Thank you, Chris, and welcome, everyone, to our third quarter report. On this call, we will cover business highlights and financial performance for the three and nine-month periods ended September 30, 2022. We’ll also provide updates to our financial guidance for the full year. Repligen President and CEO, Tony Hunt; and our CFO, Jon Snodgres, will deliver our report, and then we’ll open up the call for Q&A. 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 of Form 8-K, which we’re filing today, and other filings that we make with the Securities and Exchange Commission. Today’s comments reflect management’s 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 are 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 measures but are intended to better enable investors to benchmark Repligen’s current results against historical performance and the performance of peers while evaluating investment opportunities. Go ahead, Tony.

Okay. Thank you, Sondra, and good morning, everyone, and welcome to our Q3 earnings call. As you saw in our press release this morning, we delivered on another very productive first nine months of the company. In addition, we entered into two strategic collaborations that advance for analytics and proteins franchises which I’ll speak to later. Quarterly revenue came in at $201 million despite an 11x – $11 million of FX headwinds and slowing COVID-related revenue. Revenues for the first nine months came in at $615 million, up 28% organically, which takes into an account a 9% decline in COVID revenue during this period and 5 points of FX headwinds. Our base business continues to perform well, finishing up 29% for the quarter and 35% through the first nine months of the year. Our filtration and chromatography businesses were again the major drivers of growth in the quarter. The growth in these two franchises more than offset the decline in COVID revenues, which were down by $19 million or 40% year-on-year. We continue to see strength in gene therapy accounts where revenue growth exceeded 50% through the first nine months of the year. More importantly, we now have over 20 accounts with revenues in excess of $1 million per year, up more than 70% from a year ago. We remain on track to finish the year above our 40% growth target or over $105 million in gene therapy revenue. As mentioned earlier, we again saw predicted drop off in COVID revenues in the quarter, and we now expect coverage revenues to come in at $135 million to $140 million for the year, an adjustment of $7.5 million from the midpoint of our previous guidance and down 28% versus our 2021 finish. Looking ahead, we expect COVID revenues for 2023 to…

Thank you, Tony, and good day, everyone. Today, we are reporting our financial results for the third quarter as well as updating our financial guidance for the year. Unless otherwise mentioned, all financial measures discussed reflect adjusted non-GAAP measures. All growth figures provided for the third quarter and nine-month year-to-date periods are year-over-year comparisons to the same period in 2021. As shared in our earnings press release this morning, we reported strong revenue of $200.7 million in the third quarter at $615 million for the first nine months of 2022. This includes significant FX headwinds, which reduced our reported revenue by approximately $11 million in the quarter and $24 million year-to-date. Our base business continues its positive trajectory, growing at 29% for the quarter and at 35% on a year-to-date basis. Our base business represented 83% of total revenue during the third quarter, while COVID-related revenue and inorganic M&A represented 14% and 3%, respectively. At the market level, in cell and gene therapy, we are reflecting year-to-date growth of greater than 50%, excluding COVID-related revenue at gene therapy accounts. We continue to see customers with our appetite AAV resins and remain confident in our potential to gain market share in this area. Overall, our cell and gene therapy accounts comprised 14% of year-to-date reported revenue. We continue to be excited about our opportunities in cell and gene therapy and the recent successes in these modalities with three U.S. FDA approvals this year. At the same time, we continue to see steady growth across the maps market with six U.S. approvals so far this year, including one biosimilar. From a capacity perspective, we met the goal shared on our second quarter call, going fully online here in the third quarter with our Marlboro, Massachusetts, and Rancho, California filtration facilities expansions. As…

We will now begin the question-and-answer session. [Operator Instructions] Today’s first question comes from Puneet Souda with SVB Securities. Please go ahead.

Hi, guys. Thanks for taking the question. So first one, obviously, a topical one for the bioprocessing industry, if I may, the destocking question. So obviously, a number of your larger peers are seeing destocking from COVID accounts. Could you maybe just elaborate on what you’re seeing and Tony – and to what extent of destocking is this? When do you think we can see a trough in the inventory here and recovery again? And how does this differ from sort of the 2017, 2018 time frame? And could you elaborate what you’re seeing on your end? Thank you.

Thanks, Puneet. Yes, look, the – obviously, our pros will come out and chat a little bit about the destocking. I would say, our view of the world is not very different. But I would say that we see the industry is going through a transition as the industry moves away from COVID. We’re clearly seeing a change in order patterns, and I’ll speak a little bit to kind of what we’re seeing, we definitely see pockets of inventory related to COVID. We’re seeing these at the COVID vaccine accounts, and we’re also seeing that CDMOs and probably a little bit in the integrator side, which are companies like bioprocessing companies that are buying components that go into the manufacturing of products. And that’s all in an environment, where our customers are highly active. And I would say, as we’ve gone through the summer, our funnel, and I’ll speak to it in a second, has strengthened. So maybe I’ll take each one of those, Puneet, and kind of walk you through it, and then I’ll speak to Part B and C of your question. So on the order pattern, right, so if we went back a year ago, our customers were, in general, ordering products and getting it delivered within six months, but 80% of the product would be delivered within six and 100% in 10 to 12 months. As we’ve sort of gone through the middle of this year, and into the kind of the fall, 80% of our customers are now ordering and getting product delivered within three to four months and 90% within six months. So there’s definitely a real shift happening in terms of order pattern and people just ordering out three months, four months in advance. On the inventory side, I think where we see…

Got it. That’s super helpful, Tony. I really appreciate that. And just a quick one maybe on the guidance. And I know I appreciate the guidance for this year. But just looking into sort of 2023, you were lowering your COVID revenues for 2023. But thinking about the base business, you said 33% to 34% this year. How should we sort of think about the base business strength going into the next year? And is that a – you’ve historically talked about a 20% number for the core. Is that something we should have in mind or something higher, could you maybe just walk us through that as much as you could? I appreciate it. Thank you.

Yes. So COVID’s come down and that’s based on the forecast we’re getting now from our vaccine customers. So that’s just directly related to the information that we’ve been able to obtain over the last three months, that’s pretty clear. And I don’t think it’s too different than where most of the analysts are right now in terms of looking at what the range for next year could look like. It’s early guys to talk a little bit about growth in base business growth in 2023. But I’ll throw a few numbers out there. So when you look at Repligen situation, we’re going to be dealing with a $100 million headwind in COVID. As Jon pointed out, we’ve got probably a $25 million to $30 million FX headwind. So they are the headwinds. I think what’s positive is I think we’ve got a great product portfolio. I think we’re really well positioned I think we’re highly differentiated. And we’ve got a funnel that’s strengthening as we finish off the year. So that’s really positive. If you look at the last five years, Repligen’s delivered 26% base business kind of organic growth over the last five years 26%, 27%, on average. And when I – and when we did our Analyst Day in September, we said, hey, look, we think we’re going to grow in that 15% to 20%, 16% to 20% range. I think next year is going to be more modest growth than what you’ve seen over the last five years and probably more in line with the range that we pointed out in September.

Got it. Okay. Super, helpful, Tony. Thank you.

The next question comes from Dan Arias with Stifel.

Thanks for the questions. Tony, one of the questions that we’ve gotten a bunch in the last couple of weeks is just where and what portion of your portfolio might be fungible when it comes to non-COVID and COVID work? Is there anything that you can share with us there that sort of helps us conceptualize what the transition might look like when we think about the product offerings over the next couple of quarters?

Yes. I don’t think, Dan, it’s any of the product lines per se. I just think it’s the – what I said earlier, I think it’s just the pockets of inventory build. So if you think about customers that we’ve had that have been on the vaccine side they actually have excess inventory. We know that some of the CDMOs are working through that same challenge. So it’s not like 2017 where it was broad. It’s more pockets. What I’m most encouraged by is the fact that our funnel of opportunities is strengthening. So there’s a lot of execution that has to happen. And I do think that our customers, while they were placing orders very quickly, in 2020, 2021 and really through the first half of 2022. I think it’s – they’re looking at their dollars and their spend and spending it on the most important projects that are going on at that particular facility, that particular site. So I think it’s really that we have to work through. And I think the next four months between now and when we sit down and talk to you guys about 2023 guidance at the end of February. I think the next four months in terms of order strength would really determine a lot around what the growth rate is going to be like in 2023.

Yes. Okay. And then maybe on the chromatography side, how do you think the resin availability situation looks as entered 2023, just given where things are trending. I don’t know if you’ve given a number for this year, but I do remember you saying that 21 reps would have been two times what they were if availability wasn’t an issue. So can you just sort of catch us up on the you start the year off. And…

Dan, I’m really glad that you remember all my comments. But – so no doubt that the resin availability has improved over the last quarter. And we know from talking to our peers that capacity is coming online. And that whole capacity piece is what’s also driving the changing order patterns that I spoke about a few minutes ago. So I think on the resin supply side, it’s easing. It’s not 100% perfect yet. I would say, it continues to improve. And I would say second half of next year, based on everything we know, I think capacity will be kind of fully online and you’re looking at a kind of pre-highway of no restrictions in terms of ability to supply. And of course, that’s all outside our control. But what’s encouraging is that we finally can say that OPUS business, et cetera, growing at around 20% is up growing north of 35%. So that’s really the positive take home here.

Okay, very helpful. Thank you.

The next question comes from Julia Qin with JPMorgan.

Hi, good morning. Thanks for taking a question and congrats on a quarter. So just a follow-up on the destocking point. I was wondering if there’s any way for us to quantify the magnitude of headwind that you’ve already seen so far? And I know you previously mentioned there’s probably one or two more quarters for many to go through before ordering patterns normalize. Is there a way to think about what the magnitude of the headwind is remaining compared to what we’ve already seen so far?

I don’t think there is, Julia. It’s just that clearly summer was lighter. I think if you look at our book-to-bill through nine months on our base business, it’s 1.0, right? And I think if you go back over the last prior to COVID, I think book-to-bill tends to be at 1.0 – 1 point – between 1.0 and 1.1 kind of worked in that range. So, we’re not too far off where we were in the past. What we have to see is coming out of the summer is strengthening in the – on the order side and execution on closing the opportunities that are out there. So, I think when we get to the end of February, we’re going to be in a better position to speak to where 2023 is, and how long the headwinds are. I mean that is – I know everybody is jumping on destocking, but it’s – the destocking in pockets. What we’re seeing is just a total change in order pattern? I mean, I gave out some pretty important numbers there. I mean, we’ve gone from six months to 12 months, people taking their material to now three months to four months were 80%. So that’s got to work its way through the system as well. And it just depends on how long that takes, that’s going to determine a little bit around growth next year. So, I pay attention to the fact that we’ve got a $100 million drop-off in COVID, we’ve got a deal with. We got to deal with FX. Everybody in the industry is dealing with FX. And then we’ve got to take the portfolio that we have that we think is highly differentiated and drive growth in that portfolio so you can make up for the headwinds that we’re dealing with. That’s the way I would view it.

Got it. Appreciate all the additional color. And then regarding the book-to-bill, I appreciate you gave the year-to-date metric. Is there any way you could share us with us how the book-to-bill trend is specifically in 3Q for both the base business and overall?

Yes. Well, the overall is probably one of those comparisons where we had the highest orders for COVID in 2021. So, I think on book-to-bill for...

Q3 2021 specifically.

Yes, that’s right. Q3 2021. And then I think on the base business, the book-to-bill in the quarter was about 0.9.

Thank you.

Our next question comes from Jacob Johnson with Stephens.

Hey good morning, Tony, I’ll apologize in advance as I’ll jump on destocking question as well. But just you and your peers are talking about a lot of the stocking that you’re seeing is largely COVID customers, and you’re guiding to a COVID number in 2023, to Julia’s question around quantifying this, is it fair to say there’s a component of this destocking that is contemplated in your COVID expectations for next year and we’ll see kind of what happens with lead times on the base business?

Yes, I think maybe I would look at it a little differently, Jacob, I would say the forecast we put out there for 2023 on COVID is essentially the based on forecasts we’re getting from the companies that we’re working with. I think what sometimes people forget about is companies that have been working on COVID have products from bioprocessing suppliers, but they can use it elsewhere in their manufacturing. It’s not like they are so dedicated that can only be used in COVID. So that’s kind of what the way I think about it is that they can use it, but they’ll use it probably in other processes.

Okay. Got it. And then just, Tony, on your comment about next year, your growth has been north of 20% the last five years on a base business perspective, you’ve got the 16% to 20% range. You said next year is going to be more modest. Just so we’re clear, next year being more in line with that 16% to 20% range. Is that an overall organic growth comment? Or is that kind of that specific to the base business?

That’s specific to the base business.

Okay. Thank you , Tony.

The next question comes from Paul Knight with KeyBanc.

Hey Tony, there’s a lot of biotech skepticism about and cell and gene therapy market. Your comments are pretty upbeat obviously. Could you talk about the product lines related to cell and gene therapy and are we in eating one or two or where are we in this development?

Yes. Thanks, Paul. The cell and gene therapy market, I mean, it’s been a great market for us over the last few years, we’re up north of 50% again this year. I think the key, and I’ve said this a few times over the last year or so, which is the key is really the approval rate, right? And it’s encouraging that there are more approvals this year than last year. But I think as that approval rate increases, that’s a positive for everybody in bioprocess. And I think when you look at our journey, right? The fact is that we have now 20 gene therapy accounts that are generating over $1 million per year in revenue for us, up 70% versus a year ago. That should give people some encouragement that we’re in processes where people are scaling, but what we can’t control is whether those processes, a continued scale and they move through the clinical trial approval process. That’s really the key. So, I think as more approvals happen, I think it gives people confidence. And I think overall, long-term gene therapy, cell and gene therapy is absolutely here to stay. It’s a cornerstone. It’s going to be a cornerstone of our industry for the next 10-plus years.

And the key products that you’re providing for that market or what, Tony?

I would say that it’s mainly our filtration portfolio. Clearly, the gene therapy industry, they like pre-packed columns. But it’s not like we have 20 products in our chromatography portfolio. We’ve just really got a couple. And so it’s our systems. We just launched and we announced that BPI Boston, a dedicated system for gene therapy and mRNA. I think that’s a positive for us. We have lots of consumables. And I think over the next few years, we expect to see more traction with our appetite portfolio as we drive affinity resins into that part of the market. So the future will be a broader portfolio than the current state is really a combination of filtration with feedback comps.

Okay, thanks. Tony.

Thanks, Paul.

The next question is from Madeline Mollman with William Blair.

Hi, thanks so much for taking my question. This is Madeline Mollman on for Matt Larew from William Blair. I was just wondering – I know in your Investor Day, you talked a lot about your systems and your integrated systems. And I was wondering long term, how many of your customers do you see converting over to platformed accounts? And do you see those as converting existing customers over to platformed accounts? Or is that mainly going to be new client adds that will be joining as accounts that are interested in the systems?

Yes. So, I would say it’s a bit of both, Madeline. I think that our systems portfolio is clearly new when you look at the last, say, three years, four years, five years, we really put a big investment into it, probably starting in 2018, 2019, the addition of ARTeSYN into our portfolio, at the end of 2020 was a key kind of jigsaw piece for us, complementing what we’re doing with the spectrum systems that we got in 2017. So, we’ve been putting a fair amount of money in R&D to build out that portfolio. We’ve always had the consumables going into account. So, when I think about accounts adopting systems there’s definitely an opportunity to sell into existing accounts that have been buying or filtration of chromatography products to now buy systems and eventually by flow backs, right, that we’re producing through our food management business, but it’s definitely new accounts as well. So when you think about it, a market like mRNA, right, there’s an opportunity there to get in with a whole solution that would be systems, consumables, fluid management components and flow backs all in one.

Great. Thank you so much.

The next question comes from Liza Garcia with UBS.

Good morning guys. Thanks so much for taking the question. I just wanted to maybe touch on the pricing environment. I wanted to kind of understand kind of what you’re seeing in terms of pricing and how you’re feeling about kind of your ability kind of to take price, given the inflationary environment at the moment and how you’re feeling about that outlook. There’s been questions around kind of pricing given just the destocking environment.

Yes. Maybe I’ll start and I’ll hand it to Jon. I think in general, what we’ve been trying to do on pricing is address any inflation that’s happening in our industry and really work with our customers to kind of match up what we’re seeing on inflation. I think that’s our long-term strategy, medium, long-term strategy, but I hope Jon can add some more detail.

Yes, sure, happy to do that. If you remember last – for the 2022 period, we did implement a 7% price increase on list prices December 1, 2021 to carry us into this year. And we came back in July and implemented another 4% increase. And again, we’ve really focused on areas where we are seeing cost inflation coming in from our suppliers as well. Historically, we’ve been able to see about 1.5% to 2% price increase. This year, we’re expecting to top 5% and maybe be slightly higher than 5% overall net achievable price. So that’s kind of where we’re at. That’s really a good offset to the cost inflation side of the business.

Great. Super helpful. And then Asia seems to really be a source of strength for you guys. I’d love to kind of just dive a little bit deeper into kind of what you’re seeing in terms of trends in the region there and kind of how you think about the sustainability of kind of the growth levels that you’re seeing there and how to think about that?

Yes, it’s been a stellar year for us in Asia. I mean there’s a lot of kind of bumps that are going on, especially when you look at China in terms of being shut down for a big part of Q2. I think the team over there has done a remarkable job as we kind of manage through that. I think we’re – again, it kind of goes back Liza, to the portfolio we have. I think we’ve got a great portfolio of products. I think we’re well positioned. I think we’ve got a really good commercial organization. And as we – given the differentiation we have, that’s really going to be really important for us over the next 12-months as we all manage through the current market piece.

Great. Thanks so much guys.

The next question comes from Matt Hewitt with Craig-Hallum Capital Group.

Good morning. Thanks for taking the question. Maybe I’ll ask one about the Purolite agreement. 10 years seems a little bit longer than typically used to seeing. So what prompted maybe the longer terms and more – I guess, more importantly, is this expansion into the mAb fragments and maybe what’s driving that expansion? Thank you.

Yes. Thanks, Matt. When you think about the strategy with Purolite, it really goes all the way back to 2018. As I think the most common question in 2018 was what’s happening with GE and with your Protein A business with GE. So we put the strategy in place back then to develop best-in-class ligands worked with Navigo and then partnered up with Purolite. That – those collaborations, partnerships have gone really well. And we have an agreement with Purolite like that goes out to 2026. Purolite becomes part of Ecolab and chanting with the folks at Ecolab, we really felt like the partnership is going really well, growing very rapidly. Both companies felt like extending it from 2026 out to 2032 was a smart move for both companies. We’re an exclusive supplier of Protein A ligands into Purolite, Ecolab. And we’re also the exclusive manufacturers, right? So it’s a really good partnership. We felt from a channel point of view, that as we’ve done a lot of work with Avitide that it made more sense to put the mAb fragment part of our portfolio through the Ecolab, Purolite channel, and we would focus on the new mortality side of the equation. So we’re focusing on gene therapy, mRNA. We’re working with the – using the Purolite-based speed in our manufacturing. So it’s kind of a real win-win. We’re providing fast access to new ligands that drive Purolite success in mAb and mAb fragments, we work with Purolite with their base speed. We just not as part of our strategy going forward in the non-mAb and mAb fragments. And so having tying our hands and I think it’s something we both feel is the right decision for us out to 2032 is, I think, a strong endorsement of how well the partnership has gone.

Got it. Al1right. Thank you.

Our next question comes from Brandon Couillard with Jefferies.

Hey, thanks. Good morning. Jon, will you just remind us how COVID and FX kind of flow through the P&L? And given those two headwinds next year, is it reasonable to expect margins may be flat to down in 2023?

Yes. We’ve talked about this a little bit Brandon, in the past. And so we’re seeing some margin declines as we go through this year. As projected, right? And one of the things that we expected was cost inflation coming into the year. The other piece was capacity expansion costs and added headcount and whatnot to support that. So those things we’re definitely seeing. I think one of the things that’s kind of come into the year that we didn’t plan on was additional FX headwinds that are also putting pressure on the margins. So – and we’re going to end up seeing what kind of comes out here in Q4. Obviously, you can see our Q3 numbers now. And that’s really going to serve as kind of the starting point for next year. So yes, we do expect a little bit of compression as we absorb all the capacity that we’ve added and we’ll continue to obviously work towards the long-term to bring that back up and we’re still planning on to that goal of trying to get margins long-term above 60%. And so we’ve had good success over the last few years of expanding margins. This just happens to be that kind of reinvestment period, we’re going to absorb some additional costs, and then we’ll continue to grow out of that with volume and expand margins longer term.

Thanks.

The next question comes from Raghuram Selvaraju with H.C. Wainwright.

Thanks very much for taking my questions. Just very quickly, could you comment on what you expect the dynamics to look like going forward in terms of your relationships with both Purolite and Cytiva in the affinity ligand space? And also as a corollary to that, I think you mentioned earlier about how you were thinking about the mAb fragment segment. But if you could maybe just give us a flavor for what you expect to drive growth in that specific area within the context of the extended agreement with Purolite, that would be very helpful. Thank you.

Yes. So I would say – and thanks, Ram. I would say that obviously, relationship with Purolite and Ecolab is very good. I think the relationship with Cytiva is absolutely fine. We’ve got a long-term agreement. We’ve been working with Cytiva, the GE for 30 years. We kind of know where the projected volumes are going. It’s been very consistent with what they forecasted at the beginning of the year and expect that it will begin to drop off in 2023. And reach some steady state that where we’ll be supplying a certain percent of their business, but it will be a small percent. I don’t expect it to be anything significant. I think the bet on Purolite and Avitide right, is that we have a partner in Purolite who was focusing on the mAb fragment that’s why we added the mAb fragment piece because they have the channel, and it didn’t make sense for us to jump in and start competing with them and from a channel point of view. So it made more sense when we looked at the portfolio that we would focus our sales team on the new modality side and gene therapy and then provide the new, highly differentiated ligands and that’s the key, Ram. As we’re not providing me-too type ligands into Purolite. We believe that we have pivoted from being an OEM ligand supplier for 30 years to now being the premier developer of high affinity of affinity ligands with – that are highly differentiated versus the competition. That’s what our whole goal has been for the last four or five years. I think we’ve made massive progress in accomplishing that and fully expect that. If I look, out over the next four or five years we bring proteins back into a growth mode for Repligen and somewhere in the high single-digit type growth.

Thank you.

At this time, there are no further questioners in the queue. And this concludes our question-and-answer session. I would now like to turn the conference back over to Tony Hunt for any closing remarks.

I just want to thank everybody for joining us today. Obviously, it’s been a very busy year and delighted with the performance of the company. We look forward to catching up with everybody in February and talking about how we’re going to finish the year and what our outlook is for 2023. So thanks again for everybody for joining us today.

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