Repligen Corporation

Good day, ladies and gentlemen, and welcome to Replugin Corporation's first quarter of 2022 earnings conference call. My name is Vaishnavi and I will be your operator. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star, then zero. Please note that there will be a question and answer session following the company's formal remarks. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. In order to accommodate all individuals who wish to ask questions, there will be a limit of two questions at a time. Please note that this event is recorded. I would now like to turn the call over to your host for today's call, Sondra Newman, Head of Investor Relations for Repligen. Please go ahead.

Thank you, Vaishnavi, and welcome everyone to our Q1 call. This morning, we'll be covering business highlights and financial performance, for the three-month period ended March 31st, 2022. We'll also provide updated financial guidance for the current year, and we have with us Repligen's president and CEO Tony Hunt and our CFO John Snodgrass, who will deliver our report and then address questions. As a reminder, the forward-looking statements that we make during this call, including those regarding our business goals and expectations for 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 and our 8-K for the first quarter, which we filed today, as well as other filings that we make with the SEC. 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. We expect to be filing the 10-Q for the quarter later on today. 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, contingent consideration, 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 when evaluating investment opportunities. Now I'll turn the call over to Tony Hunt.

Hey, thank you, Sandra, and good morning, everyone, and welcome to our Q1 earnings call. As you saw in our press release this morning, we delivered an outstanding first quarter for the company, with revenues topping $200 million for the first time, along with excellent gross margins and operating margins. The story in the quarter was the continued strength in our base business, which was up 37% year over year, and up 20% sequentially versus the fourth quarter of 2021. We saw robust growth in our core monoclonal antibody markets and increasing contribution from gene therapy accounts. Gene therapy growth was up over 100%, and each of our franchises delivered over 30% year-over-year revenue growth, except for proteins, which came in flat as expected. As demand continues to increase for our products, we have stayed focused on building out our manufacturing capacity with the best in industry lead time. Our capacity expansion programs have enabled us to decrease lead times for the vast majority of our products to under 10 weeks. This has allowed us to take share in the bioprocessing market, especially infiltration, and we expect lead times to continue to be a competitive advantage for us. Finally, we're off to a good start to the year with new product introductions, a highlight being the three AEB resins launched through Abbottide to serve gene therapy customers, which I'll discuss later. On a related note, we're also pleased with the early performance of our new products launched through our R&D team, as well as the contributions of M&A completed in 2021. New product and inorganic M&A contribution combined accounted for 6% of our revenue in the quarter. From an orders perspective, we finished the quarter with a book-to-bill ratio of 1, which is encouraging given the COVID orders contributed only 15% of our overall order book. This highlights the real strength of our base business. where first quarter orders increased 20% year over year and over 17% sequentially versus the fourth quarter of last year. COVID revenues for the quarter were slightly north of 50 million, representing 26% of our first quarter total revenue. We are now seeing signs that COVID demand has been impacted by the slowdown in vaccination rate. Many of our COVID vaccine customers have either reduced their demand for the remainder of this year or shifted their demand into 2023. Within the quarter, we saw approximately 15% of our $180 million COVID order book at the beginning of 2022 push out into 2023. The impact of new COVID orders in the quarter essentially offset the impact of cancelled orders. We also saw that a majority of cancelled orders came from vaccines that are less effective against the various Omicron strains. In addition, the majority of orders that have been pushed out into 2023 came from our largest COVID vaccine manufacturers. We now expect COVID revenues for full year 2022 to decline by about 20% versus last year and come in around 150 million. For the full year, we anticipate that COVID will represent approximately 19% of our overall revenues versus 28% of our total revenue last year. We finished the first quarter with a very strong order book for our base business. and our outlook for 2022 remains very positive. Our updated guidance reflects an even greater confidence in our base business, which we are now projecting to grow at 24 to 31%, significantly up from our initial guidance of 20 to 22% at the beginning of the year. This increase in base business offsets approximately half of our expected COVID decrease, with overall revenues for the company now projected to be $770 to $800 million. a less than 4% adjustment for our initial guidance in February. Before jumping into the quarter, I wanted to spend a few minutes to review our key priority areas for 2022. Back in February, we outlined four areas of focus for the company. Number one was building out additional capacity and decreasing lead times. Two was around supporting and successfully integrating our 2021 acquisitions. Three was around developing and seeding new products, And four was continuing to win and penetrate cell and gene therapy accounts. So let's start with our progress on capacity and lead times. Our focus over the next one to two quarters is to bring our Marlboro, Mass and Rancho California expansions online. This will increase our capacity for hollow fibers, flat sheet cassettes, ATF and cross flow systems. We will also open up our first assembly center in Hopkington, Mass to support our fluid management business. As mentioned previously, the impact of the capacity expansion programs in 2021 and here again in 2022 is on our lead times. We are reducing lead times quite dramatically in the first half of this year to less than 10 weeks. During the second half, we expect our lead times will reduce even further as we bring on additional capacity. On the M&A integration, the focus has been on finalizing the integration of PolyMEM, which is essentially complete and moving forward on the integration of Avatide and BioFlex solutions. We have made real progress with the focus at Avatide on new product development and at BioFlex with increasing overall production output. Expanding on BioFlex, we're seeing demand for our fluid management products gain momentum as we integrate the company and diversify this portfolio to now include BioFlex solutions, EMT, NMS, and Artisan components. With a dedicated commercial team and a newly formed management team under the direction of our COO, Jim Byland, we expect this business to generate revenues close to $50 million here in 2022. These revenues will be accounted for in our filtration and chromatography franchises. As mentioned earlier on the new product front, in February, we announced the launch of our first AAV resins, delivering on our commitment to bring differentiated affinity chromatography products to the market through our acquisition of ABITIDE. We expect 2022 to be a year of evaluations for these residents. We are encouraged by early feedback where customers are seeing the benefits of increased caustic stability and efficiency gains as key differentiators versus other AEB residents in the gene therapy marketplace. With ABITIDE R&D fully focused on developing new ligands this year, we expect to introduce additional products in the second half of the year. This is just one example of many underway in R&D, as we continue to focus on innovation and technology leadership as drivers of our success. The majority of our current R&D efforts are focused on further expanding on our family of high-value configurable systems to support a wide range of our customers' filtration and chromatography needs. Finally, we're making good progress in cell and gene therapy, where we saw a record quarterly revenue that accounted for 14% of our total revenue in the first quarter. This exceptional performance led by our filtration business represented growth of more than 100% year on year. Within gene therapy, approximately half of our revenue came from AAV accounts and the other half from CAR T, mRNA and other modalities. Cell and gene therapy order growth for the quarter was greater than 30% with our team adding in 27 new accounts. We continue to be very encouraged by the traction in gene therapy and we now expect gene therapy to be up greater than 40% here in 2022. So moving now to our quarterly performance, as mentioned earlier, the story of the quarter was the 37% base business growth and the continued strength at MAB and gene therapy accounts. Infiltration, our business was up greater than 50% compared to the first quarter of 2021. The strength infiltration was again broad-based. Our ATF business continues to make inroads in MABs, bisimilars, and gene therapy, where single-use ATF was up approximately 40%. Within the franchise, our cross-flow holofiber systems and consumables business more than doubled, and our Tangenex flat cheek set business had a strong quarter, driven by COVID vaccine commercial demand. The expected reduction in COVID demand, especially in the second half of this year, will mainly impact our filtration franchise, which we now expect will grow in the range of 19% to 24%. Moving to chromatography, our Opus prepack column business had an excellent quarter for orders and revenues. We saw some improvement in Q1 in terms of residence supply and continue to expect our chromatography franchise will grow in the range of 25% to 30%. Our proteins business had a solid quarter, essentially flat year-on-year. A key driver of overall proteins performance is the Cytiva demand for 2022, which through the first quarter is in line with our expectations. We expect, or we believe, we will be able to partially offset this headwind through the continued traction in the marketplace of NGL ligands sold through Purolite and the anticipated market demand for Abitide resins as we move through 2022. We expect proteins to be down in the range of 5% to 10% for the year. Finally, our process analytics business had an excellent quarter, upgraded than 35%, with robust demand for both our solo and flow products. Highlights for the quarter included 100% growth in Europe, with 50% of our systems business coming from new accounts. We continue to anticipate growth of approximately 25% for the year. So overall, we're off to an excellent start here in 2022. While COVID demand will be down versus original guidance, We still expect meaningful COVID-related revenues for the foreseeable future. Balancing all of this is our base business performance, which has been exceptional over the last couple of years, driven by a combination of highly differentiated products, new product introductions, and M&A. Overall, we expect our non-COVID business to grow between 20% and 25% annually on a go-forward basis, and we remain on track to achieving our goal of a billion dollars in revenue in 2024. We look forward to updating you on our progress through the year. And with that, I'll turn the call over to John for the financial update.

Thank you, Tony, and good day, everyone. Today, we are reporting our financial results for the first quarter, as well as updating our financial guidance for the year. Unless otherwise mentioned, all financial measures discussed reflect adjusted non-GAAP measures. As shared in our first quarter earnings press release this morning, we've once again delivered record revenue, totaling $206.4 million in the period, and we've also delivered record earnings performance. Our base business continues to outperform up 37% year over year and up 20% sequentially from the fourth quarter of 2021. We also saw strong revenue performance of over $50 million related to COVID, which accounted for 26% of our reported revenue in the quarter. Operationally during the first quarter, we focused on driving base business order growth and continue to execute on our key business initiatives for the year. We're off to a good start on our 2022 initiatives, including supporting our growing fluid management portfolio with dedicated commercial resources and operational leadership, expanding relationships with our gene therapy and cell therapy customers, and successfully integrating our 2021 acquisitions. As always, innovation drives our company, and our R&D teams continue to work on new product development programs with several important launches planned for the year. With the goal of staying ahead of our growing demand for bioprocessing products, our capacity expansion plans are on track and are positively impacting lead times for our customers. We also continue to support the business with our ongoing IT system implementations and enhancements, where we've completed our Phase 4 SAP Go Live at our Korea and India selling offices and at our Auburn and Hopkinton, Massachusetts manufacturing locations. In addition, we've continued to invest in our information security capabilities and processes to protect the company, our employees, our customers, and our shareholders. With respect to our capacity expansion and information technology investment plans for the year, we spent $28 million in capital expenditures in the first quarter, and we continue to expect to invest up to $70 million here in 2022. As Tony mentioned earlier, we are focused on bringing our Marlboro, Massachusetts and Rancho California expansions online over the next three to six months to further increase our capacity for key filtration products. Our Hopkin facility will also come online in the next few months to support our fluid management business. At the same time, we are driving significant reductions in our product lead times, and we expect to create lead time advantages for ourselves and for our customers as we move forward. Now shifting to our first quarter revenue commentary. On the top line, we've delivered revenue of $206.4 million in the first quarter, representing an increase of approximately 64 million or 45% reported growth. Our organic growth during the quarter was 44% and growth at constant currency was 48% year-over-year. Inorganic acquisition revenue represented 3% of revenue and almost five points of our growth. Foreign exchange triggered a nearly four-point headwind driven by U.S. dollar strength compared to the Euro. Looking closer at our first quarter growth of 45%, our base business contributed 28 points, with an additional five points coming from our 2021 acquisitions and 12 points attributed to COVID. In the area of regional revenue growth for our total business in the first quarter, we continue to see positive results in each of our three global regions. Revenues from Asia rest of world increased 27%, Europe grew at 63%, and our North American region grew 35%. Within our total business regional revenue distribution for the first quarter, Asia represented 17%, Europe increased to 43% driven by COVID commercial vaccines, and North America represented 40% of our global business. Now moving down our income statement. Adjusted gross profit was 124.6 million in the first quarter of 2022, increasing by 39.8 million or 47% compared to the same period in 2021. Adjusted gross margin of 60.4% for the first quarter expanded by just over a hundred basis points from 59.3% in the same period of 2021. Now transitioning down the P&L to adjusted operating expenses. Adjusted research and development expenses for the first quarter were 5.7% of total revenue. Increases in R&D spend were important to the launch of our innovative new gene therapy resins from our avocade business, as well as continuing the development of several innovative new products to be launched later this year. First quarter 2022 adjusted SG&A expenses were approximately 22% of total revenue, about 20 points less than the same period in 2021. Year-over-year dollar increases in spend are linked to the timing of our 2021 acquisitions and continuing investments in personnel, facility, and systems expansions, all in support of our long-term growth expectations. Now moving to adjusted earnings and EPS. Adjusted operating income for the first quarter of 2022 was $67.4 million, an increase of $21.7 million, or 47%, compared to the 2021 first quarter. First quarter adjusted operating margin was 32.6%, reflecting an improvement of 70 basis points compared to 32% in the prior year first quarter. Adjusted gross and operating profit and margins during the first quarter were strong as a result of several factors. First, revenue volumes were up and growth outpaced the addition of expenses tied to our capacity expansion and hiring activities. Second, we benefited from inventory purchased at last year's prices ahead of the inflationary impacts we are seeing here in 2022. And third, we realized benefits from favorable product mix in the quarter. Moving to adjusted net income. In the first quarter of 2022, our adjusted net income was 53.7 million. an increase of $15 million, or 39%, compared to the first quarter of 2021. Adjusted EPS increased to $0.92 per fully diluted share in the first quarter of 2022, an improvement of $0.23, or 34%, compared to $0.68 in the 2021 quarter. And finally, our cash and cash equivalents, which are GAAP metrics, totaled $584.6 million at March 31, 2022. reflecting the impacts of annual bonus payments and tax payments related to significant vesting of employee equity grants in the quarter. We'll now transition to our 2022 full year guidance. Our GAAP to non-GAAP reconciliations for our 2022 financial guidance are included in the reconciliation tables in today's earnings press release. Previously mentioned, unless otherwise noted, all 2022 guidance discussed will be non-GAAP. Please also keep in mind that our 2022 guidance may be impacted by fluctuations in foreign exchange rates beyond our current projection of a 2% headwind on full-year sales and does not include the potential impact of any future acquisitions that the company may pursue. Based on the strength we are seeing in our base business, which we project to offset about half of the expected reductions in our COVID revenues. We are updating our 2022 full-year revenue guidance, a gap metric to $770 to $800 million, representing reported growth in the range of 15 to 19 percent, organic growth of 14 to 18 percent, and constant currency growth of 17 to 21 percent. This revenue guidance includes base business revenue of $598 to $628 million, growing at 24 to 31 percent, COVID revenue of $150 million, and inorganic acquisition revenue of $22 million from our 2021 acquisitions. We are maintaining our 2022 adjusted gross margin guidance at 57 to 58 percent. We are fine tuning our adjusted operating income guidance to the range of 225 to 231 million and maintaining our adjusted operating margins in the range of 28.5 to 29.5% of revenue for the year. Adjusted other income and expense is expected at one million of expense for the year from our previous guidance of zero due to transactional foreign exchange impacts realized in the first quarter. We continue to expect 2022 adjusted income tax expense to be approximately 21% of adjusted pretax income for the year. Our adjusted net income guidance is now expected to be in the range of $177 to $182 million from our previous guidance of $185 to $190 million. and we are guiding to adjusted EPS of $3.07 to $3.15 per fully diluted share. Our adjusted EPS guidance reflects an estimated 57.7 million weighted average fully diluted shares outstanding at year end 2022. Adjusted EBITDA is now expected to be in the range of 252 to 258 million, compared to our February guidance of 265 to 271 million. Appreciation and intangible amortization expenses expected to be approximately 26.8 million and 26.5 million, respectively. The company expects to spend approximately 70 million in capital expenditures in 2022. We now continue to expect year-end cash and cash equivalents, a gap metric, to be in the range of $660 to $680 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.

Thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. Again, we please ask that you limit yourself to one question and a single follow-up. At this time, we will pause momentarily to assemble a roster. Our first question comes from Jacob Johnson with Stevens. Please go ahead.

Hey, good morning, everybody, and congrats on this quarter. I know a lot of things are based on business, but maybe just to get it out of the way because I'm getting questions on it. Just on the COVID contribution, $150 million for the year, $50 million plus in one queue. Can you just talk about the cadence for these revenues throughout the year and then Any thoughts on kind of how we should be thinking about the 2023 COVID opportunity, Tony, especially given your comments around some orders that were pushed out until then?

Yeah, thanks, Jacob. I think maybe the way to handle this is to just kind of walk through the bridge and then talk about what we think will happen for the rest of the year. It's going to be hard to, it's too early to kind of project 2023 at this stage because we really don't have information on 2023. But in terms of how the quarter played out, we had about $30 million of orders that were canceled, majority from customers who were working on vaccines that have been a little less effective against Omicron. We had $30 million of new orders come in. So they kind of netted each other out. And then we had $30 million of the push out from 2022 into 2023 from the largest COVID vaccine manufacturers. When we look at the year, our best estimate right now is probably in that 65% range in the first half of the year, 35 in the second half. And, you know, for next year, it's just too soon. But I would think that the second half of the year is going to be more of a proxy on where 2023 is going to be as opposed to the first half of 2022. Got it.

Thanks for that, Tony. Maybe kind of higher level question, you know, a lot of cross currents over the last year, but the net of it is you guys have grown the top line rapidly and the guide for this year highlights the strength of the base business. Tony, you alluded to share gains and filtration, but maybe kind of thinking across the portfolio and your various segments, how would you kind of frame up the change in your market share over the last couple years and And how much of this has been driven by lead times, maybe new additions to the portfolio? Just kind of talk about those dynamics.

Yeah, I think the market share gains for Repligen are really coming from the strength and depth of the portfolio of products that we have. So when you look at our filtration portfolio, we're pretty differentiated in the marketplace versus the competition. Chromatography, when you think about products like Opus, there's not really a whole lot of competition out there for prepack columns. Obviously, Cytiva has their own product line. Analytics, you can see what we have with our Solo and Flow product lines. And then proteins, you know, I think you can see how the strategy that we implemented over the last few years in terms of what we're doing with Purolite, what we're doing with Navigo, what we're doing now with Avitide, that that's really our approach to how we deal with fall-off in volume, which has happened really over the last few years, but obviously more prevalent here in 2022 from Cytiva. So I think it's a combination of really good products in our portfolio that are highly differentiated, smart M&As, and new R&D products that we've brought to market. We launched 12 products last year. and you can see that they've got off to a good start here in 2022.

Perfect, I'll leave it there. Thanks, Tony.

Yeah, thanks, Jacob.

The next question comes from Dan. Ari is with Stephen. Please go ahead.

Hey, good morning, guys. Thanks for the question. Tony, within the portfolio and just looking at the new products that you guys have launched and will launch, Where do you think the biggest opportunities lie to push further into the gene therapy market, just given that there are some areas that looks like you're on your way and the product sets have an interesting opportunity attached to them? And then when you think about bringing new capacity online in 22, do you think you see the benefit fairly quickly there, just given your comments on the importance of lead times as an advantage, or do you think that you know, it kind of takes a quarter or two for the slack to be fully absorbed there.

Yeah, I would say, maybe I'll answer the last question first, Dan. I would think, you know, when we look at capacity, we really started to see a pivot point in Q4 of last year in terms of lead times coming down pretty quickly. That's continued to happen here in Q1 and into Q2. So as, you know, as I said in my prepared remarks, down to under 10 weeks. We get to the second half of the year, we're bringing on additional capacity. I think we'll be in really good shape in terms of the majority of our product lines in terms of overall capacity. And there are pockets of opportunities out there where others have longer lead times on products, and we will definitely be pushing our lead times as a competitive advantage. In terms of which products... do I think really play in the gene therapy space for us? I think it's the filtration portfolio. It starts there. We've got a really deep product line between, you know, when you look at the upstream part of gene therapy, it's between ATF and TFDF. Both are doing quite well. When you go downstream, we have our systems. We have our hollow fiber technology. And now we're starting to introduce, which is obviously not part of the filtration portfolio. It's part of proteins. now bringing in the Avatide products into the picture. We'll always get our fair share of pre-packed columns because customers just like the benefit of it, but it's no different than the MAD market or the buy similar market where customers like that convenience of pre-packed columns. And then the final area is really in the analytics business where traditionally the analytics business has not really focused on the gene therapy space. And we've put that as an area of focus for us over the last 15, 18 months, and it's beginning to pay off. And we can see an uptick in new customers coming in that are gene therapy customers that are using Solo, mainly Solo VPE, and down the road we'll be using Flow VPE.

Okay. And then, John, maybe just thinking about where EBITDA can go from here, are you able to just sort of talk a little bit about expense growth maybe beyond the next quarter or two? And then if we could push out a little further, are there considerations we should be mindful of when it comes to just getting this COVID versus non-COVID mix correct? I'm thinking about the profitability levels that you see in the out years, maybe once you get past some of this investment that you're making.

Yeah, we can talk a little bit on the second question first, Dan. The profitability levels of our COVID business... within like products between COVID and non-COVID are about the same. So there really isn't a major price difference or performance difference in margin between COVID and non-COVID type products. If you talk about the margins, we had an outstanding quarter, as you guys have seen. And we certainly had benefits that we've talked about already on that area. And as it relates to spending, One of the things that we've got to do here in the second half, you've seen that we've maintained our gross margin guidance and our operating margin guidance from what we guided earlier in the year at a higher revenue number. So we've got to do some work in terms of pacing our investments here in the second half of the year, which we will do, which will enable us to continue to stay within those guidance ranges. So should have that pretty well under control here for the second half. Okay. Thanks a bunch.

Yeah, hi, Tony, John. Thanks for taking the questions. So first one, really, I mean, great to see the strength in the base business and the gene therapy that you talked about. But, you know, wondering sort of what gives you confidence in the $150 million guide? Is that still the right way to think about it? I mean, the question that we're getting from investors is there a chance that this potentially steps down Further, if vaccine manufacturers shift more to 2023 and more cancellations come in, maybe just walk us through your process. How do you get to this number? And then when we look at the other larger bioprocessing peers, they're keeping their foliar COVID vaccine guide intact. So is there something unique about Replugin products and how they're levered to the vaccines that actually ends up bringing this number lower versus your prior estimates?

Yeah, so getting to the $150 million, I think I walked through that with Jacob, but it is essentially, you know, if you think where we started the year, which was, as we called out in February, we had $180 million of COVID orders coming into 2022. We had the cancellations. We also had new orders that came in and obviously the pushout, and they were all around $30 million. So that's how we end up at $150 million. We've had, you know, extensive conversations with the top players, the numbers I'm giving are the numbers that we know today. The fact that we're saying 65% of our revenues for COVID is going to be in the first half of the year and 35% in the second half of the year, it just means if you just do the math, right, that it's a much lower number for COVID in the second half of the year. So if it falls off, I really believe that the strength we have in our base business, the strength we're seeing in orders will deal with any smaller drop-offs that might happen. But right now, you're getting what we know. We don't believe it's going to drop further, but we also believe that our base business is doing quite well. And that's why we're able to manage 50% of the call-down straightaway through the strength in our base business. In terms of our peers, we can only speak for what's going on at Repligen. And, you know, we are in the biggest vaccine manufacturers, right? That's who we're working with. We're in a half a dozen commercial vaccine, COVID vaccines. And all I can tell you is what we see. And I can't really speak for other players in our industry. I would note, Jake, I'm sorry, Puneet, that, you know, when you look at where we are as a company, we came into the year with 28% of our revenue in COVID. And now, you know, after bringing it, you know, calling COVID down to 150 million, we're at 19%. I think a lot of the bigger players have a smaller percent of their COVID, of their revenue tied up in COVID. So that could be part of the explanation.

Okay. Okay, that's fair. Thanks for the details there, Tony. Just to follow up on the 2024 $1 billion guide, how much, if any, COVID are you expecting in that? And then just lastly, given the China lockdown is ongoing, could you maybe just outline your sort of exposure there and what you're seeing there? And is that baked into your full year guide in terms of the overall impact and potential recovery there? Thank you.

Yeah, on the 2024 number, if you actually do the math on where we are right now with our base business and you CAGR out at 20% to 25%, you pretty much get to a billion dollars at the 25% range off our projections. So we think that if we can keep our non-COVID business growing in that 20% to 25%, whatever the contribution is going to be from COVID, which we expect there will be some contribution in 2023 and 2024, we're pretty confident that we're still on track to hitting that billion-dollar number. And that doesn't incorporate any additional M&As that may come our way.

Okay, great. And on China? Thank you.

On China, the situation is that, like everybody and all our peers, we are – dealing with major cities like Shanghai where you have a lot of the bioprocessing customers basically shut down for the last month. Like everybody else, we're hoping that that opens up. We're early in the year, so if you look at it on a full-year basis, we expect that we'll be able to do the catch-up between now and as you go through Q2, Q3, Q4. What happens in the next few weeks, I think just we all have to wait and see as to when China opens up a lot more than what it is today.

Got it. Thanks, guys.

The next question comes from Julia Chen with J.P. Morgan. Please go ahead.

Hi, good morning. Thanks for taking the question. So regarding the long-term outlook, presumably I think that leads more upside than downside. So other than COVID, which I know you're leaving us upside, maybe help us think through where we might expect to see the biggest potential upside or downside for the base business, you know, either in terms of end market demand or in terms of uptake of your new products. And to what extent are you factoring any inventory levels or stocking dynamics in this outlook?

Yeah, so there's no doubt that upside is going to come from the continued launch of new products. out of the company, right? So 12 new products, Julia, last year, probably on track to do somewhere between nine and 12 products again this year. That's the sort of accelerator for us. But we think 20 to 25% on the non-COVID part of our business is, you know, we're literally putting out what we really feel we can do consistently for the next few years. That gets us up to that billion. Upside will come, as I said, from new products and obviously continued traction in gene therapy, but probably also in the mRNA space. And as others have alluded to, there's continued good progress on the biosimilar spaces and more of the originators come off patent. So all of those contribute towards a robust market and a healthy outlook for Repligen over the coming years.

Got it. And inventory dynamics? Are you factoring any destocking in 2023?

That's a harder question, and the reason it's a harder question is if you – I think everybody was asking about inventory dynamics last year, and I think there was maybe some expectation as we started off this year that we'd start to see some pullback. When we look at our order strength, it's been really really strong through the first four months of the year so we're not seeing it right now and it's you know if some if it does happen it's kind of factored into what we see over the next few years we haven't gone in and put a specific number we just think that our portfolio how we're doing in the marketplace the new products that we're coming through all lead us to a level of confidence around that 20%, 25% for non-COVID.

Got it. That's helpful. And my follow-up is, you know, to what extent have your customers already pivoted their capacity from COVID to non-COVID projects? Based on your observations, you know, how smooth has the transition process been or has any of them experienced a temporary air pocket in between projects?

Yeah, I think it's pretty fluid right now. So I can't really comment on, you know, someone who canceled, do they immediately jump back in and say, oh, I need product for X and Y. A lot of the companies you're dealing with are major multinationals, and the CDMOs that we're dealing with also have a much broader business than COVID. So it's hard to look at it and say, oh, we lost you know, let's say there was $2 million of a cancellation at a CDMO, and then, oh, we picked up X at the same CDMO, and that was an offset. I think it's more around the overall health of the industry, and I think our peers have kind of highlighted this over the last week as well. This is a robust bioprocessing market right now, and all you have to do is look at our base business and see, 37% growth in the quarter, right, and a 24% to 31% projection on base business for the rest of the year. That's healthy. You know, COVID is going to, is normalizing, right, whatever normalizing really means, right, but it's going to start to move down, and I think all of us in the bioprocessing industry will be able to move forward, absorb that, and, you know, and we're all I think very encouraged by the fact that our core-based businesses are all very healthy with strong order growth.

That's great. Thanks, Tony, and congrats on the quarter.

Thanks, Julia.

The next question comes from Paul Knight with KeyBank. Please go ahead.

Tony, there's been a lot of angst about early-stage funding issues Particularly, I think that comes down to a lot of the cell and gene therapy players. Do you have any feel for what those customers are doing? It seems like the larger ones have a lot of mature pipeline, but any caller there, appreciated.

Yeah, the early stage funding, there's clearly impacting the very small startup companies in cell and gene therapy, probably in a few other areas as well, but I think you're right. I think it's mainly on the cell and gene therapy side. When we look at that and we look at our business, the majority of the revenues that we have in cell and gene therapy are coming from large CDMOs and large, more mature gene therapy companies. There's a lot of companies out there that are working in this space, and I think, you know, today we gave a little bit more kind of color on how we split cell and gene therapy revenue up. So 50% is AAV, but, you know, the other 50% is CAR T, mRNA, and other modalities. So I think we're positioned quite well in terms of the mix that we have and the impact of the, you know, the early stage funding. at least here in the first half of 2022, and I would suspect through 2022, is just not impacting us. So I wish I could give you a further sort of color on it, but while we know it's happening, it's not really impacting what's going on in our space right now.

Okay. And then maybe this is a question for John. You had mentioned supply chain, higher costs. Is there any trouble getting material, and then what's the price dynamic on pricing, right, as we go into the year on supply?

Yeah, on inbound supply, you know, you always have the day-to-day challenges with different piece parts and things of that nature, but the most significant challenge, you know, continues to be obtaining resin for packing and chromatography columns, and so That dynamic hasn't completely changed, although we're starting to see maybe a little bit of freeing up on the resin availability side. In terms of inflation, yeah, we're definitely seeing inbound inflation. Probably anywhere on the range of high single digits to low double digits would be a reasonable average. Here in the first quarter, we were able to leverage some inventories that we purchased back in 2021 at the former prices. That did help our margins a bit here in the first quarter and got us off to a great start. But we are definitely seeing that inflation coming in. And other areas, you know, one area where we're seeing a significant increase to that really is in the freight side, where freight charges are really, really high right now. So working through that. Okay, thanks.

The next question comes from John Krieger with William Blair. Please go ahead.

Hi, good morning. This is actually Justin on for John. So I guess, you know, obviously you're getting some really good traction in cell and gene therapy. What's the anticipated growth rate you think you can achieve within that bucket, let's say in the next, you know, two to three years? Do you have the capabilities needed to achieve growth in line or above the industry CAGR of 25%? And I guess, you know, if the funding drought persists for another, three or four quarters, are you worried about long-term growth in this area at all?

Yeah, thanks, Justin. When we look at the cell and gene therapy space, I think our view is that, you know, this year, you know, we think we can grow north of 40%. I think on average, we believe we can grow probably five points above the market, so we think 30%. 30% plus is probably very attainable for us over the next few years. When you look at the funding issue, I think for us, really, when we look at this space, while the funding piece is really important, we think that the drugs, the cell and gene therapy drugs moving through the funnel and getting approved is probably more important right now. you know, the phase two to phase three successes, the phase three to commercial approval. I personally believe that that's what we need to see that will really help in terms of validating the approaches that companies have taken, whether it's on the, you know, the viral vector side or it's, you know, or it's using CAR T technology. I think those wins will give a lot more confidence to the early-stage companies and will probably secure some of the funding on a go-forward basis. So we're really paying probably more attention to how deep is the funnel. Are phase 2s becoming phase 3s? Are phase 3s getting in front of the FDA and getting approved? That's what we're looking at.

Got it. Thank you. And real quick on, I guess, AsiaPAC, I think last quarter you said it more than doubled in 2021. You grew another 27% in the quarter. I think you mentioned filtration and COVID were big contributors last quarter. As well as the driver this quarter and how should we think about the region going forward? Or in other words, like what areas are you primarily investing or expanding your presence in?

Yeah, I would say filtration is probably the one area in Asia Pac where We've done really well. I think when you look at the depth of that portfolio of products, it resonates quite well. When you look at what customers are doing in AsiaPac, you've got a lot of biosimilar activity going on. So products like ATF do very well in those processes. The MAB market continues to do well in AsiaPac. Obviously, gene therapy is also on the rise there. But if I had to pick one portfolio for us that really stands out in AsiaPac, it's filtration. So as we go through the year, I think, you know, someone asked the question, you know, I think the important piece right now, honestly, in AsiaPac is for China to open back up. You know, obviously, you know, everybody is dealing with the last four weeks. We'd like to see that clear up and then, you know, basically, you know, open up to what we know is a very robust market in China.

Got it. Thank you very much.

The next question comes from Matt Hewitt with Craig Hallam Capital Group. Please go ahead.

Good morning, and thank you for taking the questions. Maybe first up, regarding gross margins, and thank you for the color on the supply side, I'm just curious what – What opportunity do you have to pass along some of these higher prices to your customers? Are they receptive? Does it change some of their ordering dynamics? Any color on that side would be helpful.

Sure, I can speak to that, and Tony can add additional color as is necessary. But overall, we are passing along price increases to our customers. The overall, I guess, receptive to that is pretty high. pretty good in the market today, simply because it's pretty prominent, right? Everybody's seeing the inflation coming in from different suppliers. Some of those suppliers maybe not specific to bioprocessing, right, clear down the chain. And so we're seeing those price increases, and of course we're passing that along to our customers. So, you know, and we'll continue to look at those opportunities as we go forward as well.

Thank you. And then maybe a separate question. One of your larger COVID vaccine customers recently announced that they're going to be moving ahead with Mab flu vaccines. And I'm curious, are there any different dynamics to that market? How big of an opportunity could that become for you? Anything along those lines would be helpful. Thank you.

Yeah, when you look at the flu market in general using mRNA technology, I think there's a lot of opportunity out there. There are a number of companies that are working on that. It's really early stages, so I think the actual dollar contribution is going to be relatively light, but if you looked at it on a five-year horizon, I think it's definitely one of the really nice tailwinds that comes out of COVID where you take mRNA technology and it starts getting applied to multiple other opportunities. So I think everybody knows that that's an opportunity in the bioprocessing space. I think we're all working on it. But I think the revenue contribution is going to be pretty light for the next year or so. But yeah, I think in the future it becomes significant.

That's helpful. Thank you.

The next question comes from Brandon Kuya with Jefferies. Please go ahead.

Hey, good morning. Tony, most of the questions have been addressed already. I'm just curious to share an update on your latest thoughts around some of the M&A environment, whether volatility of the markets kind of opening up some opportunities and where your priorities would be as far as places you'd like to add or bulk up in the portfolios.

M&A has been a big part of our strategy over the last eight or nine years. I don't think that's going to change. I think the dynamics on M&A are pretty similar in 2022 versus what we saw say in 2021 or 2020. I'd say it's a little, it was being a little slower in the first quarter than what we maybe have seen, we saw last year. But in general, I still think there are some good assets out there. And as always, we're always talking to people and we'll see what happens as we go through the next, you know, one to two years. And, you know, I think the other piece is when we look at our portfolio, we have a, we do have an M&A strategy for each of our businesses. So as assets become available or get closer to a transaction, we're not focusing on any one division to say, oh, this is the only one we want to do M&A on. We have a strategy for each one.

I wanted to add on. I made a comment earlier when Tony talked about 20% to 25% growth. And so the Non-COVID growth does include some impact, could include some impact from M&As. And so I wanted to clarify that comment.

Okay. And then just one clarification. I think, I don't know if Tony, you mentioned this or John, you did about new products. Did you quantify that? Is it like 3% of revenue in terms of new products from the interviews last year and this year? Did I get that right? Yeah, that's right. That's about right. Okay. Great. Thank you.

Again, if you have a question, please press star, then one to be joined into the queue. The next question comes from Ram Selvaraju with HC Wainwright. Please go ahead.

Hi, thanks very much for taking my questions, and congrats again on the performance in the quarter. I was wondering if you could comment on the regulatory environment, particularly with respect to cell and gene therapy, and if you're hearing any concerns from among your, in particular, gene therapy customers regarding the regulatory situation, especially in light of a few projects that have recently been placed on clinical hold, and if you think that's likely to have any kind of knock-on effect with respect to your business.

Yeah, I think it comes back to what I said earlier. This whole market in cell and gene therapy, we need to see more approvals and more drugs moving through the process. I think it's very healthy in terms of the number of companies and number of you know phase one phase two and phase three trials that are happening so I just think that it's that progression just we need to see it and I think that will be the catalyst for growth and it'll put into the background any regulatory concerns that might be out there whether it's now or six months from now or six months ago and then the follow-up would be

If you think about the overall M&A strategy and where you intend to pursue directions for future growth, are we likely to see you continue to bulk up in areas where you already have an existing presence and focus on sort of line extensions in those arenas? Or are you thinking about this in a broader CDMO context? beyond even perhaps the existing areas within bioprocessing where you are already present. Just maybe comment on that in a general sort of qualitative way, how we should be thinking about the way in which you expect to be positioning yourselves in the coming years.

When you think about M&A and what we've done, I think our strategy has always been to build out various legs on the stool for Repligen. So we were a proteins company, and then we became a protein chromatography company. Then we added in filtration, then we added in analytics, and now we've added in fluid management. So I would say the vast majority of what we will do in the next five years will line up with those five different businesses that we have. There may be down the road some opportunity to to add in a new vector for us. But I think our focus is going to be on those five businesses.

Thank you.

This concludes our question and answer session. I would like to turn the conference back over to Tony Hunt for any closing remarks.

I just want to thank everybody for attending this morning. Obviously, we're coming off just a really fantastic Q1. We look at our markets and they're incredibly strong. And our orders as we come into, as we're starting off Q2, are also very strong. So we're really optimistic about how the company is going to perform as we go through the year and look forward to catching up with everybody at the end of July. Thank you.

the conference has now concluded thank you for attending today's presentation you may now disconnect