Catalent (CTLT) John R. Chiminski on Q2 2016 Results - Earnings Call Transcript

| About: Catalent (CTLT)

Catalent, Inc. (NYSE:CTLT)

Q2 2016 Earnings Call

February 09, 2016 4:45 pm ET

Executives

Thomas Castellano - Treasurer, VP-Finance & Head-Investor Relations

John R. Chiminski - President, Chief Executive Officer & Director

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Analysts

Mark Rosenblum - Morgan Stanley & Co. LLC

Tycho W. Peterson - JPMorgan Securities LLC

Derik De Bruin - Merrill Lynch, Pierce, Fenner & Smith, Inc.

David Howard Windley - Jefferies LLC

John C. Kreger - William Blair & Co. LLC

Tim C. Evans - Wells Fargo Securities LLC

Sean W. Wieland - Piper Jaffray & Co (Broker)

Operator

Good day, ladies and gentlemen, and welcome to the Catalent, Inc. Second Quarter Fiscal Year 2016 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 follow at that time. And as a reminder this call is being recorded.

I would now like to turn the conference over to Tom Castellano, Vice President, Finance, Investor Relations and Treasurer. Please begin.

Thomas Castellano - Treasurer, VP-Finance & Head-Investor Relations

Thank you, LaToya. Good afternoon, everyone, and thank you for joining us today to review Catalent's second quarter fiscal year 2016 financial results. Please see our agenda on slide two of our accompanying presentation, which is available on our Investor Relations website.

Joining me today representing Catalent are John Chiminski, President and Chief Executive Officer; Matt Walsh, Executive Vice President and Chief Financial Officer; and Cornell Stamoran, Vice President of Strategy.

During our call today, management will make forward-looking statements including its beliefs and expectations about the company's future results. It is possible that the actual results could differ from management's expectations. We refer you to slide three for more detail.

Please be aware that the forward-looking statements are based on the best available information to management and assumptions that management believes are reasonable. Such statements are not intended to be a representation of future results and are subject to risks and uncertainties. We refer you to Catalent's Form 10-K filed with the SEC on September 2, 2015 for more detailed information on the risks and uncertainties that have a direct bearing on the company's operating results, performance and financial condition.

As discussed on slides four and five, on the call today, we will also disclose certain non-GAAP financial measures, which we use as supplemental measures of performance. We believe these measures provide useful information to investors in evaluating Catalent's operations period-over-period.

For each non-GAAP financial measure that we use on this call, we have included in our earnings press release, issued just a short while ago, a reconciliation of the non-GAAP financial measure to the most directly comparable GAAP financial measure. Please note that the non-GAAP financial measures have limitations as analytical tools, and they should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP.

Now I would like to turn the call over to President and Chief Executive Officer, John Chiminski.

John R. Chiminski - President, Chief Executive Officer & Director

Thanks, Tom, and welcome, everyone to our earnings call. We had good financial and operating performance during the second quarter despite our situation in Beinheim. As you can see on slide six, our revenue increased 6% in constant currency to $454.9 million, which includes organic growth of 5% compared to the second quarter of the prior year.

Top line performance of all three of our reporting segments improved during the quarter led by double-digit growth in the Development and Clinical Services segment. Also, Development and Clinical Services delivered a very strong 58% EBITDA increase compared to the prior-year period. Our adjusted EBITDA totaled $101.1 million, which was below the second quarter fiscal year 2015, primarily due to the Beinheim suspension. Our adjusted net income was $44.9 million or $0.36 per diluted share.

Before discussing our key accomplishments for the second quarter, I wanted to provide an update on our Beinheim facility suspension, which is one of 11 softgel facilities to have worldwide manufacturing network of 31 sites. As we previously disclosed on November 13, 2015, our softgel manufacturing facility located in Beinheim, France received a notification from the ANSM, the French pharmaceutical regulatory agency, suspending manufacturing at the site.

The suspension was precipitated by a series of incidents within the facility involving out-of-place capsules. Catalent had detected these out-of-place capsules within our facility over the course of several months, with a spike in July that led to the facility conducting a global risk assessment and implementing enhanced security measures. However, we received notice on November 3 indicating a customer had detected an out-of-place capsule within its facility during its pre-market packaging quality assurance process. To date, there has been no indication of any detection in the market.

As we've previously disclosed, Catalent has filed a criminal complaint regarding these incidents. The ANSM issued its notice of suspension as precautionary measure to express concern with the out-of-place capsule incidents and the potential for a malicious actor within the facility who might engage in action beyond out-of-place capsules. The ANSM is also concerned with the transparency of the classifications of the incidents within Catalent's quality management system and the need for further involvement of our customers and the ANSM in further risk assessments.

In accordance with our standard continuous process improvement and quality management deviation review systems, facility quality personnel conducted risk assessments of these incidents, including the re-assessment and re-inspection of batches produced during the periods in which these incidents occurred. In addition, our customers whose products are made at Beinheim have conducted risk assessments in light of these matters and have recalled some of the products produced in this period. Following the initial concentration of incidents, we began to implement significant additional security and access control measures to limit access to products and have further strengthened these measures since the suspension. Additionally, we proposed an overall restart plan and worked with several customers on becoming eligible for the exemption process with several applications currently pending.

We believe we have formulated and are now implementing the right measures to prevent any further occurrence. We've been working diligently with all relevant authorities in order to resolve the issues that led to the suspension as quickly as possible. On December 18, we met with the ANSM and committed to engage in further discussions for development of a restart process following prioritized protocols between our Beinheim facility and our customers.

At the end of December, the ANSM approved production of a simulation or placebo batch so that we could test our new procedures in a production environment. Additionally, we've recently reached another milestone with an ANSM inspection that is a prerequisite to the initiation of individual restart processes with prioritized customers under ANSM-approved exceptions.

We currently expect that the facility will be fully operational by mid-March. Matt will provide more specifics on the financial impact of the suspension later in the presentation, but I wanted to take this opportunity to provide additional clarity on the situation. As we've done from the outset, we'll continue to fully cooperate with the ANSM and work with law enforcement officials on the ongoing criminal investigations.

Now moving to our key operating accomplishments, in the middle of January, we announced a research collaboration with Roche to develop next generation molecules using our proprietary SMARTag technology. Roche will gain non-exclusive access to our SMARTag platform and will have an option to take commercial licenses to develop molecules directed to a defined number of targets. It will permit evaluation of alternative sites of drug conjugation so that Roche may develop molecules optimized for efficacy, safety and stability.

The agreement included an upfront license fee of $1 million, which was recognized in the second quarter, and has the potential for $618 million in development and commercial milestones if Roche pursues commercial licenses and all options are exercised.

Also at the beginning of December, we entered into an exclusive long-term supply agreement to produce Pfizer's leading over-the-counter heartburn treatment, Nexium 24HR, also marketed as Nexium Control outside the United States.

Nexium is one of the leading global OTC medicines and its manufacture is well-suited to our recently expanded Winchester facility, where we have both capacity and flexibility to accommodate programs of this scale. We're proud to partner with Pfizer on delivering some important products to patients worldwide, and this is another example of the traction we're gaining in our consumer health initiative.

In conclusion, we're pleased with the performance of our base business during the quarter despite challenges from our Beinheim facility suspension. The dynamics of our industry and market remain very favorable, and we continue to leverage our market-leading position, broad capabilities, global reach and regulatory track record to further penetrate our existing markets.

Now I'd like to turn the call over to our Executive Vice President and Chief Financial Officer, Matt Walsh.

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Thanks, John. I'll start my presentation with a brief review of our second quarter operating accomplishments by reporting segment, starting with Oral Technologies on slide seven. Our softgel business, which accounted for approximately 70% of Oral Technology segment revenue, posted double-digit growth in both revenue and EBITDA on a constant currency basis, excluding the impact of the Beinheim facility suspension. More specifically, Beinheim reduced softgel's expected top line by $21 million and EBITDA by $14 million. The EBITDA impact included one-time costs of $4 million. I have more specifics to share on Beinheim momentarily.

Elsewhere across our global softgel business, our consumer health initiative is gaining traction within Latin America, Asia Pacific and Europe. Additionally, we see continued strength in North America, driven by development revenue and our Rx product slate. During these positive trends, we believe the softgel business, excluding Beinheim, is positioned well for profitable growth throughout the remainder of the fiscal year at a level nicely above recent trend lines.

The Modified Release business, which accounted for roughly 30% of all technology sales, had another challenging quarter as we expected and discussed during the last earnings call. Due to lower customer demand for certain higher margin products, revenue within controlled release declined year-over-year, and even the margin was affected by unfavorable product mix. Overall though, the Modified Release business fundamentals remain strong, however we do expect the business to continue to be challenged throughout the remainder of this fiscal year.

Now let me provide you with an update on the financial impact that the Beinheim suspension, as outlined on slide eight, to both our fiscal second quarter and to the full year as we see it today. We have separated out the one-time cost in the second quarter from the continuing operations impact for transparency. The full-year estimated impact assumed that the site is fully operational by mid-March, with progressive restart of certain individual products prior to that. For absolute clarity, the figures on this chart represent the change in financial performance as compared to the company's previously issued guidance, last affirmed November 3, 2015.

Now moving on, our Development and Clinical Services segment showed on slide nine posted strong organic growth during second quarter. The good performance of the Clinical Services business was attributable to the increased customer project activity and comparator sourcing activities. Revenue and EBITDA growth, as well as margin expansion in the Analytical Services business was driven by our integrated oral solids development and manufacturing business based in Kansas City. Additionally, a one-time volume commitment resolution within the segment Development and Analytical Services business increased the segment's revenue and EBITDA by $10 million.

Our recent Micron Technologies acquisition also contributed modestly to segment performance during the second quarter. As of December 31, 2015, our backlog for the Development and Clinical Services segment was $433.8 million, a 2% sequential increase. The segment also recorded net new business win of $133.8 million during the second quarter, representing a 33% increase year-over-year. The segment's trailing 12-month book-to-bill ratio was 1.1x.

On slide 10, turning to the Medication Delivery Solutions segment, our Blow-Fill-Seal offering continued a strong underlying performance, with the core business posting double-digit revenue and EBITDA growth during the second quarter. However, a one-time volume commitment resolution recorded in the prior year negatively affected year-on-year growth.

Market fundamentals for Blow-Fill-Seal remain attractive with a robust new product pipeline and continued (13:23-14:02).

Operator

Ladies and gentlemen, please stand by, your call will resume momentarily. Once again please standby, your call will resume momentarily. Thank you.

(14:10-15:27).

You may resume your conference.

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Okay. Thank you, operator. So, ladies and gentlemen, I apologize for the technical difficulties. We'll back up the program to where I started to talk about slide 10, that is entitled Medication Delivery Solutions segment update. Our Blow-Fill-Seal offering continued its strong underlying performance with the core business posting double-digit revenue and EBITDA growth during the second quarter. However, a one-time volume commitment resolution recorded in the prior year negatively affected year-on-year growth. Market fundamentals for Blow-Fill-Seal remain attractive with a robust new product pipeline and continued product mix shift to higher margin products.

The Sterile Injectables business experienced a modest decline in revenue during the second quarter, although EBITDA improved over the prior year due to more favorable product mix. While our expectations in this business for the rest of the year remain muted, we believe that our entry into the Animal Health market positions the business well for future growth in fiscal 2017 and beyond.

Finally, the Biologics business performed well and continued to be the fastest growing business within the company as recent investments continue to pay off. We saw growth within our Madison facility, which was driven by the completion of project milestones. Additionally, during the second quarter we recorded a $1 million license fee from Roche as John alluded to earlier, which signed a multi-milestone license and development agreement for our SMARTag ADC linker technology.

SMARTag continues to meet proof-of-concept milestones and customer interest remains strong with the research collaboration with Roche (17:17) recent development. We continue to believe that our Biologics business is well-positioned for future growth.

Once again, and in order to provide additional insight into our long-cycle business, which includes both Oral Technologies and Medication Delivery Solutions, we are disclosing our long-cycle development revenue and a number of new product introductions. 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. We do, however, expect these metrics to offer insight into the long-term organic growth potential of our long-cycle business.

Due to the inherent quarterly variability of these metrics, we will provide the numbers on a year-to-date basis. For the six months ended December 31, 2015, we introduced 86 new products, which is level with the number of new products launched in the same period of the prior year. Also, in the same year-to-date period, we recorded Development revenue, $73 million, an increase of 20% versus the same period for the prior year.

As a reminder, the number of NPIs in any given period depends on the timing of our customers' product launches, which are often driven by regulatory body approvals, or are otherwise at the discretion of our customers and thus, this figure will continue to vary quarter to quarter. I'll now provide more details on our financial results for the second quarter. As a reminder, all of the segment revenue and EBITDA year-over-year variances I will discuss on the next few slides are at constant currency.

Turning to slide 11, revenue from the Oral Technologies segment was $255.1 million for the second quarter, increased nominally versus the second quarter a year ago. This performance was attributable to the temporary suspension of operations at our facility in Beinheim, softer demand for certain higher margin offerings within our Modified Release Technologies business, and lower revenue from product participation related activities, offset by increased demand overall for softgels.

Oral Technologies segment EBITDA for the second quarter was $59.1 million, a decrease of 16% versus the second quarter a year ago. The decrease was primarily attributable to the temporary suspension of operations at Beinheim as well as to lower demand for certain higher margin offerings within Modified Release Technologies. This was partially offset by higher sales and more effective absorption of fixed costs through higher capacity utilization at our other softgel sites.

Revenue from the Development and Clinical Services segment was $131.6 million for the second quarter of fiscal 2016, an increase of 24% over the second quarter a year ago. This increase was primarily attributable to strong organic growth in our Analytical Services and Clinical Services offerings as well as to the revenue contribution from the Micron acquisition and a volume commitment resolution. Development and Clinical Services segment EBITDA for the second quarter was $34 million, an increase of 58% year-over-year. And the strong EBITDA improvement was primarily driven by increased sales across the segment, the timing of resolution of volume commitments and contributions from the Micron acquisition.

Revenue from the Medication Delivery Solutions segment was $71.1 million for the second quarter, an increase of 1% over the second quarter a year ago. This growth was primarily due to increased demand for our Biologics offering and products utilizing our Blow-Fill-Seal technology platform, partially offset by a decrease in revenue due to the timing of resolution of volume commitments with respect to the Blow-Fill-Seal platform and decreased demand for injectable products at our European prefilled syringe operations.

Medication Delivery Solutions segment EBITDA was $17.2 million, a decrease of 2% over the prior-year period. This decrease was primarily attributable to the timing of resolution of volume commitments with respect to products utilizing our Blow-Fill-Seal technology, partially offset by increased profit generated by higher revenue from our Biologics offerings and favorable revenue mix shifts from our injectable products within prefilled syringe.

Turning to slide 12, we see in precisely the same format as on slide 11, the six-month year-to-date performance of our operating segments, both as reported and in constant currency. I won't cover every various item in detail, but I will (22:07) parallel our second quarter results (22:11) constant currency revenue improvement and similar EBITDA improvements – similar EBITDA performance across all three reporting segments. The year-to-date 8% constant currency revenue growth or 7% growth on an organic basis, compared to the same period a year ago, was modestly above our long-term objective of 4% to 6% organic revenue growth per year.

Slide 13 shows the reconciliation to the last 12-months EBITDA from continuing operations from the most proximate GAAP measure, which is earnings from continuing operations. This is a mechanical computation which doesn't require much supporting commentary included there for your benefit to assist in tying out the reported figures to our computation of adjusted EBITDA, which is detailed on the next slide.

So now moving to adjusted EBITDA on slide 14, second quarter 2016 adjusted EBITDA decreased 10.5% to $101.1 million, compared to $112.9 million for the second quarter a year ago. Excluding the impact of FX translation, our second quarter adjusted EBITDA declined 7.1% to $104.9 million as higher profitability in the Development and Clinical Services segment was offset by declines in the Oral Technologies and Medication Delivery Solutions segments.

On slide 15, you can see that second quarter adjusted net income was $44.9 million or $0.36 per diluted share compared to adjusted net income of $55.9 million or $0.44 per diluted share in the second quarter a year ago.

This slide also includes the reconciliation of earnings from continuing operations to non-GAAP adjusted net income in a summarized format for your reference. A more detailed version of this reconciliation can be found in our supplemental information section of the slide deck, where you will find essentially the same add-backs as seen on the adjusted EBITDA reconciliation slide.

Now turning to slide 16. As of December 31, 2015, our leverage ratio was 4.1x compared to 3.9x as of June 30, 2015, and our capital structure was essentially unchanged during the second quarter.

On slide 17, we detail our revised fiscal year 2016 guidance, which we are lowering due to the Beinheim suspension. We expect to incur adverse impact from foreign exchange translation in the second half, which we believe will be offset by growth in the base business, which is modestly above our prior guidance.

For fiscal year 2016, we now expect revenue in the range of $1.78 billion to $1.84 billion compared to the previous range of $1.81 billion to $1.9 billion. We now expect adjusted EBITDA in the range of $410 million to $435 million, compared to the previous range of $434 million to $457 million. Net income is now expected in a range of $185 million to $205 million compared to the previous range of $203 million to $226 million.

We continue to expect capital expenditures in the range of $125 million to $135 million. Our fully diluted share count on a weighted average basis for the fiscal year ending June 30, 2016, is now expected to be in the range of 125 million to 127 million shares, compared to the previous range of 126 million to 128 million shares. It's important to note that the revenue and adjusted EBITDA ranges to which we are guiding are consistent with our constant currency long-term outlook of 4% to 6% organic revenue growth and 6% to 8% organic adjusted EBITDA growth excluding the impact from the Beinheim facility suspension.

We also wanted to take this opportunity to provide clarity related to two components of adjusted net income, interest expense and cash taxes. We expect our interest expense for the third and fourth quarters of fiscal year 2016 to be closely aligned with what we reported in the second quarter. Related to cash taxes, we expect the full-year figure to be in the range of $40 million to $46 million incurred approximately linearly across the quarters.

Slide 18 bridges our fiscal year 2015 results to our revised fiscal year 2016 guidance. As you can see, we expect that the negative impact from foreign exchange translation will be offset by solid performance of our base business which remains strong and is growing in line with our long-term outlook on a constant currency basis, leads to the change in guidance really being driven by the Beinheim temporary suspension.

Lastly, let me remind everyone of the seasonality in our business and highlight our expected quarterly progression throughout the year. Due to the timing of our customer's annual facility maintenance periods, as well as the seasonality associated with budgetary spending decisions in the pharmaceutical and biotechnology industries, the first quarter of any fiscal year is generally our lightest of the year by far, with the fourth quarter of any fiscal year generally being our strongest by far, with this trend being slightly more pronounced during fiscal year 2016 as compared to recent history. Therefore, as a result of the Beinheim facility suspension, we expect the ramp up in profitability from our fiscal third quarter to our fiscal fourth quarter to be more amplified than what we have experienced in prior fiscal years.

Operator, I'd now like to open the call for questions.

Question-and-Answer Session

Operator

Thank you. And our first question is from Ricky Goldwasser of Morgan Stanley. Your line is open.

Mark Rosenblum - Morgan Stanley & Co. LLC

Hi. This is Mark Rosenblum in for Ricky. Just on the – I'm looking at slide 18 on your deck on the ranges here. Can you guys just give a little more detail on what the assumptions for the plant opening back up is, from the bottom to the top of the range? And then also the same thing on the FX impact.

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

So, the – we expect the facility to be fully operational by mid-March with selected products coming up before then, and really, any difference between the bottom or the top in the range would just be driven by the timing of the re-onboarding of those products, whether...

Mark Rosenblum - Morgan Stanley & Co. LLC

Got it.

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

...they're before full reinstatement of operations or after.

Mark Rosenblum - Morgan Stanley & Co. LLC

Got it. Okay. And then on the profitability, it looks like the 2Q impact implies like a 66% margin on those products. Are the softgel products that are in that facility, higher margin? Like how should we think of them compared to the overall business?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

The overall business at Beinheim is pretty consistent with the rest of the network. I would discourage you from looking at these numbers as being representative of somehow the average profitability because these numbers contain all of the costs associated with remediation activities during the suspension period. So, it will make it look like these products are more profitable than they are.

Mark Rosenblum - Morgan Stanley & Co. LLC

Okay. Okay. That's helpful. All right. Thank you.

Operator

Thank you. The next question is from Tycho Patterson of JPMorgan. Your line is open. Peterson, sorry.

Tycho W. Peterson - JPMorgan Securities LLC

Hi. Yeah. Thanks. Can you maybe just touch on customer retention around Beinheim? Did you lose any kind of key customers with regards to the closure?

John R. Chiminski - President, Chief Executive Officer & Director

Yeah. Hi, Tycho. John here. What I would say is that many of these products through – at this facility are single-source, sole-source products for Catalent. And so we're working with those customers directly in terms of submitting what are called global restart plans, and then working with our customers to go ahead and restart those products. So, there's no, I would say, significant customer retention issue at this site with regards to the, broadly speaking, the product slate that we have there.

Tycho W. Peterson - JPMorgan Securities LLC

Okay. And then on Redwood, it was good to hear about the Roche collaboration. Can you maybe just talk to general interest in the technology and whether there's a decent backlog of business building up there?

John R. Chiminski - President, Chief Executive Officer & Director

Well, so as you know, this is a new technology, second-generation technology with regards to our conjugation technology for the ADC. And I would just say we had a very strong interest prior to Roche, where we have, many high-value customers that we're not disclosing, just based on the agreements that we have with them. And then obviously, post the Roche agreement, I would say we just had an even heightened awareness of both the technology as well as interest. So, I think it's really just proceeding as we've expected and as we've continued to do proof-of-concept, it's continuing to meet all of those milestones. So, I would just say we're very much on track for this technology.

Tycho W. Peterson - JPMorgan Securities LLC

And then I guess on capital deployment, you guys have been open about your desire to do M&A. Obviously, with the market volatility, the valuations have come in a bit. Are you looking more aggressively at opportunities? Are you seeing more come across your desk? What's the likelihood that you get something done here in the next...

John R. Chiminski - President, Chief Executive Officer & Director

Yeah. What I would just say is that our funnel continues to be very robust, and I would say it's independent of current market or, as you call it, valuations. And I would say we are just as active, if not more active than we've been over the last couple of years, and that's just because we've been aggressively pursuing things for a while. So, we hope that in the next 12 months to 24 months, we'll see a lot of better fruition of what's built up into that funnel, but it still remains very active, and I would say independent of current market and valuations.

Tycho W. Peterson - JPMorgan Securities LLC

Okay. Thank you.

Operator

Thank you. And the next question is from Derik De Bruin of Merrill Lynch. Your line is open.

John R. Chiminski - President, Chief Executive Officer & Director

Hi, Derik.

Derik De Bruin - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Hi. So, what was the Micron contribution to the quarter?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Micron contributed less than 1% of the quarter's sales.

Derik De Bruin - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Great. Thank you. I guess, the – so what's the risk to the March restart? I mean, what can – I mean, could this drag on for another couple of quarters? I'm just like, what's your confidence level around having to restart?

John R. Chiminski - President, Chief Executive Officer & Director

Yeah, so what I would tell you is that based on the productive, collaborative and constructive meetings that we've had with the ANSM that started in December, which I highlighted in my earnings release, I would say that they've given us significant clarity and a roadmap to what we needed to do to restart the facility, which gives us the current confidence that we have in a mid-March start. We've also built into there some contingencies based upon an additional inspection that will need to happen and when we'll respond.

Certainly I have to say that this is all contingent upon the regulatory body and the ANSM, specifically. But at this point, we have very strong clarity about what we need to do to restart the facility. It starts with doing three customer restarts that we have visibility to start within the next week or so. And then following that inspection we should have visibility to starting in that March timeframe.

So, I don't think we're off by significant numbers. If we are, it certainly would have an impact but I would say the clarity that we have right now provides us a high degree of certainty that we will be able to get the Beinheim issue behind us and we're certainly in a different spot in terms of certainty and clarity than we were sitting in November and December.

Derik De Bruin - Merrill Lynch, Pierce, Fenner & Smith, Inc.

So, I guess, are the regulators confident that – it sounds like this was a malicious act and they're confident that this isn't sort of like a general breakdown of your processes and they're comfortable with the idea that somebody – well, I don't know if comfortable is the right word, but they agree with you that this is not something that's like a broader process. It's a particular individual or individuals who are causing the problem?

John R. Chiminski - President, Chief Executive Officer & Director

Yeah. No, so what I would tell you is that the malicious act precipitated the ANSM's action. Certainly they have found other areas where they wanted us to make improvements in both how we alert the authorities to these type of acts, how we assess our – what levels we assess specific deviations and corrective actions and so forth. And we're well on our way to satisfying the ANSM's concern that they're, I would say, motivated to assist us in getting started. And again, they've told us that it's in Catalent's hands now to get this moving forward. So, we have a high degree of clarity to do that.

Derik De Bruin - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Great. Just one final question. Are you liable to any of your customers? Is there any product liability issues? Do you have to worry about any legal actions? Anything like that that come back and bite you?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

So, in terms of that, Derik, we've got I think two things to discuss. First of all, all of the key products at the site are under contract. The contract provisions include limitations of liability, which is Catalent standard across our network. That's one way of protection, if you will. We also have insurance coverage. So, we believe that (37:35) will enable us (37:38) the type of exposure you're referring to.

Derik De Bruin - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Great. Thank you.

Operator

Thank you. The next question is from Dave Windley of Jefferies. Your line is open.

David Howard Windley - Jefferies LLC

Hi. Thanks. On Development and Clinical Solutions, the volume commitment resolution seemed relatively large, and I guess, I was interested in that in – you were describing to us maybe you have those on a regular basis and we just don't know about them. So what's typical, what's average in a quarter for you to see in terms of these commitment resolutions? And was the $10 million that you're calling out, was that essentially $10 million in revenue that falls straight through to EBITDA? How should I think about that?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

To answer the last part of your question first, it is $10 million of revenue that falls directly through to EBITDA. I would say that these resolution of volume commitments are – they are small in number. They are not typical part of our business. We had, I think, three such instances in the prior fiscal year, and one so far in this fiscal year, and I would tell you, three would be on the high side for expectations. We don't ever include those kinds of things in our guidance, for example. That just gives you a feel for management's view of the predictability or number of these things.

And why the number seems large is just related to the specifics around that certain product. When the contract got signed, our customer had very rosy projections about what the product would do in the marketplace, and that underpinned what minimums were in the contract, and so the product is selling. It's a viable product, sales are increasing. But they're just not near the level that was contemplated by the customer when the contract was signed.

So in circumstances like that, customers will typically ask for relief from the minimums, and which we're willing to do as long we're able to guarantee our return on capital. And so in this case, we effectively accelerated certain payments that would've otherwise been due under the contract, such that we're able to guarantee our return on capital that we deploy. But in the same way, give the customer some added breathing room on their end. So, these amendments when we do them are typically win/wins and that's what it was in this case.

David Howard Windley - Jefferies LLC

Okay. You answered my next question already then. So moving on, sticking with DCS though, the revenue growth there is very impressive, kind of carried the quarter from a growth standpoint on both revenue and EBITDA, your backlog increased 2% sequentially. I guess I'm interested in how we should think about duration and conversion of that backlog into revenue, clearly the – obviously, the $10 million you just described had an influence on growth rate but how should we think about what current backlog can sustain in terms of DCS growth rate?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Okay. So, the way to think about backlog in this business is generally when we book new business, it will generally start some time in the next three months to six months, sometimes longer and then the average project may run in quarters in terms of its overall duration. So, the results that we're seeing we think will sustain good growth for the foreseeable future in the Dev-Clin business, and the good part about it was we saw it across our Clinical Supplies business as well as our Analytical business. And the return to growth that we believe is more indicative of the baseline growth of the clinical services business was really good to see and it was a payoff for reorganizational activities we'd undertaken to strengthen the focus of our business development efforts in Europe.

David Howard Windley - Jefferies LLC

Okay. And then I just wanted to ask one more if I could and that is going to Oral Technologies. You've talked for some time about the consumer health initiative and that driving mix shift toward consumer but in your prepared remarks you called out strength in North America driven by development and the prescription product slate. And so, I guess, I struggle, it feels like a little bit of intellectual whipsaw, I suppose, in terms of trying to figure out which way is that business really headed and what is driving the performance? Thanks.

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Sure. So, within our softgel business, the consumer health initiative is something that we have been operationalizing and planning for and it's coming to fruition as we had planned. By the end of the fourth quarter, we will have probably ramped up most or all of the volume that we had anticipated in that initiative. So, really everything's on track as far as that's concerned.

We've seen relatively better performance than we had expected when the year started out of our prescription business in North America, both in terms of commercial sale as well as development revenue. And so these things, when they happen in the actuals, we're talking about them as drivers because they are drivers, David. So, it explains why the softgel business is not only up in sale, but its margins have not – not only have they not declined as the consumer health initiative ramps up, but they've actually gone up.

David Howard Windley - Jefferies LLC

Okay.

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

And so, softgel – yeah. So, softgel excluding Beinheim is just having a very strong year.

David Howard Windley - Jefferies LLC

Okay. That helps. Thank you.

Operator

Thank you. And the next question is from John Kreger of William Blair. Your line is open.

John C. Kreger - William Blair & Co. LLC

Great. Thanks very much. Matt, in terms of the Beinheim remediation plan that it sounds like is very much in place, does any of that include changes to your broader global manufacturing footprint? And if so, is that in your guidance at this point?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

No changes to the global footprint contemplated, but everything that we know about the current situation at Beinheim is encapsulated in our guidance, right? So, that includes the ramp-up to full restart and a lot of the catch-up work from, let's say, excess of orders that have been delayed to be filled. Beinheim will be actively filling those in the fourth quarter. We've reflected that.

And we're also accounting for some additional costs that we'll be taking on to make sure that we have business continuity planning in terms of second sourcing within Catalent's softgel network any products that our customers would like to have a second source within the Catalent network. So, that all of those costs and everything that we know is encapsulated in the current guidance.

John C. Kreger - William Blair & Co. LLC

Great. Thank you. Another guidance question. You gave us CapEx for the year. Could you comment maybe a little bit more broadly about what your cash flow expectations are, either operating or free cash flow for the year?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

So, that's not guidance that we provide, John, but I think we've certainly given you the components to be able to develop that. And if you like to have more conversation on that, that's something that maybe we can handle offline. But the company doesn't provide guidance to cash flow, but the pieces are there.

John C. Kreger - William Blair & Co. LLC

Okay. And one last one. Now that you've got the Roche collaboration in place for Redwood, can you talk a little bit more broadly about when Redwood – we can expect that to start to ramp? I would assume that collaboration in particular is probably a multi-year in terms of your ability to secure any of those milestones. But maybe a little bit more broadly, what's the pace at which that turns into becoming a nice revenue driver for you?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

So, the timing of that really depends on the research and development efforts of Roche, which is just very difficult for us to pin down. And so that's a challenging question for us to answer, John. I can tell you there's nothing significant in the current guidance for it. And it's the kind of timeline that, I would say, spans years versus quarters.

John C. Kreger - William Blair & Co. LLC

Great. And would you expect other similar collaborations to happen in the coming year or two?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

We definitely do and in sort of a virtuous cycle, the announcement of the Roche deal, as John mentioned, has generated even more interest in the technology which is a nice outcome.

John C. Kreger - William Blair & Co. LLC

Great. Thank you.

Operator

Thank you. And the next question is from Tim Evans of Wells Fargo Securities. Your line is open.

Tim C. Evans - Wells Fargo Securities LLC

Thank you. I also wanted to touch on the Roche deal. Just thinking maybe into 2017 – fiscal 2017, a little bit, how would you handicap the probability of receiving milestones in that year? And I guess maybe a better way to ask it in terms of getting at how we might model this is how lumpy or how large could any individual milestones be kind of on a quarterly basis?

John R. Chiminski - President, Chief Executive Officer & Director

This is John. Let me just kind of answer it from the standpoint that when you think about this kind of a development agreement with Roche, this is basically starting out at the very beginning of their research and development in terms of how to properly conjugate different molecules, if you will, and move them forward. So, when we take a look at a development agreement like this, this is going to have – think of it as a five-year to seven-year type of agreement where the initial revenues that we're going to be receiving are going to be on the development front with them more so than I would say on the milestone front.

That's probably as much as I would probably say at this point. Certainly, we're looking to sign other deals of this nature because they end up having an overall layering affect, if you will, in terms of the overall technology. And I'll also just remind you and the folks that from a Biologics standpoint, we really see this as just a piece of our overall Biologics strategy within the company to really improve our overall relevance within the space since Biologics is going to be such an important part of our future.

Tim C. Evans - Wells Fargo Securities LLC

Okay. And so with that in mind, how do you kind of envision the longer term growth rate of the Dev-Clin segment at this point?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

So, the Biologics business is a part of our Medication Delivery Solutions segment, Tim, just to make sure that we're all aligned on that. And right now, Biologics today is approximately 15% to 20% of the sales of that segment, and it is growing double-digits and we believe can continue to grow at that pace. So, it'll be a strong contributor to the growth of the MDS segment overall.

Tim C. Evans - Wells Fargo Securities LLC

Okay. Thank you.

Operator

Thank you. And the next question is from Sean Wieland of Piper Jaffray. Your line is open.

Sean W. Wieland - Piper Jaffray & Co (Broker)

Thank you very much. Another one on the Beinheim facility. I just wanted to get my head wrapped around potential liability here still. So, I realize you haven't seen any out-of-place capsules within the marketplace. How confident are you that you won't?

John R. Chiminski - President, Chief Executive Officer & Director

This is John here. What I would just say is that the initial out-of-place capsules occurred in the July timeframe of last year. And we're now talking seven months, or six months or seven months displaced from that, and we've only had one capsule that was detected at our customer's packaging. Packaging queuing processes caught it up. So, what I would say is that the amount of time that has gone on by and the number of batches that were put out into the field, it is a high degree of confidence.

But that being said, we're not 100% certain. But there's enough signals here that make us very comfortable, and I would also say in terms of there were some initial batches that were recalled from a large number of batches that were produced during the timeframe that the ANSM was concerned with. And from the initial suspension where we had some initial recall activity to now, that recall activity has dwindled to basically zero over the last three weeks to four weeks. So, in terms of the assessments of our customers and our own assessments, along with the fact that we've had no detection in the marketplace, gives us a fair degree of certainty.

And then as I said, the ANSM has provided us some very strong clarity around restart (52:25) to do that, we have our first three, I would say kind of approved restart plans, and we have some good clarity. So overall, that's I think a good assessment of do we expect to see one out in the marketplace. I think that the data kind of speaks for itself. With regards to the liability question, again, Matt had talked to, both about the fact that all of these products are under contracts where we do have limits of liability baked into them. We also have insurance, and any claims that have been logged already have been reserved and are in our current guidance.

Sean W. Wieland - Piper Jaffray & Co (Broker)

How many batches were recalled?

John R. Chiminski - President, Chief Executive Officer & Director

We're not reporting the number of batches that were recalled, but I would say it's a small number compared to the overall number that have been produced at that time period. And as I said, nothing recent over the last three weeks or four weeks.

Sean W. Wieland - Piper Jaffray & Co (Broker)

Okay. And then do you have a – you said that you have had claims presented against the company for losses. What's the total value of the claims that have been presented so far?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

So, we're not disclosing that, Sean, but it is – it's currently reflected in our second quarter actuals, and that's – and anything that we know of in the future is already encapsulated in our guidance.

Sean W. Wieland - Piper Jaffray & Co (Broker)

Got it. That was my next question, when do you account for it? So, you account for it as soon as you get the claim?

Matthew M. Walsh - Chief Financial Officer & Executive Vice President

Correct.

Sean W. Wieland - Piper Jaffray & Co (Broker)

Okay. Super. Thanks for taking the questions.

Operator

Thank you. And there are no further questions at this time. I'll turn the call back over to John Chiminski for closing remarks.

Thomas Castellano - Treasurer, VP-Finance & Head-Investor Relations

Actually, this is Tom. Before we turn over to John, I just wanted to apologize for the technical difficulties, and given them, we've posted a copy of our prepared remarks on the Investors section of our catalent.com website for analysts and investors to go and pick up.

John R. Chiminski - President, Chief Executive Officer & Director

Okay. Thanks, Tom. So in conclusion, I'd like to reiterate that we're pleased with the underlying trends in our base business during the second quarter, and we look forward to building on that momentum in the coming quarters. The market for advanced delivery technologies and development solutions remains globally robust. We remain focused on the Beinheim remediation, capitalizing on our industry-leading partnerships and returning to our long-term growth outlook of 4% to 6% organic revenue growth and 6% to 8% organic EBITDA growth during fiscal year 2017.

I'd like to thank all of you for joining us today, and we look forward to updating you again on our next conference call. Thank you.

Operator

Thank you. Ladies and gentlemen, this concludes today's conference. You may now disconnect. Good day.

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