Repligen Corporation (NASDAQ:RGEN) Q3 2023 Earnings Call Transcript

Repligen Corporation (NASDAQ:RGEN) Q3 2023 Earnings Call Transcript October 31, 2023

Operator: Good day, ladies and gentlemen, and welcome to Repligen’s 2023 Third Quarter Earnings Conference Call. My name is Keith, and I will be your coordinator. Please note that there will be a question-and-answer session following the company’s formal remarks. In order to accommodate all individuals who wish to ask questions, there will be a limit of two questions at a time. Please also note that today’s the event is being recorded. I’d now like to turn the conference over to your host for today’s call, Sondra Newman, Head of Investor Relations for Repligen.

Sondra Newman: Thank you, Keith, and welcome, everyone, to our third quarter of 2023 report. On this call, we will cover business highlights and financial performance for the quarter and year-to-date and provide an update on our full year financial guidance. Repligen’s CEO, Tony Hunt; and our CFO, Jason Garland, will deliver our report, and then we’ll open the call up for Q&A. As a reminder, the forward-looking statements that we make during this call, including those regarding our business goals and expectations for the financial performance of the company are subject to risks and uncertainties that may cause actual events or results to differ. Additional information concerning risks related to our business is included in our quarterly reports on Form 10-Q, our Annual Report on Form 10-K, and other current reports, including the report that we are 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 only 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: book-to-bill ratio, base business revenue, revenue growth at constant currency; cost of sales, gross profit and gross margin; operating expenses, including R&D and SG&A; income from operations and operating margin; pre-tax income, income tax, net income, diluted 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 best reflect of our ongoing operations. Thank you. Now I’ll turn the call over to Tony Hunt.

Tony Hunt: Hey, thanks, Sondra, and good morning, everyone, and welcome to our Q3 earnings call. As you know, 2023 continues to be a challenging year for our company and the overall bioprocessing industry as we navigate macro headwinds, primarily destocking in the CDMO and pharma sectors overall capital conservatism and China weakness. Despite these challenges, we believe we are beginning to see the first signs of recovery play out here in the third quarter. As noted on our August Q2 call, we highlighted our high probability opportunity funnel as indicative of future order demand and projected that these orders would close in late Q3 and Q4. I’m happy to share that our commercial team closed out many of these late-stage funnel opportunities in the last half of the quarter with the majority of these orders now scheduled for delivery in the first half of next year.

Our strengthening order book through the third quarter where orders were up 16% sequentially supports our position that demand for Repligen’s products is starting to recover. Our book-to-bill 1.07 for the quarter was very encouraging and was primarily driven by large pharma accounts, which were up 50% sequentially and modest growth from CDMOs. Regionally, Europe and North America showed the strongest sequential and year-over-year order gains. The highlights in the quarter was gene therapy, which delivered solid revenue and order growth. About 20% of our total revenue in the quarter came from gene therapy accounts representing growth of 11% year-on-year. Within gene therapy revenues filtration chromatography analytics were up in the quarter.

More importantly, the average spend from our top gene therapy accounts was upgraded than 25% year-to-date as customers continue to scale. Order growth was also strong up over 50% year-on-year and close to 20% sequentially. The gains in gene therapy are coming from late-stage opportunities and commercial wins with AAV and RNA accounts dominating as the broader gene therapy market continues to be muted here at 2023. We are cautiously optimistic about the early signs of recovery we’re seeing. Our expectation is that our markets will improve as we move through the first half of next year. We anticipate that we will have sequential growth in base business revenues in the first half of 2024 versus the second half of this year. For the second half of 2024, we are expecting both sequential and year-on-year gains.

Stepping back now to our third quarter performance, before covering business level performance, I want to spend a few minutes on the three key strategic initiatives that we outlined on our Q2 call. The first is our focus on optimizing our resources and controlling costs. As discussed on the Q2 call, we started to rebalance the resources during the quarter. By the end of the year, we will have reduced our headcount by about 15% versus the end of last year. We will also have consolidated sites optimizing our manufacturing footprint, especially in the area of filtration. This streamlining of our organization will ultimately put us in a much better position to drive future margin expansion as we move into 2024. Jason will cover our rebalancing activities in more detail in his section.

Our second key initiative was to increase our commercial focus and execution. One of the challenges we observed in the first half of the year was the longer cycles on approvals, especially for capital equipment. We also talked about the implementation of a corporate key accounts team to increase our visibility and penetration at our top accounts. During the quarter, we made good progress as the commercial team pivoted to selling our whole product portfolio. The order results including the strong rebound at our pharma accounts, reflect the effort and focus of this team. That said, there’s more work to be done at our CDMO accounts where demand remains soft and our key accounts for ligands and growth factors where the slowdown in pharma spend and project delays have impacted these product lines.

Based on where we are entering Q4, we don’t expect CDMO and protein demand to pick up until early next year. As noted earlier, commercial execution is a top priority for the company. And to that end, we’re delighted that Olivier Loeillot joined us in October as our Chief Commercial Officer. Olivier experienced in bioprocessing, strengthens our team and should prove invaluable as he takes the reins on our commercial team and business units. Moving now to our third area of focus, which is launching new products, and Q3 was a really busy quarter for us. In August, we announced with Sartorius the launch of an integrated bioreactor system that incorporates Repligen ATF technology. This integrated solution simplifies profusion in both seed train and production bioreactors.

Then in September, we announced the acquisition of mixing innovator Metenova to bolster and expand our Fluid Management offering. With the acquisition of FlexBiosys earlier in the year, we could see the need to add mixing technology to this portfolio so we could further penetrate the single use bag market. Metenova addresses this gap with their mixing and drivetrain technologies. Our goal in 2024 is to build out a broader portfolio of single use bag solutions and become a more significant player in this part of the market. As noted in the press release, we expect Metenova to contribute close to $5 million in revenue here in the fourth quarter. Finally, in September, we launched the industry’s first holder free self-contained TFF device, a milestone achievement in the advancement of TFF technology.

This product will be ideal for customers working on ADCs and gene therapy drugs for – where full containment is required. So moving now to our Q3 business results. As you saw in our press release this morning, we delivered $141 million in revenue with our base business down 18% year-on-year, and 8% year-to-date. Business highlights in the quarter included strong performance of gene therapy accounts and another growth quarter for analytics. I’ll cover more on each of our franchises shortly. On the orders front, year-over-year base orders were flat. Pharma and CDMOs were up in the quarter year-over-year with notable strength in pharma, where third quarter base orders were up 23% and orders from our top 10 accounts in pharma were upgraded in 20% year-to-date, which is very encouraging given the drop off in pharma demand in Q2.

Moving now to franchise level highlights. In chromatography, third quarter revenues were down mid single digits versus prior year on tough comps and flat versus prior quarter. Within chromatography, our OPUS business was up on unit volume, but down on revenues as we continued to shift away from Repligen procure addresses. Q3 was a strong quarter in orders for OPUS, up over 20% sequentially with particular strength in North America. For the first nine months of 2023, chromatography revenues were up 5% and we now expect full year revenue to be flat. Our proteins business at a weak quarter as expected for both revenues and orders, mainly driven by delayed projects and slowdown and demanded pharma accounts. As noted on our Q2 call, we continued to expect our proteins business to be down 10% to 15% here in 2023.

In filtration, our year-over-year revenues were down by over 35% in the quarter, driven by predicted sharp decline in COVID related revenue, which was over $25 million in the same period last year. Looking at our base filtration business, year-over-year revenues were down by 17% in the third quarter and 14% for the first nine months of 2023. Within filtration, there were pockets of strength, most notably the RS and TFF systems and assemblies, which were up significantly versus prior year. On the upside, filtration orders during the quarter strengthened with the book-to-bill ratio greater than 1.15. This was driven by strong demand for XCell ATF, where we are seeing multiple site expansions and late stage wins. All in all for the year, we continue to expect the filtration franchise to be down approximately 30%.

Finally, our process analytics business had another growth quarter up 7% year-over-year, but slightly down versus expectations. We are seeing strong revenue in order growth in North America, but weaker demand in Europe and China. We continue to see good traction for our inline analytics portfolio led by FlowVPX and RPM, where we are integrating real-time process management into our KrosFlo TFF systems. While we do expect some year-end dollars to materialize here in Q4, we don’t anticipate that it will be significant enough to get us to 15% growth goal for the business in 2023. We now expect our analytics business to grow in the high single digits for the year. Based on all of these developments, we are updating and tightening our guidance to the lower end of the range discussed on our Q2 call.

We now expect our full year revenue to be in the range of $635 million to $645 million, which reflects a decline of 9% of midpoint for our base business. So overall, while it’s been a challenging quarter on revenues and margins for the business, we have made progress on a number of key initiatives. While macro headwinds continue to persist in the CDMO and China sectors, we’re cautiously optimistic that we are seeing signs of recovery with orders picking up in the quarter at pharma accounts, in particular within our filtration franchise, and continued traction in gene therapy accounts associated with late stage commercial processes. It’s very important that these early signs of recovery persist and broaden to other sectors of the market over the coming quarters.

Before turning the call to Jason, I want to mention that within the next two weeks you’ll be able to access our 2022 sustainability report on our website. We’re really proud of the progress we’ve made on many ESG topics, encourage you to check it out. With that, I’ll turn the call over to Jason for the financial update.

Jason Garland: Thank you, Tony, and good morning, everyone. First, let me say that I’m thrilled to be a part of the Repligen team. It’s been a busy first month in my role and as you can see and you’ll hear this morning, my focus is on optimizing our spending and rebalancing resources to ensure we are in a better position on margins when we kick off 2024. The team has been great and I look forward to picking up where Jon left off and supporting and continuing to provide clarity on the company’s financial and operating performance. Today, we reported our financial results for the third quarter of 2023 and updated our financial guidance for the year. We expected Q3 to be the lightest quarter of the year, and total revenue came in at $141.2 million with no COVID sales in the third quarter compared to $29 million in COVID sales in the third quarter of 2022.

This was a year-over-year decrease of 30% as reported and 31% on a constant currency basis as we continue to navigate through the macro headwinds in our industry. FX provided a slight tailwind in the quarter, and based on current conditions, we expect no significant impact from FX for the full year. Our base business, which excludes COVID related revenue and revenue from acquisitions was down 18% on a reported basis and 19% at constant currency. Tony shared the revenue performance for our franchises, but let me highlight the revenue performance across our global regions. For context, North America represented approximately 50% of our global business in Q3, while Europe and Asia Pacific and the rest of the world represented 34% and 17% respectively.

The absence of COVID revenue in Q3 versus the $29 million in the third quarter of last year contributed to contraction across all regions. Year-over-year, sales declined in North America by 18%, in Europe by 32%, and in Asia Pacific by 49%, with China being the biggest driver of that region’s decline down 58%. Third quarter 2023 adjusted gross profit was $59.3 million, a 48% decrease year-over-year and nearly $60 million of lower revenue, and on a lower adjusted gross margin, which was 42% in the third quarter down from 57% in the prior year. The year-over-year decline in gross margin continues to be driven by the effect of volume deleverage, particularly with the third quarter revenue at a low point. It was also affected by product mix, primarily the sequential and year-over-year declines from our proteins infiltration franchises.

And finally, our gross margins were impacted by higher depreciation and operating expenses tied to our capacity expansions. It’s clearly a driving volume and margin gains need to be our top [ph] company. As Tony discussed, we are continuing to execute a program that started in July to rebalance and streamline the business to support our future margin expansion. There are three main areas of the restructuring plans. First, we are rightsizing headcount and expect to reduce our workforce by 15% versus year end of 2022. Second, we are consolidating a portion of our manufacturing operations, especially where volumes have gone down significantly post the COVID peak. Third, we’re discontinuing the sale of certain product SKUs and took a deep dive into our inventory.

We’re evaluating materials and components that were secured during the 2020 to 2022 COVID-19 period when a rapid acceleration in demand was countered by a supply chain environment that was exceptionally tight and unpredictable. As a result of these restructuring activities, we still expect to realize approximately $15 million in cost savings in the second half, which will help to partially offset the impact of lower sales volumes. To execute the restructuring, we incurred approximately $24 million of charges in the third quarter, of which approximately $21 million were non-cash charges related to accelerated depreciation of fixed assets and inventory write off, and approximately $2 million were severance and employee-related costs. We expect an additional $2 million of severance charges in the fourth quarter.

All of these charges are non-recurring in nature, and are reflected only in our GAAP P&L for the third quarter and total year guidance. Continuing through the P&L, our adjusted operating income was $5.2 million in the third quarter, down $53 million compared to prior year, driven by the $55 million drop in adjusted gross profit just described offset by $2 million year-over-year reduction in total operating expenses. SG&A was down 5% versus last year, benefiting from the rebalancing actions taken in August. And R&D was consistent year-over-year as we invested in technology development and continue to introduce innovative new products like those Tony discussed earlier. Adjusted EBITDA was $14.5 million for the quarter at a 10.2% margin rate. This compares to adjusted EBITDA of $57.9 million with a 28.9% margin for the second quarter of 2022.

Adjusted net income for the quarter was $13.2 million, down $31.2 million versus last year, driven by the $53 million drop in adjusted operating income and offset by higher interest income and $10 million less of tax provisions. Our adjusted effective tax rate was negative 5.6%, driven primarily by the efficient use of cash in our Swedish operation to prepare for the funding of our Metenova acquisition. We have updated our tax rate guidance for the year to be 18% compared to our prior guidance of 20%. Adjusted fully diluted EPS for the third quarter was $0.23 compared to $0.77 in the same 2022 period, a decline of $0.54 or 70%. Finally, we continued to generate strong cash flow and ended the quarter with $630.8 million of cash, cash equivalents and short-term investments.

Please note this cash position does not reflect the Metenova acquisition that closed on October 2. I’ll now move to our updated guidance for the full year of 2023. Please note that our GAAP to non-GAAP reconciliations for our 2023 guidance are included in the reconciliation tables in today’s earnings press release. And for further clarity, our guidance includes both the impact of the FlexBiosys acquisition and the recently announcement of Metenova acquisition. As Tony shared earlier, we’re updating and narrowing our guidance towards the lower end of the range discussed on our second quarter call. We now expect the full year revenue to be in the range of $635 million to $645 million, reflecting in 19.5% to 21% decrease in total revenue compared to 2022.

Excluding COVID-related sales and acquisitions, our base business revenue is expected to be down approximately 8.5% to 9.5% year-over-year compared with our previous guidance of minus 5% to minus 9%. There’s no change in our projected COVID-related revenues of $30 million. However, our revenue guidance does now include an additional $5 million in revenue from the recent Metenova acquisition. We are revising our 2023 adjusted gross margin guidance to the range of 49% to 50%, a one percentage point reduction from our previous guidance. This incorporates the low point of the third quarter results, but also a meaningful step up in the fourth quarter. While the gross profit dropped offset by some – with the gross profit drop offset by some OpEx improvement.

We were modifying our adjusted operating income guidance to a range of $96 million to $100 million for the year, a reduction of $8 million at midpoint from our August guidance. Adjusted other operating income guidance is expected to increase to $22 million compared to our prior guidance of $18 million. And as discussed earlier, we expect the 2023 adjusted income tax expense to be approximately 18% of adjusted pre-tax income down from our August guidance estimate of 20%. With these puts and takes, we’re revising our adjusted net income guidance to the range of $97 million to $100 million, a decrease of $1.5 million at the midpoint from our August guidance, which translates to an adjusted EPS guidance of $1.70 to $1.76 per fully diluted share.

This assumes 57 million weighted, sorry, 57 million weighted average fully diluted shares outstanding at year end 2023. Adjusted EBITDA is now expected to be in the range of $130 million to $134 million, a reduction of $12 million at midpoint from our prior guidance with appreciation and intangible amortization expenses expected to be approximately $37.6 million and $30 million respectively. Adjusted EBITDA margins are expected to be in the range of 20.5% to 20.8% for the year, reflective of the exclusion of fixed appreciation costs from our capacity expansion. We expect year-end cash and cash equivalents to be in the range of $455 million to $465 million, with $45 million of CapEx investments being fully funded by cash generation from our operations.

This revised ending cash figure is inclusive of cash payments made for our October acquisition of Metenova. Overall, we are pleased with many of the developments in the quarter from strong orders at pharma accounts, continuing to execute on strategic M&A and for putting programs in place to address the margin challenges. We remain optimistic about our markets, our differentiated portfolio, and our positioning in bioprocessing, and we look forward to finishing off the year with an improved fourth quarter. With that, I will turn the call back to the operator to open the lines for questions.

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Q&A Session

Operator: Yes. Thank you. We will now begin the question-and-answer session. [Operator Instructions] And today’s first question comes from Jacob Johnson with Stephens.

Jacob Johnson: Hey, thanks. Good morning, everybody. Welcome, Jason. Tony, you mentioned 2024 that’s clearly the focus of the inbounds this morning. So you’re pointing to sequential growth in the first half. But it doesn’t seem like year-over-year growth and then both year-over-year and sequential growth in the second half of the year. That would imply something below your LRP next year and maybe a wide range at that, should we assume some form of year-over-year growth, I think consensus is looking maybe for something around high single digits organic growth next year, just any way to kind of frame up the magnitude of growth next year understanding it’s early?

Tony Hunt: Yes, Jacob. I think it’s going to be hard right now to put a number on 2024. I think there’s a high degree of confidence given what we’re seeing in the second half of this year that the first half of next year is going to improve and it’s going to be better. The magnitude of how much better? I don’t know right now. And I can also say that as we go through the year, we fully expect that orders are going to continue to improve. For us, in this quarter though was really key, right? We needed to see some change in the order pattern and it’s early, but I think it was very positive to see pharma up greater than 50%. So it really depends on how Q4 plays out, how Q1 plays out before we start calling. How much growth do we see in the first half of next year versus second half, and then year-over-year? Is that flat? Is that down? It’s hard to tell right now.

Jacob Johnson: Got it. Fair enough. And then maybe for the follow-up, Tony, you all called out strength from gene therapy customers. I think there’s a lot of debate right now about what’s going on in cell and gene therapy. It seems like maybe there’s strength at the later stage of things while maybe earlier stage demands weaker. Just curious kind of what you’re seeing in that market right now and then any changes to kind of your long-term outlook for that opportunity?

Tony Hunt: Yes, gene therapy, we’ve been pretty consistent as we talk about the gene therapy market this year. Our growth is coming from late stage and commercial wins. And it’s coming from those accounts that we talked about at the – on our Q4 2022 call where we said that we had 20 plus customers that were $1 million plus spend with Repligen. That’s where our growth’s coming from. You’re spot on when it comes to the kind of smaller players in the market, it’s been soft, right? It’s definitely been a lower activity market in 2023 versus what we saw last year. I expect though that that’s going to change. And when you look at a normal bioprocessing year, whatever normal is going to be right now. I would say that it’s a pretty clear that gene therapy can be a 20% plus grower somewhere in that 20% to 30% range. But you’ve got to get back into normal market conditions before you kind of can call that.

Jacob Johnson: Got it. Thanks for taking questions.

Operator: Thank you.

Tony Hunt: Thanks, Jacob.

Operator: Thank you. And the next question comes from Conor McNamara with RBC Capital Markets.

Conor McNamara: Hey, good morning. Thanks for taking the call. Just first on margins, if you look at your margin guide for this year, and it’ll imply a second half margin well below 15% or so. How should we think about that going into next year? And how quickly can you get back to pre-pandemic level EBIT margins?

Jason Garland: So, Conor, we’re obviously, as I’ve started, I’ve spent a lot of time getting in the details on our margin and most importantly, understanding what the actions we’re taking and what we need to continue to do. You can see in our guide that we’ll be stepping up in the fourth quarter right from where we were at a low point in 3Q. But I think there’s still a lot of work to do to understand where we are in 2024. Certainly, I think we’ll be able to improve, but right now we’re not going to issue guidance yet on our 2024 gross margins.

Conor McNamara: Okay. Thanks. And just on the pharma order strength, can you – how much of that strength was from new customers versus continuing projects and just what’s different than what you talked about three months ago in relation to pharma spend?

Tony Hunt: Yes. We could see Conor right in Q1 that pharma spend dropped off just a little bit. But it wasn’t a trend. And then Q2, it was really weak. I think what we were able to do in Q3 was the high probability funnel that we talked about on our Q2 call. We’re able to close out on that. And what we saw was existing customers some new, but I would say majority are existing customers. Moving forward with Phase 3 in commercial projects and placing large orders with deliveries in kind of the first quarter, second quarter of next year. So I think it’s very encouraging that the order pattern has increased. I’d like to add that having essentially finished the month of October, right, as of today, we can say that the order strength has maintained itself through October. So again, another data point that I think is positive for Repligen.

Conor McNamara: Great. Thanks for that color, Tony. Appreciate it.

Operator: Thank you. And the next question comes from Dan Arias with Stifel.

Dan Arias: Good morning guys. Thanks for the questions. Tony, on the order of book improvement, good to hear that come in the way that it did. Are you able to ballpark the percentage of the business where things actually improved? It sounds like it’s pharma gene therapy, not so much CDMOs. So if you were to sort of crystallize or simplify that, what might that look like assuming you have that number handy?

Tony Hunt: Yes. No, it’s absolutely pharma and CDMO or not CDMOs, but pharma and gene therapy. If you go back to what I said, we were 50% up on pharma on orders sequentially. We were 23% up on pharma on orders year-on-year. Our gene therapy strength in orders again was 50% year-on-year, 25% sequentially. CDMOs inched up a little bit in the quarter. But I would say CDMOs remain sluggish and have not really recovered from where we were in Q3, when it dropped off dramatically in Q3 of last year. So the way I look at it is, if you add up kind of pharma and gene therapy in one bucket, that’s probably about 50% of the revenue the company is coming from those two buckets. And then somewhere between 40% and 50% is coming from CDMOs and what we call integrator/OEM and those – that side of the ledger is just hasn’t moved.

Dan Arias: Yes. Okay. That’s helpful. Thanks. And then maybe on Chromatography, can you just touch on resin availability there? And at this point, whether you think that you might start 2024 off with that just no longer being a constraint, that seems like an area where growth next year can be about more than just the backdrop – the industry backdrop. So curious about the way in which you’re thinking about starting off 2024 in that particular segment? Thanks.