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spk15: Good morning. Thank you for attending today's Catalan Inc. fourth quarter fiscal year 2022 earnings call. My name is Forum, and I will be your moderator for today's call. All lines will remain muted during the presentation portion of the call with an opportunity for public and private questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. It is now my pleasure to pass the conference over to our host, Paul Serdez, Vice President of Investor Relations. Mr. Serdez, please proceed.
spk19: Good morning, everyone, and thank you for joining us today to review Catalan's fourth quarter and full fiscal year 2022 financial results. Joining me on the call today are Alessandra Maselli, President and Chief Executive Officer, and Tom Castellano, Senior VP and Chief Financial Officer. Please see our agenda for today's call on slide two of our supplemental presentation which is available on our investor relations website at investor.catalan.com. During our call today, management will make forward-looking statements and refer to non-GAAP financial measures. It is possible that actual results could differ from management's expectations. We refer you to slide three for more detail on forward-looking statements. Slides four and five discuss Catalan's use of non-GAAP financial measures and our just-issued earnings release provides reconciliations to the most directly comparable gap measures. Please also refer to Catalan's form 10-K that will be filed with the SEC today for additional information on the risks and uncertainties that may bear on our operating results, performance, and financial condition. Now, I would like to turn the call over to Alessandro Maselli, whose opening remarks will begin on slide six of the presentation.
spk03: Thanks, Paul, and welcome, everyone, to the call. Fiscal 22 was another extraordinary year for Catalan. During the year, we achieved strong results, both financially and operationally, while also making a positive impact on our global community by delivering our mission to develop and deliver products that help people live better and healthier lives. Some of our top highlights since July 21 include significantly investing in capacity and infrastructure in both North America and Europe particularly focused on servicing the high demand segments of the market. Adding another growth engine to the company through our entry in consumer-preferred dosage, Garnley dosage forms for nutritional supplements, which we continue to aggressively expand. Agreeing to acquire a new capacity that will accelerate our ability to handle demand in the attractive category of high-depot and compounds. Expanding and deepening one of our best talent tools in the industry. intensifying our long-standing commitment to sustainability, accelerating our growth strategy, and delivering regular financial results despite a difficult inflationary environment and ongoing supply chain challenges. Fiscal 2022 net revenue was $4.83 billion, which grew organically in constant currency at 20% compared to prior fiscal year. This growth was primarily driven by broad demand for our biologics offerings including the demand for COVID-19-related programs, increased demand for our customer prescription products, and a rebound in demand for our consumer health products. Adjust EBITDA for the year was $1.29 billion, reflecting cost and currency organic growth of 28% compared to fiscal 21. We also increased our Adjust EBITDA margin to 26.6%, up 110 basis points from 25.5%, we recorded in fiscal 21. Fiscal 22 adjusted net income was $694 million, or $3.84 per diluted share, up from $3.04 per diluted share in fiscal 21. Now, focusing on the fourth quarter, I'm pleased to report that we have closed out the year with strong results, as our robust business momentum more than offset headwinds from inflation and unfavorable exchange translations. As shown on slide 7, our fourth quarter revenue was $1.31 billion, increasing 10% as reported, or 15% in constant currency, compared to the fourth quarter of fiscal 21. When excluding acquisition and divestiture, organic growth was 10% measured in constant currency. This growth was primarily driven by our biologic segment, which grew double digits despite lower year-on-year revenue in the quarter from COVID-19 programs. Our fourth quarter adjusted EBITDA was $384 million, increased 10% as reported, or 16% on a constant currency basis, compared to the fourth quarter of fiscal 21. When excluding acquisition and divestiture, organic growth was 15% measured in constant currency. Our adjusted net income for the fourth quarter was $215 million, or $1.19 per diluted share, up from $1.16 per share in the corresponding prior year period. As you know, we put in place a new organizational structure effective July 1st, the start of fiscal 23, which was also the same day I transitioned to my current role as a CEO. Our new structure will help us better manage the business as it has grown over the last few years, while also enabling a value creation by giving our customers easier access to a broader array of our services. The reorganization has reduced our number of operating segments from four to two, with one focusing on biologics and the other on pharmaceuticals and consumer health. Each segment represents roughly half of the total company revenues, illustrated on slide eight. We will begin reporting our results under these new structures, starting with our first quarter earnings goal in early November. We'll also issue a restatement of recent historical results under the new structure in the coming weeks. The new pharma and consumer health segment includes the offering of three of our prior segments, soft-gen and oral technology, oral and specialty delivery, and clinical supply services, and overwhelmingly serves small molecule programs. Notable offerings in pharma and consumer health segment include our market-leading capabilities for complex oral solids, software formulation, Zadis fast-dissolve tablets, gummies and soft shoes, and clinical development and trial supply services. We have established dedicated teams focused individually on pharmaceutical, consumer health, and clinical development and supply offerings. Our long-term net revenue growth expectation for the pharma and consumer health segment is 6% to 10%, which is 200 basis points higher at the upper end than the combined growth rates of the three previous segments now included within this new segment. This is due to the commercial synergies unlocked by our new go-to-market strategy enabled by this organizational structure and greater exposure to higher growth sectors of small molecule market as a result of recent investment and acquisitions. The new biologic segment is essentially the same as the biologic segment we reported in fiscal 22. With some internal organization adjustments, we could better service the newer modalities employed by many of our biopharma customers. Our expected long-term net revenue growth rate for the biologic segment remains at 10% to 15%. There are several benefits to this important structural change. First, the simplified reporting structure enables us to be more agile in meeting and anticipating customer needs and expectations. as well as adapting to evolving customer and industry trends. Second, creating a more integrated offering makes it easier for customers to do business with Catalan, leading to an enhanced customer experience and minimized barriers for existing and potential customers to access multiple services, thereby enabling commercial synergies. Finally, it allows for even greater operational excellence, as horizontal quality and operations oversight bolsters accountability across the network. Importantly, based on our confidence in the long-term growth expected across both segments to our continued investment and synergy resulting from our reorganization, we are in a comfortable position to raise the top end of our project to consolidate the long-term growth rate to 12% compared to the previous 10% as shown in slide 8. Looking to fiscal 23, while Tom will review the details of our guidance later in the call, I would like to make some high-level remarks on our revenue outlook. I indicated on our last earnings call in May that we were comfortable projecting a fiscal 23 organic growth in line with our previous long-term organic revenue growth rate of 8% to 10% despite our focus for a considerable decline in revenue from COVID-19-related problems. Since then, given the more pronounced seasonality we project in customer ordering for these programs, as well as the facing of our fiscal year, we have further delisted the level of COVID-related care revenue in our guidance model. The new model used for the guidance we are sharing today takes into account the updated timing of the switch to single-dose formats and forecasts are roughly two-thirds decrease in COVID vaccine-related volumes in fiscal 23 compared to fiscal 22. After accounting for this additional de-risking of COVID revenue, we still expect fiscal 23 organic growth at the midpoint to be around the low end of our long-term range on a constant currency basis. Our projection of fiscal 23 revenue growth is driven by our non-COVID business, which is expected to grow organically by more than 25% at cost and currency due to several factors, including growth expansions of existing assets that came online in the past year, such as our new drug substance lines in medicine and drug product lines in Bloomington and Europe, maximizing efficiencies in other areas of our global network, including those that manufacture our GAMNI format and previously announced build-outs of our cell therapy and plasmid offerings in Europe and U.S., adding a new capacity in the next two quarters, including the opening of eight previously announced gene therapy suites in BWI and additional drug substance capacity in Bloomington. The large commercial tech transfer programs in our drug product assets we discussed on our last earnings call and later in Fiscal 23, our two new facilities currently completing construction, our commercial cell therapy facility in Princeton and our drug substance facility in Oxford will start to generate meaningful revenue. Additional growth not reflected in the Fiscal 23 guidance we are issuing today is anticipated following the closing of our recently announced agreement to acquire Metrix Contract Services, a full service specialty CDMO with a 330,000-square-foot facility in Greenville, North Carolina, for $475 million from Main Pharma, as summarized on slide 9. The acquisition of this business and facility, which has enjoyed well over $100 million in capital improvements in the last five years, will enable Catalan to accelerate existing plans to meet the increasing demand for fit-for-scale, high-potent drug manufacturing. Of course, the acquisition remains subject to customary closing conditions, including antitrust clearance. We expect to close the acquisition before December 31st. One reason for our enthusiasm about the metric business is the growth in the number of pot and compounds in the oral solids market, driven by strong growth in the oral oncology pipeline, where more than 80% of programs require pot and handling, as well as the industry shift to in silico discovery which often yields more potent and less soluble molecules. In the last several years, Catalan has seen numerous opportunities to work with the highly potent compounds, which we can now service after we complete the acquisition of Matrix. Matrix greenery facility generated the revenue of more than 90 million during our fiscal 22 from services from 30 party customers, including large pharma and emerging biotech customers, as well as manufacturing services for several main pharma-owned products. I note that our deal with the main pharma includes a long-term supply agreement to manufacture certain of its products at the Greenville facility after closing. Once acquired, the metric business will become part of our pharma and consumer health segment and is expected to deliver revenue growth comparable to the segment's projected overall long-term growth of 6% to 10%. Metrics EBITDA margin is accretive to the PCH margin, and we intend to drive this margin above 30% over time by increasing utilization. Adding important handling capabilities in fit for scale capacity through metrics represent a continuation of our strategy to maintain a balanced portfolio of offerings that closely matches the overall industry pipeline. which includes a growing number of innovative small molecules that are complex to formulate or require specialized handling. While innovation in the biologics market is more frequently mentioned in the headlines, oral delivery is still the foundation of the prescription drug pipeline with almost 6,000 oral compounds currently in development, up approximately 10% from last year, and has been the focus of recent substantial pharma M&A activities. The combination of our strategic acquisitions like Magix and our organic investments has positioned our overall portfolio for long-term success, including being in a strong position to meet our long-term targets. As I wrap up my remarks this morning, let me add that the goals and objectives for Fiscal 20 Reset by me and the rest of the executive team laid the foundation for executing on our long-term strategy. and also help a position us to deliver another strong fiscal year as we navigate the obstacle facing our industry today, which include the continuing supply chain challenges, inflationary pressures, energy supply issues in Europe, the uncertainty in the biotech funding, and lower and more seasonal demand for vaccine as we exit the pandemic. I am energized by our strategic growth ambitions, the roadmap we have in place, and the Catalan team working together to deliver for patients who rely on us. We continue to be in a strong position to succeed in the attractive markets we serve. Finally, I would like to congratulate Karen Flynn, who was elected by our board of directors last week to become the board's newest member, effective September 15. Karen recently retired after a long and distinguished career in the pharmaceutical industry, with her most recent role as Catalan's Senior Vice President and Chief Commercial Officer, and we are delighted to be able to continue current involvement with the company. Now, I would like to turn the call over to Tom.
spk02: Thanks, Alessandro. I'll begin this morning with a discussion on segment performance, where commentary around segment growth will be in constant currency. I'll start on slide 10 with the biologic segment. Biologics net revenue in Q4 of $667 million increased 14% compared to the fourth quarter of 2021. The strong net revenue growth was driven organically by increased demand in our cell and gene therapy, drug product, and drug substance offerings, which more than offset lower year-over-year revenue from our COVID-19-related programs. Our fiscal 2022 third quarter marked the peak in our COVID-19-related revenue, with Q4 down both sequentially and year-over-year. When looking at the bar graph on slide 10, you will see that biologics commercial revenue declined year on year. The driver of the year-over-year decline is the conclusion of a COVID-19 program that was classified as a commercial product for revenue recognition purposes. This program is not expected to generate future revenue. The segment's EBITDA margin of 32.8% was up more than 210 basis points year-over-year from the 30.9% recorded in the fourth quarter of fiscal 2021 and up 170 basis points sequentially over the third quarter. Year-over-year margin expansion was fueled by strong operational efficiencies, which more than offset the impact of remediation activity in Brussels. Note that remediation-related costs were lower in Q4 than in Q3, and remediation activity continues at the site in fiscal 2023. In addition, margin was aided by a mixed shift away from lower margin component sourcing revenue, which, as mentioned on past calls, represents approximately 25% of total COVID vaccine revenue. As COVID-19 revenue continues to decline, so will the related diluted margins from component sourcing that we have recently experienced. As shown on slide 11, SoftGel and Oral Technologies net revenue of $350 million increased 22% compared to the fourth quarter of fiscal 2021, with segment EBITDA increasing 9% over the same period last fiscal year. The October 1st, 2021 acquisition of Baterra contributed 18 percentage points to SOT's net revenue growth and 13 percentage points to the segment's EBITDA growth during the quarter. The operational performance of the acquired Baterra business continues to exceed our expectations and remains an important driver for continued margin expansion for the company. SOT organic net revenue increased 4% and was driven by continued growth in development revenue, as well as demand for both prescription products and consumer health products. However, supply chain challenges, inflationary pressures, and unfavorable mix weighed on overall organic results, muting the impact of increased product demand. Slide 12 shows the results of the oral and specialty delivery segment. Net revenue grew 11% and segment EBITDA was up 27% over the fourth quarter of last year. Overall demand for Arzitis offerings reached a record level, fueling significant growth. This strong demand was further supplemented by revenue from a royalty agreement related to Arzitis platform, which was a primary driver of the segment's strong EBITDA margin. As shown on slide 13, our clinical supply services segment posted net revenue of $104 million, representing 4% growth over the fourth quarter of fiscal 2021, driven by growth in our storage and distribution services. Segment EBITDA declined 2%, driven by unsafe rule mix. As of June 30, 2022, backlog for the segment was $540 million, up from $529 million, at the end of last quarter and up 10% from June 30th, 2021. The segment recorded net new business wins of $132 million during the fourth quarter compared to $119 million in the fourth quarter of the prior year. The segment's trailing 12-month book-to-bill ratio is 1.1 times. Moving to our consolidated adjusted EBITDA on slide 14, our fourth quarter adjusted EBITDA increased 10% to $384 million, or 29.2% of net revenue, which was roughly in line with the fourth quarter of fiscal 2021. On a constant currency basis, our fourth quarter adjusted EBITDA increased 16% compared to the fourth quarter of the prior year. For the full year, adjusted EBITDA increased 26% to $1.29 billion over fiscal 21, and 28% on a constant currency basis. Adjusted EBITDA margin increased 110 basis points to 26.6% in fiscal 22 from 25.5% in fiscal 21. As shown on slide 15, fourth quarter adjusted net income was $215 million or $1.19 per diluted share. compared to adjusted net income of $209 million, or $1.16 per diluted share in the fourth quarter a year ago. For the full fiscal year, adjusted net income was $694 million, or $3.84 per diluted share, compared to adjusted net income of $549 million, or $3.04 per diluted share in fiscal 21. Slide 16 shows our debt-related ratios and our capital allocation priorities. Catalan's net leverage ratio as of June 30th, 2022 was 2.9 times, slightly below our long-term target of 3.0 times. This compares to net leverage of 2.6 times on March 31st, 2022 and 2.2 times on June 30th, 2021. Our combination, our combined balance of cash, cash equivalents and marketable securities as of June 30th, 2022 was $538 million, compared to $880 million as of March 31st, 2022. Note that our free cash flow has been negatively impacted the last two years by our strategic decision at the onset of the pandemic to increase inventory levels, which continue to allow us to have the inputs we need to meet our supply obligations to our customers and their patients in a timely manner. When we feel the time is appropriate, and are more comfortable with the stabilization of our supply chain, we will begin to reverse course, which will have a future positive effect on free cash flow. Similarly, the realization of contract assets will also drive a favorable impact on future free cash flow after negatively impacting our fiscal 2022 results. As of June 30th, 2022, our contract asset balance was $441 million. an increase of $260 million compared to June 30th, 2021. The overwhelming majority of this increase is related to some notably large development programs, such as for some of the COVID vaccines where revenue is recorded based on a percentage of completion versus entirely on batch release as it is for commercial programs. This difference in approach affects when we are able to invoice customers thereby delaying cash realization and negatively affecting free cash flow. Moving on to capital expenditures, we added a new slide in the appendix to illustrate our annual CapEx spend. In fiscal 22, CapEx as a percentage of revenue was 14% compared to 17% in fiscal 21. CapEx as a percent of revenue was a bit lower than we initially expected for fiscal 22, by higher than expected revenue growth, as well as some supply chain related delays and longer lead times than initially anticipated for some of our capital projects. For fiscal 23, we expect CapEx to be in a similar range as fiscal 22, or approximately 13 to 15% of net revenue. Now we turn to our financial outlook for fiscal 2023, as outlined on slide 17. The midpoints reflected in our outlook assume the challenging macro environment remains stable. We expect full year net revenue in the range of $4.975 billion to $5.225 billion, representing growth of 3% to 8% on an as-reported basis compared to fiscal 2022. Current FX rates, which we use in this forecast, are forecasted to have a negative impact of approximately three to four percentage points on our revenue and adjusted EBITDA growth. We project that inorganic revenue, which basically reflects one remaining quarter of the Batera acquisition until the first anniversary of that acquisition on October 1st, will positively impact our annual growth rate by less than one percentage point. After taking into account these two considerations, our expected organic constant currency net revenue growth rate in fiscal 23 is approximately 8% at the midpoint of our guidance range. The acquisition of metrics will be factored into updated guidance we will share during the first earnings call following the close of the transaction. For full year adjusted EBITDA, we expect a range of $1.31 to $1.39 billion representing growth of 2% to 8% at reported rates compared to fiscal 2022. I would like to remind you of the seasonal nature of our business where revenue and EBITDA generation is historically more weighted to the back half of the year with roughly 60% of fiscal 2023 adjusted EBITDA expected to be generated in the second half of the year. Now we expect limited EBITDA margin this year on a constant currency basis. While we're still on track to achieve our fiscal 2026 EBITDA margin target of 30%, there are a number of factors impacting margin expansion in fiscal 23, including headwinds from COVID-related volume declines that we have been anticipating, inflationary and supply chain pressures, startup costs related to our acquisitions of Princeton and Oxford which we are absorbing in our organic assumptions because neither asset generated substantial revenue prior to its acquisition and foreign exchange translations as our margin profile is higher outside of the U.S. while the majority of our corporate costs are domestic. Note that swings in the Euro have a greater impact on FX translation than the pound. Moving to adjusted net income, we expect full year ANI of $660 to $730 million, representing a range from a decline of 5% to an increase of 5% compared to fiscal 2022. However, ANI is negatively impacted by FX translation of more than four percentage points. In addition, ANI growth in fiscal 23 is being impacted by all of the items affecting adjusted EBITDA, as well as the following items. First, an expected higher effective tax rate in the 24% to 25% range compared to 23.4% in fiscal 2022 given the year-on-year increase in the weighting of earnings in higher tax jurisdictions. Second, an increase in interest expense due to servicing the full year of new debt we raised in part to fund the Matera acquisitions as well as other interest-related increases in the current rising interest rate environment. And finally, increased depreciation expense due to our significantly larger asset base, which is also more heavily weighted in the US. The last piece of our guidance is the fully diluted share count. As in the past years, we offer guidance on share count on a diluted weighted average basis, which is the number needed to compute our adjusted net income per share, or adjusted EPS. For fiscal 23, we expect our share count to be in the range of 181 to 183 million shares. Operator, this concludes our prepared remarks, and we would now like to open the call for questions.
spk15: Absolutely. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by two. Again, to ask a question, press star one. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question. Please limit your questions to one question and a follow-up question, and then re-queue for any further questions. Our first question comes from the line of Sejas Savant with Morgan Stanley. Sejas, your line is now open.
spk16: Hey, guys. Good morning. So maybe just following up there, Tom, on your remarks on the margin headwinds, You know, outside of that 300 to 400 pips FX hit on both the top line as well as EBITDA, can you share some color on the moving pieces here in terms of the facility remediation, the new facility ramps, and COVID contributions normalizing? And I think you also called out some inflation dynamics. So if you can just share some color and help build a bridge from where you finished fiscal 22 and the midpoint of the guide next year on EBITDA margin, that would be helpful.
spk02: Yeah, sure, Teja. So thanks for the question. Yeah, so your numbers are spot on in terms of FX. We did talk about FX impact of three to four points on the revenue and EBITDA. We do see a little bit more of an impact to the bottom line from FX than we do to the top line, just given the geographic, I would say, mix of earnings there. So I would say the EBITDA impact to FX is more towards the top of that range where the revenue impact, I would say, is more towards the low to the midpoint of that range. So figure somewhere between a half a basis point difference between revenue and EBITDA there. Other items, you know, I did mention in my comments that we do have remediation efforts continuing in Brussels here into our fiscal 23. That obviously is reflected into our guidance for sure. From a COVID standpoint, we mentioned in our prepared remarks that we have taken a two-thirds haircut to the volumes we saw in fiscal 22. In our fiscal 23 guidance, that's further de-risking from what was assumed as part of our May comments on our third quarter call here. And just given that decrease in volume and the absorption impact-related impact to running at high levels of utilization on COVID-dedicated lines, there is a relative impact to our overall margin profile as a result of that. Supply chain and inflationary pressures, I would say, continue to be a challenge, and in some cases, even I would say more of a challenge now than they were in terms of how we've talked about this in the past. We've seen more supply chain impacts to our SOT segment, specifically more recently around our ability to get our hands on active ingredients and other key inputs related to consumer health volumes. So that will play a role into a little bit of the margin story here. And then just from an inflationary standpoint, I mean, look, just given the environment we're in, we're looking at impact related to wages that are probably about two times what we would have seen in a normal year, and that doesn't take into account what we're seeing on just the material side of things as well. Now, obviously, we're able to pass those off to customers. We're doing that. We're going after price where we can as well to help offset some of these pressures. But, you know, giving all of these moving pieces here to be sitting in a position on a constant currency basis where we are seeing modest margin improvement is a pretty good position to be in and what I would consider the most, you know, challenging macroeconomic environment I've seen in my career. Lastly, I would just say we continue to be on track from a long-term margin target year, Tejas, although we're not going to see the margin expansion of 100 plus basis points like we've seen over the last several years. We remain committed to our 28% EBITDA margin by, I'm sorry, by our 30% EBITDA margin by fiscal 2026.
spk16: Got it. That's super helpful, Tom. And then one for Alessandro, you know, just in terms of the impact of the new operating structure from a customer standpoint, what changes versus before any color there on the commercial synergies that you alluded to? And as you think about, you know, the segment growth rates that you had pointed to, you know, embedded in your prior long-term target, where do you expect to see the biggest uplift?
spk03: Sure, sure. Look, This is very simple in many ways, although not easy, as it requires a little bit of organizational adjustment. Look, when you look at the percentage of our customers which are buying more than one service from Cataract, it is still a relatively low percentage, and when you look at where the customer base is going with more and more customers which are more on the small side, the biotech type of customers, clearly they have the need of way more than just one service out of Catalan. And there is an opportunity there to significantly increase the share of existing customers, which, and the new customers, will enjoy more than one service out of a Catalan offering. In the past, our previous organization was creating some internal barriers from that to happen, both from a go-to-market strategy and from an execution standpoint. And by combining all of these together, clearly those barriers have been removed. There are incentive plans allowing people to benefit from cross-offering wins. We are already seeing, since the onset of this new organization, some very good trends in these regards. With regards to the increased guidance for this segment, look. have made already investments in the gamete business. We already said that this gamete business is growing significantly above the average of this segment. We also have expanding and resolved some bottlenecks we have in the capacity on the complex oral solid business in North America, which was constraining in the past a little bit our growth. It was self-constrained. We did have demand. We see demand. And we couldn't really enjoy the whole demand that we were seeing there. And lastly, the fact that we are now both organically and inorganically opening up our offering to Hypotent, which is the fastest growing subsegment of oral solids, primarily driven by the oncology pipeline. All of that combined really has an impact on the expected growth rate of these segments. So in many ways, these were things in the making over the last two years unlocked by these new organizations.
spk16: Got it. Very helpful. Appreciate the color.
spk15: Thank you for your question. Our next question comes from the line of Luke Sergot with Barclays. Luke, your line is now open.
spk04: Good morning, guys. Thanks for the question. So jump in real quick here on the guide. Can you help frame us what the range of COVID is down based on the guidance for 23? So if the midpoint is down two-thirds on the volumes, what the worst-case scenario would be and best case for you guys?
spk02: So, Luke, I would maybe just start here by saying I don't know that – that there's a significant variation around COVID volume to the low end here. I would say, you know, the levels that we've taken COVID volume down is reflective of contractual obligations that we have with key customers and, you know, decreasing at two-thirds from where we were in fiscal 21, you know, puts it down to a, you know, a relatively, you know, much smaller level than it has been contributing in the past. I would say you know, that's not an assumption that I would say is really the variability here in terms of the guidance range. Now, there's obviously, if we see any significant increases here related to COVID demand, that can, you know, factor into the high end or, you know, outside on the high end of the range, but I wouldn't say that there's a material swing in the assumption around COVID throughout the range of guidance. I would say the real variability here in terms of our range is just You know, a lot of the supply chain related challenges that we saw, and are we going to have any difficulty in getting our hands on materials there? As I mentioned, the midpoint of the range assumes that the macroeconomic environment we're in today remains steady. If that were to get worse, that would be more of a potential impactor. to getting us towards the lower end of that range versus any further movement on the COVID side, which, as I said, we feel pretty good around and is, you know, pretty much a firm outlook here based on contractual obligations.
spk03: Yeah, the other piece I would add, Luke, here, is during the spring, we have said many times that, you know, there was still a number of variables significantly impacting the potential outlook on COVID vaccine demand. And those variables were primarily related to what is our second half of our fiscal year, meaning the first half of next calendar year. So some of those variables have settled now and are clearer, primarily with regards to how the vaccines are going to behave from a seasonal standpoint. We made the reference in our script that now we have a pretty good outlook around the seasonality of the of the vaccines and so forth. And so we are in a better position to focus the second half of our fiscal year, which is the first six months of next year. So I believe that this is a solid outlook we are providing today.
spk04: All right, great. And then just a quick follow-up on that. So, I mean, you guys are talking about the offsets coming from all the capacity expansions that you've done in Bloomington and Indianapolis and then the suites coming on and Princeton and elsewhere. Can you just help us think about when there's these supply chains, you know, is there a particular indication that it's hitting hardest or is it just broad based? And then can you give us a sense of how you're how you're thinking about these easing?
spk03: You know, Look, when it comes to these new assets, these new assets is a combination of several assets which were meant to meet demand in a number of therapeutic areas, which we have seen over the last three years potentially in high demand. One of these is diabetes, which combines now with some obesity as well, neurological disorders, And surely oncology, you know, the new approved cell therapies for the oncology pipeline are pretty remarkable, and this is an area where we see opportunity. So all these assets were primarily built to meet these demands coming from these indications and therapeutic areas.
spk02: Yeah, I would just add to that, you know, Luke, as I highlighted earlier in my comments to Tejas, A lot of the supply chain challenges that we've been seeing more recently have been impacting our SOT business and particularly on the consumer health side. So, not, you know, geared towards those large molecule biologic assets that you were referencing.
spk04: Yeah. Awesome. Great. Thank you.
spk15: Thank you for your question. Our next question comes from the line of Julia Kinn with JP Morgan. Julia, your line is now open.
spk14: Hi, good morning. Thanks for taking a question. So just a couple to clear up the guidance. First, regarding fiscal 23, I heard you on kind of attributing the update guidance to de-risked COVID revenue and FX. How about the outlook for the other non-vaccine businesses? Has there been any changes? And in light of the inflationary pressures you said earlier, how much pricing contribution are you embedding in the guidance?
spk02: Sure. So look, I would say with the de-risking here from a guidance standpoint, you broke up a little bit during the second part of your question, Julia, so I'll do my best here to answer it. But in terms of the first part, you know, we did mention that we are seeing the base business here growing in excess of 25% in the fiscal year. That's going to be a significant offset to the two-thirds reduction COVID-related volume that we have in our fiscal year. 23 guidance, and that does contemplate growth across all of our technology offerings. I would say from a biologic standpoint, we are seeing X growth, X COVID growth on the drug product side, but obviously cell and gene therapy is a significant contributor to the fiscal 23 growth story. That is a business that was not significantly impacted by COVID-related demand or drug substance. business out of both Madison and Bloomington, as well as capacity that we'll be bringing online in Europe as a result of the Oxford facility. That was another business that is obviously not significantly impacted by COVID-related demand that we will be seeing growth from in fiscal 23. I think there may have been a part of your questions around COVID therapeutics in here. I would say COVID therapeutics are not a significant growth driver, as we've talked about, The bulk of our COVID-related revenue has been from more vaccine-related revenue. And in terms of, I think the second part of your question was related to supply chain challenges and what the impact there is. And, you know, I think we've talked about that already, mostly impacting the consumer health side of the business. In terms of deflationary pressures, you know, we are seeing wages up two times to what they would be in a normal year, as well as seeing increases from many suppliers on the vendor side. And we're looking to be active in terms of being able to recoup that through our customers where our contracts give us the ability to, as well as I would say driving off cycle price increases where we're able to from customers to ease that impact. But again, despite all of those challenges, we are looking at modest margin expansion at the midpoint of our fiscal 23 guidance on a constant currency basis.
spk14: Great, thanks. And on the long-term guidance, you're raising the high end of that. On the PCH, you know, incremental revenue synergy, can you talk about, you know, how long do you think it will take for you to achieve the full potential and push towards the high end of that 6% to 10% growth? And then on the biologic side, has there been any improved outlook on that side, given, you know, what's happening on the new modalities and around the biosimilars, or are we still maintaining kind of, you know, the midpoint of that 10 to 15% growth?
spk03: Thanks. Sure. Look, clearly we don't give very short-term indications of guidance by single segment, but in terms of answering broadly to your question, We are already seeing the transition of that segment accelerating towards the new growth that we have projected. As I said, that is driven... If you look at the factors that I did mention, which are behind that acceleration, some of them were already in play in the last couple of years. So the addition of the gamut business, will be completely organic this year. There is only one quarter where it's going to be inorganic. So not only now we have a full ownership of the assets, but we are very much accelerating or expanding capacity to meet the high demand in that area. Our expansions and acceleration on complex oil solids in North America as well has been quite executed well by the team. and is coming available for executing on programs which we have secured over the last few years and i would say in general that continue there is a continued rebound of our consumer product with specific out of coffee called categories And so in pain relief, which is another area where we are seeing significant demand, if anything there, we're trying to overcome some supply challenges. So when you look at all of these dynamics, which I did mention, these are dynamics that have been in play already in the last few quarters and coming to fruition. On top of that, we are confident that the accelerated commercial synergies we are going to enable with the new organization will allow to further accelerate this growth.
spk13: Next question, operator.
spk15: Thank you. Our next question comes from the line of Jacob Johnson with Stevens. Jacob, your line is now open.
spk06: Hey, good morning. Maybe starting off with just a higher level question. you know, two and a half billion, I think, of biologics revenue in FY22. You've got the BWI expansion, MasterCell, Princeton, Oxford, and Bloomington, a number of capacity additions there. I know capacity is hard to define or quantify, but can you just talk about the amount of capacity you've added to your biologic segment over the last couple of years and what that could mean for growth as we look out the next several years?
spk03: Yeah, sure. Look, as you pointed out, it's quite remarkable the capacity that we have added. And with the remaining execution that we're going to do, what I can tell you is that by continuing on that execution and the plans we have, you know, in the next 18 months, 18 to 24 months, we are very well positioned to deliver our fiscal 26 targets, if you like. So in many ways, we have... already created a significant amount of the capacity that once getting utilized, that will deliver the fiscal 26 target. So probably this is giving you a little bit of quantitative measure of the capacity being created. But another way to look at that, look, when it comes to drug product, we've been primarily focusing complementing the offering with the syringes on top of vials. And when it comes to drug substance, we've been just doing an expansion and densifying our production schedule. And when it comes to gene therapies, we'd be essentially going from 10 suites to 18 suites in BWI. So this, again, gives you a little bit of a measure of what is the potential of this capacity going forward.
spk06: Got it. Thanks for that, Alessandro. Just one on the COVID kind of roll off. Can you just talk about how quickly you can transition the drug product assets to new kind of non-COVID applications? Is there any lag period or downtime associated with switching those lines over? And maybe how should we think about the timing of that transition throughout 2023? Is that something where maybe there could be a little softness early in the year as you're transitioning or not so much?
spk03: The transition is mostly seamless, meaning that it's happening in parallel. One thing that is happening is that mostly the lines on which we are transferring new products, we've been transferring and onboarding new programs. are lines which were built in parallel of the COVID lines. We always wanted to have the possibility to serve new customers and new programs while still leaving enough capacity to satisfy the COVID vaccine demand, which in many ways is still not totally predictable, although we're now getting to a much better visibility on it. So I would tell you that the transition has been a pretty You don't have to think about these like stopping vaccine and starting something new, but it's mostly things that are happening on different formats and on different production lines. With regards of some of the ones that are in fact going to be served out of the current COVID vaccine lines, which are going to remember the entirety of the current vaccine supply is made in vials. But some of these programs, you know, to a large extent, we can onboard them and body them on the line while still making the vaccines. So it's a kind of face-in, face-out type of dynamic as opposed to having a gap in between. Got it.
spk06: Thanks for taking the question.
spk15: Thank you for your question. Our next question comes from the line of Derek D. Bruin. with Bank of America. Derek, your line is now open.
spk17: Hi, good morning. Thank you for taking my questions. So I've got a few which I'm just going to shoot off here. One, what's the embedded organic revenue growth guide by segment for the biologic and PCH? That's the first one. The second one is going to be when you talk about a two-thirds volume reduction for your COVID vaccines, are you also implying the two-thirds I assume that you have some take or pay contracts. And then the third one is, you know, you talked about a 28% adjusted EBITDA margin for 2024. Is that still something that, I mean, I realize you're backing your 30% number by 2026. I'm just wondering if that 28% number, if that's how we should sort of think about the rebound for next year. Thank you.
spk02: So I'll start here. Alessandro, feel free to jump in. So I'll start with your last question first, Eric. Look, we're not in a position at this point to give guidance around fiscal 24, and I think there's still a lot to understand in terms of what the macro environment looks like today and where that heads over the next year. What I have said is we're absolutely on track and continue to be confident about our ability to deliver on the 30% EBITDA margin target for fiscal 2026. In terms of The organic revenue growth on a segment-by-segment basis, I would say that's not something we've talked about here specifically. We did make comments in our prepared remarks that we're seeing 25% business, 25% growth across our business, excluding COVID demand. I think you can do some math and come based on the disclosures we've made here as well as based on customer concentration. related disclosure that will be in our 10K and be able to estimate in a pretty tight band what the COVID-related impact is here. And I would say, you know, as you take that into consideration, it's very difficult to have a two-thirds related volume headwind on COVID and be able to see growth within biologics, including that in the 10 to 15 percent range. So I think you can maybe take from that, you know, where we are there. And, you know, from a You know, SOT, OSD basis, we'll obviously be reporting those out as a farmer and consumer health segment starting in next quarter. And that is a business that's growing outside of here in 2023 guidance, that 6% to 10% long-term outlook here, obviously, considering we're seeing 25% growth across the business on the next COVID basis.
spk03: Yeah, so look, with regards to your question around the take-home pay, it's been kind of a routine question over the last few months. I'm going to reiterate what I've already shared. While we feel strong about our take-home pay commitment and so on, we're also very mindful of being partners with our great clients and making sure that we listen to the needs. And we try to find a win-win situation you know, solution for a landscape that is very hard to read for everyone. So in many ways, you know, the breadth of the offering of Kaplan gives us optionality in sometimes to trade some of what is due to volumes in these contracts with something else. I believe that part of the success we're having in non-COVID business, which is growing at more than 25%, is also due to this approach, which has been very, very successful in securing a long-term good outlook on non-COVID business as leveraging those relationships and our partnership approach. So we feel pretty good about our approach so far. We believe it's created momentum in non-COVID business, and it's partly behind our confidence in the long-term prospects of the company.
spk17: Thank you.
spk15: Thank you for your question. Our next question comes from the line of Jack Meehan with Nefron Research. Jack, your line is now open.
spk08: Thank you. Good morning. One that kind of continue along that line of questioning as it pertains to the guide. Is there any help you can provide around seasonality? You know, you talked about some of the seasonality in the business this year, just help with pacing in terms of maybe expectations, especially anything for the first quarter would be helpful.
spk02: Yeah, look, Jack, we're going to fall short of giving specific quarterly guidance here. But let me just give you some directional commentary. I would say as we we did make a point here to reference seasonality that we see in this business. And I would say, you know, what we're seeing in fiscal 22 probably feels a little bit more like what we've seen in fiscal 20 and prior to that, given that fiscal, I'm sorry, I'm referring to fiscal 23 now, feeling more like fiscal 21 and fiscal 20 from a seasonality perspective more so than what we saw fiscal 22, which was obviously a year that was significantly skewed by COVID-related increases. through sequential quarters until we got to our fourth quarter where the volume declined here. We did mention about 60% of our absolute dollar EBITDA being generated in the second half of the fiscal year, bring 40% of that for the first half of the fiscal year. And I would say, in terms of the quarterly phasing, again, going back to what Q1, Q2 splits looked like in that in that 19, 20, 21 time period is probably a close proxy to how you can see the year play out from a quarterly phasing standpoint in 23. Great.
spk08: That's helpful. And then on metrics, so you disclosed the over $90 million of trailing sales. With the supply agreement, what's the annualized revenue contribution we should expect upon close sales?
spk02: So we'll get more specifics around the guidance here of metrics when we do close the transaction, which we're hoping to do by the end of the calendar year here. We did talk about growth rates that we expect to see from that business being very closely aligned to that of what the new farmer consumer health business of 6% to 10% would look like. And you can use that $90 million as a base, knowing that obviously this will only be a partial year contribution that we would see in fiscal 23. And again, that's exactly how much will depend on the timing of the close of the transaction. So we'll give some more specifics around the revenue and EBITDA contributions to fiscal 23 once that deal closes in the first call post-close.
spk03: I would just add one comment more general. One reason why we do like the space or prescription oral solid is that you normally have a pretty good visibility on the revenues for a fairly good horizon, given the prescription nature of the business and the strength of the pipeline.
spk13: Next question, operator.
spk15: Our next question comes from the line of Paul Knight with KeyBank. Paul, your line is now open.
spk18: Hi, Alessandro. Thanks for the question. Where are you in the go-to-market strategy? Are you halfway there in the productivity you expect? Could you give us some metrics around where we are today with this strategy?
spk03: Sure. That's a great question. I believe we are in a pretty good place. I believe, look, you know, we've been always very happy about our sales machine, which has been producing consistent organic growth over the last four or five years, I would say. Here is more in terms of making sure that when one of our sales reps engages with a customer and we do have a relationship with the customer, we take the full advantage of the relationship and try to offer uh more than just one service so i would say that look at the i cannot point to a specific percentage of completion of the plan but we are pretty advanced in what we are trying to implement here um our basics and foundations of our sales machine remain very very strong and what they drove really success in the last few years. And the way you need to see is not a revolution, but an enhancement of the go-to-market strategy so that we can unlock value where the value was blocked by our internal barriers.
spk18: And you raised your long-term growth guidance by 200 basis points. Is that due to your increased optimism around... around a single dose fill finish outlook or is it that plus cell therapy? What are the components of that 200 basis point increase or the big drivers I think is the best way to ask that?
spk03: Yeah. Yeah, sure. Look, you know, I believe that on the biologic side, our outlook remains pretty much the same that was before. That's really not what is driving this increase. We remain very bullish on the biologic story at 10% to 15%. What is driving the overall increase in the growth expectation from the company is, if you like, the assets which were a little bit behind in the growth story of the company, dragging down the overall growth rate expected for the company, which were more in the small molecule side. And the refashioning of the small molecule footprint, we were able to implement through the pandemic, which went a little bit under the radar. I understand that during the pandemic, everything that was making the news was related to biologics, vaccines, and so on. But we were working very, very hard in the background in addressing some of the gaps we had in the small molecule portfolio to enable faster growth there. And I will point out again, primarily in the consumer health, getting on top of these in high demand, the dosage form of gummies and soft shoes, which is again, is a significant contributor to that acceleration. The fact that we've been investing organically in our Kentucky facility, in our Florida facility, which are serving the complex oral solid market in the United States, which is very, very healthy at this point in time. as well as leveraging some of the dynamics in the consumer health after an initial period of, if you like, a crisis at the beginning of the pandemic came back pretty, pretty strong. So it's more on the PCH side that you need to see the increase. We have increased 200 basis points uh the the top end on the pch side compared to the past and this is really what is driving our most uh more comfortable outlook about the the company and and really uh putting us in a comfortable position to raise our long-term guidance for the organization thank you thank you for your question our next question comes from the line of dave windley with jeffries dave your line is now open
spk09: Hi, thanks. Good morning. I have a couple of clarifications and then a more strategic question. So am I right in calculating that the Zytus-related royalty in the quarter would be about maybe $10 million? Is that a fair estimate?
spk02: David, we didn't disclose exactly what the contribution was there. We did point to the fact that it was a significant driver of margin profile. So I think if you were able to do that math and triangulate something in that range, I think that's directional.
spk09: Yeah, okay. And secondly, Tom, you talked about lower component sourcing with COVID, but then on the other hand, kind of lower absorption from lower COVID volumes. I guess I'm wondering if kind of the bottom line margin impact from the lower COVID assumptions in 23, is margin dilutive or margin accretive taking those two impacts together?
spk02: Yeah, look, I think you're right. We did mention both here. We mentioned that with the declining COVID-related revenue that we will see the component sourcing dynamics start to normalize here in the year. And then obviously in talking about some of the margin pressure, opportunities here. We talked about the absorption related item driven volumes. I would say the point of referencing the component sourcing piece is really more material for the biologic segment than I would say it is for the company overall. Meanwhile, the absorption piece does have a more meaningful impact on the company overall here. Dave just given the fact that, you know, we're talking about dedicated capacity that was running at very high levels of utilization. and being replaced, whether on the same asset or in other assets that we've brought online during that period here. I'm not quantifying each of those for you, but I would say they essentially offset each other, but there's probably a little bit more impact to the bottom line here from an absorption standpoint, just as we start to ramp up other assets that we've brought online during the COVID pandemic that are, I would say, slow on the uptake here. You don't plug in a new syringe line and be operating at 85%, 90% utilization and start to see that full absorption. There's a ramp-up period here that we see that takes into consideration. But I would say the fact that we're, again, in a position where we are seeing modest margin expansion despite a lot of these moving pieces and challenging macroeconomic environments is something we're pleased with, and we're obviously going to look to maximize the margin expansion opportunity that we have here in fiscal 23 on our path towards the 30% by fiscal 26.
spk03: And as a follow-up comment on these, I would tell you, clearly, as the vaccines for COVID, the transition from pandemic to endemic use, they will resemble a little bit more the pattern of the of the other vaccines, which means that you're going to produce a significant amount of volumes in a shorter timeframe. And the rest of the year, you're essentially in a much lower production mode. So that is a little bit more challenging to manage from an absorption and profitability standpoint. It's something that takes some time to organize yourself for. And that's why I believe we have a very good plan. We are discussing these also with our partners, but it's a dynamic that needs to be taken into account as you move from the pandemic, where you're essentially running flat out through the 12 months, and you move into a more traditional vaccine manufacturing, which has that challenge always had and will always have.
spk09: So the last question I wanted to ask is around your long-term growth and the RAISE guidance there. 23 will start off, I don't know if we want to think about a four-year period since you do have 26 targets in the public. Maybe a four-year period is a reasonable period to think about. You're starting that four-year period a couple points lower than the long-term guide. Should we think about this as a kind of a midpoint 10% CAGR target where at some point over that horizon you'll grow faster than the 10% or do you think of it as getting to 10% after fiscal 23? Thanks.
spk03: So look, clearly we see these, with these fiscal year 23 a little bit as a transition year from a strategic standpoint. You know, it's notable the fact that, you know, we are reducing two-thirds our expectation from COVID vaccines. And at the same time, we are, you know, in line with the expectations. And that will point you towards what we shared around the non-COVID business and the strength there. So we have highlighted that that is above 25%. I believe you guys can make some math and be a little bit more accurate on that. We provided all the relevant information to do so. But that is telling us that all the moves we've done, refashioning and retooling our portfolio on the remaining business, put us in a very strong position as we transition outside the pandemic.
spk19: Thank you.
spk09: That's great.
spk19: Thanks, Dave. Next question, please.
spk15: Thank you for your question. As a brief reminder, to give everyone a chance to ask a question, please limit your question to just one. Thank you. Our next question comes from the line of Christine Rains with William Blair. Christine, your line is now open.
spk00: Hi. Yes. Thanks for the question. Just one for me. So we've noted a slowdown in FDA approvals in the first half of the year over last year. Any insight into the dynamics playing out here? And do you see this as having any near-term impact on Catalan's business? Thanks.
spk03: Well, look, from our perspective, we've been pretty pleased with the approvals that have been impacting our pipeline. And, you know, we see further opportunities going forward. So look, it's a little bit, you know, not necessarily the macro dynamic of the approvals that happens out there significantly. It's very discrete, right, and very much focused on some products. But I got to tell you, we've been seeing some good success of the products in our pipeline in the last few quarters.
spk15: Thank you.
spk13: Okay.
spk15: Thank you for your question. Our next question comes from the line of John Sauerbier with UBS. John, your line is now open.
spk01: it looks like we've lost connection with john our next question comes from the line of justin bowers with deutsche bank justin your line is now open thank you and good morning i'll keep it uh jiffy with uh the call running long but just in terms of the new capacity specifically uk and princeton um when when does that really start coming online um in the fiscal year and then By year end, what percentage of the capacity will be built out with respect to the footprint of those facilities?
spk03: Sure. So very different answers for the two facilities. So with regards to Princeton commercial cell therapy, capacity is mostly already online. And in fact, there is already one product, which is a late stage running there we've seen very very strong interest out of the gate after we announced that and you know it's more related to the time for us to onboard these programs than the capacity so the constraining factor in princeton is really around our ability to close these deals and onboard these tech transfers and these activities into the facility which again i remember everybody is skewed more towards the late stage so we're talking about mature cell therapy programs which are which are trying to find home for that commercial you know phase three slash commercial needs so that's princeton cell therapy serving mostly oncology therapies uh with regards of oxford is a little bit of a different story the build out is uh is proceeding at pace i believe that we are very close to open our PD side of the house where we're going to start working on, if you like, the scale-up of these cell lines. This facility will be mostly serving messenger RNA and proteins to a large extent. And then the large-scale bioreactor will come a little bit later in the year. We expect these assets to start generating revenues, as we said, in the last part of the fiscal year. We believe that Princeton is going to be a little bit faster in that.
spk02: Yeah, and I'll just add, Justin, to that related to Oxford specifically. You know, this was a pivot for us here in terms of building out capacity for European drug substance originally in our Anani facility, and then we were able to accelerate that with the acquisition of Oxford. So our original drug substance plans didn't have revenue contribution until probably midway through our fiscal 24 year, if not later. And as Alessandro said, as a result of this acceleration through what we acquired as well as the capacity we're deploying in that site, we would be in a position to be able to see revenue contributions late in fiscal 23.
spk01: Yeah, that's a great point, Tom. Okay, thanks. That's it for me.
spk15: Thank you for your question. Our next question comes from the line of John Sauerbeer. with UBS. John, your line is now open.
spk10: Hi, can you guys hear me now? Yes. Thanks for taking the question. Just one for me. Can you talk a little bit more on the M&A outlook? I guess, how are you seeing the valuations tracking? And then, you know, after the metric transaction, do you see potential for additional activity in 2023 and any areas within the biologic portfolio that could present inorganic opportunities? Thanks.
spk03: So look, I believe that before the summer, we didn't see significant moves in the evaluations and so forth, as if the space was still waiting to factor in the new reality of multiples into the assets. I believe we are starting to see some early signs of more catching up with the current environment, especially when it comes to cost of capital and macroeconomical uncertainty of the next couple of years, as well as direct funding. I believe that as we move in the next few quarters, I do expect some correction there. I will add, though, that the premium assets in our space are still kind of expensive because they have a pretty good strategic prospect in front of them. I believe it's a little bit of a mixed bag. I will tell you that, of course, multiple can constitute an hurdle, but for Catalan, it's probably never only an evaluation of multiple and primarily a financial evaluation. It's more of a strategic evaluation and how we're going to make sure that when we add an asset to Cadernet, we can accelerate growth and generate synergies out of these and not only enable more growth out of Cadernet, but we can also accelerate the growth into these assets. This is what we believe for Metrix. We believe that by inserting these premium assets in our much larger commercial engine, will accelerate the pipeline creation and tech transfers. On the other hand, we expect that completing this offering in downstream high potent capacity will create additional opportunities for some of our assets, which are more early stage, which didn't have necessarily a downstream capacity prior. So metrics is squarely in the definition of debt in terms of M&A. Catalan is always having a pretty healthy portfolio of M&A opportunities as we explore the market. And whenever we see an opportunity to accelerate growth and expand margin through what I just described, we definitely are interested in exploring the debt opportunity.
spk10: Thanks for taking the question.
spk15: Thank you for your question. Our next question comes from the line of Sean Dodge with RBC Capital Markets. Sean, your line is now open.
spk05: Thanks. Good morning. On the organizational changes, Alessandro, you mentioned the revenue synergies from that. How should we think about the cost impact that is realigning the commercial organization? Is it something you need to invest or add headcount to do? Or do you think there's some cost efficiencies that you can drive longer term along with those? I guess they're revenue growth enhancing. Are they also intended to be margin percentage enhancing?
spk03: Sure. Look, as I said, on the commercial side, most of the foundations were already there. We needed to tweak a little bit our incentive plans and so forth. to make sure that we drive the right behaviors and remove some artificial P&L internal barriers, which were not really enhancing our opportunities to sell across our portfolio offerings to our customers, which, by the way, will buy them anyway, either from us or from others. So better they buy all of them from us. So, on that side, I don't believe that there will be any cost impact on the commercial side of the house. We did point towards that this organization is a little bit leaner in terms of management and surely enables us to drive operational excellence across the board. more effectively than we used to do before, sharing some best practices and surely avoiding some duplication. When you think about, for instance, managing a program which is both giving the customer formulation development clinical material and at the same time distributing the clinical trials for their own trials, clearly there is some synergy there in the way you manage this project across, while before you had to manage different pieces in slices, when in fact you had the different slices, which as I said was not as common as could have been. So clearly in that regard we see an opportunity here to continue to drive operational excellence and efficiency and leaner approach. So bottom line is that, yes, we do expect these not only to drive accelerated top-line growth, but also provide us a little bit of productivity and efficiency.
spk02: Yeah, and I would just add, Sean, this gives us even more confidence than we already had around being able to achieve our fiscal 26 long-term EBITDA margin of a target of 30%. Okay, that's clear.
spk05: Thank you.
spk15: Thank you for your question. Our final question comes from the line of Evan Stober with Baird. Evan, your line is now open.
spk07: Hey, thanks. Appreciate it. Just one for me, obviously. I wanted to relate the long-range CapEx outlook to your updated long-range kind of revenue growth plan today. You know, we're at the point where we've doubled the revenue growth goal since the IPO. Can you talk about how that would relate to CapEx after we get past kind of the bolus of projects that's elevating the number higher here, what that equates to to a longer run percent of your revenue spent on CapEx? Because you're kind of getting to the point on your long-range revenue plan where it feels like some of this higher CapEx is, structural rather than transitory. So anything you can provide on a longer range settling of that number would be helpful.
spk03: So I will let Tom to provide some more color around how you should think about it. What I can tell you is that the fact that now these overall organic growth expectation is accelerated by the PCA segment as opposed to the biologic segment is good news in that regard because our PCA segment is significantly lower in terms of capital intensity towards biologics. And again, that was very, very intentional from us. we recognize that our biologic segment is very capital intense, specifically when it comes to assets like protein, product, you know, and so forth. But when you look at complex soil solid, when you look at the gummies, when you look at the soft gels, when you look at, you know, early stage formulation development assets and so forth, these are assets we come with a lower capital intensity as a percentage of revenues. So as we accelerate that growth, and that part continues to have a significant share of the portfolio of Catalan. Overall, this is good news in terms of capital intensity of the organization. With the specific of biologics, I will let Tom to respond.
spk02: Yeah, I think it's a great point, Evan, and I think we historically have been spending capital at the clip of somewhere between 8% to 10%. We were at that time somewhere between a 4% and 6% grower, maybe 4% and 8%. tops and with the capital that we've deployed over the last couple of years into biologics. I think it's been pointed out to me that many of our peers that are more heavily biologics weighted than we are spending something like 20-25% of revenue. Look, I think Alessandro's points here around what we're seeing on the pharma and consumer health side of the business being less capital intensive but yet seeing the growth is accurate. This year we've talked about spending something in that 13 to 15% of range. I don't think that a normal year for us is 8 to 10% any longer, given the mix shift of assets we now have in the portfolio. It feels like the normal for us now, just given how much maintenance we have across 50 plus rooftops, feels more like about 10%. So we do need to get back down to that 10%. I don't know that we get there exactly next year, but we'll obviously get some more specifics around how this phases out. But I would expect 13% to 15% this year, probably a step down from that level next year, probably not quite to the 10% normal run rate, but then thereafter getting close to, if not at that 10%, and that being the new sort of base CapEx level of deployment to expect.
spk07: Appreciate it. Thank you.
spk15: Thank you for your question. This concludes our Q&A session for today's call. I will now pass the call back to Alessandro Maselli for any closing remarks. Thank you.
spk03: Thank you, everyone, for taking the time to join our call and your continued support of Caverant. We were pleased to deliver record results in fiscal 22, and we are fully committed to deliver another strong year in fiscal 23 and beyond. Thank you.
spk15: This concludes today's conference call. Thank you for your participation. You may now disconnect your line.
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