executive]

Thanks, Chuck. I'll provide an overview of our Q4 fiscal '21 financial performance for the total company, provide some additional details on the performance of each of our segments and give some thoughts on the year ahead. Given the anomaly that occurred in Q4 last year with the pandemic-induced customer lockdowns, I will also provide certain growth rates expressed as 2-year CAGRs as these are likely more representative of our midterm underlying growth momentum.

Starting with the overall fourth quarter financial performance. Adjusted EPS was $1.87 versus $1 a year ago, an increase of 87% over last year, representing a new company record. Foreign exchange positively impacted EPS by $0.08. GAAP EPS for the quarter was $0.37 compared to $1.48 in the prior year. The biggest driver for the decrease in GAAP EPS was unrealized losses on our investment in ChemoCentryx this year compared to unrealized ChemoCentryx gains in the prior year. Q4 revenue was $259 million, an increase of 47% year-over-year on a reported basis, 39% on an organic basis and an organic CAGR of approximately 13% since Q4 of '19.

Foreign exchange translation had a favorable 4% year-over-year impact and acquisitions also had a favorable 4% impact to revenue growth. For the fiscal year '21, revenue was $931 million, an increase of 26% on a reported basis, 22% on an organic basis and an organic CAGR of approximately 13% since fiscal year '19. Foreign exchange translation and acquisitions had a favorable year-over-year impact of 3% and 1%, respectively. All geographies had a strong growth in Q4, led by the U.S. growing nearly 60%, which represents a 13% CAGR since Q4 fiscal year '19, followed by EMEA with over 35% growth or a 2-year CAGR of 15%, and in China with growth north of 30% for the quarter, representing a 2-year CAGR in the high 20s.

The rest of the world grew almost 30% or at a 10% 2-year CAGR. Q4 of last year was the start of pandemic in the U.S., with shutdown severely impacting this geography, while European customers have begun to emerge in the shutdowns and China was largely reopened in Q4 for fiscal year '20. Hence, the comps in Q4 this year were easier in the U.S. compared to China and Europe. That being said, the 2-year CAGRs across the globe are impressive and illustrate that we've emerged a pandemic even stronger than before it started.

By end market, biopharma continues to be very strong, growing nearly 50%, while academia growth was impacted by the shutdowns -- was most impacted by the shutdowns last year, growing nearly 60%. The 2-year CAGR, we believe, illustrates the real relative strength with biopharma growth nearly 20% and academic growing approximately 5% per annum over this period. We expect academia to continue to improve as national funding budgets get approved and dispersed throughout the next year.

Moving on to the details of the P&L. Total company adjusted gross margin was 72.5% in the quarter compared to 69.5% in the prior year. The increase was primarily driven by volume leverage, operational productivity and favorable product mix. Adjusted SG&A in Q4 was 26.1% of revenue, a 200 basis point decrease compared to the prior year, and R&D expense in Q4 was 8% of revenue, 150 basis points lower than last year. While adjusted SG&A and R&D spend both increased sequentially and compared to the prior year, a tight life science labor market did not allow us to fill all planned headcount additions to the team at the pace we had originally anticipated, especially in the more scientific and engineering fields. However, our pace of hiring did increase over the course of Q4, and we plan to make additional progress in fiscal 2022. This investment in critical human capital will position the company for growth going forward. Additionally, Q4 was the first quarter that included a surgeon's operating costs. The resulting adjusted operating margin for Q4 was 38.5%, an increase of 740 basis points from the prior year and a 340 basis point improvement from Q4 of fiscal '19.

For the full fiscal year '21, adjusted operating margin was 38.9%, an increase of 560 basis points from fiscal year '20 and a 470 basis point improvement from fiscal year '19. Looking at our numbers below operating income, net interest expense in Q4 was $3 million, decreasing $1.4 million compared to the prior year period. The decrease was due to a continued reduction of our bank debt during fiscal 2021 as well as lower floating rates. Our bank debt on the balance sheet as of the end of Q4 stood at $341.3 million. Other adjusted nonoperating expense was $0.7 million for the quarter compared to $0.5 million of income in the prior year, primarily reflecting the foreign exchange impact related to our cash point arrangements.

For GAAP reporting, other nonoperating income includes unrealized losses from our investment in ChemoCentryx. Moving further down the P&L. Our adjusted effective tax rate in Q4 was 20.3%, a 110 basis point improvement over the prior year, with the improvement primarily driven by geographic mix. Note that the GAAP effective tax rate in Q4 was favorably impacted by the discrete timing of stock option exercises. As a reminder, during Q2, we made a strategic investment in China-based Eminence, a company focused on providing media as well as custom cell line development and media formulation services, the Chinese biopharmaceutical market. The $316,000 noncontrolling interest line item reflects a loss on a portion of Eminence we do not own. The impact to other lines of the P&L as a result of consolidating Eminence was immaterial in Q4.

Turning to cash flow and return of capital. A $122 million of cash was generated from operations in the quarter, more than 170% increase over the prior year. The increase was driven by strong working capital management while meeting our customer commitments on much higher demand. In Q4, our net investment in capital expenditures was $12.8 million. And during Q4, we returned capital to shareholders by way of $12.4 million in dividends. We finished Q4 with 41 million average diluted shares outstanding. Our balance sheet finished Q4 in a very strong position with $231.6 million in cash and short-term available for sale investments and a total leverage ratio of well under 1x EBITDA.

Next, I'll discuss the performance of our reporting segments, starting with the Protein Sciences segment. Q4 reported sales were $192.3 million, with reported revenue increasing 51% compared to the prior year. Organic growth was 46% with foreign exchange having a favorable impact of 5%. The organic CAGR since fourth quarter of fiscal '19 was approximately 14% per annum. Within this segment, the strong growth was very broad-based in nearly all reagent, assay and instrument platforms. Looking at 2-year CAGRs going back to fourth quarter of fiscal year '19, standouts in the group would be Simple Plex with approximately 75% annual growth, Cell and Gene Therapy with approximately 50% annual growth, with the GMP protein component growing well over 100% annually. Biologics was approximately 25% annual growth and Simple Western with approximately 20% annual growth.

Operating margin for the Protein Sciences segment was 46.7%, an increase of 780 basis points year-over-year, due primarily to favorable volume leverage, operational productivity and cost management.

Turning to the Diagnostics and Genomics segment. Q4 reported sales were $67.1 million, with reported revenue increasing 38%. Organic growth for this segment was 22% with acquisitions contributing 15% and foreign exchange translation having a favorable 1% impact on revenue. The organic CAGR since the fourth quarter of fiscal year '19 was approximately 11% per annum. The ACD-branded spatial analysis portfolio, together with the Exosome Diagnostics, led the segment in the quarter with 2-year CAGRs of nearly 20% and 70% per annum, respectively. As Chuck mentioned earlier, our Diagnostics Reagents business did a very nice job executing on both COVID-related antibody opportunities to cover for the softness in the general diagnostics market, resulting in a mid-single-digit CAGR over the last 2 years since the fourth quarter of fiscal '19.

Moving on to the Diagnostics and Genomics segment operating margin at 16.7%, the segment's operating margin improved 430 basis points compared to the prior year. The increase also reflects strong volume leverage, operational productivity and strong cost management across the segment.

In summary, we finished fiscal '21 on a very strong note. Our products are clearly addressing the current needs of the research and clinical communities we serve, providing the proteomic, genomic and diagnostic tools necessary to drive science forward. With some of the largest opportunities still in front of the company, we believe we are just getting started and are looking forward to updating everyone on our vision for the future during our upcoming Investor Day. In the more near term, with favorable life science research funding as a tailwind, we expect the organic growth momentum that we've experienced over the last 2 years to carry on into fiscal year '22. We foresee continued strength across our entire portfolio. With Cell and Gene Therapy, our analytical instrument portfolio and spatial genomic analysis tools, leading the way once again, while 4 reagents maintained their market leadership position and the Exosome Diagnostic prostate test continues to ramp. We also anticipate Asuragen to add approximately 3% growth to our top line during fiscal year '22 and begin to be accretive to our organic growth in the fourth quarter. As Chuck and I mentioned in our prior commentary, we have recently made progress in making the investments needed to support our future growth, but have further to go to catch up to our strategic plan and enable the acceleration of growth in the future. Additionally, with our biopharma and academic customers now back to work, increasingly more receptive to in-person interaction, we are expecting a return of pre-pandemic activities, including corporate travel to normalize as fiscal year '22 progresses.

Finally, Asuragen is still in the initial stages of profitability and making the investments necessary to fully realize the synergies and global potential of this business. All these considerations taken together, we expect our adjusted operating margin going forward to be sequentially lower compared to our Q4 fiscal '21 results, but returning back to this level in the back half of fiscal year '22.

That concludes my prepared comments. And with that, I'll turn the call back over to open the line for questions.

[Operator]

[Operator Instructions] And we will take our first question from Dan Arias with Stifel.

[Daniel Arias, analyst]

Jim, I appreciate the color there on the business. Did I hear you give an organic growth guidance number for the year for 2022?

[James Hippel, executive]

What you heard me say was that our CAGR for the past 2 years has been approximately 13%, and we expect that kind of momentum to continue into fiscal year '22.

[Charles Kummeth, executive]

We always give an annual.

[Daniel Arias, analyst]

Okay. Obviously, a lot of room for interpretation or just a range of outcomes for double digit or just expecting the CAGR to continue. Is there any way you could comment just on maybe where the Street is? The Street is looking for, I think, right around 15%. I hear what you're saying on 13% is the fair assumption that something...

[Charles Kummeth, executive]

Yes. We'll have more commentary at the Investor Day. And we'll get into more specifics and kind of break down where things are at. But right now, it's kind of hard. And we typically -- we don't give guidance. We give target ranges. And we went many years talking about 10 to 12 and numbers like that and stuff. We're certainly at 13-ish right now, and it could be much higher, and we certainly are over a 5-year target, a range we're guiding higher than that and to reach our stated goal as it has to be, but we're very bullish right now. It's just kind of hard to put too much more than that. But by September, we will. I mean it's a good story, but as Jim said, the momentum continues. We don't see anything changing. And since we've been beating quarter after quarter, maybe that's a good sign.

[Daniel Arias, analyst]

Yes, that's true. Okay. Maybe just a high-level question. I mean, obviously, you guys have a portfolio that's pretty well-positioned in a bunch of areas and you're growing in certain areas and you're expanding capacity in certain areas. Are we -- are you able to sort of parse out for us where in the business or what portion of the business you think growth is most likely to be limited by just your own capacity or you're still ramping capabilities versus what the customer base might bring in terms of demand?

[Charles Kummeth, executive]

Well, first, I comment -- it's one thing to grow double digits and deal with which you need to expand because nobody does expansion for ways to double your business very quickly. You go in increments, so it makes sense. You don't want to have your facilities empty. It's a competitive world, right? You start growing at 20-plus percent and the kind of growth rate you're seeing and you get kind of caught. On top of that with the shortage and talent is just the whole economy or life sciences kind of kind of booming right now, funding looking good. It's kind of a race. So we're kind of -- we're expanding and kind of ahead of it for now, looking for continued and accelerated growth per our last discussion here. And to be frank, we're virtually expanding every business we have. We don't have a single thing we're doing that we're not behind and don't need to expand and invest in. They're all doing great. We also are not behind to your question, we can meet. I think we're there in time. We have the capital, we have the talent, we have the consultants, we have the land, we have the buildings. We have the supply chain figured off what we need for instantiation, but we don't think we're going to get caught behind and throttle in any business that we have. Last year, the one that's been the toughest has been Simple Plex, right? We have been...

[Daniel Arias, analyst]

Yes, that's what I was going to talk about.

[Charles Kummeth, executive]

Certainly a little under that. But 65% growth on top of 100% a year earlier, that's phenomenal. Now that one, we're going to pretty much blow it out with the new building, new everything this year, and we'll be online in a year. So I don't predict that we'll be able to not ship every order that we have, to be honest. Growth rate will take only over 13% on that one.

[Operator]

We take our next question from Jacob Johnson with Stephens.

[Jacob Johnson, analyst]

Just one quick follow-up, not to belabor the '22 outlook. The 13% growth number you referenced, Jim, that's an organic figure and you expect that momentum to continue plus Asuragen is about a 3% inorganic benefit. Is that kind of the way to think about it?

[James Hippel, executive]

That is correct.

[Jacob Johnson, analyst]

Okay. Perfect. And maybe for Chuck, following up on your comment on Simple Plex. You seem to be finding more and more uses for Ella. I think I heard you mention neurology. And I think your competitors talking about the opportunity for the use of their instrument and screening and testing for Alzheimer's drugs. Is that maybe an opportunity you could find for Ella?

[Charles Kummeth, executive]

Yes, absolutely. It's fast. It's microfluidic. It has incredible sensitivity. So yes, we're definitely involved in those kinds of applications. It's a biomarker discovery tool for therapy creation, for drug discovery. It's primarily what's used for. And now we're -- it's morphing into all these possible clinical applications too, which we're working on, as you know. So probably the biggest sleeper we have there. It's probably the biggest sleeper we have at really identifying all the different addressable markets and potential things we can do with it. So that's why you see the growth rates you see with it. It's just kind of off the charts.

[Jacob Johnson, analyst]

Got it. If I can just squeeze one more in. Just, Chuck, on the expansion in the GMP median antibodies. Is that something you'll implement at your existing GMP facility? Or is this something that requires additional capacity?

And two, is this something that is contemplated kind of in the $140 million of capacity you brought online for proteins? Or is this something that's added into that opportunity?

[Charles Kummeth, executive]

No, it's all the same discussion. We have the capability of doing a roughly $40 million in revenue at headquarters. It just would be in smaller lots. We're GMP here, but it's primarily research. So therefore, we built the new facility which is open now, and we're going to get started selling out of inventory, qualified lots here in the coming months here. And that is $140 million to $200 million in capacity depending on which product mix you have. It's further expandable very quickly within 6 months inside the current building, which we haven't used out space yet or on site as well.

[Operator]

We take our next question from Catherine Schulte with Baird.

[Catherine Ramsey, analyst]

I guess, first, in your core Reagent Solutions Division, just curious what you're seeing in terms of lab activity levels, how has the reopening varied by geography? And do you think there's still improvements to be had out there?

[Charles Kummeth, executive]

Well, as we mentioned last quarter, kind of probably near the end of the quarter, but it became apparent that we're probably back to full strength. I think there's confusion over just because people aren't in the lab and maybe doing their analytics and their math and their paper writing at home, it doesn't mean they're not bad. Their experiments are ongoing and they're being productive in the labs. And so we think we're academically kind of back to full strength. They're just working differently. They're working smarter. They're being a little more biopharma like. And that would be a comment for both U.S. and Europe. China is full on, has been for quarters. And we're into the next 5-year funding cycle in China. And the first year, we're actually going into the second year at pretty soon, and that's usually a big ramp year for China.

[Catherine Ramsey, analyst]

All right. Got it. And I was curious if you could just talk through M&A priority areas. You've done a lot on the diagnostic side and Cell and Gene Therapy over the last couple of years. And you mentioned in your prepared remarks about proteomics being on fire from a research application area. Are there applications like that where you'd be interested in adding on to your capabilities through M&A?

[Charles Kummeth, executive]

Yes, we're hunting all the time. We've probably never spent the quarter with so much activity and so little to show for it actually. We were -- we came in second and third on a lot of deals in this quarter. So as you know, prices are high and we can be picky. We've got great numbers. We've got great growth. We've got a great balance sheet, and there's no sense for us to overpay or take too stupid a risk or confuse the Street with something too adjacent that people don't understand. So we're being kind of true to our strategic plan, and we're hunting within those guidelines and within the math we want to find. And finding double-digit ROIC on deals have been very difficult right now. So we'll be patient, and it means we're probably still lean more towards private deals where we can kind of get something with a management team and investors that understand this and want to come on board versus public auctions, which are -- seem to be still in a friendly mode and going too high.

Yes. We're focused on tools probably more so than diagnostics. I think we've got enough things integrated now in diagnostics, and we see a great plan coming together between Exosome Diagnostics, Asuragen and even our ACD platform. So there's a lot of growth coming there and also the Ella application. So we've got quite a franchise forming and diagnostics that you've probably got to start focusing back on tools and core areas if we can find it. They're just isn't enough out there and they're going very high, as you saw BioLegend went for over $5 billion. I mean, that's unbelievable. We have a comparable antibody business here that tells you something about our valuation.

[Operator]

We take our next question from Alex Nowak with Craig-Hallum.

[Alexander Nowak, analyst]

Chuck, going on the diagnostics side, it seemed to be a little bit of a tone shift with the Asuragen acquisition closing, including Bio-Techne being more of a kit diagnostics company than a clear lab. Did I hear that correctly? And maybe expand on what you plan to push through the Asuragen kittable model that could include the EPI test, the Exosome TRU test that all the exosome test they have in the pipeline? And then I guess the bigger picture in a couple of years here, do you think Bio-Techne's going to have both a CLIA lab and a kittable diagnostics model?

[Charles Kummeth, executive]

Well, you're a diagnostics guy. So I know you get it. And Yes, first of all, they're focused on their panel, right? Their panel here, what's Fragile X SMA and CF, which will be coming out here this fall. That will be a really kind of a best-in-class only thing you can get in the world kind of a panel. With that experience, of course, we want to kit as much as we can because we have a home kit version of our EPI test right now. We're launching that. We're in Europe, going through distribution with a kit. And we're expanding that model and probably deemphasizing the CLIA side over time. But CLIA is certainly important right now, we're doing the work. But over time, it will be a mix. I don't think we probably totally ever out of CLIA. I think you need to be in CLIA because that's the way a good way to start these things, these tests of an LDT. And I think we'll just see how the mix goes, but I think better scale potential. I think better faster acceleration exists with kitting if you can get it done. But as you know, it's a bit of an art to kit. And you need people who know how to do it, and there's a lot of details to get kitting successful and then channel issues, at which Asuragen team are really expert at. So they're definitely grueling over the chance to get at the Exosome portfolio, to be honest. So we're just trying to hold them off until we can integrate completely. We want to make sure that we take care of them fairly as part of the Asuragen deal first. It's all coming, spot on.

[Alexander Nowak, analyst]

No, that makes sense. And one just on ExoTRU. Maybe any update on the commercialization plan there that could be a direct sales team, you're going to go through a partner. And then you mentioned the reimbursement on ExoTRU and you're currently working through NGS. Any update if you plan on seeking out in the lab to go after more of a MolDX MAC? Or just any update on the reimbursement progress there?

[Charles Kummeth, executive]

Well, with Asuragen, we have the opportunity to be in their MAC district. So that's being evaluated. We also have a site near Atlanta, so we can be in the Palmetto area, which has the favorable jurisdiction here around CareDx. So that's -- so we're not breaking ice there. That's also a very strong possibility. There is -- with the numbers we've shown in our papers, it's best-in-class, we beat everybody out there by far as far as I can tell. There's a lot of interest.

All the main players are talking to us right now, and there's a potential for a partnership. We won't do a bad partnership. So if you see one, it will be great terms. Otherwise, we will go it. In my mind, this will be a hell a lot easier than the prostate test because, again, these are organ transplant centers, and we're not talking about a channel of 20,000 urologists. We're talking about less than 100 centers that we can deal with in almost like a key account model. We also don't have the wall to climb over of talking docs out of doing test like biopsies, right? So it's commercially should be somewhat simpler, especially to the great test a great number. So we've done surveys with these rejection centers or these transplant centers. And they've come back over 90% positive. They want to try out the test, but they don't they don't see what they're using today is being perfect by any means, and there's a more room for improvement. And what they've seen understand about the simplicity of a mail and type kittable test like we have with urine that they want to try it. So we're pretty gun hole. I think we had in our commentary, we expect to be out within a year here.

[Alexander Nowak, analyst]

No, that's great.

[Charles Kummeth, executive]

I also think -- I think the MAC will be easier on us too. This isn't the like prostate, the cancer, you live with and not die from, like a perception is, which is inaccurate. This is a big bad one out there with double the market size. And as you know, half of all kidneys fail in 10 years and roughly 30% fail on the first 5. So it's an awful, awful condition. So finding something that's more upstream like exosomes can provide versus cell-free DNA could really help that primary physician or that the docs figure out what's going on before you have trouble. It is going to be really important to sustaining that thing or that organ long term for the patient.

[Alexander Nowak, analyst]

Yes. Multi exosome is very favorable there.

[Operator]

We take our next question from Patrick Donnelly with Citi.

[Patrick Donnelly, analyst]

Chuck, I know you called out China in the prepared remarks. I think you talked about 30% growth, approaching $100 million a year. You're usually pretty bullish on that, but how are you thinking about '22 setup there? Again, it seems like all things are pointing in the right direction for you guys, but would love your take on trends there in the quarter and then again the expectations for this year.

[Charles Kummeth, executive]

Yes. Well, I think Jim was spot on going through the analysis and providing color on a 2-year look back, not just 1 year. It's just such a goofy year last year. And when you look at all our numbers on 2-year pre-pandemic, then you see, I think, still best-in-class results for our industry. And China is no different. So that's a near 30% high 20s for 2 years. We see that consistent. We've always kind of said we expect China to be a 25% grower. And I guess we see no reason why not to stay with that game. And even as we get past $100 million, it's only $100 million. So we've got a long way to go in China before we're going to take any victory laps. And the brand is a gold standard brand. There's no let down there. I think if anything, we're going to see things accelerate in China around research around our products, to be honest.

There is this point of -- we mentioned that we're tipping points in our commentary. I love the term because I think it's really accurate. Things need to get to a certain size before they get easier to sell. And we've reached that point in a lot of our stable of unicorns here. We've got a dozen different platforms that are all hitting and achieving and getting over that tipping point and becoming almost simpler to accelerate. So China is going to be very good at selling the whole stable and they have been and they're going to continue. So I think the numbers will be better going forward.

[Patrick Donnelly, analyst]

That's helpful. And then maybe one on just the GMP order pace. You touched on it a little bit, but how is that trending relative to your expectation? I think last quarter, you talked about plan to sell out inventory by September, October. I think you touched a little bit on it earlier, but would love just kind of a ground floor view there and expectations, how we should think about that piece.

[James Hippel, executive]

Well, we're closer and landing some more big customers, we land another one, another bigger one. I think 145% growth in the quarter coming out of our little headquarters facility, I think, is an amazing execution by the team to be honest. I don't think we've been over 100 before that, just we've hanging on 100, so that's like record growth. We'll start transitioning to the factory here come this fall. We're just -- we're getting close right now, and there's a lot of excitement. The product looks fabulous. It's peer. It's the lot-to-lot consistency at the volumes we're going to be able to create are going to be best class in the world. No one is going to be able to compete with us in terms of that. So I really -- we mean when we say get online and look at the video, you're going to see this factory and go, wow, that's a deal closure for sure. And people who are coming in are amazed, and it's going to all come down to [indiscernible] testing. And how fast we can ramp these bigger customers as they come off the other end. And there, as you know, hundreds of clinical. It's going to take a couple of years to get this thing really going. But I mean, to be honest, I think we're going to have an amazing business, but I don't think we'll be alone. I think it's an everybody wins market here for 5 years, to be honest.

[Patrick Donnelly, analyst]

Okay. Got you. And maybe one last one for Jim. Just on the op margin commentary. I think you said entering '22 will be a little lower than 4Q than the second half getting back to these levels. Can you just talk about, I guess, the key levers as we get into '22 again, some of the spend coming back? Maybe talk about the impact of Exo and then kind of the underlying expansion as well would be great.

[James Hippel, executive]

Yes. I mean some of the factors on the margin. First of all is the acquisition of Asuragen, right? So for 3 out of the 4 quarters next year, it will be dilutive to overall margins to the tune of 70 to 100 basis points. So that's kind of a big headwind inherent right there. Of course, we even talked about getting back in front of customers and business travels somewhat returning. That's a pretty hefty number in itself in terms of a headwind year-over-year, assuming that, that activity ramps back up.

With regards to your comment on Exo, I mean Exo will become less dilutive going forward but still be dilutive. But as we continue our growth trajectory, despite those headwinds in the near term, and let me back up for a second. We did hire pretty successful here in the -- towards the end of Q4. So not necessarily representative in our fiscal year '21 run rate much less even the Q4 one, to be honest with you. And that will provide some headwind that you're not currently seeing. So all those factors combined, we see in the near term the margin dipping slightly. But again, because as we continue to grow the back half of the year with the leverage we get from that growth, we see it normalizing back to Q4 level by the end of the year.

[Operator]

We take our next question from Paul Knight with KeyBanc Capital.

[Unknown Analyst]

It's Mike on for Paul. Just following up on Patrick's question on the operating margin line, I guess it sounds like the diagnostic genomics is going to take most of the impact with Asuragen. So I'm guessing Protein Sciences kind of maintains the level that you saw in 2021. Can you kind of just talk to the dynamics between those 2 a little bit deeper?

[Charles Kummeth, executive]

Yes, I'll start and Jim can finish. I think that's right on. And clearly, our investment portfolio to when scaling it, it's going to help the overall mix. But our core continues to scale and continues to find leverage too. I would, quite frankly, amazed at how well we execute this year on our core. In the past, this hasn't been the kind of business model where you get as much leverage as other manufacturing models I've been involved with. But we have found incredible productivity internally, and we have found more scale leverage than I thought possible. It's been helped, in fact, by, I think, as we talked about the hiring needed and the headcount shortages. I think we're a little lean there. We're catching up fast, started last quarter and travel, of course, has helped everyone. But the fact remains, even on gross margin is really strong, and we're finding leverage. I think it will continue. We're all pretty well Six Sigma trained here and PPI from Thermo and every other flavor of this productivity therapy you want to do, and we use them all here. We've even talked about coining our own version, the Bio-Techne version because we do it, and we target and task our teams of productivity every year, and they find it. And I see it going forward. And maybe Jim wants to comment for that.

[James Hippel, executive]

Yes. In terms of how that margin might look like by segment, actually, right now, we think it might be slightly the opposite in terms of the impact. Protein Sciences already had a very high operating margin. And a lot of the hiring that we're behind on to accelerate growth in Cell and Gene Therapy in other areas as well as the instrument portfolio will be in that Protein Science segment. So they'll be more heavily impacted by the actual investments that we need to make. You're correct in that the diagnostics genomics segment will be impacted by the Asuragen acquisition. But again, they have the lowest overall operating margin and that's where we've gotten the most expansion in the past with leverage, and we expect that to continue and, frankly, overcome the Asuragen headwinds in that segment. So that's kind of how we see it playing out as of right now.

[Charles Kummeth, executive]

Don't forget that that's an 80-plus percent gross margin kitting kind of model, which we understand. And so as that scales, that will reach up and won't add some to until near 40%, and we're in the high teens right now. So we've got a ways to go. Come up 1,000 points in a year, but it's just starting to stride and it's on roughly a $90 million run rate. So we always said it'd be probably at $40 million to about $200 million or so. And I don't see any reason to change that tone right now.

[Paul Knight, analyst]

Great. Very helpful. And then, Chuck, just on Asuragen, it looks like it came in a little bit ahead of expectations of what you were guiding back in Q3. So can you kind of unpack some of the trends you saw with the business there? Was that just organic growth within Asuragen? Was it some synergies playing out being underneath the Bio-Techne umbrella or some maybe easy comparables back in 2020?

[Charles Kummeth, executive]

Yes. We're not breaking down division numbers anymore for competitive reasons, I would say it's more or less on track. It wasn't really too much ahead. We've given them a lot of homework. And if anything, keeping them and focused on their business and not over integrating with Exo too fast, I think, has been the challenge. They just know so much. They're so experienced. I can't also tell you how good this integration has been out of 17 acquisitions. This has been the easiest. These guys, a 15-year-old company. They all came and there was a spin-off of a bigger company, as you know. And so their financials are all auditable. It's just been more or less this team. They're all keepers, and we're working hard on doing that.

Going forward, I think we bought them like we've done a lot of acquisitions, been pretty good and sometimes clever in reaching some things just before that inflection point up. And these guys are no different. They've been working on this SMA and cystic fibrosis for a while and they're launching. So over the coming years as they launch, yes, I would expect there'll be some accelerated growth. That's what we're hoping for. It's where we bought them, among other things.

[Operator]

And as we have no further questions in the queue, I would like to turn the call back over for any additional and closing remarks.

[Charles Kummeth, executive]

Okay. Well, thanks, everyone. It was a year we're all behind us in a lot of ways. But business-wise, we're quite happy with the results and that we're able to execute and provide the world with a lot of badly needed things this past year with the problems we've all faced. We're ready to go in the future. We're investing. We're catching up in terms of headcount, the numbers look pretty good. The momentum, as Jim has said, is stable, and we see no reason to change our tone. And we'll give you more transparency when you all show up in New York and attend. So thanks a lot. Bye.

[Operator]

Thank you. That would conclude today's conference call. Thank you for your participation, ladies and gentlemen. You may now disconnect.