Good morning and welcome to the Bio-Techne Earnings Conference Call for the First Quarter of Fiscal Year 2022. At this time all participants have been placed in listen-only mode and the call will be open for questions followed by managements prepared remarks. During our Q&A session, please limit yourself to one question and one follow up.

I would now like to turn the call over to David Clair, Bio-Techne's Senior Director, Investor Relations and Corporate Development..

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 maybe 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 2021 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 because 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..

Thanks, Dave and good morning everyone. Thank you for joining us for our first quarter conference call. The Bio-Techne team kicked off our fiscal 2022 on a very strong note, as we continued the momentum we experienced during our last fiscal year.

Our first quarter 21% organic growth rate reflects broad strength across geographies and ongoing penetration and demand for our proteomic research reagents, diagnostic reagents, analytical tools and services especially within our biopharma end market.

The standouts in the quarter included our instrument portfolio, namely our Biologics, Simple Western and Simple Plex offerings, broad strength across our research reagents, and triple digit growth for our burgeoning GMP protein business.

Not only were these significant growth drivers for the quarter, but these platforms as well as our spatial biology and molecular diagnostics portfolio remain at the forefront of under penetrated high growth markets to position the company for future growth.

I'm very proud of the global team's execution and the company is off to a great start as we march forward to the longer term targets we provided during our recent Investor Day event. We deliver this strong Q1 revenue performance with a continued focus on profitability with an adjusted operating margin of 37.8%.

During the quarter, we made progress hiring to our growth plan. Although the tight labor market remained a constraint to us building a team at our desired pace. We anticipate making continued progress with our hiring plans as fiscal 2022 unfolds, supplementing the commercial and technical teams that will enable execution of our long-term growth plan.

From a geographic perspective, we experienced robust growth across all geographies. China especially was a standout where the team delivered record organic growth of over 50% in the quarter.

The government authorities there are strongly encouraging the development of therapies in the areas of stem cells, organoids, regenerative medicine, and immunology. All areas that have a strong need for our reagents and analytical solutions. For the first time this quarter our business in China annualized at over $100 million in revenue.

While this is an important milestone, we believe we remain in the early innings of realizing our potential in this important geography. Turning to our end market. Demand for our unique high quality products and solutions continues to be very strong for our biopharma end users with revenue growth increasing approximately 25%.

Performance within our academic end markets also remain solid overall delivering organic growth in the mid-single digits. Now let's discuss the performance of our growth platform starting with the Protein Sciences segment where we delivered organic growth of 26% in the quarter.

We made significant progress with our cell and gene therapy initiatives as growing awareness and demand for our portfolio of workflow solutions led to over 60% organic growth in the quarter.

We are nearing completion of the qualification process for initial lots of GMP grade proteins out of our state of the art GMP protein manufacturing facility in Saint Paul, Minnesota, and anticipate commercial orders to be shipped from the facility in the coming weeks.

As a reminder, GMP proteins are critical ingredients for growing both autologous and allogeneic cell therapies and we anticipate increasing demand going forward as the rich pipeline of therapies make their way through the regulatory approval process. Our GMP protein business increased over 160% in a quarter.

And with our new GMP manufacturing facility open for business, we are well positioned to meet the anticipated growing demand for these critical reagents.

Continuing in cell gene therapy, we added to our portfolio especially cell culture products with the launch of ExCellerate iPSC Expansion Medium, a new medium for the expansion and maintenance of induced pluripotent stem cells or iPSCs for use in both research and translational workflows.

The ExCellerate iPSC Expansion Medium builds on Bio-Techne's portfolio products and services in regenerative medicine and fits seamlessly into our offerings for stem cell workflows, including cell isolation, reprogramming, genome engineering, cell expansion, differentiation and characterization.

Importantly, ExCellerate iPSC Expansion Medium is manufactured without using components derived from animals or humans, making it ideally suited for use in translational research to produce iPSC based cell and gene therapies.

This latest offering builds on our growing portfolio especially cell culture products addressing customer needs across natural killer or an NK, T cell and B cell media. Momentum in our core research use only protein and antibody businesses also continues to be very strong, with growth in the low 20s in the quarter.

We believe that continued success in our core is a reflection of our best in class development of a new high quality relevant reagents that address our customers' current research needs, while making them increasingly aware of our capabilities through our strategic digital marketing efforts.

Moving on now to our proteomic analytical tools, where we continue to see strong demand across our portfolio of cost effective productivity solutions. In Q1 our instruments and related consumable pull through grew over 30%. Reflective of a very strong biopharma environment, our Biologics instruments led the way growing nearly 50%.

These analytical tools, namely our Maurice instrument, enable the reproducible and quantitative analysis of therapeutic protein identity, purity, homogeneity, with ease of use fast results, and reproducibility all qualities that continue to represent a compelling proposition for new and existing CROs, CDMOs large pharma accounts and we are now also seeing adoption in cell and gene therapy quality control applications.

Demand for our Simple Western instruments also continues to be strong with over 20% growth compared to the prior year. Encouragingly, we are seeing significant lead generation for Abby and sold several of these systems during its first full quarter on the market.

As a reminder, Abby is a lower cost fully automated chemiluminescence western platform that we introduced in April to further penetrate Simple Western technology into our academic customer base.

Separately, we saw real robust adoption, of Simple Western within cell and gene therapy market and view this is a significant and largely untapped opportunity for this technology going forward. Our Simple Plex multiplexing amino acid system Ella, also had a strong quarter growing over 20%.

This result is especially impressive given the challenging year-over-year comparison where Simple Plex increased more than 75% in the prior year period.

We are experiencing a significant uptick in Ella accounts using or evaluating the platform for neuro degenerative applications specifically for neurofilament light chain or neuro NFL and neurofilament heavy chain or NFL detection in serum and plasma.

Ella continues to be the platform of choice for customers requiring excellent sensitivity and assay speed. Now let's discuss our diagnostics and genomic segment where organic revenue increased 6% in the quarter.

Our spatial biology business branded ACD increased mid-single digits in the quarter as continued demand from our biopharma customers, especially CROs was partially offset by lower reorder rates from our academic customers.

I would note our ACD business and especially in the academia market faced a challenging comp in the prior year when the business increased over 30%.

Within biopharma, the emergence of gene therapy and RNA interface or RNAI therapeutics has created a shift toward an animal model based projects, driving larger order sizes and increasing custom probe design projects making for a little more lumpiness in our spatial biology business.

Our menu of process is now approaching 50,000 targets over many species and publications have crossed over 4500 demonstrating the continued academic interest in the platform. Next, our diagnostics reagents business delivered its ninth consecutive quarter of growth, with organic revenue increasing in the upper single digits.

Encouragingly, the pandemic related headwinds that impacted his business in recent quarters are starting to diminish and we are experiencing a reacceleration in the chemistry, glucose and hematology controls product lines.

The diminishing headwinds combined with new product launches, and additional penetration within existing OEM customers, we believe are just at the beginning of accelerated growth in this business.

During our Investor Day, we highlighted some organizational changes within our diagnostics and genomics segment, designed to fully realize across developmental opportunities and synergies within our liquid biopsy and molecular products businesses.

The new molecular diagnostics division is a combination of our Exosome Diagnostics business, and the recent Asuragen acquisition and is being led by Matt McManus, the former CEO of the legacy Asuragen business.

This new division structure includes an Exosome center of excellence as the Exosome based liquid biopsy innovation engine, developing lab developed test, companion diagnostics as well as kitted Exosome based diagnostic products. We will leverage the established Asuragen channel as well as our two CLIA labs to commercialize these products.

Our ExoDx prostate cancer test continues to make progress despite ongoing challenges with the urology market. During COVID patients were not leaving their home to do annual checkups or seeing urologists.

This dramatically reduced the volume of PSA test the primary tool used by urologists to identify the appropriate patients for our ExoDx test for prostate cancer risk analysis and potential biopsy.

With patients' beginning to return to their doctors for routine checkups or follow ups, the diagnostic market is continuing to recover and encouragingly our Q1 ExoDx volume was the highest since the onset of the pandemic and continues to show improvement early in Q2.

I would also note that our sales reps are increasingly getting in person meetings and hosting educational and awareness events with the physician community, which we expect to be a strong impetus to testifying going forward. We also made progress on ExoDx reimbursement front during the quarter.

We added to contracts with multiple regional payers expanding both a network of private payers reimbursing for ExoDx and men with covered access to test.

We are very excited about the opportunity to present at an overview of the science and publication supporting ExoDx to 600 medical directors and policy decision makers this week during NAMCP's 2021 Live Fall Managed Care Forum. The confirmed audience includes representatives from the largest national and regional payers.

Events like this are an excellent opportunity to drive awareness and acceptance and eventually reimbursement of this important test among the private payer community.

Our recent publication of a pooled analysis of over 1200 patients in the journal of prostate cancer and prostatic diseases demonstrated ExoDx's ability to discriminate between high grade, low grade and benign prostate cancer.

Using ExoDx's validated 15.6 cutoff score would have avoided 23% of all prostate biopsies and 30% of unnecessary biopsies with a negative predictive value of 90%. We have a pipeline of additional studies and anticipate a steady cadence of publications to drive reimbursement and adoption going forward.

In addition to the ExoDx prostate tests, we continue to advance our pipeline of innovative Exosome based diagnostic tests including our non-invasive kidney transplant rejection assay Exo TRU Kidney.

As a reminder, initial Exo TRU Kidney 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 are preparing additional studies for publication on Exo TRU assay performance, and remain on track to launch this non-invasive urine based assay later in our fiscal year.

With regards to the products from the legacy Asuragen business, we continue to gain market traction with our leading portfolio of genetic and oncology molecular diagnostic products, including our kits for FMR1 and Bcr-Abl.

This business is largely US centric today and we see significant potential for these products outside the US and have taken initial steps to position the business to penetrate the European markets.

In addition to the geographic expansion, this business has a very full pipeline, including the expected launches of a cystic fibrosis or CFTR kit as well as a hard to do panel, which combines carrier screening assays for FMR1, SMA1 and 2 and CFTR in one user friendly kit. To conclude my opening comments, our fiscal '22 is off to a great start.

Our end markets remain strong, and our portfolio of differentiated proteomic tools reagents and electrodiagnostic products are meeting the needs of our customers in growing and under penetrated markets.

Our cell and gene therapy initiatives continue to gain acceptance from biopharma customers, and the deepening relationships with these end users are driving adoption of our proteins, media, assays instrumentation, antibodies and other offerings in our portfolio.

During our recent Investor Day in New York City, our leadership team and I laid out the vision and strategy to bring Bio-Techne from 1 billion revenue company it is today to a target of $2 billion over the next five years.

Our first quarter end we are off to a great start in this journey, and I'm excited to share our progress as we realize this vision over the many quarters to come. With that I'll hand the call over to Jim..

Thanks, Chuck. I'll provide an overview of our Q1 fiscal 2022 financial performance for the total company, provide some additional details on the performance of each of our segments and give some thoughts on the remainder of the fiscal year.

Starting with the overall first quarter financial performance, adjusted EPS was $1.83 versus $1.43 one year ago, an increase of 28% over last year. Foreign exchange positively impacted EPS by $0.07. GAAP EPS for the quarter was $1.69 compared to $0.83 in the prior year.

The biggest driver for the increase in GAAP EPS other than from business operations, was unrealized gains on our investment in ChemoCentryx this year compared to an unrealized ChemoCentryx loss in the prior year period. Q1 revenue was 257.7 million, an increase of 26% year-over-year on a reported basis and 21% on an organic basis.

Foreign exchange translation had a favorable 1% year-over-year impact and acquisition had a favorable 4% impact for revenue growth. All geographies had strong growth and one led by China growing over 50% followed by the US and EMEA both growing over 20% for the quarter, the rest of the world grew in the upper teens.

By end market biopharma remained very strong growing near 20% while academia increase mid-single digits year-over-year. Moving on to the details of the P&L, total company adjusted gross margin was 71.2% in the quarter compared to 71.9% in the prior year.

The decrease was primarily driven by unfavorable product mix within the protein sciences segment partially offset by favorable volume leverage. Adjusted SG&A in Q1 was 25.1% of revenue, a 70 basis point decrease compared to the prior year, while R&D expense in Q4 was 8.3% of revenue, 40 basis points higher than the prior year.

While adjusted SG&A and R&D spend both increase sequentially and compared to the prior year, a tight Life Sciences labor market not allow us to fill all planned headcount additions to the team at the pace we originally anticipated, especially in the more technical, scientific and engineering fields.

However, our pace of hiring continues to increase and we plan to make additional progress in our fiscal second quarter. This investment in critical human capital will position the company for growth going forward. The result in adjusted operating margin for Q1 was 37.8%, a decrease of 40 basis points from the prior year period.

However, excluding the impact of the Asuragen acquisition made last April, adjusted operating margin increased 40 basis points over the prior year. Looking at numbers below operating income, net interest expense in Q1 was 3.1 million, decreasing1.1 million compared to the prior year period.

The decrease was due to a continued reduction of our bank debt as well as a lower blended interest rate. Our bank debt in the balance sheet as of the end of Q1 stood at 300.2 million.

Other adjusted non-operating income was 1.2 million for the quarter compared to 1.1 million in expense in the prior year, primarily reflecting the foreign exchange impact related to our cash pooling arrangements. For GAAP reporting, although non-operating income includes unrealized gains from our investment and ChemoCentryx.

Moving further down the P&L, our adjusted effective tax rate in Q1 was 21%. As a reminder, during the second quarter of fiscal 2021, we made a strategic equity investment in China based Eminence, a company focused on providing media as well as custom cell line development and media formulation services to the Chinese biopharmaceutical market.

The $634,000 non-controlling interest line item reflects the loss from a portion of Eminence we do not own. The impact of other lines of the P&L as a result of consulting Eminence was immaterial in Q1. Turning to cash flow and return of capital.

48.4 million of cash was generated from operations in the quarter compared to 66 million in the prior year period. The decrease was primarily driven by the timing of cash payments for payroll, income taxes and other accounts payable.

In Q1, our net investment in capital expenditures was 6.1 million, and during Q1, we returned capital to shareholders by way of 12.5 million in dividends. We finished Q1 with 41.2 million average diluted shares outstanding.

Our balance sheet finished Q1 in a very strong position with 235.1 million in cash and short-term available for sale investments, and a total leverage ratio of well under one times EBITDA. Next, I'll discuss the performance of our reporting segments starting with Protein Sciences segment.

Q1 reported sales were 197.2 million, with reported revenue increasing 28% compared to the prior year. Organic growth increased 26% with foreign exchange having a favorable impact of 2% on revenue growth. Within this segment, the strong growth was very broad based in nearly all reagent assay and instrument platforms.

As Chuck mentioned, cell and gene therapy increased over 60%, including growth over 160% in our GMP protein products, while biologics grew almost 50% and our Simple Western, Simple Plex, proteins and antibodies all grew at least 20%.

Operating margin for the Protein Sciences segment was 45.7%, an increase of 10 basis points year-over-year due primarily to favorable volume leverage, largely offset by strategic investments to support future growth. Turning to the Diagnostics and Genomics segment, Q1 reported sales worth 61 million, with reported revenue increasing 22%.

Organic growth for this segment was 6%, with acquisitions contributing 15% and foreign exchange translation having a favorable 1% impact on revenue. The diagnostics reagents business increased upper single digits, and the ACD branded spatial biology portfolio increased mid-single digits.

Although spatial biology had a challenging year-over-year comparable this quarter, we view this business unit as being in a high growth area within life science tools, and are extremely well positioned to capitalize on this growth with our multi-omics product portfolio.

For Exosome Diagnostics, revenue was lower year-over-year, but this was mostly due to cash to accrual revenue recognition accounting change in the prior year for Medicare patients. Timing of companion diagnostics projects with biopharma customers also negatively impacted growth for the quarter.

Exosome Diagnostic prostate cancer test volume continues to improve with more patients now going back to see their physicians. Test counts increased 20% year-over-year in Q1 and are continuing to ramp as we enter Q2.

Moving on to Diagnostics and Genomics segment operating margin, at 12.2% the segment's operating margin decreased 510 basis points compared to the prior year. The decrease reflects the impact of strategic investments to support future growth as well as the Asuragen acquisition. In summary, our research oriented end markets remain strong.

And as our Q1 performance indicated, we are executing extremely well on serving these markets. The diagnostics end market is also improving and we believe will continue to be a tailwind going forward. Our end markets have been on an upward march since the depths of the COVID crisis in the fourth quarter of our fiscal 2020.

This means our comps become increasingly more challenging and our growth rates will likely be tempered proportionately in the near term. However, given our strong performance out of the gate in Q1, we have increasing confidence that we can achieve a growth rate in fiscal year 2022 that is greater than our two year CAGR at the end of fiscal year 2021.

As Chuck and I mentioned in our prior commentary, despite progress executing to our hiring plan, there is more to do in order to support our long-term growth plans.

We anticipate continued progress in our hiring objectives to put downward pressure on our adjusted operating margins sequentially in the near term, before returning to prior year levels by the end of our fiscal Q4. That concludes my prepared comments. And with that, I'll turn the call back to the operator open the line for questions..

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is from Puneet Souda of SVB Leerink. Please proceed with your question..

Hi, thanks, Chuck, Jim. Thanks for the questions here. So first one on GMP proteins, clearly strong. Just wondering if you could parse that out was that due to qualifications of new orders or additional orders sort of shipping out in the quarter. 160% is really strong and obviously maybe it seems like it's coming off of small comparisons of last year.

But just trying to understand the sustainability of the GMP growth and how should we think about an annualized growth rate here for GMP proteins in 2022?.

Yeah, we've been pretty clear in the past that their growth rate for next couple of years is probably at 100% level. So we're ahead of that. But we're still - as of today, we're actually open for business. The factory has an inventory of lot qualified material, products and we've been gaining more and more, I guess, customers.

You saw the slides in the investor deck talk about the potential domain of customers, we're got a couple dozen already. And we're getting a lot of help from our scale ready partners to dramatically increase that. So we're getting more scale for existing customers, and we're getting more customers. So therefore the lift.

We're well over a $20 million run rate, which is really just the beginning right Puneet, so kind of we're on track. We're ready to start transitioning as much as we can of our orders into the new factory.

As you know, we have the largest catalogue out there for GMP proteins, but we know we're only set up for a handful right now in the new factory, and in the majority of businesses really in under 10 type of product versus the 50 or so we have in our catalogue. We still - a lot of capacity back at headquarters, it's just in small lots.

So we are ready to go on the bigger lots for a few of the more important products that are being asked for being put into clinicals, et cetera. And I see the growth rates to be largely consistent with our guidance and I think it'll continue..

Okay, great. Thanks for that details, Chuck. So on ACD, wondering if there's something we need to keep in mind for sort of second quarter. Just it seems the comments you made were around lumpiness. But this is the first time we're seeing sort of mid-single digit growth here after the leadership change to happen in that business.

And just trying to understand is this - should we just continue to expect lumpiness in the business and/or is there any competitive dynamics that we need to be aware of, just trying to think about the full year number that's traditionally been more than 10% here historically for ACD..

We're as bullish as ever on this platform, you got to remember, the comp was amazing they were coming off of, and then we had - the lumpiness primarily in the service area. But we do a lot of custom work. And that part was - just balances, it's just kind of ebbs and flows.

So that combined with - as you know, we're a couple 100 people right in our hiring plan, just like the rest of the world. I mean, we added 275 people last quarter, and we lost 240, we're net 35 ahead, which is even better than average out there. So it's been really crazy, especially in the Bay area, and guess where ACD lives in the Bay area.

So we are we are shorter there than most other business units. We are also the largest spatial business out there. So we're a target as well, especially for our reps and we're definitely shorthanded in our reps, we've put additional focus on it now. And we're correcting that.

But those are the kind of the one, two and three issues of why this was mid-single digit growth and why it wasn't 15 to 20. It's - there's no issue, it's all there. It's actually looks better than ever. DNA scope is coming on. We have X-Plex coming on. We are working forward with other partnership ideas with automation.

We're stronger than ever with Leica. We're getting going with Antenna. The leadership changes we made year, year and a half ago, have done pretty well. And it's more an issue of comps, lumpiness, especially in services, and probably a handful of sales reps short in some key areas that we need to get refilled. But we'll do we'll do that.

That's kind of nature of the beast in SPD. It's a hot area, spatial and generally, so a lot of movement right now. So we'll win, don't worry..

Got it. And last one quickly on China if I could.

100 million really great to see that number, but just in terms of what can you do in China now at the current scale versus you couldn't do before? And how should we think about the sustainability of growth there in China? You obviously highlighted, strong long-term, but just how should we think about this year? Thank you..

We're not saying it over and boat. So inventory. So that's a good thing. We ship it in. We can sell as much there as they can. We can ship as much in as they need to sell. The growth rate - forever we've talked about - my goal of getting this growth rate in China over 25%. And being told consistently, it's just impossible to grow more than that in China.

It's hard. And we've been roughly about 25% over the years here and today is just to remind you it's my is my 35th earnings call for this company. So we're just ecstatic that we just knock it out of the park and all cylinders are now instrumentation is just flying. Big part of it. But it's also in our regions. So we're on all cylinders.

We are increasing our inventory levels. We are looking at shipment schedules. We're giving them all the help they need. We didn't have any supply issues last quarter and we're trying to work on that going forward. Everyone's talking about supply chain problems.

We haven't had any to date, knock on wood we won't have in the future, but we're trying to be as careful as we can. I would just say it's broad based. And this is one year, we had great growth for SPD by the way. It was a strong growth there. It's just small, but it's a good sign of the future.

I would love to see us be safely at 25% or better in China, which we've always said 20 to 25. And for this year 25, or better, looks pretty good now, when you start out at 50, over 50..

Great, super helpful Chuck. Thanks..

I don't think I've seen any peer so far, having numbers this great as good in China. So we're definitely in the right areas. And we're taking sharing antibodies, which is great to see..

Great, congrats on the growth there. Thanks..

Our next question is from Dan Arias with Stifel. Please proceed with your question..

Good morning guys. Thanks for the questions. Chuck, on Simple Plex, can you just talk about how system utilization there looks like attracting the quarter relative to the first half of the calendar year.

And then when you look at the instrument portfolio, I'm sort of curious where if anywhere you think we should think about growth in consumables pull through per instrument this year? It feels like it's easier to envision that for Simple Western and Biologics more than Simple Plex, but I'd love to hear what's your take on ..

You're right, Dan. And by the way, congrats. I think your predictions for our quarter are like within 1%. So we should be using you more often on our staff maybe, but -.

I couldn't agree more Chuck..

Yeah. Simple Flex is the lumpiness of the bunch. Now we have $12,000 a pull through per instrument on Simple Western, we have roughly 15 on Biologics, it's 50 on Simple Plex, it's huge.

This is a closed system, we made the cartridge for the customer and less, it's an open cartridge, which some customers use especially to start to figure out their assay. So that that makes it lumpier by definition. We actually had over 50% growth in instruments this quarter. So we're well on track for instrument deployment.

And with that kind of pull through, it's all about getting boxes out there. So we're very bullish. It's just coming off a huge comp from last year is one thing. So we studied all that. We're sitting pretty good. I think, in a lot of the use of large studies.

And so some of the instruments - some of the cartridge orders get very large and then that's what makes it somewhat lumpy. So we could have, a complete turnaround in cartridges next quarter, and then all of sudden, we're you know, back to 50%, 60% growth. It didn't really help us much in the instrument front.

Because we've been right against the rail of trying to finish out our orders every quarter. And this quarter wasn't much different, because instrument growth was still 50%. We're having to build a whole new factory just down the road from Arad. We will be done in a year with that. So that's off and running.

We did take cartridge manufacturing up last year. And then we've got a couple 100 a week, I think this last quarter of forgiveness of which will hopefully fill back up but it's still very strong year-on-year. So I think all things aside, it's still full steam ahead.

It's a $50 million plus run rate or better now and probably over more than half the size of Quanterix. And we're gaining traction on them and others out there..

Yeah, okay. All right. That's helpful. Thank you. And then Jim, if I'm hearing your comments on the outlook correctly, it sounds like you're calling out the comps that are obviously getting harder, but the confidence in getting above the historical average is higher.

And that average that you're thinking about is the 13% number that you alluded to last on, I believe you talked about at the Investor Day, is that right?.

That is correct..

Okay, thanks a bunch..

Thanks, Dan..

Our next question is from Jacob Johnson of Stephens. Please proceed with your question..

Hey, good morning. Maybe chuck on the cell and gene therapy side, I think you've been clear that that end markets an opportunity for you and a lot of initiatives there. But it seems like yourself, and maybe some others saw some pickup in activity from that end market this quarter.

Is there something that's changed in the end market? Or was the kind of performance you put up this quarter, just a function of kind of your internal efforts and GMP?.

Yeah. I think so. Yeah, I can answer that. It's plain old fashioned critical mass. So this is getting bigger and bigger. Our scale ready partners are doing better and better out there and they're providing additional visibility to our agents to be embedded within their solutions in clinicals.

And we're just getting more and more traction, more and more reorders. The orders are going up in size, but it's just we aren't even to the pregame warm ups yet for the size of this market. It's all preclinicals and clinicals, and it's already getting sizable.

I mean, this, I've mentioned the word tsunami in the past this, this is going to be a hallway that I think is just going to be hard to stay on top of, it's a couple of two, three, four or five years.

So in our - we've talked in the past about this division of the future being in five years, 300 million or so, it might be dramatically larger than that. We don't see a lot of people catching up to us or doing we're doing with total workflow, and we've got like 10 stops on the flywheel here for cell and gene therapy workflow.

I think we're going to be nearly unstoppable. And the lead position, of course, as GMP proteins, and being a protein leader in the world, we expect to fully capitalize on that first, and then follow with everything else we have to our customers who are amazed at all the things we are able off already. So it's a one stop shop now as a portfolio.

We had our first customer, I wouldn't call it a full audit, but a great tour and partial audit of our new factory and they were blown away..

Got it. That makes sense. I guess maybe Chuck, the natural follow up to that I guess, you've got the capabilities you have today. But it seems to me you probably like to add to that at some point.

Can you just talk about your thoughts on adding cell and gene therapy capabilities? The potential to do that organically and maybe thoughts on inorganic efforts there as well?.

Well, I think there's the antibody side, we're going to continue to build out. We just talked about the launch of the medium. We're definitely are looking beyond T cell and NK. So there's a lot of expansion just in the therapeutic side. I think instrumentation wise, we're in great shape. It's amazing.

We've had over $2 million of revenue this quarter and Simple Plex being designed into call a QC type of applications for cell and gene therapy. And Maurice is going to be used in purity as expected. So we've got a lot going there. There, we don't have everything. I mean, the non-viral future that we're trying to be part of will use electroporation.

We do not have an electroporation partner at this point we're using we're kind of ubiquitous. We have our favorites, but there's more than one out there. That'd be an area. I think there's always room for more spatial interrogation. I think we have RNA scope.

And that'll be used, but I think with the right automation, we can probably get into the production side of that, QC sides. So there's a few spots we're looking at.

But we got a lot of it covered and with great partners like Wilson Wolf bioreactors who have hundreds of customers and the new cube platform from Fresenius, which we think out does the competition on all fronts.

I think it's going to be an amazing future and hopefully we'll be talking about billions in revenue in a few years, not just hundreds of millions..

Alright, I'll leave it on that point. Thanks, Chuck..

Our next question is from Alex Nowak of Craig-Hallum. Please proceed with your question..

Great. Good morning, everyone.

Chuck, as we reached the end of the calendar year, what are you hearing beyond the US about life science budget next year specifically thinking Europe and China any reason to suspect a slowdown are these budgets as strong as ever?.

We're not hearing anything negative yet. I mean, Europe you saw the numbers, over 20% growth seems to be really good country by country. We're kind of through all the Brexit stuff. We're opening up an entirely new warehouse facility in Dublin.

We're working to be probably seen some tax savings and other mainland Europe type of changes going forward that will help us. Asia really looks good on all fronts except India. India, even is dramatically good for hell with trouble they're still in. Japan is stable.

Korea's growing well, Southeast Asia is really back on track better than it's been in a while. And China again, we talked about the numbers they're kind of off the charts. We're in the China's second year now going into their five year plan, which is just a big spend here, so for the next couple of years, it should be big spending in China.

And we'll see..

Yeah, that's good. And now that Matt McManus has been - you just had the ExosomeDx. And then the Asuragen business now under him through this new molecular diagnostics unit, has him or the team recommended any changes to the ExosomeDx sales strategy with either Abby or the upcoming Eco TRU.

Any push to kid those tests or really any changes to the pipeline focus?.

Not really No, I mean, they provide incredible help for us on the regulatory side as well as kidding, which you saw mentioned that you and saw us mentioned to CLIA labs, not one because they have one too. You saw us mention the center of excellence, so that really is implying partners.

So we're going to be able to focus on a lot more call them indications, different tests, because this is a platform not a one trick pony. And we're going to be doing some ourselves and we're going to be going in parallel with other partners and other channels.

So those negotiations, those relationships are well underway and forming and new ones happen. There's a lot of interest in all of these things we're talking about, and I think it's going to be amazing future. And that's the right guy..

No, get it. And I understand you're not shipping stuff via boat to your customers.

But I guess at the customer level on the supply chain, is there anything that's getting shore basic materials, and obviously labor that would cause maybe your customers to see a slowdown and thus, push the slowdown up to you?.

Well, I think killer growth we've been seeing in the last few quarters, our biggest issue has been labor, for sure. It's hiring. And we've made some - we've made improvements. We're catching up. But we keep seeing in 20% plus growth, which we'd love to see. We've got to stay in the game here on that first.

In terms of supplies, we put the word out early on and we're not making cars here, right. So it's a supply chain issues, aren't that complicated. Our instrumentation, I think we've looked into, are we going to see a chip shortage or something like that? Well, again we're making hundreds of a certain instrument per year, it's not 1000s.

So it's not too big a deal. And these are not million dollar instruments, either. These are great productivity tools that are roughly $100,000 to $50,000, in that range. So it's doable.

Not to say we won't see a problem next quarter whenever, I mean, if things don't start getting better there's mundane things like labels and paint and chassis ease and everything else, but we're staying on it. All we can say is we had no issue last quarter. And we don't foresee a problem this quarter. But you can promise everything we'll see..

Chuck, if I could add from our customers' perspective, one of the things we keep an eye on is our daily sales of our reagents. And we talked about our core reagents, proteins, antibodies were up 20% year-over-year.

So that's a good indication of the activity that's going on in our customers labs, so it doesn't appear as though any supply chain issues are slowing them down..

That's great. Thank you appreciate it..

Our next question is from Catherine Schulte of Baird. Please proceed with your question..

Hey, guys, congrats on the quarter and thanks for the questions. Is first on Exo TRU, have you made a decision on whether you'll commercialize the test on your own versus finding a partner there? And then I believe your previous target had been to launch it in calendar year '21.

So is that still the plan and if not what's driving the delay there?.

Yeah, it's going to be close to calendar year. I think it's possible. I mean, it all comes down to the LET and there isn't anything regulatory wise we have to really commit to now which is working with NGS, so it's anyone's guess. So we're kind of ready to go. There's a - we have the second study being written now. The data is all been collected.

So we're often running on more data than we need to launch. On the partnership front, there's been a lot of interest. So we're kind of, to be honest, we're kind of waiting through the interest here and seeing what makes sense from us strategically, as well as business wise, but good chance it could happen, but stay tuned..

And then you talked a bit about government funding for life science research, but if we think about the pharma and biotech side of the business we've seen robust funding over the last couple of years, but some volatility in in biotech financing over the last few months.

So what's your outlook for that end market? And how much of that is driven by what we see on the biotech financing side?.

It was a tremendous quarter. And that's been followed up by previous tremendous quarters. I think, everything from vaccine makers to bioteches in general, there's been big demand. We had roughly flat on COVID.

But there's a lot of halo stuff coming off of all that it's creating more investment opportunities by all of biotech, biopharma and we're participating all that because we work in all levels of the food chain and those businesses, so it's been good for us.

I mean, you don't look any further than - you have 20% growth in proteins and antibodies doesn't get more fundamental than that, it's just proof that the funding is strong..

Great, thank you..

I should make a comment to that. Our digital strategies are also continuing to work and work really well. We had just in our antibody channels alone. We had in our Novus brand over 50% year-on-year traffic increases. In our R&D systems brand our premier products 75% year-over-year traffic increases on our websites. That's pretty amazing.

That's why we're taking share..

Our next question is from Patrick Donnelly of Citi. Please proceed with your question..

Hey, guys, thanks for taking the questions. Chuck, you touched a little bit on some of the inflationary pressures, labor, et cetera.

Jim, I was wondering if you could just talk through kind of the moving pieces on the margin side, as we work through the rest of the year between again, some of the rising costs, Exo and then obviously, again, you guys pushing some of that price over to the customers just want to make sure we talk through that..

Yeah. On the inflationary aspect of it, we're trying to manage that through combination of productivity as well as selected price increases. So we're not necessarily forecasting the margin pressure as a result of that. You may recall, last quarter, when I talked about the margin view for fiscal '22.

We said initially, that we expected a sequential hit to our margins. I think I messaged roughly a percentage point due to the acquisition of Asuragen and roughly a percentage point due to getting caught up in our hiring for strategic growth. And that was going to impact us in the first half of the year.

And given that we did make some successes around hiring. We didn't go - we didn't hire as much as we had planned. And therefore, actually, our margin was better than we internally thought it would be for Q1. And we think we will catch up in Q2.

So I think the message that I left you with at the end of last quarter is the same and that by the time we get to the end of the first half of this fiscal year, we're expecting our year-over-year margin to be down roughly two percentage points, one - as one point as a result of a surgeon and the other point as a result of strategic growth investments, then that'll start to rapidly recover in the second half of the year, so that by the time we get to the end of Q4, we think we'll be year-over-year pretty comparable..

Okay, that's helpful. And then Chuck, just on the Exo side, encouraging to hear about the volume recovery there, sales seems like it's get - the reps are able to get into the docs.

Where do you think we are there in terms of the recovery? What are you hearing from customers, again, as the pandemic hopefully lifts, I just want you to talk through expectations on that front?.

Well, it's coming back fast, especially this quarter. I mean, we had 1700 docs order last year with about two thirds on a reorder rate. And already this year, this fiscal year-to-date, one quarter, and we're over 1100. So it's really picking up steam. And we see that really from just more customer touch, the reps are being like that back in.

If the reps aren't seeing the docs, it's hard to get orders, it's just that simple. And the patients have got to be seeing them and getting PSA tests. So there's something to talk about. So it's all coming back pretty quickly. So I still think we're really in early innings here. It's just getting started.

And there's like 15,000, 20,000 different docs out there. So we've been we've really addressed like 20%. So it's just a matter of getting it going and imagine dilution, which we're doing a really good job of, and Matt and team are going to be helping a lot as well. And there's leverage there.

So that's also probably part of the improvement already in a quarter is just by the McManus team taking over, but stay tuned. We're really excited. Got one out there ramping Exo TRU ready to come and we're in discussions on a bunch more that we are doing and can do.

And it's an amazing technology and its way more predictive than cell free DNA way more upstream..

Great, thanks, Chuck..

[Operator Instructions] Our next question is from Paul Knight of KeyBanc Capital Markets. Please proceed with your question..

Chuck, when you see customers gain, let's call it maturity at your GMP protein production facility.

What do you think the average size will be?.

For a customer?.

Yeah..

Well, I can tell you right now, it's hard for them to forecast. And so we've done our contracting in terms of percentages. So the deals we put in place, which are quite a few at this point. As they get beyond clinicals and go into production, we are contracted to receive 95% of the volume they need. This is such a critical area.

They're always going to have backups and we're going to get backup for some probably as well. But that's good. Most of come in with the requirements before they get started with us and they range from between $10 million a year annualized per protein all the way to a couple over 50 million.

Of course this is for them getting through their clinicals and surviving and meeting their sales forecasts, of course, but this is orders of magnitude beyond proteins for REO, right. So I don't think you'll see anything in production of a therapeutic for probably less than a $1 million per protein, to be honest..

And these cost is what, starting out at preclinical Chuck?.

Most of these are preclinical, some in clinical at this point, but we're at we're at a couple of dozen in, we're being looked at by our scale ready partners. As an example, go from Wolf bioreactors becoming a de facto standard, it's in well over a couple 100 different accounts out there in clinicals.

And they're out there putting pressure and talking to their customers about, if you just choose the proteins from Bio-Techne, we can actually deliver them already encapsulated, ready to be reconstituted in the bioreactor. So it takes a bunch of risk, and a bunch of cost off the table for you. And their eyes are lighting up.

So we're getting that process going, it'll take a year or two. But that's the kind of opportunity we have by being part of scale ready..

Okay.

And then what's your read on the mRNA market? Number of candidates, customer interest, whatever metric you see or feel since we've had, obviously the COVID vaccine success?.

Well, if you land at Moderna, there'd be 20 different drugs they are working on that are going to use mRNA, right. So good premier wise, they've landed a great - they've been in the right place at the right time and have a great product and they've got Cap technology IP to get around.

So mRNA is probably tougher for the rest that's out there then plasmids per se. But we're working on all these I think in a couple of years, we'll be in all this stuff at some level. It's not rocket science is read down our alley. So it's just a matter of investment in going.

Now, if we were to get large in mRNA to the same kind of vision that we're talking about with proteins, we would need another factory the size we have now, so it would take some investment. But first things first, to make sure we have the science right. We'll get around the IP and we have working products and then we'll do what we need to do..

Yeah, okay, thanks..

We have reached the end of the question-and-answer session. I will now turn the call back over to Chuck Kummeth for closing remarks..

Well, thanks, everyone. It was a great start to our year. Love seeing over 20% organic growth as always. I'm sure you do as well. We look forward to next quarter and hopefully we can keep it all going. Thanks again. Bye..

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. Have a great day..