Repligen Corp

NASDAQ:RGEN

Earnings Call Transcript 2020-Q2

[Operator]

Good day, and welcome to the Repligen 2020 Second Quarter Conference Call and Webcast. All participations will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Ms. Sondra Newman, Head of Investor Relations. Please go ahead.

[Sondra Newman, Global Head of Investor Relations]

Great. Good morning. Thank you all for joining our Q2 earnings call. Today, we’ll be covering financial results and business highlights for the 3- and 6-months period ended June 30, 2020. We’ll also provide revised financial guidance for the full year.

President and CEO, Tony Hunt, will cover business updates; and our CFO, Jon Snodgres, will cover our financial results and guidance.

As a reminder, the forward-looking statements that we make during this call, including those regarding our business goals and expectations for the financial performance of the company are subject to risks and uncertainties that may cause actual events or results to differ.

Additional information concerning risks related to our business is included in our annual report on Form 10-K, our quarterly reports on Form 10-Q, the current report on Form 8-K, which we filed this morning and other filings that we make with the SEC. Today’s comments reflect our current views, which could change as a result of new information, future events or otherwise. The company does not obligate or commit itself to update forward-looking statements, except as required by law.

During this call, we’re providing non-GAAP results and guidance. Reconciliations of GAAP to non-GAAP financial measures are included in the press release that we issued this morning, which is posted to Repligen’s website and on sec.gov. Non-GAAP figures in today’s report include the following: revenue growth at constant currency, gross profit and gross margin, operating expenses including R&D and SG&A, operating income and operating margin, income tax expense, net income and earnings per share as well as EBITDA and adjusted EBITDA.

These adjusted financial measures should not be viewed as an alternative to GAAP, but are intended to better enable investors to benchmark Repligen’s current results against historical performance and that of peers.

With that, I’ll turn the call over to Tony Hunt.

[Tony Hunt, President and Chief Executive Officer]

Hey, thank you, Sondra, and good morning, everyone, and welcome to our Q2 earnings call. As discussed during our Q1 call, it continues to be a challenging time for our global workforce as we focus our priorities on ensuring employee and family health and safety, keeping our manufacturing sites operational and managing supply chain and logistics.

We are now more than 5 months into the COVID-19 pandemic, which has pushed us to be creative in how we think, plan and execute on our overall business strategy. I could not be more proud of what we’ve been able to accomplish. Our whole organization has done a remarkable job, keeping us operating at full capacity, delivering products on time to our customers, including rapid response deliveries to customers or developing drugs, vaccines and diagnostics targeting COVID-19.

Our results for the second quarter and through the first half of 2020 have been stellar. We delivered overall revenue growth of 25%, including organic growth of 19% in the second quarter, despite really tough comps, with Q2 of 2019 being our strongest quarter last year, where we had organic growth of 46%. All of our businesses continue to perform well, with very strong order demand for our direct product lines, which were up to about 40% in the quarter.

The ramp-up in orders is broad based with contributions from existing mAb and gene therapy accounts, and in particular, from customers working on the development of vaccines and therapeutics for COVID-19. We estimate that about 75% of our revenue beat in the quarter is related to COVID demand with proteins being the major driver. Gene therapy related demand also remains strong. And we now expect gene therapy revenue to grow by 30% to 40% in 2020.

We expect that our direct revenues in the second half of 2020 will accelerate further as many of our customers get back to full manufacturing, and key biopharm and CDMOs ramp up manufacturing capacity for COVID programs.

Based on this momentum, we are increasing our revenue guidance by $22 million at the midpoint for the year, which includes $3.5 million to $4 million from our recent acquisition of Engineered Molding Technology or EMT.

We expect second half of 2020 revenue to be generally balanced across the 2 quarters. We’re also increasing our guidance on gross and operating margins, while raising adjusted EPS by $0.15 at the midpoint of our guidance.

Before jumping into the quarterly results, I want to spend a few moments on the acquisition of EMT and the performance of C Technologies at 1 year post acquisition. We are delighted to have completed the EMT deal, which gives us core competency in silicone extrusion and molding and strengthens our supply chain for single-use components.

Our goal over the next 6 to 12 months is to build out EMT’s commercial structure, expand our core OEM and direct customer base, and finally, develop new products that integrate into our single-use flow path assemblies and filtration.

We expect EMT to grow at 25%-plus over the coming years as we complete integration and execute on our overall single-use strategy.

On the C Technologies front, it’s been a great first year for the business and team. Core to our analytics strategy is the expansion of the commercial organization to help broaden the customer base, and go direct in Europe and Asia.

With the full complement of salespeople since the beginning of the year, we’ve been able to build up a deep funnel of opportunities, especially in Q2, which resulted in a 29% year-on-year pro-forma revenue growth in the quarter, and 26% for the first half of 2020.

The analytics team in Bridgewater also has expanded the applications for VPE technology. Up until now, the success of Solo and Flow VPE products has been primarily centered on protein concentration measurement and biological drug manufacturing. Now, the applications are expanding and we’re confident that VPE technology can be applied into gene therapy processes.

As mentioned during our Q1 call, we observed some challenges for analytics, especially in the area of onsite service and support at pharma accounts due to COVID. While many of these challenges still exist, our service organization has skillfully managed through the last 4 months, and our expectation is that C Tech will deliver $32 million this year in line with our guidance back in February.

Adoption of FlowVPE is beginning to accelerate with multiple customers working to implement this technology and clinical processes. With next-gen FlowVPE ready to launch by the end of the year, we are in a very strong position to further accelerate the C Tech business in 2021.

So jumping now to Q2 and overall performance by product lines. Our proteins business had an excellent quarter driven by increased orders from Cytiva for ligands and MilliporeSigma for growth factors. The additional demand from COVID customers for ligands combined with the strong growth factor quarter resulted in organic growth of greater than 10% in the quarter and through the first half of 2020.

True to historical performance, we expect proteins revenue to be more heavily weighted to the first half of the year similar to what we saw in 2019. And for the full year, we’re increasing our expectations and guiding now to the high end of 5% to 10% organic growth for this business in 2020.

Our filtration business had another outstanding quarter with our hollow fiber franchise leading the way. We saw strong demand for hollow fiber modules, assemblies and systems with revenue up greater than 30% year-over-year. Our flat sheet cassette business also performed very well with important contributions from gene therapy accounts. Finally, the single-use XCell ATF business continues to grow and expand as lead times have come down significantly and new accounts have adopted the technology.

Looking ahead, we expect ATF to have a very strong second half, as large implementations are on track over the next few months. Regionally, both Asia-PAC and Europe had excellent filtration quarters, with Asia bouncing back to deliver greater than 60% year-over-year growth after the challenges in Q1 due to COVID.

Finally, from an orders perspective, we’ve benefited in the quarter from customers ramping up their activity on COVID programs, which will drive an overall strong second half for our filtration business. We expect filtration will now grow 25% to 30% in 2020.

Our chromatography business had a solid second quarter led by OPUS pre-packed columns. Demand for our mid-range columns increased significantly as lead times have come down here in 2020 stemming from capacity investments, we made in late 2019. While we did see some COVID orders in the quarter, the majority of OPUS growth came from large pharma and gene therapy accounts. We continue to expect our chromatography business to deliver 15% to 20% growth in 2020.

As discussed in previous calls, we’ve made key investments in our manufacturing capacity over the last 18 months with focus on OPUS and ATF. Given the acceleration we are seeing in demand, we’ll be spending an additional $10 million for a total of $30 million to $32 million in CapEx programs this year. The focus of this additional investment will be on our filtration business as we ramp up capacity across our network.

From an R&D perspective, we are on track to launch 5 new products here in 2020. Today, we’ve launched 2 with the introduction of our TangenX scanner cassettes on our KrosFlo TFDF systems. In the second half, we will launch our XCell ATF lab controller, new affinity ligands on the next generation FlowVPE.

As a reminder, our Gamma cassettes allow us to serve viral vector manufacturing. TFDF is a disruptive technology for upstream harvest clarification. Our next-gen ATF controller adds flexibility, including multiplexing capability. And the new FlowVPE will simplify in line real time measurement for our customers.

So in summary, we’ve had an excellent start to the year. We’ve delivered on our financial goals, executed on an important acquisition that strengthens our single-use portfolio. We’ve invested in people and infrastructure to scale our company and introduce exciting new products to improve the process of manufacturing biological drugs. With a healthy balance sheet, we’re well positioned to execute on our blueprint for growth, which remains centered on technology leadership and bioprocessing to internal development and M&A.

With that, I’ll turn the call over to Jon for a financial update.

[Jon Snodgres, Chief Financial Officer]

Thank you, Tony, and good morning, everyone. Today, we are reporting our financial results for the second quarter of 2020 as well as updating our financial guidance for the year. Unless otherwise mentioned, all financial measures discussed reflect adjusted non-GAAP measures. As you’ve seen in our press release this morning, we delivered record quarterly revenue and strong earnings growth in the second quarter, benefiting from overall market strength and increased demand related to COVID programs.

In step with our longtime strategy of driving growth through innovation, we proceeded to develop and launch new products through R&D in the second quarter, and we announced and have since completed our acquisition of EMT. The financial impacts of the acquisition, which closed in July, are included in today’s updated financial guidance for 2020.

Now moving to more specifics on our second quarter financial results. On our top-line inclusive of tailwinds from COVID-19, we delivered record revenue of $87.5 million representing 24% reported growth and 19% organic growth. All 4 of our product franchises continue to perform very well, with each generating double-digit growth in the quarter. Within these growth figures, we realized approximately 6 points of non-organic growth from our C Technologies business, and nearly 1 point of foreign currency headwind in the quarter.

Overall, in the second quarter, we achieved a 12% consensus beat on revenue, and we estimate that COVID-19 related projects contributed approximately 9% of this overdrive with our proteins and filtration franchises driving the majority of COVID-related revenue gains. Our overall revenue for the first half of 2020 was $163.6 million, representing growth of 25% as reported and 17% organic.

On a regional basis, strength in Asia was the highlight of the second quarter with pro forma direct – pro forma revenue growth of greater than 60%. Asia was also the strongest performer in terms of growth for the first half of 2020 with pro forma revenue growth in excess of 40%. On a year-to-date basis, North America represented approximately 53% of direct product revenue, with Europe and Asia accounting for 29% and 18%, respectively.

Based on market strength and our strong order load from the first half of the year, we continue to expect strong revenue performance in the second half of 2020 from each of our direct product franchises. We now expect our filtration franchise to deliver organic growth in the range of 25% to 30%. Chromatography products to achieve 15% to 20% organic growth and our process analytics franchise to achieve $32 million or 25% pro forma growth for the year.

In addition, we now expect our proteins franchise to finish the year toward the high end of 5% to 10% organic growth, a significant increase from our previous guidance of minus 5% to 7%. In terms of revenue phasing for our proteins business, we estimate that 55% to 60% of this revenue has shipped in the first half of the year, leaving 40% to 45% of revenue remaining to ship in the second half.

Now moving down our income statement. Adjusted gross profit was $50.9 million in the second quarter of 2020, reflecting an increase of $9.5 million or 23% over the second quarter of 2019. Our second quarter 2020, adjusted gross margin was 58.2%, reflecting a strong performance driven by robust sales volumes, productivity programs and favorable mix, including strong proteins revenue, and OPUS column to resin mix in our chromatography franchise.

Based on continued strength of our second quarter adjusted gross margin performance, the healthy view of our order book moving into the second half of the year, and the strength of our productivity programs, we are tightening our gross margin guidance to 56.5% to 57% for the year.

Adjusted gross margins were 58.3% for the first half of 2020. Similar to the trend we experienced in 2019, we expect a reduction of second half gross margin levels of approximately 300 basis points based on increased investments we’re making in manufacturing capacity and personnel to support higher and long-term growth expectations.

With respect to operating expenses, adjusted research and development costs for the second quarter of 2020 were $4.1 million compared to $5.1 million for the second quarter of 2019. R&D expenses finished the first half of the year at 5.2% of revenue, and we expect a meaningful increase in the second half of the year as we continue to work through key product launches. We expect overall R&D spend to be in the range of 6% to 6.5% of revenue for the full year.

Adjusted SG&A costs for the second quarter of 2020 were $21.2 million compared to $16.2 million for the second quarter of 2019. The year-over-year increase of $5 million supported investments made in late in 2019 to build out customer-facing teams, as well as ongoing investments in capacity, operating infrastructure and IT systems to support growth and inclusion of a full quarter of expenses from C Technologies, which we acquired on May 31, 2019.

Now shifting to earnings and EPS. Adjusted operating income for the second quarter of 2020 was $25.5 million, an increase of 27% compared to $20.1 million reported in the second quarter of 2019. Operating margin expanded to 29.2% compared to 28.4% in the second quarter of 2019. Based on our strong performance, we’re raising our full year adjusted operating margin guidance by 100 basis points to 24% to 25%.

Our first half of 2020, adjusted operating margin was 26.8%. Similar to our trends in 2019, we plan to make significant capacity and personnel investments in the second half of this year to support anticipated market demand.

We are projecting an approximate 400 basis point reduction in adjusted operating margin for the second half of 2020. This assumption is included in our guidance increase for the year.

On the bottom line, adjusted net income for the second quarter of 2020 was $22.5 million, a year-over-year increase of $6.3 million or 39%. Net income also benefited from a lower-than-normal adjusted income tax rate of 9.1%, related to the impact of incentive stock transactions.

Finally, adjusted EPS increased to $0.42 per fully diluted share in the second quarter of 2020, an increase of 30% compared to $0.33 recorded in the second quarter of 2019.

Our cash and cash equivalents which were GAAP metrics totaled $560.4 million at June 30, 2020, an increase of $32 million compared to yearend 2019. This does not include EMT acquisition costs.

For the first half of 2020, we generated free cash flow of $19.4 million inclusive of $30.9 million of operating cash flow plus $11.5 million of capital expenditures.

Now, moving to 2020 full-year guidance, our GAAP to non-GAAP reconciliations for our 2020 financial guidance are included in the reconciliation tables in today’s earnings press release. As previously mentioned, unless otherwise noted, all 2020 financial guidance discussed will be non-GAAP.

Please also keep in mind that our 2020 guidance may be impacted by fluctuations in foreign exchange rates, beyond our current projection of net zero impact on full-year sales. Our guidance does include the impact of our EMT acquisition for the second half of the year, but does not include the potential impact of any future acquisitions that the company may pursue.

Today, in recognition of our strong bioprocessing market, and operational execution, as well as our acquisition of EMT, we are raising our 2020 full-year revenue guidance, a GAAP metric by $22 million at midpoint to $332 million to $340 million, reflecting growth in the range of 23% to 26% as reported and 18% to 21% on an organic basis.

As I mentioned earlier, we are tightening the range of our adjusted gross margin guidance for 2020 to 56.5% to 57%, to the upper end of our previous guidance of 56% to 57%.

We are increasing our adjusted operating margin guidance to a range of $81 million to $84 million, up $8.5 million at midpoint from our prior range of $72 million to $76 million. As mentioned, this expands our adjusted operating margin guidance by 100 basis points to the range of 24% to 25%.

Adjusted other income and expense is expected to be $0, a reduction of $1 million of income from our previous guidance. This update is based on continued declines in interest rates on our invested cash and second quarter transactional foreign exchange exposure incurred.

Moving to tax, we’re reversing our 2020 full-year adjusted income tax rate guidance to approximately 18%, down from our previous guidance of 20% to reflect second quarter benefits realized from stock exercises.

This guidance assumes an effective rate of 25% for the second half of the year and does not consider the potential impact of additional employee stock transactions which we expect to be significantly lower in the second half of the year compared to the first half.

We are increasing our full-year 2020 adjusted net income guidance to a range of $66 million to $69 million, up $8 million at midpoint compared to our previous guidance. In turn, we are also increasing our adjusted EPS guidance to a range of $1.24 to $1.29 per fully diluted share, up $0.15 at midpoint from our prior guidance.

Our guidance continues to reflect an estimated $53.4 million average fully diluted shares outstanding for the full year. Finally, we are increasing our adjusted EBITDA guidance by $8 million at midpoint to a range of $91 million to $94 million for full year 2020, with depreciation and intangible amortization expenses expected to be approximately $10.7 million and $15.7 million respectively.

With respect to capital expenditures, the company now expects to invest $30 million to $32 million for 2020, an increase of $10 million from prior guidance.

Inclusive of our EMT acquisition, we expect yearend cash and cash equivalents, a GAAP metric, to be in the range of $560 million to $570 million, with our CapEx investments being fully funded by cash generation from our operations.

This completes our financial report and guidance update. And I will now turn the call back to the operator, to open the lines for questions.

[Operator]

We will now begin the question-and-answer session. [Operator Instructions] The first question is from the line of Dan Arias with Stifel. Please go ahead.

[Dan Arias, Stifel Financial Corp.]

Good morning, guys. Thanks for taking the questions here. Tony, can you just add some color to the COVID vaccine opportunity and the way that that’s shaping up just in terms of buying patterns? I mean, obviously, the pace of development here is just kind of pretty amazing. So how is that translated to purchasing ahead of assumed campaign advancement? How is the demand here different or the same as traditional non-crisis-related vaccine programs?

And then, what kind of visibility do you have when it comes to the next several quarters here?

[Tony Hunt, President and Chief Executive Officer]

Okay, thanks, Dan. I – so maybe I’ll split the question up into few parts. I’ll tell you what’s happened in Q2. I’ll tell you what is going on in the second half of the year. And I’ll give you visibility to kind of what we know as we sort of finish off 2020 and go into 2021.

So what’s interesting about COVID is, I mean, it is unique. I mean, you listen to all the other companies who are involved in this and the pace that companies are moving at is tremendous. The demand is high. So I would say our Q2 really accelerated based on – when we finished Q1 and we did our earnings call in May, we talked a little bit about the fact that we have seen a ramp-up in our orders for our Protein A Ligands, which is coming from Cytiva. So we knew that was going to materialize in Q2, which was all COVID driven. And that’s what happened.

On top of that, there were some extra orders that came in towards the end of the quarter. In addition, what we saw across the rest of our product lines was, as the companies we were working with started to ramp up and move into Phase 1 and 2 type trials in the quarter, there were smaller orders that we delivered in our filtration and in our chromatography businesses, and in analytics as well. So right across the board, there’s demand for all our products.

But I’d say the majority of the Bs in Q2 really came from the protein side of the equation. Now, when you get into the second half of the year, that’s going to change. We saw significant orders come in, in Q2, for the second half of the year for COVID-related programs. And those orders, we’re going to be delivering on here in Q3 and in Q4.

In terms of our visibility, I think our visibility goes out to the end of the year with some early hints of Q1 of 2021. But our expectation is that if these companies continue to scale and move forward, and we remain in those opportunities that, clearly, this is something that’s going to move through all of 2021 and probably beyond.

In terms of your – last part of your question around how different is this versus a non-pandemic, I personally haven’t come across anything quite like this. I think the demands are high. You’ve got a lot of companies working and racing to get to vaccines. You’ve also got companies working on therapeutic programs.

So it really has turned into a market by itself right now. And so, lot of companies have changed their programs and focused a lot of their capacity on COVID. And so, that’s also driven a lot of the activity and the demand. So hopefully that, Dan, gives you some color. You there, Dan?

[Dan Arias, Stifel Financial Corp.]

Well, yeah, sorry, I put you back on mute there, because my kids are running around here. On the other side of the coin with monoclonal antibody production for COVID, how does that figure into things? I mean, our tally was that there are 50 or 60 of these programs that are ongoing. And it sounds like the opinion from some in the clinical community is that the role here might be preventative or as a treatment until a vaccine arrives.

But it also felt like some of the comments that you made in the spring, kind of had you thinking that this would be a wave behind vaccines, just given the pace that the vaccines were on. So what is the current thought on just how you see scale up activity for the mAbs from a timing perspective relative to what you’re seeing for the vaccine?

[Tony Hunt, President and Chief Executive Officer]

We’re definitely – yeah, we’re definitely working with companies on the mAbs side. And clearly, there are some groups that are moving fairly quickly. But I think from at least what we’re involved in, I would say that vaccines are moving at a very rapid pace. And I do think that as we get into the second half of the year, we will see more activity on the mAbs side. But that’s just a Repligen view. That’s not a view. I’m not trying to make that to be a global view. That’s just what we’re seeing.

[Dan Arias, Stifel Financial Corp.]

Got it. Okay, if I could sneak one more in for Jon. Jon, just on the guidance for the year, how much of the top-line increase is due to EMT versus just a better view on organic? And then, on the outlook for the balance of the year, when you look at 3Q and 4Q kind of being similar? I’m just curious why the nature of the scale up and development and production would sort of lend itself to 4Q being a little bit higher than 3Q?

Is there something discrete there that you’re thinking about? Or is it more than just that’s a prudent way to looking at the back-half at this point?

[Jon Snodgres, Chief Financial Officer]

Yeah, sure. So I’ll start with the EMT question. We’ve included about $3.5 million to $4 million in the second-half for EMT in terms of revenue. So that covers that question. And then the second question is, why don’t we see, I think, margin expansion in Q4 versus Q3? As we look at our second half, I think Tony mentioned, the revenue levels are fairly linear through Q3 and Q4. And equal levels between the 2 quarters, so that coupled with the fact that we’re significantly adding human resources and capacity costs, will be ramping up on travel costs back in the second half of the year, at least our expectation, more visits to customers and things of that nature.

So if you look at all those things combined, that’s dropping down gross margins here in the second half, and probably dropping gross and operating margins more significantly in Q4 than they are in Q3, because of…

[Dan Arias, Stifel Financial Corp.]

I was actually referring – that is in itself helpful, but I was actually referring to the top-line and why 4Q wouldn’t actually be a little bit higher than 3Q, just given that you’re that much farther along on this stuff that’s being done.

[Jon Snodgres, Chief Financial Officer]

Yeah, I mean, based on – just based on what our order load looks like right now and the deliveries based on what we’re seeing, we think it’s fairly linear. And remember, we do have a pretty meaningful drop from H1 to H2 in our proteins business, which is also giving us some headwind there that we have to make up with the right products.

[Tony Hunt, President and Chief Executive Officer]

And maybe, Dan, one final comment on that. I mean, we’re basing what we know on, obviously, what happened in Q2 with the order jump up. So as we go through Q3, there could be other companies that are going to start to scale that could push Q4 to be a higher quarter than Q3. But right now, they look pretty even, yeah.

[Dan Arias, Stifel Financial Corp.]

Yeah, that’s fair. Okay, thanks a bunch.

[Sondra Newman, Global Head of Investor Relations]

Operator, would you take the next question, please?

[Operator]

The next question is from the line of Puneet Souda with SVB Leerink. Please go ahead.

[Puneet Souda, SVB Leerink LLC]

Yeah, hi, Tony, Jon, thanks. First one, first of all, congrats on the really strong quarter here versus a very tough compare. So the first one is, on vaccines it’s still – I just wanted to understand, if you could characterize – we’re seeing on the order of magnitudes or 200 plus different projects out there. Anything you can provide in terms of number of COVID vaccine projects that you’re levered to? Obviously, you’re getting levered to at different phases of those projects, as those projects are maturing.

And if you could also characterize for us, the 75% of the growth that you mentioned, would that number go even higher as sort of percent of the growth in the second half? And also, on that point, was Asia driven more by mAbs or gene therapy or vaccines, if you could elaborate a bit there too? That’d be helpful.

[Tony Hunt, President and Chief Executive Officer]

Okay. So on the COVID side, Puneet, I think, we’re unlike maybe some of the bigger players in the industry that clearly touch almost every vaccine therapeutic that’s happening. I think Repligen – we’re a little bit more tied to those companies that we’ve been working with for the last number of years. So we’re in a significant number of programs in both vaccine and therapeutics, and it spans North America, Europe and Asia. So it’s not just centered in one region, we’re really across all regions. So that’s very encouraging. There continues to be activity going on in COVID where companies are maybe later than some of the big guys in terms of moving forward, but there is definitely signs that other companies are beginning to scale, and we’ll see what the impact of that is in the second half of the year.

In terms of growth, there could – there’s definitely the potential to be upside. And it will come from, I think, what happens to the companies that are scaling do they move through Phase 2 into Phase 3, and how that plays out over the next 6 to 9 months. And obviously, the other companies that are at the very early stages as they move through, so they would be the areas where we would expect to see potential upside in the second half of the year.

But we think in general, most of our second half beat is really coming from COVID pretty much all our other product lines are moving in the direction we were expecting them to move at the beginning of the year. And if you look at filtration is doing very well, our chromatography products are doing well. C Tech, as you could see from like earlier comments, is doing very well. And our proteins business has obviously been a real surprise for us versus where we were expecting it to be at the beginning of the year, and again, that’s mainly driven by COVID.

And then the final part of your question, which was on Asia. Asia, I would say is, is mAbs biosimilars. There’s definitely COVID activity going on, so maybe small amount of gene therapy, not a huge amount for us in Asia right now. But I would say, mAbs and COVID are the major drivers. And after a pretty slow start to the year, which was not unexpected, given China shutdown for essentially March and April. It’s incredibly encouraging to see Asia bounce back with a great Q2 and actually turns out H1 per Asia actually is the highest growth, as Jon pointed out, in all our regions. Obviously, off a much smaller base than North America and Europe.

[Puneet Souda, SVB Leerink LLC]

Okay. That’s super helpful. If I could also ask on the sort of the second half and the visibility that you have in the order book, and the lead times that you’re currently seeing, if you could – some companies have quantified, some of the peers have quantified this order book, is that something you can quantify in terms of the growth you’re seeing year-over-year. And then in terms of the – on the capacity end, we are seeing that the lead times are 6 to 12 weeks on some of your products XCell ATF 6 weeks, cross-flow TFDF 12 weeks or so in process development? So just wondering if those are within the norms or if there are any some capacity constraints here with the strong growing demand?

[Tony Hunt, President and Chief Executive Officer]

Yes. Maybe start with the capacity part of the question. I think our lead times are no different on our filtration products than they were maybe a year ago or 2 years ago, I think, we’ve improved our ATF lead times down significantly with the investments we made last year. On the chromatography side, obviously, we had very long lead times on OPUS a year ago, we’ve made some significant investments and brought those lead times down to very reasonable number of weeks, depending on the size of columns that people want to order.

On the filtration side, clearly, strong demand that’s coming from COVID, we’re investing. We’re adding lots of people in basically our East Coast and West Coast filtration sites. We’re increasing our CapEx investment to bring in additional equipment as we think through where we want to be in 2021 and 2022. So our CapEx investments are with the 2021, 2022 mindset, not really a 2020 mindset. The people piece is 2020 going into 2021.

And remind me the first half of the question, again, Puneet, was…

[Puneet Souda, SVB Leerink LLC]

The quantification of the order book, if you could.

[Tony Hunt, President and Chief Executive Officer]

Yeah. So I don’t have the exact numbers, but ballpark, if you look at our 40% increase in orders on the direct portfolio, probably 40% to 50% of those orders were COVID-related. So we’ve a very strong order book going into Q3 into the second half. Some companies have placed orders all the way out to the end of the year. Others have placed it through Q3. And I’m referring to COVID. The rest is very similar to what we see with our typical customers in terms of how they place orders are typically placing orders 2 to 3 months out. And I think the only other comment I would make on the order side is that we had a really strong order book in Q2 as well for our perfusion product line ATF. And so that’s going to lead to a very strong second half for ATF.

[Puneet Souda, SVB Leerink LLC]

That’s great. Thank you. And congrats again.

[Tony Hunt, President and Chief Executive Officer]

Thank you.

[Operator]

The next question is from the line of Tycho with Peterson. Please go ahead.

[Tycho Peterson, JPMorgan Chase & Co.]

Okay. Thanks. Another COVID-related question for you, Tony. Just curious about the degrees of tailwinds across the portfolio. Why are protein and filtration benefiting more than chromatography now? And how do you see that mix shift evolving as some of these trials scale up? And are you skewed into it any particular type of vaccine platform?

[Tony Hunt, President and Chief Executive Officer]

Yeah, good question. I think the – proteins is pretty clear, right. It’s really driven by the Protein A Ligand demand, right. And so we know that there was some stockpiling that went on in Q1 and Q2. And we know that the therapeutic protein opportunities as people scale those up are driving demand on the ligand side. So that’s kind of the major driver. We did see on the protein side, less or not really related to COVID, but just very strong growth factor demand through the first half of the year.

On the supply filtration proteins versus, say, chromatography, I think the difference is that when you look at our filtration portfolio. We have flat sheet cassettes, we have hollow fiber membranes. We have the single use assemblies like ProConnex. We have the TFF skid systems. We have a very broad portfolio of products. And when you look at our chromatography portfolio, it’s essentially one product line, it’s OPUS.

And so we are seeing demand for pre-packed columns going into COVID programs be it vaccine or therapeutic programs. So it is happening. It’s just that you kind of have 4 product lines in filtration, and we have one major product line in chromatography. And the same thing is true around our analytics business, where our C Tech, solo and FlowVPEs are also seeing activity around meeting instrumentation for COVID programs. But again, it’s one product line. That’s kind of the reason, Tycho, that is – it’s more skewed towards filtration. We have kind of 4 product lines buried in our filtration portfolio.

[Tycho Peterson, JPMorgan Chase & Co.]

Okay. And then in terms of being skewed toward any particular type of vaccine program, is there any new [announcements there?] [ph] I assume, maybe less mRNA, but just any color you can provide there on the types of programs?

[Tony Hunt, President and Chief Executive Officer]

No. I think it’s across the board. I don’t think there’s anything that – I think our portfolio is really suited to both protein-based drugs on to RNA based drug, so there’s no differentiation for us.

[Tycho Peterson, JPMorgan Chase & Co.]

And then if I go back to last quarter, there was a fair amount of talk on clinical trial delays, obviously, two-thirds of your businesses is kind of exposed on the clinical side. Can you just talk about, where you see the resurgence of clinical trials at this point? And any risks in the back half of the year with kind of COVID flaring up in some of these markets that trials could get pushed out again?

[Tony Hunt, President and Chief Executive Officer]

Yeah, I think that, clearly some of the big players have re-juggled their schedules and put a lot of effort into the COVID programs. We’re probably not the best company to comment on where clinical trials are, I think the CDMOs and the large pharma guys are going to probably have a lot more insight. But we haven’t seen any slowdown in order demand for our major product lines for non-COVID-related activities.

So gene therapy is probably a good one, Tycho, you think about, we started the year of saying gene therapy will grow about 30%, we think we’re now going to be more like 30% to 40% of gene therapy. It doesn’t mean that some of those trials haven’t been delayed, but I think the overall market is very healthy. And we haven’t seen any slowdown in order demand outside COVID. And that’s kind of probably our leading indicator as opposed to – we don’t spend a whole lot of time looking to see which companies are slowing down on clinical trials is more looking at our order book, and how that looks for the second half of the year.

[Tycho Peterson, JPMorgan Chase & Co.]

And then – that was a good precursor of my last question on gene therapy, obviously, you took up the growth rate there. Where do you see that going, I guess, from a kind of mix perspective over the next year or 2? And then, can you talk to investments you’re making to kind of scale up that business a little faster?

[Tony Hunt, President and Chief Executive Officer]

Yeah, so the good news on the scale-up of the business and the investments we’re making, it is all of our – so all the products we’re using today that are going into mAb processes are going into gene therapy. Now, I would say, we’re supplementing our existing portfolio of products with products that are even more suited to gene therapy applications like our TFDF technology we think as a – will have a huge impact on the upstream side of gene therapy on the viral vector side. So that’s going to be very, very positive. We think that there is an upside in our C Technologies business, where we put a focus on really looking to see how you can use this technology in gene therapy. So we’re close to being able to roll out some applications that we think will be fairly unique for us.

So there are areas where we see some upside. I don’t think we have to do anything different beyond making sure that from a capacity point of view that we can stay ahead of demand whether it’s in mAbs, biosimilars, COVID gene therapy. And as I mentioned on a prior call, we have a dedicated team now in the company that’s really focused on the gene therapy market, and that’s really helping our commercial organization, that’s helping our field applications piece. And it’s also helping our customers, because these individuals are more experts in the viral vector side of gene therapy than, say the regular sales team.

[Tycho Peterson, JPMorgan Chase & Co.]

Great. Thanks for the color and congrats again on the quarter.

[Tony Hunt, President and Chief Executive Officer]

Thank you.

[Operator]

The next question is from the line of Jacob Johnson with Stephens. Please go ahead.

[Jacob Johnson, Stephens Inc.]

Hey, thanks for taking the question. I guess, first, Tony, if I remember correctly, I think spectrum’s customer base included a pretty significant amount of vaccine work as we look into the second half, is this kind of where you’re seeing the most activity in terms of filtration sales into the vaccine workflow?

[Tony Hunt, President and Chief Executive Officer]

Yeah, I know, it’s across the board, Jacob, all our filtration products are being used in vaccine and in the mAb processes. So it’s not just our hollow fiber portfolio, it’s our flat sheet, it’s our ATF products, all – and it’s our systems. So all of our products are being used, which is really encouraging.

[Jacob Johnson, Stephens Inc.]

Got it. And then from everybody who’s reported so far this quarter, it seems like the bioprocessing market is really strong right now. It seems like a lot of that in the near-term is COVID-19 related activity. But can you expand on the growth you’re seeing in monoclonal antibodies? And then you already kind of touched on cell and gene therapy.

[Tony Hunt, President and Chief Executive Officer]

Yeah. The mAb markets are still doing well. So when you think about the portfolio of products that we have, whether it’s our pre-packed columns, it’s our ATF systems which go into perfusion processes. A lot of – remember, we – on our last call, we talked a little bit about there was some push out of projects that went from Q2 into Q3. So that actually happened. And so we’re seeing all of those projects that were delayed by a few months because of companies closing or are going to a very small workforce. That’s coming back, and so we see a very strong second half of the year for our ATF product line.

So I think that the mAb market is healthy. I think a hard piece to gauge is within the big biotech CDMOs, how much capacity is being diverted over to COVID-related activities. And how does that impact say the mAb recombinant protein programs that would have been run. So I think between the combination of COVID, the strength in gene therapy and solid performance on the mAb side. It’s played out quite well for Repligen.

[Jacob Johnson, Stephens Inc.]

I’ll leave it there. Thanks for taking the questions.

[Tony Hunt, President and Chief Executive Officer]

No problem.

[Operator]

The next question is from the line of John Kreger with William Blair. Please go ahead.

[John Kreger, William Blair & Company]

Hi, thanks very much. Tony, could you remind us in a normal year, what percentage of your order flow would be vaccine related and what you think that percentage will likely end up to be this year?

[Tony Hunt, President and Chief Executive Officer]

Yeah. So I’m not going to be able to answer the second part of the question, because I just don’t know the number. But typically, it would be like 5% to 10%, it would be the normal percent. And I think the best way would be, I think around 5% of our total revenue in 2020 will be COVID, so that would be therapeutics, diagnostics, vaccines. So we’re probably adding about, I can’t say, it’s all vaccines, because it’s not. But if you think about the impact of COVID, we’re probably adding another 5 points of growth on to – 5% of our revenue is going to come from those programs. Hopefully, that gives you a bridge.

[John Kreger, William Blair & Company]

It does. Thank you. Sounds like China and Asia did very well. Would you say that’s kind of back to normal or is it still in recovery mode at this point?

[Tony Hunt, President and Chief Executive Officer]

I definitely think it’s back to – well, there’s no one that’s really back to normal. But it’s back to normal as best you can expect. And there’s a lot of activity going on in China, in Korea, in Japan, in India. India is being a little slow, right? I mean, we saw that at the end of Q1, as India went into a shutdown.

So I would say probably India is not quite moving back to the levels of where the other 3 areas – 3 countries are. But Asia’s been a real bright spot for us.

[John Kreger, William Blair & Company]

Great, thank you. And then, lastly, can you tell us – I’m curious if your commercial strategy has changed at all, given the pandemic? I would think with the new product Flow and your efforts to sort of open up new relationships, are you able to still do that or some of that gotten pushed into 2021 or beyond?

[Tony Hunt, President and Chief Executive Officer]

Yeah, I think that’s probably one of the areas that’s been the most challenging. So we have a really great field applications team. We are definitely doing more onsite trials in June and July than we were doing in March, April, May. There’s no doubt that that’s gone up. But I think it’s mainly trials that companies view as critical, right, that they want to really get an evaluation done of a technology, because of specific programs.

I think the ability to get new products tested is much harder. And so, while we will do – we’re probably going to be doing more quality than quantity in the second half of the year, in terms of our new products and getting evaluations going. I think that’s definitely a challenge, John. And it’s – if it’s a nice to have, it’s really unlikely that a customer is going to say come on in and let’s do a study together.

So I think it’s more of the critical studies that we’re in and doing. And the team is very busy. But the volume of trials that we’re running is not like what we would have done a year ago.

[John Kreger, William Blair & Company]

Interesting. Okay, thank you.

[Operator]

The next question is from the line of Matt Hewitt with Craig-Hallum Capital Group. Please go ahead.

[Matthew Hewitt, Craig-Hallum Capital Group LLC]

Good morning. Congratulations on the strong quarter.

[Tony Hunt, President and Chief Executive Officer]

Thanks, Matt.

[Matthew Hewitt, Craig-Hallum Capital Group LLC]

One housecleaning item first, the EMT contribution, will that be a new bucket or will that fold into one of the existing buckets?

[Tony Hunt, President and Chief Executive Officer]

No, I think we’ll end up putting it probably into the filtration bucket.

[Jon Snodgres, Chief Financial Officer]

Yeah.

[Matthew Hewitt, Craig-Hallum Capital Group LLC]

Okay, great. And then FlowVPE, it’s great to hear that’s still on track. Are you starting to take preliminary orders for that? Or are you going to wait until the formal launch to really start to ramp the efforts there?

[Tony Hunt, President and Chief Executive Officer]

Yeah, good question. So I think sometimes when we talk about the next generation FlowVPE, people forget about the fact that we have an existing product in the marketplace that works really well. So customers are continuing to order the existing product. And then, when we get to a crossover point towards the end of the year, we’ll be able to make the move to the next generation version of the product, which is a smaller footprint, improve software capability, more intuitive in terms of how you use it.

But the activity around FlowVPE with existing product has been really encouraging through the first half of this year.

[Matthew Hewitt, Craig-Hallum Capital Group LLC]

That’s great. Thanks. And then, one final, the last time you guys hit 30% EBITDA margins, you made some investments. It sounds like you’re doing the same thing here. How should we think about that? Is it going to be a couple of quarters and then it pops back up and will we get back to that, maybe the 30% EBITDA margin a quarter faster this time? Or just help us think about the timing there. Thank you.

[Tony Hunt, President and Chief Executive Officer]

I’ll start and I’ll hand it over to Jon. I think from our point of view, it’s really more around – you kind of have to look at what’s going on in the market and where we need to make investments. And so, we’re always going to drive, making the appropriate investments to keep our lead times where they need to be, to add more people so that we have the right balance of individuals in operations internally/externally in the commercial organization.

So I think that’s really a function of how we see the markets. And right now, obviously, we see strong market demand. We have to invest. It’s hard to say when it will bounce back to 30%. I’m not sure Jon has some additional comments he wants to add.

[Jon Snodgres, Chief Financial Officer]

Yeah, I can add a little bit of color. I mean, it sounds like you’re looking for a little bit more specifics on 2021. If you look at our ending point for the year, I think those are pretty good starting points for looking at where we might finish up next year overall. And so, it’s a phasing of investments.

We always want to stay one step ahead of, obviously, market demand, as Tony mentioned. And that kind of gives you a sense of where we think we’ll be for 2021. We’re heading into our budget cycle right now. And I think in future calls, we’ll be able to give you more clarity on that Matt. But for now, that’s kind of the starting point. That’s very helpful. Thank you.

[Operator]

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Mr. Tony Hunt for any closing remarks. Thank you.

[Tony Hunt, President and Chief Executive Officer]

So just quickly, just want to thank everybody for joining us. Obviously, a great Q2 for us, great first half of the year. Lots for us to do in the second half of the year around execution. And I look forward to catching up with everybody over the coming weeks and back on, on this call in November. And so, thanks everybody.

[Operator]

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.