Catalent - Earnings Call - Q1 2020

Transcript

Operator (participant)

Ladies and gentlemen, thank you for standing by. Welcome to the first quarter, fiscal year 2020, Catalent Inc. earnings conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Thomas Castellano, Vice President of Investor Relations and Treasurer. Thank you. Please go ahead, sir.

Thomas Castellano (VP, Finance, IR and Treasurer)

Thank you, Jimmy. Good morning, everyone, and thank you for joining us today to review Catalent's first quarter, fiscal year 2020, financial results. Please see our agenda on slide two of our accompanying presentation, which is available on our Investor Relations website. Speaking today for Catalent are myself, John Chiminski, and Wetteny Joseph. 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. Slides three, four, and five discuss the non-GAAP measures, and our just-issued earnings release provides reconciliations to the nearest GAAP measures. Catalent's Form 10-Q, to be filed with the SEC later today, has additional information on the risks and uncertainties that may bear on our operating results, performance, and financial condition. Now, I'd like to turn the call over to John Chiminski.

John Chiminski (CEO)

Thanks, Thomas, and welcome everyone to our earnings call. We're pleased with our first quarter financial results, which have us off to a strong start in our 2020 fiscal year. As you can see on slide six, our revenue for the first quarter increased 20% as reported, or 22% in constant currency, to $665 million, with 11% of the constant currency growth being organic. All four of our reporting segments recorded double-digit revenue growth during the quarter and contributed to the strong first quarter growth rates, which were nicely above our long-term outlook. Our adjusted EBITDA of $127 million for the quarter was above the first quarter of fiscal year 2019 on a constant currency basis by 28%, with 13% being organic.

Our adjusted net income for the first quarter was $41 million, or $0.26 per diluted share, which is $0.08 above the same figure from the prior fiscal year. The strong results at the profitability line also included contributions from all four of our reporting segments. Now, moving on to our operational update. First, we continue to make great strides on our biologic strategy, and I'm pleased to announce that the Bloomington site recently received approval for its 21st commercial product, which is up from the 12 it was producing at the time of the acquisition, with several additional launches on the horizon. We continue to manage a robust funnel of late-stage clinical opportunities across Bloomington and Madison that bodes well for future growth. Additionally, the expansions supported by our $200 million investment in biologics spanning both Bloomington and Madison are well underway and progressing according to plan.

This investment will add more drug substance manufacturing and drug product fill-finish capacity to meet projected growth among existing and future customers. Another significant aspect of our biologic strategy is reflected in our entrance into the gene therapy space through our acquisition of Paragon Bioservices in May 2019. Through that acquisition and the related acquisition of additional gene therapy assets in late July, we have gained new expertise and capabilities in one of the fastest-growing therapeutic areas in healthcare. These developments reinforce Catalent's leadership position across biologics and position us for accelerated long-term growth by bringing deep expertise in adeno-associated viral vectors, the most commonly used delivery system for gene therapy, as well as a platform for development of an expanded offering of vectors, enabling entry into other adjacent technology categories to support the development and manufacturing of gene and cell therapies.

Our gene therapy business combines this expertise with strong manufacturing capabilities and world-class facilities in order to capitalize on substantial industry tailwinds in gene and cell therapy. The integration of our gene therapy assets into the Catalent portfolio is well underway and progressing ahead of our expectations. The gene therapy business is performing well out of the gate, and the expected positive impact of the gene therapy business on our future revenue and EBITDA profile will deliver highly compelling value to shareholders, as evidenced by the increase in our expected long-term revenue growth outlook from 4%-6% to 6%-8%. We also recently launched our OneBio suite, which combines our large molecule development, manufacturing, fill-finish, packaging, and clinical supply solutions into one integrated and simplified service offering.

Essentially, this service is designed to accelerate biologic development by leveraging all of Catalent's capabilities and expertise to successfully move the customer's molecule from gene to clinic as fast as possible. There's been great interest among customers looking to trim weeks to months off standard development timelines, and Catalent just signed our first OneBio contract with dozens more in active discussions. We've also seen an overall increase in cross-selling opportunities between our biologics and clinical supply businesses, which is another outgrowth of our OneBio offering. The OneBio suite is just one example of how Catalent continues to innovate to meet customer needs and differentiate our biologics capabilities in this exciting and fast-growing market.

As a reminder, Catalent Biologics, including gene therapy and our pre-existing drug substance and drug product biologics businesses, can provide integrated solutions from protein and viral vector manufacturing and analytical services through clinical and commercial supply and fill-finish in a variety of finished dose forms, including vials, cartridges, and syringes. Biologics represented more than 32% of the company's revenue in fiscal 2019 and will become an even larger percentage of our revenue over the next few years. The combination of organic and inorganic investments we are making in biologics is already delivering substantial benefits to patients and will continue to create significant value for the company, our customers, and our shareholders. Second, we remain positioned increasingly well in an attractive, robust, growing market and have the strongest development pipeline since Catalent's inception, with more than 1,100 active projects.

Next, we remain fully committed to delivering results aligned with our fiscal year financial guidance and are reaffirming our guidance range, which reflects revenue growth of 10%-14% and Adjusted EBITDA growth of 17%-22%. Finally, the press release we issued this morning describes adjustments we have made to our operating segments to better align our internal business unit structure with our follow-the-molecule strategy and our increased focus on our biologics-related capabilities. Slide seven shows our adjusted segment structure, the capabilities within each, and the fiscal year 2019 revenue contribution from each of the segments. Our revised structure, which parallels and reflects how we manage our business internally, provides complete transparency to the performance of our large molecule drug substance, drug product, and gene therapy assets through the revised Biologics reporting segment, which no longer includes our specialty delivery platforms.

Our renamed Softgel and Oral Technologies segment includes the former Softgel Technology segment in its entirety, as well as our large-scale commercial solid oral dose platforms that were previously included in our oral drug delivery segment. Our Oral and Specialty Delivery segment includes small molecule development technologies and supply for small to medium-scale specialty oral, respiratory, and ophthalmic products, including our Zydis orally dissolving tablet business, our spray-drying capabilities, and our facilities devoted to early development activities, as well as analytical services. There is no change to our Clinical Supply Services segment. Therefore, for financial reporting purposes, we continue to represent four segments: softgel and oral technologies, biologics, Oral and Specialty Delivery, and Clinical Supply Services. A more comprehensive description of our segments can be found in our Form 10-Q to be filed with the SEC later today.

Now, I'll turn the call over to Wetteny Joseph, our Chief Financial Officer, who will take you through our first quarter fiscal year 2020 financial results.

Wetteny Joseph (CFO)

Thanks, John. I will begin this morning with a discussion on segment performance, where both the fiscal 2019 and fiscal 2020 first quarter results are presented on the basis of our revised reporting segments. Please turn to slide eight, which presents our Softgel and Oral Technologies business. As in past earnings calls, my commentary around segment growth will be in constant currency. Softgel and Oral Technologies revenue of $263.7 million increased 12% during the quarter, with segment EBITDA increasing 15% due to strong performance across the entire portfolio. The segment experienced growth from prescription and consumer health volumes in North America, which was partly attributable to the strong uptake from recently launched products. The segment also recorded higher demand for consumer health products in Europe. Additionally, the strong EBITDA performance was driven by improved capacity utilization and favorable product mix across the network.

All of the segment revenue and EBITDA growth was organic. Additionally, in late October, we completed the sale of our Bayside Australia VMS softgel facility to Blackmores, which we announced back in April of 2018. As a reminder, the closing date of the sale was known as we entered the current fiscal year, and its impact is already reflected in our financial guidance. Slide nine shows that our revamped biologics segment recorded revenue of $188.6 million in the quarter, which was up 51% versus the comparable prior year, with segment EBITDA growing 33% during the quarter. However, most of the segment's revenue growth and all of the segment's EBITDA growth was inorganic and driven by the gene therapy acquisitions, which contributed 45 percentage points to the segment's revenue growth and 51 percentage points to the segment's EBITDA growth.

Excluding acquisitions, the segment recorded organic revenue growth of 6% in the first quarter, but an EBITDA decline of 18%. Recent investments in our biologics business continue to translate into growth during the first quarter, as we recorded strong growth in drug product volumes across the U.S. But as highlighted in our last earnings call, the business has been experiencing declines in its drug substance revenue, partly due to the completion of a limited duration customer contract for non-cell line clinical manufacturing services, as the customer completed the build-out of its own capacity. We continue to expect this to be a headwind for our drug substance business over the next couple of quarters, as we work to onboard new customers and continue to increase our utilization levels. However, we remain confident that our biologics business is positioned well overall to drive strong future organic growth.

As a reminder, in June, we announced our agreement to purchase Bristol-Myers Squibb oral solid biologics and sterile manufacturing and packaging facility in Anagni, Italy. This transaction will enhance our global network and provide us drug product sterile fill-finish capacity and oral solid dose manufacturing in Europe, along with an agreement to continue to manufacture BMS's current product portfolio at the site. The addition of the Anagni facility provides our European customers with great biologics and oral dose capabilities to accelerate their development programs and improve commercial supply. We anticipate completing the transaction in the next few months. Slide 10 shows that our Oral and Specialty Delivery segment recorded revenue of $132.6 million in the quarter, which is up 21% versus the comparable prior year, with segment EBITDA increasing 51% during the quarter. 18% of the revenue and 46% of the segment EBITDA growth was organic.

The strong performance was driven by increased end-market demand and favorable product mix for overall oral delivery commercial products across the U.S. and Europe, as well as increased intake of new molecules, which drove strong analytical and development services revenue. Additionally, the segment continues to have one of our strongest development pipelines, including several late-stage freeze-dry development programs. Due to the timing of the close of the Juniper Pharmaceuticals acquisition in the first quarter of fiscal year 2019, one month of the result is considered inorganic, which contributed 3 percentage points to the segment's revenue growth and 5 percentage points to the segment's EBITDA growth during the quarter. The results for the respiratory and ophthalmic business, which are now included in this segment, were in line with the prior year, but the fundamentals remain attractive for these key sterile fill technology platforms.

In order to provide additional insight into our long-cycle businesses, which include softgel and oral technologies, biologics, and oral and specialty delivery, we are disclosing our long-cycle development revenue and the number of new product introductions, or NPIs, as well as revenue from NPIs. As a reminder, these metrics are only directional indicators of our business, since we do not control the sales or marketing of these products, nor can we predict the ultimate commercial success of them. For the first quarter of fiscal 2020, we recorded development revenue across both small and large molecules of $203 million, which is more than 40% above the development revenue recorded in the first quarter of the prior fiscal year. Additional disclosure on our development revenue is included in our Form 10-Q to be filed today with the SEC.

In addition, we introduced 50 new products, which are expected to contribute approximately $13 million of revenue in the fiscal year. Now, as shown on slide 11, our Clinical Supply Services segment posted revenue of $84.6 million and segment EBITDA of $21.6 million, both of which increased 11% compared to the prior quarter of the prior year. The double-digit growth in both revenue and EBITDA was driven by higher volumes of storage and distribution, as well as manufacturing and packaging services. All of the segment revenue and EBITDA growth recorded within CSS was organic. As of September 30, 2019, our backlog for the CSS segment was $374 million, or 2% sequential increase. The segment recorded net new business wins of $93 million during the first quarter, which is an increase of 28% compared to the net new business wins recorded in the first quarter of the prior year.

The segment's trailing 12-month book-to-bill ratio remained at 1.2 times. Slide 12 contains reference information. We have already discussed the segment results shown on this slide, and the remainder of the slide contains consolidating information necessary to compare the total segment results to our overall results. Slide 13 provides a reconciliation of EBITDA from operations from the most proximate gap measure, which is net earnings or loss. This bridge will assist in tying out the reported figures to our computation of adjusted EBITDA, which is detailed on the next slide. Moving to adjusted EBITDA on slide 14, first quarter adjusted EBITDA increased 27% to $127.1 million. On a cost and currency basis, our first quarter adjusted EBITDA increased 28%, with 13% of the 28% being organic and driven by the double-digit growth across our softgel and oral technologies, Oral and Specialty Delivery, and Clinical Supply Services segments.

On slide 15, you can see the first quarter adjusted net income was $40.5 million, or $0.26 per diluted share, compared to adjusted net income of $25.4 million, or $0.18 per diluted share in the first quarter a year ago. Slide 16 shows our debt-related ratios and our capital allocation priorities. Our total net leverage ratio as of September 30 was 4.3 times, which is modestly reduced from the ratio as of the end of the prior quarter. Pro forma for the gene therapy acquisition, our total net leverage ratio was 4.2 times, which is an improvement of 3/10 of a turn compared to the ratio at the time we announced the transaction. Given the free cash flow generation of the company and its growing adjusted EBITDA, the company naturally delivers between 0.5 and 0.75 of a turn per year.

Additionally, continued investments in biologics, including gene therapy, are expected to increase our fiscal year 2020 capital expenditures to approximately 11%-12% of net revenue. Our capital allocation priorities remain unchanged and focus first and foremost on organic growth, followed by strategic M&A. Turning to our financial outlook for fiscal year 2020 on slide 17, as John previously stated, we are reaffirming our financial guidance and continue to expect full-year revenue in the range of $2.78-$2.88 billion. We expect full-year Adjusted EBITDA in the range of $700-$730 million, and full-year Adjusted Net Income in the range of $300-$330 million.

We expect that our fully diluted share count on a weighted average basis for the fiscal year ending June 30 will be in the range of 159-160 million shares, counting the preferred shares we issued in May to fund part of the Paragon acquisition as if they all were converted to common shares in accordance with their terms. In addition to reaffirming our guidance on revenue, Adjusted EBITDA, and Adjusted Net Income, we also now reiterate that we expect our consolidated effective tax rate to be between 24% and 26% in the fiscal year. Lastly, let me remind everyone of the seasonality in our business and highlight our expected progression through the year. As discussed for several years now, the first quarter of any fiscal year is generally our lightest quarter by far, with the fourth quarter of any fiscal year generally being our strongest by far.

This will continue to be the case in fiscal year 2020, where we expect to realize between 40% and 41% of our Adjusted EBITDA in the first half of the year and between 59% and 60% of our Adjusted EBITDA in the second half of the year. Operator, we would now like to open the call for questions.

Operator (participant)

Thank you. As a reminder, to ask a question, you will need to press star one. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Tycho Peterson with JPMorgan. Your line is now open.

Tejas Savant (VP and Healthcare Equity Analyst)

Hey, guys. Good morning. This is Tejas Savant for Tycho. John, I just wanted to get your perspective on a couple of things here. I mean, one, looks like the overall top-line performance was pretty healthy, came in well ahead of at least our model. Yet you left your fiscal 2020 guidance unchanged. Just trying to get a sense for what drove that dynamic. Were there any sort of one-offs or fall forwards that you saw in one Q, which will result in a little bit of an offset later on in the year?

John Chiminski (CEO)

Hey, Tejas. This is Wetteny here. As we've consistently said in prior years, the first quarter is our lightest quarter by far, given the seasonality in the business and the timing of when we do the majority of our maintenance shutdowns. And we tend to really, as we look at the guidance that we set out at the beginning of the year and we continue to have line of sight into, we don't really move in either direction after posting our results on the first quarter, and again, given the consistent visibility that we have across the year. So that was the case in the last several years, and will continue to be the case for us.

Tejas Savant (VP and Healthcare Equity Analyst)

Got it and then just to follow up on margins here, specifically within the biologics business, I think, Wetteny, you mentioned that segment EBITDA was down about 18% on an organic basis. What did that number look like once you adjusted for that fiscal 2019 completion of that limited duration contract in drug substance?

John Chiminski (CEO)

Yeah. So as a reminder, look, we've completed a very strong quarter here overall with posting solid double-digit organic growth overall for Catalent, as well as three of our segments posting double-digit organic growth. Tejas, our acquisitions are really executing well for us and performing very well at or above our expectations. And as we've said during the prepared comments, we're reaffirming our guidance for the year. Now, biologics, as you reminded here in your question, in the fourth quarter, we did highlight that we have a customer that had non-cell line clinical manufacturing that we were performing for them over the last few years, and that was a known time frame for doing that as they were building out their own capacity and that concluded.

If you adjust that out, the top line for the biologics business would have been about 12% organic growth and about a 5% organic growth of the EBITDA line as we continue to make investments in various parts of our business. Now, as I highlighted in the last call as well, our drug product business continues to have significant demand. Our utilization across our biologic drug product manufacturing site in the U.S. continues to ramp up quite nicely for us. And we've seen, as John mentioned earlier, the 21st commercial product approval in that business, and we'll continue to see the ramp-up of utilization there. Drug substance, however, is a business that is almost entirely in pre-clinical and clinical stages. And until we have a commercial product in our U.S. drug substance manufacturing facility, we'll continue to see some level of availability in that business.

We have certainly plans to have that site commercial ready, and we continue to see the programs advance in that pipeline for us. But it's a matter of time before we'll have a commercial approval, which will drive a bit more less variability in the business, if you will. So those are the contributions here. But if you exclude the one customer we referenced, you'd be looking at about 12% top-line growth and about 5% EBITDA growth organically in that segment.

Tejas Savant (VP and Healthcare Equity Analyst)

Got it. Thanks so much, guys.

Operator (participant)

Thank you. And our next question comes from John Krieger with William Blair. Your line is now open.

Jonathan Kaufman (Equity Analyst and Global Investment Management)

Hi, good morning. This is Jonathan Kaufman on for Krieger. Just following up on the last question here in drug substance. So obviously, a lot of this is pre-clinical and clinical. Are you guys seeing significant demand volatility? Are any of your clients talking about, for example, the election cycle and how it might impact their strategies at all?

Wetteny Joseph (CFO)

Yeah. So Jonathan, look, we're certainly not seeing significant demand variability here. The market continues to remain really robust. I think what we're seeing here is variability on clinical cycles. So as you know, compared to a commercial drug that you know that you're manufacturing a certain amount to supply the market, clinical programs tend to have need for biomanufacturing batches from time to time, and those vary depending on where they are in the cycle. One thing we're seeing, I would say, is the third suite, which we launched in April of previous years, so it was about 15, 18 months ago. That third suite, which is the largest manufacturing site in terms of bioreactors we have, so there's a two by 2,000-liter, continues to ramp up really, I would say, above our expectations. We're seeing anywhere from 60%-70% plus utilization on that third suite.

It's really in reference to the programs that are continuing to advance and are needing larger-sized batches. It's the smaller suites that we're seeing more availability, and those would be the ones that have earlier clinical programs. One last point I'll make is we are starting to see some early signs of uptake in terms of the earliest part of the business, if you will, where we are doing the cell line development and some other process development work, which would lead to more biomanufacturing down the road. That's a little bit more in terms of what we're seeing and what that might signal for the future for the business. I would say that the clinical pipeline is typically more variable than commercial. Until we have commercial product manufacturing in that facility, we'll continue to see variability.

Jonathan Kaufman (Equity Analyst and Global Investment Management)

Okay. Great. And then one follow-up here. You guys mentioned cross-sale opportunities earlier. So where are you gaining traction in terms of which client base is most interested or most open to using multiple of your offerings? And then how do you think about the revenue opportunity from cross-selling over the next, let's say, two to three years?

John Chiminski (CEO)

Yeah. John Chiminski here. First of all, I would say that our customers in the small to medium size who are really looking for a full suite of service are the ones that we're getting the most traction with regards to cross-selling. Some of the simple things that we did besides launching the OneBio suite is to put basically project managers into some of our early development sites, giving them access to the customers very early on for our Clinical Supply Services. And these, again, small to mid-sized companies are really looking for end-to-end capabilities. And previously, I would just say that we had not made it easy enough for them to access all of our capabilities, and I think we've got a significant focus there. We continue to see our Clinical Supply Cervices business as a critical asset to provide that end-to-end capability.

It's the business unit that is probably closest to our customers and patients, given that we're literally shipping clinical supplies directly to the patients. So being able to access those customers early on as they're doing early development for their molecules and providing them access to our Clinical Supply Services, project managers is a big deal. And I would just say overall, given the broad capabilities that Catalent has, as customers look to partner more and have fewer, bigger, better suppliers, it's really an opportunity for us to do a lot more overall cross-selling. And again, we specifically designed an offering through OneBio to be able to do that through our biologics business, but are certainly in a position to do that more frequently and improve outcomes for also our oral businesses.

Jonathan Kaufman (Equity Analyst and Global Investment Management)

That's really helpful. Thank you.

Operator (participant)

Thank you. And our next question comes from David Windley with Jefferies. Your line is now open.

David Windley (MD)

Hi. Thanks for taking my questions. John, I wanted to follow up on your follow-on molecule commentary and just to understand that in a little more depth from a couple of standpoints. One, as I look at the descriptions around the segmentation now as you're presenting it, I see that manufacturing of oral solid dose is in a couple of different segments, and so I want to understand how that's consistent with I figure I must not understand the follow-on molecule because that doesn't seem obvious to me, and then broadly, I think in the past you guys have talked about the financial presentation really mirroring the way you're managing the underlying business, and this is, I think, at least the third, maybe the fourth time that has changed since you came public.

And so if you could talk about kind of the catalyst for the change and the stability of the underlying org chart and the managers of these businesses to the extent that kind of the segmentation is changing as frequently as it is. I'd appreciate it. Thank you.

Wetteny Joseph (CFO)

Yeah. No, that's a good question, David. And I'll start with that. If you take a look at where we were from an IPO standpoint to where we are today, we've significantly transformed the business. We started with a business at the time of the IPO that was only exposed to biologics at about 10% of our revenue. And where we're sitting now is about 32%. The second thing is we went through a pretty significant transformation, actually putting in place an early development platform for the company, which was missing. I would say that we were much more of a late-phase company at the time of the IPO. Although we had the follow-up molecule strategy, we didn't have enough early development assets. So we added Pharmatek, the acquisition of Juniper, and then also repositioned our Somerset site.

And then in addition to that, we launched a pretty significant activity to get into spray drying because of those early development activities. So if you take a look at the transformation of the business over the last five years, we now have a very substantial biologics business. We have a substantial early development business that we didn't have at that time that's bringing in over 100 molecules, and we still have the late-phase commercial business. So though, I would say from an alignment standpoint, you can look at it and say, "It's not perfect." From an internal standpoint, what we've done is, number one, we've now completely put into one contained business unit biologics, which contains our biologics and gene therapy business unit that doesn't have the specialty dose forms in it before. So that's the way we're now running it internally.

Obviously, from an investor standpoint, it gives you complete visibility into that. Because of the growth of those early development, that early development platform, if you now take a look at our Oral and Specialty Delivery group, it contains those assets combined with, I would say, other assets that are basically more tuned into small and mid-size capacity. Then now in our, I would say, our ultimate late-phase commercial business being Softgel, we've now added into that several of our large commercial late-stage tech transfer assets into it. The one point where you may think it to be inconsistent is in the commercial manufacturing of our Zydis, which is in the Oral and Specialty Delivery. That dosage form Zydis is purely an organic growth business, meaning we bring in molecules and develop them. There's no opportunity for a tech transfer in.

So I think what we've done is continue to optimize our business unit organizations to mirror the transformation of the business. And so again, as you take a look at that transformation over time, we feel as though we've now really tuned in right now the right business unit structure that is aligned with the new assets that we've brought on board and are growing. And that's the way that our teams are going to be able to drive them. So very comfortable with it. And as you take a look at some specific units, I think, again, it provides additional transparency. Even as you take a look at our Softgel and oral technologies, 75% of that business unit will still continue to be Softgel. The performance for this quarter roughly mirrors the Softgel performance.

So I think, again, it's very helpful for us to continue to modify our organization as we continue to transform the business. And we're providing, I would say, improved visibility to those segments with this reporting structure externally.

David Windley (MD)

Yeah. Thanks for that. That's helpful. If I could follow up on just drug product, the commentary certainly have had great success on drug product approvals in biologics I'm speaking to. As you've seen those products launch, have you now progressed to a point, particularly the ones that have been approved since the acquisition, are they progressing to a point where you are getting repeat orders and you're kind of seeing a stability, or are you to some degree in that void of waiting for the launch quantities to be exhausted before the reorders come back?

Thanks.

Wetteny Joseph (CFO)

I would say that across all of those 21 launch products, it's provided a level of visibility and consistency that we love. These products have not been, I would say, volatile as in the previous commentary that we had from Windley with regards to our drug substance, which is primarily a clinical-based business, and you can have some quarter-to-quarter variability with the large number of commercial products that we have in our drug product business for biologics out of Bloomington. What we're seeing is just consistent, strong uptake with, quite frankly, it gives us a sense of urgency for those additional assets that we're bringing on board over the next year and a half to double the capacity there for drug products, so couldn't be more pleased with the way the drug product is progressing.

And then on the drug substance side, we're aggressively working to be commercial-ready and acquire that first customer. And I think we should have some good visibility into that over our calendar year 2020. And that will, I think, put it in position to be as consistent and strong performing as we have now on the drug product side. So I would just say green light on both fronts. Feel very good about it.

David Windley (MD)

Great. Thank you.

Operator (participant)

Thank you. Our next question comes from Juan Avendano with Bank of America. Your line is now open.

Juan Avendano (VP and Healthcare Equity Research)

Hi. Thank you. I believe you said that organic growth for the company came in at 11%. Relative to our estimate, I think the organic beat was primarily driven by the Oral and Specialty Delivery segment. And so were there any non-recurring or timing-related benefits that drove the beat and organic growth of, I believe, 18% in that segment? And was that due to particularly the oral business, Zydis, continuing to do well? Or did you have a rebound on the specialty drug delivery business that was struggling for the most part of fiscal year 2019?

Wetteny Joseph (CFO)

So Juan, first of all, the organic performance in the quarter was really driven not only by the oral and specialty, but across our Softgel and oral technologies and our CSS. All three of them delivered double-digit organic growth, both on the revenue and Adjusted EBITDA line. With respect to OSD in particular, posting 18% organic top-line growth, 46% on the EBITDA, I would say across the business, we saw strength in the first quarter. The latter part of your question with respect to ophthalmic and respiratory, that was really not a driver in the quarter. I would say that was roughly in line with what the business performed in the prior year for that part of it. Across our development and our local services, we saw strength as well as our commercial end of the spectrum, including what you mentioned, which is our Zydis platform.

So I would say, relatively speaking, if you recall, just a reminder in terms of how last year transpired, the first quarter was, in relative terms, a weaker for that segment, certainly. So as we look at these organic performances, I would not expect that to be the level of performance of the business for the year. Our visibility is strong across the business, and all those things are factored into the guidance that we started with, and we just reaffirmed today.

Juan Avendano (VP and Healthcare Equity Research)

Okay. I guess related to that question, given that you have reorganized your reporting segments once again, can you share with us your normalized growth expectations organically for each of the segments as they are now?

Wetteny Joseph (CFO)

Yeah. So Juan, what I would say, first of all, we don't give segment-level guidance, right? So I just want to remind you, we factor all of our businesses and our visibility and our guidance certainly from an annual basis. But we have shared and will continue to share what our expectations are for our segments long-term. And so from a long-term perspective, I would say that what we're now calling Softgel and oral technologies SOT, the legacy Softgel business, we said was a 2%-4% grower long-term. And I would say, look, the portion that we've now moved into the segment is roughly 20-25% of that segment. So not large enough to move it substantially, but I would say probably at the point on both ends of that. So rather than 2%-4%, you're probably looking at 3%-5% for that segment long-term.

Our oral and specialty segment would be. Previously we said it should be performing at the higher end of the former 4%-6%. So we're saying this is a business that should grow in that 6%-8% ish, if you will, long-term. I would say with the pieces that we've moved out, it's probably about the same to slightly, maybe 50, 60 basis points below that. So I would put it probably in that 5%-7% range long-term is what I would say. So you add a point to the sort of SOT business, and you take one out from the OSD. So those are the primary moves. If you look at biologics, we've now removed the ophthalmic and respiratory from that segment that was a slower end of the spectrum, if you will.

So previously, we said the BSDD business had 60% core biologics with the remaining 40% in the specialty. Having removed that portion, we still have our sterile injectables business in Europe, which is largely a small molecule, but our long-term plans are to continue to transform that to be more biologics focused. But if you were to take the segment now, I would say it's about 85%-90% biologics focused, which we would expect long-term to be growing in the teens with that latter 15%, if you will, 10%-15% being more in the 4-6 range. So hopefully that gives you a sense from a long-term what we expect from our various segments. And obviously, CSS remains unchanged.

We would expect that to be, again, more along the lines of a 6%-8% grower long-term, clearly above that right now, given the recent uptick we've seen in new business wins, which we're now seeing execute and burning through that backlog, which we're very, very pleased with.

Juan Avendano (VP and Healthcare Equity Research)

Thank you.

Operator (participant)

Thank you. Our next question comes from Daniel Brennan with UBS. Your line is now open.

Daniel Brennan (MD and Senior Research Analyst)

Great. Thank you. Thanks for taking the questions. Maybe just back to the guidance question. I know, Wetteny, you answered it earlier that you can or maybe John, I apologize. I think you mentioned post Q1, given it's heavily weighted to the back half of the year, I guess your policy isn't to raise. But just to take the low end of your guidance, it would imply kind of 1% growth for the remaining three quarters. I just want to understand, is that a plausible outcome, or is it really just steadfast your policy is after Q1 you guys don't change your guidance?

Wetteny Joseph (CFO)

Look, I would say, first of all, again, the first quarter represents about anywhere from 16%-18% of our year, typically is what we see in the first quarter. So it's not substantial in terms of proportional portion of the year where we would change our guidance unless we see something material in our visibility, which we continue to be confident in what we see in the business across both our long-cycle and our short-cycle parts of the business across our segment. So we just tend to have to not shift our thinking on the guidance. The other thing I would just remind you of in terms of the buildup of our guidance that we issued, I would reference you back to the prior quarter where we laid out our guidance, including the Australia facility, which we just closed.

That's going to take out about $34 million-$37 million of revenue of the top line, $3 million-$4 million of the EBITDA line. So I just want to make sure as you model out, you're taking those things into consideration. And keep in mind, we also take the organic the Paragon acquisition is largely inorganic for the year. So that would not be included in the commentary we're giving from an organic perspective. So look, we're pleased with the start of the year. It's a solid first quarter. We continue to have strong visibility as we look out for the rest of the year and are confident in delivering what we've reaffirmed here today. But we just tend to not, again, unless there's a material shift that we're seeing, we just don't change the outlook for the rest of the year.

Daniel Brennan (MD and Senior Research Analyst)

Got it. Okay. And then maybe just on Paragon, it was slightly better than we expected. Can you just comment on the expectation for 2020 that's implicit in your reported revenue versus organic? It's basically, I know it was $200-$250, I think $220-$225. So just confirm that's the right kind of area that we should be thinking about for Paragon, or is that changed? And then any comments you can provide on demand trends and visibility, how they look for this year, and as well, any revenue commitments. I'm not sure what you've discussed previously, but any revenue commitments you kind of look out beyond this year for Paragon?

Wetteny Joseph (CFO)

Yeah. So when you look at Paragon, the guidance we provided, you're correct in terms of that column in the buildup was in that range. It does not include the portion that is organic. As you may recall, we closed the deal in the middle of the fourth quarter. So all in, it represents closer to $260 million at the top line, roughly $75 million at the EBITDA line is what's embedded in the overall guidance. With respect to what we're seeing in the business, we continue to see really robust demand across the slate of visibility. I would say for a business that's largely in the clinic, the visibility is, I would say, higher than you would normally see given the amount of contracted portion of what we're seeing for the year. I would say this is a business that continues to perform at or above our expectations.

We haven't seen any change in terms of what the outlook looks like in terms of demand. As you may recall, when we announced the deal, we took our growth rate from a long-term perspective from an organic growth rate of 4-6% at the top line to 6-8% for the overall Catalent picture. I think you can back calculate what that implies from a long-term perspective for the Paragon business. We continue to have that as part of what we expect from the business and are seeing it execute too.

Daniel Brennan (MD and Senior Research Analyst)

Okay. All right. Great. Thanks a lot.

Operator (participant)

Thank you. Our next question comes from Evan Stover with Robert W. Baird. Your line is now open.

Evan Stover (VP and Healthcare Services Equity Research)

Hi. Thank you. I'm going to continue on Paragon a little bit. If I run the math on the quarter, it looks like the EBITDA margin was in the mid-20s. I think your guidance implies around 30% EBITDA margins for the year. I know you opened up new facility around at BWI Airport, and you're filling up capacity. Is that the primary function that you expect to get some leverage on for the rest of the year? Or can you just talk generally about the EBITDA margin trends from here in that business?

Wetteny Joseph (CFO)

Yeah. Evan, you're about right. I think when you look at the Paragon business, again, continues to perform, I would say, above our expectations. We did announce and close the acquisition of certain assets from Novavax early in the quarter. We continue to make investments there as we onboard those individuals and those new sites, which really expand our front end, I would say, for the business. And our ability to continue to attract more and more programs into the gene and cell therapy business through Paragon. So we're very pleased with how that integration is going. And it is part of the picture here. As you look at the first quarter with respect to what the business delivered is a bit of that investment. I would say the Novavax assets were marginally diluted to what we've seen in the first quarter.

It's what we expected when we gave our guidance. We had certain visibility into that, and it continues to be in line with what we expect.

Daniel Brennan (MD and Senior Research Analyst)

Okay. Thank you. And the second one on Paragon, can you confirm that the fiscal 2020 outlook there doesn't include any significant commercial stage revenue? And I just ask that knowing that you put out a press release saying you are one of the suppliers of Zolgensma, even if it's a secondary supply. I'm just kind of wondering if there's any commercial in the equation there for Paragon this year.

Wetteny Joseph (CFO)

Yeah. So look, Evan, first of all, certainly there are things that our customers may put out in their public domain rather than us putting out. But I would say, again, with respect to Paragon, our visibility level in the business is, I would say, higher than what you would expect for a business that's largely in the clinic, given the contracted revenues, the sort of take-o-pays, and things like that that our customers may have in place. As we model the business and the acquisition, we certainly modeled what is contracted, not necessarily any significant uptake, if you will, on banking on any particular commercial programs as we work with our customers to get those products approved and launched and so forth. So I'll cap it there in terms of any further detail I would give on Paragon.

The $260-ish million of revenue and $75 million of EBITDA all in, including the portion that's inorganic as well as the portion that's organic, is something that I would say we have fairly high visibility into.

Daniel Brennan (MD and Senior Research Analyst)

Okay. Separate topic and final question for me. I might have missed it, but I didn't hear any commentary on ibuprofen API supply. I know we're moving past that a little bit, but can you kind of wrap that up and tell us where you stand on availability of that product and if we're now growing on that ibuprofen issue in fiscal 2020?

Wetteny Joseph (CFO)

Yeah, so as we said throughout last year, this was really a worldwide shortage that we grappled with, and we put in plans to get alternative suppliers so that we can mitigate on a go-forward basis, and we continue to have those mitigation plans in place and are working according to our expectations. Just in terms of how the year went last year and what this year looks like in relation to that, last year, the first quarter was not a particularly challenging ibuprofen quarter for us. The second quarter was far more pronounced in terms of the impact of ibuprofen on the year than the first quarter, so as we look out versus prior year, I wouldn't say it was a meaningful driver. In fact, I think it was roughly in line with what we would have seen last year from an ibuprofen perspective in the first quarter.

The second quarter becomes where last year was a bigger impact. So I would say it's hard to say precisely where our customers stand in terms of replenishing their supply chains, but this is a business that's far more stable this year than we saw certainly throughout last year. And so those mitigation plans continue to work for us.

Daniel Brennan (MD and Senior Research Analyst)

Okay. Just to clarify, you're saying the comparisons on ibuprofen get easier over the next couple of quarters versus fiscal 1Q?

Wetteny Joseph (CFO)

Yeah. I would say that's roughly right, particularly Q1 versus Q2.

Daniel Brennan (MD and Senior Research Analyst)

Okay. All right. Thank you very much.

Operator (participant)

Thank you. And our next question comes from Joseph Munda with First Analysis. Your line is now open.

Joseph Munda (Analyst)

Good afternoon, guys. I'm sorry, good morning, guys. Thanks for taking the questions. A lot of questions have been answered. But I guess my question focuses on the clinical supply business. And just was wondering, the backlog is growing nicely here. Can you give us some sense of the types of projects that are in the backlog, the length of time for these projects, and if that book-to-bill ratio you think is going to hold true going forward? Thanks.

Wetteny Joseph (CFO)

Yeah. So look, our clinical supply business is a bit of a shorter cycle business than the rest of our segments. And we're able to see timing-wise from when we start to book business to when we start executing on those anywhere from two to three quarters or so. And so visibility is fairly strong. And you would have to go back to a year ago to have seen that uptick in terms of net new business wins that is not translating into the growth that you're seeing in that business. So in terms of the types of projects we're seeing here, they're, I would say, typical Clinical Supply Services projects where we are engaging, whether it's from phase one all the way through phase three. We are performing manufacturing and packaging for those projects.

And then we handle the drugs as they go through the clinic and get delivered to the clinics to those patients. We're actually seeing a nice uptick in terms of the packaging part of the business. And so it's a good balance between packaging and, I would say, the logistics part of it. We also see good demand across biologics clinical trials as well, which the handling of those tends to be more cold chain, etc., and good level in terms of margins for those. So nothing, I would say, out of the ordinary in this business. The book-to-bill ratio of 1.2 is a fairly good indicator, I would say, for what we would expect from the business. And every quarter, we do provide visibility into what the new business wins are. And you'll see the fluctuations on that book-to-bill ratio accordingly.

Joseph Munda (Analyst)

Okay. Thank you.

Operator (participant)

Thank you. And I am showing no further questions in the queue at this time. I'd like to turn the call back to John Chiminski for any closing remarks.

John Chiminski (CEO)

Thank you and thanks, everyone, for your questions and for taking the time to join our call. I would like to close by reminding you of a few important points. First, we're committed to delivering FY20 results consistent with our financial guidance and are focused on continuing to drive organic growth across all of our segments. Second, we will continue to grow our world-class biologics business as demonstrated by our fiscal 2019 gene therapy acquisitions and hundreds of millions of dollars of CapEx being deployed to further build out capacity and capability there and in our Madison and Bloomington sites. The continued successful and efficient integration of the gene therapy businesses into the Catalent family remains a top priority. We look forward to continued strong revenue and enhanced high-margin EBITDA growth from our biologics offerings.

Third, expanding the Adjusted EBITDA margin of our business is a key focus area for this management team as we drive towards 200 to 300 basis points of further expansion over the next two to three years. Last, but certainly not least, operations, quality, and regulatory excellence are at the heart of how we run our business and remain a constant focus and priority. We support every customer project with deep scientific expertise and a commitment to putting the patient first in all we do. Thank you.

Operator (participant)

Ladies and gentlemen, thank you for your participation in today's conference. You may now disconnect.