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spk01: My name is Glen. I'll be the operator of today's call. At this time, all participants will be in a listen-only mode. If you would like to ask a question during the presentation, you may do so by pressing star 1 on the telephone keypad. I will now hand you over to host, Paul Sutter, Vice President of Investor Relations, to begin. Paul?
spk06: Good morning, everyone, and thank you for joining us today to review Catalan's fourth quarter 2023 financial results. Joining me on the call are John Greisch, Executive Chair of the Board, Alessandro Masselli, President and Chief Executive Officer, and Maddie Masanovich, Senior Vice President and Chief Financial Officer. During our call today, management will make forward-looking statements and refer to non-GAAP financial measures. it is possible that future results could differ from management's expectations. Please refer to slide two of the supplemental presentation available on our investor relations website at investor.catalan.com for a discussion of risks and uncertainties that could cause actual performance or results to differ from what is suggested by those forward-looking statements. And slides three and four for a discussion of Catalan's use of non-GAAP financial measures. Please also refer to Catalan's fiscal 2022 form 10-K-A and third quarter fiscal 2023 form 10-Q 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 John Greich for some brief opening remarks, which are covered on slide five.
spk08: Thank you, Paul. Good morning, and thank you for joining us. As I'm sure you have seen by now, we issued two press releases this morning. our preliminary fourth quarter earnings release, and a release announcing several initiatives reflecting our ongoing commitment to strong corporate governance and shareholder value creation, including the appointment of four new independent directors to the board, two of whom were nominated by Elliott. The new directors are as follows. Steven Barg, Global Head of Engagement at Elliott Management, one of Catalan's largest shareholders, Michelle Ryan, former Treasurer at Johnson & Johnson, Frank D'Amelio, recently retired Chief Financial Officer of Pfizer, and Stephanie Oakey, former Senior Vice President and Head of North America Rare Diseases and U.S. General Manager Rare Diseases at Genzyme. We've also established a new Strategic and Operational Review Committee of the Board to conduct a review of our business, strategy, and operations as well as our capital allocation priorities in order to maximize the long-term value of the company. The committee's charter provides more detail about the scope of our review and is included in the form 8K filed this morning. In addition, I was named executive chair, succeeding Marty Carroll as board chair. The board and I are very appreciative of Marty's leadership and look forward to his continuing contributions as an ongoing board member. As executive chair, I will be working closely with Alessandro and the team to drive improved operational performance and execute on the shareholder value creation initiatives announced today, as well as chair the strategic and operational committee. The second press release also notes that we entered into a cooperation agreement with Elliott. This agreement addresses the matters I just discussed and contains customary provisions for an agreement of this type, including a standstill, voting commitments, and confidentiality provisions. Elliot shares the Board's confidence in Catalan's leading position as a key partner for the biopharmaceutical industry and is committed to working with us to drive shareholder value. We look forward to providing an update to the market on the work of and ultimately recommendations by the Strategic and Operational Review Committee following our reviews. We believe that these initiatives will improve Catalyst's positioning for long-term growth and success. We will be acting quickly and taking decisive action to strengthen operational performance, enhance profitability, and create value for all stakeholders. I am personally excited to be partnering with Alessandro and the management team to drive profitable, sustainable, and capital-efficient growth, along with long-term shareholder value as we move forward. We're all very pleased to be working collaboratively with Elliott to accomplish these shared goals together. With that, I would like to turn the call over to Alessandro and Matti to discuss our recent performance.
spk13: Thanks, John. My opening remarks will relate to slide six of our presentation. As we said in May, this fiscal year was very disappointing, largely as a result of the COVID revenue and operational cliffs we have discussed. Additionally, as we previously explained, and as our peers have also more recently disclosed, The pharma services industry is facing a macro-driven pressure, primarily from defects of lower biotech funding, slower and more cautious decision-making by customers, and lackluster consumer discretionary spend. We are acting urgently to mitigate all these impacts, reducing costs at underutilized facilities, bolstering our commercial efforts to accelerate new business wins, slowing our capital deployment in affected areas. We're also making progress on the operational improvements in our biologic segment that we outline for you in the spring. From this perspective, we see fiscal 23 as a year of transition and fiscal 24 as a year of improvement that will create the foundation for long-term sustainable value creation. I will spend my opening remarks reviewing our strategic, operational, and financial progress. First, we have the right strategy in place to achieve the performance levels you expect from Catalan. This includes continuing to change our leadership team by bringing in new strengths, skills, and fresh perspectives to bear to ensure we have the industry best talent on our management team. In June, we appointed Mehdi Masanovic as our new Chief Financial Officer. Mehdi is a proven finance leader with deep experience growing and driving the profitability at public, global manufacturing companies. He most recently served as a Chief Financial Officer of Teneco Automotive until it was acquired by Apollo. Previously, He was the chief financial officer at Superior Industry International and General Cable Corporation. It's great to have the benefits of Maddy's fresh perspective to the cabinet and to have Maddy join us on this call. John and I also want to thank Ricky Hobson for stepping in as interim CFO prior to Maddy's arrival and assisting Maddy's transition in these last two months. In addition, in August, We announced the appointment of Lisa Evoli as our new Chief Human Resources Officer. Lisa joins Cadena from Integral Life Sciences, a global medical technology company. Lisa has more than 25 years of experience achieving organizational results, building robust talent pipelines, and creating an inclusive and engaged workforce for a variety of multinational public companies. As you can see, we are putting a profound emphasis on ensuring we are recruiting and retaining top talented cadets and making great progress on rounding out our core leadership team, including my top priority, which is to fill the biologics president role, a search which is needing completion. Our operational performance as a whole has shown improved trends over the last few months. While we see meaningful evidence that the fourth quarter will be a bottom for our biologic performance, more work and time will be needed to return to our previous matching levels. remains to exit fiscal 24 with the company-wide operating margins closer to our historical levels. Encouragingly, operational improvement has been particularly evident in our gene therapy offerings. As previously discussed, the startup phase of our ERP implementation caused underutilization at BWI in the beginning of the fourth quarter. As we expected, this challenge has led revenues at the site to dip in the fourth quarter from the third quarter. However, as a result of our focus on rapid operational improvement, productivity levels at the site are in line with our high standards, and revenue at the BWI is growing sequentially into the first quarter of fiscal 24. Speaking of gene therapy. We could not be prouder of our gene therapy teams, both at our manufacturing center of excellence in Maryland, as well as at our packaging facility in Philadelphia. As they closely partner with our customer, Threat Therapeutics, to deliver the first commercial dose of this Duchenne muscular dystrophy gene therapy to a five-year-old patient. that was a day away from turning six and aging out of the program. This outcome is a perfect example of our patient-first mindset, and we are thankful to Doug Ingram, Sarepta's CEO, for visiting our manufacturing team this month to celebrate this important patient milestone with our employees. At Brussels and Bloomington, We've also seen some progress in our operational execution. Of the two sites, Brussels has been training better, with its output getting closer to historical levels. At Bloomington, our customer received a complete response letter in June related to an FDA inspection that occurred in May and was still open at the time of the DUFA date. We worked closely with both the customer and the FDA to bring the inspection to closure as quickly as possible and we are pleased that the FDA recently approved the customer's product as well as another product produced on the same line. Aside from the specific issues at Brussels and Bloomington, our values always put the patient first and this was evident in the Bloomington over the summer. where we prioritized everything needed to bring the FDA inspection that occurred in May to a successful closure. While these activities had some impact on our anticipated productivity improvements at the site, and led to increased costs in the first quarter of fiscal 24, they were the right move for Cadament, for our customers and our patients, given they led to extremely rapid and positive outcomes for our customers' products. We continue to expect to complete the tech transfer activities related to large programs at Bloomington during fiscal 24 and enter fiscal 25 with more normalized margins. Catalan's overall inspection track record remains as strong as ever, with 14 successful regulatory inspections in the last few months, including An FDA inspection at our sterile field finished facility in Anagni, Italy, that resulted in zero observation and no form 483. Our pharma and consumer health segment is expected to grow revenue in the mid to high single digits in fiscal 24. Product approvals, including a dozen of new approvals since January, are expected to contribute to year-on-year growth. In addition, supply chain issues related to one of our top products have recently been resolved and new production orders are underway. Finally, our consumer health business, which felt short of expectation in fiscal 23, has been leveling out. From a financial perspective, despite our assumption of a significant incremental COVID reduction, and previously mentioned continued biotech funding softness, we see a resilient top line for the fiscal year, including double digits non-COVID revenue growth. While we are pleased with our top line momentum, our outmost focus will be on improving our EBITDA margin, financial forecasting, and cash flow generation. which will lead to enhanced shareholder value creation. For example, we previously announced two separate cost reduction plans during fiscal 23, and we already realized approximately $40 million of cost savings in the back half of fiscal 23. We expect a total of over $100 million in incremental savings in fiscal 24, as the effects of our plan continue to bear fruit. When completed, the analyzed run rate savings from these plans are expected to be in the range of $150 to $170 million. We also embedded the mechanisms in the company, including our lean program called the Catalan Way, designed to deliver better operational consistency, increase level of utilization, reduce waste, and greater efficiency. We will keep you appraised on our progress regarding announced savings plan and new cost initiatives in the coming quarters. Turning back to the overall biologic segment, as you will recall from June, we discussed that our biologics margins were being impacted by significant investments that we made at our facilities operating in new modalities. including cell therapies and plasmids, just before the start of the period of reduced biotech funding. While we continue to believe all of these assets will create great value over time for innovators and patients, as well as the shareholders, our prior expectation for high growth related to these assets in fiscal 23 did not materialize. As a result, these facilities are now experiencing a lower level of utilization and are running below break-even levels, leading to a decrease of several hundred points in the EBITDA margin of our biologic segment in Q4. We continue to actively address all aspects of this imbalance to maximize our ability to effectively leverage these assets and deliver value to all stakeholders in the near term. Most importantly, our advanced capabilities continue to garner substantial commercial interest, positioning the company for long-term sustainable growth. As a result, once utilization normalizes, we continue to expect the biologic segment to return to its historical EBITDA margin. Regarding our forecasting process, we have been working hard to improve our rigor and discipline, including embedding greater conservativism in our future assumptions. More work remains, but under MEDIS guidance, we are implementing plans to strengthen our forecasting and internal control processes. Given the extensive footprint we have built over the last several years and our focus on improving our margins, we are also reducing our capex in fiscal 24 to around 8% to 10% of sales. And we expect to maintain this lower level of capex intensity over the coming years as we grow into our existing footprint. With that, I would like to close by saying that our board, management team, and I are collectively focused on executing on our mission to improve the lives of patients every day. while striving to create value for all of our stakeholders. We are taking decisive actions to bring our operational performance consistently to levels we achieved across the company prior to the pandemic. Finally, as John mentioned earlier, I look forward to working more closely with him as an executive chair I want to welcome to our board the four new members announced today. I am looking forward to working with them, as well as Elliott, to drive long-term shareholder value for our investors. I continue to have the utmost confidence and optimism in the government's leading market position, long-term opportunities, and growth prospects as the industry's essential partner. We know what needs to be done to deliver the level of financial performance that we all expect, and we are doing so. I will now turn it to Maddy for a discussion of our Q4 financial results and the details of our fiscal 24 guidance.
spk07: Thank you, Alessandro. I'm very happy to be part of the Catalan team and contributing to the meaningful impact our company has on helping people with longer, healthier lives. In my first two months at Catalan, I have been deeply focused on bolstering our internal finance team and improving our financial processes to position Catalan for long-term success. I look forward to meeting many of our investors and analysts in the coming weeks. Starting with the consolidated numbers on slide seven, Net revenue in the quarter was $1.1 billion, down 17%, both on a reported basis and on a constant currency basis, compared to the prior fourth quarter. Mergers and acquisitions had minimal impact on our results. Our fourth quarter adjusted EBITDA decreased 61% to $139 million, or a margin of 13%, versus a margin of 27.8% in the prior year quarter. On an organic, constant currency basis, Our fourth quarter adjusted EBITDA declined 65% compared to the fourth quarter of the prior year, primarily driven by a decline in COVID demand. I will speak further to the major drivers of these results in the segment commentary. Adjusted net income was $16 million, or $0.09 per diluted share, compared to adjusted income of $195 million, or $1.08 per diluted share last year. Reconciliations. From GAAP net earnings to each of adjusted EBITDA and adjusted net income are in the appendix of the slide deck. Excluded from net income are non-cash asset impairments totaling $85 million on an after-tax basis. These non-cash impairments couple several assets in both of our business segments. The largest non-cash impairment is related to the partially constructed biologics development and manufacturing facility near Oxford, UK. Now let's discuss our segment performance. Our commentary around our segment growth will be in constant currency. As shown on slide eight, fourth quarter net revenue in our biologic segment was $406 million, a decrease of $239 million, or 37%, compared to the prior fourth quarter. The decline is primarily driven by significantly lower year-on-year COVID demand. Fourth quarter COVID revenue declined approximately $180 million to approximately $65 million. Our COVID work is no longer focused on take or pay arrangements and is now tied to more standard ordering arrangements based on rolling forecasts with binding periods, which are typical arrangements in our business. On a non-COVID basis, biologics revenue in the fourth quarter declined 16% versus the fourth quarter of 2022. In the fourth quarter, Our drug product and drug substance offerings, excluding COVID and cell and gene therapies, each grew double digit year on year. However, with our core gene therapy business, however, while our core gene therapy business was the strongest source of growth for cattle in the first three quarters of fiscal 23, in the fourth quarter gene therapy revenue was down over the prior fourth quarter. This was in line with our expectations. and the results of production issues outlined on our third quarter earnings call in June. As you can see on the bar chart, there were notable movements in our biologics commercial and development revenue streams, where the classification of development versus commercial is driven by contractual language, which does not always align with the regulatory status of a given product. The large drop in development revenue in the fourth quarter has two primary drivers. First, year-on-year decline in COVID revenue that has been designated as development revenue. And second, a large gene therapy product whose revenue was treated as development revenue a year ago and is now treated as commercial revenue. When looking at the full year for biologics, COVID-related revenue declined over 50% from $1.3 billion in fiscal 22 to approximately $625 million in fiscal 23. Non-COVID biologics revenue increased by approximately 12% across the full year. Moving to EBITDA, the biologic segment fourth quarter EBITDA was down $206 million to a loss of $12 million. Margin was negative at 2.9% compared to the positive 30% recorded in the prior fourth quarter. The drop in EBITDA was primarily driven by the COVID declines and resulting underutilization, as well as underutilization at new modality facilities. We are working to align our costs in these areas to be in line with demand and expect margins to improve on a year-over-year basis, primarily in the second half of the fiscal year. As shown on slide 9, the pharma and consumer health segment generated net revenue of $662 million, an increase of $19 million, or 3%, compared to the prior year fourth quarter, with segment EBITDA of $187 million, down $11 million, or a 6% decline over the same period. The segment's revenue growth was primarily driven by the October 2022 acquisition of Metrix, which contributed four points to the segment's top line growth and five points to the change in adjusted EBITDA. On an organic basis, the segment declined 1% as growth in clinical supply services was more than offset by continued supply chain challenges related to a top product and a decline in prescription product revenue. EBITDA margin of 28.2% was lower by 260 basis points year over year from the 30.8% recorded in the prior fourth quarter. The decline was primarily a result of lower organic volume, unfavorable product mix, and cost inflation. Slide 10 discusses our debt, debt maturities, related ratios, and capex plans. Our debt load remains well structured and permits us good flexibility. Our nearest maturity is not until 2027. Our primary debt covenant is the ratio of net first lien debt over the trailing 12 months of adjusted EBITDA. The covenant requires this ratio to remain below 6.5 times, and that June 30th, the actual level was 2.8 times. Catalan's overall net debt leverage ratio as of June 30, 2023 was 6.4 times, a sequential increase from the third quarter at 4.9 times. driven by the lower year-on-year LTM adjusted EBITDA as measured at fiscal year end. Because the EBITDA portion of the net debt leverage ratio is calculated on an LTM basis, we expect this ratio to move higher, ultimately peaking at the end of the second quarter due to a significant decline in COVID revenue on a year-over-year basis, and then improving in the second half of the fiscal year back to current levels as our EBITDA improves. We expect to be free cash flow neutral in fiscal 2024. Reducing our leverage is our top priority. This is being achieved by maximizing EBITDA through continued revenue growth, improved utilization, better productivity, and continued cost structure alignments. At the same time, we are focusing on a number of opportunities to deliver incremental free cash flow in 2024 above and beyond our current guidance. These incremental opportunities include, first, working capital, which includes accounts receivable, inventory, and contract assets at June 30th was over $2 billion. We have a significant opportunity ahead of us to reduce working capital and drive free cash flow for the company. Our initial focus will be on reducing the accounts receivable balance of over $900 million, reducing our inventory balance of over $700 million, and reducing our contract asset balance of over $400 million. Our goal is to drive sustainable improvement in these categories to deliver incremental free cash flow while simultaneously working to restore our historical EBITDA margin. Second, we will ensure all CapEx spend is either aligned with our core values of patient first, quality, safety, and compliance, or contributes to key strategic initiatives with shorter, more appropriate payback periods. And finally, With our newly created Strategic and Operational Review Committee of the Board, we plan to continue to evaluate our strategy and portfolio. These activities to enhance cash generation, balance with returning to more normalized EBITDA margins, should improve our overall net debt leverage. Our target for our overall net debt leverage remains less than three times. Our combined balance of cash, cash equivalents, and marketable securities as of June 30, 2023 was $280 million, an increase of $78 million from March 31, 2023, before a $50 million partial pay down of our revolver that we were able to make in the quarter. The increase in cash was driven by strong cash collections in the quarter. I would now like to discuss our contract assets, which, as of June 30, 2023, had a balance of $436 million, a sequential decrease of $69 million, and flat year on year. We are working with key customers to further reduce this balance through more favorable contract terms that are more aligned with our manufacturing timelines. At June 30, we had one strategic customer a majority of whose business relates to our gene therapy platform that represented 20% of our $1.4 billion in aggregate net trade receivables and contract assets, we are confident that our contract asset balance is fully collectible. The same customer was less than 10% of total revenue in the fourth quarter, but represented nearly 10% of our revenue for fiscal 2023, compared to approximately 5% in fiscal 2022. Finally, CapEx in fiscal 2023 was $601 million, or 14% of revenue. In light of the significant capital investments we have already put into the business, we are reducing CapEx in fiscal 2024 by more than 30% to a range of 8% to 10% of revenue. Now please turn to our financial outlook for fiscal 24 as outlined on slide 11. We expect our 2024 net revenue in the range of $4.3 billion to $4.5 billion, representing growth of 3% at the midpoint. This includes COVID revenue of approximately $130 million, a roughly $500 million decrease from 2023. Our non-COVID business is expected to continue to deliver strong performance with full-year revenue growth of approximately 15% to 20%. This is driven by roughly 30% growth in our non-COVID biologics portfolio, primarily driven by significant growth from our largest customer, as well as completion of tech transfer activities. In PCH, we expect mid to high single-digit growth. Current FX rates, which we use in this forecast, are forecasted to have a positive impact of one to two percentage points on our revenue. We project that inorganic revenue, which reflects one remaining quarter of the metrics acquisition, will not have a meaningful impact. We expect adjusted EBITDA in the range of $680 million to $760 million. While this is a slightly wider range than usual, as Alessandro mentioned earlier, this is reflective of our new, more conservative approach to forecasting. These temporary low margin levels anticipated for 2024 reflect our low facility utilization as our reliance on COVID revenue declines. As we ramp up our non-COVID business and align our cost structure, we expect margins to recover towards historic levels as we exit fiscal 2024. We expect the margin of our biologic segment to improve modestly as we move sequentially from our 2023 fourth quarter to the first quarter of 2024 and progressively improve through the year with a more pronounced ramp in the second half. In addition, given the historically seasonal nature of our PCH business, where revenue and EBITDA generation is the lightest in the first quarter and more weighted to the back half of the year, combined with our expected productivity ramps later in the year, we forecast roughly two-thirds of our consolidated adjusted EBITDA to be generated in the second half of the year. While this is more back half weighted than most years, The overall expected revenue split is more balanced, with approximately 55% expected in the second half of 2024. We expect adjusted net income in the range from $113 million to $175 million. Adjusted net income growth in fiscal 2024 is being impacted by all the items affecting adjusted EBITDA, as well as the following items. First, an expected effective tax rate in the 25% to 27% range compared to 25.5% in fiscal 23. Second, an increase in interest expense due to rising interest rates. Though, as a reminder, with our rate hedge in place, nearly 70% of our debt is effectively fixed rate. And finally, increased depreciation expense due to substantial investments we have previously made. I'd now like to share an update regarding the status of our filing of our Fiscal 23 Form 10-K. As we continue to improve our accounting, finance staffing, and related processes, and we continue to bolster our internal finance resources, some additional steps remain to finalize our 10-K. This will not allow enough time for all of our closing procedures to be completed today. Therefore, the completion of our financial statement closing processes and subsequent filing with the SEC will require more time, extending beyond today's deadline. Tomorrow, we plan to file a notification of late filing on Form 12B25. Our team is working expeditiously to finish the 10-K within the 15-day grace period permitted by the Form 12B25 filing. We do not expect any change to the numbers we released today. We appreciate your patience. To close, I want to summarize with you my top priorities as Catalan CFO, which are partnering with Alessandro to improve our margins by supporting productivity and cost alignment plans, to delivering incremental free cash flow by reducing the capex and the working capital intensity of the business, and finally, strengthening our internal controls and processes over financial reporting and forecasting. All of these priorities are within our control. Operator, this concludes our prepared remarks. We'll now open up the call for questions.
spk01: Thank you. Ladies and gentlemen, if you'd like to ask a question, please press star followed by 1 on the telephone keypad now. When preparing to ask your question, please ensure your phone is unmuted locally. With our first question, it comes from from Morgan Stanley. Your line is now open.
spk12: Hey guys, good morning and thanks for the time here. Maybe Alessandro and Maddy, can you just help us build a bridge from the $715 million or so in 2023 to $720 million in 2024? You called out COVID assumptions of about $130 million, but could you clarify the contribution from Sarepta that you're assuming at the midpoint here Sounds like you're expecting very substantial growth there, given your 30% non-COVID biologics growth assumption. So, you know, any sort of color versus the 425 you generated this year would be great. Thank you.
spk13: Hey, Dajas, Alessandro here. Thanks a lot for your question. Look, first of all, we are pleased here today to be able to share our new guidance for fiscal 24 in phase of 2021. Well, as we disclose a significant drop, further drop in our COVID revenues, but still seeing resilience in our top line. So that's something that is speaking to the underlying strength of our business. As we shared, and as you're pointing out, some of that growth is related to our gene therapy business, which is now running at full cylinders after some of the challenges that we shared during the spring. So, top line is pleasing us. It's also well balanced in H1 versus H2. As we shared during the spring in our biologics business, there is still some work to do to restore previous margin. We are working expeditiously on addressing underutilization and some performance improvements some more time. and work is required in the first half of the year, but we are confident that restoring sequentially our margins over the quarter. So I will turn it now to Maddy to give you a little bit more granularity on the breach.
spk07: Yeah, so you asked about going from the 714 of Ibadan 23 to our, I'll go to the midpoint or approximately midpoint, the 720. Obviously, as Alessandro pointed out in his comments and my comments, we're seeing COVID demand down year on year of approximately half a billion dollars, and that has a high margin profile attached to it, and it leaves behind costs that we have to action. So there's a statement downer from an EBITDA perspective related to that down volume. We're replacing that down volume, as we mentioned, with one of our largest customers in gene therapy. It should be up year on year. We talked about one of our facilities that Alessandra mentioned is doing better, which is Brussels, and some of the performance underlying Brussels is doing better, as well as Bloomington turning the corner. So those are primarily the biggest pieces, and we've got the biologics other piece, which is growing at a very rapid rate year over year. Got it.
spk12: That's helpful.
spk13: Maybe the last point I would add, also pointing you out to some of the one-off impacts we recorded in the last fiscal year, something that you should consider as you model this.
spk12: Got it. Yep, makes sense. And then my next question really is around the strategic review that's underway. Any color you guys can share around sort of the anticipated timelines for that to be completed? And then, you know, understanding that there's a few moving pieces here in terms of the balance sheet initiatives you spoke about, Matty, do you currently anticipate having to meet, you know, the need to raise capital either via equity or debt? Or do these anticipated working capital improvements and the cut in CapEx, et cetera, mean that you feel pretty confident that you wouldn't need to pull that lever?
spk08: I'm going to go for Sean. Yeah, this is John Grice. I'll take the first part of that question. Firstly, you know, Alessandro, the team, the board, we all look forward to working and partnering with Elliott towards achieving our shared goals that we talked about in our prepared comments. The agreement between the company and Elliott is really designed with the primary intent of enhancing long-term shareholder value. And specifically to your question, the mandate included in the charter of the Strategic and Operational Review Committee is to review our businesses and strategies with the objectives of one, improving our operational performance, two, strengthening the financial profile of the company along the lines of some of Maddie's comments around portfolio assessment, and three, maximizing the long-term value for our shareholders. We've got our first meeting of the committee in September. We've obviously been doing a lot of work ahead of that anyway. And some of our board appointments are part of that. The two nominated by Elliot as well as two emanated from a search that we had been conducting. So I think over the next few months, it's hard to put a specific timeline on it. I think it's going to come down to Alessandro's proposals that he and the management team will bring to the committee and to the board. But certainly by our next earnings call, we should have some traction to speak to you about and we're acting with a sense of urgency, not just at the committee level, but Alessandro and his team to address all of the initiatives and come up with the actions appropriate to drive and maximize long-term value for our shareholders.
spk07: Yeah, and then just to answer the backside of your question, I think, you know, right sitting here today, we've got ample liquidity to manage the affairs of the company between cash and revolver availability. We also have what I would call a significant and unique opportunity to sustainably take down the working capital intensity and the CapEx intensity of the company, which we're looking at for the year. And then with the return of profitability in the back half of the year on the operational improvements that we'll make, I don't necessarily believe it's an issue to go after from a capital and or a debt race.
spk12: Got it. Very helpful. Thanks for the time, guys.
spk01: Thank you. With our next question comes from David from Jefferies. David, your line is now open.
spk14: Hi, thanks. I'll start with the first question. Just a slight follow-up to Tejas. For Mr. Greisch, the strategic review, you mentioned the first meeting in September. Could you tell us when you would expect to be in a position to report out findings of the committee or plans as a result of the committee? approximate timeframe would you put on that?
spk08: Yeah, it's hard to put a pinpoint, uh, timeline on coming out with, with, uh, conclusions or recommendations from the committee to the board. So I hesitate to put a specific timeline on it. Uh, I just reiterate what we said in our prepared comments, you know, working with Elliot with a sense of urgency, working between Alessandro and his team, And the board really to drive the things that we spoke to assume we're going to be taking some actions sooner rather than later, but to put a specific timeline on it, I think would be, I think, imprudent at this point in time.
spk14: Okay, thank you for that. From a, for Alessandro and Maddie, Maddie, congrats on the new seat. On guidance, you've commented both in prior calls and today about trying to improve the accuracy or the conservatism in your guidance. Wanted to maybe understand practically how you're doing that, but maybe more specifically to look at the PCH segment outlook and a mid to high single digit growth rate on that, which quite honestly seems pretty optimistic. The environment, the comments by some of your peers on demand, the potential for a slowing economy, all seem like they would point to a more conservative assumption there. And so I guess I would, you know, would ask kind of, you know, substantiate that the way you're going about guidance this time around is more conservative than the mistakes that were made in the past. Thanks.
spk13: Yeah, look, I'll cover first probably the second part and lean into the first part. Look, With regards to our PCH segment, you know, Dave, it's always hard to really understand trends when you evaluate business primarily on a year- or two-year basis because, again, we have a business that has a high level of concentration in few assets. And when you look at the performance of PCH into fiscal 2013, it was sure below expectations, below what you expect from a business that should really grow in the single digits. So when you extend your time of observation and evaluation on a longer period, you will see that PCH is really growing in the middle of the range that we expect the PCH to grow. When you extend your evaluation on a two-year horizon, keep in mind that in between you also have some inorganic contributions to the growth there. um speaking of some more specifics as we pointed out in our prepared remarks some of the reasons why we were we were impacted pch last year were delayed approval on some new programs and as such launches consumer health which on a near three year basis was was uh was really not performing as expected and one key product which has a significant impact on revenues and more so on profitability, which was impacted by a supply chain disruption and in reality didn't contribute to the story of last year. So all of these elements are a little bit returning back now. Consumer health is stable. While the approvals have happened in the second half of last fiscal year, now we expect these launches to contribute. And finally, this product now is back on track, and not only we need to satisfy the end market demand, but we also need to restore safety stock levels, which of course will create a short-term higher than the normal demand for this very asset. I would also add that underlining in the business, we still have very good franchises like Zydus, which continues to be on a high path of growth. Overall, across the board, there are elements to be optimistic, and I would say that there is a lot of realism in how we're guiding the PCH in the mid to high single digits, and we feel pretty good about that guidance. With regards to the second part of your question, I'm going to give you a very brief perspective for me that maybe is more historical, and I'm going to use the word money to elaborate more. Look, I believe that we've been surely learning a lot in the last 12 months, sometimes learning the hard way, but we're learning a lot not only about how we should be thinking about COVID, but also how we should be thinking about the growth profile of some of these new modalities during this time period. And we also have changed a little bit our internal mechanism to go after the forecast and to build the forecast from ground up. I feel that these improvements have brought the right level of balance and conservatism in our future forecast. Again, I feel confident about the guidance we are putting out today.
spk07: Yeah, I think that's fair, everything you just said, Alessandro. I mean, I think at the end of the day, going to a ground-up forecast, looking at it, looking at pulling out any stretch that's in there, pulling out any items that, you know, just don't have a business or a plan behind it. I think that's the critical nature of the forecast and getting on it sooner. It'll allow us to identify pockets that are under utilization sooner and then get after those pockets that are under utilization. So I think that's what's really driving it.
spk10: Great. Thank you. It's helpful.
spk16: Our next question today is from the line of Jacob Johnson of Stevens. Jacob, your line is open.
spk04: Hey, thanks. Good morning. Maybe a question on Bloomington. I think from some recent headlines, it seems like there could be some new therapies ramping there this fiscal year. Could you just How should we think about utilization at Bloomington and FY24, given the COVID roll-off and then some of these new tech transfers? And then maybe kind of longer-term, you know, with this kind of reset in COVID at Bloomington, how should we think about the long-term growth opportunity and kind of still finish broadly?
spk13: Look, Bloomington is a launchpad for many new therapies, hands down. It's always been and will always be. Sometimes some of the reasons why it's in the news for inspections more than other facilities is because of that reason, because there is a lot of PIA work going on. There are a lot of launches, a lot of launches that are also requiring those inspections. Sometimes the timing is a challenging one. You need to work through these situations. We continue to be pleased about the pipeline. We have assets which are very heavily utilized. sharing all along that we are seeing a significant demand in pre-filled syringes. And so that capacity is very highly utilized. And I believe that overall we are at the, not only of the pipeline, but also some of the franchises where we expect to play a major role. One of the biggest one being the GLP-1. It's something that we've been investing on and investing in for a few years now coming to fruition and we are very excited about the opportunity coming from that specific therapeutic area, which we expect to be a very dominant one in years to come.
spk04: Got it. That's helpful. Thanks, Alessandro. And then I guess for the follow-up, maybe on the kind of these newer modalities, cell therapy and plasmids, you know, this is an area of underutilization. The earlier stage assets and clearly a drag on your margin, but initially you're kind of thinking about this strategic review and cost initiatives, maybe using these as a proxy for kind of near-term profitability versus the long-term strategy. You know, how much are you willing to accept the near-term drag on profitability from these assets while maybe kind of looking to the long-term growth opportunity from those end markets? And I'm just kind of curious if you still view those as key to your strategy.
spk13: Yeah, look, you know, first of all, you know, you always need to start from the clinical promise and the successes that you see in the clinical trials for some of these therapies. And I have to say that, you know, the last few months have been exciting in these areas, right? So these are areas which we believe will continue to drive a lot of growth into the industry. Also areas that have an incredible promise of having a significant impact on patients and the meeting unmet needs. So surely, strategically, these are areas where we need to stay in, and we need to stay in with the purpose of being a significant player with a significant market share. That all being said, we need to be realistic around what is the curve of growth of these areas, which we don't expect to be linear. This is going to be more looking like an exponential curve, in our opinion, with a little bit slower start, partly due to funding, partly due to the industry figuring out manufacturing processes which are positioning these therapies also for financial sustainability. And when all of these will come together, this is going to be a great growth engine for the industry and for sure for Calavent. In the meantime, we need to understand the growth profile and we need to adjust the cost structure, making sure that we can mitigate those short-term margin impacts as we go forward. But overall, I believe that we need to avoid to jeopardize the long-term opportunity here.
spk04: Makes sense. Thanks for taking the questions.
spk01: Thank you. We have our next question. It comes from Jack Meeam from NIFROM Research. Jack, your line is now open.
spk17: First question is on GLP-1s. I was wondering if you could elaborate more for investors, just frame out the opportunity you see here. And within your guidance, if these ramp as expected, could you share what percentage of sales will they represent just from a concentration perspective?
spk13: Well, look, first of all, the reason why I'm speaking about the GLP-1 category and not a necessarily specific product is because, as you know, as a company, policy and agreement with customers, really speak specifics of customers or products. I will tell you that overall in fiscal 24 we're going to start to see the fruit of the growth in this area, but even more so we're going to see that in fiscal 25. I believe and I do believe that the second half of fiscal 24 Surely, fiscal 25 is going to start to be an inflection point for this category as more assets will come to fruition to accelerate the manufacturing and increase the volumes and output. We're very excited. We are very committed to our customers, and we have a lot of confidence that this will be a significant contributor to the future growth story of CADA.
spk17: Great. And I wanted to also ask about Batera. How did that perform within PCH in the quarter? Maybe for John, I was wondering if you could comment on, just as you do the strategic review, how you feel about kind of the long-term contribution from this business or whether it's something you would consider potentially divesting.
spk13: So, look, I will take a little bit of the question and I will let John to close it out. As we said, the consumer health market, as I highlighted to some of our peers, is going through a little bit of a correction, both from an inventory level standpoint to preserve cash and the consumer discretionary spend, which is probably orientating towards a more, you know, less expensive dosage forms. That being said, from a commercial standpoint, we have disclosed that the time of the acquisition in the portfolio of customers of these assets, there were not significant presence of the big consumer companies with the biggest brands. And we are pretty pleased with the progress that our commercial team has done in building the relationship and penetrating these different segments of the market, which was not present at the time of the acquisition. Of course, nothing happens overnight in our industry, so it will take some time, but we believe we are close to signing some additional work and business with some of these blue chip companies, which will drive additional growth in this area. Now, that being said, as John mentioned, we are exploring all the potential strategic options on the table to make sure that we streamline the portfolio of the company and we accelerate the shareholder value creation, and as such, all options are on the table.
spk08: Just to add to Alessandro's comment, albeit some of it may be repetitive, I think he and I are going to work with the committee, and just to be clear on the objectives of the committee again, you know, to drive actions to improve operations, perform a strategic review of the company as well as the individual businesses, portfolio assessment, as Alessandro just said, you know, do we have all the pieces that we want, as well as allocating capital among the portfolio individual businesses, all with the objective of driving long-term shareholder value. I think it would be premature to comment on any specific business at this point in time. Clearly understand your question, but give us some time to go through those activities and initiatives. And as I said earlier, we'll report back on the findings that Alessandra and I recommend to the committee and ultimately to the board. But commenting on specific actions today, I think it would just be premature.
spk17: Understood. Thank you.
spk01: Thank you. With our next question comes from Sean Dodge from RBC Capital Markets. Sean, your line is now open.
spk03: Yep, thanks. Good morning. So maybe going back to the guidance one more time, the significant growth you're expecting from the gene therapy customer, how dependent is that on the Embark data that will come out later this year? How big of a swing factor does that have the potential to be for you all if that reads out? good versus bad, and how are you handicapping that for the purposes of the guidance?
spk07: Any upside? None of that is included, so if it does get expanded, it's not included in the forecast.
spk13: That being said, I just want to make one other point, which is, as we said many times, the fact that You know, we are, you know, as we should, you know, mentioning explicitly and transparently one specific customer doesn't mean that the relation with that customer is only related to one program. And, in fact, I'm happy to share that the relationship with that specific customer is across several different programs, some of that closer to full approval, some of them a little bit earlier in the pipeline, but we are pretty pleased about that pipeline.
spk03: Okay, that's good color there. And then on Bloomington and the challenges you've had there, can you talk about the changes you've made in terms of personnel or oversight at that facility that give you confidence and maybe give clients confidence that Bloomington has turned a corner and you are on a path to restoring the consistency and operational excellence there?
spk13: Sure. Look, first of all, I just want to give a shout to the Bloomington team because it's always coming to the news as of late for, you know, some of these challenges. But this is the one facility that has played an incredible role during the pandemic, serving the United States and the world with an incredible effort of producing billions of vaccine doses which have saved millions of lives. And I just want this not to be lost from our memories because it's easy to move on from this. So the Bloomington team is a team that has accomplished an historical mission which will never be taken away from them. That being said, clearly the work has changed now and the work is a little bit different and as such you need the different skills and talent. And since the beginning of the year, as you said, we have made several changes both in the site leadership, we have a new general manager there, as well as in several leadership positions at the site and above the site, including our quality function. And we are very pleased with the progress and sustainable progress that this team is driving, looking at not only cost reductions but also driving the customer excellence and services because at the end of the day, in the long term, what really matters is to make sure that we deliver on our customers' expectations and that we continue to serve patients. So changes have happened. have been progressed over the last three, four months, I would say. And we have the confidence that we have now in place the leadership for this new phase of the site, which is more launching new products and therapies as opposed to do one only product in a pandemic setup.
spk03: Okay. That's very helpful. Thanks again.
spk01: Thank you. We have our next question. It comes from John Salvia from UPS. John, your line is now open.
spk11: Good morning. Thanks for taking my question. You know, just maybe starting off here, clarification. I guess just given the strategic review, I didn't hear a confirmation of that $6.5 billion of revenue capacity that was talked about in the fiscal 3Q update. Are you confirming that number still?
spk13: So look, when you think about where are we going to put the sweet spot of utilization of this company, and where are we going to get the most of our operating leverage? And we believe that the range of utilization you want to achieve in this business is between 70% and 80% of utilization across the board of your assets. And you translate in what that utilization in our current footprint can translate, it is $6.5 billion. Of course, this is predicated in being in the right therapeutic categories, having the right pipeline and winning the right amount of business, all of which we are working very actively in. So the potential of our network is that one, and I guarantee you we're going to do everything that we possibly can to continue to fill our facilities and to get to that level of utilization which generates healthy levels of cash flows.
spk11: Thanks, and just a follow-up here on the process facility. Appreciate the color and prepared remarks on the improvements there. Just any additional details you can provide on timelines and improvements and how you expect to get to maybe more of a normal projectivity level there. Thank you.
spk13: Well, look, we have seen very good progress from that facility, so we are pleased with what we are already seeing. I believe that some of the lines for some very critical product have recorded the record output in the last few months. So pretty pleased with what we're doing there, and I believe that Brussels is on the right trajectory. And as we go through the first part of the year, which is a little bit slower also because of preplanned vacations and shutdowns at these facilities, and we look into the second half of the year, we're going to continue to see progress. And we're going to continue to see Brussels returning to output level first and then margin as a consequence. We need to remind ourselves that this facility, we have all the demand we want because we are still catching up some of the demand of coming from the previous periods. And we expect in the second half of the year this facility to really come back where it needs to be.
spk11: Thanks for taking the question.
spk01: Thank you. We have our next question comes from Justin Bower from Deutsche Bank. Justin, your line is now open.
spk16: Hi. Good morning, everyone. In the prepared remarks, you mentioned about returning to historical margin levels in the biologic segment and also about returning to a 3x target leverage level. Can you provide us a framework on you know, order of magnitude and perhaps duration on reaching those milestones?
spk13: Well, sure. Look, at the moment, where we stand today, there is a significant amount of revenues that we are recording in our biologic segment, which are translating in very little EBITDA levels. And this is not the function of... having the wrong market, the wrong product mix, or the wrong products is a function of the things that we have discussed in terms of underutilization and productive improvement. So there is a significant opportunity for us in continuing to work on these programs and revenues and returning those revenues in contributing to the bottom line. Our leverage is very sensitive to the bottom line, so as we work through fiscal 24 and we enter fiscal 25, as we shared with the normalized margins, we have a line of sight that we'd be returning to what we expect it to be and as such that leverage will take care of itself. I also believe that Maddy will be absolutely focused on our two billions of working capital with all the initiatives that he has highlighted and looking at the progress that he has already accomplished in the last few weeks since he's joined. I'm very confident that there will be a significant change in that area of our business, driving short-term cash flow but also repositioning the company going forward as we continue to grow the top line for less need of capital to be infused into the company to operate. So it's a pretty simple playbook. Grow EBITDA, use working capital, and improve cash flow.
spk16: Okay, so just to clarify then, should we think of normalized margins in terms of the pre-pandemic margins in the biologic segments? And then my other quick follow-up is just on the C-19 revenue outlook, does that include other respiratory program revenue for that large customer as well?
spk13: So first of all, I believe that the way I would respond to the first part of your question, there is nothing that is not in our control or that would prevent us to get back to the historical margins level in biologics. Nothing. The product mix is the same, the pricing is the same, the equipments are the same, and it's a pretty healthy space to be in. So we'll get there. It's a matter of work and time. The second part of your question, Alessandro Frassica- We will we will over time, try to carve out the other respiratory vaccine work from the pure copy work right it's it's more appropriate because we believe that you know, these are less. Alessandro Frassica- Pandemic selection, then it's related to, and so the simple answer to your question is no.
spk06: Alessandro Frassica- got it Thank you alessandro.
spk01: Alessandro Frassica- Thank you. With our next question comes from Derek DeBruin from Bank of America. Derek, your line is now open.
spk02: Hi, good morning, and thank you for taking my question. Just one, really, just looking at the cost savings. I'm just sort of interested in, I mean, have you done, I assume you've done a systematic review of all your facilities and look for potential other areas where there may need to be investment or remediation. How should we think about that, you know, 150, 170 number in respect to, you know, in terms of me, is that a net number after you sort of look at all your facilities and what you might have to spend? Just basically just like what's your confidence in achieving that cost number?
spk07: It's Matty. We're highly confident in getting to the cost savings number. And then the overall cost, remember that when we get to from 25, 150 to $170 million that Alessandro outlined, which is the cumulative cost savings against the baseline. It's really got hard actions behind it. So if you think about what's been done at the company, it's headcount related, taking down significant numbers of heads, both in the corporate section as well as in some of the underutilized facilities. So we've got that. We do have more work to do. As we talked about earlier, the Strategic Review Committee will look at we'll be looking at capacity as well and utilization as well. And we'll be looking, you know, we're taking it a step further. So there could be more, there could be more to come.
spk02: Sorry, just one follow up then on when you look at the cell and gene therapy demand, I mean, obviously a big impact from early stage biotech. I think at one point, you know, Catalin had said there's maybe like 150 programs you had ongoing and in sort of the cell and gene therapy area. Sort of like, how are you looking at that, you know, triaging that pipeline, looking at that pipeline longer term and, you know, basically sort of adjusting it for the health of the client. Basically just like what your, basically your outlook in terms of the early stage for the cell and gene therapy business.
spk13: Sure. Look, I don't believe that early stage is one part of the equation. The other part of the equation is that as we continue to have good successes in bringing assets to commercialization and we build our track record of commercializing products in new modalities and now this track record is increasing, we believe we are becoming also the partner of choice to take on assets which maybe have been early stage elsewhere and we're gonna be able to be the partner of choice to transition them into convalidation. So more specifically, engaging also in the later clinical phases, which is in fact possible. So we believe that our market share in that specific stage is significant, but will become even more significant as a result of our track record. So again, we believe that our growth in debt will be both coming from our continued focus on the commercial team in winning these early stage assets, which is a little bit of the nature of it, but also being very surgical in going after the opportunity in late stage as this pipeline matures and position ourselves as a partner of choice for commercial assets.
spk10: Thank you.
spk01: Thank you. With our next question comes from Max from William Blair. Max, your line is now open.
spk05: Great. Thanks for taking our questions. Just a couple of clarifying ones for me here, starting with GLP-1s. Alessandro, I believe I could have heard you wrong, but I believe you mentioned seeing significant assets were all coming to fruition in fiscal 2025 on the GLP-1. I just wanted to try to clarify that. Are you expecting to be involved with another major GLP-1 besides the one that has been well discussed here over the last year or so?
spk13: So what I said is that the reality is that for GLP-1 there is a large amount of demand that they need capacity to be satisfied across the board. and our job as a cdmo is to bring this capacity as fast as possible online to satisfy their demands we are trying to do everything we can possibly can across all our facilities and i believe what we are pleased that almost all our sterile feeling facilities are some way in some in some way in different ways involved with these therapeutic area which as i said is one that will be very exciting is for years to come so We're happy about our role. Our role will increase as a result of additional capacity coming online and will be very much spread across the network.
spk05: Understood. Thank you. And then on SRT901, just confirming, your guidance does not assume that the upcoming data readout from SREP is positive and that the label remains restricted to boys aged four to five. I guess you mentioned that. I just wanted to confirm that. And then if that readout is positive, what has SREPTA told you about how manufacturing plans might change? Or I guess put another way, what level of SREPTA growth is currently assumed in guidance, and what should that go to if the upcoming readout is positive? Thank you.
spk13: Yeah, look, in any way, the readout from the study is going to be an important event for us. not only from a business standpoint, but from a patient first standpoint. So that is, in fact, a big deal for us. I don't want that to be underestimated. I do believe that you need to always think about the length of this process and how this process is really, you know, if you like, whatever happens today is going to have an impact delayed in time. But clearly, as you think about our growth into the future, that it is an event that will be important to us, one that we're going to be observing with a lot of attention.
spk05: Understood. Thank you.
spk01: Thank you. With our next question comes from Rachel from JP Morgan. Rachel, your line is now open.
spk00: Great. Good morning. Thank you for taking the questions and putting me in here. I wanted to follow up on David's earlier question around PCH to get some additional color on the assumptions to reach that mid-single to high single-digit growth next year. So you highlighted some of the supply chain issues that will be resolved and drive a tailwind paired with some of the new approvals. But can you walk us through what you're seeing from some of the macro headwinds that you've highlighted this year? And then what are you assuming for that magnitude and duration of those macro headwinds in 24 for PCH?
spk13: Sure. First of all, look, as we said all along, PCH has some macro-driven dynamics primarily related to consumer health, where consumer discretionary spend is really what can drive end-market demand. We've been pretty open and forthcoming about these in the fall of last year. But when you think about the rest of the footprint of PCH is in large commercial approved pharmaceutical product or products that are late stage and due to be approved. So the way you need to think about the dynamics in that business is less macro related and more pipeline related. And as I said, last year was a disappointing one because some of the Assets we had in the pipeline, which were expected to drive growth on top of the base business, were a little bit delayed. We have been open about how we were getting those approvals. A dozen of them did happen in the last six months, and as such, they are now launching. They are building stock. We are producing commercial volumes. So that's the other dynamic. There is a specific product for which we have resolved the supply chain disruption, and now we do have primary materials to be able to deliver that important product. And as always happens in these cases, after one year of suspension, not only do you serve the end market demand, but you also double down on inventory rebuild, so there is an inflated demand in the short term. And finally, we are pleased with the way we are winning business. in our early stage there as well. So across the board, I believe that PCH is posed for a good year. When you look at the year over the horizon of the last two years, it's really where it needs to be, you know, mid to single digits. Clearly, because last year was kind of flat, this year looks a little bit higher. But, you know, this business is performing now as we expect it to perform.
spk00: Great. That was really helpful. Then my follow-up, I just want to ask about conversations that you've been having with customers. So given some of the recent challenges, can you give us any color on what your win rates have been with new customers in recent months? And then can you discuss, has there been any discussions around cancellations or requests for concessions from customers given some of those challenges? Thank you.
spk13: Sure, look, as you can, I've been always pointing out that the data set of our customers, especially our existing customers, in terms of evaluating the current performance is a little bit wider. And as we shared in the script, just to point to one example, on one side you have a CRL, which makes it to the news, and you have an inspection ending up with the 0483 observations in the range that doesn't make it to the news. And we are sharing now that today, just for the very purpose of providing a little bit of a more balanced view, which is hard to get from the external world, but surely is one that our customers get real time. So when you think about some of those challenges, one, the perspective is a little bit different and the set of information available is a little bit different. According to our quality agreements, we do share with our customers all our regulatory requirements. outcomes include both the ones that are impacting their products and the ones that are not impacting their products to provide a perspective on the overall compliance profile of the company. And with regards to the other news, of course, me and the rest of the management team are on the front line all the time and providing perspective of the news that have been coming up in the recent months, including the ones that are coming up today. And we're going to be, as always, transparent, providing perspective of But also, you know, reassuring customers that Catalan has been here for decades and will be here for decades to come.
spk09: Thank you.
spk01: With our last question comes from Tim Daly from Wells Fargo. Tim, your line is now open. Great, thank you.
spk15: So first off, just wanted to follow up on earlier answer to the last of today's many GLP-1 questions. So, Alessandro, I think you said that all your sterile facilities are involved in GLP-1 projects in some way. So, could you just update us on the global count of sterile fill finish lines currently offering commercial scale, and what percent of those have prefilled syringe and or cartridge capacity?
spk13: So, look. I would tell you that at the moment we have a pretty sizable capacity in sterile fill and finish. I believe at the moment I would say that probably close to 40% of our capacity in prefilled syringes and we are rapidly increasing that. I believe that our capacity will become skewed towards prefilled syringes in calendar 24. And what you should think about is that most of our sterile finish volumes will come from pre-fill syringes as we go forward. I just would like to point you out also to the fact that our service does not finish with the filling operations, but we provide also packaging to our customer. We provide auto-injector assembly to our customers. So there are a lot of corollary capacities, which seems to be ancillaries, but are pretty relevant in the overall economics of these franchises, specifically also in the one that you did mention. So we have a pretty large footprint. We are pleased with what is coming online, what will be coming online, and we believe that with our footprint, we're going to be able to play a major role in these therapeutic areas.
spk15: That's really helpful. And then my second one here is on free cash flow generation efforts. So, you know, Maddie, you called out the inventory balance as the second priority in working capital opportunities behind accounts receivables. So appreciate muted capacity utilization is likely inflating the balance here. But, you know, given supply chain and supplier lead times have normalized, Why haven't we seen inventories come down already? Or why is that not higher in the pecking order in terms of working capital initiatives?
spk07: Well, I mean, I think right now, I wouldn't say there, maybe it was my phrasing of the ordering, but it is high on the pull. I think from an ease of getting the cash out, I think it's receivables. We've shipped the product. We have an outstanding receivable. We've got to go collect it. So it's a lot easier to go and get. It just comes back, comes in quicker. inventory you have to burn it off and you have to utilize it and burn it off and then change your ordering patterns and look at the SINOP process to really get at what I'll call the DIOs and the underlying metric of DIOs and bring it down. And so I do think there's a little bit more work to do from an inventory perspective. I do think the company just really hadn't focused on it to date as much as they should have and I think when you sit here and look at the inventory balance, I think it's a bit bloated. I do think we have an opportunity to take it down. like I said, and burn into those inventory balances and bring it down to a more normalized number where it's sustainable. I think the idea here is, to your point, the supply chain has leveled out. As I see it, I think it's more normalized. With some products, clearly, they're not clearly fixed. We also have stuff on boats. We have to look at the whole supply chain in totality. But I do believe there's a substantial opportunity sitting here looking at the working capital in total. And I don't think there's going to be much. It's a different team that's going to be. Commercial team is going to be going after receivables. The manufacturing team and the supply chain is going to be going after inventory.
spk15: All right. Got it. Thanks for the time. Appreciate it.
spk01: Thank you. We have no further questions on the line. I will now hand back to Alessandro Mazzelli for closing remarks.
spk13: Thank you. I'd like to thank everyone on the Catalan team for their commitment to our customers and patients as a showcase by the delivery in partnership with our customers Repta Therapeutics of the first dose of LFDS gene therapy to a young child in the U.S. suffering from DMD, making an historical milestone in the promise of treating these terrible conditions. We remain focused on leading Cadaren towards sustainable and profitable growth and increasing the shareholder value. And I believe that actions announced today have placed us on a clear path to doing so. Thank you everyone for taking the time to join our call and your continued support of Cadaren.
spk10: Thank you. Ladies and gentlemen, this concludes today's call. Thank you for joining. You may now disconnect your line.
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