Good morning, my name is Demetre and I will be your conference operator today. At this time, I would like to welcome everyone to the Perrigo's Fiscal 2012 Second Quarter Earnings Results. [Operator Instructions] Thank you. Mr. Shannon, you may begin your conference.
Thank you, very much. Welcome to Perrigo's Second Quarter 2012 Earnings Conference Call. I hope you all had a chance to review our press release which we issued earlier this morning. A copy of the release is available on our website at perrigo.com, also on our website is a slide presentation for this call. Before we proceed with the call, I'd like to remind everyone that the Safe Harbor language contained in today's press release also pertains to this conference call. Certain statements in this call are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934 as amended and are subject to the Safe Harbor created thereby.
Please see the cautionary note regarding forward-looking statements on Page 1 of the company's Form 10-K for the year ended June 25, 2011. I would now like to turn the call over to Perrigo's Chairman and CEO, Joe Papa. Joe?
Thank you, Art, and welcome everyone to Perrigo's Second Quarter Fiscal 2012 Earnings Conference Call. Joining me today is Judy Brown, Perrigo's Executive Vice President and Chief Financial Officer.
For our agenda today, I will provide a brief perspective on the quarter and the continued strength in store brand market share growth. Next, Judy will go through the details of the quarter, then I will provide additional comments on our plans for new product launches, plus an overview of our expectations for the remainder of fiscal year ’12. Finally, this will be followed by an opportunity for Q&A.
First, the year 2012 represents Perrigo’s 125th year anniversary as a company, what a great achievement. I would like to thank all of our past and present employees around the world for the great work allowing us to achieve this milestone.
Now, let’s discuss the quarter. It was another great quarter. As you can see on slide five we had strong year-over-year growth this quarter on a consolidated basis. The net sales trend was driven primarily by the acquisition of Paddock Laboratories and consolidated new product sales of $55 million in fiscal year quarter two. This top line net sales performance translated into expansion of both adjusted gross profit and adjust gross margin. The adjusted operating margin has expanded even further due to continuing operating expense leverage.
Turning to slide 6, you can see the business segment breakdown. Judy will walk you through the detail, but I wanted to touch on a few items. Our consumer healthcare unit had all time record fiscal second quarter sales. The performance was driven by $26 million in new product sales led by the highly successful launch of fexofenadine, the store brand version of Allegra. In fact store brand penetration for fexofenadine is ramping into the mid 50% range at this time with Perrigo having the majority share of its store brand market. That is the fastest store brand market penetration in our history.
To put that in perspective, in 2006, our new product launch goal was to gain a 30% store brand market share penetration in the first 12 to 18 months. In this launch the store brand market share penetration is over 50% in the first six months. Consumers and retailers are even more quickly capturing the value of the store brands.
Adjusted operating income was up versus last year despite competitive pressures in gastrointestinal category and promotional new product spending. We anticipated both this GI pricing pressure and the marketing costs in our plan. As a side note, the gastrointestinal pricing has stabilized during the past four to six months.
Our nutritional segment, net sales were down slightly from last year due to difficult comparables this quarter. Remember that during the fiscal second quarter of last year, a competitor had a recall in the infant formula category which gave us a $12 million in additional sales during the quarter.
Margins in the segment were impacted by increasing commodity costs as well as production variances. I will discuss initiatives we are implementing to mitigate the impact of these challenges after Judy’s comments.
Our RX business segment had a very strong quarter, as it continues to execute ahead of our expectations. RX net sales increased 82% and adjusted operating income grew 125% as a result of the Paddock acquisition, organic net sales growth of 11% and a favorable pricing environment.
The RX team continues to execute very effectively across their entire product portfolio and the Paddock integration continues to go well. Our API segment continues to perform well driven by strong performance from the base business and highlighted by robust sales of fluticasone.
Looking at Slide 7, the overall OTC consumer market was up just 1.1% versus last year, with national brands down, but store brands gained 8% on the strength of new product launches, national brand recalls and increased market share. This is based on IRI 52 week data ending January 15, 2012. I want to highlight a couple of areas in this data.
First, the cough/cold season is down versus last year. However, the category is up 2.7% primarily due to fexofenadine launch. National brands are down slightly, but store brands have gained 11.2%. When you dig through the data you will see that store brand continues to gain share overall but in fairness the pastries gains is not as strong as it was in the past few years when only saw up to 300 basis points of annual growth on the heels of major new product launches and the severe economic downturn.
In our guidance we assume store brand share growth of approximately 100 basis points a year more in line with the longer term historical average. Going forward, the additional positive impact of the launch of our new products in the second half of this fiscal year should help to accelerate store brand growth by approximately 50 to 100 basis points. For all these reasons we feel confident raising lower end of our full year adjusted earnings from continuing operations guidance to 470 to 480, up from the previous range of 465 to 480 per diluted share. Now, let me turn over the call to Judy, who will provide more detail.
Thanks Joe. Good morning everyone. As you just heard we delivered another strong quarter with record quarterly revenue earnings and cash flow slightly ahead of our expectations. We continue to look forward to a strong second half of fiscal 2012 which I will discuss in a few minutes. But, first, I will review the fiscal second quarter results. As always, I’d like to remind you that my comments are focused exclusively on adjusted results from continuing operations. You can view reconciliations between GAAP and non-GAAP adjusted results in the table to our press release as well as the appendices to this morning’s presentation. Additionally, please note that the second quarter of fiscal year 2012 includes 14 weeks of activity.
Now, let’s walk through the financial results for each business segment. On slide 8, you can see net sales in the consumer healthcare business grew 10% year-over-year driven by new product sales of $26 million primarily fexofenadine and a diabetes care category, along with an increase in sales of existing products of $20 million. These increases were offset by a year-over-year decline of $4 million in sales of certain products within the analgesics category due to the fact that our fiscal second quarter 2011 experienced increased demand during the absence of a key competitor. Absent analgesics revenue for all of the remaining product categories within our consumer healthcare segment grew year-over-year in the second quarter. Net sales were also negatively impacted by approximately $2 million of unfavorable changes in foreign currency exchange rates.
The decline in adjusted gross margin was due primarily through expected year-over-year relative pricing pressures on a key product in the gastrointestinal category, though increased volume bolstered the impact on sales.
The adjusted operating margin decreased by a slightly larger amount than the adjusted gross margin, as we elected to continue to make the necessary marketing and promotional investment this quarter to prepare for the second half launches of numerous new OTC products.
Dollar investments year-over-year and consumer healthcare R&D continued at the same level as last year but decreased as a percent of sales. On slide 9, you can see that net sales within the nutritional segment declined 4% year-over-year. This is in large part due to the fact that in the second fiscal quarter last year a competitor had a product recall that resulted in an increase in our infant formula category net sales of approximately $12 million equal to approximately 10% of net sales in that segment for the quarter.
In the second fiscal quarter this year, we are pleased that notwithstanding of 3% decline in US birthrates year-over-year, we were able to offset most of the decline related to the absence of the prior year week recall with other growth.
Net sales in the VMS category declined due to both increased competition and our continued SKU rationalization program, combined these cause lower product volume output and pressure gross margins. Adjusted gross margin in the segment decreased 1110 basis points to 25.3% due to several converging factors. First, we are continuing to see increased cost of raw materials for infant formula such as lactose, nonfat dairy milk and whey protein as these commodities continue to see very high global demand.
Second, we experienced a weaker product mix between higher margin infant formula and the relatively lower margin toddler foods which grew year-over-year. Most importantly, third, to ensure continuous flow of infant formula to our retail customers, the decision was made to run production at both facilities causing an under absorption of fixed cost over the quarter.
We continue to monitor the situation and are taking appropriate actions as needed. While the adjusted operating margins decreased 920 basis points year-over-year, we were able to mitigate the larger adjusted gross margin impact to sound expense management.
On slide 10, you can see that RX business continues to perform even our own high expectations with net sales growing 82% over the second fiscal quarter last year. As Joe noted the Paddock Lab acquisition contributed net sales of $69 million in the quarter, and our legacy business grew 11% on new product sales of $5 million. Adjusted gross profit increased dramatically compared to last year due to the success of new product sales, market share gains, improvements in pricing and the acquisition of Paddock.
Adjusted gross margin and operating margin expanded 870 and 880 basis points respectively as a result of the previously stated rationale.
Next, net sales in the API segment grew 6% as you can see on slide 11. Sales of existing products increased due to increased US demand for fluticasone partially offset by relatively lower sales of temozolomide in Europe due to changing channel dynamics in this time last year.
The adjusted growth in operating margin expansion was due to favorable product mix, improved cost leveraging in our manufacturing operations and continued SG&A leverage within our API segment. The effective tax rate this quarter was 30.9% as the acquisition of the Paddock Lab increased the exposure of earnings mix to higher US tax rates. Had the effective tax rate remained at the midpoint of our October 27th guidance, 28%, then adjusted earnings per diluted share from continuing operations would have been even $0.05 higher this quarter.
Now, some quick highlights on our balance sheets. Excluding cash and current investments, working capital from continuing operations was $536 million at the end of the quarter, up from $448 million at this time last year due primarily to additional working capital from the Paddock acquisition and relatively higher inventory from this time last year due to seasonal factors and relative supply constraints experienced last year. Cash flow from operations for the second quarter was an all time record $166 million.
As of December 31, 2011, total current and long-term debt on the face of the balance sheet was $1.5 billion; this is up sequentially from $1.2 billion as of September 24, 2011, primarily due to the funding of the $350 million of senior private placement notes during the quarter. This increase was offset by $55 million that we paid off under our accounts receivable securitization program during the quarter. Including cash and cash equivalents, our net debt to total capital at the end of our second quarter fiscal 2012 was 37.1%.
Now, I'd like to update our earnings outlook for the full-year fiscal 2012. On slide 12 you can see our consolidated Perrigo guidance information. Based on our current expectations that our full year forecasted earnings mix will be more heavily weighted towards US earnings, we anticipate the effective full year tax rate at the high end of this disclosed range. Despite the expectation that this effective tax rate may be higher, we are raising the bottom end of the adjusted diluted EPS range to $4.70 from $4.65 tightening the range from last quarter.
As you can see, the only other change from our October guidance is that capital expenditures are now anticipated to be between $110 million to $125 million for full year fiscal 2012. As we’ve noted on other calls this year, we have several manufacturing, productivity and growth initiatives underway globally including the Michigan Consumer healthcare facilities enhancement, Israel RX expansion, the Minneapolis on-boarding, India API ramp-up, nutrition productivity initiatives as well as IT infrastructure projects.
To me our progressive product launch and productivity plans, we are advancing more quickly than originally assumed on several of these products, and as such expect to use more cash flow for investing activities this year than originally anticipated.
As always, we are maintaining our unwavering focus on execution, innovation as well as ROIC. These things, while painfully consistent, we feel are the right ones and have been for over a 125 years.
Now let me turn it back over to Joe.
Thank you, Judy. As Judy just outlined for you, we had a great quarter, but quite a few things have happened since December 2011. In January, we announced the filing of an ANDA for the generic version of Astepro nasal spray. On January 12, we announced that Perrigo won summary judgment in the Mucinex case and that we expect to launch the product in the next 90 days. We also acquired the assets of CanAm Care to broaden our offering in the store brand diabetes care market.
In fiscal 2012, we expect to launch over 45 new products representing more than $190 million in sales as you even see on slide number 14. Essentially, we plan to launch the equivalent of one new product every week in fiscal 2012. For the second half of the year we plan to launch the generic store brand versions of Prevacid, Mucinex, Delsym, Allegra D12, Claritin D, Rogaine Foam and potentially Clarinex with combined annual branded sales of approximately $1.1 billion.
One other note on our CHC business, is competitor has temporarily halted production at a facility that makes OTC products. We believe this issue represents a store brand opportunity of approximately $15 million to $25 million per quarter. There are numerous competitors in these products which are in general older products with lower overall store brand margins. Still, this provides an opportunity for Perrigo to support our customers to meet the demand for quality affordable healthcare products.
As it is early in the process, we do not yet know the extent or duration of this issue, and therefore we had added only minimum sales within our guidance to reflect new store brand commitments. We will update you more as we get further along with this opportunity. Also in the store brand market nicotine gum we received commitments from a large retailer who previously had not stocked the store brand product. We are excited about this opportunity.
In the nutritional segment as Judy mentioned earlier we have retained the capacity available for future customer demand which impacted absorption variances of this quarter. However, we have taken several steps to help mitigate the future impact of this issue.
Let me highlight three items. First, we made the decision to close an all electrolyte solution facility in Florida to increase manufacturing efficiencies based on recurring and invested capital. Second, to improve gross margins we negotiated long term agreements in Q2 with key suppliers of our most expensive raw material to reduce our cost, and also we are in the process of submitting pricing initiatives.
Third, we acquired several new additional customers in Asia for future infant formula orders.
The generic Rx business continues to grow including expected launches of the generic versions of Duac and Clobex Lotion which have combined branded sales of $210 million as you could see on slide 15. Add to this the continued growth in our ORX products and our Rx based business and we expect to have a traffic year ahead for Rx team.
Overall, we believe the strength of our total business and the significant future R&D targets justified a 27% increased investment in our QT R&D expense. In addition to our organic growth initiatives we have continued to fill our business development pipeline with opportunities that fit our strategic imperatives of adjacent categories, new product technologies and geographic expansion.
In summary, we had another great year, another great quarter looking towards the rest of the year we are poised for strong new product launches and strong execution. The market continues to rise the value of store brands and our Rx business continues to outperform our expectations.
Perrigo is the right company in the right place at the right time to meet the world’s growing need for quality affordable healthcare products.
Operator, let’s now open up the call for questions.
Thank you. [Operator Instructions] Your first question comes from the line of Louise A. Chen with Collins Stewart.
Louise A. Chen – Collins Stewart
Hi, thanks for taking my question. One question I had was about the sales progression for fiscal third quarter through different business segments. So for example given that consumer sales are going to be potentially lighter in the third quarter because of a weak season, can you talk more about how we should be modeling those different portions of business?
Sure, well, I mean I think the first comment I would offer is relative to the numbers really referring back to what we were looking at, we don’t make quarterly comments. We would refer you back to our guidance for the full year and what we have said relative to the full year guidance for our consumer healthcare business or all of our businesses for that matter. We are looking at for the consumer healthcare business the 12% to 14% improvement versus last year, Louise, relative to, that really is the best comment I can make.
The obvious other point I would add to it is what's critical to us is the new product launches, we only have these numbers of products we had mentioned earlier in the year that our year is going to be second half loaded relative to the new product launches especially in the consumer healthcare side. That’s going to obviously input or certainly had some impact on what we expect to see further in both the third quarter and the fourth quarter. Judy, do you want to add anything to that comment as well.
Sure. We talked throughout the year about how to model the quarters. We’ve said that this year was more heavily second half weighted and with CHC being the biggest driver of the business, the largest sales component of our current business portfolio on the same [indiscernible] definitely applies to CHC and with many of the launches that we are talking about being weighted towards the fourth quarter, if you start thinking about how to model out the year, remainder of the year, although we are not going to get specific quarter to quarter guidance, you can assume that the waiting is – even the second half, less heavier to the second quarter of the second half of the year.
Louise A. Chen – Collins Stewart
The second question I had was in your operating margin expansion which has been pretty impressive. Can we expect to see more of this in the coming years and if so what might be driving that?
Sure. Well, first of all thank you for the comment about the movement in operating margin. I think we have a very simple business model that basically as we look to add new products to our portfolio we can get leverage in our operating margin because we have got one of our trucks going from Perrigo today to one of our leading customers and we add an additional products, new product or an additional new adjacent category to that truck. We simply get to leverage it. We don’t require additional sales people, additional distribution clerks, etc. So it is that leverage we are seeing in the operating margin as a result of building our business and continuing to build our business with our large retail customers.
We have moved the operating margin up from the single digits percentage to 20 something percent today, and I think what I would say today is that we are going to continue to look to strive to improve that. Yes, I would not take the model up to something similar over the next five years of what we’ve done in the last five, but I certainly do think we can get to it somewhere in the mid 20s.
Louise A. Chen – Collins Stewart
We’ve got some questions on the slowing store brand growth and how that might affect your outlook for longer-term growth in your consumer health business, maybe you can provide some more color there? Thanks.
Sure. Well first of all, I would say that the way we look at this business is that store brand continues to gain sheer versus national brands. We are still really very early in this process versus what you would see in a generic pharmaceutical market where 90% of the product goes generic or as soon as the product gets approved. So, we are very early in this process. But when you look at products like a Fexofenadine that we get to a store branch here more part 50% within the first six to nine months, it is those kind of progress that gives us the belief that the future opportunity will continue to be very strong to drive store branch here from the low 30s in December to 40 plus range. That kind of movement is what we expect. We though model our business on only approximately a 100 basis point move per year from national brand to store brand – we try to be conservative on that regard and only use the 100 basis points per year relative to the movement. Obviously, though any new products help us to accelerate that number and that’s certainly what we expect with some of these new products we would launch in the second half of this year.
Louise A. Chen – Collins Stewart
Thank you, very much.
Could we limit the questions to one question per caller, because we have a lot of people on the line?
Thank you, your next question comes from the line of Linda Bolton-Weiser with Caris.
Linda Bolton-Weiser – Caris & Company
Just on the vitamin business, your comments there about SKU reduction, I kind of thought the whole point of reducing SKUs is that it improves the profitability and the mix. Why would you be doing it or this just unintentional share loss that's going on there. Can you address that?
I would say most of what we have done in the vitamin, nutritional, mineral supplement business has been to selectively look at where we can make money on these products and where we have a good return on invested capital relative to that facility. In some places that has led to us deselecting some products or getting out of some products, that’s something that we believe is important. On occasion though, the markets still will be competitive and we may find ourselves in a product that we believe is important to our retailers and important to our facility, and continue to stay with that product.
But I think on balance we are very much online with what you said Linda, continuing to look at what I would say weeding the garden keeping the products that are the best margin opportunities. Judy, do you want to add anything to that?
Yeah. Linda, just a little color. Year-to-date, the VMS business is performing better in terms of margins than we were last year. This particular quarter with volume through the factory just being a bigger differential versus last year, there was more pressure in this quarter, but as we talked about weeding the garden and becoming as efficient as possible on our plant and focusing on gross margins, we have been making progress there, and are expecting for the full year would still be ahead year-over-year in terms of our profitability.
Linda Bolton-Weiser – Caris & Company
Great. Thank you.
Your next question comes from the line of Ami Fadia with UBS.
Ami Fadia – UBS
Hi, good morning. Well, I’ve got one broad question on your guidance. If you could sort of address a couple of things around what you’ve included in your guidance and what you’ve assumed regarding the following things. First of all, have you changed your assumption around the expectation for changes we’ve done to the market, and we saw a $4 million headwind this quarter year-over-year. Where do you see that progressing by the fourth quarter in your guidance? I’ve got a couple of more but I’ll let you answer this one.
Let’s talk about our overall guidance first. What we’ve not changed in our guidance is our belief that consumer healthcare is going to grow 12% to 14% that continues to be our guidance. As it would relate to J&J, I’ll make comments on both of them, J&J is making progress and returning their products to the portfolio in the quarter two, let’s say it differently October, November, December is when they are reentering with liquids and we are seeing some reentry now. Their plan was to reenter in January, February, March with additional oral south and we are seeing some of that now. They are not fully back to be clear.
The expectation we have built into the plan is that they will be fully backed based on what we’ve heard some more in the mid year 2012, midyear calendar 2012 and that’s what we’ve built in our guidance and that’s what we’re seeing so far. I would say there may be a little bit behind on liquid so far, I mean they are in stores but they do not have the supply that at least they’ve had prior to their problems at this time. It was another – you want me to address Novartis as well, I think was part of your question.
On Novartis we are seeing a small amount at this time, we think that it was a over a $200 million national brand opportunity and $75 million to $100 million store brand opportunity on an annual basis or somewhere between $15 million and $25 million on a quarterly basis. We had put in very minimal amount at this time really reflecting couple of things, number one, we still don’t know the extend and duration of their issue, and number two, which is important, most of these are older products which there are multiple players and multiple store brand players, and therefore we’ve at this time taken a conservative approach to putting any estimate in for the Novartis portfolio.
Linda Bolton-Weiser – Caris & Company
Three other things on the guidance, what kind of a food season do you factor in within your guidance and whether you’ve included anything from CanAm acquisition in your guidance? Also if you’ve included anything from the benefit from China, the China deal on infant formula, and is the slow birthrate already factored in or is there further headwinds coming?
Okay, there is a lot of focus on guidance here. We did highlight that there would be a flu season. Our expectation is that there will be a flu season. However, we have seen year-to-date, well I should say season to date flu sales, comparable flu sales below the last year by approximately 8% and that’s what we have to factor into our guidance for the remaining part of the year, is that we are seeing a decreased flu season this year especially in categories, some categories like the fever category or the product use for fever.
The second part, is CanAm in, yes, we have CanAm in as this was an acquisition that was completed in January. We have included CanAm into the rest of the calendar year numbers albeit they are not major numbers but we did include them.
China, we have done as I mentioned several new ventures in China to supply infant formula in China, especially our organic infant formula. We’re one of the few companies to have organic infant formula approved in China. So we have done some additional work there, but it fits into what I would call a China strategy with the founder of [indiscernible] and then some of these other products categories.
Your next question comes from the line of Jami Rubin with Goldman Sachs.
Jami Rubin – Goldman Sachs
Thank you. Just a couple of questions. Joe, just generally speaking on revenue guidance this year, I am actually surprised that your revenues aren’t going up despite the CanAm acquisition, the Novartis recall and J&J’s reentry which has been delayed to some extent, I mean I think J&J has talked about six months being back on the market by 2012, now they are saying midyear 2012. So if you could just maybe talk about what are the pulls against that or the pushes against that as to why revenues wouldn’t actually go higher.
And really more importantly, if you look at your year-to-date margins in consumer healthcare as well as nutritional, to get to your guidance implied a significant step up in the second half, particularly nutritionals and just with raw materials rising, I am not sure how you hit that and as you’re launching new products from the second half, I mean is your plan to significantly pull back on that spending. Can you just talk about your confidence level in hitting those operating margin targets? Thank you.
Sure. Good questions. I think the answer to almost everything you talked about is really new products. One of the things that we would comment on certainly is as we look at our range for consumer healthcare, our expectation for year-over-year growth is between 12% to 14%. Big part of the question there become the new products and the assumptions on the new product, as you know we take a probability waiting on any new products, and we try to weigh that probability factor as to how we are going to be successful and number of players that we expect to compete with in any new products, and the timing for those new products that’s all part of what we try to factor in.
I think for us, we always feel it’s better to be somewhat conservative on those assumptions until we get the products approved. Obviously, once they are approved and are out in the market it’s a whole different situation, but I think much of what we’ve tried to do and what the inputs and outputs for the forecast guidance really deals with new products. The other part that is obvious that we have talked about already is that this cough/cold flu season is a slow season for us to build significant incremental into where we are with our consumer healthcare business.
At this time we thought it would not be prudent decision for us and would not reflect in how we approach a conservative approach especially when, yes, is J&J is behind a little bit in their shipment of products, yes, but they are improving their presence, therefore we felt it would be best to be conservative until we see what’s going to happen in the marketplace. And the same comment, I think I mentioned Novartis already so I probably won't say more about that. But really it’s just looking at, until I get a better understanding of the extend and the duration of the Novartis issue, it’s hard for me to put a lot more into that. I just think it’s better to take it a quarter at a time.
Jami Rubin – Goldman Sachs
And then on margins Joe.
Margins, sorry, same comment on margins. It’s new products, new products, new products. It’s really the new products differential is what really drives the margins in our consumer healthcare business.
Jami Rubin – Goldman Sachs
And what about nutritional?
Nutritionals it’s going to be some of the steps that I outlined on what we are going to do. Number one, we closed the facility in Florida. Number two, we’ve got significant reductions in our cost of goods for one of our expensive raw materials and of course we have to do something on pricing. And then number three is these incremental infant formula sales in China that are going to help drive our nutrition margins, is those three things that I had mentioned during the call.
Your next question comes from the line of Gregg Gilbert with Bank of America.
Gregg Gilbert – BofA/Merrill Lynch
One two-part question on Rx. Judy, could you walk us through how you are viewing the market share gains there, are there few or several and how temporary versus permanent do you see those, because it seems to me the big story of this quarter was the size of revenue and how high margins were, and I am sure folks wants to understand how sustainable that is. Secondly, Joe, are you able to pursue the Androgel 1.62 formulation under the terms of your agreement?
Gregg, on the Rx margin front, we’ve seen strong positioning in our legacy business as well as the incremental add that comes from the Paddock acquisition in the legacy business. The team has seen stability in the pricing work, the pricing improvements that they have been able to achieve over the last several quarters, and as I said they’ve been pretty stable. So, are we able to predict exactly how long that stability will exist, and how dynamic the pricing environment will be 12 months out with any certainty, no. But given the competitive landscape of those particular products and what is happening for our team right now, we are feeling good obviously for the remainder of the year in being able to confirm guidance.
Yeah, maybe the only thing I would to it, what Judy stated is I think absolutely clear, was that the other part of what our team has done very well on the Rx business is you make money in the generic prescription business when you are first to the market, which our team has done that, but they also make money when you are last in the market and the team has done that with some of the other competitors and some of these products had discontinued some products that's given us a chance to reassess where we were versus the national brand. I think it’s that ability to be first and last that is truly what has differentiated the team activities in the Rx business and helped us to get the numbers we did.
On the latter part, Gregg, I really can’t comment on exactly where we would go with any formulation of Androgel. I would simply say that if it is a topical product, it is something that Perrigo will look very seriously at, because really we like the space and target to get into these products as you know in terms of the expense and the commitment to take us upfront. But our team is absolutely looking at all topical products as really the place we want to play. So, any topical product we are going to look at.
Your next question comes from the line of David Steinberg with Deutsche Bank.
David Steinberg – Deutsche Bank
Just wanted to pick up on Gregg’s question about your generic business. It looks like an outstanding quarter, $30 million above most estimates, and I was just wondering if this is your first full quarter after the acquisition of Paddock, is the $177 million a good basis for moving forward the year, do you see sequential growth in this business in Q3 and Q4, or are there any one time exclusive oranges or onetime gains in your prescription in your Rx business.
Well, we did have some launches during the quarter to be clear, absolutely yes. What I would say to that though is that the best comment I can make relative to the go forward is the full year guidance that we initially issued. Earlier in the year, in august, we talked about Rx revenue growth at 55% to 57%, and then we adjusted that to 69% to 71% in October and we are staying with that 69% to 71% here today. So, I would say from a guidance point of view that is the kind of growth, the 69% to 71% that we are expecting and we continue to expect in terms of the total business. I will once again say that the team has executed extraordinarily well. A large part of what we – the unknown though in the Rx business is always new products. We have two new products that we expect during the year, the ones I mentioned being Duac and Clobex and that really is the commentary about, you know, could we do better, certainly, if new products come in, but we think you have to always put a weighted average conservative approach to any new product opportunity.
Thank you. Your next question comes from the line of Elliot Wilbur with Needham & Company.
Elliot Wilbur – Needham & Company
Thanks, good morning Joe. Maybe just real quickly if you could provide a little bit more color on the fexo launch and the differentiating factors, why you saw such a significant uptake in a relatively short period of time, obviously that's more than just a incremental in the right direction. That's a large step in the right direction, and perhaps this has set kind of a new standard benchmark for OTC launch uptake.
Yeah. Well, let me just back up maybe a little bit on your question. First of all let me say we did a great job in launching the Allegra brand, that brand is on pace to be over $500 million at least from our numbers, so they did a great job. We simply followed it with obviously being fast to market and having a good store brand promotional program, the team and the consumer healthcare group just continues to get better in terms of execution on store brand programs to drive the education for the consumer, the education for the pharmacist, the displays, the ability to show that this product is a store brand of Allegra. All the activities everything from the color of the graphics, all of that is being very well implemented into making sure the consumer understands that we can offer the same quality of Allegra with a more affordable option with store brand fexofenadine and for us to be at over 50% I think certainly is target that I am going to certainly held the team accountable to as we look to future launches yes. We will thought probably be a little bit more conservative in terms of what we actually guide to, but certainly that is a target that we now know is achievable and certainly one that we will speak to try to duplicate for future launches.
Thank you and next question comes from line of Randall Stanicky with Canaccord Genuity.
Randall Stanicky – Canaccord Genuity
Thanks guys. Again on your consumer business and a followup to Elliot’s question. The $26 million in new sales revenue that was largely fexofenadine. Joe, should we be thinking of that as a good run-rate or should we be thinking as we go forward that number could be 30, 35 million and then I have a followup.
Yeah, I think that it’s a good number for the quarter. Obviously that particular product is going to have some seasonal variations with allergy seasons. So there is going to be some seasonal variation. I guess I want to point to first comment. Second comment on that is it is not our expectation that we will see a significant number of new entries here, we could, but we do not expect significant number of new entries into the category. So that would argue towards more of a stable number of players in the business right now.
The third comment which is probably the most important one for Perrigo is the launch of the Allegra D12 is a significant opportunity for us that we expect launch sometime in the next several months. So that to me would be the – certainly before the end of the current fiscal year, that would be the biggest upside to Allegra as a total product category would be the launch of the D12 formulation.
Next question comes from the line of David G. Buck from Buckingham Research Group, Inc.
David G. Buck – Buckingham Research Group, Inc.
Thanks. Just a couple of quick ones. For nutritional business can you talk a little bit about what the current size of the China sales are now. I believe it’s pretty small and just want to get a sense of what you expected to stay small during the fiscal year or into fiscal 2013. Also you talked about generic Mucinex launching in the fourth quarter. Can you talk about what plans you might have for Mucinex D either alone or in partnership? And then just finally can you give enough data on where the API cost savings program stands in terms of moving manufacturing and in the end getting products from that. Thanks.
All good questions David. First, China, we have stated publically that we sell in China single millions of dollars of sales, but obviously we think the potential is significantly more than that. I would say and relative to the numbers that we are still in that single million is heading to double digits or tens of millions. But in terms of a ballpark number it’s still single million, high single million dollars of sales for China, but with a very important growth rate that we see relative to these new ventures that we have ventured in, as well as adding some new customers this year.
On the second part of the question I think was Mucinex. It is our expectation as I stated we will launch it in the next 90 days. We are looking forward to launching the single entity of the Guaifenesin where everything is on track for the validation for that. It is currently all that we are talking about launching right now is the single entity Guaifenesin product. I really have no other promise that I can offer on the Mucinex D or DM. And I'm sorry I left out the last one also.
David G. Buck – Buckingham Research Group, Inc.
And then last one point just API cost savings update and manufacturing update.
Yeah. Well, in general we are always striving across our both vertically integrated API as well as the utilizing the vertically integrated capability to get reductions in our API resource from outside of Perrigo. We use our vertically integrated API is what I would call a credible threat to continue negotiate down our cost of API team has been very good in doing that and they are continuing make progress from that. India, we have made good progress in the building out of the facility.
We have our first DMF product at this time. We tried to get it approved of course, but that’s good progress in terms of our ability to get a DMF put together and certainly look forward to that very soon. I don’t want you though to built that into the model suggesting that’s going to be a major change right away. That’s going to take you know couple of years as we bring out really more APIs for the new product launches that we expect for Perrigo Consumer Healthcare products.
So it’s really a more of a two or three year horizon relative to impacting the cost of our API, the input cost of our API. What we are doing though in the meantime is using the ability of this team to help us understand where our API cost should be to go out into negotiate down our current from – with our current suppliers of raw materials.
Your next question comes from the line of Jon Andersen with William Blair.
Jon Andersen – William Blair
I just had a question on the competitive pressure that you cited in gastrointestinal and whether that is stabilized somewhat from the first fiscal quarter and whether you have seen any movements compared to the pressures to other product lines in CHC? Thanks.
Yeah. So as we stated that we acknowledge in our first quarter that we did have some competitive pricing issues in our GI category and that is something that we did experience. We expected it because of really the issue on the expectations there is something that we knew we had a significant cheer and that we are going to, there will be some pricing pressure there and we expected it and we did see that. But over the last four to six months that has been very stable. There has been no new competitive questions issued there and that is what we are seeing right now. And it has not extended to other – I think the question was did it extend to other product categories. Really it was isolated to a specific product in the GI category.
Your next question comes from the line of Chris Schott with JP Morgan.
Chris Schott – JP Morgan
Thanks very much. Just had two quick questions on the consumer business. First, the release today talks about a $20 million increase in sales from existing products. Is that a reasonable proxy for growth we shouldn’t expect in the next few quarters before we consider obviously these new launches that you’ve discussed?
The second was on your consumer growth targets. I think it grew to about 7% year-to-date. Is that growth in line with your plans as we think about the overall targets for this year or has the year become a bit more backend loaded than originally anticipated between [indiscernible] and the Novartis opportunity diabetes etc. Thank you.
The question on the existing products, one of the hardest things to do at Perrigo is talk about existing products versus new products. Because one of the challenges we always face is we may have a grape flavor cetirizine, but then we are going to add the cherry flavor as a new product. Now, so that technically is a new product, that’s new flavor, but does it cannibalize some of the grape flavor enters absolutely yes. So it’s a very hard distinction between new products and existing products. Having said that I continue to say that we expect that 12% to 14% growth rate in the consumer healthcare, yes, you know I agree with that sentiment somewhere on that 7% range year-to-date.
The difference though that I would say is critically important to us and we said it from the very beginning is new products, new products, new products and it is the launch of those new products which are unfortunately all grouped into the February, March, April, May, June timeframe that is influencing our numbers to-date. But once we get these product launch I believe it will do two things. It would obviously drive the revenue growth and also drive the operating and gross margin operating margin, and importantly it also will drive what you see externally in the IRI data as we get opportunities to launch new products and categories we did not have then before.
So I think it’s really all three things that it does and that’s really going to drive the future performance and success of our business.
Your next question comes from the line of Frank Pinkerton with SunTrust Robinson Humphrey, Inc.
Frank Pinkerton – SunTrust Robinson Humphrey, Inc.
Joe, could you make some comments around the diabetes acquisitions and businesses. When I think of those ultimately can they be as large and aggregate from a product stand point as may be your cough/cold or your gastroenterology businesses that are about 13% to 15% of sales, did they have that growth potential and if so do you have everything you need or there are more acquisitions or more need to fill out our diabetes product portfolio? Thanks.
Frank, thank you, it’s a great question because it really speaks to the future and what we are really excited about for diabetes. Some people would view what we bought a business say, $40 million of revenue so that’s good, but what's really much more important to me is we created a platform. The platform we created for diabetes which unfortunately I think we all know is growing by double digit numbers in terms of the number of patients with diabetes continues to just grow significantly and so the product they consume are also the demands they have for products are growing very quickly.
We look at this as a platform. So, for example, now we have the broadest offering for any company in diabetes. We have obviously the blood glucose monitors, the meters, and strips, but we also now have the glucose tablets, glucose gel. We have the blancets [ph], we have the syringes, the needles, the pen needles. We have a broad category. To this though I believe this is a future platform for us as a company. So I believe as an example we can now add to that as simply an example a sugar free nicotine lozenge that patients don’t have today. And that’s something that we could be unique and get out there and really bring it in as something is a value add to our customers. Another very easy example to understand is the sugar free cough syrup. So putting it all into what I would call a display at point of purchase for our retailers and the entire category of diabetes.
That to me is a really exciting platform opportunity that this begins to shape for the future. Yes, it’s a $40 million acquisition, but more importantly gives us an entire platform for the diabetic patient which could unfortunately continues to grow very quickly and is utilizing it a lot of pharmaceuticals and we want to make sure that we get the best quality affordable healthcare offering available. So it is a platform that I think is really exciting for the future.
You have a follow-up question from the line of Gregg Gilbert from Bank of America.
Gregg Gilbert – BofA/Merrill Lynch
Thanks. Judy, you mentioned the 14 week issue. How should be think about that? Is that 7% or 8% more sales than it would normally occur?
So the 14th week issue occurs because of the fact that we are in an SAP calendar and so every six to seven years this is only the second time in our history that this has happened because we have only been on SAP since 1999, but every six, seven years this will occur and it will going forward occur in the second fiscal quarter. And it occurs if you will the week between Christmas and New Year’s. So if you are trying to come up with a model of what’s the impact, suffice it to say you can take a simple average of the quarter 14, divide the quarter by 14 weeks to come up with an assumption of approximate sales, but knowing that it is if you will a holiday week.
Gregg Gilbert – BofA/Merrill Lynch
Okay and then Joe on the adult nutrition, how do you expand your business there? Is that a combination of organic and acquisition? Thanks.
Yeah, I think Greg the easy answer to the question is yes. We talked about. One of the things that PBM, we acquired PBM couple of years ago now gave is the capability to reduce some of the formulations for the adult nutrition and that capability is something that we have today. However, there may be some opportunities there on the acquisition side as well. So we got capabilities for the formulation side of adult nutrition. We believe that they are very large category one that the PBM can Perrigo is very much focused on. The question is what else can we do to grow it.
There are so many different opportunities, there is Ensure, there Ensure Plus, there is Ensure Plus, there is Ensure Muscle, there is Special K, diet drinks, there is Muscle Milk. There is so many adult nutrition drinks that we are very excited about going into because it really is not a lot of good store brand opportunity or offerings today. So, a lot of opportunity and once we have got some capabilities there as a result the PBM that we will seek to bring into the category.
We have a follow-up question from the line of Jamie Ruben with Goldman Sachs.
Jamie Ruben – Goldman Sachs
Just curious to know what your expectations are for the competitive dynamic for Prevacid OTC and I guess my question really is triggered by the Dr. Reddy’s [ph] conference call it was either yesterday or the day before. And they talked about a citizen’s petition that you issued and their view that would actually hurt you although it’s actually kind of confusing to me. So if you can just please remind us all what the citizens petition is about? If you expect to be the only store brand Prevacid OTC on the market. And if Dr. Reddy’s were to launch would you expect that they would be as aggressive on price as they have been with Omeprazole? Thanks.
Sure. So first of all competitive dynamics on Prevacid, it is our expectation that we will have competitors in the market place and it will not be a Perrigo only product launch. First comment, relative to the citizen’s petition, we actually believe that what we are saying to the FDA is that if there is a product already available in a category like Prevacid OTC that people need to conduct the clinical bio-study versus the OTC product not versus the Rx product.
It is our belief that some people have attempted to get approval based on the Rx product and not the OTC product. That is the simplicity of our difference of opinion. Dr. Reddy can make whatever comment they want. We think that we are just simply stating the, run the right side of this argument that if there is an OTC product that is the reference listed product that one needs to do the bio-study versus their product, not versus the Rx product that is the simplicity of our belief.
On the question of what could happen, we competed against a number of players. I go back to cetirizine. We launched head to head with players. I go back to omeprazole, we had a head start, but then we launched against the players. In each of those cases, well into the product lifecycle, Perrigo is the market leader with a majority share. We don’t have a 100% share not do I want a 100% share, but we are the majority leader in the market place. And so I feel very good about the upcoming launch and we look forward to the opportunity to bring out quality affordable healthcare version of Lansoprazole.
There are no further questions at this time. I would like to turn the call back over to management for closing remark.
First of all, thank you very much everyone for your interest in Perrigo. I once again want to say thank you to all the current and past employees of Perrigo as we enter our 125th year anniversary. It’s an exciting time to be at Perrigo. We clearly believe we are the right company at the right place, at the right time. Thank you very much for your interest in Perrigo. Have a great day.
That concludes today’s conference call. You may now disconnect.
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