RGEN - NASDAQ

Good day, ladies and gentlemen, and welcome to Repligen Corporation's Third Quarter of 2024 Earnings Conference Call. My name is Chad, and I will be your coordinator. All participants will be in listen-only mode. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the call over to your host, Sondra Newman, Head of Investor Relations. Please go ahead.

Thank you. And welcome to our third quarter of 2024 report. On this call, we will cover business highlights and financial performance for the three and nine-month periods ending September 30, 2024, and we will provide financial guidance for the full year of 2024. Joining us on the call today are Repligen's President and Chief Executive Officer, Olivier Loeillot, and our Chief Financial Officer, Jason Garland. 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 quarterly reports on Form 10-Q, our annual report on Form 10-K, and other current reports on 8-K, including the report that we're filing today and 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 financial results and guidance, unless otherwise noted. 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. Adjusted non-GAAP figures in today's report, include the following, base revenue and organic revenue growth, cost of goods sold, gross profit and gross margin, operating expenses including R&D and SG&A, income from operations and operating margin, tax rate on pre-tax income, net income, diluted earnings per share, EBITDA, adjusted EBITDA, and adjusted EBITDA margins. These adjusted measures should not be viewed as an alternative to GAAP measures, but are intended to best reflect the performance of our ongoing operations. Now I'll turn the call over to Olivier.

Thank you, Sondra. Good morning, everyone, and welcome to our Q3 earning calls. I'm very pleased to report strong third quarter returns. Excellent team execution, coupled with improving market conditions, has enabled us to deliver 10% year-over-year sales growth and 6% order growth, with orders pacing above sales by 4%, despite the seasonality headwinds we typically see in the third quarter. Most of the momentum we have seen in quarter two has carried into quarter three. In fact, we saw sequential improvements with our non-COVID sales of 3% versus last quarter and orders of 2%. We were especially encouraged to see a strengthening CDMO business, which is a great indicator of the overall industry health. This business rebounded nicely and reached its highest revenue level in the last 18 months with orders dollars trending ahead of sales through the first nine months. Pharma and consumables continued to show solid sales and order growth, and we grew our opportunity funnel for equipment. It was a record revenue quarter for new modalities, where we're tracking to the highest annual revenue and order intake to date. At the franchise level, filtration-led revenue growth and chromatography delivered an exceptional quarter for orders. In total, for the nine months year-to-date, our orders are up 8%. And if you include protein, up 14%. During the third quarter, we managed to build backlog for the future. In addition, our other funnel is very healthy, setting us up for a solid exit to the year. Overall, we are really happy with the progress we're seeing as we continue monitoring macro-level trends with China, CapEx spending and biotech funding. With this positive context, we are narrowing the range and confirming the midpoint of our full year revenue guidance. We now expect to finish 2024 with revenue in the range of $630 million to $639 million. For clarity, this includes close to $7 million of incremental revenue following our 8-K filing in September. Jason will provide an update on the related restatement process, but please note that all of the figures being reported today do include the impact of this shift in revenue timing. Let us now deep dive a bit in the quarter and our year-to-date performance. Pharma delivered a solid growth in quarter three, with revenue up mid-single digits year-over-year. Orders were also strong at the highest level since 2021 and had high-single digits sequentially, but flat year-over-year on the [indiscernible] in quarter three 2023. Orders came primarily from our top biooharma customers. Year-to-date, our pharma revenues are at high single digits and orders are at mid-teens. More importantly, pharma order dollars are tracking 12% above revenue in the quarter. CDMO revenues and order grew approximately 20% year-over-year. CDMO sales are now back to 2022 levels, and our order intake year-to-date is at high single digits. In fact, over the last two quarters, orders are up mid-teens versus the same six-month period last year. It is good to see the activity level at some of our top 10 CDMOs picking up again, and particularly at those where we have put a key account manager in place. In Q3, we also saw a more even distribution of orders coming from both larger tier 1 and the smaller tier 2 CDMOs. We look forward to getting further confirmation in the first quarter, but the situation has really improved from a year ago. Moving to consumables and equipment performance, consumable momentum is still strong, with revenues up 10% year-over-year and at their highest level in the last five quarters. Consumable orders were at the highest level they've been since Q1 of 2022, up high teens year-to-date, which furthers our belief that destocking is indeed behind us. We continue to gain market share in capital equipment despite a challenging environment. Our sales were at mid-single digits year-on-year and low single digits sequentially. Sales and orders are now up mid to high single digits year-to-date. While equipment orders have been slower to recover, we could not be happier with the funnel we have for our systems. For example, several big pharma companies are adopting our PAT technology integrated with these systems to improve their productivity. In particular, these companies are platforming our system for new modalities. Thinking about new modality business, we delivered another great quarter, with sales up more than 20% year-over-year. In fact, quarter three was the highest revenue quarter ever for new modalities. Our orders were also at low double digits compared with quarter three of 2023. What is driving our success in this area is innovation and continued adoption at our top 20 accounts. It's become even more clear to me that Repligen has the best, most advanced portfolio of products to serve these important markets. Our strategy to develop and launch tailored solutions for the different new modalities is very successful and, with the expected rapid growth of this market, we are ideally positioned. Our pending acquisition of Tantti will also enable us to develop unique and innovative purification solution for that market segment. As a percent of total revenue, new modalities continue to increase, tracking to 20% for the full year compared with 18% in 2023. From a regional performance point of view, we are really happy about the progress we are seeing in the Americas and Asia, including China. America revenues were up mid-teens in quarter three, while Asia ex-China was up more than 40% in quarter three. China remains a big headwind for us this year, and will only represent about 4% of our 2024 revenues. Asia will remain a critical focus for growth for us in 2025. Let us now deep dive into our third quarter franchise performance. Starting with our largest franchise, filtration, Q3 has been another successful quarter. Revenues were up mid-teens year-over-year and around 10% year-to-date. Orders were flat year-over-year on very tough comps, but up high single digits sequentially and up greater than 10% year-to-date. Our ATF revenues are up more than 50% this quarter, as we capitalize on our ATF late-phase design-ins and significant consumable uptick. Our ATF technology was also designed into another blockbuster mAbs during the quarter. Our filtration systems portfolio is gaining market share at several large pharma accounts. In fact, we are starting to be platformed at some of these accounts, which will help us to generate ongoing growth, thanks to the recurring nature of the associated consumables. Another reason for the positive traction is that we are seeing the integration of FlowVPX technology with our filtration system at several accounts, creating a new market need for this differentiated technology combination. Finally, our TangenX flat sheet cassette portfolio grew greater than 15% this quarter, driven by large pharma wins. And with a strong funnel, we continue to work on several large scale opportunities for the future. Moving to chromatography, we are very encouraged by our performance in quarter three. While revenue was down on a very tough comp, it was an exceptional quarter for orders, which were at 35% year-over-year. In fact, the last two quarters have been record quarters for orders intake, driven by increasement for both large scale and small scale OPUS columns. Though protein remains a roughly $32 million headwind for the year, the franchise had a strong quarter overall, with sales at 15% versus quarter three 2023 and orders flat. Ligand revenues and orders were as expected, with trends in growth factors and Avitide programs. Our Avitide customers' ligand funnel has strengthened over the last 12 months, as more customers implement this solution for custom and catalog products. We're excited about the addition of Tantti to our portfolio and hope to close this deal here in the fourth quarter. The goal will be to launch some disruptive solutions into the new modality space as we move into 2025. The work we are doing with Avitide/Tantti new modalities combined with our mass collaboration position us well to move beyond the known headwinds here in 2024 and reestablish growth for our protein business. Finally, process analytics also had a strong quarter with 7% top line growth and 6% order growth. Our FlowVPX solution for measuring protein concentration drove the overall business growth across all modalities and compensated for a more difficult business environment for standalone systems. So our franchise did well across the board. Our unique and innovative products combined with a successful implementation of our key account strategy and focus on new modalities is generating a lot of new business opportunities for Repligen. As I wrap, I also wanted to share another highlight of the quarter. On September 23rd, we had the grand opening of the Repligen Training and Innovation Center in Waltham called RTIC. This dedicated space showcases all of our Repligen bioprocessing technologies with product exhibits, purpose-built demo areas, and technical training space, all designed to provide our customers with pre and post-sale support and hands-on experience with our technologies. Every week, we're adding customers willing to open new doors to expand our business. This is reflected in our 50% plus probability funnel, which is 30% greater than prior year. So in summary, I'm very pleased with the momentum we saw in quarter three, and believe we are well positioned for achieving our full year goals. We are very encouraged by our order strengths over the last nine months, and the 10% year-on-year revenue growth in quarter three. With improving CDMO and capital equipment markets and continuous strength in pharma, consumable, and new modalities, we're excited about our markets and the future as we move into 2025. Finally, I really want to thank our entire Repligen team for delivering such a strong quarter. Over the last 6 to 12 months, we have added several experienced leaders and talented people to an already high-performing team and, therefore, we are excited and confident about the future of our company. It has also been a real pleasure meeting many of you over the past couple of months. I've enjoyed sharing my vision for the ongoing success of Repligen and look forward to our discussion in the months ahead. With this, I will hand over to Jason for the financial updates.

Thank you, Olivier. And good morning, everyone. I'm pleased to share more details on our Q3 financial report and to step through the pieces of our updated financial guidance. As Olivier mentioned earlier, please note that all the financials discussed will be inclusive of the adjustments related to the required restatement we disclosed in September. At that point, we are only able to share how top-line revenue timing would shift and the estimated impacts on operating income. We can now share a detailed summary of our restated financials for the past six quarters, including GAAP to non-GAAP reconciliations. Please refer to the supplemental presentation posted today on the Investors section of our website for the summary, which is also included as an exhibit to the 8-K we filed this morning. The restated financials addressed a specific COVID-related contract modification that gave rise to the need for the restatement, along with some minor adjustments to the historical financials for certain other immaterial items. I want to thank the team for working through a very detailed and robust process to get to this point. Given the effort required, we're still in the process of finalizing all the required amendments for the impacted 10-Qs and 10-K, and we plan to file them as quickly as possible. Moving now to the third quarter of 2024. Revenue of $155 million marked a return to double-digit growth, up 10% year-over-year on a total reported basis, and up 7% organically. Recent acquisitions contributed 3% of reported growth with de minimis impact from currency. There were no COVID sales in the third quarter of 2024 or in the third quarter of 2023. Sequentially, from the second quarter, we were down approximately $4 million from $159 million. But for context, Q2 now includes $5 million of additional sales due to the restatement. Year-to-date revenue is $467 million, in line with our updated expectations. This was flat year-over-year, but up about 5% if you exclude known COVID and protein headwinds. As Olivier shared color on our product franchise performance, I'll provide more detail on the performance across our global regions, starting with revenue, where we saw year-over-year growth across all regions during the quarter. North America represented approximately 51% of our global business in Q3. Europe represented 33%. And Asia Pacific and the rest of the world represented 16%. Within Asia, China was down about 50% year-over-year and represented 3% of our total business in the quarter. We continue to expect China to be about $20 million headwind to revenue in 2024 as shared in July and to represent approximately 4% of our restated revenue. Excluding China, we saw a very strong year-over-year and sequential sales growth for the Asia-Pacific region, up over 40% and 30% respectively. Year-to-date, the strongest region was North America, up about 10% with healthy growth across all four franchises. On regional orders, North America and Asia Ex-China were both up double digit on orders year-to-date. Europe is down due primarily to proteins and China continues to present a meaningful headwind, though we did see some slight order grows sequentially from the second to the third quarter after a decline for three quarters in a row. Transitioning to profit and margins, the third quarter 2024 adjusted gross profit was $78 million, a $19 million increase year-over-year on $14 million higher revenue. With this, we delivered a 50.7% adjusted gross margin. This is up 8.7 percentage points versus last year, driven by higher volume, year-over-year productivity, and with some offset due to inflation. Sequentially, gross margin is down about 40 basis points from the second quarter. But keep in mind that Q2 now includes the benefit of high margin. from approximately $5 million of restated COVID-related sales. Excluding those sales, our third quarter gross margin improved by 1.1 percentage points. Looking at year-to-date, the first three quarters of 2024 adjusted gross margin is 50.3%. This is in line with achieving our total year guidance for gross margin, which we are increasing today by 50 basis points to a range of 49.5% to 50.5%, entirely from the impact of the restatement. The implied midpoint guidance for the fourth quarter does suggest a drop from the third quarter. Even with the benefit we get at higher volumes and positive leverage in the fourth quarter, 3Q benefited from higher margin product sales that do not repeat in 4Q. This has a negative mix impact on the adjusted gross margin, essentially from higher material costs. Continuing through the P&L. Our adjusted income from operations was $23 million in the third quarter, with significant improvement over last year, up approximately $18 million. This increase was driven by the fall through of the $19 million increase in gross profit, with an offset of $1 million of higher adjusted operating expenses. Though our adjusted operating expenses are up versus last year, primarily due to the return of incentive compensation in 2024, sequentially, they are down approximately $5 million in the second quarter. This is in line with the projected reductions primarily in SG&A that we highlighted as part of our guidance in July's earnings call. We continue to closely manage our operating expenses. From a run rate perspective, we do expect the fourth quarter to step up from the third quarter due to the timing of expenses, but should still remain below the first half run rate. Our third quarter 2024 adjusted operating income margins are up more than 11 percentage points year-over-year, driven primarily by strong operating and OpEx productivity, higher volume, some price tailwinds offset by incentive compensation and inflation. Operating margin also improved sequentially by approximately 200 basis points to nearly 15%. Our third quarter, 2024, adjusted EBITDA margin rate was approximately 21%, which reflects a greater than 5% point drag from depreciation. The implied guidance at midpoint for fourth quarter adjusted operating margin is a small step up from 3Q. Even with gross margin down sequentially, as discussed earlier, we expect to see an increased impact on volume leverage at the adjusted margin level, which more than offset the gross margin mix headwind. With cost optimization and margin expansion remaining a priority, we expect to continue to execute programs and evaluate the need for future optimization and restructuring actions. To this end, we incurred just under $3 million of restructuring charges in the third quarter, all of which were cash expenses. For clarity, these expenses are excluded from our adjusted results. Adjusted net income for the third quarter was $24 million, up nearly $11 million versus last year. This was driven by the $18 million increase in adjusted operating income, offset by greater than $7 million of higher tax provisions. Our third quarter adjusted effective tax rate was 21.9% versus negative 5.8% last year. Our adjusted effective tax rate was also up over the first half, primarily due to a shift in our profit before tax mix being less US driven. With this increase in the quarter, we are maintaining our total year adjusted effective tax rate outlook and still expect it to be approximately 20%. Interest income net of interest expense was up slightly over last year. We expect this to decline in the fourth quarter on decreasing interest rates, though still see a path to higher interest income for the total year versus our prior guidance. There is no impact from the restatement. Adjusted fully diluted earnings per share for the third quarter was $0.43 compared to $0.23 in the same period of 2023. Finally, our cash position at the close of the third quarter was $784 million, down $25 million sequentially after using $70 million for the settlement of our remaining 2019 convertible notes as previously discussed. This was partially offset by another quarter of strong cash flow from operations as we generated $49 million. As we end the year, we still expect the Tantti acquisition to close in the fourth quarter and plan to fund the transaction with our available cash on hand. I'll now move to an update on our guidance for the full year of 2024. I'll speak to adjusted financial guidance, but please note that our GAAP to non-GAAP reconciliations for our 2024 guidance are included in the reconciliation table in today's earnings press release. And for further clarity, our guidance is fully inclusive of the restatement and inclusive of the FlexBiosys and Metenova acquisitions we made in 2023, but still excludes any impact from the pending acquisition of Tantti. As highlighted earlier by Olivier, we have updated our total year adjusted guidance ranges that we shared last July. We have tightened our revenue guidance range around the same midpoint of $634.5 million communicated in our restatement disclosure. We now expect total revenue in 2024 to be between $630 million and $639 million. As Olivier mentioned, includes approximately $7 million of incremental revenue following our 8-K filing in September. We still expect year-over-year revenue growth in the second half of the year. And even with the restatement, we still expect second half 2024 to be above the first half. At our midpoint, we expect total revenue growth in the second half of 2024 to be 5% higher than the second half of 2023, and 3% higher than the first half of 2024. Excluding COVID, we expect revenue in the second half of 2024 to be 12% higher than the second half of 2023 and 7% higher than the first half 2024. Overall, for the full year, we expect growth in the range of 2% to 3% for our non-COVID business, with M&A contributing approximately 3 percentage points to that growth. We now expect to deliver adjusted gross margins in the range of 49.5% to 50.5% with the increase solely due to the restatement impact on the first half of 2024. We also expect our adjusted income from operations to be between $80 million to $85 million or 12.5% to 13.5% adjusted operating margin rate. This 50 basis point increase from our guidance in July is driven by approximately 90 basis points of benefit from the restatement, partially offset by a 40 basis point of headwind in our expected operating expenses versus our July outlook. This equates to about a $1 million higher SG&A than previously forecasted as we continue to balance making important investments for growth while driving prudent spending. Adjusted EBITDA margins are now expected to be in the range of 17.5% to 18.5% for the year, reflective of the adjusted operating margin changes and no impact on our prior outlook of roughly 500 basis points of fixed depreciation costs from capacity expansions we have made. Our adjusted other income outlook has increased by $3 million to approximately $27 million. And our 2024 adjusted effective tax rate is unchanged at an estimated 20%. Incorporating all of the updates discussed above, our guidance for adjusted net income is now $85 million to $89 million. And our adjusted diluted earnings per share is $1.50 to $1.58. In closing, we continue to be encouraged by the momentum we are seeing in the market and our performance in the third quarter. We believe that our focus on key accounts, delivering innovation, driving orders growth for the company, continuing to develop and acquire differentiated technologies, and progressing on our revenue and profitability goals sets us up well for a successful exit to the year and into 2025. With that, I will turn the call back to the operator to open the lines for questions.

[Operator Instructions]. And the first question will be from Dan Leonard from UBS.

I have a question on the fourth quarter revenue ramp. Can you walk through some of the assumptions that are behind the ramp from a budget flush perspective or anything else?

Olivier here. Yeah, we said a couple of times already, quarter four is always the highest quarter, was always the highest quarter pre-COVID due to seasonality. And on our side, obviously, we've seen a nice ramp up of orders too during the entire year, with book-to-bill around 1, if not above 1, during the every quarter, one after the other, and quarter three being another good example here. So we've grown our order intake consistently during the entire year, which is putting us in a very strong position to enter into quarter four and deliver the higher number that we have to deliver in quarter four versus the previous quarters. And the good news is October has been a very strong month as well. So that's why we decided to reduce the overall guidance as we did in the range.

And as a follow up, I think you mentioned that equipment revenue was up low single digits sequentially, which was better than we were expecting. Can you speak at all to – and you mentioned you have a strong funnel as well. I'm curious if you could speak to funnel velocity. Are deals that are entering the funnel closing at the same rate? Are they closing faster? Any change on that front?

We were really happy to see some growth in what has been indeed a tough environment. And we've heard that. We've even seen it ourselves. But you're right, we have a great funnel. And if I look at the entire portfolio of products we have, particularly the ARTeSYN portfolio, has enabled us to regain quite significant market share. And the good news is, particularly in new modalities, several big pharma companies have decided to platform us across the board for those new modalities with our systems. And we're also benefiting from the integration of our full VPX PAD system. So, yes, it's definitely a good position we're in right now. In terms of the time it takes between you generate the funnel and you close the deal, it really depends quite heavily from one customer to the other, but you would say typically it can take something between three to six months to close the smaller scale type of hardware, and maybe six to nine months for the larger scale.

And the next question will be from Dan Arias from Stifel.

Olivier, you sound pretty encouraged by the CDMO picture. If I go back to the end of last year, demand stepped up and then it took a step backwards in early 2024. What about the improvement that you're seeing here suggests that the path forward might be more sustainable? Is it breadth of orders, order size, or frequency? Anything that gives you extra confidence entering next year on just the CDMO side specifically?

I think we've repeated consistently like the health of the industry is really at the highest level when you see CDMO recovering. So from that point of view, we are really happy to see what we've seen now for, I would call it even the last two quarters. In fact, when you look at the last two quarters orders, they are up mid-teens versus the same two quarters last year. So it's really a very significant improvement. In fact, our sales are back to the 2022 level at this stage. And what we're also very happy about, it's both large and small CDMOs that are really showing some very good performance. And when you look at large ones like a Lonza or Samsung, they are announcing very significant deals lately. But also some of the smaller ones are starting to probably benefit quite a bit from the BIOSECURE Act. So, it is really an improvement across the board. And another stuff we are happy about, we are covering four of these CDMOs with our key account management team, and partly at those four accounts, we've seen incredible improvement over the last few quarters now.

Jason, as we think about next year, is it fair to say that the growth rate that might've been contemplated before the accounting change would now need to reflect the 100 basis point headwind from the $7 million that falls into 2024? Or do you think you can offset that? And then as we think about the quarters for next year, what would you call our attention to when it comes to the impact of these changes, just sort of trying to get ahead of any modeling surprises that might show up when revenues and costs move around?

I think that as we look into next year, we still are maintaining the view that we've shared before. I think that as we talk about next year, right, certainly, when you exclude COVID, which again most of the reshaping impact is in that bucket, that that's where we're going to focus on our continued growth. And I don't know if you want to share anything more on 2025, Olivier.

No, I think we're good to go.

Yeah, quarter-wise, we'll continue to look at that as we go through and release overall guidance. But I think as Olivier shared, we feel like we're seeing back more of the seasonality that may have been typical before COVID and would expect that we follow a similar pattern as we go into 2025.

Jason, just to be clear, when we show up 90 days later, you don't envision there being something that surprises the Street, surprises investors, surprises analysts about the 4Q and 1Q dynamics that resulted from that accounting change?

That's right.

And the next question will be from Rachel Vatnsdal from J.P. Morgan.

First up, just on the order intake, you mentioned that orders grew 6% year-on-year. Can you also just give us what was the sequential order growth given some of the COVID comps, especially in the first half? And then also what was book-to-bill this quarter? Was it truly above 1?

Versus quarter two, our orders increased by 2%. In fact, year-to-date, our orders are up 8%, which is a very significant increase for us. And then we did mention like our orders were ahead of sales by 4% in quarter three.

Just on my follow up on 2025, I know Dan just pushed on top line, but maybe I wanted to look at margins a little bit more. You typically have grown gross margins by 100 to 200 basis points a year, give or take. But you mentioned that this COVID restatement is margin accretive. So walk us through the moving pieces and really what that means for margin expansion in 2025 at this point.

Really, there's no change in the dialogue we've been having about 2025. Again, we're not issuing guidance, but we do expect to be able to still achieve that 100 to 200 basis points of gross margin over the next few years. So, no impact in particular from an impact to restatement. Certainly, the step-off point becomes higher.

And the next question will be from Puneet Souda from Leerink Partners.

First on, you pointed out both CDMOs and newer modalities. Can you talk about how much of that is an overlap between those two categories? And then, if you can maybe help us understand how much of the business is picking up in your phase one and two versus phase three and commercial? Can you maybe just help us parse out both revenue and revenue growth and order growth that you're seeing? How much of that is phase one and two versus later stages?

We don't have the exact number of how much of our new modality sale is going through CDMO versus pharma. I would say there is no reason why it should be any different from the rest of the business because the only difference probably is that a lot of CDMOs active in new modalities are on the smaller hand of the CDMO range as well, particularly on the gene therapy side, but we don't have the exact number here. What I think is important really to mention on the new modality side is we have about 20 plus customers that are really significant customer of ours and a big chunk of them are CDMOs indeed. But I don't have the exact number here to give you. In term of clinical phase, as you know, about 65% of our overall business is in clinical phase. Slowly, but surely, obviously some of these projects are moving from the early phase clinical to the later phase, which is why we're seeing a very nice consumable order uptick and sales during the last several quarters because we really have a tail end of this product moving to the later phases. But here, again, I can't give you exactly the exact number. Typically at the end of the year, we do a reconciliation of where our sales went during the entire year and we will probably be able to give you more granularity during the next call on the split between the early phase and the later phase here.

Just on M&A, there have been significant speculation lately, and I think that's been an important question for investors as well. I understand it's always challenging to address any near-term discussions, but just wanted to see and get a view from you on your M&A approach and if you can provide any clarity on that and your ability to deploy capital for the right asset.

As you all know, M&A has been absolutely critical for the growth of Repligen in the past, and there is no reason why we are going to stop that. So we are having a very active funnel of opportunities. One of the messages conveyed over the last few months is, well, I need a bigger company today than we were 5 to 10 years ago or so, which is why we are definitely looking at potential bigger targets today than we were 5 to 10 years ago. But what does remain similar is we are looking for very unique technologies that will really enable us to further differentiate ourselves on the market. So we are not into the me too type of products. So we're not interested to acquire businesses that wouldn't bring something that is really going to be very differentiating. And differentiating means in the very short term, or by adding it to the rest of the portfolio we already have, where we can create something that's going to be very differentiating in the short to mid-term with that acquisition. So nothing really has been changing heavily on that side. We have a very strong funnel of opportunities. And Tantti, by the way, which is the latest acquisition we've done, is a good example of the fact we are still interested by bolt-on acquisition as well. Because even though it doesn't bring us a lot of top line in the very short term, the complementarity to our current portfolio is gigantic and will enable us to speed up the growth of the Avitide ligand customized offering.

The next question will be from Matt Larew from William Blair.

Olivier, you mentioned part of the growth driven, especially in equipment, by being platformed at Big Pharma. Obviously, the enterprise sales strategy has been a focus for the last couple of years. Are these totally new accounts to Repligen? Are they accounts where perhaps you existed in a small way, but now have a much bigger opportunity? Sounds like ATF and FlowVPX were entry points. Could you maybe provide a bit more color on the success at Big Pharma in the quarter?

You nailed it well, Matt. We obviously have been very active with the key account management organization. In fact, today, we are up to a team of seven people covering 20 accounts, 16 pharma, 4 CDMOs. And this has given us really a lot of traction. And yeah, you phrased it very well, which is like we typically potentially had only one part of the business covered with those big accounts and slowly but surely now we're working on two, three, sometimes four of the different parts of the portfolio we have. So, this has really enabled us to grow much faster. But also what's very important to consider with those big accounts is you want to get access to the C-suite level people. And there is nothing better than having one person who has the ability to present the overall portfolio because then suddenly you get access to those higher level decision-makers at those big accounts. And particularly, for a company like ours that has got very differentiating innovation, you really want to make sure you get access to the key decision-maker because sometimes from a company are a little bit reluctant to embed changes. So having access to the higher level decision maker has enabled us to speed up – them taking up on the innovation we are launching every year.

On China, you referenced 3% in the quarter. I think some speculation about potential stimulus activity for the space, how that might affect things next year, where it might come through. But you also referenced to an earlier question, I think a positive impact from some CDMOs related to BIOSECURE, which, I don't know, sort of is maybe an offset to sort of what's going on in China. I'm just curious if you could explain, one, to provide current thoughts on the go-forward business in China, and two, maybe flesh out a bit more what your customers are telling you about the positive impact from BIOSECURE.

I think we are all thinking and hoping that China is bouncing along the bottom at this stage. And you're right. Slowly, but surely, it has reached a very small portion of our overall revenue, about 3% in quarter three, we think probably a little bit less than 4% for the overall year. Well, what's great, by the way, and I just take a very short segue, the rest of Asia is doing very well. In fact, our sales outside of China were up 40% in quarter three. But back to China, we need to focus more on that market for sure in the upcoming few months because we think there will be a rebound coming sooner or later. And yes, you're right, the stimulus that seems to be hitting more every quarter. I think, in August, there was a specific announcement made for equipment for bioproduction, which we start to see reaching some of the potential customers in China. So we hope indeed to see some positive impact coming from that side. And in terms of the BIOSECURE Act, well, what I was talking about earlier is, yes, there have been some companies, some pharma companies, who have started inquiring with alternative CDMO sources and very often there's a smaller hand of CDMOs considering the projects they are considering moving faster might be the early phase one. So it's a fact like a few of the small CDMOs in the US have been really benefiting from a probably much higher opportunity funnel intake during the last two quarters. And we start to even see some M&A activities in the small CDMO arena in the US, as you've seen Avitide being acquired by a private equity company. So there are quite a lot of stuff happening on that side for sure right now.

The next question will be from Jacob Johnson from Stephens.

Maybe just on clinical demand. I think that's been a focus area for investors and perhaps some concern there that we could see a slower recovery in clinical next year versus commercial. I think one of your larger peers called out muted growth from earlier stage demand earlier this quarter. You guys are pointing to improving demand from CDMOs, I think last quarter maybe also earlier stage customers. Can you just talk about what you're seeing in the clinical piece of the business? And do you think that business could hold up relatively well, even if the broad – for Repligen specifically, even if the broader space is a bit more muted next year?

Yeah, as usual, you're spot on here. Yeah, if there is one area that is probably still a bit of concern, including for us as well right now, it's with emerging biotechs. And then you're absolutely right, like in Q2 we mentioned, we saw a very significant improvement. There is only one sub-segment of our overall business that didn't do very well in quarter three, that was the emerging biotech. And we've been trying to really understand what was going on, obviously, both from a funding of biotech point of view, but as well as from a clinical trial staff point of view. And you might remember, we've changed a bit on that where quarter one to a very nice increase in biotech funding to I think we said something like $18 billion, then quarter two went down to $15 billion and then quarter three and four went down to $12 billion. So even though year-to-date we are still at 44% versus last year, we've seen like a constant decline of biotech funding this year. In order to try to better understand what the pattern might be, we will look into that clinical trial start this year. And in fact, year-to-date, clinical trial start in the US have gone down by about 20% to 25% versus last year. So there seems to still be a little bit of a story here. And if I look at our own business, indeed, the only right figures we have across the entire portfolio, whether from business unit point of view, whether from the market segment point of view, this is really still with emerging biotech. So we're hoping to see some improvement coming from that side hopefully in the next few quarters.

Jason, just one maybe last question on 2025. You talked about gross margins in response to Rachel's question, but as we think about the OpEx side of things, OpEx was down nicely sequentially, seems like maybe it'll pick up a little bit in 4Q, but as we look into next year, should we assume that maybe you get kind of some benefit from the savings in the back half of this year that helps margin expansion in the first half of next year, or are there any moving parts on the OpEx side of things like incentive comp that we need to pay attention to as we're thinking about modeling next year?

Obviously, we'll get more clarity as we issue our 2025 guidance in February. But, yeah, there will be moving parts. And we do expect to get some additional leverage at the op margin level. And I don't know that I'd say there's a particular timing sort of dynamic. But, yeah, we need to sort through all those different pieces. But we'll get the leverage from the improvement at the gross margin level, see that fall through, and maybe some additional OpEx leverage as well.

And the next question is from Conor McNamara from RBC Capital Markets.

One, just quick housekeeping, and this is a follow-up on margins going in next year. But just first off, what is your Q4 implied base revenue growth, ex-COVID, and then what's your Q4 implied EBITDA margins? And are both of those a good jumping off point as we go into next year?

On the revenue side, if you exclude COVID, our growth for quarter four is going to be in the 12% to 13% range at midpoint of the guidance, Conor.

I have op margin in front of me. I don't have it at the EBITDA level, but the implied is probably just over 15% for 4Q for op Margin. Again, I think there's going to be always ebbs and flows as you look at OpEx levels through the course of a given year. And so, we'll determine how that transitions in 2025. But that's the fourth quarter implied at the op margin level.

You talked about the couple of big platform wins with large pharma. Are those competitive wins or you see more activity at the overall market with large pharma?

It's a bit of both, Conor. As you know, we've launched a couple of new systems that are particularly focusing on new modalities about four months ago or so. So you would say like in that specific case, there is not really a lot of competition today, but there are also cases where we know we are getting market share. And what we love about the FlowVPX offering is when people didn't know about it, obviously they didn't think they would need it, but like when you buy a new feature on one of your high-tech products, once you start using the feature and you appreciate it, you realize you can't live without it. So what I think we're starting to really benefit from very broadly on the system side that people realize like having that feature is becoming absolutely critical for them, which is why, for the next buy of equipment, they are just not considering going anywhere else than at Repligen because they want to have that feature offered with the system here.

And the next question will be from Brandon Couillard from Wells Fargo.

This is Evan on for Brandon. A lot's been covered here. One thing I did want to – I think we just kind of touched on in the last question, but in terms of your system strategies, so you put these systems in there and then you have these, I think, fairly high-priced consumables that get attached to them that – you're only able to put on Repligen produced consumables. Can you maybe just talk about how that strategy is helping you guys and how that maybe is helping you to gain share, which is something you talked about previously?

What's beautiful about the system portfolio is not only you're selling a system once, but you're generating future recurrence sales of consumables. And by the way, not only consumable, services as well. So what you want to really ensure is, indeed, the consumable, you're joining to your systems are going to really enable customers to run their processes in a very efficient manner. And one of the reasons why we differentiated ourselves on the system side is because we are really indeed enabling customers to deal with lower volume of products than they were capable of dealing with the other system, for example. So you're right, there will be recurrence sales of consumables over the next several years. We're also making sure from a productivity yield point of view, our customers benefit from a state-of-the-art system that enables them to be much more efficient, much more productive than they were with the other system they got access to. So it's really a win-win on both sides here.

As my follow-up, I don't think anyone touched on this yet, but you did mention a nice win for ATF, I believe, in what you described as a blockbuster drug. I guess now that I think about it, I guess ATF would generally be integrated further down the path as you're looking to kind of increase yields and you're later in the clinical stage. But maybe just touch on, is that the right way to think about it? And then two, how big of an opportunity could this blockbuster drug be as we look into next year?

Actually, the beauty of ATF is you can start using it more or less at any stage. You can start using it at the early stage with the latter scale equipment we have for ATF to become familiar with the technology itself, testing it on early phase projects to figuring out what it can really bring you at the lab scale level. But you can also use it at the very large scale. And in fact, it's particularly interesting for very large scale type of products because, as the name stipulates it, process intensification means you can get higher productivity with the same manufacturing plan just by adding an ATF loop to your manufacturing plan. So what we've seen, and we mentioned it in quarter one of this year is, we've seen a lot of large scale biopharmaceutical products or even biosimilars starting to implement ATF to improve indeed the productivity and the cost of goods. We mentioned we got designed in in about nine late phase projects. At the beginning of this year, this quarter three, we were very happy to get designed in to a blockbuster, which is really one of the top 10 biopharmaceutical drugs, because obviously this is not only generating short term, significant equipment, but in the longer term, very nice flow of consumable for the next several years as well. But really, ATF can be used not only late or early phase, but also with different types of modalities from monoclonal antibody to some of the new modalities as well. We are very happy. As we mentioned, we have great traction. Our sales grew by more than 50% in quarter three. So that's really a very well-performing business for us.

And the next question will be from Matt Hewitt from Craig-Hallum Capital Group.

Maybe first up, for the sake of consistency, I feel like you've talked about your go-forward expectations on a half basis. You talked about one half 2024 being better than the second half of last year, two half 2024 being up versus first half. As we look out at next year, and I realize you haven't provided guidance, but are you anticipating further growth first half versus second half of 2024?

Obviously, yes. We are growing much more in the second half of this year than in the first half of this year, obviously. Talking about 2025, indeed, we are always waiting for the February call to give formal guidance for the next year. But obviously, we are very encouraged by the way the year has played out overall. We had very positive momentum starting in quarter two. It kept on going in quarter three as we are reporting out today. And the first month of quarter four has been very strong as well. So again, our H2 growth excluding COVID is about 12%. We grew 13% in quarter three. The growth ex COVID in quarter four is going to be 13%. So we're in a much better spot today than we were 12 months ago for sure. We just want to wait for the CDMO and the hardware improvement we've seen ourselves in quarter three to be confirmed in quarter four. But overall, yeah, we are like in a much better spot today than we were a year ago. Also keep in mind the seasonality that we – I know we've all forgotten during COVID because we had so much backlog for several quarters that nobody cared about seasonality anymore. Quarter three has always been the weakest quarter for bioprocessing company, which is why we're very happy about the performance we had because we even managed to show growth between quarter two and quarter three. But we know quarter four is always the strongest quarter in the year by far.

Maybe in a similar vein, I think pre-COVID, you typically had good six months visibility. Like you had a very good idea based on order flows and backlog on how things were going to shake out. And then COVID hit and then the reprioritization of pipelines and all these different things that have hit over the past couple of years. Do you feel like you're getting back to that level of visibility that you had pre-COVID where you've got a pretty good sense for how things can shake out over the next one, two, or even three quarters? So kind of back to normal?

In fact, pre-COVID, the typical backlog bioprocessing company would have would always be in the range of three to four months. And then, indeed, during COVID getting bombarded by customer orders and so on, those backlogs went up to sometime up to 10 months or so. So in fact, you could say we had more visibility during COVID than before and after. But, obviously, the 10 months backlog was not a normal situation when you are a bioprocessing company. Yes, back to your question, we are like back to the normal pattern we experienced before COVID for the previous 10 years before COVID. And probably one of the reason why we've been doing very well on the book-to-bill ratio side ourselves now for the last five quarters is because probably we've been back to the normal situation ourselves already for almost a year now. But, yes, the real visibility you always have is typically four months of backlog in that industry.

And the next question is from Subbu Nambi from Guggenheim Securities.

Following up on Puneet's question on M&A, you mentioned product differentiation, but for operating margin improvements, would you consider businesses that would probably help with operating margin despite not drastically changing top line growth rate?

You know what I keep on saying is, you never have the perfect M&A opportunities to go. And you are looking really, first of all, at a different shading technology that will not only add to your portfolio in the short term, but potentially in the midterm as well, because it's very complementary to something else you have. That's a perfect example of the Tantti acquisition that combines Avitide. It's going to give us tons of upside on the resin market side. With the example of the Metenova acquisition where you're acquiring what is mostly a stainless steel mixing business, but now our [indiscernible] single use business is going to enable us to launch a state-of-the-art single use mixing technology which is a best in the industry. So you always start with technology. The second piece you want to look at is how is this really going to complement potentially your A to

And the next question will be from Justin Bowers from Deutsche Bank.

Just taking a step back as we think about 2025, I think most of your peers have characterized it as a year of normalization for the industry. And in your perspective, is that still the case? And what are some of the swing factors that would drive growth sort of at the high end or low end or outside of those ranges into 2025.

Again, that's what I was saying earlier. The situation we're in today versus 12 months ago is very different. Totally different, I should say even now. Look at the traction we've had on CDMOs in the last four quarters. In fact, three out of the four last quarter were really good on the CDMO side. There was only one that was a little bit behind. Pharmas, we were already doing very well beginning of this year, have just improved constantly over the entire year. If I look at quarter three, we had the highest level of orders since 2021 on pharma. Our orders are mid-teens year-to-date on the pharma side. So, pharma are doing very well. The consumable business, we had the highest sales in the last five quarters on consumable. We had the highest orders for the last two years on consumable as well. Equipment, when you say about the watch out, equipment might be one, but from our side, we had a really good performance in quarter three. Again, the funnel we have is at the highest we ever had, which is why we're so very confident about a real turnaround, but probably one we had to watch out a little bit. And then finally, on your modalities, we had a record quarter in quarter three. We never had such a high level of sales. So again, when I look at where we have today versus 12 months ago, we're in a much, much better spot. We've all learned to be just a little bit careful because the recovery has taken much more time than expected. But at least when I look at it from the Repligen point of view, we feel like we're in a very good spot today versus where we were 12 months ago for sure. The only other little watch out I would have really, as I mentioned earlier with Jacob, is on the smaller biopharmaceutical company. It is a fact that we've seen some kind of softness still there, which doesn't impact us too much. As you know, a small biotech business is only 10% of our overall business. But that is something we still need to watch out a little bit. But overall, we think we're on a very good spot today, for sure.

One quick follow up. How are activity levels changing for process development and that part of the value chain within your portfolio?

Honestly, I think there might be more constraint on that side for the reason I mentioned earlier, maybe lower number of clinical start and where funding of biotech is significantly higher this year than it was last year. It hasn't probably been declining now for two quarters in a row. We don't see really a lot of impact from our side because we're just doing a lot of the lunch and learn with customers right now with the traction we have with the big accounts in particular. So we managed to bring a lot of people from the PD Group probably more than ever. We just had an event last week on the West Coast. We have another one coming. I think we had probably three times more PD people than we would have had in the past and so on. So we don't seem to be suffering from that a lot. We're just watching out in terms of the clinical trial start to make sure like funding and clinical trial start are going to recover again in quarter four and beyond that. But overall, we were not particularly worried about that ourselves.

And the next question is from Paul Knight from KeyBanc.

Looking at 2025, what would you say will be kind of your dynamic growth drivers? Will it be protein A maybe getting traction above historical level? Will it be OPUS? Will it be FlowVPX? What are the kind of the two, three products you think are kind of the secret to 2025?

It's probably a bit of all of that, but I'll start by saying, as you all know, we had a lot of headwind entering into 2024. Remember, and obviously with the restatement, the headwind has changed slightly, down probably to about $60 million to $65 million only, but it's still $60 million to $65 million of headwind, which we will have more or less none left next year. So at least on that side, that's going to put us in a much better shape to start 2025. And if I have to pick up really within the different franchises, we are very excited about most of them right now. But if I would have to pick up probably two or three, I would restart with ATF where indeed all of these design-in we've managed to achieve over the last several years is giving us a lot of tailwind in terms of consumable order uptick and then sales for 2025. I'm also very excited about the systems and I know the industry is having some changes but the uptick of orders and funnel we've had is absolutely very good in this difficult environment. For whatever reason, funding on CapEx improved significantly. We should really see a huge increase coming from that side next year hopefully. And then finally on proteins, yes, it has been a tough business for us this year. It's a really reset year for us with no more Cytiva sales and very limited from the second big players. We have so much fraction now coming from our Avitide/Tantti product offering that we think that's going to be a real big tailwind for us. We are launching our first resin combining Tantti and Avitide technologies as early as Q4 of this year. And we are really very positive that this is going to be also generating a lot of growth for the future as well here.

Lastly, cell and gene therapy, what portion of revenue in that market getting better or no?

Like, we've aggregated all new modalities together. So now what we call new modalities also include mRNA, so it's cell and gene therapy, mRNA in particular. We've always said like we were in the range of 18% to 20% of our total revenue going into new modalities. For 2024, it will be the upper end of that of that range. It's not maybe even slightly above. So. I have to say this new modality business for us has been a huge tailwind during the last several quarters. I didn't mention that quarter three was the highest sales we ever had, but even on the order intake side, our order intake year-to-date on new modalities are high teens growth versus 2023. So it's really going very well for us across the board on that side. Well, what I think is making us successful is, first of all, we have a very tailored focus offering for that market. And then secondly, we decided to play across all of these new modalities. You don't want to be only in one or the other because life is teaching you like it's always going in ways where there is a first very positive way, then there might be a slowdown, and then comes the second way. Then antibody drug conjugate is our perfect example where the second wave now is gigantic, and it's very good to be selling products for that type of products line as well right now.

And the next question is from Matt Stanton from Jefferies.

Maybe first one for you, Olivier. I want to follow up to one of your answers to one of the questions on phasing between the halves. I think you said that there's good momentum that's continued in the first half or the first month of 4Q here. Did I hear that right? And then any color on either demand or orders you'd be willing to give for October, just given a bit of a later reporting period this time around with the accounting adjustments?

We won't give any numbers for the timing for sure, but yeah, we had a very strong start to the quarter. We were very, very happy with the October order intake and so on. So which is why we were very confident about the guidance for the year 2024 and the fact we're going to be able to enter into 2025 in a strong position here as well.

I know you guys have disclosed a bit in the past, but any color on what new products added either in 3Q or year-to-date and how that's trended versus historical? And then I would love to get an update on some of the newer launches. I think this was the first quarter, full quarter you were selling the RS 10. If we start to think about 2025, would you expect the new product cohort to fare better given a more normalized demand backdrop or is that cohort of products launched last few years actually held up maybe a bit better even though we've seen some weaker industry demand more broadly.

The impact of new products this year is very similar to the impact it had last year and we're exactly in the same range. We're tracking products that have been launched over the last three to four years and how much of the total sales of the current year they represent. And the overall percentage is very similar to what it was last year. So no real big changes. If I'm more really specific about some of the key launches we had this year, and you mentioned RS10, which for us has been a really great success story because indeed it's mostly focused on the new modalities, partly on the gene and cell therapy and mRNA side of the business. The beauty of this product line back to the stickiness to consumable is that it's generating a significant amount of consumable sales very early because the beauty of new modalities is that you need to run many batches because more or less every single patient needs a single batch. So we see a lot of traction not only coming from the hardware piece but also with significance of the order intake in terms of consumable as well on the RS10 side. Back to FlowVPX which we are now offering across the vast majority of our artists in portfolio. We've been delighted to see now a lot of the new order we're getting on systems are including FlowVPX. We are convinced that in the midterm, it's probably going to be one system out of two that will include FlowVPX. We are not there yet, but the traction we've had has been very significant. And again, we feel like that's going to become a feature that – this is becoming so important for customers that they won't even imagine not having it included in the system they buy in the future. So really good traction on that side. Finally, and I mentioned briefly about it with the acquisition of Tantti, we're all going to be able to launch our first resin, including both Tantti and Avitide, part of the offering quarter of this year. And on this specific resin, we are getting a lot of traction as well already, even though it has not been officially launched yet. So lots of good things coming from NPI. Next year is going to be an exciting year. We're launching our single use mixers and we're going to be launching products more across the entire portfolio in every single business you need. So it's going to be a very strong year next year as well.

And ladies and gentlemen, this concludes today's question-and-answer session. I will turn the conference back over to Olivier Loeillot for any closing remarks.

I would just like to thank you so much for joining our quarter three call. We are really looking forward to seeing many of you at the coming events starting as early at the end of this week. And then on our Q4 call in February, we expect to share our first formal guidance for the year 2025. Have a great day all. Thank you.