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Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Good day, ladies and gentlemen, and welcome to the Second Quarter Fiscal Year 2018 Catalent Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time.
I'd now like to turn the conference over to Tom Castellano, Vice President, Investor Relations, and Treasurer. Please go ahead.
Thank you, Candice. Good morning, everyone, and thank you for joining us today to review Catalent's second quarter fiscal year 2018 financial results.
Please see our agenda on slide 2 of our accompanying presentation, which is available on our Investor Relations website. Speaking today for Catalent are John Chiminski; and Matt Walsh, whom you all know well.
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 3 for more detail.
Slides 3, 4, and 5 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, financial condition.
Now, I'd like to turn the call over to John Chiminski.
Thanks, Tom, and welcome, everyone, to our earnings call. We're very pleased with our second quarter and year-to-date results for fiscal year 2018, which position us well as we enter the second half of our fiscal year. For the second quarter, we recorded strong revenue growth and double-digit adjusted EBITDA growth in constant currency across all three of our reporting segments.
As you can see on slide 6, our revenue for the second quarter increased 25% as reported and increased 22% in constant currency to $606.3 million, with 8% of the 22% being organic and with all reporting segments contributing to the growth.
Our adjusted EBITDA of $139.3 million was above the second quarter of fiscal year 2017 on a constant currency basis by 39%, of which 15% was organic; again, with all segments contributing to year-over-year EBITDA growth.
Our adjusted net income was $60.7 million or $0.45 per diluted share for the second quarter, an increase of $0.18 per share versus the prior year. Additionally, through the first six months of fiscal year 2018, we've recorded revenue growth of 24% as reported and 22% in constant currency, with 11% of the 22% being organic, which is significantly above our long-term outlook of 4% to 6 % top line growth.
As discussed previously, we continue to work internally on our annual update to our strategic plan and assessing the future impact of the Cook Pharmica acquisition on our long-term outlook. We anticipate being in a position to update our analysts and investors of any change to our long-term guidance on our Q3 FY 2018 earnings call.
Now, moving to our key accomplishments. First, during the quarter, we closed the acquisition of Cook Pharmica, a biologics-focused contract development and manufacturing organization based in Bloomington, Indiana. The company was founded in 2004 as a unit of the Cook Group. Since then, the business has developed with careful attention to staffing, operational excellence and best in category fixed asset investment.
Today, the acquired company operates a world-class 875,000 square foot development and manufacturing facility in Bloomington and employs more than 750 people. The combination of Catalent and Cook Pharmica significantly strengthens our position as the leader in biologics development and manufacturing.
Together, we will provide customers a single partner providing cell line development, large molecule analytical services, drug substance manufacturing, and drug product manufacturing to accelerate biologic drug development programs for customers and bring better treatments to patients worldwide through a comprehensive portfolio of integrated solutions. The integration is well underway, progressing slightly ahead of our expectations and already creating value for the company, our customers, and our shareholders.
As a reminder, we took our pro forma net leverage ratio up to 5 times to fund the acquisition. But as of December 31, we've already reduced our pro forma net leverage ratio to 4.4 times, which is a faster de-leveraging path than expected as a result of the strong Q2 EBITDA performance across the business.
Second, I'll provide a brief update on another component of our biologic strategy which continues to make great strides. The expansion of our facility in Madison is progressing well, and we've recently completed engineering runs. We expect to have the new capacity officially cleared for use during the third quarter, with utilization expected to ramp up during the fourth quarter.
As mentioned on previous earnings calls, we've already signed a number of customer contracts for the third train, also growing a robust funnel of late-stage clinical opportunities, which together should lead to significant utilization of the new capacity on the fast pace we were anticipating.
Next, I'm pleased to announce the appointment of Wetteny Joseph to the position of Senior Vice President and Chief Financial Officer effective tomorrow, succeeding Matt Walsh, who has announced his desire to leave the company to assume the position of Chief Financial Officer of Allergan.
We're excited to have Wetteny move into this new role within the company. His leadership as President of our Clinical Supply Services business for the last two years, together with his deep experience in finance and controllership, developed both here at the company and throughout his career, will make him a key asset to all of our strategic and financial initiatives. We look forward to his continued success as a member of our Executive Leadership team. Wetteny is in the room here with us today.
I'd also like to thank Matt for his nearly 10 years of service and for what he's done to help us and our shareholders. He's been an important part of the Catalent story from its inception as a stand-alone business, through its initial public offering, and its maturation as a public company. We wish him well. We wish him all the best in his new endeavor.
Last, I want to reiterate that the dynamics of our industry and market continue to remain very strong, and our customers' needs for fewer, bigger, better development and manufacturing partners will continue to be the drivers of long-term growth.
Now, I'd like to turn the call over to Matt, who'll take you through our second quarter fiscal year 2018 financial results, as well as provide a revised outlook for fiscal year 2018.
Thank you, John. Let me begin by acknowledging John's gracious words. It has been my sincere pleasure to be CFO of Catalent and to work for you and with you, John, and be part of Catalent's transformation to the great company it is today. While I look forward to starting my new job, I'm also happy to know that I leave Catalent in a strong financial position and with a tenured successor and overall financial team that I admire and respect. And I expect the transition to be seamless between myself and Wetteny.
Please turn to slide 7 for a more detailed discussion on segment performance, beginning with our Softgel business. As a reminder, my commentary around segment growth will be in constant currency. Softgel revenue of $228.1 million grew 9% during the quarter, with EBITDA growing at 13%, which is primarily driven by the acquisition of Accucaps.
As a reminder, Accucaps is a Canada-based developer and manufacturer of over-the-counter, high-potency and conventional pharmaceutical softgel products. We acquired the business during the third quarter of fiscal year 2017.
In the second quarter of the current fiscal year, the business continued to perform well above our expectations and contributed 12 percentage points to the segment's revenue growth and 9 percentage points to the segment's EBITDA growth. Excluding the acquisition, our Softgel business declined 3% organically at the revenue line, but increased 4% at the EBITDA line, driven by a historical contract settlement recorded in the quarter.
Slower organic revenues within the business was due to a decrease in product participation revenue and lower consumer health volumes in Asia Pacific. Our Softgel North American and Latin American businesses performed modestly above prior-year levels. It's important to note that we continue to expect the Softgel business, excluding the Accucaps acquisition, to perform at revenue and EBITDA levels that are in line with the prior year during the second half of this fiscal year.
The update for Drug Delivery Solutions segment is shown on slide 8. The DDS segment recorded revenue of $285.4 million, which was up 30% versus the prior year, with EBITDA growing 58% during the quarter. A sizable portion of the segment's revenue and EBITDA growth was driven by the Cook Pharmica acquisition, which closed in October 2017. And this contributed 21 percentage points to the revenue growth and 40 percentage points to the EBITDA growth. In its first quarter as part of the Catalent family, the site is off to a fast start. And we continue to feel good about the immediate and long-term growth prospects of this business.
The acquisition of Cook Pharmica in its Bloomington site strengthen our position as a leader in biologics development, analytical services, and finished products supply. The combined business of Catalent Biologics in Bloomington will be able to provide the integrated solutions from protein expression through commercial supply of biologics in a variety of finished dose forms. This helps fill one of the major gaps in our biologics strategy by adding fill/finish formulation, development, and manufacturing capabilities that we did not have in the Catalent network prior to the transaction, including lyophilization, vial filling, and cartridges, as well as adding U.S.-based sterile formulation and pre-filled syringe to our already strong sterile capabilities.
As we're seeing in the numbers, the acquisition of the Bloomington site significantly accelerates the already strong growth of our existing Biologics business by extending biomanufacturing capacity for clinical and commercial manufacturing across the network. As a reminder, biologics comprised approximately 14% of Catalent's consolidated revenue since fiscal year 2017 and the acquisition of Cook Pharmica is expected to increase our biologics percentage to 21% of the combined entities' pro forma revenue. Please see the Form 8-K that we filed with the SEC on October 24, 2017, for important information concerning how we calculate pro forma revenue.
Recent organic investments in our legacy Biologics business continue to translate into growth during the second quarter, and it remains the fastest-growing business within Catalent. We recorded strong revenue and EBITDA growth at our Madison facility driven by the completion of project milestones and larger clinical programs. We continue to believe that our Biologics business is positioned well to drive future growth, as indicated by business development signings of Roche, Moderna Therapeutics, Triphase Accelerator, Therachon AG, and Grid Therapeutics.
The whole delivery portion of the DDS business had another strong quarter with favorable end market demand for high margin offerings within our U.S. controlled release business. Our European prefilled syringe business also had a strong quarter, but a significant portion of the strength was timing-related. This was driven by the normal maintenance shutdown of the Brussels facility, which occurred in the second quarter of fiscal year 2017 being moved to the third quarter of this fiscal year.
Our blow-fill-seal offering recorded results during the second quarter that were below the prior-year period due to lower volumes and operational challenges, resulting from us taking steps to enhance our quality and manufacturing protocols and processes at the site, which we expect to continue throughout the remainder of this fiscal year. Strategically, market fundamentals continue to remain attractive for this key sterile fill technology.
The segment also experienced declines in high-margin product participation revenue during the quarter. You will recall, we highlighted this dynamic as a fiscal year 2018 headwind during the start of the fiscal year. We expect these declines to carry into remaining quarters of this year, which has already been incorporated into our guidance communications.
In order to provide additional insight into our long-cycle business, which includes both Softgel Technologies and Drug Delivery Solutions, we're 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 six months ended December 31, 2017, we recorded development revenue of $70 million, which is in line with the development revenue recorded in the same period of the prior fiscal year. In addition, during the first six months of the fiscal year, we introduced 100 new products, which are expected to contribute $33 million of revenue, which is 20% lower than the revenue contribution of NPIs launched in the first six months of last year. This is aligned with our plan and based on timing of launches this year. We expect the fiscal year 2018 NPI launches and our revenue contribution to be in line with our long-term growth outlook.
As a reminder, the number of NPIs in the corresponding revenue contribution in any given period depends on the type and timing of our customers' product launches, which are often driven by regulatory approvals or at the discretion of our customers, and thus, these figures will continue to vary quarter to quarter.
Now, as shown on slide 9, our Clinical Supply Services segment posted revenue of $108.7 million, which was up 36% compared to the second quarter the prior year, driven by increased customer project activity across our core storage and distribution services business. Low-margin comparator sourcing activity contributed approximately half of the segment's revenue growth.
Segment EBITDA increased 55% compared to the second quarter the prior year, primarily driven by the revenue growth in our core storage and distribution services business and improved capacity utilization across the network. Given the low-margin of the comparator sourcing activity, it contributed modestly to the segment's second quarter EBITDA growth. All of the revenue and EBITDA growth recorded within the CSS segment was organic.
As of December 31, 2017, our backlog for the CSS segment was $306 million, an 8% sequential decrease. The segment recorded net new business wins of $80 million during the second quarter, representing a 26% decrease year-over-year. The second trailing 12-month book-to-bill ratio was 0.9. These indicators are below recent historical trends due to a faster than expected burn of a backlog in the first half of the fiscal year, as evidenced by the higher levels of organic growth recorded during the first and second quarters. Additionally, in the second half of this fiscal year, we expect more tempered year-over-year revenue growth, given the strong results posted in the comparable prior-year period, as well as the first two quarters of this fiscal year.
The next slide contains reference information. We've already discussed the segment results shown on the consolidated income statement by reporting segment, which is on slide 10.
Slide 11 shows in precisely the same format as on slide 10 the six-month year-to-date performance of our operating segments, both as reported and in constant currency. I won't cover the variance drivers in detail since our year-to-date results parallel our second quarter results and show constant currency revenue growth and similar EBITDA performance across all three reporting segments. The year-to-date 22% constant currency revenue growth or 11% growth on an organic basis compared to the same period a year ago was nicely above our long-term objective of 4% to 6% organic revenue growth per year.
Slide 12 provides a reconciliation to the last 12 months EBITDA from the most proximate GAAP measure, which is earnings from continuing operations. This bridge will assist in tying out the reported figures to our computation of adjusted EBITDA, which is detailed on the next slide.
So, moving to adjusted EBITDA on slide 13, second quarter adjusted EBITDA increased 42% to $139.3 million. On a constant currency basis, our second quarter adjusted EBITDA increased 39%, of which 15% was organic driven by strong performance across Drug Delivery Solutions and Clinical Supply Services segments.
At slide 14, you can see that second quarter adjusted net income was $60.7 million or $0.45 per diluted share compared to adjusted net income of $34.7 million or $0.27 per diluted share in the second quarter a year ago. This slide also includes the reconciliation of earnings from operations to non-GAAP adjusted net income in a summarized format. A more detailed version of this reconciliation is included in the Supplemental Information section at the end of the slide deck, shows essentially the same add-backs we've seen on the adjusted EBITDA reconciliation slide.
One important item I want to draw your attention to is the tax add-back, which is higher than in prior periods. During the second quarter, we recorded a onetime net charge of $46 million within our income tax provision as an estimate of the net accounting impact of recent U.S. tax legislation. We expect less than one-fourth of this charge to be paid in cash after considering the use of certain NOLs. The payment will be made over an eight-year period and will be funded with U.S. generated cash.
Given the significant complexity of the provisional estimate we recorded during the quarter, it's important to note that it may require adjustment over the next 12 months. I'll provide more color on the impact of tax reform on our forward-looking effective tax rate during the FY 2018 guidance section of these prepared remarks.
Slide 15 shows our capitalization table and capital allocation priorities. Our total net leverage ratio on a reported basis as of December 31 was 4.8 times due to the incremental debt added during the quarter to partially fund the Cook Pharmica acquisition. However, as John mentioned earlier, to calculate our leverage ratio on a pro forma basis for the Cook Pharmica acquisition, which would include a full 12 months of earnings rather than only for the two months that we own the business, our total net leverage ratio will be 4.4 times, which is nicely below the pro forma total net leverage ratio of 4.8 times we recorded during the prior quarter and the 5.0 times discussed at the time of the acquisition announcement. We continue to believe that given the strong free cash flow generating ability of the combined entity, Catalent plus Cook Pharmica, we will be able to de-lever, back down to pre-transaction levels faster than the 24 months we previously communicated.
As a reminder, we also successful refinanced the company during the quarter. In mid-October, we issued $450 million aggregate principal amount of eight-year U.S.-dollar-denominated senior notes, a very attractive coupon of 4.875%. The proceeds from the debt issuance, along with cash on-hand and the proceeds from the September equity issuance, were used to fund the upfront portion of the purchase price for the Cook acquisition, which closed on October 23.
Concurrently, with the debt issuance, we completed an amendment to our senior secured credit facilities to lower the interest rate on our U.S.-dollar-denominated and euro-denominated term loans, as well as extend the maturity of the term loans three years to 2024. The new applicable rate for our U.S.-dollar-denominated term loans is LIBOR plus 2.25%, which is 50 basis points lower than the previous rate; and the new applicable rate for our euro-denominated term loans is Euribor subject to a floor of 1% plus 1.75%, which is 75 basis points lower than the previous rate. The annualized interest expense savings for the re-pricing of the term loans is approximately $9 million per year. We also lowered the interest rate and extended the maturity of our revolver, although, we currently have nothing drawn on it.
Finally, our capital allocation priorities remain unchanged to focus first and foremost on organic growth.
I'll now provide our updated financial outlook for fiscal year 2018, which reflects the continued underlying strength in the business. As seen on slide 16, we expect full-year revenue in the range of $2.42 billion to $2.48 billion. We expect full-year adjusted EBITDA in the range of $537 million to $557 million and full-year adjusted net income in the range of $212 million to $232 million. We expect in the range of $152 million to $165 million of capital expenditures; and we expect that our fully diluted share count on a weighted average basis for the fiscal year ending June 30, 2018, will be in the range of 133 million to 135 million shares.
In addition to the guidance we just provided on revenue, adjusted EBITDA and adjusted net income, we also wanted to provide some clarity on our consolidated effective tax rate, given the tax legislation signed at the end of calendar year 2017. As a result of the U.S. corporate tax rate decreasing to 21%, we expect our FY 2018 consolidated effective tax rate to be between 27.5% and 28.5% due to the partial year impact of the rate change. As we enter FY 2019 and beyond, we expect our consolidated effective tax rate to be between 26% and 28%.
Slide 17 shows the walk from our prior FY 2018 guidance to our revised FY 2018 guidance. The first set of bar shows the net change from a base business perspective. Within the base business, we continue to see strength across four major areas: the Accucaps business acquired in the third quarter of FY 2017; our core Madison Biologics business; our U.S. controlled release business; and the Cook Pharmica acquisition which, as we mentioned, is out-of-the-gate strong.
The second set of bar shows the impact to revenue from the increasing volume in our lower-margin comparator business within our CSS segment. However, the revenue increase, we expect, should have an immaterial impact on our consolidated adjusted EBITDA, given the low-margin nature this business. The last set of bars brackets the additional positive FX translation impact to revenue and adjusted EBITDA we're seeing as a result of the continued strengthening of the euro and pound sterling in relation to the U.S. dollar.
Additionally, let me remind everyone of the seasonality in our business and highlight our expected quarterly progression through the year. As discussed for several years now, the first quarter of any fiscal year is generally our lightest quarter of the year by far, with the fourth quarter of any fiscal year generally being our strongest by far, and this will continue to be the case in fiscal year 2018 where we expect to realize approximately 42% of our adjusted EBITDA in the first half of the year and 58% of our adjusted EBITDA in the second half of the fiscal year.
Operator, we'd now like to open the call for questions.
Thank you. And our first question comes from Tycho Peterson of JPMorgan. Your line is now open.
Hey. Thanks. I want to start out with the Cook performance in the quarter. It was a little bit better than we've been modeling. Any one-time items to call out there? And maybe can you talk about your confidence in the sustainability of the strength you saw here?
The strength of the Cook acquisition that we saw was mainly mix-related, as well as timing-related. We were expecting that the business would have a normal maintenance turnaround in the second quarter. And just due to the underlying strength in the business, we decided to postpone that turnaround to the third quarter, Tycho. So more timing-related. But we did see overall good strength and mix in the business.
Okay. And then, Matt, can you comment a little bit more on the blow-fill-seal operational inefficiencies you called out and kind of plans to remedy that?
Sure. Sure. So we have, within Catalent, a rigorous internal audit process of our quality and operational processes that turned up several issues at Woodstock some months ago that we needed to attend to. And that's exactly what we've been doing. So we have been directing company time, managerial resources to the site to do a bit of a reset and make sure that the way that we're operating is rigorously adhering to all of our own internal SOPs, Tycho.
So this is self-imposed and completely discretionary on the company's part. But one of the consequences there, we had slowed down our throughput and cycle times on the various batches that we're doing. And so, that's showing up in the financials. And as we look at the timeline of the activities that we're undertaking, we see this as a fiscal year 2018 issue, so we will see it going into the second half. And we'll be steadily recovering during that time with most of that – with the expectation being that we'll be back at full run rate by the end of the fiscal year.
Okay. And then just last one on guidance. EBITDA guidance is only coming up around $30 million at the midpoint. Obviously, you've had nice top line beats in both the first and second quarter. Maybe can you just talk a little bit on the puts and takes around EBITDA, just incremental investment around Cook that may be limiting the EBITDA expansion here?
So we talked about the areas that we're seeing strength, which is in our Biologics business, both our legacy business as well as the Cook business, and we're seeing strength in our U.S. controlled release business. But where we've got some either flatness or maybe some timing-related issues where we might see declines in the second half of the year would be in our Softgel business, blow-fill-seal, as we've talked about, and the CSS business, which we mentioned will be up against some pretty tough year-on-year comparison in Q3 and Q4.
Okay. Thanks. And congrats on the new job, Matt. It's been great working with you here.
Thank you, Tycho. Likewise.
Thank you. And our next question comes from Ricky Goldwasser of Morgan Stanley. Your line is now open.
Yeah. Hi. Good morning, and, Matt, congratulations on the new opportunity. So just a couple of questions here. When we think about the Madison facility, can you just give us a little bit more color on where you stand in capacity? And then, also, just some more color. We've seen obviously a lot of M&A activity in the past six months in the space, companies being taken private or merging. How are you thinking about competitive dynamics in the space as a result of these transactions?
Yeah. So, Ricky, I'll start off with the answer to that part of the question. First of all, it remains a highly dynamic space where, honestly, the way I've been describing it is that I think we're in a probably a 10-year to 15-year secular growth trend. And what's really happened is between the Lonza acquisition of Capsugel; the Thermo Fisher acquisition of Patheon; and now, Catalent is kind of the last standing premier CDMO, we're seeing a lot more business, I guess, I would say, accruing to the bigger players because our customers are really looking for these CDMO partners that have the ability to invest in the quality operations and the investments required from a capacity standpoint. So, I think the larger players are going to continue to accrue more of the benefits from what I think is a long-term secular 10 to 15-year trend.
From a competitive dynamics standpoint, I would say, that we haven't seen any significant changes or increases to competitiveness based upon those large acquisitions, or even in the situation of AMRI, being taken private, which we really didn't have any head-to-head type of competition with them. But I can tell you that there seems to be more stability from a competitive standpoint which it exists, but it hasn't changed dramatically. And as I said, I think there's really kind of a 10 to 15-year secular growth trend as these larger CDMOs, of which, again, Catalent is the last standing premier pharmaceutical services business. I think you're just going to continue to see the pharma and biotech businesses that have now become very comfortable partnering with these larger groups. And this is why they want fewer, bigger, better providers.
From an overall M&A standpoint, certainly Catalent has been part of the M&A story, I would say, over the last decade, in fact, over the last two decades, which is how Catalent really came together. And we continue to be very active in this space, with the underlying comment that our primary capital allocation is for organic growth drivers with M&A following in behind that. We really see organic growth as a fundamental driver with M&A being used to fill in our strategic priorities or accelerate our strategic plans.
And Ricky, it's Matt. The first part of your question related to Madison capacity. So, at the present time, Madison is operating at very high rates of capacity utilization. We have known for some time that we would get to this point, which is why we green-lighted the third train capacity, which construction has completed. And we're doing engineering validation runs right now. And we will see recordable revenue ramping up small amounts in the third quarter and increasing into the fourth quarter. So, we will be able to continue the rate of revenue growth at Madison – the high rate of revenue growth that we have enjoyed there in recent quarters.
Thank you.
Thank you. And our next question comes from Dave Windley of Jefferies. Your line is now open.
Hi. Thank you for taking my questions. Good morning. Congrats on a nice quarter. I wanted to follow up on that last question, Matt. You talked about small amounts of recordable revenue in the third quarter. Beyond that, are you able to contract with clients at this point for ramp? In other words, do you have visibility to that, or are kind of signings of contracts contingent on the engineering runs and things like that? I'm just curious about the timing of kind of gaining that visibility.
Yeah. Hey, Dave. John Chiminski here.
Hi. Good morning.
I'll say that we're on plan for signed business for what we had in our business case for the first half, which means that we had previously booked business into that asset, which when we did our original buildout, there was a lag time between when we build it out and when people had confidence in coming in and placing business. And we don't have any of that business. That business was signed before we even had our engineering validation runs done. So, it just shows what is out there.
From an overall business standpoint, there's a significant demand for the type of work that we can do from a commercial manufacturing standpoint in terms of our 1,000, 2,000, and now, 2x2,000 liter capability that we're going to have. So, very strong, and as I've said, we already have business booked to what was, I would say, a pretty decent plan for the facility for the last half of fiscal year 2018. And the business that's booked already completes that business case that we had. So, it's a terrific news for the company, and again, just talks to the level of demand there is out there for flexible biologics manufacturing.
That sounds like it. If I could zoom out from that, then, John, on this topic and think about how – love for you to describe how you envision servicing the demand in that market. Between your two facilities seems like one of the real beneficial aspects or assets of Cook is available space for you to grow into.
Yes.
And just wanted to better understand how you see expanding that space? Is it important to have, say, substance as a Center of Excellence in Madison and drug product in Bloomington or vice versa, or combined in both? Just curious how you see that build out happening and how that services the market best?
Sure. I will tell you, our thinking has evolved quite a bit over the last three or four months since we've gotten our hands on the Bloomington facility. And we're now positioning it towards having two Centers of Excellence, towards drug substance manufacturing. As, you know, given the very strong demand that we see over the next five-plus years, we were already had on the books a potential fourth and fifth train that requires a greenfield buildout at the Madison site.
And over the last several months, as we stare into our strategic plans that are coming up over the next couple of months, there is just immediate and readily available space in this world-class facility. In fact, I was just there a couple of weeks ago. And our thinking now is that we may be able to accelerate that fourth and fifth train through readily available space that's within the facility. Those decisions aren't made, but it just tells you the quality of this asset that we have, and the flexibility, and the fact that we might actually be able to accelerate some of our timelines depending on the route that we go whether it's greenfield or just building out within Bloomington.
Bloomington will not be a second cousin with regards to drug substance manufacturing. A very different look and feel, actually more of a big pharma field there in terms of the available space and capability for drug substance. And it's really turning our heads towards thinking about where we're going to place that fourth and fifth train, or whether or not we can accelerate it faster than our Madison alone timelines, so really exciting times.
We also think that we're hitting a real sweet spot here. As you know, our strategy is what we call flexible development in manufacturing within biologics, with our single-use bioreactors and the bioreactors that we're targeting here which is the 2,000 liter, just gives us a lot of flexibility, which is bringing a lot of customers.
The other part of this is Bloomington has really a terrific mix of high-end pharma customers. In fact, complementing our own portfolio, so we're also very conscious on what they're looking for. So, we don't expect to have a second cousin here in drug substance. Certainly, they have a leadership position in drug product, but drug substance, I think, is going to be shared very well across both of those facilities which are geographically relatively close also. So, we're going to able to get some use across both of those teams.
Thank you. One last question, just for clarification, Matt, you talked on the CSS piece about the difficult comps and more tempered growth. If I also take into account the change in backlog and the lower bookings, should we be thinking growth there, or should we actually be thinking that, that's going to be down against those difficult comps in the second half of the year? Thanks.
Our best look right now, Dave, it says that flat is the math for the second half.
Okay. All right. Great. Thanks.
Thank you. And our next question comes from Tim Evans of Wells Fargo Securities. Your line is now open.
Thanks. Matt, could you quantify the onetime contractual settlement in Softgel?
It was about $3 million, Tim.
Great. Thank you. And then, can you talk a little bit more about why the APAC consumer is down? Is this temporary? Is this sort of a structural long-term thing? Is it something that will grow again next year? Just trying to get a little bit more color on the longer-term outlook there.
Based on the information that we're looking at, Tim, it does seem to be more of a structural long-term issue for our Softgel business in the Asia-Pac region. This has always been a product slate that was more geared towards VMS business, which had an OTC component to it. For years, we've been trying to push that high-value OTC component bigger and bigger. It was just more challenging to do. And then, with some of the dynamics around changes within how China sources VMS materials, we had become less optimistic about the ability to grow our Softgel franchise in Asia-Pac for the long term.
Okay. And just given that dynamic, can you give us a sense for the size for APAC Softgel?
It's not large. Tim, it's been shrinking. And I will tell you, its profitability contribution is even lower than the sales contribution.
Okay. Will do. Thank you.
Thank you. And our next question comes from Derik de Bruin of Bank of America. Your line is now open.
Hey. Good morning.
Good morning, Derik.
Good morning, Derik.
So, on the backlog in the CSS business, just sort of a question mark, is the reduction there incorporating the ASC 606 changes in the accounting?
No.
And I guess sort of how does – yeah, so, can you just walk us through that as we sort of get into that change in the reporting?
Sure. So, I will talk about the technical reporting part of the question first, and then zoom back out and talk about more strategic implications. On the ASC 606, which is the revenue recognition standard, Catalent adapts that on July 1, so that's the first day of our next fiscal year. This does not have a big impact across most of Catalent, but for this certain aspect of revenue recognition within CSS, and that's the comparator business, which is, at any point in time, between 20% and 25% of the current top line of that segment. And we will be recording that on a net basis versus a gross basis starting July 1. So, there's nothing, either in our reported results or in our backlog statistics, at this point, that reflects that.
Now, in terms of, Derik, why the numbers have backed off a bit, we've just been burning the backlog faster than we've historically done. That's contributed to the outsized revenue growth we've seen in the business really for the last three or four quarters. And so, we've got to catch up with our sales efforts and replenish that backlog.
Great. And just a housekeeping question. A lot of moving parts in the capital structure. What sort of is the net interest expense guide for the rest of the year – or for the full year?
For the full-year basis, it'll be $114 million.
Great. Thank you. And just it looks like that the EBITDA performance on Cook was a lot better than expected. Where did that sort of come in?
So, there were – we had better product mix than we thought out of the gate, but there was a significant timing component to this. We expected the business to take its normal maintenance turnaround in Q2. It pushed it through Q3, so we'll just be trading that with Q3 performance.
Great. All right. Great. And then just one final one. Accucaps, I believe, annualizes this quarter. And so, what is sort of the inherent organic revenue growth rate of that business as we look out?
So, we have always said that Softgel should be growing on the lower end of Catalent's 4% to 6% top line expectation. We expect the Softgel business in the second half of this fiscal year though to be flat year-on-year.
Great. Okay. Great. Thank you very much.
Yeah. Okay.
Thank you. And our next question comes from John Kreger of William Blair. Your line is now open.
Hey. Thanks very much. I have another biologics question. Can you talk about – is the demand being driven more from clinical contracts or commercial longer-term mandates? And how should we think about sort of the volatility of the business over the next two, three years, given that mix?
Yes, sure. So, first of all, on the drug substance front, it's fundamentally today for clinical trials. And we do see and are actively pursuing some customers that will be moving us into the commercial range as we exit FY 2018 and head into FY 2019. And as a matter of fact, some of the customers that we're looking at to fill the new capacity are going to require commercial manufacturing. And we're readying the facility for that transition from an FDA standpoint.
From a Cook Pharmica standpoint, they're already very strong from a drug product standpoint for commercial products. They had 12, and then in last quarter had one more approval, so they now have 13 products that are in commercial manufacturing. And they have another dozen or so that have the potential, if approved, to go to commercial manufacturing.
I think from a longer-term standpoint, clearly, the very strong demand is from the high amount of large molecules that are in the pipeline, and those are growing at a faster rate than the small molecule. So we're going to continue to see very strong demand on that clinical front. And then, it just depends on whether or not some of these products get approved moving forward.
As you know, the FDA appears to be accelerating its drug approvals and had its biggest year ever last year. But again, that's a piece much different than the roughly 12,000, 14,000 molecules that are in the pipeline. So, I think, clinical will continue to be very strong, and then the hopes are that you continue to have clinical products that maybe the ones that get approved.
Great. Thank you. And then, John, maybe a longer-term one. You've now had over a year with organic revenue growth, well above your longer-term targets. And I think you said at the beginning of the call you're still sort of reassessing your...
Yeah.
...longer-term plan. Can you just maybe talk a bit more about where you see the puts and takes in the business? What parts of the business maybe cause you to hesitate to think about a longer-term higher trajectory?
Yes. So, first of all, we're going to take very seriously any changes to long-term guidance. It's obviously not a quarterly or annual guidance change. So we're going to do this in conjunction with our strategic plans. And we have been growing at rates that are higher than our long-term guidance, and there've been several factors for that. But now, we also have the addition of Biologics. And I think the factors that will come involved will be a much stronger look in Biologics and its mix in the business, and how we see that evolving over the next three to five years. We'll also have to take into effect the change that will happen with what we just mentioned with ASC 606 from a clinical trial supply standpoint that obviously take out that revenue component from comparator.
From there, Softgel will continue to grow at the lower end of that 4% to 6% guidance. And then, on top of that, we have performance in our oral drug business which we have some strong potential with regards to an extension of our Zydis product. We have something that is now called Zydis Ultra. And if we can sell into that combined with continued strong performance out of our Winchester and Kansas City facilities, we've got to put that all into the mix and then determine whether or not a long-term outlook change is warranted.
So the fundamentals of the business are very strong, again, growing at the top end. And it's just whether or not we want to make a fundamental change in that outlook. And we'll do that very purposefully through our strat plan. And we expect that to happen either at our Q3 or Q4 guidance – or Q3 or Q4 earnings reports that will be coming up.
Great. Thank you.
Thank you. And our next question comes from Sean Wieland of Piper Jaffray. Your line is now open.
Thank you. Good morning. And, Matt, congrats on the new gig. Can you give us a sense of what Cook and Accucaps did on an organic basis year-over-year?
So both acquisitions are growing organically very well. Let's talk about Cook first, because we acquired the business when it was really still in its infancy. All the capital had been built out. They spent years laying the groundwork for the sales growth that they're now realizing, which is well into the 20% year-on-year growth rates. And so, the business is still, on a percentage basis, growing very strong off of what was a fairly low base, even though it was still close to $200 million. The business has a lot of potential and a lot of capacity to grow.
The Accucaps business also growing double digits, organically higher at the EBITDA line as we are recognizing operating synergies that we had forecasted as part of the acquisition, and just the benefits of asset utilization at Accucaps, which were substantially above what we had forecasted they would be when we were valuing the opportunity and diligence. So the organic growth of those two acquired entities has been terrific and above our expectations from the diligence phases of both deals.
Okay. Thank you. And a question on tax reform. So beyond what the rate will be, which you mentioned. How does the new law affect really how you're going to plan on running the business, whether it's capital structure, capital allocation, wages, things of that nature?
Right now, Sean, we don't anticipate any material changes to the way that we manage the business as a result of the changes in tax law. Our business shows pretty good balance between U.S. – now, with the acquisition of Cook, we show good balance between U.S. and ex-U.S. The overall way that we're running the business, we don't expect to see it substantially change.
Okay. Thanks so much.
Thank you. And our next question comes from George Hill of RBC Capital. Your line is now open.
Hey. Good morning, guys. And Matt, I'll add to the list of people wishing you well on the new job. Most of my questions have been hit at this point. I guess, John, I would ask, can you comment on how much of the Madison capacity is already sold through, or can already be sold through? And then either Matt or John, I don't know if there's a way to talk about kind of the revenue of the capacity that you guys are bringing online or like the revenue capacity of Madison.
Yeah. So, I'll just give you a rough number that you won't be able to back into, so sorry. But we've already sold about 10% of the capacity, if you will, through that first quarter, which is really terrific noting that most pharma assets run at 40%, and we're just bringing this online, and we really got about 10% sold into it. That will be through the second half of this fiscal year, and then, obviously, we're going to see that continuing to accelerate.
As you know, we were at full capacity, stretching to get one last batch out of the existing Madison facility. We filled that probably, I would say, at least two years in advance of what we thought would happen. So, we really had to dovetail in between maxing out that capacity and bringing online new capacity, which again just bodes incredibly well. There is, overall, very strong demand out there. But I'd also say that Catalent's sitting in the sweet spot of that demand with our single-use bioreactors, the 2,000, and kind of our flexible manufacturing approach. So, all in all, it so far turned out to be a really strong story for the company and bodes well for the future.
The only other thing I would add, George, is when we – I think we've mentioned this in prior calls. I think I'm just repeating something from the past. But we had forecasted that the addition of the third train could potentially just about double the potential revenues from the Madison site, not just because that their train is relatively large capacity at 2x2,000 liters. They can do large clinical; they can small commercial. So, even though it's increasing our number of trains by a third, it's the capacity of what we're putting that actually enables us to just about double the revenue at Madison.
Okay. That's helpful. And maybe just kind of a quick follow-up. John, you kind of described a pretty dynamic market as it relates to the competitive environment. Maybe, Matt, just give us a quick reminder before you need to get leverage back down to – before you guys can be in the M&A market again? And, I guess, do you guys feel capacity constraints because of the size of the Cook acquisition, or six, nine months from now are we back looking at more assets in the space? Thanks.
Thanks, George. So, in terms of how we're thinking about M&A, we said at the time of the deal, this was a big deployment of capital. We as an operating team, we're certainly comfortable being levered at 5 times. We've been levered well above that in private equity days. But we set the 5 really for public market purposes, and then issued a small equity stub to keep us at 5. And we never set a hard and fast rule for ourselves that we would have to de-lever back down to pre-transaction levels before we would do another deal, because there'd be a chance that we could miss something that would be really attractive.
So, the good news since our initial thinking is we delivered faster than our projected trajectory six months ago. And so, that doesn't – so, because of that we're not precluding ourselves from looking at deals before we de-lever all the way back down to the 4 times, which is where we were pre-Cook. And I will tell you that the capital markets continue to be accommodative for pharma services companies with good platforms that are looking at attractive growth opportunities through M&A. So, capital raising is actually lower down on the list of things that we worry about as we consider future M&A opportunities.
Great. I appreciate the color. Thanks, guys.
Thank you. And our next question comes from Dana Flanders of Goldman Sachs. Your line is now open.
Hi. Congratulations on the quarter and thanks for the questions. My first one here, can you just talk a little bit more specifically about the longer-term opportunity in biologics, and just where are we in the supply-demand equilibrium with the capacity you have coming online, as well as competitors? I mean, just how long of a runway do we have here before that finds its greater balance?
And then, my second question, just following up on M&A, are there any holes now within the Biologics business that you still feel like you need to fill or might you be more opportunistic across other parts of your business as you look at just opportunities across the space? Thank you very much.
Well, first of all, Dana, welcome to the Catalent name. Great to have you on board. So, first of all, we've done a tremendous amount of work from, I would say, just understanding and analyzing the market for biologics. We have a strong biologics team internally. We've used external consultants. We also have an excellent, biologics-focused strategic advisory board, in fact just met last week on Thursday. And all of the data that we have shows that really demand should outpace supply over the next five years. And that is continuing to hold.
The other side of that is we continue to see a tremendous amount of capacity being either announced for investment or bringing online. So, to-date, that hasn't muted any of the opportunities, but we're going to continue to watch that very closely, but it certainly is a very robust marketplace. Pricing continues to be very strong if you have that capacity. And again, we're hitting a sweet spot with our single-use bioreactors and really going up to the 2,000 liters and now be doing 2x2,000 liters. So, overall, I would say, it bodes well.
I'll dip a little bit into your second question that was focused around M&A and say that there continues to be opportunities. I think with the Bloomington biologics facility that we now have, there's a tremendous opportunity for us organically. However, if there are other assets that we think can continue to accelerate what we're doing and specifically the drug product area continues to be very robust. There's probably a little bit more that we can do there. And we're also finding that from a biologics standpoint, having that integrated solution all the way from cell line development, all the way to finished drug product, and also cartridge manufacturing for some of these auto-injectors is a big deal.
So, we're going to continue to look pretty hard in this space. Our first priority is going to continue to fill things out from a capital standpoint, where we've seen strong organic plays in both our Madison and Bloomington facility, but again, active for other pieces that we might be able to fill out.
Thank you. And our next question comes from Kevin Caliendo of Needham & Company. Your line is now open.
Good morning. Thanks for taking my call. Couple of questions for Matt, just on cash flow looking through the Q, it was a nice bump for the first half of the year. Should we think about operating cash flow first half versus second half being sort of the same ratio as you're predicting for earnings? I know there's a big gain in the receivables this quarter. I'm just trying to gauge what the free cash flow might be for the year.
Yeah. So, we generally believe, on an annual basis, that we should be generating free cash flow that's on the order of 75% of adjusted net income. It's likely going to be higher than that this year, because we've had some pretty strong performance on working capital efficiency. Our cash cycle working capital efficiency metrics have really improved as you just noted, Kevin. So, that 75% kind of looks low now. And it's just a question of what happens at working capital efficiency in the second half of the year in terms of where we ultimately end up. But, hopefully, those guideposts give you some help in terms of modeling us.
Absolutely. Thank you. And on the tax rate, I understand that corporate rate's 27.5% to 28%, and I think you guided going forward to 26% to 28%. As well, trying to understand sort of the long-term implications of tax reform, does it make sense – or is this range that you're getting really based on how much interest you're paying down versus what your CapEx might be and that's really the delta here between the 26% and 28%, or is there anything else, as we think about tax rate into fiscal 2019 and beyond?
So, those two things that you highlighted are certainly elements of it. But really, what ends up being the biggest driver of volatility within that 26% to 28% range is going to be our geographic mix of earnings, right. We've got half to more than half of our profitability outside the U.S., where we have been a cash tax payer for years. And so, it really is more dependent on geographic mix than those other items that you mentioned.
Okay. One last one. So, Softgel organically was down 3% in the quarter. Again, was there anything specific about that? I know you're guiding for sort of flattish for the second half of the year. Was there any timing issues, or anything, just not – ex-Accucaps?
So, I would say we alluded to some volume down in the Asia-Pac region that we've seen in the first half of the year. And we would be likely to see that in the second half of the year as well. Just as a watch out, we're not quite sure on this item as this is moving in real-time, but there has been some shortages globally of a key raw material, specifically ibuprofen, which is a significant part of our business within Softgel.
Ibuprofen producers are racing to get material out to customers. And we do see that as a watch out for the second half of the year. Just to repeat what we said earlier, we do think that ex-Accucaps, Softgel will be – Matt says that it'll be more flat year-on-year than anything else that we can forecast at this point.
Is the ibuprofen shortage a material issue or a demand issue?
This is a supply issue. There's only a few producers of ibuprofen globally and they've all – the totality of ibuprofen production has been spotty and not able to fully satisfy demand, or if they are, it's just by the skin of their teeth. So, that's the situation that we're looking at carefully. We're working with our customers, some of whom have a lot of influence with the ibuprofen producers. And it's just something that we've got our eye on for the second half.
How meaningful is ibuprofen for Softgel's business? Excuse my ignorance on this.
So, this is a little bit hard for me to pin down on this call, Kevin, because our ibuprofen business is global. But it is – my first estimate, subject to confirmation that I'd have to put pencil to paper, I think it's about – ibuprofen is probably about 10% of the business in all the forms that we manufacture ibuprofen. So, there's many different customers, many different brands across the world. There's ibuprofen combos, right, cough, cold, sinus-type SKUs that we manufacture, but my initial estimate would be about 10% global Softgel revenues.
(01:04:30).
...characterize it more as it's tight versus a regular shortage. And a large part of it was driven a little bit by the hurricanes that hit specifically to our Texas facility for one of the manufacturers, and so, additional capacity needs to be put online. But we don't expect any of that to be a long-term effect, it's just the short-term effect. And I think Matt properly characterized it, it's just a watch out for us. But we do see our way to that kind of flattish second half for Softgel.
Great. Thanks so much. And Matt, good luck with everything going forward.
Thank you. Thanks, Kevin
Thank you. And that concludes our question-and-answer session for today. I'd like to turn the conference back over to John Chiminski for any closing remarks.
Okay. Great. Thanks, operator, and thanks, everyone, for your questions and for taking the time to join our call.
I'd like to close by reminding you of a few important points. First, we're confident and committed to delivering FY 2018 results consistent with our updated financial guidance. Second, we're committed to building a world-class Biologics business for our customers and for patients and look forward to another year of double-digit revenue and EBITDA growth for our core biologics offering. The successful and efficient integration of Cook Pharmica into the Catalent family is a top priority for the management team as we look to swiftly capitalize from the benefits of having both drug substance and drug product capability under one roof.
Third, we're aware our business continues to outperform our long-term outlook of 4% to 6% revenue growth. We continue to work internally on our annual update to our strategic plan and assessing the future impact of the Cook Pharmica acquisition on our long-term growth targets. Next, I'm confident that Wetteny Joseph will flourish in his new role as our CFO, building on a strong foundation established by Matt Walsh and his team.
Last, but 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 commitment to putting the patient first in all we do. Thank you.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a great day.