Earnings Labs

West Pharmaceutical Services, Inc. (WST)

Q4 2017 Earnings Call· Thu, Feb 15, 2018

$291.37

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Q4 2017 West Pharmaceutical Services Earnings Conference Call. [Operator Instructions]. I would now like to turn the call over to Quintin Lai, Vice President of Investor Relations. Please go ahead.

Quintin Lai

Analyst

Thank you, [indiscernible]. Good morning, and welcome to West's fourth quarter and full year 2017 conference call. We issued our financial results this morning and the release has been posted in the Investor section on the company's website located at www.westpharma.com. This morning CEO, Eric Green and CFO, Bill Federici, will review our results, give you an update on our business and provide a financial outlook for the full year 2018. There's a slide presentation that accompanies today's call and a copy of that presentation is available on the Investor's section of our website. On Slide 2 is the safe harbor statement. Statements made by management on this call and in the presentation contain forward-looking statements within the meaning of US federal securities law. These statements are based on management's beliefs and assumptions, current expectations, estimates and forecasts. There are many factors that can influence the company's future results that are beyond the ability of the company to control or predict. Because of these known or unknown risks or uncertainties, actual results could differ materially from past results and those expressed or implied in any forward-looking statement. For a non-exclusive list of factors which could cause actual results to differ from our expectations, please refer to today's press release as well as any further disclosures the company makes regarding the risk to which it is subject in the company's 10-K, 10-Q and 8-K reports. In addition, during today's call, management will make reference to non-GAAP financial measures, including: sales in constant currency, adjusted operating profit, adjusted operating profit margin and adjusted diluted EPS. Reconciliations and limitations of the non-GAAP financial measures to the most comparable financial results prepared in conformity to GAAP are provided in this morning's earnings release. I now turn the call over to West's CEO and President Eric Green. Eric?

Eric Green

Analyst

Great. Thank you, Quintin. Good morning everyone and thank you for joining us this morning. As you've seen the press release issued this morning our Q4 performance returned to more typical growth patterns for our Biologics and Generics market units. While we saw a decline in our Pharma business this was balanced by very strong quarter from our contract manufacturing team. If we exclude impacts from the de-consolidation of operations in Venezuela and hurricane related shutdowns, we estimate that organic sales growth would have been 6% for the quarter. Fourth quarter 2017 was also impacted by a discrete tax charge related to the US tax reform legislation that reduced EPS by $0.64; excluding this impact, fourth quarter 2017 adjusted diluted EPS grew by 19%. As we turn to 2018, we expect to see another year of above market sales growth and operating profit margin expansion. The underlying markets we serve have been growing at 2% to 3% in unit growth. Our annual revenue growth rate has consistently outperformed the market. We continue to leverage the demand for our high-value products and contract manufacturing services. Along with the technical and scientific leadership that differentiates West and the industry. This remains our focus for growing our business organically. Let's now turn to the detail of our market unit performances for Q4 and the full year on Slide 4. As noted earlier, we saw a return to double-digit growth in our Biologics market unit in Q4. Biologic customers continue to demand West high-quality product offerings and our growth was led by the adoption of NovaPure products as well as Westar components. We are encouraged that West maintain participation on 100% of the Biologic new molecular entity FDA approvals in 2017. Both large and small biologics customers rely on West and our partner Daikyo…

Bill Federici

Analyst

Thank you Eric and good morning, everyone. We issued our fourth quarter results this morning. Our Q4 results include the effects of US tax reform which resulted in a discrete charge to reflect the Repatriation Tax on unremitted offshore earnings and the reduction of our US deferred tax assets. Excluding the effects of special items from both this quarter and the prior year. Fourth quarter 2017 earnings were $0.64 per diluted share versus $0.54 we earned in Q4, 2016. A reconciliation of these non-GAAP measures is provided on Slide 16 through 20. Turning to sales, Slide 11 shows the components of our consolidated sales increase. All references to sales announcement to constant currency. Consolidated fourth quarter sales were $415.6 million, an increase of 4.5% over fourth quarter 2016 sales. Proprietary product sales were $306.4 million, a 1.4% increase over same quarter 2016. Sales price increases and the volume mix increase contributed equally to the Q4 sales growth. High-value product sales increased 5.1% versus the prior year quarter. For the full year 2017 high-value product sales increased approximately 4% versus 2016. Our Biologics segment sales increased by double-digit and our generics market unit saw high single-digit growth. But our pharma market unit sales decline low single-digit in the quarter. Combined CZ and SmartDose sales and development activity were $40 million for the full year 2017, a 47% increases versus the prior year 2016. Contract manufactured product sales were $109.2 million, a 14% increase over sales in the prior year quarter as customers ramped up activity in our recently expanded government contract facility. As provided on Slide 12, our Q4, 2017 consolidated gross profit margin was 30.9% versus 32.3% margin we achieved in the fourth quarter, 2016. Proprietary products fourth quarter gross margin of 34.8% is 2.1 margin points lower than the…

Eric Green

Analyst

Thank you Bill. In conclusion we're making progress in executing our long-term market lead strategy. Our commercial team has developed an even greater understanding of the underlying market dynamics of our industry and is delivering tailored product and service offerings that meet the unique needs of our discrete customer groups. Our global operations team is driving improved quality, safety and service to our customers and is working to streamline our manufacturing network to make room for investments that will fuel future growth. In our innovation and technology team is building a strong pipeline of integrated containment and delivery products to meet customer needs. We look forward to another year of above market growth and remain committed to our long-term outlook for West. Operator, we're ready to take questions. Thank you.

Operator

Operator

[Operator Instructions] our first question is from Dave Windley with Jefferies. Your line is now open.

Dave Windley

Analyst

I think they called on me. At least on my end of the line just FYI. And Eric your concluding remarks there the audio went pretty choppy. I'll start.

Eric Green

Analyst

Sorry.

Dave Windley

Analyst

It sounds like the old Blackberry interference type stuff. So anyway, I wanted to start with questions around the sales performance by market unit by customer unit and just a clarifying question first, that I guess as I think about the relative size of the units. I'm having a little bit of hard time understanding how double-digit biologics, high single-digit generics and then offset by low single-digit pharma nets to only 1.4% growth, is there something that I'm not taking into account and thinking about those net together.

Bill Federici

Analyst

Hi Dave, it's Bill. I think you're thinking about it correctly. You have to remember that the size of those business units are slightly different and the growth is relatively as you said double-digit for the biologics and high single for generics. The pharma business which is the largest of those business was actually low single-digit decline. So when you add all of those things together you get to your 1.4% in proprietary. Now if you remember then the issue that are effecting those as Eric said on the call. There were some inventory destocking that was going by customers. There was a product that was pulled from the market by the customer, so there are some special items that are impacting that and when you take those in the Venezuela impact on our proprietary organization the Q4 growth rate for proprietary products will be somewhere in the 5% and 5.5% range.

Quintin Lai

Analyst

Dave, I think we may be losing you here. Operator, let's go to the next caller. Dave, if you can just come back in the queue and maybe the line will clear up for you.

Operator

Operator

Our next question is from Tim Evans with Wells Fargo. Your line is now open.

Tim Evans

Analyst

Bill, can you just for everyone walk through what exactly happened in Venezuela? Why did you have to deconsolidate this facility? Is it something where the volume moves somewhere else or is it something where you just don't get the volume anymore? And then lastly, exactly how much revenue did it do in Q4, 2016 and how much did it do in Q1, 2017 so we can understand the comp?

Bill Federici

Analyst

Okay, great. So Venezuela as you know has been suffering from very, very high inflation and a lack of ability in that country of getting cash out of the country. So many, many of the companies that serve in Venezuela have deconsolidated their subsidiaries. We hung on as long as we could, we hung on through all of 2016 when a lot of companies have bailed and through the first quarter, but at that point in time we had - been almost a year since we had received any cash payments out of the country and we deemed that point in time that our asset, our ability to control our subsidiary was no longer there. So under GAAP rules we are required to deconsolidate, what that means, is that we took a charge it was a deconsolidation charge of about $11 million relative to our Venezuelan subsidiary and we no longer from that point forward have any income or expense associated with that. We're serving those customers, many of them anyway from other parts of our South American operations. So we've not lost customers other than customers who have gone out of business or have diverted elsewhere. Some of these customers that asked us to sell through Brazil and others of our South American operations. So we have not lost the business per se. In terms of the actual financial results in the fourth quarter of 2017 versus the fourth quarter of 2016 the sales differential was $3.5 million less in 2017, Q4 than 2016, Q4. In Q1, 2017 we had $9.1 million of sales in Venezuela that we will have none in 2018's first quarter.

Tim Evans

Analyst

So I guess this is where the confusion comes in, right. So if you had $9 million of sales in Q1, 2017 and some of that business is effectively been moved to other sites in South America, why is it zero in Q1, 2018?

Bill Federici

Analyst

It's a demand issue. So when you have - we've been selling them. We had stocked up a lot of inventory through that time period and we have been - customers are ordering a whole lot in that area and we are serving them with the existing inventory on the ground. We don't have - there's been some of that $9 million has been will be made up in Q1, but not a tremendous amount.

Tim Evans

Analyst

And this is standard products that go mostly to large pharma customers?

Bill Federici

Analyst

Standard products that go to large pharma customers. Yes.

Tim Evans

Analyst

Okay, you usually call out committed orders for the proprietary I didn't hear that. Did I miss it or?

Bill Federici

Analyst

No, it's $377 million which is roughly 1% on a currency mutual basis higher than the same period in 2016.

Tim Evans

Analyst

Okay, lastly. Can you walk through the dynamics of Q1 EPS? I think you said there was going to be $0.11 year-over-year headwind. But then you said you'd offset all of it except for the stock comp accounting. What does that net do?

Bill Federici

Analyst

Okay, so when you think about let's take them into two pieces. So the stock comp will go first. The stock compensation expense in Q1, 2017 was $0.21. We are projecting for two reasons a lot smaller number in 2018. The first reason is that, now that the tax rate is 21%, not 35%. The actual benefit you'll derive from stock - we as a company will derive from those stock option exercises will be about a third less. Secondly, we had a number in 2017 of our - of large option exercises deep in the money options that have either because they're getting ready to expire, so a lot of those have already gone through the system. So we expect a smaller pool of, we have a smaller pool of option benefits to be earned over the next several years. So our estimate is only $0.04 to $0.06 for option - the tax benefit from our production [ph] sizes in Q1, 2018. So take that and put that aside. Okay.

Tim Evans

Analyst

Yes.

Bill Federici

Analyst

Because that is the first decline. The second one is, when you look at the Venezuela impact, the impact of that consumer product customer and some of these under absorbed overheads that we talked about and their impact Q1, 2018 versus Q1, 2017 will be about $0.11. We fully expect that our growth in operations, our favorable mix from generics and the biologics space coming back. And our operational efficiencies will help us offset the $0.11, but that net delta between the $0.21 of excess tax benefits versus the $0.04 to $0.06 we believe will happen in the first quarter of 2018 we do not believe that we will be able to overcome that.

Tim Evans

Analyst

So just to be very clear about $0.15 to $0.17 lower than Q1, 2018.

Bill Federici

Analyst

Correct.

Tim Evans

Analyst

Okay, that's good. All right turn it over to others. Thanks.

Quintin Lai

Analyst

Operator, can we go back to Dave? If he's back on the line.

Operator

Operator

Yes. Our next question is from Dave Windley with Jefferies. Your line is now open.

Dave Windley

Analyst

I call back you on my cell phone, so look - I'll get your answer to the first question off the transcript, but I wanted to continue to clarify a couple of things. So you guys said 100 basis points. I think Eric talked about 100 basis points of volume growth in high-value products in 2017. Should I think about that in the frame work of the like 83% standard, 17% high-value that shift in mix is continuing at 100 basis points? Is that what that means?

Eric Green

Analyst

That's correct. It's 100 basis point shift from standard to high-value products on a per unit basis. That's correct.

Dave Windley

Analyst

Yes and so, am I because I'm thinking about with the inventory destocking some of the tougher year-over-year comps etc., that the high-value product and a kind of an isolation high vale product growth was relatively low, by comparison to prior years. I guess I would have thought that I certainly want to see that mix shift continue, but I would have thought 2017 would have been a little bit of weak year on that front.

Eric Green

Analyst

Yes, absolutely so when you look at the volume component, we had - when you take a look at the volume component of the standard of about 83% back in 2016 that was about 100% impact going into for high-value products for this particular year, 2017. There is a shift between the different market units which would drive some of that behavior. So to give you [technical difficulty] biologics customers they tend to be the higher quality materials all NovaPure offering, but much smaller units and that particular part of the [indiscernible].

Dave Windley

Analyst

Okay, that's helpful. And then maybe continuing with that as you mentioned NovaPure, I think Westar was another one. You highlighted a couple quarters ago I believe that one of your large - a large biopharma customer with a fairly substantial injectable product portfolio had made the decision to transition the high-value products over a period of time understanding that's multi-year effort. But I guess I'm curious on maybe high level update as to how that - what the cadence of that transition will be roughly and is it right to think that, having the customer make a big decision like that would accelerate that 100 basis points shift a year, that you could actually see that being a little bit higher for a period of time while that's happening.

Eric Green

Analyst

That's a good point. So we're on track with that particular customer, which we won't name. But it is approximately a little over two-year process doing the transition completely. A little bit less volume in year one and you've seen year two, so this should be more in acceleration. It requires our customer be onsite to do [indiscernible] validation and also their documentation. So we're well on track. We're seeing the conversion occurring and we're quite pleased by this particular conversion. We do think this will help us with our discussions with other customers to transition from standard to high-value products with their existing portfolio of other large pharmas. So we're on track. There could be a potential uptick as we talk about number of units moving from standard to high-value products as we look into 2018 and little beyond that due to the step of transition.

Dave Windley

Analyst

Okay and last one and I'll drop. Bill you emphasized that you're now basically in a net cash position small. What are the major thoughts about levels of debt that you're comfortable kind of based on recent pattern that you seem zero, net debt. But I guess I'm wondering particularly is there an opportunity to be a little bit more aggressive and opportunistic on the share repurchase side of things. Now that you're in a position where CapEx is trended on the low end of your range or your P&L is growing, you're going to generate more cash flow and you don't have a lot of debt.

Eric Green

Analyst

I'll start talking little bit about the use of cash because that's a very good comment in regards to - our number focus is around investing in the organic growth and you're absolutely correct, when you sort of - when you look at CapEx spend in 2017 is roughly around $130 million in prior year, so it's - was north of that. And kind of seeing there results to we do have a couple of facilities that are state-of-the-art customers are excited transfer projects into those sites, but they're underutilized at this point and so we believe, we'll continue to invest in organic growth, but because of our global operations approach that they're taking with more of network approach we feel comfortable that. We're looking at below the 150 that we've mentioned. The second area that is we're starting to put more emphasis around is, now that the team's aligned around our innovation, technology group. You'll see while the number is still as a percent of sales below 3% we're trying to continue to invest in that area in double-digit growth. We're very encouraged with the pipeline and the type of payout that's happening in the next three to five years. One last comment, we will continue to look at both on technologies and tuck-in type of acquisitions that we really broaden our portfolio to really drive the vision of integrated containment and delivery devices for injectable medicines. We don't have 100% complete portfolio as you know and we're working on ways to leverage innovation or through bolt-on opportunities to bring that in the fold. I'll let Bill talk real quickly about the debt and how we use cash also around share buyback and dividends.

Bill Federici

Analyst

Eric is absolutely right. The other two items in the mix there are, we do pay dividends, Dave as you know it's you know in the 40 million-ish range now on an annual basis and we're just 800,000 share buyback for the year 2018 that we hope for effect. In terms of debt and our thoughts about debt. Yes, you're right we're de-levered but we're not adverse to debt if there were strategic opportunities that were out there from a bolt-on perspective as Eric mentioned or if we see opportunities to invest elsewhere in our network. We certainly will do that and as I said, we're not debt adverse. We just happen to be in a delevered state right now.

Dave Windley

Analyst

Okay, thank you. I'll drop out.

Operator

Operator

Our next question is from Paul Knight with Janney. Your line is now open.

Paul Knight

Analyst

So I guess can we say that now Puerto Rico is behind us, de-stocking is behind us. Is that done and taken care of so to speak?

Eric Green

Analyst

Yes, Paul it's a good question. Puerto Rico is behind us. And I would just real quick comment about Puerto Rico, our site is operating and our customers on the island of Puerto Rico we're importing at this point. So we believe that is truly behind us. In fact, we will continue to invest in our Puerto Rico site because it's actually one of our top producing sites per performance. In regards to de-stocking, I'm really pleased on how we've been able to come out of the situation with the generics side and as you know, there was customer inventory builds, they were de-stocking. We do see normalized levels. We have visibility. We're pretty comfortable there. Biologics we will see a little bit up and down fluctuations based on product launches. When they're about to launch new molecule they'll come to us and we'll help them, build inventory. But the positive part there is, you know Paul very well is that the pipeline of molecules tend to be more biologics, so we should see that to be very healthy for us. So I would say there's less de-stocking type activities. We do hear one last thing Paul I add. This 40% reduction on lead times, is significant. And our customers have noted it, they've been very pleased. And now are head of operations, where the commercial heads have announced to customers and they continue to talk about how do they reduce their own safety stock to drive working capital improvements at their own facilities. So we'll have some oscillations as we go for next few quarters, but it's a very good reason why that's happening and I think for long-term we're in a very good position.

Paul Knight

Analyst

Okay and then can you give us an update on Crystal Zenith. What's the customer involvement there etc.?

Eric Green

Analyst

Yes as far as the number of - the interest level remains strong. We have various projects that are in either in Phase 1, 2 or 3. We have several that are really in the development early on discovery phase at this point. So the interest level remains strong. I'll tell you though, it really is a focused niche area that we have been going after because it won't display, it's all glass. So we're pleased especially in the biologics space we're actually seeing some of our pharma customers exploring because the size, the variability that we can provide in larger scale and so that is our option that we have at this point in time.

Paul Knight

Analyst

And then last Bill, could you give us a little color on where Q1 growth and up margins are going year-over-year?

Bill Federici

Analyst

We expect for the full year that we will be able to increase margins. We will have those headwinds as we suggested Paul and I lined out all of those things. So we should be able to offset as I mentioned the Venezuela impact, the impact from that consumer customer and our overhead under absorption issues with mix growth and operational efficiencies. So we feel very, very comfortable that on - for the full year that we'll be expanding margins. The first quarter because of the headwinds that we faced, that we were talking through happens to be very, very pronounced so again we feel comfortable with the full year outlook. The first quarter will be continue to be margin will continue to be soft.

Paul Knight

Analyst

Okay, thanks.

Operator

Operator

Our next question is from Dana Flanders with Goldman Sachs. Your line is now open.

Dana Flanders

Analyst

My first one here and apologies if I missed it. Did you guys give just the high-value product organic growth this quarter? And then as we look at 2018 I know 2016 you guys were lapping some tough comps, should we expect that to accelerate as we head into 2018.

Bill Federici

Analyst

Yes so I'll answer first question, first. For the fourth quarter our highlighted product growth was right around 5%, as I mentioned in the script. And for 2018, we mentioned that we'll see high-value products accelerating in the back half of the year as biologics and generics come back. So we believe that we will have more normal growth in our high-value products for the year, we expect high singles to low doubles.

Dana Flanders

Analyst

Okay, great. And then just my second one quickly here. I know you announced modest restructuring program not included in EPS guidance. How should we think about just the magnitude of savings over the course of 2018, is that more 2019 weighted?

Bill Federici

Analyst

Yes, absolutely. So and Dana thank you for the question. In a regulated environment that we operate in, it is very, very difficult to move product around the network. There is validation protocols with the customer etc. So these things take a long time. Historically that's why we talk in the 12 to 24 months category for when we expect to see those savings. We will see my guess and you know the way it works, is you can only take the charge and you get the savings then once those activities are actually exited which we believe will start to happen towards the back half of 2018. So the savings they maybe a little bit in the back half of 2018, but certainly not a substantial amount and most of that will come through in 2019 and beyond. It will be an annual effect.

Dana Flanders

Analyst

Okay, great. That was it from me. Thank you very much.

Operator

Operator

Our next question is from Larry Solow with CJS Securities. Your line is now open.

Larry Solow

Analyst

Most of my questions have been answered, just a few clarifications. So on just to take you back on net savings. It sounds like you're not building although you may get a little bit in the back half on Q4. You're not building it anything in your actual guidance for 2018, right?

Bill Federici

Analyst

Right.

Larry Solow

Analyst

Okay and then the total of $0.15 to $0.20 or so it looks like that the math. And that sounds like we'll get that full impact, some of it 19, but annualized we'll probably get that full impact by 2020.

Bill Federici

Analyst

Yes, absolutely.

Larry Solow

Analyst

Great and on the improved capacity, 40% reduction lead times. Obviously a little - success on the backlog side. Backlog sort of flat. Going forward should we, is backlog no longer as good of an indicator as it was maybe a couple years ago before you sort of had this surge of supply orders. How should we view that now that I looks like your capacity is or your improved capacity is somewhat normalized?

Eric Green

Analyst

Larry it's a good question because of the lead times have been reduced significantly. I mean talking matter of each nine, ten weeks in some cases reduction. Our customers are actually not ordering as much in advance. So if I take a look at giving example. If you take a look at end of January. The growth of the backlog for Q1 delivery again just to be clear though. The backlog isn't the entire growth of the business to sub-segment is up about 10%. So there's a good indicator from a short-term period and that's where the shift will occur. We're not going to have larger backlogs going forward because of the fact their lead times are significantly less than the constant level from our customers that we can deliver consistently as we said we would is a very high percentage at this point in time. So we got to be little bit careful looking at what we looked at three, four, five years of backlog is a true way to get at this point of time.

Larry Solow

Analyst

Right. Okay so it sounds it might be little, what period of shakeout until we could sort of better analyze that number, if you will but it sounds like your read outside the backlog sounds consistent and remains positive. Okay, great. Just switching gears little bit. Obviously high-value products little bit volatility during the quarter-to-quarter but all in it sounds like, you finished the year pretty good. Did you just - pharma obviously down, I think a little bit more than expected maybe in this quarter? Did you give an outlook for 2018? And quote the outlook on biologics and generics, but I didn't quite hear the pharma one and maybe that skewed by that as well - more to.

Eric Green

Analyst

Yes, Larry it's a little bit, what you just commented. Let me put it into - look at pharma and the issue that we had in Q4. Some of these are predictable, some are not predictable and/or forecastable [ph] with our customers. The one was we had a decline, with one of our clients in - drug molecules taken off in the European market which had an impact on one of our containment closures. And we also saw in this particular area what we call tooling, so we do a lot of work with our customers and we provide tooling in our pharma business and the demand was quite noticeable difference between Q4 of 2016 versus 2017 which - it's quite a large number. We had Venezuela on top of that. I know Bill mentioned earlier when you bring these elements back, plus the Venezuela to our base we're roughly on little over 5% growth in that pharma business. So that was - the impact was in Q4. It wasn't clearly visible to us at the time we were talking with you in October unfortunately we continue to work on the visibility and the transparency to our investment community in regards to the future demands.

Larry Solow

Analyst

Okay, great and then on the gross margin. On quarter little bit less than expected, you offset by lower SG&A and realized it's explainable again little bit over your - success on the new capacity coming online and under absorption. It sounds like you expect to improve upon that in 2018, but still have some drag from under absorption, is that fair to say?

Eric Green

Analyst

That is absolutely right way to say it, Larry.

Larry Solow

Analyst

Okay and I guess sort of hard to time, but I guess as you continue to grow and overtime hopefully that will switch to.

Bill Federici

Analyst

Absolutely and you know having excess capacity while it's a drag now is a good thing as you go into the future in a growing business where you can satisfy that demand for highest quality products in these plants that are specifically designed to give our customers the highest value of products that we can offer.

Larry Solow

Analyst

Excellent and then on the in sourcing of the plastics contract. It sounds like that business obviously has become quite sort of non-core going forward and less of a focus. This one contract it looks like little over $20 million, $23 million, $24 million. Is that a lower margin contract? And is this something that you expect additional contracts that come off overtime. I realize this is getting small as a whole, but any color on that.

Eric Green

Analyst

Yes, Larry I mean obviously we want to bill, service all of our customers. In this particular case, our client we've been working with for a long, long period of time [indiscernible] in sourcing. So it having impact in our consumer part of the business. But it's an area to be - we de-emphasize this area strategically as we put investments in place. But you're correct when you said it is a lower margin business. The consumer business going forward without this, the one we're talking about is roughly around $60 million and it will be declining slightly as you've seen over the last five years. So that's your magnitude of that business as of today. Just to remind you, as well 50% of the business was consumer will be acquired tech group about 10 years ago. So this has been a shift especially over the last several years.

Larry Solow

Analyst

Okay, great. Thank you very much guys.

Operator

Operator

Our next question is from Derik De Bruin with Bank of America. Your line is now open.

Derik De Bruin

Analyst

Sorry, I'm traveling and jumped on late. So my apologies if you hit this, but just to sort of follow-up on the last question. So what's the outlook for the gross margin for the different segments for 2018? Just trying to think about how the dynamics work, given all the moving pieces.

Bill Federici

Analyst

Thanks Derik for your question. On the contract manufacturing side we'll continue to see margins benefiting from the move away from consumer and towards more of our device and diagnostic businesses in pharma, so that will continue to be and operational efficiencies. Longer term we still feel very, very comfortable with the overall ability to grow organically and expand margins as Eric mentioned in this comment Derik. That will be for 2018 we talked about the headwinds that are impacting us in Q1, 2018 and that the fact that, both biologics and generics are building as the year goes, so as you know we will get to we believe for the full year high-value product growth in the high single to low doubles in the back half of the year, but in the front half that will be a, will continue to be challenged. So margins in the first quarter will continue to be challenged.

Derik De Bruin

Analyst

Okay and I guess just from a - just some question and my apologies you already answered these. I guess how does the FX impact of the top line for the full year and what's that gain on the margin level just from FX and I know there are some changes in pension accounting rules. I'm [indiscernible] M&A effect on the margin as well.

Bill Federici

Analyst

Yes that will have an effect on the margin as well. It's a good point, the pension accounting change. For us in the - you're talking about low to mid-single millions of dollars, so it's not like it's a violent change, but it is a change and it's strictly an accounting change, you're just reclassing [ph] from one area of the P&L to another. But it does have an impact on the margin. On the - I'm sorry what was the first?

Derik De Bruin

Analyst

FX.

Bill Federici

Analyst

So as I mentioned in my prepared remarks, the FX we are - we've budgeted the guidance we have prepared is at $1.20 per Euro. Last year's full year effect was $1.13 per Euro Derik and that's each one $0.01 is roughly a million, it's a little over, over $0.01 of EPS. So little bit more than that. So you're talking about going from that $0.07 between $0.05 and $0.07 where is the range what you should expect from FX. If it were to hold, at a $1.20 for the whole year, which we know it won't but that's kind of the stake in the ground, you have to put.

Derik De Bruin

Analyst

Okay, great. Thank you very much.

Operator

Operator

And our last question is from Dave Windley. Your line is now open.

Dave Windley

Analyst

I'm coming back for three. A couple more clarification, so am I right in thinking that after the third quarter or through the third quarter your year-over-year pattern in high-value product orders was negative that because of the reduction in wait times that you would actually see a negative year-over-year pattern and then, at the end of December you're back to kind of 1% improvement in that pattern such that the fourth quarter itself would represent quite a strong catch up. Am I thinking about that correctly?

Bill Federici

Analyst

The general commentary is correct. We expect over an average year Dave as you know the construct says that, we expect about 100 basis points of margin expansion due to mix shift, a little bit of price and the operational efficiencies and volume obviously. So we see that over long periods of time we're impacted as we know in the individual quarters by the inventory de-stocking and the building. We talked about the first half of 2018 being more severely impacted by things like Venezuela than the back half. We also talked about the fact that biologics and generics as they come back to more normal order patterns it's going to be towards the back half, the back half of the year. So yes you're - what we're counting on and we're guiding to is a high single to low double-digit growth in high-value products for the year, but that will be challenged in the first part of the year.

Dave Windley

Analyst

Okay, next follow-up is. Coming out of 2016 we had what 22 drug approvals of which maybe 25% of those five, six something like that were injectable. 2017 we had 46 approvals of which significantly more maybe 10, 11, 12 were injectables or more maybe it was even 20. So significant improvement in overall approvals and a commensurate increase in injectables that you care about. You already talked about how you had a 100% coverage of biologic approvals. What's the cadence? What's the timing with regard to when approvals then drive? Order patterns and revenue uptick for you in injectable products and should we be thinking about that being a big driver of your ramp up in 2018.

Eric Green

Analyst

Yes, so there's two areas that we look at, one is, there is a ramp up. Where they get approval and launch into the market place. So it's roughly about a year lead time you get into the marketplace, into the distribution channel. The second thing just to be aware - we're seeing while there's a tremendous increase in number of molecules going through the approval process more recently, we have seen in some cases smaller volumes per drug molecule. In some therapies there have been launch recently which are very exciting obviously and very effective for patient, but the volume is they're just quite small. So we have to balance it. It's not the ratio is not 1:1 with every molecule it does very - biologics tends to be smaller volumes, while the obviously the generics and pharma is larger.

Dave Windley

Analyst

Okay and then final question. On the restructuring I just want to make sure I understand because you got both a restructuring charge, you got CapEx that you were going to spend for that and then a savings amount that you expect to get. Just operationally are we talking about having identified a facility that you're able to completely take offline and exit and shutdown and then in order to do that, you got to do some build out and some other places to absorb that productive volume, that productive capacity before you can do that? Is that in fact what you're executing?

Bill Federici

Analyst

Yes, so the idea is exactly what you said to move certain of our products for certain customers into consolidate into some locations. A couple of those locations will actually close, but it will take some time to do that as you can imagine with regulated products, there will be some capital needed. We mentioned in the release $9 million to $14 million that's a very modest amount that we believe will happen over the course of 2018 and 2019 and then as we migrate those products over and those customers over, then we will have the opportunity to exit those facilities and those activities. So as you know it's - because of the regulated nature it takes a little bit of time to do these things that why we've estimated 12 to 24 months. So we don't expect a whole lot of savings in 2018, a little bit at the back and through 2019.

Dave Windley

Analyst

And is the recipient of this volume, are you able to come - is this part of moving the volume into kind of centers of excellence and kind of more call it super regional hubs like a Waterford or someplace like that?

Eric Green

Analyst

Yes, so what we're doing through aligning towards our global operations strategy that we outlined last year where we basically consolidated centers of excellence. So you're actually correct, we're pooling the resource and the technologies and capabilities into more discreet locations. This gives us an opportunity to run more efficiently. So it's really moving towards more strategic sites and as you know we have 28 today on [indiscernible] so we do have some opportunities.

Dave Windley

Analyst

Okay, thanks.

Operator

Operator

And we're showing no further questions.

Quintin Lai

Analyst

Thank you for joining us on today's conference call. An online archive of the broadcast will be available on our website at www.westpharma.com in the investors section. Additionally, you may access a telephone replay through Thursday, February 22, by dialing the numbers and conference ID provided at the end of today's earnings release. We will be presenting at any Investor Conference in New York next Wednesday and as always that webcast is available on our website as well. Thank you and have a nice day.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. You may all disconnect. Everyone have a great day.