Perrigo Company plc (PRGO) Q3 2012 Earnings Report, Transcript and Summary

Good morning. My name is Demetris, and I will be your conference operator today. At this time, I would like to welcome everyone for the Perrigo Fiscal 2012 Third Quarter Earnings Results. [Operator Instructions] Thank you. I would now like to turn the call over to your host, Mr. Joe Papa, President and Chief Executive Officer. Please go ahead, sir.

Thank you. This is Art Shannon. Thank you very much. Welcome to Perrigo's Third 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 press 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 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'd 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 Third Quarter Fiscal 2012 Earnings Conference Call. Also joining me today is Judy Brown, Perrigo's Executive Vice President and Chief Financial Officer. For our agenda today, I'll provide a brief perspective on the quarter. Next, Judy will go through the details of the quarter, and then I'll provide some additional comments on our key success drivers, including 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 question-and-answer. Now let's just discuss the quarter. As you can see on Slide 4, we had a great quarter with strong year-over-year growth on an adjusted consolidated basis. The net sales strength was driven by strong execution across our generic prescription business, especially the integration of Paddock Laboratories; and new product sales of $64 million, with the majority of those sales coming from our Consumer Healthcare business in fiscal year '12 Q3. This top line net sales performance translated into expansion of both our adjusted gross margin and adjusted operating margin. In fact, adjusted operating margin expanded 250 basis points to a record 22.1% due to continuing operating leverage, even though we made a significantly higher incremental investment in research and development, which was up 19% versus last year. I want to congratulate the entire Perrigo team for executing a 13% increase in net sales year-over-year, while more than doubling that on the bottom line with an increase of 32% on an adjusted basis. Furthermore, quarter-over-quarter, adjusted operating margin for each of our 4 largest business segments all increased. In this quarter, our store brand private label businesses of Consumer Healthcare and our Nutritionals segment together combined to generate approximately 73% of this quarter's sales. So great performance. Turning to Slide 5. You can see the business segment breakdown. Judy will walk you through the detail, but I want to touch just on a few items here. First, our Consumer Healthcare unit had all-time record fiscal third quarter sales. Global Consumer Healthcare sales grew 6% in the quarter, while OTC U.S. sales rose 8% despite the historically mild cough, cold, flu season which hurt sales by approximately $25 million. The growth was driven by $34 million in new product sales led by the highly successful fexofenadine product, the store brand version of Allegra; and our launch of Minoxidil Foam, the store brand version of Rogaine Foam. Adjusted operating income was up versus last year despite competitive pressures in the gastrointestinal category and promotional new product spending in advance of our expected launches in the second half of the fiscal year. We anticipated both the GI pricing pressure and the marketing cost in our plan. As a side note, the gastrointestinal pricing has appeared to stabilize over the past 6 months. Our Nutritionals segment net sales were down slightly from last year due to difficult comparables this quarter. Remember that during the fiscal second and third quarter last year, a competitor had a recall in the infant formula category, which gave us plus $8 million in additional sales in the third quarter last year. When you remove these additional sales, year-over-year, the infant nutritional business actually grew approximately 12% despite a very weak market. Also, sales in the Vitamin, Mineral and Supplements were down over 15% in the quarter, which impacted our results. I will discuss the VMS segment further after Judy's comments. Adjusted margins in the total Nutritionals segment improved over 460 basis points versus quarter 2 fiscal year '12, as long-term supply agreements we implemented last quarter mitigated the impact of rising material cost. The Rx business had another very strong quarter. Rx net sales increased 84%, and adjusted operating income grew 130% as a result of 3 factors: number one, the successful Paddock integration; number two, the gains of market share from both Paddock and our legacy Rx business; and number three, organic net sales growth of 11% from a favorable pricing environment in our Rx business. The Rx team continues to execute very effectively in the legacy business and the Paddock integration. Looking at Slide 6, the overall OTC consumer market was relatively flat versus last year, with national brands down 2.2%. But store brands gained 6.8% on new product launches, national brand recalls and just increased market share based on IRI 52 Week Data ending April 8, 2012. This trend has also accelerated in the most recent quarter, with store brands growing 7.6% based on the latest quarterly data ending April 2012. I want to highlight a couple of areas on -- in this data. First, the cough/cold/flu season is down versus last year. However, the category, which includes allergy, is up 2.1% primarily due to a very early and very strong allergy season. National brands are down slightly, but store brands have gained 8.9%. While the allergy season is going very well, there wasn't much of an impact in our third quarter as this quarter was mostly a channel fill. We are optimistic for the rest of the season, although we are certainly sympathetic to all of you allergy sufferers. Primarily as a result of the historically mild cough, cold and flu season and the lighter sales of the VMS business, we are adjusting our consolidated revenue guidance for fiscal year 2012 back to our original August 2011 guidance of 15% to 18% growth year-over-year. We still feel confident raising our adjusted diluted earnings guidance to $4.90 to $5 per diluted share, up from the previous guidance range of $4.70 to $4.80 per diluted share, based on stronger operating margin expectations and a onetime tax benefit of approximately 20% realized this quarter. So now let me turn this call over to Judy, who will provide more detail.

Thanks, Joe. Good morning, everyone. As you just heard, we had another very solid quarter. On a consolidated basis, our team continues to perform well, with record third quarter revenue and earnings. I'll provide updated consolidated and segment earnings guidance for the remainder of the year in a few minutes, but first I'll give a brief review of our fiscal 2012 third quarter results. As always, I'd like to remind you that my comments today are focused exclusively on adjusted results from continuing operations. You can view reconciliations between GAAP and non-GAAP adjusted results in the tables to our press release, as well as the appendices to this morning's presentation. Now let's walk through the financial results for each business segment. On Slide 7, you can see net sales in the Consumer Healthcare business grew 6% year-over-year, driven by new product sales of $34 million, primarily in the cough, cold and dermatological categories; a $5 million increase in sales of existing products in the smoking cessation category; and net sales attributable to the acquisition of CanAm Care of approximately $8 million. These increases were partially offset by a decline of approximately $25 million in sales of existing products, primarily due to the historically mild cough, cold and flu season that Joe just mentioned. As we've discussed throughout the quarter, the incidence of cough, cold and flu was down 9% year-over-year, according to IMS FAN data, which helps to explain the absence of typical reorders of product by our customers in this quarter. The decline in adjusted gross margin was due to several factors. First, as expected, we observed year-over-year relative pricing pressures on a key product in the gastrointestinal category, although increased volume buffered the impact on the top line sales. Secondly, the dynamics of the relatively slower cough, cold and flu season played out in several ways within the CHC adjusted gross margin. Although efficiencies in production processes are improved from this time last year, production volumes in Michigan were down double-digit percentages across the board year-over-year. As a result, we experienced under-absorption of fixed production costs relative to this lower volume output. In addition, as cough, cold and flu product sell-through was lower this quarter, inventory balances have grown and, therefore, the inventory carrying costs have risen, negatively impacting adjusted gross margin. However, we are pleased to report that service levels are much higher than at this point last year. The adjusted operating margin decreased by a lesser amount than the adjusted gross margin as we were able to control operating expenditures well in the quarter, without sacrificing product investment. DSG&A expense increased on a dollar basis, with both the inclusion of CanAm Care expenses, as well as with the continuation of necessary marketing and promotional investments this quarter to prepare for the fiscal fourth quarter launches of numerous new OTC products. Even with these investments, as a percent of net sales, adjusted DSG&A expense declined 20 basis points year-over-year. On Slide 8, you can see that net sales within the Nutritionals segment declined 5% year-over-year, due primarily to 2 factors. One, the absence of $8 million of additional sales in the third quarter of last year as a result of a competitor's product recall that Joe mentioned earlier. Removing this effect, we are pleased that, notwithstanding a continued 2% decline in U.S. birth rates, the infant nutrition categories grew by approximately 12% year-over-year. Two, net sales in the VMS category declined year-over-year, due both to unattractive pricing and our continued SKU rationalization program. These factors together caused lower VMS production volume output and pressured the category's adjusted gross margin. Adjusted gross margin in this segment decreased 390 basis points to 29.2%, due to many of the same factors that affected this segment last quarter: increased cost of raw materials for infant formula such as lactose, nonfat dairy milk and whey protein; weaker product mix between higher-margin infant formula and relatively lower-margin toddler foods; and an under-absorption of fixed cost during the quarter as we continued to run production of infant formula at both our Vermont and Ohio facilities. Despite these year-over-year challenges, though, I'm pleased to note that the steps outlined last quarter to increase both gross and operating margins have made a substantial impact this quarter, as the adjusted gross margin increased 390 basis points and the adjusted operating margin increased 460 basis points sequentially from the second fiscal quarter. These steps included negotiating long-term agreements with key suppliers of our most expensive raw materials to reduce our cost, and continuing to implement pricing initiatives. On Slide 9, you can see that our Rx business continues along the strong growth trajectory we have seen over the last several quarters. Net sales growth was driven by the Paddock Labs acquisition, favorable new pricing and new product sales. Our newly combined Rx team has made great strides gaining market share and net sales, bringing our broader, combined portfolio of products to our customers, a real example of how an acquisition can deliver on the promise of 1 plus 1 equals 3. Adjusted gross margin for the quarter was strong compared to last year due to the favorable pricing on new and selected products and production cost leverage in the business. I'm pleased to note that our organic Rx business' adjusted gross margin expanded by approximately the same amount as the combined segment. DSG&A leverage was once again evident this quarter as the adjusted operating margin increased 200 basis points over the adjusted gross margin and 990 basis points year-over-year. Next, looking at the API segment on Slide 10. The net sales decline was due to expected unevenness of revenues in the overall business and was not attributable to any one particular product. Adjusted gross and operating margins increased 480 basis points and 210 basis points year-over-year, respectively, due to favorable product mix and improved cost leveraging in our manufacturing operations. This quarter, the effective tax rate was favorably impacted by the conclusions of several tax audits and various statute expirations. As a result, the adjusted effective tax rate this quarter was 17.2%. These tax audit conclusions translated into a $0.20 diluted earnings per share tax benefit or an approximately 12 percentage point improvement to the adjusted effective tax rate for the fiscal third quarter. Now some quick highlights on our balance sheet. Excluding cash and cash equivalents, working capital from continuing operations was $607 million at the end of the quarter, up from $471 million at this time last year, due primarily to the additional working capital from the Paddock and CanAm Care acquisitions and higher inventory as a result of the mild cough, cold and flu season this year compared to the supply constraints in those categories experienced last year. Cash flow from operations for the third quarter was $91 million. As of March 31, 2012, total current and long-term debt on the face of the balance sheet was $1.49 billion, essentially flat sequentially from last quarter. Excluding cash and cash equivalents, our net debt to total capital at the end of our third quarter fiscal 2012 was 34.7%. Now I'd like to discuss our updated earnings outlook for fiscal 2012. Looking at Slide 11, you will see that we are making 3 changes to our detailed consolidated guidance. As Joe already highlighted, we are now estimating consolidated year-over-year revenue growth in a range of 15% to 18%, but are raising our adjusted diluted EPS guidance range by $0.20. Let me explain. As I noted a few moments ago, in the fiscal third quarter, we realized a $0.20 EPS benefit related to the closing of various tax audits. With this benefit, we are adjusting our expectations for the worldwide effective tax rate to be between 25% and 27%. However, although we have adjusted our top line net sales expectations slightly down, we still feel confident in raising the adjusted bottom line guidance by this full $0.20 to be between $4.90 and $5 per diluted share due to the team's ability to translate new product launches and operational efficiencies into operating income dollars. Looking to our segments on Slide 12. We continue to anticipate strong demand for our product in Consumer Healthcare segment. However, we're making slight adjustments to revenue and adjusted margins. These adjustments are due to a few factors. First, this quarter, we experienced a historically mild cough, cold and flu season, which impacted sales. Second, our international Consumer Healthcare sales and contract manufacturing operations have not performed in line with our internal expectations. Third, we have not seen any indication that the sponsor holder of Desloratadine will be launching an OTC version of the product. And thus, we now do not expect to launch a store brand version of Clarinex. And fourth, we are adjusting our probability weights on new products, including Fexofenadine D12 and Dextromethorphan. And as a reminder, both of these are partnered products and not 100% Perrigo-controlled. Incorporating these factors into our risk-adjusted model, we now expect Consumer Healthcare's year-over-year revenue growth to be in a range of 9% to 11%, with adjusted gross margin in a range of 31% to 32% and adjusted operating margin in a range of 17% to 19%. In our Nutritionals segment, we've made great strides this quarter-over-quarter and are pleased with our growing market share in the U.S. despite the declining infant formula market. However, given the continued competitive environment within our VMS category, we now estimate Nutritionals revenue to be flat to down 2% year-over-year, with adjusted gross margins of between 28% and 30% and adjusted operating margin of between 13% and 15%. In Rx, we are now expecting top line growth of 81% to 83% compared to fiscal 2011, driven by new products and operational excellence. We now expect Rx adjusted gross margin to be in a range of 57% to 59% and adjusted operating margin to be in a range of 46% to 48%. In our API segment, we now expect year-over-year top line sales to grow 5% to 7% compared to fiscal 2011 due to the overall expectations of exact timing on orders of key products. However, given our focus on productivity improvement and expense management, we now expect API adjusted gross margin to be in a range of 48% to 50% and adjusted operating margin to be in a range of 28% to 30%. Execution will continue as the focal point for the organization throughout the rest of the fiscal year. At the same time, there were external factors that affected our performance for the quarter, which we were able to mitigate with strong operational performance. The next months will be busy as we march towards our many new product launches which will further solidify our foundation for continued growth into the future. Now let me turn it back to Joe.

Thank you, Judy. As Judy just outlined for you, we had a great quarter. In fiscal 2012, we are on track to launch over 45 new products totaling more than $190 million in sales, as you can see on Slide 13. We launched the store brand versions of Claritin-D and Rogaine Foam. We launched the generic version of Mucinex 600 milligrams in bottles to a number of customers, and we are now preparing for a full OTC distribution, including the potential to launch NBE blister packaging prior to the next cough, cold, flu season. We still expect to launch the generic versions of Prevacid, with a date certain market formation of May 19, plus Allegra D12 by fiscal year end as well. Year-to-date, we have launched approximately $160 million in new product sales already this year. We are well positioned for a strong new product year in fiscal 2013, with great momentum as we enter into the new year. One other note on our CHC business. A competitor has temporarily halted the 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. We have realized some sales from this opportunity, but we believe there are additional opportunities in the future. We are focusing on a few of the products and are ramping up production to meet that demand. Since this wasn't a product recall, we will look to replace future shipments by the competitor. We believe there will be more of an impact in fiscal 2013, and we will provide an update in the future. Another branded competitor continues to have difficulties re-entering the analgesic and cough, cold and flu market. We continue to focus on the children's liquids product line, where we have added capacity target $75 million in annual sales. The historically mild season in cough, cold, flu has dampened sales for these products, but we believe that we are well positioned to capture this opportunity in the upcoming fall season. In the Nutritionals segment, we are pleased to announce that we signed 2 new large customers for our vitamins business. These new sales will begin shipments in our fiscal 2013 time frame, which gives me optimism for growth in this category. The generic Rx business continues to grow. We are still awaiting final approval from the FDA for our launch of the generic version of Duac. But add this to the continued growth in our Rx products and our Rx-based business, and we expect to have a terrific year for our Rx team. In summary, we had another strong quarter on a consolidated basis. As our fiscal year winds down, we are poised for a strong new product launches and strong execution. The market continues to realize 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 health care. Operator, let's now open up the call for any questions.

[Operator Instructions] Your first question comes from the line of Frank Pinkerton with SunTrust.

This one may be a little long but, Joe, can you speak to the $34 million in new products in the quarter? Was there more to that than just Claritin and Rogaine? And given that was a little bit ahead of what I was thinking those kind of products could do, what does that mean about your efficiency of launching and realization of profits from some of these products as we get to some of the larger things like Mucinex, Allegra and Prevacid?

Okay. So first of all, Frank, the launches in the quarter were -- yes, was more than Claritin, more than Rogaine Foam. Obviously, the fexofenadine still is a new product launch for us, so that was in there as well, which was obviously a very strong product. But on balance, I think what we -- we are, I think -- I'm pleasantly surprised about is the success we're having with these new products. As I said, to date, we're at $160 million, 45 products. Our plan was $190 million of new product sales for the full year. We are well on track to surpass that $190 million, just based on the $64 million we did in the quarter. So we're delighted. We had always stated that we saw our new products second half-weighted, and we continue to say we think they are second half-weighted, which, if we step back from, we think gives us tremendous momentum as we go into our fiscal year 2013. But clearly, the Minoxidil Foam, the Claritin-D, the fexo were all important products for us.

Okay, great. And then just as a follow-up, you made a comment about utilization of manufacturing assets on the consumer health side. And maybe this is a broader question, but can you just explain how a light or a mild cough, cold season doesn't translate over into maybe some pre-manufacturing or other things for the Novartis and Johnson & Johnson recalls? I know not all lines are converted 1:1, but was there an ability to maybe pre-manufacture for some of these opportunities in the future? And how certain are we in capturing some of these opportunities?

Yes. I'll start, Frank, and then Judy may want to add some follow-up. But as I think about it, is there opportunity for us to move some of the manufacturing capacity we have from the weak cough, cold, flu season to pick up some of the opportunities for any of our competitors that run into problems, certainly on the branded side? The answer is yes. And we are doing that and certainly on a product like Excedrin Migraine, we've seen incremental demand for that product, and we continue to ramp up for that demand. The only thing that I was trying to say with the difference on the recall -- I'm sorry, the Novartis situation, we think that, that's a $15 million to $25 million opportunity. But they did not have a recall and, therefore, it wasn't withdrawn from the shelves. It was simply no further product going to the retailer. Therefore, we're really replacing as those future shipments materialize, if you understand my point. It's different than a recall issue. So we're seeing that really materialize now in our fourth quarter of our fiscal year. That's the primary difference from the previous situation where there are actually -- one of the branded competitors had actual recalls in the marketplace, which means that there's an empty shelf that you have to fill immediately. On the other part of -- probably best, Judy, talk more about the entire absorption of what we're trying to accomplish with our business.

So it's all -- it's based on relativity. And as I said, year-over-year, volumes in the plant are just down dramatically. You remember where we were at this point last year, with tremendous pull as a competitor was pulling things off the shelves, and we were meeting normal demand and compensating for that lack -- additional space on the shelves. So the production process was extremely, extremely high last year. And this year, while the procedures within the plant are actually more efficient than they were last year on a per-unit basis, the lack of volume or the relatively lower volume year-over-year just causes a drag on overall fixed cost absorption. So it's not anything that isn't completely reversible when volumes are at a normal pace. But again, it's back to the relative volume dynamics in the plant year-over-year.

And the $25 million cough, cold, flus that we just didn't ship this year versus what we would've shipped in a normal season. In fact, if we look at the U.S. business -- if I maybe add just one other point, I mentioned the U.S. OTC business was up 8%. If we had to ship that incremental $25 million of cough, cold, flu sales, the U.S. OTC business would've been up somewhere in the 15% range. So it gives you some sense of how we try to manage through a challenging cough, cold, flu season.

Your next question comes from the line of Greg Gilbert with Bank of America.

I'll ask one 3-part question upfront. First, on Rx, what drove the $20 million or so sequential decline from the December quarter? Was there a buy-in in retrospect? Second, Judy, can you talk to the tax rate longer term in light of the comments you made today about the rest of this fiscal year? And third, for Joe, is there a risk that Nexium may not go OTC? Or if it does, that there would be 3 years of exclusivity on that one?

Yes. I'm going to -- I'll start with the Rx business. I think the Rx business obviously continues to be very strong, Greg, in terms of total. We looked at the growth rate, still very strong. In fact, as we look at it now, we're actually increasing our growth rate to 81% to 83% for the full year. So that was one part of it. Do we have in a quarter some products that just, for example, imiquimod having some additional competition? Yes. I mean, that clearly is part of it. But on balance, we're still seeing very strong growth in our Rx segment. So we feel very positive about that. I'm going to take the Nexium question, and I'll give it back to you, Judy, for the middle question. Do I think that Nexium will go OTC? I believe the answer is yes. Do I -- can I be 100% confident? No. As you know, we do not control that decision. That decision in the U.S. is controlled by the innovator company. But I look at the success they've had with the Prilosec product and look at that and suggest that, that gives them a great opportunity, for AstraZeneca to do something with the Nexium brand. Also, number two, I look at how much direct-to-consumer promotion they put behind the brand. They are clearly establishing Nexium as a very important brand for consumers. So, I think, for those 2 reasons, I do expect to see Nexium go over-the-counter. On the question of the exclusivity, I do believe they will get exclusivity. I do believe they will get a 3-year exclusivity because their current indications are for ulcers and -- I'm not sure what the other one -- I think it's Zollinger-Ellison or something like that. But I do believe they'll get a 3-year exclusivity for the frequent treatment of heartburn. But obviously, that will be up to the FDA. Judy, do you want to take that middle question?

Sure. Effective tax rate. Great question given the volatility we've seen in the tax rate over the course of this particular fiscal year. I'm proud to say that as of right now, we are audited by the major taxing authorities in our major jurisdictions through fiscal year '08, have a few tax audits underway. But the main driver of course in this quarter was the fact that we resolved a few tax audits and had a few additional statutes expire. So we actually go through a process of evaluating the effective tax rate for our current year and, as we look forward, by looking mainly at jurisdictional mix, as well as the process that we have to go through under U.S. GAAP, to put together tax reserves in expectation of eventual tax audit resolution. So that process is reviewed in great detail by our team, by our auditors, of what is an appropriate tax reserve to put in place by jurisdiction and for specific line items? As you saw this year, we've had 2 quarters where there have been positive adjustments, in the first fiscal quarter, as well as in this fiscal quarter, and we're very pleased to be able to announce those results. And at the same time, the key question is, so what's the core rate going forward? As I noted in my prepared remarks, if you take away that onetime adjustment or that tax benefit this quarter, you're back to a core rate of approximately 29%. So to think about next fiscal year and maybe a little bit beyond that, if you assume that the business stays essentially as -- mix stays essentially as it is today, you're exactly back to where we were in our original, beginning-of-the-year, pretax audit tax rate guidance which, if you remember, was 29% to 31%. And that's exactly where I would be modeling next year. In fact, that's where we're going to be modeling next year as a starting point as we think about FY '13. So core rate, 29% to 31%. And this year, we had the benefit of releasing those tax reserves in accordance with U.S. GAAP at the completion of these tax audits.

Your next question comes from the line of Louise Chen with Auriga.

First question I had was, what gives you confidence that the weakness that we've seen in CHC relative to expectations this year is due more to the timing of your launches and not deteriorating fundamentals or slowing growth in the OTC category? And then the second question I had was on the margins. It looks like you continued to expand your margins quite a bit. And can you talk about where that could go to over the longer term? And then the last question is just the breakout in sales between -- in CHC between cough, cold and allergy, as allergy becomes a larger part of your overall business.

Okay. So a lot of good questions there. Let me try to take them all in sequence. First of all, our confidence in the business from the Consumer Healthcare, I think, is driven by 2 factors, the first one being that if you -- there was clearly a weak cough, cold, flu season. We've absolutely recognized that, and it's been a historically weak or mild cough, cold, flu season. So that wasn't really a surprise. That amount of dollars that we had determined is somewhere around $25 million of sales that we would have realized, were it to be a normal cough, cold, flu season. In the U.S. numbers, we believe that the U.S. numbers grew 8%. However, when I added back that -- a normal cough, cold, flu season, the U.S. would be running at somewhere around a 15% growth rate. I think that's an important driver for how things are going relative to the business. The other point I would focus your attention on, to this question in terms of confidence, is that if you look at our Page 6 in the handout, you can see from the all category update 2 things. Number one, if you look at the total OTC market where we are playing, although the market is flat, up 0.6%, you see the store brand continuing to gain market share, up at 6.8%. So a majority of the growth in the category is being driven by store brand, and we continue to gain share in the overall OTC market. And we expect that to continue based on everything we're seeing with our patients. So that part is clearly one other important reason for our confidence. The final point I would mention that gives reason for being confident is that, as I mentioned in my comments, we also look not only at the growth in the 52 Week Data, but we also looked at the latest quarterly data. And the latest quarterly data was up even more than the 6%. So those reasons is why we felt the opportunity was bigger than just -- actually, store brands were up 6.8%. If you look at the quarterly data, it was up 7.6%. So it's an accelerating quarterly number there. On the questions of margin, as we look at margins, we've been very pleased with the results we've seen. As you -- we talked about a 22% operating margin. The team has just done an absolute fabulous job, 22.1%, in growing our operating margin, up 250 basis points versus last year, up 70 basis points just versus the last quarter, quarter 2. So it's been a great operating margin story in terms of leverage, and we're continuing to look to that. Obviously, as we look at any quarter though, we don't want to -- we're also thinking about next year, so we want to make sure we're balancing all of our levers and -- as we push and pull levers. So we felt that we had a great quarter at $1.41, and that's really the way we looked at it. The final question you had was...

On the CHC sales, the breakout between cough and cold versus...

Oh, allergies. Yes. Yes, we don't give out that specific breakdown, Louise. Obviously, though, in the allergy season, we feel very good about what we have relative to the launch of the fexofenadine, the Loratadine, the Claritin-D or Loratadine-D 12. So all of those being -- obviously and the Cetirizine. So all of those are clearly driving our total gestalt of what we've got in our business in terms of allergy. But we really just don't break out the individual allergy versus cough, cold, flu.

Your next question comes from the line of Jami Rubin with Goldman Sachs.

Just a few, Joe and Judy. First question is, Joe, you were very helpful in quantifying the $25 million hit from the weak cold and flu season. Can you also quantify the upside from J&J not being on the market? Novartis, you did address, but they certainly weren't shipping in the -- what we thought was a strong and early allergy season. Secondly, if you can provide some color around where -- what we can expect for Delsym? My understanding is that you got tentative approval in April 2011, followed by summary judgment in December, and we just -- we're surprised that we haven't yet seen final approval, and what you think the holdup is. And then finally, Joe, what is the next milestone in the FDA's considering a new Rx-OTC paradigm? And where are we with PDUFA legislation?

Okay. You have great questions, Jami. Let me try to make sure I get them all. Certainly, in the quantification of the weak cough, cold, flu season, somewhere around $25 million is our best number, as you stated. J&J, as we said last year, we were at the run rate of about $50 million of the analgesic liquids. At this point, we built up our capacity to go to the $75 million or an additional 50% improvement in our capacity. I will say though, that we did not get anywhere close to that $75 million because of the weak cough, cold, flu season. So it is -- in fact, I would guess the total cough, cold -- I don't have the exact number in front of me, but it's probably stable to down versus last year in terms of our analgesic liquids total for the J&J side. So it's really once again a big impact of what's going on with the weak cough, cold, flu season. Novartis, I think I mentioned sufficiently. It's $15 million to $25 million, but we have just not seen it yet, really because it's not a recall. It is just a -- they stopped shipping, and what we're doing is gearing up our manufacturing to get ready for that. Final -- the final part of your question was Delsym, at least on this section. All of the data you stated was correct. There was a tentative approval. The part -- this is a partnered product in that I do not control this. This is my partner controlling it. While I don't want to speculate exactly on the issue, I will say that we believe the issue -- the situation now is really dealing with one of the DMF suppliers of the raw material inspection that was required, and we expect to get that approval any day. But that is one of the things that -- we just don't control that one directly as this is a...

So it's not a manufacturing -- it's not a manufacturing challenge or a batch challenge?

No. I don't believe it's a manufacturing. I think it's a DMF inspection from the FDA that was just -- is lagging. It's an overseas inspection that needs to happen. And that really is what the issue is for that one. The last comment was FDA and the Rx-to-OTC paradigm switch. That's a tough call. We have had meetings with Fred Upton, who's the chair of the committee that oversees the PDUFA legislation. I don't know exactly what's going to happen with that. I would say though, that as we look at this, I do think it's going to take a couple of years for the FDA to sort this out in terms of what's happening. But I think the good news is that the FDA recognizes that there's opportunities here to make more products available over-the-counter. The good news is that some of these categories like migraine products, like statins are very large, sizable products -- allergy products. And if some of those products move from prescription to OTC, we obviously think that would be good for consumers. They'd make greater availability of product available, or greater accessibility of products. So I think that would be good. And obviously, I think the other part that's driving the commissioner of the FDA is the desire to lower health care cost. And I think that's the other part of the paradigm. So I can't say exactly what's going to happen. I think it's at least a couple of years off. But if it does happen, obviously, we think that's great news for consumers in terms of availability and access. But obviously, good news for Perrigo.

Joe, can I just ask a quick follow-up? And I'm sorry, because I know there are a lot of other people on the phone. But you had said with J&J and Novartis, you didn't see a benefit this quarter because of the still weak allergy season. But you had really only focused on the liquid analgesics. What about the benefit from everything else, from J&J not getting their act together and getting back on the market?

Yes. Well, J&J -- first of all, J&J has some products back in the market. Where they had the problem in the recent quarter was they relaunched the liquid analgesic product, starting at the end of the -- let me think -- the end of the fourth quarter calendar 2011. They relaunched it, and then they had to recall that out of the market. That's the real area where we have focused on our upside. The rest of the product that J&J has had really did not make a significant contribution to our numbers, simply because we're not really focused on some of those lower-margin opportunities. They tend to be the older products and therefore, they haven't been material in our opportunity upside as we looked at the business. Just one quick clarification. On Novartis, we did see some incremental demand for products like Excedrin Migraine, the store brand version of that. But that hasn't been -- once again, it really wasn't -- because it wasn't a recall. We're really just filling the new orders for the retailers. It hasn't been something that we had to fill an entire pipeline. The real opportunity for Novartis, we think, will be in our fourth quarter and our fiscal 2013 as those products are just emptying off the shelf. That's where we will refill the demand at that point.

Your next question comes from the line of David Risinger with Morgan Stanley.

I have a couple of questions. First, Judy, could you please just talk a little bit more about other income this quarter and what we should expect for the fourth quarter?

Sure. On the Other Income Other Expense line, there was an item as we have completed the exit of our German facility. If you remember, we had an API facility that had been functioning there for years. And we closed it down, sold the assets approximately 1.5 years ago, and the remaining component of that was finally selling the service rights that we had at that facility. And hence, you see a onetime -- a good guy of approximately $5 million on the Other Income line as we sold those rights, which were a previous income stream on that same line but just smaller. So on a go-forward basis, if you were to remove the onetime $5 million good guy there, that would be a more reasonable run rate below the line, before earnings, before tax. Back to just basically the interest expense that you see booked.

Okay. And then changing gears to the prescription segment, Glenmark got imiquimod approved, and Medicis is obviously promoting the new ZYCLARA Pump. Could you just talk about whether that will impact your business in any noticeable way?

Yes. This is Joe. I do think that there will be some contribution or some loss of some market share for the imiquimod product on the new competitors. Some pricing but it's not -- obviously we still feel very -- that we've got very strong growth in our Rx business and why we've been able to increase our revenue guidance for the Rx from the, let's call it, the 70% range to the 80% -- over 80% range. So we still feel very strong about the growth. It's just really -- we're going to see a product have some challenges, but we're going to see, clearly, launches of new products. The other thing, though, that is probably more important than that is that on some of the older products, what we're really seeing is a favorable pricing environment in our Rx business. We've been able to look at pricing on some of the products that -- where we're first, but also where we're last with our products, and that's really been probably the more important aspect, rather than any individual product. ZYCLARA is making inroads into the imiquimod product sales. So that's why I don't want to believe [ph] that one out. They are gaining some share there.

Okay. And then just sort of bigger picture. Obviously, consumer was weaker than expected. Generics was above. Could you talk about how that's going to transition over the course of the next year? Meaning, could you provide a framework for how much you think the consumer business can accelerate and start to grow as a percentage of the business?

Sure. Well, I don't want to talk about our fiscal year '13. We'll really talk more about that -- specifics on that for our August meeting. That's when we'll talk about the upcoming year. But just in general comments, what do we think is going to happen? I think the key drivers in our Consumer Healthcare business are still the same. Number one, it's still the movement from national brands to store brands. That's the clear big driver in terms of the absolute movement in unit volume. And you're seeing that from the IRI data that we presented and, importantly, even seeing it accelerate in the quarterly data, which we've seen as well. Number two for us in the Consumer Healthcare business is really going to be all about the launch of these new products. As we said, for the total business, we've got over $190 million of product launches, 45 new products. What we clearly are seeing though, that the majority of the big products are our second half-weighted products, now that we've launched the Rogaine Foam, the Claritin-D, the Mucinex. As we get ready for Prevacid, which is a May 19 event, those will be important drivers for the growth of our next year, as well as putting in the Fexofenadine D12 [indiscernible] some products. So that is really what we expect to be the bigger driver for our business, which -- we've always talked about our Consumer Healthcare business absent -- just looking at it from an organic point of view, we've always talked about it being in the 5% to 10% high-single-digit rate. As I think about that, we put these new products in, you get some bolus from the new products. But that's got to be high-single digits to low-double digit for our -- for the Consumer Healthcare. The Rx team, they've continued to perform. And they've just done, I think, a fabulous job with the integration of the Paddock. And what I talked about, and I just want to make sure the subtlety is clear, not only did they do well with the integration effort, but they are actually gaining market share with what they've done with the Paddock product. So we got the Paddock product, but they also gained incremental customers with those products, as well as gaining share with our own business as we become more important to the retailers. I think Judy said it very well in the presentation. The Rx business clearly is under the synergy of 1 plus 1 equals 3, is really what we've seen in our Rx business. So I do expect continued strong growth in that business. I don't know we'll be able to talk about 80% growth next year, but we certainly expect strong growth, certainly organically and above the double-digits rate for the Rx business. But I probably don't want to make many more comments beyond that.

Great. That's helpful. And one final question. Could you just talk in a little bit more detail and maybe quantify the J&J liquid versus tablet benefit, since you mentioned that you're not really focused on the lower-margin tablet opportunity?

Yes, I don't know if I can say much more to it. I think the real upside that we experienced over the last several years because of the J&J issue was on the pediatric suspensions. We've stated that previously, last year, we did about $50 million, but we were constrained by our ability to supply product. We did ramp up this year to go up to about $75 million of product. We have the additional capacity to do that for suspensions, and this is very special technology. So that's why it took us the better part of a year to do it. We have that capacity. Unfortunately, the very weak or mild cough, cold, flu season has resulted in less demand than even last year. So we're there. We're ready with the capacity. We'll just have to wait and see if next year's season is sufficient to be able to come back into this with the full $75 million opportunity. The tablets for us were really almost meaningless. I mean, they didn't really drive -- we didn't go after them. They weren't that big of items for us. Remember, many of these products are Tylenol tablets that have been around for, I don't know the exact year, but 50 years. And as a result, they're not -- they're monograph products without significant margin opportunities. Therefore, for -- as you know, we focus on return on invested capital. They weren't big opportunities for us. We -- did we pick up some? Yes. But it wasn't a major opportunity for us.

Your next question comes from the line of Randall Stanicky with Canaccord Genuity.

I'll just keep it to one 2-part question. You're coming up on the anniversary of your last sizable acquisition. So can you just, Joe and Judy, maybe talk about deal appetite and then the attractiveness of vet care as a tangential opportunity?

Okay. So good question. And you're absolutely correct there. Our last deal we did -- large major deal was Paddock. It closed in July. But we did a small deal, CanAm, but that was in the $40 million range. So the last big deal was -- for M&A was Paddock. Relative to where we -- what we think about M&A? Clearly, we still believe there are opportunities to leverage our strategy and drive operating margins for our business with M&A. I would say the good news is that we don't feel we need to do M&A. We think we've got a good organic growth rate. However, if we can find M&A activities that hit our strategy, which would be continuing to grow our store brand private label business, as well as add critical mass in Rx, or going after geographic expansion -- if they can hit those strategic advances and they also passed our return on invested capital hurdle, we're going to keep looking at them. I do think there's more out there. And you happened to pick one specific category that we believe makes sense, pet care. And that's -- think of the item for dogs and cats. Companion animals is what we're thinking about there. But we're also interested in a number of other ones. We also think -- continuing to look at diabetes, looking at the growth of what's happening in diabetes. Really, it is -- obesity and diabetes is really becoming an epidemic, and that's something we are going to continue to look at, diabetes and also the effects of obesity on what it could mean for the store brand private label. We also really strongly believe in what we're looking at for adult nutrition. Think of things like Special K diet, think of Muscle Milk [indiscernible] Ensure, Ensure plus. Those kind of store brand opportunities, we think, make a lot of sense as well. We also think wound care is an important item. This really spins off of that diabetic comment as well. But those, I think, would be most of the areas. Judy, do you want to touch on that as well?

And I was just going to add to that, that the funnel of opportunities that we're looking at is fairly robust right now. The amount of flexibility we have in our balance sheet. Now fortunately, with the performance we've seen and with the strength of the balance sheet, we have a lot of depth to do a variety of activities. But patience is a virtue in this process. And as we've talked about before in our other transactions, you have to have a lot of shots on goal and a lot of patience in this process. So as you know, we focus on ROIC. So to Joe's point, a lot of things we're looking at. But if there's an expectation that there's a deal announced every x months, you might be disappointed. We go through the process and are diligent in that.

Well, Judy, are these deals in the size perhaps of PBM Holdings-type of a deal? I mean, are you seeing private opportunities of that magnitude out there?

There are opportunities of that magnitude, yes.

Yes, I would agree.

Your next question comes from the line of David Buck with Buckingham Research.

I'll try to keep it to a couple of quick questions. First, on consumer health, Joe, can you give a little bit more detail in terms of what the dollar value was in GI, and whether that was just omeprazole or whether it was other products? Just on type of magnitude there. Secondly, on consumer health, to make the 9% revenue growth, it looks like you need to do about 18% growth in the June quarter, which is obviously a big step up from 6%. So can you talk about maybe a little bit more of your confidence in getting there? And then if we look at the Rx business, unfortunately, you had a death of an executive in the past quarter. Can you talk about what the plans are for replacement and of the management team there? And then Duac, what are the gating factors in terms of the launching?

What part? Okay. You've got...

Good job.

I'll try to get every one of them, David, but if I leave any out, I'll [indiscernible]. On the first comment though, it's really Consumer Healthcare, what's happening with omeprazole. Really, it is omeprazole that was impacting the GI category for us, but there's nothing unexpected there. We had anticipated giving up some share. And indeed, we talked about that, going back now for about -- it's about 6 months ago that it happened. And then we also talked about it -- it would have -- it would contribute to gross margin, and that's happened. That is behind us. What I would say positively about GI though, is the volume continues to expand and we're growing the product, notwithstanding the pricing hit that we took going back -- like I said, it was about 6 months ago. Over the last 6 months, the GI category has been very stable. The good news, we think, is that what we're seeing is more and more patients transferring from the older therapy of antacid tablets, H2 antagonists, moving over proton pumps. And that's only going to accelerate, we believe, with the Lansoprazole or Prevacid launch on May 19. So in general, we think our GI category is very robust. We await the outcome -- or the launch of the Lansoprazole or the Prevacid product on or about May 19 is obviously the next important milestone. Your numbers are correct, David, on the CHC side in terms of growth. We are expecting significant growth. And once again, what's the drivers? The drivers are these new products we've talked about, continuing to see the good, strong growth for Rogaine Foam, Claritin-D, the Mucinex, but then also adding to that the Prevacid, the fexofenadine and potentially Delsym, although that's a little uncertain because it's outside of our control. It's not -- it's a partnered product. So it's going to be the new products that's going to drive the real -- the growth in that in terms of the second half effect. I also do think that we will pick up some international sales. We didn't talk as much about international, but international was a little bit of a lagger this quarter. We will expect to see some additional growth internationally for our business and also in what we call our contract segment of our Consumer Healthcare business. On the next question you asked, we did experience a very unfortunate passing of our dear friend, Rafi Lebel. He was not directly responsible for the Rx business though, just to correct one comment. He was responsible for our API business as well as many of our activities in Israel, which includes some of the Rx R&D that occurs in Israel. The only thing I would say about our dear friend Rafi, who's passed away, is he has built a great team and really, the team is just doing an outstanding job of stepping up in Rafi's absence or Rafi's dying during the quarter. Final comment, Duac, I can't say. This is just hung up at the FDA. It's a first product approval for the category. We expect it any day. But to be clear, it is hung up. There was an inspection of a raw material supplier that has had to occur with this product as well. And I know that has occurred. And then there's been a reinspection of that raw material supplier, so I do expect to see this product approved in the near future, David. But you know, I don't want to make a comment to say that it's going to occur this month or next month. I do expect it though -- if you ask me, the expectation, it is that we will see it in the current fiscal year. However, I have to put the caution that, that's -- it's in the FDA's hands right now. But the important part, it is a first approval for this category. So we do think we will get the expedited look and review by the FDA. But we -- we're ready when it happens.

Your next question comes from the line of Ami Fadia with UBS.

Most of my questions have been answered. I'll stick with 2 questions. Firstly, for Consumer Healthcare, do you think it's reasonable to expect the operating margins to trend towards 20%, something which you've talked about before, once we have some of these new products launched? That's one. And the second one, for the nutritions business, how should we think about growth going forward? Should we think about it as tied directly just to the birth rates? Or do you still anticipate that there could be some share gains that could sort of accelerate the growth rate?

Yes. Good questions. On the Consumer Healthcare, the operating margin, do I think in the longer term it will trend up? The answer is yes. Do I -- I think what we've looked at is it -- clearly, at this point, is not. We've talked about a forecast between a 17% to 19% for our future. I do think there's an opportunity to get to the 20% range, but it's not going to be this year. It'll be some point into the future as we launch our new products. To me, the real message on the adjusted operating margin for Consumer Healthcare is really the story about the new products, because that's really where -- when we launch those new products, we don't drive expenses from the SG&A side. It really is an opportunity to leverage the P&L. And that's, when we launch these new products, when we expect to see the higher operating margin for Consumer Healthcare. Remember though, in the first couple of quarters that we launch, there is some incremental display expense, other expenses as we get out there with the new products. But after that, that's when we'll really see the returns from the Consumer Healthcare new products. On the question of Nutritionals, it's 2 functions. Number one, it's the birth rate. That clearly is part of it. The other part of it though, in terms of growth for us beyond the birth rate, is what we do to gain store brand share here in the United States and then, number two, what we do outside of the United States. It is both those factors that we think will help us to drive our business. If we took away the onetime effect of what happened with one of our branded -- the branded recall of infant formula last year, we're seeing very good growth. I think the number was 12%, if I'm not mistaken. So we feel very good about the infant formula business. And I certainly would say, just based on what -- it appears [indiscernible] for the Pfizer infant formula business, you see it's a very valuable business, and we're delighted to have that -- our infant formula version of that business.

The next question comes from the line of Chris Schott with JPMorgan. Christopher Schott - JP Morgan Chase & Co, Research Division: Just 2 quick ones. First on the Novartis opportunity, how sustainable do you see that if in fact we see Novartis back in the market, let's say, in calendar '13 and there's not this prolonged period of national brand absence? I think you mentioned that $15 million to $20 million opportunity. Is that something you can hold over time? Or just how do you think about that? Second is on Nutritional gross margins, this 28% to 30% range. How should we kind of think about that evolving over time? I know there's a number of initiatives you have in place here. But as we think out to like maybe 2013, 2014, is that a number you think you can significantly improve from here? Or should we think about just maybe incremental improvements from this new gross margin target?

Okay. First on Novartis, I mean, I think you'd have to go with the Novartis guidance they gave relative to when they will be back in the market. We're going to take Novartis a quarter at a time, is really the way we always take it with any company that we see has run into problems from an FDA issue, because I can't give you better guidance than they give you. Right now, we heard that they will be -- it will take them longer than the midyear calendar 2012 to get back in the market. So we do expect it to be slightly longer than where they were at the first announcement of this issue. On the question though, we do think there's about a $15 million to $25 million per quarter issue out there in the marketplace for store brand, our opportunity. We're not going to get all of it, but we do think we'll get a certain share of it, especially on some of the flu products and also the products that are the Excedrin Migraine-type products. Those are the ones we'll pick up. We'll pick up some other liquid-type products, et cetera, just simply because we're in there, but they're not higher-margin opportunities for us. So do I think we can be somewhere in the $10 million to $15 million range once this market stabilized? I do think that, that's the kind of opportunity we're talking about in terms of Perrigo achieving somewhere in that $10-plus million range of opportunities on a quarterly basis. But I want to be really cautious on the duration. I don't want to overstate the duration. Really, it's one -- I can't say how long it'll be. It's up to Novartis to determine when they'll get back in. I think they've got 2 problems. One of them is a relatively quick fix. The other one's a longer fix. And it just depends on how the FDA views that item that has a longer fix in terms of duration. On the question of Nutritional gross margin, we clearly are taking steps to improve Nutritional gross margin. As you can see, we've taken some steps. The operating margin improved dramatically as a result of some of the things we've done here quarter-versus-quarter, last -- second quarter versus third quarter. So those are steps that we are going to take. Do I believe that one of the things we did was lower the cost of one of our more expensive raw materials? Did I -- did we get that done? Yes. Will we look at pricing going into the future for our products? The answer to that, we told you previously, is yes. We will get better pricing out in the marketplace. That's occurring now as we speak, not though -- it hasn't shown up in the last quarter that we're reporting. It's showing up now in our fiscal fourth quarter. So those things are going to help me to drive the operating margin. The other part, though, of operating margin will be back to the comments Judy made about capacity utilization as we drive demand for our 2 facilities, both the one in Vermont and our one in Ohio. That utilization of our facility will drive the rest of our operating margin. The final comment I would offer in nutrition is VMS. VMS is a -- it's a rocky road here relative to what's happening with our Vitamin/Mineral Supplements. We believe that when the FDA truly enforces some of the requirements for products made in the U.S. as they look at some of the overseas manufacturers, we think that could help us. But the bigger opportunity that's going to help us in the near term right now from a gross margin point of view is what we're doing with new business with new customers right here in the United States. So I think that's going to be the shorter-term improvement that we expect to see in our Nutritional gross margin.

So empirically, Chris, is there opportunity to get gross margins back up? Yes. And we're working on actions to get them to where they were in previous quarters.

And your final question comes from the line of Jon Andersen with William Blair. Jon Andersen - William Blair & Company L.L.C., Research Division: I guess I'll make it a 2-parter. Just taking omeprazole out of the equation, I know focusing on maintaining price in OTC has been important to you over the past several years. So again, taking omeprazole out, have you been able to maintain your pricing on your other product lines? And is that your expectation going forward? And then second, just an update on temozolomide in the U.S.

Sure. Good question. If you remove omeprazole from the Consumer Healthcare business, the pricing environment in our Consumer Healthcare business is essentially flat. I will say, we planned for that. We -- all of our plans were that we would face some challenges in omeprazole. And indeed, those did come to fruition and -- but take that out of the equation, our pricing is flat. The good news is that while our pricing is flat, we're continuing to drive efficiencies in our raw material supplies, and that's where we think we can continue to drive that and help us to get continued improvements in our operating margins, as well as just the important point I was talking about before, is launching these new products. I'm sorry, the second part of that was?

Temo. Jon Andersen - William Blair & Company L.L.C., Research Division: Temo U.S....

Temo. Yes, temo U.S. is very straightforward. We will launch that, August 2013. That product will be launched in August 2013. We have a partner with that, but that -- nothing will happen until -- that will be our fiscal year '14, just as a reminder to everybody. So that product launch -- I will say though, just -- you didn't ask about the x U.S., but x U.S. continues to do well. There's always going to be some ups and downs with an API supplier in terms of how you recognize the value. But there's not a lot of competition out with temozolomide, so we do think it's a good foreshadowing of opportunities here in the United States. Well, thank you, everyone, for your interest in Perrigo today. Operator, that will conclude our call. Have a great day, everyone.

Thank you. This concludes today's conference call. You may now disconnect.